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Capecitabine
Abstract: Capecitabine, an oral fluoropyrimidine carbamate
with substantial activity in advanced colorectal cancer: results of a
randomized phase II study.
PURPOSE: To evaluate in patients with advanced colorectal cancer (CRC)
three treatment regimens of oral capecitabine in order to select the
most appropriate regimen for testing in phase III.
PATIENTS AND METHODS:
Three capecitabine schedules were evaluated in a randomized phase II
design: arm A, 1,331 mg/m(2)/d bid continuously; arm B, 2,510 mg/m(2)/d
bid intermittently (2 weeks on/1 week off); and arm C, 1,657 mg/m(2)/d
plus oral leucovorin 60 mg/d bid intermittently (2 weeks on/1 week off).
RESULTS: One hundred nine patients were randomized; 39 patients were
assessable for efficacy in arm A, 34 in arm B, and 35 in arm C. Patient
characteristics were balanced in the arms. Confirmed tumor responses
(partial response [PR] + complete response [CR]) were reported for eight
patients with two CRs (21%; 95% confidence interval [CI], 9% to 36%) in
arm A, eight patients with one CR (24%; 95% CI, 11% to 41%) in arm B,
and eight patients with two CRs (23%; 95% CI, 10% to 40%) in arm C.
Median times to progression (TTP) in arms A, B, and C were 127,
230, and
165 days, respectively. Overall, more toxicity was seen with capecitabine plus leucovorin, particularly
diarrhea and hand-foot
syndrome. There was no grade 3 or 4 marrow toxicity.
CONCLUSION: Capecitabine offers a new, effective treatment option as an oral single
agent in advanced CRC. Promising overall response rates were reported
for all three regimens. The addition of leucovorin to the intermittent
regimen had no marked effect on tumor response or median TTP. The
intermittent single-agent capecitabine schedule is proposed for phase
III evaluation, based on considerations of toxicity, dose-intensity,
response rate, and TTP.
References
Van Cutsem E, Findlay M, Osterwalder B, Kocha W, Dalley D, Pazdur R,
Cassidy J, Dirix L, Twelves C, Allman D, Seitz JF, Scholmerich J, Burger
HU, Verweij J. Capecitabine, an oral fluoropyrimidine carbamate
with substantial activity in advanced colorectal cancer: results of a
randomized phase II study. J Clin Oncol 2000; 18:1337 - 1345.
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| Regimen |
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Capecitabine.... 2510 mg / M2 / d PO (divided BID) days 1 -
14
FREQUENCY....... Repeat every 21 days. |
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Summary |
Results of
Capecitabine in treatment of advanced colorectal cancer |
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Overall Response
Rate |
24% |
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Time To
Progression |
230 days |
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Toxicity |
Diarrhea,
hand-foot syndrome |
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