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Colorectal Metastasectomies Feasible After Treatment With Bevacizumab (Avastin) and Chemotherapy: Presented at ESMO

By Jill Stein

ISTANBUL, TURKEY -- October 3, 2006 -- Metastasectomy surgery is feasible and safe in patients treated with bevacizumab (Avastin) plus combination chemotherapy when bevacizumab is stopped 6 to 8 weeks before surgery, researchers reported October 2^nd at the 31^st European Society for Medical Oncology (ESMO) Scientific Conference.

Maria DiBartolomeo, MD, research oncologist, Istituto Nazionale Tumori, Milan, Italy, presented results in 1,903 patients treated with first-line chemotherapy in combination with bevacizumab 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks, until disease progression. In the event of toxicity-limited administration, the remaining agent could be continued until progression.

Patients requiring surgery during treatment were assessed for wound healing and bleeding complications, Dr. DiBartolomeo said.

Elective surgical interventions were scheduled a minimum of 6 to 8 weeks after the last dose, as bevacizumab could interfere with wound healing. During this time, the patients received 1 or more chemotherapy doses, as clinically appropriate. Bevacizumab was restarted 28 days after surgery, when appropriate, or once wound healing was complete.

"Bevacizumab increased overall survival by 30% when added to first-line irinotecan, 5-fluorouracil (5-FU) and leucovorin in a phase 3 pivotal trial in patients with metastatic colorectal cancer," Dr. DiBartolomeo pointed out. "Overall, 13% of patients had wound healing complications after major unplanned or elective surgery."

The present trial, Dr. DiBartolomeo added, was undertaken to assess the safety of bevacizumab when used with a variety of chemotherapy regimens in a more representative sample of patients with metastatic colorectal cancer.

At a median follow-up of 13 months, 81 patients (43% of the patients with baseline data) had undergone metastasectomy for residual disease after bevacizumab plus chemotherapy.

The most common chemotherapy regimens used in combination with bevacizumab were oxaliplatin- (69%) and irinotecan-based (28%). The most common double-chemotherapy regimens used in combination with bevacizumab were FOLFOX (42%),¹ FOLFIRI (23%),² and XELOX (25%).³

The median follow-up was 16.9 months. One patient died because of disease progression 5.5 months after surgery.

Intra-surgical bleeding or wound healing complications were observed in only 2 patients.

Overall, the preliminary results support the feasibility and safety of metastasectomies after treatment with bevacizumab and chemotherapy, Dr. DiBartolomeo said.

This study was funded by F. Hoffmann-LaRoche.

1. fluorouracil; folinic acid (leucovorin); oxaliplatin
2. folinic acid; fluorouracil; irinotecan
3. capecitabine; oxaliplatin


[Presentation title: Feasibility of Metastasectomy in Patients With First-Line Bevacizumab for MRC: Preliminary Results from the First BEAT Study. Abstract 373P]

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