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Dr Dylan Narinesingh and Team Presenters : Dr P.Sylvester and Dr N.Bhim PALLIATIVE CARE DELIVERY IN SOUTH TRINIDAD Outpatient Palliative setting Inpatient Inpatient setting Assess and treat symptomatically Family meeting concerning options for home care vs hospice care Home care not feasible referral to Hospice Family advised to visit place to meet health care providers at the Hospice Then patient is transported from SFGH Hospice Outpatient setting Zometa DHF Clinic Paliative care clinic Xeloda Zometa Intravenous bisphosphonate Indicated for Rx with metastatic bone disease Multiple Myeloma Prevents SRE and relieves bone pain Administered every 4 to 5 weeks Zsuzsanna Nagy : Zoledronic acid (ZOMETA) : a significant improvement in the treatment of Bone metastases. Pathology and Oncology Research Vol 11, No 3, 2005. Initial clinic visit for Zometa Counselling side effects Calcium supplements Monthly blood tests to review prior to administering (RFT’s and Ca2+) Informing physician on dental procedures Severity of Bone pain Pain management according to the WHO Analgesic ladder Palliative radiotherapy @ NRC http://www.zometa.com/dosing-and-administration/dosing-for-solid-tumours-and-multiple myeloma/treat-every-3-to-4-weeks.jsp Palliative Radiotherapy Patients referred to be assessed at National Radiotherapy Centre on Tuesdays Clinical mark-up planning Radiation dose of 8Gy x 1 Fraction or 20Gy x 5 Fractions (administered to the area that gives the patient the most pain) Chow E, Harris K, Fan G : Journal of Clinical Oncology, Vol 25, No 11 (April 10), 2007: pp. 1423-1436 Palliative Xeloda clinic Indicated in Metastatic Colorectal Cancer 1 and Breast Cancer2 Initial visit Counseling patient on side effects and how to manage them Blood test to review before prescribing ( CBC, RFT, LFT) Vitamin B6 to be taken daily Patients seen every 3/52 Reassessment after 3 cycles 1. http://www.xeloda.com/about/prescribed-for/mcrc 2. Blum JL, Jones SE, Buzdar AU, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol. 1999;17(2):485-493. District Health Facilities Princes Town / Couva / Siparia Providing best supportive care Team effort comprising Physicians, Nurses and counselors Provide education and counseling of Patient and relatives Paliative Care clinic Situated at SFGH outpatient Oncology Clinic every 2/52 Dr S. Chamely Palliative care physician Patients receiving home care Hospice care in South Trinidad Soon to be established at Petrotrin Medical Centre ZOMETA AUDIT Overview Audit period 10/7 (October 4th, 2011 to October 19th , 2011) Inclusion Criteria Metastatic bone disease Duration of treatment with Zometa >3mths Total population approx. 100 patients Demographics Sample size 34 patients: 28 males and 6 females Age Distribution: Age Group <50 50-59 60-69 70-79 >80 No. of Patients 0 6 11 15 2 % 0 17.6 32.4 44.1 5.9 Primary site of cancer •Prostate Breast 15% Other 15% •Breast •Other Prostate 70% ZOLEDRONIC ACID AUDIT DATA COLLECTION SHEET Date:_____________ Name:__________________________________________________________________ DOB (age): Gender: M F Ethnicity: Address:________________________________________________________________________________________________ Cancer Type: Breast Prostate Lung Colon/Rectum Kidney Lymphoma (HL/NHL) Melanoma Brain Head & Neck Gastric Esophagus Pancreatic Other______________________________ Histology:________________________________________________________________________________ Date Diagnosed with Cancer:___________________________ Date Diagnosed with Bony Metastases:_________________________ Imaging Modality used for diagnosis: X-rays Bone Scan MRI CT Site of Bony Metastates: Pelvis Spine (Cervical Thoracic Lumbar Sacral) Rib Cage Skull Scapula Clavicle Femur Humerus Other____________________ Spinal Cord Compression (at time of diagnosis): Y N RT administered for SCC: Y N / / Black Record No._____________ _____yrs Asian Liver East Indian Caucasian Cervix Endometrial Mixed_____________ Ovarian Malignant CUP Bone Pains: Y N Site of Bone Pains: ___________________________________________ RT administered for Bone Pain: Y Receiving Palliative Chemotherapy/Hormonal Therapy: Y Date Zoledronic Acid started:________________________________________________ Baseline Creatinine and Calcium levels:_______________________________________ Duration of Treatment (months):_____________________________________________ Date Zoledronic Acid Discontinued:__________________________________________ Reason for discontinuation: Renal Failure Hypocalcaemia Osteonecrosis of Jaw Atypical Fracture Other__________________ Did patient experience any adverse skeletal-related event (SRE) or hypercalcemia of malignancy (resulting in admission) whilst receiving Zoledronic Acid: Y N Specify:_________________________________________________________________ Dose Reduction of Zometa: Y Reason for Dose Reduction: Renal Impairment N N N Other_________________________ Objective Improvement in Quality of Life Compare Before and After Zoledronic Acid administered: Describe in patient’s (and/or caregiver’s) own words: _______________________________________________________________________ Objective