Generalizability of toxicity data from oncology clinical trials to clinical practice: Toxicity of irinotecan-based regimens in patients with metastatic colorectal cancer

Current Oncology

Volumn 16, Issue 6, 2009, Pages 13-20

  Tam, V C ^a   Rask, S ^a   Koru Sengul, T ^a   Dhesy Thind, Sukhbinder ^a  

^a MCMASTER UNIVERSITY   (Canada)

Author keywords

Clinical trials; Colorectal neoplasms; Drug therapy; Drug toxicity

Indexed keywords

BEVACIZUMAB; CAPECITABINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN;

ARTICLE; CANCER PATIENT; CLINICAL PRACTICE; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUOUS INFUSION; DIARRHEA; DRUG FATALITY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; HUMAN; LIVER METASTASIS; MEDICAL RECORD REVIEW; METASTASIS POTENTIAL; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; ONCOLOGY; QUANTITATIVE ANALYSIS; TREATMENT OUTCOME; VOMITING;

EID: 72949085053     PISSN: None     EISSN: 17187729     Source Type: Journal    
DOI: 10.3747/co.v16i6.426     Document Type: Article

References (23)

1. Elting LS, Cooksley C, Bekele BN, et al. Generalizability of cancer clinical trial results: prognostic differences between participants, and nonparticipants. Cancer 2006;106:2452-2458 (Pubitemid 43787670)
2. Hori A, Shibata T, Kami M, et al. Age disparity between a cancer population and participants in clinical trials submitted as a new drug application of anticancer drugs in Japan. Cancer 2007;109:2541-2546 (Pubitemid 46906474)
3. Mayers C, Panzarella T, Tannock IF. Analysis of prognostic effects of inclusion in clinical trial and of myelosuppression on survival after adjuvant chemotherapy for breast carcinoma. Cancer 2001;91:2246-2257 (Pubitemid 32552809)
4. Cottin V, Arpin D, Lasset C, et al. Small-cell lung cancer: patients included in clinical trials are not representative of the patient population as a whole. Ann Oncol 1999;10:809-815 (Pubitemid 29367998)
5. Fossa SD, Skovlund E. Selection of patients may limit generalizability of results from cancer clinical trials. Acta Oncol 2002;41:131-137 (Pubitemid 34557072)
6. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within, and outside clinical trials: conceptual framework, and structured review. Lancet 2004;363:263-270 (Pubitemid 38142408)
7. Kelly H, Goldberg RM. Systemic therapy for metastatic colorectal cancer: current options, current evidence. J Clin Oncol 2005;23:4553-4560 (Pubitemid 46196586)
8. Douillard JY, Cunningham D, Roth AD, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multi-centre randomised trial. Lancet 2000;355:1041-1047 (Pubitemid 30162806)
9. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 2000;343:905-914 (Pubitemid 30727802)
10. Köhne CH, van Cutsem E, Wils J, et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol 2005;23:4856-4865
11. Colucci G, Vittorio G, Paoletti G, et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell'Italia Meridionale. J Clin Oncol 2005;23:4866-4875
12. Patt YZ, Lee FC, Liebmann JE, et al. Capecitabine plus 3-weekly irinotecan (XELIRI regimen) as first-line chemotherapy for metastatic colorectal cancer: phase II trial results. Am J Clin Oncol 2007;30:350-357 (Pubitemid 47356678)
13. Cunningham D, Pyrhonen S, James RD, et al. Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet 1998;352:1413-1418 (Pubitemid 28510874)
14. Rougier P, Van Cutsem E, Bajetta E, et al. Randomised trial of irinotecan versus fluorouracil by continuous infusion after fluorouracil failure in patients with metastatic colorectal cancer. Lancet 1998;352:1407-1412 (Pubitemid 28510873)
15. Fuchs CS, Moore MR, Harker G, Villa L, Rinaldi D, Hecht JR. Phase III comparison of two irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol 2003;21:807-814 (Pubitemid 46606439)
16. Repetto L. Greater risks of chemotherapy toxicity in elderly patients with cancer. J Support Oncol 2003;1(suppl 2):18-24.
17. Balducci L, Extermann M. Cancer chemotherapy in the older patient: what the medical oncologist needs to know. Cancer 1997;80:1317-1322 (Pubitemid 27407235)
18. Chau I, Norman AR, Cunningham D, et al. Elderly patients with fluoropyrimidine and thymidylate synthase inhibitor-resistant advanced colorectal cancer derive similar benefit without excessive toxicity when treated with irinotecan monotherapy. Br J Cancer 2004;91:1453-1458 (Pubitemid 39486347)
19. Fata F, Mirza A, Craig Wood G, et al. Efficacy, and toxicity of adjuvant chemotherapy in elderly patients with colon carcinoma: a 10-year experience of the Geisinger Medical Center. Cancer 2002;94:1931-1938 (Pubitemid 34270045)
20. Sastre J, Marcuello E, Masutti B, et al. Irinotecan in combination with fluorouracil in a 48-hour continuous infusion as first-line chemotherapy for elderly patients with metastatic colorectal cancer: a Spanish Cooperative Group for the Treatment of Digestive Tumors study. J Clin Oncol 2005;23:3545-3551 (Pubitemid 46243499)
21. Souglakos J, Pallis A, Kakolyris S, et al. Combination of irinotecan (CPT-11) plus 5-fluorouracil, and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: a phase II trial. Oncology 2005;69:384-390 (Pubitemid 41797914)
22. Lewis JH, Kilgore ML, Goldman DP, et al. Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 2003;21:1383-1389 (Pubitemid 46606420)
23. Miller RJ. The role of chemotherapy in the hospice patient: a problem of definition. Am J Hosp Palliat Care 1989; 6: 19-26.