Capecitabine and irinotecan with and without bevacizumab for advanced colorectal cancer patients

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 pro-...

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Published in:World journal of gastroenterology : WJG 2009-01, Vol.15 (4), p.449-456
Main Authors: Moehler, Markus, Sprinzl, Martin-F, Abdelfattah, Murad, Schimanski, Carl-C, Adami, Bernd, Godderz, Werner, Majer, Klaus, Flieger, Dimitri, Teufel, Andreas, Siebler, Juergen, Hoehler, Thomas, Galle, Peter-R, Kanzler, Stephan
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Bevacizumab
Brief
Camptothecin - administration & dosage
Camptothecin - adverse effects
Camptothecin - analogs & derivatives
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - therapy
Deoxycytidine - administration & dosage
Deoxycytidine - adverse effects
Deoxycytidine - analogs & derivatives
Disease-Free Survival
Drug Tolerance
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Fluorouracil - analogs & derivatives
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Prospective Studies
直肠癌
结肠癌
老年人
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Summary: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 pro- spective open-label phase Ⅱ trial, in German commu- nity-based outpatient clinics. Patients received a stan- dard 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 sec- ondary 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 re- sponses were observed. The median progression-free survival was 11.4 mo and 12.8 mo for CAPIRI and CA- PIRI-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 under- went 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 out- patient setting. Severe gastrointestinal toxicities and thromboembolic events were rare and if observed were never fatal.
ISSN:1007-9327
2219-2840
DOI:10.3748/wjg.15.449