improvement in mobility: ECOG/Karnofsky/Lansky Performance Status Before Zoledronic Acid:______________ ECOG/Karnofsky/Lansky Performance Status After Zoledronic Acid:________________ Number of Doses/Cycles given before improvement noticed:_______________________ Objective improvement in bone pain (see NIPC rating scales): Numeric Rating Scale Before Zoledronic Acid: _________________________________ Verbal Pain Intensity Scale Before Zoledronic Acid:______________________________ Numeric Rating Scale After Zoledronic Acid: __________________________________ Verbal Pain Intensity Scale After Zoledronic Acid:_______________________________ Number of doses/cycles of Zoledronic Acid given before improvement noticed:________ KARNOFSKY PERFORMANCE STATUS SCALE DEFINITIONS RATING (%) CRITERIA Able to carry on normal activity and to work; no special care needed. Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed. Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly. 100 Normal no complaints; no evidence of disease. 90 Able to carry on normal activity; minor signs or symptoms of disease. 80 Normal activity with effort; some signs or symptoms of disease. 70 Cares for self; unable to carry on normal activity or to do active work. 60 Requires occasional assistance, but is able to care for most of his personal needs. 50 Requires considerable assistance and frequent medical care. 40 Disabled; requires special care and assistance. 30 Severely disabled; hospital admission is indicated although death not imminent. 20 Very sick; hospital admission necessary; active supportive treatment necessary. 10 Moribund; fatal processes progressing rapidly. 0 Dead ECOG PERFORMANCE STATUS Grade ECOG 0 Fully active, able to carry on all pre-disease performance without restriction 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5 Dead 0–10 Numeric Pain Rating Scale Duration of Treatment 12 10 8 No of patients 6 4 2 0 <6mth 6-12mths 13-18mths 19-24mths >24mths Dose reduction Chart Title Y N 44% 56% Spinal Cord Compression Y 21% N 79% Bone Pain Y N 38% 62% Improvement in pain scores Percentage of patients 64.7% 23.5% 11.8% Yes No No pain Improvement in pain Average no. of doses before decrease in pain noticed 2.5 doses Average decrease in numeric pain rating: approximately 3.5pts Improvement in mobility Percentage of patients 55.9% 44.1% Yes No Improvement in mobility Average no. of doses before change noticed: 2months Average increase in performance status by ECOG Scale approximately 2pts Average increase in performance status by Karnofsky Scale approximately 20pts Skeletal Related Events Nil adverse events SRE DISCUSSION What is Zometa? Zometa (Zoledronic acid) belongs to a class of drugs known as bisphosphonates. Zometa fights against skeletal destruction in advanced tumours and multiple myeloma Mechanism of action Mechanism of action In addition to being a potent inhibitor of bone resorption, Zometa also possesses anticancer properties that could contribute to its overall efficacy in the treatment of metastatic bone disease Zometa is administered as an IV infusion every 3-4 weeks in MM and advanced solid tumours SRE Skeletal Related events can shorten the survival in patients with advanced prostate and breast CA Prostate CA 49% of patients with advanced prostate Ca and bone metastases will experience a SRE within the first 2yrs Average time to first SRE is 10.7mths Average frequency of SRE was approximately every 8 mths Breast CA 68% of patients with advanced breast Ca and bone metastases will suffer a SRE within 2yrs The average length of time to first time SRE was 7mths The frequency of SREs occur approximately every 3mths In view, of data collected in audit thus far. At a cost of $2400.00TT per dose of Zometa vs an average $1100.00TT per hospital bed per night. How cost effective is the use of Zometa in Palliative care in our setting? References 1. Coleman RE. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treatment Rev. 2001;27:165-176. 2. Lipton A, Theriault RL, Hortobagyi GN, et al. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials. Cancer. 2000;88:1082-1090. 3. Saad F, Lipton A, Cook R, Chen Y-M, Smith M, Coleman R. Pathologic fractures correlate with reduced survival in patients with malignant bone disease. Cancer. 2007;110:1860-1867. 4. ZOMETA Summary of Product Characteristics. Novartis Pharma AG. 5. Andre F, Slimane K, Bachelot T, et al. Breast cancer with synchronous metastases: trends in survival during a 14-year period. J Clin Oncol. 2004;22:3302-3308. 6. Rosen LS, Gordon D, Kaminski M, et al; Zoledronic Acid Breast Cancer and Multiple Myeloma Study Group. Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. Cancer. 2003;98:1735-1744. 7. Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2005;23:3314-3321. 8. Aapro M, Abrahamsson PA, Body JJ, et al. Guidance on the use of bisphosphonates in solid tumours: recommendations of an international expert panel. Ann Oncol. 2008;19:420-432. 9. Van Poznak CH, Temin S, Yee GC, et al. American Society of Clinical Oncology executive summary of the Clinical Practice Guideline update on the role of bone-modifying agents in metastatic breast cancer. J Clin Oncol. 2011;29:1221-1227.