A phase II study of fixed-dose capecitabine and assessment of predictors of toxicity in patients with advanced/metastatic colorectal cancer

British Journal of Cancer

Volumn 94, Issue 7, 2006, Pages 964-968

  Sharma, R ^a   Rivory, L ^a   Beale, P ^a   Ong, S ^a   Horvath, L ^a   Clarke, S J ^a,b  

^a SYDNEY CANCER CENTRE   (Australia)

^b UNIVERSITY OF SYDNEY   (Australia)

Author keywords

Advanced colorectal cancer; Capecitabine; Efficacy; Folate; Safety

Indexed keywords

CAPECITABINE; FOLIC ACID; HOMOCYSTEINE;

ADULT; ADVANCED CANCER; AGED; AMINO ACID BLOOD LEVEL; ANEMIA; BLISTER; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER CHEMOTHERAPY; CANCER GROWTH; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL TRIAL; COLORECTAL CANCER; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DESQUAMATION; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; DYSESTHESIA; EDEMA; ERYTHEMA; FATIGUE; FEMALE; FOLIC ACID BLOOD LEVEL; FOLLOW UP; HAND FOOT SYNDROME; HUMAN; LABORATORY TEST; LIFE EXPECTANCY; LIVER TOXICITY; MAJOR CLINICAL STUDY; MALE; METASTASIS; MULTICENTER STUDY; NAUSEA; PAIN; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; REVIEW; STOMATITIS; SURVIVAL TIME; TABLET; ULCER;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; COLORECTAL NEOPLASMS; DEOXYCYTIDINE; DIARRHEA; DISEASE PROGRESSION; FATIGUE; FEMALE; FOLIC ACID; HOMOCYSTEINE; HUMANS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; PREDICTIVE VALUE OF TESTS; SURVIVAL ANALYSIS;

EID: 33645742923     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6603049     Document Type: Review

References (28)

