A phase II study of sequential capecitabine plus oxaliplatin (XELOX) followed by docetaxel plus capecitabine (TX) in patients with unresectable gastric adenocarcinoma-TCOG 3211 clinical trial

[[abstract]]Background: Fluorouracil and platinum can be considered a standard option for advanced gastric cancer (AGC). Docetaxel is also an effective agent with no cross-resistance with fl uorouracil and platinum. Concomitant combination of docetaxel with fl uorouracil and platinum had been explored, but demonstrated intolerable toxicities. A different way to include all active agents in fi rst-line treatment of gastric adenocarcinoma may be to use them sequentially. We aimed to evaluate the activity and the safety pro file of sequential chemotherapy with capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in the fi rst-line treatment of AGC. Methods: We conducted a phase II study of fi rst-line sequential chemotherapy in AGC. Treatment consisted of six cycles of capecitabine plus oxaliplatin (XELOX; capecitabine 1000 mg/m 2 bid on days 1 – 10 and oxaliplatin 85 mg/m 2 on day 1; Q2W) followed by four cycles of docetaxel plus capecitabine (TX; docetaxel 30 mg/m 2 on D1 and D8; capecitabine 825 mg/m 2 bid on days 1 – 14; Q3W). Primary endpoint was the objective response rate. Results: Fifty-one patients were enrolled: median age 63 years, male/female: 37/14. Main grade 3 – 4 toxicities were ANC decreased (25.5%), diarrhea (11.8%), hand-foot syndrome (15.7%), and anemia (11.8%). The objective response rate was 61.7%. Median PFS and OS were 8.6 and 11.0 months; respectively. Conclusions: This sequential treatment demonstrated feasibility with a favorable safety pro fi le and produced encouraging results in terms of activity and ef fi cacy