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Clinical Trial
. 2010 Oct;21(10):1999-2004.
doi: 10.1093/annonc/mdq065. Epub 2010 Mar 23.

A phase II study of bevacizumab, oxaliplatin, and docetaxel in locally advanced and metastatic gastric and gastroesophageal junction cancers

B F El-Rayes  1 , M Zalupski  2 , T Bekai-Saab  3 , L K Heilbrun  4 , N Hammad  5 , B Patel  5 , S Urba  2 , A F Shields  5 , U Vaishampayan  5 , S Dawson  5 , K Almhanna  5 , D Smith  4 , P A Philip  5
Affiliations
Clinical Trial

A phase II study of bevacizumab, oxaliplatin, and docetaxel in locally advanced and metastatic gastric and gastroesophageal junction cancers

B F El-Rayes et al. Ann Oncol. 2010 Oct.

Abstract

Background: Bevacizumab has demonstrated antitumor activity in multiple diseases. This phase II study was undertaken to determine the effects of adding bevacizumab to a regimen of docetaxel and oxaliplatin in patients with advanced adenocarcinoma of the stomach or gastroesophageal junction.

Patients and methods: Previously untreated patients with locally advanced or metastatic disease and a performance status (PS) of 0-1 were eligible for this study. Patients received bevacizumab at 7.5 mg/kg, docetaxel at 70 mg/m(2), and oxaliplatin at 75 mg/m(2) administered on day 1 of a 21-day cycle. The primary end point of the study was progression-free survival (PFS).

Results: A total of 38 eligible patients (median age 57 years, 45% gastric, 55% PS 0) were enrolled on to the study. Median PFS was 6.6 months [95% confidence interval (CI) 4.4-10.5] and median survival 11.1 months (95% CI 8.2-15.3). Complete responses were documented in 2 (5%) patients, partial responses in 14 (37%), and stable disease in 14 (37%). No treatment-related deaths were observed. The most commonly reported grade 3-4 toxicity was neutropenia (34%), and gastrointestinal perforation occurred in three patients (8%).

Conclusion: The combination of bevacizumab, docetaxel, and oxaliplatin has promising activity for further evaluation in randomized trials.

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Figures

Figure 1.
Figure 1.
The Kaplan–Meier estimate of progression-free survival (PFS) in the 38 eligible patients with metastatic gastroesophageal junction cancer or gastric cancer who were treated with docetaxel, oxaliplatin, and bevacizumab. The dashed lines represent the 95% confidence interval (CI) about each successive estimate of the progression-free rate. The median PFS was 6.6 months (95% CI 4.4–10.5 months). The 6-month PFS rate was 55% (95% CI 35% to 74%).
Figure 2.
Figure 2.
The Kaplan–Meier estimate of overall survival (OS) in the 38 eligible patients with metastatic gastroesophageal junction cancer or gastric cancer enrolled in the study. The dashed lines represent the 95% confidence interval (CI) about each successive estimate of the survival rate. The median OS was 11.1 months (95% CI 8.2–15.3 months). The 12-month OS rate was 40% (95% CI 17% to 63%).
See this image and copyright information in PMC

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