1. 1 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 FMUP/SBIM

2. 2 Gastric Cancer in the World FMUP/SBIM 850 000 deaths worlwide each year cause due to gastric cancer World, age-standardized rates (per 100.000 persons.year) Eucan - Database

3. 3 Gastric Cancer in Europe Male Female FMUP/SBIM Cumulative risk, 0-64 years Eucan - Database

4. 4 Introduction 1  Stomach adenocarcinoma is the most common form of gastric cancer (95% of the cases). 1 2-3  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. QoL after Chemo/Radiotherapy in Gastric Cancer

5. 5 Introduction 5  Treatment for gastric cancer often involves surgery, usually a partial or a total gastrectomy (removal of stomach tissue). 5 5  Chemotherapy and 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. QoL after Chemo/Radiotherapy in Gastric Cancer

6. 6 Introduction 6  Chemotherapy is the use of chemical agents to stop cancer cells from growing. 6 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. QoL after Chemo/Radiotherapy in Gastric Cancer

7. 7 Introduction 7  Radiotherapy uses high energy x-rays to destroy cancer cells. 7 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. QoL after Chemo/Radiotherapy in Gastric Cancer

8. 8 Introduction  These multiple treatments have different consequences in Quality of Life (QoL) in patients. 8  QoL cannot be yet universally defined 8, 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 QoL after Chemo/Radiotherapy in Gastric Cancer 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

9. 9 Aim FMUP/SBIM 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. ____________________________________________

10. 10 Methods  The Query used was: ◊ ″Gastric cancer AND (Quality of Life OR Psychology) AND (Radiotherapy OR Chemotherapy)” FMUP/SBIM QoL after Chemo/Radiotherapy in Gastric Cancer  Literature searches were conducted in Medline.

11. 11 Limits FMUP/SBIM QoL after Chemo/Radiotherapy in Gastric Cancer  Publication Date until September 2005.  Only items with an abstract.  Humans.

12. 12 Methods  Inclusion Criteria -More than one participant; -QoL evaluated by the patients; -Patients who had gastric cancer; -Patients submitted to chemo or radiotherapy; -QoL measured with an appropriate instrument. FMUP/SBIM QoL after Chemo/Radiotherapy in Gastric Cancer

13. 13 Methods  Exclusion criteria -Articles based on mixed diagnostic groupings (in the article these have to be approached separately); -Articles in which QoL was measure but only symptoms were studied; -Articles that referred to patients submitted to a surgery during or before treatment. FMUP/SBIM QoL after Chemo/Radiotherapy in Gastric Cancer

14. 14 Methods  Validation Papers oA 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. QoL after Chemo/Radiotherapy in Gastric Cancer FMUP/SBIM

15. 15 Fluxogram QoL after Chemo/Radiotherapy in Gastric Cancer

16. 16 Results  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. QoL after Chemo/Radiotherapy in Gastric Cancer FMUP/SBIM

17. 17 Results ArticleQuestionnaire 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 CBR Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. 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 [177Lu- DOTA0,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 QoL after Chemo/Radiotherapy in Gastric Cancer

18. 18 Results Article Publication Date Name of first Author Validation Paper of the instrument PresentAbsent 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 2002Tebbutt NC √ Marimastat as maintenance therapy for patients with advanced gastric cancer: a randomised trial. 2002Bramhall SR √ Evaluation of Clinical Benifit of Chemotherapy in Patients with upper Gastrointestinal Cancer 1998Katarina H √ Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. 1997Glimelius B √ A phase II study in advanced gastro-esophageal cancer using epirubicin and cisplatin in combination with continuous infusion 5-fluorouracil (ECF). 1994Findlay M √ Epirubicin, cisplatin, and protracted venous infusion of 5-fluorouracil for esophagogastric adenocarcinoma: response, toxicity, quality of life, and survival. 1996Bamias 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. 2002Ross P √ Alternative methods of interpreting quality of life data in advanced gastrointestinal cancer patients. 2001Nordin K √ Quality of life in patients with gastroenteropancreatic tumors treated with [177Lu-DOTA0,Tyr3]octreotate. 2004Teunissen 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. 2004Chau I √ QoL after Chemo/Radiotherapy in Gastric Cancer FMUP/SBIM