1. Ardalan B, Flores MR (1995) A new complication of chemotherapy administered via permanent indwelling central venous catheter. Cancer 75: 2165-2168
2. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, Osterwalder B, Burger HU, Brown CS, Griffin T (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17: 485-493
3. Bunn P, Paoletti P, Niyikiza C, Rusthoven J, Nelson K, Hanauske AR, Stabler S, Calvert AH, Allen R (2001) Vitamin B12 and folate reduce toxicity of Alimta™ (pemetrexed disodium, LY231514, MTA), a novel antifolate/ antimetabolite. Proc Am Soc Clin Oncol 20: 76a (abstr 300)
4. Calvert H (2002) Folate status and the safety profile of antifolates. Semin Oncol 29: 3-7
5. Cassidy J, Twelves C, Cameron D, Steward W, O'Byrne K, Jodrell D, Banken L, Goggin T, Jones D, Roos B, Bush E, Weidekamm E, Reigner B (1999) Bioequivalence of two tablet formulations of capecitabine and exploration of age, gender, body surface area, and creatinine clearance as factors influencing systemic exposure in cancer patients. Cancer Chemother Pharmacol 44: 453-460
6. Cassidy J, Twelves C, Van Cutsem E, Hoff P, Bajetta E, Boyer M, Bugat R, Burger U, Garin A, Graeven U, McKendric J, Maroun J, Marshall J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schilsky RL (2002) First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol 13: 566-575
7. de Gramont A, Figer A, Seymour M, Homerin M, Hmissi A, Cassidy J, Boni C, Cortes-Funes H, Cervantes A, Freyer G, Papamichael D, Le Bail N, Louvet C, Hendler D, de Braud F, Wilson C, Morvan F, Bonetti A (2000) Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol 18: 2938-2947
8. Douillard JY, Cunningham D, Roth AD (2000) Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet 355: 1041-1047
9. Feliu J, Escudero P, Llosa F, Bolanos M, Vicent JM, Yubero A, Sanz-Lacalle JJ, Lopez R, Lopez-Gomez L, Casado E, Gomez-Reina MJ, Gonzalez-Baron M (2005) Capecitabine as first-line treatment for patients older than 70 years with metastatic colorectal cancer: an oncopaz cooperative group study. J Clin Oncol 23: 3104-3111
10. Giacchetti S, Perpoint B, Zidani R, Le Bail N, Faggiuolo R, Focan C, Chollet P, Llory JF, Letourneau Y, Coudert B, Bertheaut-Cvitkovic F, Larregain-Fournier D, Le Rol A, Walter S, Adam R, Misset JL, Levi F (2000) Phase III multicenter randomized trial of oxaliplatin added to chronomodulated fluorouracil-leucovorin as first-line treatment of metastatic colorectal cancer. J Clin Oncol 18: 136-147
11. Gurney H (1996) Dose calculation of anticancer drugs: a review of the current practice and introduction of an alternative. J Clin Oncol 14: 2590-2611
12. Hoff PM, Ansari R, Batist G, Cox J, Kocha W, Kuperminc M, Maroun J, Walde D, Weaver C, Harrison E, Burger HU, Osterwalder B, Wong AO, Wong R (2001) Comparison of oral capecitabine vs intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: results of a randomized phase III study. J Clin Oncol 19: 2282-2292
13. Kolesar JM, Johnson CL, Freeberg BL, Berlin JD, Schiller JH (1999) Warfarin-5-FU interaction - a consecutive case series. Pharmacotherapy 19: 1445-1449
14. Midgley R, Kerr D (1999) Colorectal cancer. Lancet 353: 391-399
15. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, Shimma N, Umeda I, Ishitsuka H (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34: 1274-1281
16. National Cancer Institute Common toxicity criteria, v 2.0. http://ctep. cancer.gov/forms/CTCManual_v4_10-4-99.pdf
17. Niyikiza C, Baker SD, Seitz DE, Walling JM, Nelson K, Rusthoven JJ, Stabler SP, Paoletti P, Calvert AH, Allen RH (2002) Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol Cancer Ther 1: 545-552
18. Pinedo HM, Peters GF (1988) Fluorouracil: biochemistry and pharmacology. J Clin Oncol 6: 1653-1664
19. Reigner B, Blesch K, Weidekamm E (2001) Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet 40: 85-104
20. Saltz LB, Cox JV, Blanke C (2000) Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med 343: 905-914
21. Sawyer M, Ratain MJ (2001) Body surface area as a determinant of pharmacokinetics and drug dosing. Invest New Drugs 19: 171-177
22. Schmoll HJ (1996) Development of treatment for advanced colorectal cancer: infusional 5-FU and the role of new agents. Eur J Cancer 32A(Suppl 5): S18-S22
23. Schmoll HJ, Buchele T, Grothey A, Dempke W (1999) Where do we stand with 5-fluorouracil? Semin Oncol 26: 589-605
24. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 92: 205-216
25. Van Cutsem E, Hoff PM, Harper P, Bukowski RM, Cunningham D, Dufour P, Graeven U, Lokich J, Madajewicz S, Maroun JA, Marshall JL, Mitchell EP, Perez-Manga G, Rougier P, Schmiegel W, Schoelmerich J, Sobrero A, Schilsky RL (2004) Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Br J Cancer 90: 1190-1197
26. Van Cutsem E, Twelves C, Cassidy J, Allman D, Bajetta E, Boyer M, Bugat R, Findlay M, Frings S, Jahn M, McKendrick J, Osterwalder B, Perez-Manga G, Rosso R, Rougier P, Schmiegel WH, Seitz JF, Thompson P, Vieitez JM, Weitzel C, Harper P (2001) Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol 19: 4097-4106
27. van der Wilt CL, Backus HH, Smid K, Comijn L, Veerman G, Wouters D, Voorn DA, Priest DG, Bunni MA, Mitchell F, Jackman AL, Jansen G, Peters GJ (2001) Modulation of both endogenous folates and thymidine enhance the therapeutic efficacy of thymidylate synthase inhibitors. Cancer Res 61: 3675-3681
28. Verso M, Agnelli G (2003) Venous thromboembolism associated with long-term use of central venous catheters in cancer patients. J Clin Oncol 21: 3665-3675