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Avastin (Bevacizumab, anti-VEGF, rhuMab-VEFG)


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  • 4 weeks later...


Success at last

The angiogenesis inhibitor bevacizumab (Avastin) lengthens the average survival times for patients with metastatic colorectal cancer by almost 5 months — this is the first time that targeted anti-angiogenic therapy has shown a survival benefit in clinical trials. The results of the Phase III trial, which compared treatment with standard therapy alone or in combination with bevacizumab, were presented by Herbert Hurwitz (Duke University, USA) in a late-breaking abstract at the annual American Society of Clinical Oncology meeting in Chicago.

Genentech's bevacizumab is a recombinant humanized monoclonal antibody that binds vascular endothelial growth factor — a key regulator of tumour-induced angiogenesis — and should therefore interfere with tumour growth and metastasis.

The trial included more than 800 previously untreated patients who were randomized to receive either the standard therapy of irinotecan, fluorouracil and leucovorin (IFL) in combination with placebo, or with bevacizumab. Hurwitz reported that the median survival time of the patients that received IFL alone was 15.6 months, whereas patients that received bevacizumab plus IFL survived a median of 20.3 months. Cancer did not progress for a median of 10.6 months in the bevacizumab group, compared with 6.2 months in the control group. Tumours also decreased in size by 50% or more in 45% of patients who received bevacizumab, but in only 35% of patients who received IFL alone.

Bevacizumab therapy was well tolerated. Its main side effect was high blood pressure (11% of patients treated with the combination had grade 3 hypertension, versus 2.3% of the patients that received IFL alone), but this could be easily managed. Phase II trials had indicated that proteinuria and thrombosis might be associated with use of bevacizumab, but these were not supported by the Phase III data. In addition, a rare complication of bevacizumab therapy was perforation of the gastrointestinal tract, leading to one death and the discontinuation of five other patients from the study.

Several other Phase III cancer trials to evaluate bevacizumab in patients with metastatic colorectal cancer are underway. The National Cancer Institute is planning to evaluate bevacizumab in patients who are not good candidates for irinotecan as first-line treatment, or who have failed standard therapy with oxaliplatin or irinotecan regimens. Patients in this trial will receive bevacizumab in combination with 5-fluorouracil (5-FU) and leucovorin. Previous studies have shown that bevacizumab is not effective as a single agent in treating patients with progressive colorectal cancer.

Genentech is providing bevacizumab for a large Phase II programme that encompasses more than 22 trials in a variety of malignancies. The drug has shown particular promise in treating patients with metastatic renal-cell cancer — two Phase III trials are opening later this year that will hopefully confirm the positive data observed in a Phase II setting.

Two other new agents, oxaliplatin and cetuximab (Erbitux) have also recently been shown to be effective in randomized trials for patients with advanced and metastatic colorectal cancer. New trials are being planned to compare these two agents and bevacizumab in various combinations.

FURTHER INFORMATION http://www.asco.org

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