November 19, 2014
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Adjuvant regimen improved outcomes in gastric cancer after D2 gastrectomy

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Adjuvant treatment with capecitabine and oxaliplatin extended survival compared with observation among patients with stage II to stage IIIb gastric cancer who underwent curative D2 gastrectomy, according to long-term follow-up of a randomized phase 3 trial.

The multicenter, open-label CLASSIC trial included 1,035 chemotherapy- and radiotherapy-naive patients with stage II, IIIa or IIIb gastric cancer who underwent curative D2 gastrectomy.

Researchers randomly assigned 520 patients to undergo adjuvant therapy with capecitabine 1,000mg/m2 plus oxaliplatin 130mg/m2. The other 515 patients underwent observation alone. DFS served as the primary endpoint.

The planned interim analysis, performed with a median follow-up of 34 months, showed the adjuvant regimen significantly improved DFS compared with observation.

In the current analysis, Sung Hoon Noh, MD, of the department of surgery at Yonsei University College of Medicine in South Korea, and colleagues reported 5-year follow-up data. Median follow-up in the intention-to-treat population was 62.4 months.

DFS events occurred in 39% of patients assigned observation and 27% of patients assigned capecitabine plus oxaliplatin (HR=0.58; 95% CI, 0.47-0.72).

Researchers reported higher rates of 5-year DFS (68% vs. 53%) and 5-year OS (78% vs. 69%) in the treatment arm. Fewer deaths occurred in the treatment arm than the observation arm (103 vs. 141; HR=0.66; 95% CI, 0.51-0.85).

“Postoperative adjuvant treatment with capecitabine plus oxaliplatin should be considered for patients with operable stage II or III gastric cancer after D2 gastrectomy,” Noh and colleagues wrote. “The relevance of our findings for patients who have had less extensive gastrectomy is unknown.”

Disclosure: The study was supported by F. Hoffmann La-Roche and Sanofi. The researchers report consultant roles with, research funding or honoraria from, employment relationships with and stock ownership in F. Hoffmann-La Roche and Sanofi-Aventis.