Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study

被引:879
作者
Hoff, PM
Ansari, R
Batist, G
Cox, J
Kocha, W
Kuperminc, M
Maroun, J
Walde, D
Weaver, C
Harrison, E
Burger, HU
Osterwalder, B
Wang, AO
Wong, R
机构
[1] Univ Texas, MD Anderson Canc Ctr, Houston, TX 77030 USA
[2] Phys Reliance Network Inc, Dallas, TX USA
[3] Michiana Hematol Oncol, South Bend, IN USA
[4] Hematol & Oncol Assoc Virginia, Richmond, VA USA
[5] Response Oncol, Memphis, TN USA
[6] Hoffmann La Roche Inc, Nutley, NJ 07110 USA
[7] McGill Univ, Dept Oncol, Montreal, PQ, Canada
[8] London Reg Canc Ctr, London, ON N6A 4L6, Canada
[9] Ottawa Reg Canc Ctr, Ottawa, ON K1Y 4K7, Canada
[10] Grp Hlth Ctr, Sault Ste Marie, ON, Canada
[11] Tom Baker Canc Clin, Calgary, AB, Canada
[12] H Bliss Canc Ctr, St John, NF, Canada
[13] F Hoffmann La Roche & Co Ltd, CH-4002 Basel, Switzerland
关键词
D O I
10.1200/JCO.2001.19.8.2282
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: To compare the response rate, efficacy parameters, and toxicity profile of oral capecitabine with bolus intravenous (IV) fluorouracil plus leucovorin (5-FU/LV) as first-line treatment in patients with metastatic colorectal cancer. Patients and Methods: We prospectively randomized 605 patients to treatment with oral capecitabine for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily for 5 days in 4-week cycles. Results: The overall objective tumor response rate among all randomized patients was significantly higher in the capecitabine group (24.8%) than in the 5-FU/LV group (15.5%; P =.005). In the capecitabine and 5-FU/LV groups, median times to disease progression were 4.3 and 4.7 months (log-rank P =.72), median times to treatment failure were 4.1 and 3.1 months (P =.19), and median overall survival times were 12.5 and 13.3 months (P =.974), respectively. Capecitabine, compared with bolus 5-FU/LV treatment, produced a significantly lower incidence (P <.0002) of diarrhea, stomatitis, nausea, and alopecia, Patients treated with capecitabine also displayed lower incidences of grade 3/4 stomatitis and grade 3/4 neutropenia (P <.0001) leading to significantly less neutropenic fever/sepsis. Grade 3 hand-foot syndrome (P <.00001) and grade 3/4 hyperbilirubinemia were the only toxicities more frequently associated with capecitabine than with 5-FU/LV treatment. Conclusion: Oral capecitabine was mare active than 5-FU/LV in the induction of objective tumor responses. Time to disease progression and survival were at least equivalent for capecitabine compared with the 5-FU/LV arm. Capecitabine also demonstrated clinically meaningful benefits over bolus 5-FU/LV in terms of tolerability. <(c)> 2001 by American Society of Clinical Oncology.
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收藏
页码:2282 / 2292
页数:11
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