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Exceptional Medicine PeaceHealth Physicians Journal n Volume 6, Number 1, Fall 2013 “A diagnosis of cancer will forever change a person’s life. Here at the PeaceHealth Kearney Breast Centers in Vancouver and Longview, our teams of dedicated professionals focus on every aspect of care for women and men with breast cancer.” — Sheila Lynam, MD 2013 REGIONAL CANCER CENTERS ANNUAL REPORT Exceptional Medicine Physicians Journal PeaceHealth Southwest Medical Center (PHSW) PeaceHealth St. John Medical Center (PHSJ) Fall 2013 Volume 6, Number 1 PUBLISHING STAFF Editorial Director Laurie Christensen, RN Contributing Editors Sheila Lynam, MD, FCAP Dane Moseson, MD Janet Mendel-Hartvig, MD, PhD Kelly Smith, MD Michael Myers, MD Submission Guidelines Exceptional Medicine is a free, editorial-reviewed publication by credentialed Medical Center staff for regional physicians. For complete details and submission guidelines, go to www.swmedicalcenter.org/exceptionalmedicine or contact the editorial staff ([email protected] or 360-514-3066). www.swmedicalcenter.org/exceptionalmedicine Mission Statement We carry on the healing mission of Jesus Christ by promoting personal and community health, relieving pain and suffering, and treating each person in a loving and caring way. © Copyright 2013 PeaceHealth Marketing Department, PO Box 1600, Vancouver, WA 98668 TABLE OF CONTENTS Fighting Breast Cancer: Diagnosis, Staging and Treatment 1 Introduction 2 Meet our Teams 5 Who will get Breast Cancer? 7 How is Breast Cancer Diagnosed? 11 What are the Types of Breast Cancer? 18 How is Breast Cancer Treated? 28 What is the Role of Research? 31 What is the PeaceHealth Experience? 32 Conclusion Fighting Breast Cancer: Diagnosis, Staging and Treatment B reast cancer is the second leading cause of cancer death in women and while every woman is at risk to develop breast cancer, there are many factors that play into that level of risk. In this report, we explore risk factors, detection, types of breast cancer, pathology, staging and treatment of breast cancer. Sheila Lynam, MD, FCAP Pathologist, PHSJ Dane Moseson, MD Surgeon, PHSJ Janet Mendel-Hartvig, MD, PhD Radiologist, PHSJ Kelly Smith, MD Medical Oncologist, PHSW Michael Myers, MD Radiation Oncologist, PHSW Kara Makin-Bond, RN PHSW Rhonda Wrolson, CTR Certified Tumor Registrar, PHSJ Marie Tesdale, RHIT, CTR PHSW Kelly DeRoiser, RN, BSN, CBPN-IC Nurse Navigator, KBC PHSJ Ruth Melvin, RT (M) Clinical Operations Supervisor, KBC, PHSJ Sherril Allen, RN Manager, KBC, PHSW Volume 6, Number 1 Correspondence: Sheila Lynam, MD [email protected] Lower Columbia Pathologists PO Box 3012 Longview, WA 98632 360-425-5620 www.peacehealth.org PeaceHealth Southwest Medical Center (PHSW) and PeaceHealth St. John Medical Center (PHSJ) are referenced as Lower Columbia Region (LCR) throughout this report. Exceptional Medicine 1 Meet our Teams C ancer Care at PeaceHealth St. John and PeaceHealth Southwest Medical Centers involves a coordinated approach, utilizing the services of cancer specialists throughout our medical centers. KEARNEY BREAST CENTER PEACEHEALTH ST. JOHN MEDICAL CENTER PeaceHealth St. John Medical Center Cancer Team The Mammography Clinic at St. John Medical Center (SJMC) was established in 1986 to provide a supportive environment where women’s unique health issues could be addressed. The first clinic was located off campus with one mammography machine and two employees. Since then we have relocated twice, most recently in 1999 to the SJMC medical office building. The Breast Center received a substantial donation from Lee and Connie Kearney and the local community to renovate and redesign the space to become the second Kearney Breast Center within PeaceHealth. The center now has the latest in technology with two 3-D Hologic systems, the Affirm breast biopsy unit and GE ultrasound equipment. Approximately 46 patients are seen each day for screening and diagnostic exams. There 2 is also an ongoing breast cancer support group that has been meeting monthly for more than 20 years. We facilitate a biweekly Breast Case Management Review, which includes all of the breast cases, benign and malignant, which have been seen in the Breast Center. Participating in each conference are breast surgeons, radiologists, nurses, medical and radiation oncologists, pathologists, mammography technologists, and tumor registrars. Our staff is a close-knit group, and we are well known within the community for the exceptional care and customer service we deliver to our patients. Our technical staff is highly skilled, with more than 175 years of experience, and most have been with the clinic since it began. We promote compassionate patient care in an environment that supports our patients and our staff. www.peacehealth.org Fall 2013 KEARNEY BREAST CENTER PEACEHEALTH SOUTHWEST MEDICAL CENTER PeaceHealth Southwest Medical Center Cancer Team The Kearney Breast Center at PeaceHealth Southwest Medical Center developed from small and humble beginnings in a one room unit located at what was the original St. Joseph hospital in Vancouver. In 1977, St. Joseph and Vancouver Memorial hospitals merged forming Southwest Washington hospital. In 1989, the name was changed to Southwest Washington Medical Center (SWMC). In 2004, the unit was named The Breast Care Center and moved into its own suite adding an ultrasound room, bone density and a stereotactic unit. A year later the breast center traded in its two analog mammography units and became fully digital. In 2009, with the help of community donors, the Kearney Breast Center at SWMC was established and built. We have brought in state-of-the-art equipment including three mammography units that are fully Tomosynthesis (3-D), two ultrasound units, a stereotactic biopsy unit, bone densitometry Volume 6, Number 1 and a Breast Specific Gama Imaging (BSGI) camera in our center, providing women with the most up-to-date advanced imaging technology. The Kearney Breast Center has become a comprehensive Center of Excellence that goes beyond breast screening and diagnosis, with an environment that promotes comfort, healing and support. The center has been designed to give women an inter-disciplinary approach with our team of surgical oncologists, medical oncologists, radiation oncologists, plastic surgeons, radiologists, technologists, pathologists, social workers, research coordinators and nurse navigators. Our staff collectively has 235 years of experience and on average, sees more than 60 women a day. We are proud of where we have been and what we have become in fulfilling our vision of providing extraordinary care for every patient, every time, every touch. Exceptional Medicine 3 “The impressive development of new medical therapies has increased the number of women eligible for breast conserving treatment, by shrinking their tumors before surgery with appropriately selected regimens.” — Dane Moseson, MD 4 www.peacehealth.org Fall 2013 Who will get Breast Cancer? E very woman has an inherent level of risk for developing breast cancer. This risk is determined in part by her own genetic composition, the age at which she began menstruating, the age at which she bore her first child, the number of children she bore, and the age at which she experienced menopause. Use of oral contraceptives and other female hormone medications, body weight, smoking history, and alcohol use are also factors. Computer programs are available to calculate this inherent risk.1 Men develop breast cancer much less frequently than women, however they are not immune. According to the current statistics from the American Cancer Society, breast cancer is the second most common type of cancer among women in the United States, following skin cancer. About 1 in 8 (12%) women in the United States will develop invasive breast cancer during their lifetime, while the lifetime risk for men is 1 in 1,000. Breast cancer is the second leading cause of cancer death in women, second only to lung cancer. According to the American Cancer Society’s statistics, 232,340 new cases of invasive breast cancer and 64,640 new cases of noninvasive breast cancer will be diagnosed in 2013, of which 39,620 women will die from breast cancer. Approximately 2,240 new cases of Volume 6, Number 1 invasive breast cancer will be diagnosed in men in the United States and 410 men will die from breast cancer this year. But the good news is that there are more than 2.8 million breast cancer survivors in the United States. Death rates from breast cancer have been declining since 1989, with larger decreases in women younger than age 50. These decreases are believed to be the result of increased awareness, earlier detection through screening, and improved