Irinotecan/fluorouracil combination in first-line therapy of older and younger patients with metastatic colorectal cancer: Combined analysis of 2,691 patients in randomized controlled trials

Journal of Clinical Oncology

Volumn 26, Issue 9, 2008, Pages 1443-1451

  Folprecht, Gunnar ^a   Seymour, Matthew T ^a   Saltz, Leonard ^a   Douillard, Jean Yves ^a   Hecker, Hartmut ^a   Stephens, Richard J ^a   Maughan, Timothy S ^a   Van Cutsem, Eric ^a   Rougier, Philippe ^a   Mitry, Emmanuel ^a   Schubert, Ute ^a   Köhne, Claus Henning ^a  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; DRUG DERIVATIVE;

AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER SURVIVAL; CLINICAL TRIAL; COLORECTAL CANCER; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; FEMALE; HAND FOOT SYNDROME; HUMAN; INFECTION; LEUKOPENIA; LIVER TOXICITY; MALE; MONOTHERAPY; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; RISK ASSESSMENT; STOMATITIS; THROMBOCYTOPENIA; THROMBOSIS; TREATMENT RESPONSE; VOMITING; AGE; CANCER STAGING; COLORECTAL TUMOR; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; EPIDEMIOLOGY; KAPLAN MEIER METHOD; META ANALYSIS; MIDDLE AGED; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROPORTIONAL HAZARDS MODEL; RISK; STATISTICAL MODEL; TREATMENT OUTCOME;

AGE FACTORS; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; CLINICAL TRIALS, PHASE III AS TOPIC; COLORECTAL NEOPLASMS; CONFOUNDING FACTORS (EPIDEMIOLOGY); DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; KAPLAN-MEIERS ESTIMATE; LEUCOVORIN; LOGISTIC MODELS; MALE; MIDDLE AGED; NEOPLASM STAGING; ODDS RATIO; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 41149180580     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.14.0509     Document Type: Article

References (35)

1. Simmonds PC: Palliative chemotherapy for advanced colorectal cancer: Systematic review and meta-analysis. Colorectal Cancer Collaborative Group. BMJ 321:531-535, 2000
2. Tournigand C, Andre T, Achille E, et al: FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: A randomized GERCOR study. J Clin Oncol 22:229-237, 2004
3. 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 multicentre randomised trial. Lancet 355:1041-1047, 2000
4. de Gramont A, Figer A, Seymour M, et al: Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947, 2000
5. 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 23:4856-4865, 2005
6. Saltz L, Clarke S, Diaz-Rubio E, et al: Bevacizumab (Bev) in combination with XELOX or FOLFOX4: Updated efficacy results from XELOX-1/NO16966, a randomized phase III trial in first-line metastatic colorectal cancer. J Clin Oncol 25, 2007 (suppl; abstr 4028)
7. Van Cutsem E, Nowacki M, Lang I, et al: Randomized phase III study of irinotecan and FU/FA with or without cetuximab in the first-line treatment of patients with metastatic colorectal cancer (mCRC): The CRYSTAL trial. J Clin Oncol 25, 2007 (suppl; abstr 4000)
8. Hurwitz H, Fehrenbacher L, Novotny W, et al: Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med 350:2335-2342, 2004
9. Parkin DM, Bray F, Ferlay J, et al: Global cancer statistics, 2002. CA Cancer J Clin 55:74-108, 2005
10. Ries LAG, Harkins D, Krapcho M, et al (eds): SEER Cancer Statistics Review, 1975-2003. National Cancer Institute. Bethesda, MD, National Cancer Institute, 2003. http://seer.cancer.gov/csr/1975_2003/
11. Boyle P, Leon ME: Epidemiology of colorectal cancer. Br Med Bull 64:1-25, 2002
12. Townsley CA, Selby R, Siu LL: Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 23:3112-3124, 2005
13. Ayanian JZ, Zaslavsky AM, Fuchs CS, et al: Use of adjuvant chemotherapy and radiation therapy for colorectal cancer in a population-based cohort. J Clin Oncol 21:1293-1300, 2003
14. Schrag D, Cramer LD, Bach PB, et al: Age and adjuvant chemotherapy use after surgery for stage III colon cancer. J Natl Cancer Inst 93:850-857, 2001
15. Sargent DJ, Goldberg RM, Jacobson SD, et al: A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med 345:1091-1097, 2001
16. Popescu RA, Norman A, Ross PJ, et al: Adjuvant or palliative chemotherapy for colorectal cancer in patients 70 years or older. J Clin Oncol 17:2412-2418, 1999
17. Folprecht G, Cunningham D, Ross P, et al: Efficacy of fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: A pooled analysis of clinical trials. Ann Oncol 15:1330-1338, 2004
18. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343:905-914, 2000
19. Seymour MT, Maughan TS, Ledermann JA, et al: Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet 370:143-152, 2007
20. 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 352:1407-1412, 1998
21. 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 352:1413-1418, 1998
22. 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 91:1453-1458, 2004
23. 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 23:3545-3551, 2005
24. Souglakos J, Pallis A, Kakolyris S, et al: Combination of irinotecan (CPT-11) plus fluorouracil and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: A phase II trial. Oncology 69:384-390, 2005
25. Lichtman SM, Wildiers H, Chatelut E, et al: International Society of Geriatric Oncology Chemotherapy Taskforce: Evaluation of chemotherapy in older patients-an analysis of the medical literature. J Clin Oncol 25:1832-1843, 2007
26. Talarico L, Chen G, Pazdur R: Enrollment of elderly patients in clinical trials for cancer drug registration: A 7-year experience by the US Food and Drug Administration. J Clin Oncol 22:4626-4631, 2004
27. Köhne CH, Cunningham D, Di CF, et al: Clinical determinants of survival in patients with fluorouracil-based treatment for metastatic colorectal cancer: Results of a multivariate analysis of 3825 patients. Ann Oncol 13:308-317, 2002
28. Sundararajan V, Mitra N, Jacobson JS, et al: Survival associated with fluorouracil-based adjuvant chemotherapy among elderly patients with node-positive colon cancer. Ann Intern Med 136:349-357, 2002
29. Goldberg RM, Tabah-Fisch I, Bleiberg H, et al: Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer. J Clin Oncol 24:4085-4091, 2006
30. Rothenberg ML, Meropol NJ, Poplin EA, et al: Mortality associated with irinotecan plus bolus fluorouracil/leucovorin: Summary findings of an independent panel. J Clin Oncol 19:3801-3807, 2001
31. Van Cutsem E, Douillard JY, Kohne CH: Toxicity of irinotecan in patients with colorectal cancer. N Engl J Med 345:1351-1352, 2001
32. Goldberg RM, Sargent DJ, Morton RF, et al: A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 22:23-30, 2004
33. Fuchs CS, Marshall J, Mitchell EP, et al: Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: Results from the BICC-C study. J Clin Oncol 25:4779-4786, 2007
34. Feliu J, Salud A, Escudero P, et al: XELOX (capecitabine plus oxaliplatin) as first-line treatment for elderly patients older than 70 years of age with advanced colorectal cancer. Br J Cancer 94:969-975, 2006
35. Seymour MT, Maughan TS, Wasan HS, et al: Capecitabine (Cap) and oxaliplatin (Ox) in elderly and/or frail patients with metastatic colorectal cancer: The FOCUS2 trial. J Clin Oncol 25, 2007 (suppl; abstr 9030)