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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 1 FMUP/SBIM Gastric Cancer in the World 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) FMUP/SBIM 2 Gastric Cancer in Europe Cumulative risk, 0-64 years Female Male Eucan - Database FMUP/SBIM 3 Introduction QoL after Chemo/Radiotherapy in Gastric Cancer Stomach adenocarcinoma is the most common form of gastric cancer (95% of the cases).1 Stomach cancer is a multifactorial disease:diet, hereditary factors, Helicobacter pylori infection are possible causes.2-3 Tobacco smoking has also been clearly accepted as increasing the risk of stomach cancer.4 1- Crew KD, Neugut AI. Epidemiology of upper gastrointestinal malignancies. Seminin Oncol 2004; 31: 450–464. 2- World Cancer Research Fund (WCRF) Panel. Diet, nutrition and the prevention of cancer: a global perspective. Washington, DC, USA: World Cancer Research Fund; 1997. 3- IARC Monograph on the Evaluation of Carcinogenic Risks to Humans, Vol. 61. Schistosomes, Liver Flukes and helicobacter pylori. Lyon, France: International Agency for Research on Cancer; 1994. 4- IARC Monographs on the Evaluation of Carcinogenic Risk to Humans. Vol. 83: Tobacco Smoke and Involuntary Smoking. Lyon, France: International Agency for Research on Cancer; 2004. 4 Introduction Treatment cancer for often QoL after Chemo/Radiotherapy in Gastric Cancer gastric involves surgery, usually a partial or a total (removal gastrectomy of stomach Chemotherapy and tissue).5 radiotherapy are standard for some stages of stomach cancer.5 5-Ross P, Nicolson M, Cunningham D, Valle J, et al. 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. 5 Introduction QoL after Chemo/Radiotherapy in Gastric Cancer Chemotherapy is the use of chemical agents to stop cancer cells from growing.6 Chemotherapy is considered a systemic treatment.6 6-Janunger KG, Hafström L, Nygren P, Glimelius B for teha SBU-group. A Systematic Overview of Chemotherapy Effects in Gastric Cancer. Acta Oncologica, Vol. 40, No. 2/3, pp. 309-326, 2001. 6 Introduction QoL after Chemo/Radiotherapy in Gastric Cancer Radiotherapy uses high energy x-rays to destroy cancer cells.7 A small dose of radiotherapy may be very helpful to relieve pain.7 7-Kim GE, Shin HS, MD, et al. 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. 7 Introduction These multiple treatments have different consequences in Quality of Life (QoL) in patients.8 QoL after Chemo/Radiotherapy in Gastric Cancer QoL cannot be yet universally defined8, however there are many attempts to do so. Schipper et al. proposed: “the functional effect of illness and its consequent therapy upon a patient, as perceived by the patient”.9 8-Spilker B, ed. Quality of Life and pharmacoeconomics in clinical trials. Philadelphia:Lippincott-Raven, 1996. 9- Schipper H, Clinch J, Olweny LM. Definitions and conceptual issues. In: Spilker B, ed. Quality of Life and pharmacoeconomics in clinical trials, Philadephia : Lippincott- Raven, 1996: 11-24 8 Aim QoL after Chemo/Radiotherapy in Gastric Cancer ____________________________________________ • To review which instruments were used to measure the QoL in patients with gastric cancer submitted to chemo and radiotherapy. • To summarize QoL measures across studies. ____________________________________________ FMUP/SBIM 9 Methods QoL after Chemo/Radiotherapy in Gastric Cancer The Query used was: ◊ ″Gastric cancer AND (Quality of Life OR Psychology) AND (Radiotherapy OR Chemotherapy)” Literature searches were conducted in Medline. FMUP/SBIM 10 Limits QoL after Chemo/Radiotherapy in Gastric Cancer Publication Date until September 2005. Only items with an abstract. Humans. FMUP/SBIM 11 Methods QoL after Chemo/Radiotherapy in Gastric Cancer Inclusion Criteria one had gastric cancer; - Patients submitted to chemo or radiotherapy; - QoL measured with an Instrument to measure QOL? who QOL evaluated by the patient? - Patients Submitted to chemo or radiotherapy? patients; 90 80 70 60 50 40 30 20 10 0 Gastric cancer? - QoL evaluated by the No. of articles participant; More than one participant? than Was QOL evaluated? - More Inclusion criteria appropriate instrument. FMUP/SBIM 12 Methods QoL after Chemo/Radiotherapy in Gastric Cancer Exclusion criteria - Articles in which QoL was measure but only symptoms were studied; - Articles that referred to patients submitted to a surgery during or before treatment. 40 35 No. of articles - Articles based on mixed diagnostic groupings (in the article these have to be approached separately); 30 25 20 15 10 5 0 Mixed groups? Were only the symptoms measured? Surgery? Exclusion criteria FMUP/SBIM 13 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. FMUP/SBIM 14 Fluxogram QoL after Chemo/Radiotherapy in Gastric Cancer Start Read title and abstract Excluded by 2 reviewers Yes Exclude article No Included by 2 reviewers Yes no Yes Include article Opinion of a third reviewer Read complete article Yes Excluded by 2 reviewers Discuss until reviewers agreement No Include Article Exclude article Yes Included by 2 reviewers Include article no Opinion of a third reviewer No Yes Introduce data in the SPSS Discuss until reviewers agreement Include Article No Exclude Article 15 End Results QoL after Chemo/Radiotherapy in Gastric Cancer 116 articles were found; Due to the application of the inclusion and exclusion criteria, 10 were included and 76 were excluded; Some of the articles found couldn’t be read and so we don’t have information referred to them; Only 1 of the included articles didn’t have a validated paper of the instrument. FMUP/SBIM 16 Results QoL after Chemo/Radiotherapy in Gastric Cancer Article Questionnaire A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer EORTC) QLQ-C30 Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. EORTC) QLQ-C30 Evaluation of Clinical Benifit of Chemotherapy in Patients with upper Gastrointestinal Cancer Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. CBR EORTC) QLQ-C30 A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). Rotterdam Symptom Checklist Epirubicin, cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastric adenocarcinoma: response, toxicity, quality of life, and survival. EORTC) QLQ-C30 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. EORTC) QLQ-C31 Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients. EORTC) QLQ-C32 Quality of life in patients with gastroenteropancreatic tumors treated with [177LuDOTA0,Tyr3]octreotate. EORTC) QLQ-C30 Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer--pooled analysis from three multicenter, randomized, controlled trials using individual patient data. EORTC) QLQ-C30 17 Results QoL after Chemo/Radiotherapy in Gastric Cancer Validation Paper of the instrument Publication Date Name of first Author A multicentre, randomised phase III trial comparing protracted venous infusion (PVI) 5-fluorouracil (5-FU) with PVI 5-FU plus mitomycin C in patients with inoperable oesophago-gastric cancer 2002 Tebbutt NC √ Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. 2002 Bramhall SR √ Evaluation of Clinical Benifit of Chemotherapy in Patients with upper Gastrointestinal Cancer 1998 Katarina H Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. 1997 Glimelius B √ A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). 1994 Findlay M √ Epirubicin, cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastric adenocarcinoma: response, toxicity, quality of life, and survival. 1996 Bamias A √ 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. 2002 Ross P √ Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients. 2001 Nordin K √ Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. 2004 Teunissen JJ √ Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer--pooled analysis from three multicenter, randomized, controlled trials using individual patient data. 2004 Chau I √ Article Present Absent √ FMUP/SBIM 18