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Assessment of Quality Of Life in patients treated with Chemo and Radiotherapy for Gastric Cancer: A Systematic Review Authors: Turma 14 Supervisors: Mário Dinis Ribeiro Cláudia Camila Dias Professor Doutor Altamiro da Costa Pereira Background Gastric Cancer European Distribution QoL after Chemo/Radiotherapy in Gastric Cancer Cumulative risk, 0-64 years Female Male Eucan - Database Stomach adenocarcinoma is the most common form of gastric cancer (95% of the cases).1 1- Crew KD, Epidemiology of upper gastrointestinal malignancies. Seminin Oncol 2004; 31: 450–464. Gastric Cancer Incidence Background QoL after Chemo/Radiotherapy in Gastric Cancer 35 31 30 850 000 deaths worlwide each year cause due to gastric cancer 25 20 16 14 15 10 13 10 10 8 8 9 8 8 6 5 0 4 4 3 4 3 0 Men Women 3 2 4 1 1 0 1 0 0 0 Eucan - Database World, age-standardized rates (per 100.000 persons.year) Gastric Cancer Incidence Background QoL after Chemo/Radiotherapy in Gastric Cancer Aproximately 1,440,000 cases worlwide per year 35 31 30 850 000 deaths worlwide each year cause due to gastric cancer 25 20 16 14 15 10 13 10 10 8 8 9 8 8 6 5 0 4 4 3 4 3 0 Men Women 3 2 4 1 1 0 1 0 0 0 Eucan - Database World, age-standardized rates (per 100.000 persons.year) Background Treatments QoL after Chemo/Radiotherapy in Gastric Cancer Treatment for gastric cancer often involves surgery, usually a partial or a total gastrectomy (removal of stomach tissue).2 Chemotherapy and radiotherapy are standard for some stages of stomach cancer.2 2-Ross P. Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin and PVI 5-FU in advanced esophagogastric cancer. Journal of Clinical Oncology, Vol. 20, Issue 8 (April), 2002. Background Chemo and Radiotherapy QoL after Chemo/Radiotherapy in Gastric Cancer Chemotherapy is the use of chemical agents to stop cancer cells from growing.3 Chemotherapy is considered a systemic treatment.3 Radiotherapy uses high energy xrays to destroy cancer cells.4 A small dose of radiotherapy may be very helpful to relieve pain.4 3-Janunger KG. A Systematic Overview of Chemotherapy Effects in Gastric Cancer. Acta Oncologica, Vol. 40, No. 2/3, pp. 309-326, 2001. 4-Kim GE. The role of radiation treatment in management of extrahepatic biliary tract metastasis from gastric carcinoma. Int. J. Radiation Oncology Biol. Phys., Vol. 28, No. 3, pp.711-717, 1994. Background Quality of Life QoL after Chemo/Radiotherapy in Gastric Cancer Some definitions Schipper et al. proposed: “the functional effect of illness and its consequent therapy upon a patient, as perceived by the patient”.5 World Health Organization proposed: “Quality of life is defined as the individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by a person's physical health, psychological state, level of independence and their relationships to salient features of their environment”. 5- Schipper H. Definitions and conceptual issues. In: Spilker B, ed. Quality of Life and pharmacoeconomics. in clinical trials, Philadephia : Lippincott- Raven, 1996: 11-24 6-WHOQoL Group (1993) Background Quality of Life QoL after Chemo/Radiotherapy in Gastric Cancer Some definitions Schipper et al. proposed: “the functional effect of illness and its consequent therapy upon a patient, as perceived by the patient”.5 World Health Organization proposed: “Quality of life is defined as the individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by a person's physical health, psychological state, level of independence and their relationships to salient features of their environment”. 5- Schipper H. Definitions and conceptual issues. In: Spilker B, ed. Quality of Life and pharmacoeconomics. in clinical trials, Philadephia : Lippincott- Raven, 1996: 11-24 6-WHOQoL Group (1993) Aim QoL after Chemo/Radiotherapy in Gastric Cancer __________________________________________________________________________ • Summarize the QoL of patients with gastric cancer after treatment with chemo and radiotherapy • Clarify the validity/validation of instruments used • Summarize the QoL of patients with gastric cancer according to the instrument. __________________________________________________________________________ Methods QoL after Chemo/Radiotherapy in Gastric Cancer Article Search: The Query used was: ◊ ″Gastric cancer AND (Quality of Life OR Psychology) AND (Radiotherapy OR Chemotherapy)” Literature searches were conducted in Medline. Limits: Publication Date until September 2005. Only items with an abstract. Humans. Methods Fluxogram QoL after Chemo/Radiotherapy in Gastric Cancer Beginning Read title and abstract Excluded by 2 