treatment. Early detection is key, because small breast cancers are much less likely to have spread beyond the breast to lymph nodes or other organs when compared to large Exceptional Medicine 5 cancers. Improvements in surgical techniques, chemotherapy, hormone and targeted therapies, and radiation therapy have increased the numbers of women and men surviving breast cancer. Research to discover new and better ways to diagnose and treat breast cancer offers the promise of even better survival rates in the future. We are excited to share with you all of the ways in which the dedicated professionals at PeaceHealth Kearney Breast Centers care for our patients with breast cancer. BREAST CANCER STATISTICS FOR PEACEHEALTH LOWER COLUMBIA REGION Table 1: Age at Diagnosis 2003-2012 Female Only Analytic Cases Table 2: Breast Cancer Clinical Stage at Diagnosis, 2012 n=3,930 n=339 Age at Diagnosis Number of Cases Stage at Diagnosis Number of Cases 0-29 19 Stage 0 68 30-39 150 Stage1 153 40-49 603 Stage 2 65 50-59 1011 Stage 3 24 60-69 1031 Stage 4 10 70-79 721 Unknown 19 80-89 356 90+ 39 Based on AJCC Clinical Stage Figure 1: Age-specific Incidence of Breast Cancer Measured Between 2003-2012, PeaceHealth Lower Columbia Region n=3,930 1200 1011 1031 Number of cases 1000 800 721 603 600 356 400 150 200 39 19 0 0-29 30-39 40-49 50-59 60-69 70-79 80-89 90+ Age at diagnosis 6 www.peacehealth.org Fall 2013 How is Breast Cancer Diagnosed? M asses or abnormalities in the breast tissue may be identified through physical examination or with the aid of imaging techniques such as mammography, ultrasound, or magnetic resonance imagery (MRI). Abnormalities in the breast can be caused by benign, pre-malignant, or malignant disease processes. Most breast cancers in the United States are detected due to abnormal mammograms, however, some women present with a palpable breast mass. Approximately 15% of women diagnosed with breast cancer have a palpable breast mass that is not visualized on mammography and 30% of women present with a breast mass in between screening mammograms.2 Typically, breast cancer presents as a hard, fixed, non-tender mass with irregular borders. Women with locally advanced disease may present with axillary adenopathy or skin changes such as erythema, thickening or dimpling of the skin (known as peau d’orange), which suggests inflammatory breast cancer. Women with metastatic breast cancer often have bone, liver, and lung involvement so they frequently present with back pain, nausea, abdominal pain, shortness of breath, and/or cough. Volume 6, Number 1 IMAGING Breast cancer develops in breast tissue, which is why it occurs in all mammals, male and female, young and old. There are ways of decreasing occurrence, but, with the exception of removing all breast tissue, there is no means of prevention. In this setting, detection is of utmost importance; the sooner, the better. This is what breast imaging is all about; detecting all of the cancers at their earliest stage. At some point, all cancers can be palpated as a mass. In breast imaging, we want to find it before that point. Fortunately, through the efforts of many radiologists and much research, breast imaging and screening programs have been a great success story, which continues to unfold. Exceptional Medicine 7 Figure 2: Breast tomosynthesis can demonstrate lesions not otherwise seen in mammography, and provides computer assisted guidance for needle biopsy of those lesions. 2D Digital Mammogram Image vs 3D Digital Mammogram Slice The screening 2D mammogram shows a possible lesion in the central breast. Even when the 2D view is enlarged, the margins are difficult to assess. 3D mammography shows a spiculated mass—very likely a malignancy. Breast imaging began with mammography. In fact, when Wilhelm Roentgen developed radiology in 1895, he predicted that one of the greatest impacts of radiology would be on breast cancer. Since then, screening programs evaluating variables of imaging frequency, patient age, number of views, and radiation dose evolved under much scrutiny and criticism throughout the world. Although breakthroughs in technology have greatly improved mammograms, finding the cancers remains a challenge. As in scientific research, where you want to assume the negative of your hypothesis and prove it wrong, the radiologist must assume every mammogram has a cancer until proven otherwise. Or, less grimly, asking “Where’s Waldo?” However, the breast cancer Waldo can wear various hats and can be as subtle as crossed lines or can hide in a dense forest of breast tissue. Digital mammography provided greater contrast and resolution over film screen mammography, and the recent development of digital breast tomosynthesis, currently used at both of the PeaceHealth Kearney Breast Centers, allows radiologists to separate overlying linear densities and see “between the trees” to more confidently determine if there is reason for concern. Tomosynthesis, represented in Figure 2, is similar to computed tomography (CT), but with a much lower radiation dose, comparable to screening mammography. It allows radiologists to find more cancers at an early stage, more confidently discern benign breast tissue and therefore avoid repeat imaging with focal compression. But, there’s more. Fortunately, mammography is only one modality under the umbrella of breast imaging. Each modality is comparable to one of the five senses we use for detecting things in Figure 3: Ultrasound guided biopsy with real time imaging confirms that the biopsy needle aperture is in the abnormal tissue. 8 www.peacehealth.org Fall 2013 everyday life. Mammography is our x-ray vision, which may not work in deep dense breast tissue. Some cancers are mammographically invisible/ occult. So, just as people depend on their sense of hearing in the dark, the radiologist uses ultrasound when something is suspected but not seen (Figure 3). This is especially common when a patient feels a breast lump in the setting of dense breast tissue or a normal mammogram. Sound waves also provide additional characterization of a visible, concerning mammographic finding. Advances in ultrasound are even more unbelievable than those in mammography, allowing characterization of vascularity, tissue elasticity and vocal fremitus, all without radiation of the tissue. It also provides opportunity for the radiologist to feel the lesion, examine the axilla for enlarged lymph nodes, and address patient concerns. Another exciting modality used in both Kearney Breast Centers is Breast MRI (Figure 4). This modality is also without radiation, which we strive to minimize in breast tissue. MRI is performed on all the breast tissue, chest wall and axillary tissue, at the same time and without compression. MRI is the most sensitive and specific means available for characterizing Figure 4. Breast MRI is reserved for cases of known breast cancer, extremely dense breast tissue, and strong family history of breast cancer, and can also be used to guide needle biopsy under minimally invasive techniques. Volume 6, Number 1 Exceptional Medicine 9 non-osseous, soft tissue structures. However, it is not necessary, pragmatic, cost effective or amenable to functioning as a front line modality in screening programs, and is used for special high risk, preoperative or postoperative patients. The usefulness and clinical indications for MRI continue to expand. Each of these modalities is not only used to detect cancers, but to provide guidance for biopsy and subsequent diagnosis of the abnormality. Ultrasound guided biopsies are preferable because of low costs, low complications, increased comfort and absence of radiation. Therefore, ultrasound is often performed to determine the feasibility to perform US guided biopsy of a mammographic lesion. However, if suspicious calcifications or architectural distortion is only seen in digital mammographic tomosynthesis or MRI, they must be sampled using the modality by which they were detected. The Kearney Breast Centers have prepared for this with equipment facilitating advanced biopsy techniques using each modality. 