Patients with advanced gastric and esophagogastric junction adenocarcinoma who underwent first-line treatment with fluorouracil, leucovorin and irinotecan demonstrated significantly longer time to treatment failure than those treated with epirubicin, cisplatin and capecitabine, according to results of a randomized phase 3 study.
The analysis, performed at 71 centers in France, included 416 adults (median age, 61.4 years; 74% men) with unresectable, locally advanced or metastatic gastric or esophagogastric junction adenocarcinoma.
Researchers randomly assigned patients to first-line treatment with epirubicin, cisplatin and capecitabine (ECX), or fluorouracil, leucovorin and irinotecan (FOLFIRI). Researchers stratified patients by WHO performance score, measurable lesions, treatment center, adjuvant chemotherapy or radiotherapy history, localization of tumor and pathologic type.
First-line treatment continued until disease progression, unacceptable toxicity, patient discontinuation request or death. Second-line treatment was administered after a treatment-free period of least 3 weeks to patients who demonstrated biological and clinical recovery.
Time to treatment failure served as the primary endpoint. Secondary endpoints included PFS, OS, toxicity and quality of life.
Median follow-up was 21 months.
Patients assigned FOLFIRI demonstrated significantly longer time to treatment failure than those assigned ECX (5.1 months vs. 4.2 months; P=.008). However, researchers observed no significant differences between the FOLFIRI arm and ECX arm with regard to PFS (5.3 months vs. 5.8 months; P=.96), OS (9.5 months vs. 9.7 months; P=.95) or response rate (39.2% vs. 37.8%).
Patients assigned ECX experienced a higher rates of grade 3 to grade 4 toxicity (84% vs. 69%; P<.001), hematologic adverse events (64.5% vs. 38%) and nonhematologic adverse events (53.5% vs. 53%; P=.81).
“FOLFIRI as the first-line treatment for advanced gastric and esophagogastric junction cancer demonstrated significantly better time to treatment failure than ECX,” the researchers wrote. “The parity of other outcomes — including PFS, tumor response and OS — indicates that FOLFIRI is an acceptable first-line regimen in this setting and should be explored as a backbone regimen for targeted agents.”
Disclosure: The researchers report consultant or advisory roles with Pfizer and Roche. They also report honoraria from Baxter, Pfizer, Roche and Sanofi-Aventis.