Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 3523
© 2006 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Michael, M. Search for Related Content PubMed Articles by Michael, M.

Abstract

Feasibility of metastasectomy in patients treated with bevacizumab in first-line mCRC - Preliminary results from the First Beat-study

Peter MacCallum Cancer Institute, East Melbourne, Australia; University Hospital Gasthuisberg, Leuven, Belgium; HELIOS-Klinikum, Berlin, Germany; Sunnybrook Regional Cancer Centre, Toronto, ON, Canada; Hospital Marqués de Valdecilla, Santander, Spain; Istituto Nazionale Tumori, Milano, Italy; Parexel, Paris, France; Roche, Basel, Switzerland; Royal Marsden Hospital, Sutton, United Kingdom

3523

Background: In a phase III pivotal trial in patients (pts) with mCRC, bevacizumab (BEV) increased overall survival by 30% when added to first-line irinotecan, 5FU and leucovorin. The study reported 10% of pts having wound healing complications after major unplanned or elective surgery. The study had limited data on the feasibility and safety of metastastasectomies. First BEAT was opened to evaluate safety events of BEV in a broader pt population using a variety of chemotherapy (CT) regimens. Methods: First BEAT started in June 2004 and aims to enrol up to 2000 mCRC pts in 41 countries. Eligible patients starting with first-line CT are treated until progression with BEV (5mg/kg q2w (5FU based CT) or 7.5mg/kg q3w (Capecitabine (CAP) based CT). In case of major elective surgery, BEV should be stopped 6–8 weeks prior to the planned surgery and could be restarted 28 days after surgery and complete wound healing. At protocol visits, bleeding and wound healing data was collected according to CTC AE grading (v3.0). Results: By Dec 20th, 2005, 31 pts (13 male; median age 55 years; PS 0/1 90%/10%) had undergone metastasectomies. 27 were liver (1 pt had two operations), 3 lung, 1 peritoneal and 1 other resections. 27 were curative, 3 palliative and 2 other resections. 17 reported no residual disease, 5 had residual disease and for 8 resections the outcome was missing or unknown. Median time from first BEV treatment to surgery was 167 days and 54 days from last BEV administration to surgery, respectively. Median follow-up was 12.4 months. One pt died due to disease progression 5.5 months after surgery. CT regimens used with BEV included FOLFOX (N=9), CAPOX (N=9) and FOLFIRI (N=7). No wound healing or bleeding were reported. 21/31 pts reported no complications at all, for 3/31 data was currently missing and 7/31 pts reported the following complications: stomach perforation, right pleural effusion, surgical area infection, thrombosis portal vein/myocardial infarct, bowel-obstruction, ascites, ileus/cornea infection. Updated data will be available in June 06. Conclusions: Preliminary data suggest metastasectomies are feasible after treatment with BEV and CT. Stopping BEV 6–8 weeks before major surgery resulted in no bleeding or wound healing complications.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche Roche Roche Roche Roche

Abstract presentation from the 2006 ASCO Annual Meeting