10 In this country, imaging results are processed into a standardized classification system refined by the American College of Radiology. Patient history, risk factors, annual mammographic findings and recommendations are recorded in terms of the Breast Imaging Reporting and Data System, fondly known as BIRADS, which has become the common “language” of breast imaging. The nationwide standardization and consistency of this system provides continuity of care throughout the country and facilitates auditing and registries of data to evaluate trends, enhance research and keep us on the front line. Consequently, recommendations from the United States Preventative Services Task Force, several years ago, regarding screening mammography, could efficiently and definitively be determined to result in an estimated 71% increase in breast cancer morbidity and mortality as compared to recommendations by the American Cancer Society guidelines3. In breast imaging, we don’t want anyone to have breast cancer, but if they do, we can’t wait to find it and expedite the best possible outcome. www.peacehealth.org Fall 2013 What are the Types of Breast Cancer? E ven though the patient and the pathologist rarely meet, the pathologist is an important part of the team when it comes to the diagnosis and treatment of breast cancer. It is the pathologist who confirms the presence or absence of malignancy, determines whether or not the cancer was removed in its entirety, and provides essential information about the unique characteristics of a patient’s cancer. This information helps the medical and radiation oncologist to formulate a treatment plan that addresses each patient’s individual needs. After tissue is removed from a patient, the pathologist examines it first without the aid of magnification, and then with the aid of the microscope. The structure of the breast is relatively simple. It is composed of clusters of tiny glands, called acini, which are arranged in lobules and connected to a system of ducts, which in turn exit the breast at the nipple. The acini and ducts are surrounded by connective tissue and fat, which support and cushion the breast. The cells of the ducts and acini are sensitive to the hormonal fluctuations of the menstrual cycle and pregnancy over the course of a woman’s lifetime. This sensitivity allows for the production of milk for the nourishment of an infant, but can also impart vulnerability for the development of malignant cells in the breast. Volume 6, Number 1 Benign breast changes are very common; some reports suggest it may affect as many as nine out of ten women.4 Benign changes, which can present as mammographic changes or lumps, include fibrocystic change, fibroadenoma, and intraductal papilloma, and benign soft tissue tumors such as lipomas. Atypical (pre-malignant) breast changes are not malignant, but they do carry with them an increased risk for malignancy. This risk is roughly four times the patient’s baseline risk.5 These atypical changes include atypical ductal hyperplasia (DIN1) and atypical lobular hyperplasia (LIN1). They have some, Exceptional Medicine 11 but not all, of the features of carcinoma in-situ and can be seen at the outer edge of a cancer. The actual incidence of atypical hyperplasia is difficult to quantify; however in one recent study, atypical ductal hyperplasia (DIN1) was identified in 2-11% of core biopsies done because of abnormalities identified on breast imaging.6 Carcinoma in-situ occurs as two specific types. Ductal carcinoma in-situ (DIN2 and DIN3) is thought to begin in the ducts of the breast. Lobular carcinoma in-situ (LIN2 and LIN3) is thought to originate in the lobules of the breast. In either type, cells with malignant features fill the ducts and/or acini of the breast, but they do not extend out into the supporting connective tissue or fat. Ductal carcinoma in-situ and intraductal carcinoma are synonymous. Invasive breast carcinomas also are divided into ductal and lobular types. Malignant cells, with features resembling the cells lining the ducts or the cells of the lobules, spread out of the ducts and/or acini into the connective tissue and fat of the breast. Some terms that are used in pathology reports to describe invasive carcinoma of the breast include invasive ductal (or lobular) carcinoma, or infiltrating ductal (or lobular) carcinoma. Certain special types of invasive or infiltrating carcinoma include pure tubular carcinoma, classic invasive lobular carcinoma, mucinous carcinoma, medullary carcinoma, adenoid cystic carcinoma, and metaplastic carcinoma. These special types each carry with them certain characteristic patterns of architecture and behavior in terms of growth rate and likelihood of metastasis. Table 3: Primary Tumor Primary Tumor (T) TX Primary tumor cannot be assessed T0 No evidence of primary tumor Tis Carcinoma in situ Tis(DCIS) Ductal carcinoma in situ Tis(LCIS) Lobular carcinoma in situ Tis(Paget’s) 12 Paget’s disease of the nipple NOT associated with invasive carcinoma and/or carcinoma in situ (DCIS and/or LCIS) in the underlying breast parenchyma. Carcinomas in the breast parenchyma associated with Paget’s disease are categorized based on the size and characteristics of the parenchymal disease, although the presence of Paget’s disease should still be noted T1 Tumor < 20 mm in greatest dimension T1mi Tumor < 1 mm in greatest dimension T1a Tumor > 1 mm but < 5 mm in greatest dimension T1b Tumor > 5 mm but < 10 mm in greatest dimension T1c Tumor > 10 mm but < 20 mm in greatest dimension T2 Tumor > 20 mm but < 50 mm in greatest dimension T3 Tumor > 50 mm in greatest dimension T4 Tumor of any size with direct extension to the chest wall and/or the skin (ulceration or skin nodules). Note: Invasion of the dermis alone does not qualify as T4 T4a Extension to the chest wall, not including only pectoralis muscle adherence/invasion T4b Ulceration and/or ipsilateral satellite nodules and/or edema (including peau d’orange) of the skin, which do not meet criteria for inflammatory carcinoma T4c Both T4a and T4b T4d Inflammatory carcinoma (see “Rules for Classification”) www.peacehealth.org Fall 2013 Both in-situ and invasive/infiltrating carcinoma are graded by the pathologist to convey to the surgeon and oncologist just how aggressive the cancer is likely to be. Ductal carcinoma in-situ is graded as low, intermediate and high grade. The Van Nuys system is the most commonly used system for the grading of in-situ breast carcinoma. Invasive/infiltrating carcinomas are graded as well differentiated (grade 1), moderately differentiated (grade 2) and poorly differentiated (grade 3). The Elston-Ellis modification of the Scarff-Bloom-Richardson system (also known as the Nottingham system) is used for grading invasive/infiltrating breast carcinoma. This system uses the rate at which the tumor forms glands, the appearance of the tumor cell nuclei, and the rate of tumor cell division to assign the tumor grade. Generally speaking, well differentiated carcinomas tend to be the least aggressive and poorly differentiated carcinomas tend to be the most aggressive. The pathologist also tests the patient’s cancer for estrogen and progesterone hormone receptor status, proliferation index, and HER-2/neu status. Recently, proprietary tests have been developed which are useful and appropriate for defined groups of breast cancer patients. These tests may be indicated for patients with small, low grade, invasive tumors that have not metastasized to regional lymph nodes. The tests predict the probability of future recurrence or metastasis of the cancer outside of the breast, and can help the oncologist determine whether or not the patient is likely to benefit from chemotherapy. They are not intended for use in patients with large, high grade tumors or tumors with lymph node metastasis, as these patients are known to be at high risk for recurrence and generally do need chemotherapy. Based on all of the information obtained from the surgical specimen, the pathologist assigns a pathologic stage to the patient’s cancer, based Table 4: Regional Lymph Nodes Regional Lymph Nodes (N) Clinical NX Regional lymph nodes cannot be assessed (e.g. previously removed) N0 No regional lymph node metastasis N1 Metastasis to movable ipsilateral level I or level II axillary lymph node(s) N2 Metastasis to ipsilateral level I or level II axillary lymph nodes that are clinically fixed or matted; or in clinically detected ipsilteral internal mammary nodes in the absence of clinically evident axillary lymph node metastasis N2a Metastasis to ipsilateral level I or level II axillary lymph nodes fixed to one another (matted) or to other structures N2b Metastasis only in clinically detected ipsilateral internal mammary lymph nodes and in the absence of clinically evident axillary lymph node metastasis N3 Metastasis to ipsilateral infraclavicular (level III axillary) lymph node(s) with or without level I or level II axillary lymph node involvement: or in clinically detected ipsilateral internal mammary lymph node(s) with clinically evident level I or level II axillary lymph node metastasis; or metastasis in ipsilateral supracalvicular lymph node(s) with or without axillary or internal mammary lymph node involvement N3a Metastasis to ipsilateral infraclavicular lymph node(s) N3b Metastasis to ipsilateral internal mammary lymph node(s) and axillary lymph node(s) N3c Metastasis to ipsilateral supraclavicular lymph