BACKGROUND: In 2005, bevacizumab was approved by Health Canada for patients with metastatic colorectal cancer (mCRC). Newfoundland and Labrador was one of the first Canadian provinces to fund this agent in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) chemotherapy. In this analysis, the entire provincial bevacizumab sample for the first 2 years was assessed for overall safety and efficacy. METHODS: The medical records of 43 patients with mCRC who had received FOLFIRI with bevacizumab were identified and reviewed. The longitudinal data collection format that was adopted assessed occurrences of adverse events after each cycle of treatment. Toxicity outcomes such as gastrointestinal (GI) perforations, bleeding, diarrhea, myelosuppression, proteinuria, and venous thromboembolic events (VTEs) were collected and graded using the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Time to treatment failure (TTF) and overall survival (OS) were determined using the Kaplan-Meier method. RESULTS: Overall, the 43 study patients received 398 cycles of anticancer therapy (median: 6 cycles; range: 1-24 cycles). No gi perforations were identified. However, 4 bleeding events occurred (9.3%), 3 requiring permanent discontinuation of bevacizumab. Also, 6 grade 3 or 4 VTEs occurred (14.0%), 3 of which required a hospital admission. In addition, grades 3 and 4 diarrhea, febrile neutropenia, and proteinuria showed cumulative incidences of 11.6%, 2.3%, and 2.3% respectively. Median TTF was 6.3 months; median os was 24.4 months. CONCLUSIONS: Bevacizumab in combination with FOLFIRI appears to be well tolerated, and efficacy is consistent with trial reports. However, patients should be closely monitored to avoid potentially serious events such as bleeding and VTEs.
BACKGROUND: In 2005, bevacizumab was approved by Health Canada for patients with metastatic colorectal cancer (mCRC). Newfoundland and Labrador was one of the first Canadian provinces to fund this agent in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) chemotherapy. In this analysis, the entire provincial bevacizumab sample for the first 2 years was assessed for overall safety and efficacy. METHODS: The medical records of 43 patients with mCRC who had received FOLFIRI with bevacizumab were identified and reviewed. The longitudinal data collection format that was adopted assessed occurrences of adverse events after each cycle of treatment. Toxicity outcomes such as gastrointestinal (GI) perforations, bleeding, diarrhea, myelosuppression, proteinuria, and venous thromboembolic events (VTEs) were collected and graded using the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Time to treatment failure (TTF) and overall survival (OS) were determined using the Kaplan-Meier method. RESULTS: Overall, the 43 study patients received 398 cycles of anticancer therapy (median: 6 cycles; range: 1-24 cycles). No gi perforations were identified. However, 4 bleeding events occurred (9.3%), 3 requiring permanent discontinuation of bevacizumab. Also, 6 grade 3 or 4 VTEs occurred (14.0%), 3 of which required a hospital admission. In addition, grades 3 and 4 diarrhea, febrile neutropenia, and proteinuria showed cumulative incidences of 11.6%, 2.3%, and 2.3% respectively. Median TTF was 6.3 months; median os was 24.4 months. CONCLUSIONS:Bevacizumab in combination with FOLFIRI appears to be well tolerated, and efficacy is consistent with trial reports. However, patients should be closely monitored to avoid potentially serious events such as bleeding and VTEs.
Authors: Stephen H Rosenoff; Nashat Y Gabrail; Richard Conklin; John A Hohneker; William J Berg; Ghulam Warsi; Jennifer Maloney; John J Benedetto; Elizabeth A Miles; Wei Zhu; Lowell Anthony Journal: J Support Oncol Date: 2006-06
Authors: Roy S Herbst; David H Johnson; Eric Mininberg; David P Carbone; Ted Henderson; Edward S Kim; George Blumenschein; Jack J Lee; Diane D Liu; Mylene T Truong; Waun K Hong; Hai Tran; Anne Tsao; Dong Xie; David A Ramies; Robert Mass; Somasekar Seshagiri; David A Eberhard; Sean K Kelley; Alan Sandler Journal: J Clin Oncol Date: 2005-03-07 Impact factor: 44.544
Authors: Leonard B Saltz; Stephen Clarke; Eduardo Díaz-Rubio; Werner Scheithauer; Arie Figer; Ralph Wong; Sheryl Koski; Mikhail Lichinitser; Tsai-Shen Yang; Fernando Rivera; Felix Couture; Florin Sirzén; Jim Cassidy Journal: J Clin Oncol Date: 2008-04-20 Impact factor: 44.544
Authors: Herbert Hurwitz; Louis Fehrenbacher; William Novotny; Thomas Cartwright; John Hainsworth; William Heim; Jordan Berlin; Ari Baron; Susan Griffing; Eric Holmgren; Napoleone Ferrara; Gwen Fyfe; Beth Rogers; Robert Ross; Fairooz Kabbinavar Journal: N Engl J Med Date: 2004-06-03 Impact factor: 91.245
Authors: Alok A Khorana; Michael B Streiff; Dominique Farge; Mario Mandala; Philippe Debourdeau; Francis Cajfinger; Michel Marty; Anna Falanga; Gary H Lyman Journal: J Clin Oncol Date: 2009-08-31 Impact factor: 44.544