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CLASSIC: Capecitabine, oxaliplatin bested observation in gastric cancer

Issue: July 10, 2011

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2011 ASCO Annual Meeting

CHICAGO — Treating patients diagnosed with gastric cancer with oxaliplatin and capecitabine following D2 gastrectomy was superior to observation alone, according to data from an international study.

“CLASSIC demonstrated superior efficacy of adjuvant Xelox vs. observation,” Yung-Jue Bang, MD, of the Cancer Research Institute, College of Medicine, Seoul National University, Korea, said during his presentation.

Bang and colleagues conducted the CLASSIC trial – a randomized, open-label, multicenter, international trial – to determine whether capecitabine plus oxaliplatin (Xelox, Roche) is an effective adjuvant regimen for patients with operable gastric cancer. The study included 1,035 chemotherapy- and radiotherapy-naive patients with stage II, IIIa or IIIb disease that was resected within 6 weeks of randomization. Patients were randomly assigned to capecitabine 1,000mg/m² plus oxaliplatin 130mg/m² (n=520) or observation (n=515). Median follow-up was 34.4 months.

Three-year PFS was 60% in the observation arm vs. 74% in the treatment arm. In addition, the combination treatment was associated with a 44% reduction in the risk for relapse (P<.0001). Although OS data are not mature, the HR for death was 0.74 (95% CI, 0.53-1.03; P<.0775) in the treatment group.

According to Bang, there were no unexpected adverse events in the treatment group, and toxicity rates were similar to those seen in other trials. Neutropenia was observed in 21% of patients in the treatment arm; it was the only adverse event that occurred in more than 10% of patients. Serious treatment-related grade 3/4 adverse events occurred in 7% of patients. Death occurred among 13% of patients in the safety population of the treatment arm and 17% of those in the observation arm. These were mostly due to disease progression, Bang said. – by Stacey L. Fisher

For more information:

• Bang Y. #LBA4002. Presented at: 2011 ASCO Annual Meeting; Chicago; June 3-7, 2011.

Disclosure: Dr. Bang reported a consultant or advisory role at Novartis.

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