node(s) Volume 6, Number 1 Exceptional Medicine 13 on the American Joint Committee on Cancer TNM Staging System.7 This pathologic stage is identified as the “pTNM” stage on the pathology report. It is determined based on the presence or absence of invasive/infiltrating carcinoma, the size of the tumor as measured in the pathology specimen, presence or absence of lymph node metastasis and number of lymph nodes involved, and presence or absence of metastatic carcinoma beyond the breast and its adjacent lymph nodes. for breast cancer is an internationally accepted system used to determine the disease stage. Staging is used to guide treatment decisions regarding appropriate local and systemic therapies. In addition, staging provides us with important prognostic information. All patients with breast cancer need to be assigned a clinical and pathologic stage. The tumor node metastasis (TNM) staging system Finally, based on a combination of the clinical, imaging and pathology results, a final stage known as the Collaborative Stage, is assigned.8 This staging is used to guide treatment decisions regarding appropriate local and systemic therapies. In addition, staging provides us with important prognostic information. Table 5: Anatomic Stage/ Prognostic Groups Figure 5: Breast Cancer – Clinical Stage at Diagnosis Stage 0 Tis N0 M0 Stage IA T1* N0 M0 T0 N1mi M0 T1* N1mi M0 T0 N1** M0 T1* N1** M0 T2 N0 M0 T2 N1 M0 T3 N0 M0 T0 N2 M0 T1* N2 M0 T2 N2 M0 T3 N1 M0 T3 N2 M0 T4 N0 M0 T4 N1 M0 T4 N2 M0 Stage IIIC Any T N3 M0 Stage IV Any T Any N M1 Stage IB Stage IIA Stage IIB Stage IIIA Stage IIIB Notes: 14 3% 7% 6% Stage 0 20% Stage 1 Stage 2 19% Stage 3 45% Stage 4 Unknown Diagnosis Year 2012 PeaceHealth Lower Columbia Region *T1 includes T1mi. **T0 and T1 tumors with nodal micrometastases only are excluded from Stage IIA and are classified Stage IB. www.peacehealth.org Fall 2013 Table 6: Pathologic Pathologic (pN)†** pNX Regional lymph nodes cannot be assessed (eg, previously removed, or not removed for pathologic study) pN0 No regional lymph node metastasis identified histologically pN0(i-) No regional lymph node metastases histologically, negative immunohistochemistry (IHC) pN0(i+) Malignant cells in regional lymph node(s) no greater than 0.2 mm (detected by H&E or IHC including isolated tumor cell clusters (ITC)) pN0(mol-) No regional lymph node metastases histologically, negative molecular findings (RT-PCR) pN0(mol+) Positive molecular findings (RT-PCR), but no regional lymph node metastases detected by histology or IHC pN1 Micrometastases; or metastases in 1-3 axillary lymph nodes; and/or in internal mammary nodes with metastases detected by sentinel lymph node biopsy but not clinically detected pN1mi Micrometastases (greater than 0.2 mm and/or more than 200 cells, but none greater than 2.0 mm) pN1a Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm pN1b Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected pN1c Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected pN2 Metastases in 4-9 axillary lymph nodes; or in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases pN2a Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2.0 mm) pN2b Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases pN3 Metastases in ten or more axillary lymph nodes; or in infraclavicular (level III axillary) lymph nodes; or in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive level I, II axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected; or in ipsilateral supraclavicular lymph nodes pN3a Metastases in ten or more axillary lymph nodes (at least one tumor deposit greater than 2.0 mm); or metastases to the infraclavicular (level III axillary lymph) nodes pN3b Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected pN3c Metastases in ipsilateral supraclavicular lymph nodes Table 7: Distant Metastasis Distant Metastasis (M) M0 No clinical or radiographic evidence of distant metastasis cM0(i+) No clinical or radiographic evidence of distant metastasis, but deposits of molecularly or microscopically detected tumor cells in circulation blood, bone marrow, or other non-regional nodal tissue that are no larger than 0.2 mm in a patient without signs or symptoms of metastasis M1 Distant detectable metastasis as determined by classic clinical and radiographic means and/or histologically proved larger than 0.2 mm Volume 6, Number 1 Exceptional Medicine 15 CANCER REGISTRY: A WEALTH OF INFORMATION PeaceHealth Cancer Registrars T he data you have before you is the combined work of our dedicated cancer registrars. These individuals have specialized training in documenting exactly how cancer patients are treated, and then closely tracking outcomes. This data is surveyed by the Chicago-based Commission on Cancer every three years to evaluate accuracy. As a liaison physician of the commission, serving various roles for 30 years, Dr. Moseson has had the opportunity to observe this survey process at a national level in a variety of institutions as a member of the Approvals Committee. By comparison with national norms, our registrars in Southwest Washington are consistently excellent, routinely achieving commendations from the survey teams. As we move forward into accountable care, this capability is invaluable to our communities seeking assurance that state-of-the-art, meeting or exceeding national benchmarks, is being delivered. 16 This year’s report focuses on breast cancer, extracting information from over 40,000 patients tracked by this registry system. For those interested, the registry has much more detailed information utilized by physicians evaluating specific areas of progress. Attempting to define quality in real time, we are moving into a system of Rapid Quality Reporting known as RQRS. Nationally, it has been determined that there are key steps in successful treatment for specific cancers. Instead of limiting the registry to retrospective information about survival and recurrence rates, we are developing www.peacehealth.org Fall 2013 the capability to monitor ongoing treatment protocols to ensure that each patient is completing each phase of therapy. For example, it is known that to be effective at curing breast cancer by lumpectomy, appropriate coordination with radiation and systemic therapy is critical. The RQRS program is a way of tracking that there is follow through with the complete treatment plan. Our registry system is invaluable as we collaborate to provide effective, efficient care in this new era of healthcare reform. Table 8: Comparative Cancer Incidence LCR vs WA State vs National Comparative Cancer Incidence Lower Columbia Region (LCR) vs Washington State vs National LCR Site WA State Number Percent Number National Percent Number Percent Breast 272 18 5,240 15 226,870 14 Lung & Bronchus 222 14 4,700 13 226,160 14 Colon & Rectum 119 8 2,770 8 143,460 9 Melanoma 63 4 2,140 6 76,520 5 Corpus Uteri 85 6 1,080 3 47,130 3 Leukemia 27 2 1,050 3 47,150 3 Cervix 20 1 220 1 12,170 1 Prostate 96 6 5,060 14 241,740 15 Bladder 65 4 1,670 5 73,510 4 NH Lymphoma 85 5 1,600 4 70,130 4 493 32 10,260 28 474,070 28 1,528 100 35,790 100 1,638,910 100 Other Total *Washington State and National Data from ACS Cancer Facts and Figures 2012 *Totals exclude in situ carcinomas except for urinary bladder Volume 6, Number 1 Exceptional Medicine 17 How is Breast Cancer Treated? T here are two related issues of importance to breast cancer patients and their families. The first is survival and the second is the impact of surgery, radiation, and chemotherapy on their lives. Figure 6 depicts survival of 1,941 breast cancer patients, broken down into those treated by breast conserving methods (lumpectomy) or by mastectomy. Treatment decisions are made based on a combination of factors about the tumor, which is then grouped into five stages beginning with Stage 0, which means there has been no spread of the cancer beyond the confines of the breast duct, through to those tumors that have already spread to other organs, Stage 4. Although hotly contested in the past, one can see that breast conserving surgery in appropriately selected patients has been very effective. The availability of excellent screening capabilities in our area have resulted in a big shift over time to early stage 0/1 cancers where you can see the 5-year survival of both types of treatment to be over 95%. The impressive development of new medical therapies has increased the number 18 of women eligible for breast conserving treatment, by shrinking their tumors before surgery with appropriately selected regimens. Figure 7 compares patient outcomes from our Lower Columbia Region with national benchmarks from the National Cancer Data Base. This data combines patients treated with both breast conserving surgery and