PMID- 19967487 OWN - NLM STAT- MEDLINE DCOM- 20100331 LR - 20211020 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 14 IP - 6 DP - 2009 Dec TI - Safety of bevacizumab treatment in combination with standard chemotherapy for metastatic colorectal cancer: a retrospective review of 65 Japanese patients. PG - 513-7 LID - 10.1007/s10147-009-0911-6 [doi] AB - BACKGROUND: Bevacizumab (BV) prolongs overall survival and progression-free survival when combined with standard chemotherapy for metastatic colorectal cancer (mCRC). However, because this drug was approved in Japan only in 2007, there has been little experience in Japan. This study was conducted to evaluate retrospectively the safety of BV in clinical practice. METHODS: Sixty-five consecutive mCRC patients who received BV at our institution between June 2007 and March 2008 were selected. All patients were treated with chemotherapy in combination with BV. We surveyed the medical records of all patients for adverse events (AEs). We assessed the AEs using the Common Terminology Criteria for Adverse Events version 3.0. RESULTS: The characteristics of the subjects were: male, 45 patients; median age, 57 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, 62 patients; number of prior chemotherapy regimens 0/1/ > 2, 15/28/22 patients. The incidence of BV therapy-related AEs of all grades was: hypertension, 47.7%; proteinuria, 33.8%; bleeding, 35.3%; gastrointestinal (GI) perforation, 3.1%; thrombosis, 7.7%; and wound-healing complications, 6.2%. The incidence of grade 3/4 AEs related to BV therapy was: hypertension, 13.8%; bleeding, 1.5%; GI perforation, 1.5%; and thrombosis, 4.6%. Four patients (6.2%) had to stop chemotherapy because of the development of BV therapy-related AEs. New events of hypertension, bleeding, and proteinuria emerged until 120 days and thereafter. CONCLUSION: The incidence of BV therapy-related AEs in this study was consistent with that observed in Western prospective clinical trials, with the exception of hypertension and proteinuria. A careful follow up is recommended for up to 120 days after the initiation of BV administration. FAU - Tamiya, Akihiro AU - Tamiya A AD - Division of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan. FAU - Yamazaki, Kentaro AU - Yamazaki K FAU - Boku, Narikazu AU - Boku N FAU - Machida, Nozomu AU - Machida N FAU - Kojima, Takashi AU - Kojima T FAU - Taku, Keisei AU - Taku K FAU - Yasui, Hirofumi AU - Yasui H FAU - Fukutomi, Akira AU - Fukutomi A FAU - Hironaka, Shuichi AU - Hironaka S FAU - Onozawa, Yusuke AU - Onozawa Y LA - eng PT - Journal Article DEP - 20091205 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 2S9ZZM9Q9V (Bevacizumab) SB - IM MH - Adult MH - Aged MH - Angiogenesis Inhibitors/administration & dosage/*adverse effects/therapeutic use MH - Antibodies, Monoclonal/administration & dosage/*adverse effects/therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Bevacizumab MH - Colorectal Neoplasms/*drug therapy/mortality/pathology MH - Female MH - Humans MH - Japan MH - Male MH - Middle Aged MH - Neoplasm Metastasis MH - Retrospective Studies MH - Treatment Outcome EDAT- 2009/12/08 06:00 MHDA- 2010/04/01 06:00 CRDT- 2009/12/08 06:00 PHST- 2008/12/26 00:00 [received] PHST- 2009/05/24 00:00 [accepted] PHST- 2009/12/08 06:00 [entrez] PHST- 2009/12/08 06:00 [pubmed] PHST- 2010/04/01 06:00 [medline] AID - 10.1007/s10147-009-0911-6 [doi] PST - ppublish SO - Int J Clin Oncol. 2009 Dec;14(6):513-7. doi: 10.1007/s10147-009-0911-6. Epub 2009 Dec 5.