Comparing safety and efficacy of first-line irinotecan/fluoropyrimidine combinations in elderly versus nonelderly patients with metastatic colorectal cancer: Findings from the bolus, infusional, or capecitabine with camptostar-celecoxib study

Cancer

Volumn 115, Issue 12, 2009, Pages 2617-2629

  Jackson, Nadine A ^a   Barrueco, José ^b   Soufi Mahjoubi, Raoudha ^b   Marshall, John ^c   Mitchell, Edith ^d   Zhang, Xiaoxi ^b   Meyerhardt, Jeffrey ^a,e  

^a DANA FARBER CANCER INSTITUTE   (United States)

^b Pfizer Global Pharmaceuticals   (United States)

^c GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

^e NONE   (United States)

Author keywords

Colorectal cancer; Elderly; Fluoropyrimidine; Irinotecan

Indexed keywords

BEVACIZUMAB; CAMPOSTAR; CAPECITABINE; CELECOXIB; FLUOROPYRIMIDINE; FLUOROURACIL; FOLINIC ACID; IRINOTECAN; PLACEBO; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGE DISTRIBUTION; AGED; ARTICLE; ASTHENIA; BONE MARROW SUPPRESSION; CLINICAL TRIAL; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DEHYDRATION; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HAND FOOT SYNDROME; HUMAN; LEUKOPENIA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; METASTASIS; NAUSEA; NEUTROPENIA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; VOMITING;

ADMINISTRATION, ORAL; AGE FACTORS; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CAMPTOTHECIN; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; HUMANS; INFUSIONS, INTRAVENOUS; LEUCOVORIN; MALE; NEOPLASM METASTASIS; PYRAZOLES; SULFONAMIDES; SURVIVAL RATE;

EID: 67649201009     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.24305     Document Type: Article

References (50)