mastectomy. It is again reassuring to see that multidisciplinary teams of specialists working together in our communities on the north shore of the Columbia River have been able to match outcomes from the more than 400,000 patients treated during a similar time frame nationally. www.peacehealth.org Fall 2013 Although these results are very reassuring, a report presented at the San Antonio Breast Conference in 2012 prompted us to look back even further to see if we had experienced the same findings as those researchers looking at really long term survival for breast cancer patients. The results of the ATLAS trial suggested that perhaps our long-term survival rates could be improved by continuing to utilize hormonal modulating therapies for ten years instead of the traditional five years commonly accepted to be appropriate. lack of exercise have a very deleterious effect on breast as well as other cancer related issues. The multidisciplinary breast care teams at the Kearney Breast Centers are in the process of implementing survivorship plans that will include specific recommendations for patients. Now that the issue as to whether or not breast conserving surgery is as safe as mastectomy has been resolved; there are multiple approaches being considered to decrease other aspects of harm associated with breast cancer treatment. Our pathologists are finding better ways to define each cancer by using various markers. This, in turn, allows our oncologists to personalize treatment plans. Our radiation oncologists are looking at treating only the portions of the breast containing cancer, and over shorter time frames. Our medical oncologists are now shrinking cancers in advance of surgery, to allow more women to preserve their own breast if they wish to do so. The excellent medical oncology team at PeaceHealth is also examining situations in which chemotherapy regimens are modified to Figure 8 compares the 10-year survival of patients that we have treated to national averages. As you can see in this graph, there is a small, but continued, loss of survival in each stage which supports the ATLAS trial report. This report suggests we can achieve better long term results by continuing hormonal treatment for 10 years, in addition to other interventions. There is increasing data that supports lifestyle choices, which include modifying exercise and diet that will have a very significant impact on long term health and survival. It has become apparent that obesity and Figure 6: Mastectomy Compared with Breast Conserving Therapy Lower Columbia Region n=1,941 total cases. Observed 5-year Survival by Treatment for Breast Cancers diagnosed 2003-2007 100 80 60 40 20 0 Stage 0 Mastectomy 1 year 100% Stage 0 BCS 100% Stage 1 Mastectomy 99% Stage 1 BCS 99% Stage 2 Mastectomy 95% Stage 2 BCS 99% Stage 3 Mastectomy 96% Stage 3 BCS 100% Stage 4 Mastectomy 100% Stage 4 BCS 87% Overall Survival Mastectomy 97% Overall Survival BCS 99% 2 years 100% 97% 99% 98% 92% 98% 87% 95% 63% 75% 92% 97% 3 years 100% 95% 95% 97% 89% 96% 81% 86% 55% 65% 88% 95% 4 years 95% 92% 92% 95% 83% 95% 73% 84% 55% 55% 81% 94% 5 years 95% 92% 87% 94% 81% 92% 71% 77% 47% 42% 80% 91% Volume 6, Number 1 Exceptional Medicine 19 Figure 7: Observed 5-year Survival for Breast Cancer Cases Diagnosed 2003-2005, Lower Columbia Region n=1,124 compared with the National Cancer Data Base n = 405,697 100 80 60 40 20 0 1 year LCR Stage 0 2 years NCDB 99% LCR 99% 3 years NCDB 98% LCR 99% 4 years NCDB 97% LCR 98% 5 years NCDB 94% LCR 97% NCDB 93% 96% Stage 1 99% 99% 98% 98% 95% 96% 93% 94% 92% 92% Stage 2 97% 98% 95% 95% 92% 92% 90% 88% 86% 85% Stage 3 94% 94% 83% 85% 76% 78% 64% 71% 62% 66% Stage 4 77% 65% 62% 47% 40% 35% 36% 27% 25% 21% Overall 97% 97% 95% 94% 91% 91% 88% 88% 86% 85% Figure 8: Observed 10-year Survival for Breast Cancer Cases Diagnosed 1998-2002, Lower Columbia Region compared with the National Cancer Database NCDB n=680,855. Survival Comarison with NCDB only available for the first 5 years. 100 80 60 40 20 0 1 year LCR LCR NCDB 3 years LCR NCDB 4 years LCR NCDB 5 years LCR LCR LCR LCR LCR LCR 100% 99% 99% 99% 97% 98% 95% 97% 95% 95% 89% 89% 88% 85% 84% Stage 1 99% 99% 97% 97% 97% 95% 93% 93% 91% 91% 87% 83% 80% 77% 75% Stage 2 97% 98% 95% 94% 90% 90% 86% 86% 82% 82% 77% 74% 72% 68% 65% Stage 3 93% 92% 83% 80% 69% 70% 62% 63% 58% 57% 48% 43% 40% 37% 37% Stage 4 44% 62% 19% 44% 18% 32% 18% 24% 14% 19% 7% 7% 2% 2% 2% Overall 97% 97% 94% 93% 91% 90% 88% 87% 85% 84% 80% 77% 74% 71% 69% www.peacehealth.org NCDB 6 7 8 9 10 years years years years years Stage 0 20 NCDB 2 years Fall 2013 include a more select group of patients. Surgeons are examining ways to decrease the morbidity of surgery in the lymph nodes. Phenomenal advances in reconstructive surgery, imaging and the biologic understanding of breast cancer are allowing those women requiring mastectomy to be reconstructed in a fashion that it is very difficult to discern they have even had surgery. These developments are guided by national clinical trials that prove what can be done. The results of the clinical trials are then evaluated by multidisciplinary teams to determine what can be done effectively in our own community. Again, the work of our excellent registry staff is tremendously important to document that treatment delivered in our community meets or exceeds national benchmarks, as measured by short and long term patient survival. A team of physicians review and debate the merits of the individualized treatment plans offered to each patient at the Kearney Breast Centers. Those of us who provide care to the patients of the Lower Columbia Region are extremely grateful for the generous donations made by the Kearney family and multiple other donors in our community. Their gifts allow us to deliver comprehensive state of the art care in a setting that encourages teamwork and professional excellence. We are appreciative of the opportunity presented, and are committed to do our best. SURGERY When “less is more...” As surgeons trained with an emphasis in oncology, it has been absolutely invigorating to participate in the evolving treatment of breast cancer. The report before you includes data from thousands of cancer patients treated here in Southwest Washington, compared with national data. It is especially energizing now that the generous communities along the north bank of the Columbia River have come together to provide support for the complex integrated networking of the entire breast team now so crucial in diagnosing and treating breast cancer. Volume 6, Number 1 Due to philanthropic support, increasingly important expensive technology is now available. The Kearney Breast Centers provide a setting for all specialty physicians to work together in an environment created to meet the needs of women in our community. No longer will surgeons be isolated from their colleagues in imaging, pathology, medical oncology, research and radiation therapy. Patient care is becoming more complex, requiring integrated, multidisciplinary treatment plans for optimum results. Surgeons, initially skeptical about departing from radical surgery, championed the development of a registry of cancer patients now known as the National Cancer Data Bank (NCDB). Amazingly it was also a surgeon, Dr. Bernard Fischer, who took the lead in identifying that “less surgery may actually be more beneficial” through multiple clinical trials begun in the National Surgical Adjuvant Breast Project. This NCDB registry system, supported by PeaceHealth, has allowed us to track the effectiveness of the increasingly innovative ways we now treat breast cancer as we enter this period of accountable care. In Southwest Washington, we have more than 25 years of data which supports the fact that radical mastectomy has no higher cure rate than lesser procedures. Initially, only small cancers could be treated by breast preservation techniques. Over the past decade, we have developed the ability to better understand an individual patient’s tumor biology. This has led to the development of treatments that shrink the patient’s tumor and allow smaller operations to be equally effective as more radical procedures. This technique, known as neoadjuvant therapy, may utilize either chemotherapy or hormonal treatment, followed by surgery and radiation therapy. Each step in the process must be coordinated, requiring increasingly complex teamwork between specialty physicians. The tumor registry system has been integral in validating safe incorporation of these techniques into community practice. Exceptional Medicine 21 With acceptance that less disfiguring operations can be effective when applied to the breast itself, there has been an equally effective move to decrease the extent of surgery in the axilla (arm pit) which is