Longitudinal quality of life study in patients with metastatic gastric cancer: Analysis modalities and clinical applicability of QoL in randomized phase II trial in a digestive oncology

Gastroenterologie Clinique et Biologique

Volumn 29, Issue 11, 2005, Pages 1113-1124

  Bonnetain, Franck ^a,d   Bouché, Olivier ^b   Conroy, Thierry ^c   Arveux, Patrick ^d   Raoul, Jean Luc ^e   Giovannini, Marc ^f   Etienne, Pierre Luc ^g   Mitry, Emmanuel ^h   Seitz, Jean François ⁱ   Rougier, Philippe ^h   Girault, Cécile ^a   Bedenne, Laurent ^a,j  

^a INSERM   (France)

^b SERVICE DE DERMATOLOGIE   (France)

^c CENTRE ALEXIS VAUTRIN   (France)

^d CENTRE GEORGES FRANÇOIS LECLERC   (France)

^e CENTRE EUGÈNE MARQUIS   (France)

^f INSTITUT PAOLI CALMETTES   (France)

^g Clinique Armoricaine   (France)

^h ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

ⁱ TIMONE HOSPITAL   (France)

^j HÔPITAL DU BOCAGE   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; FLUOROURACIL; FOLINIC ACID; IRINOTECAN;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CARDIOTOXICITY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DETERIORATION; DIARRHEA; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; INFECTION; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; MEASUREMENT; METASTASIS; MULTICENTER STUDY; NEUROTOXICITY; NEUTROPENIA; ONCOLOGY; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SCORING SYSTEM; SKIN TOXICITY; STOMACH ADENOCARCINOMA; STOMACH CANCER; STOMATITIS; THROMBOCYTOPENIA; TREATMENT OUTCOME; TREATMENT WITHDRAWAL;

EID: 30044446936     PISSN: 03998320     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0399-8320(05)82175-X     Document Type: Article

References (47)