reviewers ? Yes No Exclude article yes Included by 2 reviewers ? Include article no Opinion of a third reviewer Read complete article Discuss until reviewers agreement Introduce data in the SPSS Include article End Exclude article Methods QoL after Chemo/Radiotherapy in Gastric Cancer Validation Papers o A second search was conducted, to discover if the instruments used in the included articles were valid. To find the validation papers we search the questionnaire title through Google and Medline Results QoL after Chemo/Radiotherapy in Gastric Cancer Type of Study: Systematic review to chemo or radiotherapy; - QoL evaluated by the with an patients; - QoL measured appropriate instrument; - More than one participant. Inclusion criteria Instrument to measure QOL submitted QOL evaluated by the patient - Patients Patients submitted to chemo or radiotherapy cancer; Patients with gastric cancer gastric More than one participant with 100 90 80 70 60 50 40 30 20 10 0 Evaluation of QOL - Patients No. of included articles Inclusion Criteria of the article: These data refers to 97 articles Results QoL after Chemo/Radiotherapy in Gastric Cancer Exclusion criteria of the article: 40 - Articles in which QoL was measured but only symptoms were studied; 35 No. of excluded articles - Articles based on mixed diagnostic groupings (in the article these have to be approached separately); 30 25 20 15 10 5 0 - Articles that referred to patients submitted to a surgery during or before treatment. Mixed groups Only the symptoms were measured Exclusion criteria Patients submitted to surgery These data refers to 97 articles Results Start Search in Pubmed 116 articles found Searches Apply inclusion and exclusion criteria 11 were included 86 were excluded QoL after Chemo/Radiotherapy in Gastric Cancer 19 couldn’t be used Search for the validation paper All the instruments had a validation paper End Results Included Articles QoL after Chemo/Radiotherapy in Gastric Cancer A summary of the data extracted from the included articles Is presented In the following Table Fist author and Publication date of the article Instrum ent Validation paper of the instrum ents Group in study Control group Patients stage Results Park SH, 2005 EORTC QLQ-C30; HADS Patients submitted to second-line chemotherapy Patients not submitted to chemotherapy Locally advanced or metastic disease QoL increases w ith second-line chemotherapy EORTC QLQ-C30 Patients not submitted to chemotherapy Patients treated w ith [177LuDOTA0,Tyr3]octreotate Metastic tumor (GEP) QoL increases in patients treated w ith [177-LuDOTA0,Tyr3]octreotate Teunissen JJ, 2004 Tebbutt NC 2002 EORTC QLQ-C30 Patients submitted to protracted venous infusion (PVI) 5fluorouracil (5-FU) Bramhall SR 2002 EORTC QLQ-C30 Placebo Ross P, 2002 EORTC QLQ-C30 Nordin K, 2001 EORTC QLQ-C30 Katarina H, 1998 EORTC QLQ-C30 Glimelius B, 1997 EORTC QLQ-C30 Bamias A, 1996 Chau I, 2004 Findlay M, 1994 Locally Patients submitted to PVI 5- advanced or FU plus mitomycin C metastic disease Locally Patients submitted to advanced or chemotherapy metastic disease Patients submitted to mitomycin, cisplatin, and Patients submitted to protracted venousepirubicin, cisplatin, and infusion fluorouracil (PVI 5PVI 5-FU FU) Patients submitted to Patients submitted to chemotherapy w ithout chemotherapy w ith best best supportive care supportive care No differences in QoL No differences in QoL Inoperable QoL increases if w e adenocarcino use epirubicin, cisplatin, ma and PVI 5-FU Advanced gastric cancer Advanced gastric cancer Locally advanced or metastic disease Locally advanced or metastic disease QoL increases in chemotherapy w ith best supportive care QoL increases w ith second-line chemotherapy Patients not submitted to chemotherapy Patients submitted to second-line chemotherapy Best supportive care Chemotherapy and best suportive care EORTC QLQ-C30 Patients submitted to a treatment w ith epirubicin and cisplatin Patients submitted to a venous infusion of 5fluorouracil EORTC QLQ-C30 Patients submitted to chemotherapy Patients submitted to fluoreouracil-based combination chemotherapy Inoperable carcinoma No differences in QoL Patients submitted to a treatment w ith epurubicin and cisplatin in combination w ith infusion 5-fluorouracil Patients not submitted to this treatment Locally advanced or metastic disease No differences in QoL Rotterdam Symptom Checklist QoL increases in chemotherapy w ith best supportive care QoL increases in both groups Fist author and Publication date of the article Instrum ent Validation paper of the instrum ents Group in study Control group Patients stage Results Park