the cause of arm swelling and discomfort in many patients. At the end of this report, you will find a brief summary of exciting current clinical trials validating the changes taking place in breast care. ”And conversely, when more is better...” In concert with the growing understanding of tumor biology, there is also growing insight as to genetics and host factors that predict high risk for the development of breast cancer. The innovation in reconstructive surgery is absolutely astounding, at least to those of us familiar with the initial attempts at breast reconstruction. With proper patient selection, preventive procedures such as bilateral mastectomy with immediate reconstruction allow selected women to maintain their physical appearance to a point it is frequently hard to tell that the woman has had surgery at all. In selected patients, the nipple areolar complex may even be preserved. The surgery is complicated, requiring specialized techniques, but is very rewarding for those patients who elect this option. As surgeons trained in oncology, it is intriguing that it is now the plastic and reconstructive surgeons that are doing these larger complex operations, and doing them extremely well. SYSTEMIC THERAPY Systemic therapy is usually given in the adjuvant setting in patients with stage I-III disease to decrease the risk of recurrence and cancer-related deaths. It is becoming more common, though, for systemic therapy to be given in the neoadjuvant setting to help shrink large tumors before surgery to increase the likelihood of being able to do breastconserving surgery. In patients with stage IV breast cancer, systemic therapy is utilized to control tumor growth, improve cancer-related symptoms and prolong survival. Oncologists use three types of systemic therapy to treat breast cancer: hormone therapy, targeted therapy and chemotherapy. 22 Hormone therapy About 75% of breast cancers express the estrogen and progesterone receptors. These cancers are fueled by estrogen so hormonal therapies that decrease estrogen levels or block the estrogen receptor are very effective in decreasing relapse rates. Tamoxifen is a selective estrogen receptor modulator (SERM) which binds to the estrogen receptor and has anti-estrogen effects on breast tissue and pro-estrogen effects on the bones, uterus, liver and coagulation system. It can be used in both pre-menopausal and postmenopausal women. Tamoxifen decreases the risk of recurrence by 41% and risk of death by 33%.9 Recent evidence suggests that ten years of tamoxifen is superior to five years with a 3-4% decreased risk of recurrence and 2% decreased risk of death with a longer course of treatment.10, 11 Aromatase inhibitors, such as anastrazole, letrozole and exemestane, block the aromatase enzyme that converts androgen into estrogen. Aromatase inhibitors only work in post-menopausal women and are recommended for five years in the adjuvant setting. Aromatase inhibitors are preferred in postmenopausal women since they are associated with a 3% decreased risk of recurrence when compared to tamoxifen.12 In addition, aromatase inhibitors have a safer side effect profile. Tamoxifen increases a woman’s risk of uterine cancer and blood clots. Aromatase inhibitors are associated with osteoporosis and musculoskeletal complaints. Targeted Therapy HER-2/neu is a trans-membrane tyrosine kinase receptor and a member of the epidermal growth factor receptor (EGFR) family. Activation of this class of cellular receptors leads to increased activity of a variety of molecular pathways associated with tumor growth. Approximately 20% of breast cancers overexpress the HER-2/ neu receptor. Trastuzumab (Herceptin) is a monoclonal antibody that binds to the HER-2/ neu receptor. Prior to the advent of trastuzumab, HER-2/neu positive breast cancers were more aggressive with a higher rate of relapse and worse www.peacehealth.org Fall 2013 Table 9: Breast Cancer First Course Treatment by AJCC Stage, Lower Columbia Region 2012* Stg 0 Stg I Stg II Stg III Stg IV Unknown Total D 0 2 2 2 2 0 8 D, C 0 0 1 0 0 0 1 D, H 0 1 1 1 0 0 3 D, O 1 0 0 0 0 0 1 D, S 19 16 9 0 1 1 46 D, S, C 0 3 13 8 3 0 27 D, S, C, H 0 3 6 3 1 0 13 D, S, H 5 26 12 0 1 0 44 D, S, R 9 12 3 0 0 0 24 D, S, R, C 0 1 8 6 1 0 16 D, S, R, C, H 0 2 13 12 0 0 27 D, S, R, H 11 52 14 2 1 0 80 S 10 8 0 0 0 0 18 S, C 0 2 0 0 1 0 3 S, R 3 0 0 0 0 0 3 S, R, C 0 1 0 0 0 0 1 S, R, C, H 0 0 0 2 0 0 2 S, R, H 6 5 2 0 0 0 13 S, R, H, O 0 0 0 1 0 0 1 Hospice care only 0 0 0 1 0 0 1 69 137 85 38 11 1 341 Total D = Diagnostic procedure D,C = Diagnostic procedure, Chemotherapy D,H = Diagnostic procedure, Hormone Therapy D,O = Diagnostic procedure, Other Treatment D,S = Diagnostic procedure, Surgery D,S,C = Diagnostic procedure, Surgery, Chemotherapy D,S,C,H = Diagnostic procedure, Surgery, Chemotherapy, Hormone Therapy D,S,H = Diagnostic procedure, Surgery, Hormone Therapy D,S,R = Diagnostic procedure, Surgery, Radiation D,S,R,C = Diagnostic procedure, Surgery, Radiation and Chemotherapy D,S,R,C,H = Diagnostic procedure, Surgery, Radiation, Chemotherapy and Hormone Therapy D,S,R,H = Diagnostic procedure, Surgery, Radiation and Hormone Therapy S = Surgery S,C = Surgery, Chemotherapy S,R = Surgery, Radiation S,R,C, = Surgery, Radiation, Chemotherapy S,R,C,H = Surgery, Radiation, Chemotherapy and Hormone Therapy S,R,H = Surgery, Radiation and Hormone Therapy S,R,H,O = Surgery, Radiation, Hormone Therapy and Other *This table shows combined totals for PeaceHealth Southwest Medical Center and PeaceHealth St. John Medical Center Volume 6, Number 1 Exceptional Medicine 23 prognosis. Trastuzumab is used in combination with chemotherapy and continued afterwards for a total of one year in HER-2/neu positive breast cancers. Trastuzumab decreases the risk of recurrence by 40% and the risk of death by 33%.13 There are other HER-2/neu targeted therapies such as lapatinib, pertuzumab and trastuzumabemtansine that have been recently approved for use in the metastatic setting and are currently being studied for use in the adjuvant setting. Chemotherapy It can be challenging to determine which patients will benefit from chemotherapy. Oncologists must take into account multiple factors including a patient’s age, co-morbidities, tumor hormone and HER-2/neu receptor status, tumor size, tumor grade, and lymph node status. There are online algorithms such as AdjuvantOnline that can aid in decision making by calculating the benefit of chemotherapy based on certain patient characteristics. In addition, genomic profiling can provide additional insight into the biological behavior of a patient’s breast cancer. Oncotype DX is a validated assay that examines twenty-one genes and calculates a recurrence score. Patients with high recurrence scores derive benefit from chemotherapy while those with a low recurrence score do not benefit from chemotherapy. The benefit of chemotherapy in patients with intermediate recurrence scores is unknown and currently being investigated with the clinical study, TAILORx. There are multiple chemotherapy drugs that can be used in various combinations to treat breast cancer. Anthracyclines, taxanes and alkylating agents are among the most effective and commonly used chemotherapy drugs. Frequently used regimens include dose dense Adriamycin and cyclophosphamide followed by paclitaxel (ddAC-T) and docetaxel with cyclophosphamide (TC). Chemotherapy is often given for three to five months. Chemotherapy can be administered before surgery to facilitate breast24 conserving surgery or after surgery to eradicate micrometastases and decrease the risk of relapse and cancer-related death. Patients with metastatic disease are usually treated with single agents in order to decrease toxicity unless there is significant organ involvement which requires a more aggressive approach. In addition to anthracyclines and taxanes, anti-metabolites (such as capecitabine and gemcitabine) and microtubule inhibitors (such as vinorelbine and eribulin) are preferred drugs in this setting. RADIATION Radiation treatments play an important role in the multidisciplinary management of most patients with breast cancer. Data from prospective phase III trials indicate that for patients treated with breastconserving surgery, radiation reduces the risk of local recurrence, provides a clinically significant reduction in distant metastases, and improves overall survival.14, 15 Radiation treatments are also well tolerated and, when delivered using modern technologies, carry a low risk of serious morbidity. For women who have breast-conserving surgery radiation therapy treatment options include standard whole breast radiation (~ six weeks), hypofractionation (~three weeks), accelerated partial breast irradiation (one week), and possible omission