1. National Institutes of Health. Surveillance Epidemiology and End Results. Available at: http://seer.cancer.gov/ Accessed on January 23, 2008.
2. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74-108.
3. United States Census Bureau. Population Projections of the United States, by Age, Race, and Hispanic Origin, 1993-2050, 1993. Available at: http://www.census.gov. Accessed on January 23, 2008.
4. Rosati G. Elderly patients with advanced colorectal cancer: which therapy is the safest? Expert Opin Drug Saf. 2005;4:1041-1049.
5. Walter LC, Covinsky KE. Cancer screening in elderly patients: a framework for individualized decision making. JAMA. 2001;285:2750-2756. (Pubitemid 32525372)
6. Grothey A, Sargent D, Goldberg RM, Schmoll HJ. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol. 2004;22:1209-1214. (Pubitemid 41079833)
7. 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. 2006;24:4085-4091. (Pubitemid 46622283)
8. Berardi R, Saladino T, Mari D, et al. Elderly patients with advanced colorectal cancer: tolerability and activity of chemotherapy. Tumori. 2005;91:463-466. (Pubitemid 43251114)
9. Dranitsaris G, Shah A, Spirovski B, Vincent M. Severe diarrhea in patients with advanced-stage colorectal cancer receiving FOLFOX or FOLFIRI chemotherapy: the development of a risk prediction tool. Clin Colorectal Cancer. 2007;6:367-373. (Pubitemid 46340203)
10. Emmanouilides C, Sfakiotaki G, Androulakis N, et al. Front-line bevacizumab in combination with oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) in patients with metastatic colorectal cancer: a multicenter phase II study. BMC Cancer. 2007;7:91. (Pubitemid 46995467)
11. Figer A, Perez-Staub N, Carola E, et al. FOLFOX in patients aged between 76 and 80 years with metastatic colorectal cancer: an exploratory cohort of the OPTIMOX1 study. Cancer. 2007;110:2666-2671. (Pubitemid 350250335)
12. Kim JH, Oh DY, Kim YJ, et al. Reduced dose intensity FOLFOX-4 as first line palliative chemotherapy in elderly patients with advanced colorectal cancer. J Korean Med Sci. 2005;20:806-810. (Pubitemid 41587237)
13. Nardi M, Azzarello D, Maisano R, et al. FOLFOX-4 regimen as fist-line chemotherapy in elderly patients with advanced gastric cancer: a safety study. J Chemother. 2007;19:85-89. (Pubitemid 46255477)
14. 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)
15. 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. 2004;22:23-30. (Pubitemid 41095110)
16. Folprecht G, Seymour MT, Saltz L, et al. 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. J Clin Oncol. 2008;26:1443-1451.
17. 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. 2004;22:229-237. (Pubitemid 41095086)
18. Aparicio J, Fernandez-Martos C, Vincent JM, et al. FOLFOX alternated with FOLFIRI as first-line chemotherapy for metastatic colorectal cancer. Clin Colorectal Cancer. 2005;5:263-267.
19. Colucci G, Gebbia V, 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. (Pubitemid 46223991)
20. Golfinopoulos V, Salanti G, Pavlidis N, Ioannidis JP. Survival and disease-progression benefits with treatment regimens for advanced colorectal cancer: a meta-analysis. Lancet Oncol. 2007;8:898-911. (Pubitemid 47488054)
21. Kalofonos HP, Aravantinos G, Kosmidis P, et al. Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: a multicenter, randomized, phase II study. Ann Oncol. 2005;16:869-877. (Pubitemid 40903911)
22. Matasar MJ, Sundararajan V, Grann VR, Neugut AI. Management of colorectal cancer in elderly patients: focus on the cost of chemotherapy. Drugs Aging. 2004;21:113-133. (Pubitemid 38293789)
23. Ragnhammar P, Hafstrom L, Nygren P, Glimelius B. A systematic overview of chemotherapy effects in colorectal cancer. Acta Oncol. 2001;40:282-308. (Pubitemid 32588124)
24. Fuchs CS, Marshall J, Mitchell E, 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. 2007;25:4779-4786. (Pubitemid 350086481)
25. Solomon SD, McMurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med. 2005;352:1071-1080. (Pubitemid 40365348)
26. Camptosar [package insert]. New York, NY: Pfizer Oncology; 2006.
27. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205-216.
28. Cox D. Regression models and life-tables. J R Stat Soc. 1972;34:187-220.
29. Chau I, Norman AR, Cunningham D, et al. A randomised comparison between 6 months of bolus fluorouracil/leucovorin and 12 weeks of protracted venous infusion fluorouracil as adjuvant treatment in colorectal cancer. Twelve weeks of protracted venous infusion of fluorouracil (5-FU) is as effective as 6 months of bolus 5-FU and folinic acid as adjuvant treatment in colorectal cancer. Ann Oncol. 2005;16:549-557.
30. Cunningham D, Pyrhoenen S, James R, et al. Randomized 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)
31. Fuchs C, Moore M, Harker G, Villa L, Rinaldi D, Hecht J. Phase III comparison of 2 irinotecan dosing regimens in second-line therapy of metastatic colorectal cancer. J Clin Oncol. 2003;21:807-814. (Pubitemid 46606439)
32. Schaaf L, Ichhpurani N, Elfring G, Wolf M, Rothenberg M, Von Hoff D. Influence of age on the pharmacokinetics of irinotecan (CPT-11) and its metabolites, SN-38 and SN-38 glucuronide (SN-38G), in patients with previously treated colorectal cancer. Proc Am Soc Clin Oncol. 1997;16:A708.
33. Rothenberg ML, Cox JV, DeVore RF, et al. A multicenter, phase II trial of weekly irinotecan (CPT-11) in patients with previously treated colorectal carcinoma. Cancer. 1999;85:786-795. (Pubitemid 29077554)
34. Mitry E, Phelip J, Bonnetain F, et al. Phase III trial of chemotherapy with or without irinotecan in the front-line treatment of metastatic colorectal cancer in elderly patients (FFCD 2001-02 trial): results of a planned interim analysis. 9th Meeting of the Society of International Geriatric Oncology Meeting. Critical Reviews in Oncology/Hematology. 2008;68:S23.
35. Kabbinavar FF, Hambleton J, Mass RD, Hurwitz HI, Bergsland E, Sarkar S. Combined analysis of efficacy: the addition of bevacizumab to fluorouracil/leucovorin improves survival for patients with metastatic colorectal cancer. J Clin Oncol. 2005;23:3706-3712. (Pubitemid 46252465)
36. Falcone A, Ricci S, Brunetti I, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007;25:1670-1676. (Pubitemid 46797946)
37. Souglakos J, Androulakis N, Syrigos K, et al. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Br J Cancer. 2006;94:798-805.
38. Teufel A, Steinmann S, Siebler J, et al. Irinotecan plus folinic acid/continuous 5-fluorouracil as simplified bimonthly FOLFIRI regimen for first-line therapy of metastatic colorectal cancer. BMC Cancer. 2004;4:38. (Pubitemid 40180248)
39. Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist. 2000;5:224-237. (Pubitemid 30429942)
40. Hutchins LF, Unger JM, Crowley JJ, Coltman CA Jr, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341:2061-2067. (Pubitemid 30035956)
41. Mahoney T, Kuo YH, Topilow A, Davis JM. Stage III colon cancers: why adjuvant chemotherapy is not offered to elderly patients. Arch Surg. 2000;135:182-185. (Pubitemid 30078472)
42. Mor V, Masterson-Allen S, Goldberg RJ, Cummings FJ, Glicksman AS, Fretwell MD. Relationship between age at diagnosis and treatments received by cancer patients. J Am Geriatr Soc. 1985;33:585-589. (Pubitemid 16238707)
43. Sanoff HK, Bleiberg H, Goldberg RM. Managing older patients with colorectal cancer. J Clin Oncol. 2007;25:1891-1897. (Pubitemid 46854423)
44. Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112:228-242.
45. Howerton MW, Gibbons MC, Baffi CR, et al. Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer. 2007;109:465-476. (Pubitemid 46190954)
46. Kornblith AB, Kemeny M, Peterson BL, et al. Survey of oncologists' perceptions of barriers to accrual of older patients with breast carcinoma to clinical trials. Cancer. 2002;95:989-996. (Pubitemid 34925347)
47. Kumar A, Soares HP, Balducci L, Djulbegovic B. Treatment tolerance and efficacy in geriatric oncology: a systematic review of phase III randomized trials conducted by 5 National Cancer Institute-sponsored cooperative groups. J Clin Oncol. 2007;25:1272-1276. (Pubitemid 46646519)
48. Lai GY, Gary TL, Tilburt J, et al. Effectiveness of strategies to recruit underrepresented populations into cancer clinical trials. Clin Trials. 2006;3:133-141. (Pubitemid 43829213)
49. 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)
50. Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol. 2005;23:3112-3124. (Pubitemid 46224135)