Abstract
Background
A dose-finding phase I/II trial that evaluated the maximum tolerated doses of a combination
of three drugs with irinotecan, oxaliplatin and capecitabine (COI regimen) has been
conducted in patients with metastatic colorectal cancer (mCRC). In this study the
safety and activity of the combination of COI regimen plus bevacizumab (COI-B) were
assessed.
Methods
Patients judged to be unresectable for metastatic disease, were enrolled in a phase
II, open-label study and treated with the combination of bevacizumab (5 mg/kg on day 1) and COI regimen (irinotecan 180 mg/mq on day 1, oxaliplatin 85 mg/mq on day 2, capecitabine 2000 mg d2–6; q14) as first-line treatment. Induction treatment was administered for a
maximum of 8 cycles, followed by maintenance treatment with bevacizumab (7.5 mg/kg on d1, q21) until progression.
Results
Fifty-one patients were enrolled in six Italian centres. The primary end-point of
overall response rate was met, reaching the value of 62% in the per-protocol population
and 57% in the intent-to-treat population, patients with stable disease were also
taken into account, the clinical benefit rate was 94%. In the intention-to-treat population,
median progression-free and overall survivals were 10.3 and 22 months, respectively. Toxicity was different from 5-fluorouracil-based triplet regimens,
with 31% of severe diarrhoea, but a low incidence of grade 3/4 neutropenia (6%) and
mucositis (4%).
Conclusions
Our results show the feasibility and promising activity of the combination of capecitabine,
oxaliplatin, irinotecan and bevacizumab.
Keywords
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Article info
Publication history
Published online: January 27, 2015
Accepted:
December 29,
2014
Received in revised form:
December 15,
2014
Received:
October 29,
2014
Identification
Copyright
© 2015 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