1. Parkin DM, Whelan SL, Ferlay J, Teppo L, Thomas DB et al. Cancer incidence in five continents. Lyon: IARC, 2002.
2. Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 2000;343:905-14.
3. Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 2000;355:1041-7.
4. Blanke CD, Haller DG, Benson AB, Rothenberg ML, Berlin J, Mori M, et al. A phase II study of irinotecan with 5-fluorouracil and leucovorin in patients with previously untreated gastric adenocarcinoma. Ann Oncol 2001;12:1575-80.
5. Kohne CH, Catane R, Klein B, Ducreux M, Thuss-Patience P, Niederle N, et al. Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial. Br J Cancer 2003;89:997-1001.
6. Lin-Shin L, Hecht J: A Phase II Trial of Irinotecan in Patients with Advanced Adenocarcinoma of the Gastroesophageal (GE) Junction (abstract). Proc Am Soc Clin Oncol 2000;19:1130.
7. Bouche O, Raoul JL, Bonnetain F, Giovannini M, Etienne PL, Lledo G, et al. Randomized multicenter phase II trial of a biweekly regimen of fluorouracil and leucovorin (LV5FU2), LV5FU2 plus cisplatin, or LV5FU2 plus irinotecan in patients with previously untreated metastatic gastric cancer: a Federation Francophone de Cancerologie Digestive Group Study - FFCD 9803. J Clin Oncol 2004;22:4319-28.
8. Carr AJ, Gibson B, Robinson PG. Measuring quality of life: Is quality of life determined by expectations or experience? BMJ 2001;322:1240-3.
9. Wood-Dauphinee S. Assessing quality of life in clinical research: from where have we come and where are we going? J Clin Epidemiol 1999;52:355-63.
10. Addington-Hall J, Kalra L. Who should measure quality of life? BMJ 2001;322:1417-20.
11. Moinpour CM, Feigl P, Metch B, Hayden KA, Meyskens FL, Jr., Crowley J. Quality of life end points in cancer clinical trials: review and recommendations. J Natl Cancer Inst 1989;81:485-95.
12. Sloan JA, Loprinzi CL, Kuross SA, Miser AW, O'Fallon JR, Mahoney MR, et al. Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol 1998;16:3662-73.
13. Michael M, Tannock IF. Measuring health-related quality of life in clinical trials that evaluate the role of chemotherapy in cancer treatment. CMAJ 1998;158:1727-34.
14. Gotay CC, Korn EL, McCabe MS, Moore TD, Cheson BD. Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst 1992;84:575-9.
15. Bottomley A. The cancer patient and quality of life. Oncologist 2002;7:120-5.
16. Cohen SR, Mount BM. Living with cancer: "good" days and "bad" days - what produces them? Can the McGill quality of life questionnaire distinguish between them? Cancer 2000;89:1854-65.
17. Machin D, Weeden S. Suggestions for the presentation of quality of life data from clinical trials. Stat Med 1998;17:711-24.
18. Fairclough DL. Summary measures and statistics for comparison of quality of life in a clinical trial of cancer therapy. Stat Med 1997;16:1197-209.
19. Testa MA, Nackley JF. Methods for quality-of-life studies. Annu Rev Public Health 1994;15:535-59.
20. Fayers PM, Hopwood P, Harvey A, Girling DJ, Machin D, Stephens R. Quality of life assessment in clinical trials - guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office. Eur J Cancer 1997;33:20-8.
21. Young T, de Haes H, Curran D, Fayers P,Brandberg V, Vanvoorden V, et al. Guidelines for assessing quality of life in EORTC clinical trials. Brussel: EORTC Quality of life group 2004.
22. Hobday TJ, Kugler JW, Mahoney MR, Sargent DJ, Sloan JA, Fitch TR, et al. Efficacy and quality-of-life data are related in a phase II trial of oral chemotherapy in previously untreated patients with metastatic colorectal carcinoma. J Clin Oncol 2002;20:4574-80.
23. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-76.
24. Ringdal GI, Ringdal K. Testing the EORTC Quality of Life Questionnaire on cancer patients with heterogeneous diagnoses. Qual Life Res 1993;2:129-40.
25. Anderson RT, Aaronson NK, Wilkin D. Critical review of the international assessments of health-related quality of life. Qual Life Res 1993;2:369-95.
26. Hjermstad MJ, Fossa SD, Bjordal K, Kaasa S. Test/retest study of the European Organization for Research and Treatment of Cancer Core Quality-of-Life Questionnaire. J Clin Oncol 1995;3:1249-54.
27. rd ed). Brussels: EORTC 2001.
28. Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Stat Med 1994;13:1727-36.
29. Pauler DK, McCoy S, Moinpour C. Pattern mixture models for longitudinal quality of life studies in advanced stage disease. Stat Med 2003;22:795-809.
30. Fairclough DL, Gagnon DD, Zagari MJ, Marschner N, Dicato M. Evaluation of quality of life in a clinical trial with nonrandom dropout: the effect of epoetin alfa in anemic cancer patients. Qual Life Res 2003;12:1013-27.
31. Klee M, Groenvold M, Machin D. Using data from studies of health-related quality of life to describe clinical issues examples from a longitudinal study of patients with advanced stages of cervical cancer. Qual Life Res 1999;8:733-42.
32. Schwartz CE, Sprangers MA. Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Soc Sci Med 1999;48:1531-48.
33. Cnaan A, Laird NM, Slasor P. Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Stat Med 1997;16:2349-80.
34. Diggle PJ. An approach to the analysis of repeated measurements. Biometrics 1988;44:959-71.
35. Dixon WJ, Merdian K. ANOVA and regression with BMDP 5V. Los Angeles 1992.
36. Simes RJ, Greatorex V, Gebski VJ. Practical approaches to minimize problems with missing quality of life data. Stat Med 1998;17:725-37.
37. Fairclough DL. Design and analysis of quality of life studies in clinical trials. Boca Raton: Chapman & Hall/CRC 2002.
38. Glimelius B, Ekstrom K, Hoffman K, Graf W, Sjoden PO, Haglund U, et al. Randomized comparison between chemotherapy plus best supportive care with best supportive care in advanced gastric cancer. Ann Oncol 1997;8:163-8.
39. Ross P, Nicolson M, Cunningham D, Valle J, Seymour M, Harper P, 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. J Clin Oncol 2002;20:1996-2004.
40. Webb A, Cunningham D, Scarffe JH, Harper P, Norman A, Joffe JK, et al. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer. J Clin Oncol 1997;15:261-7.
41. Fairclough DL, Peterson HF, Cella D, Bonomi P. Comparison of several model-based methods for analysing incomplete quality of life data in cancer clinical trials. Stat Med 1998;17:781-96.
42. Bernhard J, Cella DF, Coates AS, Fallowfield L, Ganz PA, Moinpour CM, et al. Missing quality of life data in cancer clinical trials: serious problems and challenges. Stat Med 1998;17:517-32.
43. Cox K. Assessing the quality of life of patients in phase I and II anticancer drug trials: interviews versus questionnaires. Soc Sci Med 2003;56:921-34.
44. Moinpour CM, Lyons B, Schmidt SP, Chansky K, Patchell RA. Substituting proxy ratings for patient ratings in cancer clinical trials: an analysis based on a Southwest Oncology Group trial in patients with brain metastases. Qual Life Res 2000;9:219-31.
45. Pater J, Osoba D, Zee B, Lofters W, Gore M, Dempsey E, et al. Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial. Qual Life Res 1998;7:273-8.
46. Vickers AJ. Message to complementary and alternative medicine: evidence is a better friend than power. BMC Complement Altern Med 2001;1:1.
47. Blazeby JM, Conroy T, Bottomley A, Vickery C, Arraras J, Sezer O, et al. Clinical and psychometric validation of a questionnaire module, the EORTC QLQ-STO 22, to assess quality of life in patients with gastric cancer. Eur J Cancer 2004;40:2260-8.