SH, 2005 EORTC QLQ-C30; HADS Patients submitted to second-line chemotherapy Patients not submitted to chemotherapy Locally advanced or metastic disease QoL increases w ith second-line chemotherapy EORTC QLQ-C30 Patients not submitted to chemotherapy Patients treated w ith [177LuDOTA0,Tyr3]octreotate Metastic tumor (GEP) QoL increases in patients treated w ith [177-LuDOTA0,Tyr3]octreotate Teunissen JJ, 2004 Tebbutt NC 2002 EORTC QLQ-C30 Patients submitted to protracted venous infusion (PVI) 5fluorouracil (5-FU) Bramhall SR 2002 EORTC QLQ-C30 Placebo Ross P, 2002 EORTC QLQ-C30 Nordin K, 2001 EORTC QLQ-C30 Katarina H, 1998 EORTC QLQ-C30 Glimelius B, 1997 EORTC QLQ-C30 Bamias A, 1996 Chau I, 2004 Findlay M, 1994 Locally Patients submitted to PVI 5- advanced or FU plus mitomycin C metastic disease Locally Patients submitted to advanced or chemotherapy metastic disease Patients submitted to mitomycin, cisplatin, and Patients submitted to protracted venousepirubicin, cisplatin, and infusion fluorouracil (PVI 5PVI 5-FU FU) Patients submitted to Patients submitted to chemotherapy w ithout chemotherapy w ith best best supportive care supportive care No differences in QoL No differences in QoL Inoperable QoL increases if w e adenocarcino use epirubicin, cisplatin, ma and PVI 5-FU Advanced gastric cancer Advanced gastric cancer Locally advanced or metastic disease Locally advanced or metastic disease QoL increases in chemotherapy w ith best supportive care QoL increases w ith second-line chemotherapy Patients not submitted to chemotherapy Patients submitted to second-line chemotherapy Best supportive care Chemotherapy and best suportive care EORTC QLQ-C30 Patients submitted to a treatment w ith epirubicin and cisplatin Patients submitted to a venous infusion of 5fluorouracil EORTC QLQ-C30 Patients submitted to chemotherapy Patients submitted to fluoreouracil-based combination chemotherapy Inoperable carcinoma No differences in QoL Patients submitted to a treatment w ith epurubicin and cisplatin in combination w ith infusion 5-fluorouracil Patients not submitted to this treatment Locally advanced or metastic disease No differences in QoL Rotterdam Symptom Checklist QoL increases in chemotherapy w ith best supportive care QoL increases in both groups Fist author and Publication date of the article Instrum ent Validation paper of the instrum ents Group in study Control group Patients stage Results Park SH, 2005 EORTC QLQ-C30; HADS Patients submitted to second-line chemotherapy Patients not submitted to chemotherapy Locally advanced or metastic disease QoL increases w ith second-line chemotherapy EORTC QLQ-C30 Patients not submitted to chemotherapy Patients treated w ith [177LuDOTA0,Tyr3]octreotate Metastic tumor (GEP) QoL increases in patients treated w ith [177-LuDOTA0,Tyr3]octreotate Teunissen JJ, 2004 Tebbutt NC 2002 EORTC QLQ-C30 Patients submitted to protracted venous infusion (PVI) 5fluorouracil (5-FU) Bramhall SR 2002 EORTC QLQ-C30 Placebo Ross P, 2002 EORTC QLQ-C30 Nordin K, 2001 EORTC QLQ-C30 Katarina H, 1998 EORTC QLQ-C30 Glimelius B, 1997 EORTC QLQ-C30 Bamias A, 1996 Chau I, 2004 Findlay M, 1994 Locally Patients submitted to PVI 5- advanced or FU plus mitomycin C metastic disease Locally Patients submitted to advanced or chemotherapy metastic disease Patients submitted to mitomycin, cisplatin, and Patients submitted to protracted venousepirubicin, cisplatin, and infusion fluorouracil (PVI 5PVI 5-FU FU) Patients submitted to Patients submitted to chemotherapy w ithout chemotherapy w ith best best supportive care supportive care No differences in QoL No differences in QoL Inoperable QoL increases if w e adenocarcino use epirubicin, cisplatin, ma and PVI 5-FU Advanced gastric cancer Advanced gastric cancer Locally advanced or metastic disease Locally advanced or metastic disease QoL increases in chemotherapy w ith best supportive care QoL increases w ith second-line chemotherapy Patients not submitted to chemotherapy Patients submitted to second-line chemotherapy Best supportive care Chemotherapy and best suportive care EORTC QLQ-C30 Patients submitted to a treatment w ith epirubicin and cisplatin Patients submitted to a venous infusion of 5fluorouracil EORTC QLQ-C30 Patients submitted to chemotherapy Patients submitted to fluoreouracil-based combination chemotherapy Inoperable carcinoma No differences in QoL Patients submitted to a treatment w ith epurubicin and cisplatin in combination w ith infusion 5-fluorouracil Patients not submitted to this treatment Locally advanced or metastic disease No differences in QoL Rotterdam Symptom Checklist QoL increases in chemotherapy w ith best supportive care QoL increases in both groups Limitations Related with Search Discussion QoL after Chemo/Radiotherapy in Gastric Cancer Lack of information due to: Japan is a country with a high Many articles in japanese incidence of gastric cancer.7 Most of the papers focus on surgery Because Surgery is the only potencially curative treatment in gastric cancer.8 7-IARC Scientific Publications. In: Whelan SL, Parkin DM, Masuyer E, eds. Trends in Cancer Incidence and Mortality. Lyon: WHO Publications, 1993;102. 