of radiation in a select population. The eligibility, benefits, technologic advances, and possible disadvantages of these options are as follows. Whole breast irradiation (WBI) is considered standard of care for women who have had breast-conserving surgery. WBI has the longest track record and an abundance of literature to support its efficacy.15, 16 WBI after lumpectomy has been shown to decrease breast tumor recurrence by roughly two-thirds when compared to lumpectomy alone.17 Furthermore, a metaanalysis of 42,000 women noted a statistically significant survival benefit of 5%.18 www.peacehealth.org Fall 2013 Improvements in the treatment of whole breast irradiation include the implementation of 3-D conformal radiotherapy that uses multiple radiation fields to deliver precise doses of radiation to the breast while sparing normal tissue. More recently, PeaceHealth has implemented the use of intensity-modulated radiation therapy (IMRT), which further modifies the radiation beam, varying the intensity of radiation to allow for greater sparing, such as decreased acute skin toxicity.19 The latest developments in the treatment of breast cancer take into account respiratory motion, allowing further reduction in the dose to the heart and lung.20 We expect to have this ability soon with the purchase of a new CT simulator that has this capability. Hypofractionated radiotherapy delivers radiation in larger doses using fewer treatments. In patients with early-stage breast cancer treated with breast-conserving surgery, randomized trials have found little difference in local control and survival outcomes between patients treated with conventionally fractionated whole breast irradiation and those receiving hypofractionated WBI.21, 22 Eligibility criteria has been addressed by the American Society of Radiation Oncology (ASTRO) which includes women over the age of 50, early stage breast cancer (Stage pT1-2 pN0), women not receiving chemotherapy, and the ability to deliver a dose of radiation to the whole breast that does not exceed a hot or cold spot in excess of 7%.23 The possible disadvantage to hypofractionated radiotherapy would include a higher risk of late side effects such as fibrosis. Therefore, it is paramount to ensure a plan that minimizes the dose to normal structures such as the heart. The use of accelerated partial breast irradiation (APBI) has increased significantly over the last 10 years from 3.4 % in 2003 and increasing to 12.4 % in 2010 for patients receiving radiation after lumpectomy.24 Accelerated partial-breast irradiation (APBI) is a technique that typically delivers a relatively high dose of radiation twice daily to the breast tissue immediately adjacent to the lumpectomy cavity region over five days (Figures 9 and 10). Compelling evidence supporting the targeting of a smaller volume of breast tissue with radiation comes from prospective, randomized studies of lumpectomy only versus lumpectomy plus WBI. These trials document that the in-breast cancer recurrence is most prevalent in the breast tissue immediately adjacent to the lumpectomy cavity; therefore, the primary benefit of WBI may be to prevent breast cancer recurrence at the site of the lumpectomy bed.15, 24 The benefits of this approach are that it may facilitate patient compliance with radiation therapy, increase the attractiveness of breast conservation, and potentially decrease toxicity, while also providing greater savings to the health care system. There is a growing body of evidence supporting the benefits of APBI. The largest randomized study comparing APBI and WBI (NSABP B-39) has closed with over 4,000 women enrolled in the study. Although the results of the study will require a few years to mature before publication, there have been no significant adverse events identified by the Data Safety Monitoring Committee during interim analyses of these patients. There have been multiple studies reporting promising results, including Figure 9: Examples of Radiation Dose Examples show how the radiation dose (the colored lines, with the white lines representing 50% of the dose) is targeted to the area where the original tumor was using three different partial breast radiation techniques (SAVI, Contura, interstitial catheters). Volume 6, Number 1 Exceptional Medicine 25 Figure 10: Whole Breast Radiation This is in contrast to these examples of standard whole breast radiation where the entire breast is considered the target. a recent update of the Hungarian study which randomized patients to either APBI versus WBI.25 After a median follow up of 10.2 years, the ten-year actuarial rate of local recurrence was 5.9% and 5.1% in APBI and WBI arms, respectively (p=0.77). There was no significant difference in the ten-year probability of overall survival (80% vs 82%), cause specific survival (94% vs 92%), and disease free survival (85% vs 84%), either. The rate of excellent-good cosmetic result was 81% in the APBI, and 63% in the control group (p<0.01). There was also a recent publication of the final analysis of the American Society of Breast Surgeons MammoSite® Breast Brachytherapy Registry Trial which published the results of 1,449 cases of APBI with a median follow-up of 63 months.26 Five-year actuarial rate of breast tumor recurrence was 3.8%, which compares favorably to historical rates for whole breast irradiation. Furthermore, the study noted that the majority of patients had good to excellent cosmetic results and few side effects when compared to traditional radiation. The American Society of Radiation Oncology (ASTRO), American Society of Breast Surgeons (ASBS), and the American Brachytherapy Society (ABS), have all published guidelines on appropriate patient selection for treatment with APBI.27-30 These recommendations were based on the results of a systematic literature review of the APBI data and were supplemented by expert opinions on risk factors for recurrence in the setting of WBI (Tables 10 and 11). For a select group of women there is evidence that radiation therapy may offer little or no benefit. The 26 most compelling study, CALGB 9343 (Intergroup trial), randomized women over 70 years old with stage 1 breast cancer to tamoxifen plus radiation therapy or tamoxifen alone.31 The updated results reported 90% of patients in the tamoxifen only arm compared with 98% in the tamoxifen plus radiation arm were free from locoregional recurrence. Although the 8% difference was significant, the study concludes that tamoxifen remains a reasonable option for women age 70 years and older with ER-positive early-stage breast cancer due to the similar rate of metastatic disease and overall survival. A second study from Princess Margaret Hospital evaluated 769 women over the age of 50 with early stage breast cancer who received either tamoxifen or tamoxifen plus whole breast radiation.32 In a subset of women over the age of 60 with tumors <1cm the risk of relapse was 2.6% versus 0%, which was not statistically significant. However, this was an unplanned analysis with a short follow-up. Regardless, the National Comprehensive Cancer Network (NCCN) guidelines state that radiation therapy may not always be necessary for women 70 years or older with Stage 1 breast cancer that is hormone receptor positive in those that receive endocrine therapy. An aid to possibly help in this decision is a nomagram available online (www. mdanderson.org/RadiationBenefitPredictor) that is based on 7,400 women over the age of 70 years that would have been eligible for the CALGB study.33, 34 At PeaceHealth all the women who are treated for breast cancer are discussed prospectively at a multidisciplinary tumor conference. The group’s recommendations are then presented to the patient to allow a well-informed decision regarding their treatment. www.peacehealth.org Fall 2013 Table 10: Patient Selection for Accelerated Partial Breast Irradiation (APBI) According to the American Society for Therapeutic Radiology and Oncology (ASTRO) Series Age Tumor Size Histology Lymph Nodes Margins American Society of Breast Surgeons ≥ 50 yrs < 3 cm Invasive ductal Negative No tumor on ink American Brachytherapy Society ≥ 45 yrs < 3 cm Invasive ductals Negative No tumor on ink Table 11: Patient Selection for Accelerated Partial Breast Irradiation (APBI) According to the American Society of Breast Surgeons and American Brachytherapy Society Criteria used Suitable Cautionary Unsuitable Age ≥ 60 yrs 50-59 yrs < 50 yrs Tumor size Up to 2 cm 2 to 3 cm > 3 cm Surgical margins ≥ 2 mm < 2mm positive Lymph node Negative - Positive Estrogen receptor Positive - Negative Lymphovascular invasion Negative Focal Extensive Volume 6, Number 1 Exceptional Medicine 27 What is the Role of Research? P eaceHealth Cancer Center has 27 years of experience in