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Two Bevacizumab-Based Combination Regimens Equally Effective in Patients With Metastatic Colorectal Cancer: Presented at ESMO-GI

By Jenny Powers

BARCELONA, Spain -- July 2, 2009 -- Combining bevacizumab (BEV) with capecitabine plus irinotecan (XELIRI) is an effective alternative to BEV plus 5-fluorouracil (5-FU), leucovorin, and irinotecan (FOLFIRI) in patients with metastatic colorectal cancer (mCRC), researchers reported here at the 11th World Gastrointestinal Cancer Congress of the European Society for Medical Oncology (ESMO-GI).

Michel Ducreux, MD, Institut Gustave Roussy, Villejuif, France, presented the results of a phase 2, noncomparative, randomised trial on June 25.

A total of 145 patients, aged 18 to 72 years, were randomised to receive either BEV plus XELIRI (n = 72) or BEV plus FOLFIRI (n = 73).

Patients in the XELIRI arm received irinotecan 200 mg/m² on day 1, capecitabine 1,000 mg/m² BID on days 1 to 14 plus bevacizumab 7.5 mg/kg on day 1, every 3 weeks for a maximum of 8 cycles.

Patients in the FOLFIRI arm received irinotecan 180 mg/m² on day 1 plus 5-FU 400 mg/m² plus leucovorin 400 mg/m² on day 1 followed by 5-FU 2,400 mg/m² as a 46-hour infusion plus bevacizumab 5 mg/kg on day 1, every 2 weeks for a maximum of 12 cycles.

The 6-month overall response rate was 54% (95% confidence interval [CI], 48%-60%) in the BEV plus XELIRI arm compared with 59% (95% CI, 53%-65%) in the BEV plus FOLFIRI arm.

Disease progression was seen in 14 (19%) of patients in the BEV plus XELIRI arm versus 10 (14%) of patients in the BEV plus FOLFIRI arm.

Stable disease was achieved by 13 (18%) patients in the BEV plus XELIRI arm and in 15 (21%) patients in the BEV plus FOLFIRI arm.

The most frequent clinical and haematological grade 3 adverse events reported in the XELIRI and FOLFIRI groups were neutropenia (15 vs 23), asthenia (14 vs 11), diarrhoea (11 vs 5), vomiting (7 vs 7), and hand-foot syndrome (6 vs 1). The most common grade 4 adverse event was neutropenia (3 vs 4).

The most frequent bevacizumab-specific grade 3 adverse events were venous thrombosis (11 vs 3) and hypo- or hypertension (3 vs 8).


The investigators concluded that both treatment groups demonstrated manageable toxicity and that XELIRI and FOLFIRI plus bevacizumab are both effective in the treatment of patients with mCRC.

Funding for this study was provided by Roche, Pfizer, and Chugai.

[Presentation title: Efficacy and Safety of Bevacizumab-Based Combination Regimens in Patients With Metastatic Colorectal Cancer: Preliminary Results From a Randomised Phase II Study of Bevacizumab + FOLFIRI vs Bevacizumab + XELIRI (FNCLCC ACCORD 13-0503 STUDY). Abstract O-0006]

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