8-Wilke Hj, Van Cutsem E. Current treatments and future perspectives in colorectal and gastric cancer . Ann Oncol, 2003;14: 49-55. Discussion Limitations Related with Treatment QoL after Chemo/Radiotherapy in Gastric Cancer Chemo and radiotherapy are considered: Adjuvant therapies (before or after surgery)8 Palliative treatments7 8-Current treatments and future perspectives in colorectal and gastric cancer . Discussion Limitations Related with Papers QoL after Chemo/Radiotherapy in Gastric Cancer Just a few could be included Some of the causes: Studies just evaluated differences on survival time according to treatment Only the physical parameters were considered Discussion Limitations Related with Papers QoL after Chemo/Radiotherapy in Gastric Cancer Just a few could be included Some of the causes: Studies just evaluated differences on survival time according to treatment Only the physical parameters were considered QoL is still a minor concern! Discussion Meta analysis QoL after Chemo/Radiotherapy in Gastric Cancer Evaluation of QoL is qualitative, although a scale exists in every instrument Therefore: It was impossible to achieve a meta analysis with the obtained data Discussion Meta analysis QoL after Chemo/Radiotherapy in Gastric Cancer Evaluation of QoL is qualitative, although a scale exists in every instrument Therefore: It was impossible to achieve a meta analysis with the obtained data More research is needed Discussion Questionnaires used QoL after Chemo/Radiotherapy in Gastric Cancer Questionnaire Number of Items Areas Measured EORTC QLQ-C30 30 physical, functional, social, and emotional RSCL 30 psychological and physical HADS 14 psychological Discussion Questionnaires Some differences QoL after Chemo/Radiotherapy in Gastric Cancer Maybe this isn’t the best approach... Items removed from the applied questionnaires Do you have any trouble taking a long Items of the questionnaires for patients under palliation walk? you limited in pursing your hobbies or other leisure time activities? I am satisfied with my sex life I am able to enjoy life Lack of sexual interest Approximately how many hours per day (8 a.m. to 8 p.m.) have you been lying down? How much help have you needed with dressing and hygiene? How much pain have you had last week? How many days during the past week have you spent in a hospital/nursing home? Discussion Questionnaires proposed QoL after Chemo/Radiotherapy in Gastric Cancer Questionnaire Number of Items Areas Measured AQEL 36 physical, psychological, social, existential EORTC QLQ-C15-PAL 15 Functional, choice of treatment, psychological PQLI 28 McGill 16 FLIC 22 functional, symptom, choice of treatment scale, psychological physical symptoms, psychological symptoms, outlook on life, and meaningful existence physical well-being and ability, emotional state, sociability, family situation and nausea Discussion Final Remarks QoL after Chemo/Radiotherapy in Gastric Cancer When chemo and radiotherapy are used as treatment The instrument to measure QoL should not be the same used with the other treatments The most appropriate option is a Questionnaire to Patients under Palliation A Systematic Review about these instruments can be consulted to better understand their characteristics Discussion Final Remarks QoL after Chemo/Radiotherapy in Gastric Cancer When chemo and radiotherapy are used as treatment The instrument to measure QoL should not be the same used with the other treatments The most appropriate option is a Questionnaire to Patients under Palliation “Instruments for assessing quality of life in palliative care settings.” Massaro T, McMillan SC; Int J Palliat Nurs.; 2000 Oct; 6(9):429-33 Web Site QoL after Chemo/Radiotherapy in Gastric Cancer Trabalho anual - FMUP- Faculdade de Medicina da Universidade do Porto Acknowledgments QoL after Chemo/Radiotherapy in Gastric Cancer We acknowledge the help of: Cláudia Camila Dias Mário Dinis Ribeiro We are also very grateful to: Professor Doutor Altamiro da Costa Pereira Not forgetting: All the authors that have promptly fournished the articles necessary for the succes of our work