Bevacizumab Combined With Chemotherapy in the Second-Line Treatment of Metastatic Colorectal Cancer: Results from the Phase II BEVACOLOR Study

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• 作者：Jaafar Bennouna¹ ; ^{j-bennouna@nantes.fnclcc.fr} ; Christophe Borg² ; Jean-Pierre Delord³ ; Faress Husseini⁴ ; Vé ; ronique Trillet-Lenoir⁵ ; Roger Faroux⁶ ; Eric Franç ; ois⁷ ; Marc Ychou⁸ ; Franç ; ois Goldwasser⁹ ; Olivier Bouché ; ¹⁰ ; Helene Senellart¹ ; Sandrine Kraemer¹¹ ; Jean-Yves Douillard¹
• 关键词：Anti-angiogenic therapy ; Chemotherapy ; Metastatic colorectal cancer ; Phase II
• 刊名：Clinical Colorectal Cancer
• 出版年：2012
• 出版时间：March, 2012
• 年：2012
• 卷：11
• 期：1
• 页码：38-44
• 全文大小：311 K

文摘

Background

This prospective phase II study assessed the efficacy and safety of bevacizumab plus chemotherapy regimens commonly used in the second-line treatment of metastatic colorectal cancer (mCRC).

Methods

Patients with mCRC who progressed or relapsed after first-line oxaliplatin-based or irinotecan-based treatment received bevacizumab 2.5 mg/kg/week plus chemotherapy until disease progression. The primary endpoint was disease-control rate (DCR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety.

Results

Fifty-three patients (66 % men; median age, 62 years old) received second-line bevacizumab plus folinic acid, fluorouracil, and irinotecan (FOLFIRI; 57 % ), folinic acid, fluorouracil, oxaliplatin (FOLFOX; 26 % ), irinotecan (15 % ), or capecitabine plus irinotecan (XELIRI; 2 % ). The DCR was 87 % (95 % CI, 77 % -97 % ); ORR was 32 % (95 % CI, 19 % -46 % ). Median PFS was 6.5 months (95 % CI, 5.8-7.8 months) and median OS 19.3 months, (95 % CI, 14.2-25.1 months).The most frequent grade 3/4 adverse events included neutropenia (21 % ), diarrhea (15 % ), asthenia, and vomiting (9 % each). Five patients (9 % ) had grade 3/4 targeted toxicities: grade 3 hypertension (n = 2), grade 3 venous thromboembolism (n = 2), and grade 4 arterial thromboembolism (n = 1). None of these events led to death during the study.

Conclusion

Bevacizumab plus standard second-line chemotherapy is highly active in patients with mCRC and has an acceptable safety profile.