Brief Articles
Copyright ©2009 The WJG Press and Baishideng. All rights reserved.
World J Gastroenterol. Jan 28, 2009; 15(4): 449-456
Published online Jan 28, 2009. doi: 10.3748/wjg.15.449
Capecitabine and irinotecan with and without bevacizumab for advanced colorectal cancer patients
Markus Moehler, Martin F Sprinzl, Murad Abdelfattah, Carl C Schimanski, Bernd Adami, Werner Godderz, Klaus Majer, Dimitri Flieger, Andreas Teufel, Juergen Siebler, Thomas Hoehler, Peter R Galle, Stephan Kanzler
Markus Moehler, Martin F Sprinzl, Carl C Schimanski, Andreas Teufel, Juergen Siebler, Peter R Galle, 1st Medical Department, Johannes Gutenberg-University, Langenbeckstrasse 1, 55116 Mainz, Germany
Murad Abdelfattah, Bernd Adami, Outpatient Clinic, Spiessgasse 58b, 55232 Alzey, Germany
Werner Godderz, Outpatient Clinic, Bahnhofplatz 2, 55116 Mainz, Germany
Klaus Majer, Outpatient Clinic of City Hospital, Kapuzinerstrasse 15, 55411 Bingen, Germany
Dimitri Flieger, Outpatient Clinic of City Hospital, GPR Klinikum, 65423 Rüsselsheim, Germany
Thomas Hoehler, Outpatient Clinic of 1st Medical Department, Mühlenstrasse 27, 45659 Recklinghausen, Germany
Stephan Kanzler, Outpatient Clinic of 2nd Medical Department, Leopoldina Krankenhaus, Gustaf Adolf Strasse 8, 97422 Schweinfurt, Germany
Author contributions: Moehler M and Sprinzl MF contributed equally to the preparation of the manuscript; Moehler M and Kanzler S designed the study proposal; All authors treated the patients, collected and provided patients data; Moehler M, Sprinzl MF and Abdelfattah M analyzed the data and wrote the paper.
Supported by The companies Pfizer and Roche provided partial support for the study and data monitoring
Correspondence to: Markus Moehler, MD, 1st Medical Department, Johannes Gutenberg-University, Langenbeckstrasse 1, 55116 Mainz, Germany. moehler@mail.uni-mainz.de
Telephone: +49-6131-176839  
Fax: +49-6131-176410
Received: September 23, 2008
Revised: December 16, 2008
Published online: January 28, 2009
Abstract

AIM: To investigate the efficacy and safety of cape-citabine plus irinotecan ± bevacizumab in advanced or metastatic colorectal cancer patients.

METHODS: Forty six patients with previously untreated, locally-advanced or metastatic colorectal cancer (mCRC) were recruited between 2001-2006 in a prospective open-label phase II trial, in German community-based outpatient clinics. Patients received a standard capecitabine plus irinotecan (CAPIRI) or CAPIRI plus bevacizumab (CAPIRI-BEV) regimen every 3 wk. Dose reductions were mandatory from the first cycle in cases of > grade 2 toxicity. The treatment choice of bevacizumab was at the discretion of the physician. The primary endpoints were response and toxicity and secondary endpoints included progression-free survival and overall survival.

RESULTS: In the CAPIRI group vs the CAPRI-Bev group there were more female than male patients (47% vs 24%), and more patients had colon as the primary tumor site (58.8% vs 48.2%) with fewer patients having sigmoid colon as primary tumor site (5.9% vs 20.7%). Grade 3/4 toxicity was higher with CAPIRI than CAPIRI-Bev: 82% vs 58.6%. Partial response rates were 29.4% and 34.5%, and tumor control rates were 70.6% and 75.9%, respectively. No complete responses were observed. The median progression-free survival was 11.4 mo and 12.8 mo for CAPIRI and CAPIRI-Bev, respectively. The median overall survival for CAPIRI was 15 mo (458 d) and for CAPIRI-Bev 24 mo (733 d). These differences were not statistically different. In the CAPIRI-Bev, group, two patients underwent a full secondary tumor resection after treatment, whereas in the CAPIRI group no cases underwent this procedure.

CONCLUSION: Both regimens were well tolerated and offered effective tumor growth control in this outpatient setting. Severe gastrointestinal toxicities and thromboembolic events were rare and if observed were never fatal.

Keywords: First-line therapy, Metastatic colorectal cancer, Bevacizumab, Capecitabine, Irinotecan, Tumor response