offering breast cancer studies to the women and men of Clark, Cowlitz, and surrounding counties. The cancer research team works every day to identify patients who are eligible for possible participation on a clinical trial. All newly diagnosed breast cancer patients and new patient consults at PeaceHealth are screened by the research staff and if eligible for a study are offered participation in a national clinical trial. In 1986 the first patient to enroll on a national clinical trial at PHSW was a breast cancer treatment patient. Following the first enrolled patient and continuing for the last 27 years, PHSW and our breast cancer patients have participated in hundreds of breast studies. Throughout the years, PeaceHealth has been a leader in the advancement of new diagnostic techniques and treatments including: sentinel node biopsies vs. full axillary node dissections, tamoxifen for hormone receptor positive tumors, Oncotype DX to determine recurrence risk, Herceptin for HER-2 positive tumors, partial breast irradiation following lumpectomy, targeted 28 therapies for breast cancer, and circulating tumor cells to indicate appropriate therapy. The research staff at PeaceHealth is passionate about supporting breast cancer research and offering patients the opportunity to participate in trials to find new treatments or improve on current research-proven therapies. PeaceHealth is an active member of Western Oncology Research Consortium (WORC), a National Cancer Institute accredited consortium of local healthcare systems and providers offering clinical trials in cancer prevention, symptom control and treatments, advancing the knowledge of cancer and improving the health of cancer patients in the www.peacehealth.org Fall 2013 Northwest. Through WORC, PHSW is a member of the major national research bases including Southwest Oncology Group (SWOG), Radiation Therapy Oncology Group (RTOG), North Central Cancer Treatment Group (NCCTG), National Surgical Adjuvant Breast and Bowel Project (NSABP), among others. As a member of all of the major research bases we are able to offer national treatment trials with new chemotherapy medications, targeted medications, new combinations of chemotherapy treatments, new radiation modalities, and new surgical treatments. We also offer clinical trials that address prevention of breast cancer and cancer recurrence. Other clinical trials are conducted to look at ways to control symptoms or manage the side effects of cancer treatment. Quality of life studies are also offered that look at the ways that cancer treatments affect the patients well-being. For women who are undergoing breast biopsy, PeaceHealth is currently offering participation in a trial that is developing a test for the early detection of breast cancer using proteins that are present in human tear samples. After the patient consents to participation, proteins are collected from the patient’s eye with a simple saline eye flush. This study may discover new ways to screen patients for breast tumors in the future. Volume 6, Number 1 The cancer treatments that we use today were developed based on knowledge gained from previous clinical trials. As a result, people treated for breast cancer, as well as other types of cancer, are living longer. Participation in a clinical trial not only offers the patient the most up to date treatment, but also offers the patient a way to contribute to the future of cancer care. Breast cancer clinical trials have always led the way in research at PHSW. We are currently accruing patients to seven different breast cancer treatment trials and two cancer control studies. The first cancer control study is a study of the effects of exercise on cancer related fatigue. The second is assessing vitamin D in premenopausal women at high risk for breast cancer. PeaceHealth remains on the cutting edge of breast cancer diagnosis, treatment, and follow-up care using research-proven therapies to benefit our community. We thank our patients who have participated in these trials. Without them, this life-saving research would not be possible. There is still much work to be done and more exciting discoveries to be made. Contact PHSW Cancer Research for more information about current clinical trials or to ask about participation on a clinical trial, 360-514-3940. Exceptional Medicine 29 Selected Breast Clinical Trials, Biopsy Techniques A) Decreasing extent of axillary surgery 1. ACOSOG Z1011( 2012) …sentinel nodal surgery better than formal axillary node dissection in early breast cancer when breast preservation planned(no data for mastectomy or partial breast irradiation patients) 2. EORTC AMAROS (After Mapping Axilla, Radiation or Surgery?) 2013 …large European trial found that even in biopsy proven node positive patients, radiation to axilla associated with similar local control and fewer side effects than surgical axillary dissection 3. ACOSOG Z1071(2013) …select patients with biopsy proven nodal metastasis by core or FNA convert to negative in 40% of cases with chemotherapy, and sentinel node can be safely done with 90% accuracy following neoadjuvant therapy. Supports concept of sentinel node surgery after neoadjuvant therapy B) Is it possible to decrease the inconvenience of radiation therapy? 4. NSABP 39(completed, awaiting results) …for tumors less than 3 cm in size with 1-3 nodes, can radiation be decreased to part of the breast & completed in 1 week ? 5. RTOG 1005(in progress) …can whole breast irradiation be given over a shorter course of 3 weeks instead of the 5 weeks usually done (hypofractionation) 6. NSABP 51(in progress) …In which of those 40% of patients that convert from positive to negative with neoadjuvant therapy, can radiation be safely omitted? C) Is it possible that the discomfort of needle biopsy may be replaced by even less invasive techniques? 7. D) Are there instances where the need for surgery can be completely eliminated? 8. 30 The “tear trial” ( in progress) …as far out as it seems, there is a question whether there may be changes of a molecular nature in tears which may correlate with the biology of cancer enough to be useful NSABP concept schema (Dr Thomas Julian) …concept working way through NSABP for new trial for patients whose cancers have had complete response to treatment using triple imaging (mammography, ultrasound,& MRI) with core biopsy www.peacehealth.org Fall 2013 What is the PeaceHealth Experience? NURSE NAVIGATORS – A TEAM APPROACH TO CANCER CARE A dvances and improvements in cancer treatment have helped to save millions of lives during the last 30 years. Yet, it is easy for a patient newly diagnosed with cancer to feel overwhelmed and lost, adrift in a rapidly changing, complex, and unfamiliar medical system. Nurse Navigators help patients understand their diagnosis and overcome their fears. Our Nurse Navigators provide educational resources to assist patients in making informed medical decisions. Nurse Navigators facilitate referrals to doctors’ appointments, procedures, other disciplines, and make sure patients stay on track with their treatment plans. Volume 6, Number 1 PeaceHealth Nurse Navigators identify patient goals during treatment and place special consideration and emphasis on quality of life by offering a listening ear, compassion, and emotional support. Like compasses that provide direction, nurse navigators are registered nurses specializing in oncology who help guide patients and their loved ones through the health care system during the cancer experience. Exceptional Medicine 31 CONCLUSION A diagnosis of cancer will forever change a person’s life. Here at the PeaceHealth Kearney Breast Centers in Vancouver and Longview, our teams of dedicated professionals focus on every aspect of care for women and men with breast cancer. From diagnosis through surgery and all phases of treatment, we are here for you and your loved ones. Our staff is continually seeking ways to improve the care we deliver through ongoing professional training and quality improvement projects. Through access to clinical research trials, we are partnering with our patients and our community to constantly improve the survivability and quality of life for patients with cancer. The PeaceHealth Mission: We carry on the healing mission of Jesus Christ by promoting personal and community health, relieving pain and suffering, and treating each person in a loving and caring way. Our vision: Every person receives safe, compassionate care; every time, every touch. 32 www.peacehealth.org Fall 2013 References 1. National Cancer Institute Breast Cancer Risk Assessment Tool 2. Esserman LJ, Shieh Y, Rutgers EJ, Knauer M, Retèl VP, Mook S, Glas AM, Moore DH, Linn S, van Leeuwen FE, van ‘t Veer LJ . 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