Multi-institutional trial of preoperative chemoradiotherapy in patients with potentially resectable gastric carcinoma

Purpose In the West, curative (RO) resection is achieved in approximately 50% of patients with localized gastric carcinoma, and more than 60% die of cancer following an RO resection. A multi-institutional study of preoperative chemoradiotherapy was done to assess the RO resection rate, pathologic complete response (pathCR) rate, safety, and survival in patients with resectable gastric carcinoma. Patients and Methods Operable patients with localized gastric adenocarcinoma were eligible. Staging also included a laparoscopy and endoscopic ultrasonography (EUS). Patients received up to two 28-day cycles of induction chemotherapy of fluorouracil, leucovorin, and cisplatin, followed by 45 Gy of radiation plus concurrent fluorouracil. Patients were then staged and surgery was attempted. Results Thirty-four patients were registered at three institutions. One ineligible patient was excluded. Most patients had a promixal cancer and EUST3N1 designation. Twenty-eight (85%) of 33 patients underwent surgery. The RO resection rate was 70% and pathCR rate was 30%. A pathologic partial response (< 10% residual carcinoma in the primary) occurred in eight patients (24%). EUS T plus N and postsurgery T plus N correlation showed significant downstaging (P = < .01). The median survival time for 33 patients was 33.7 months. Patients achieving a pathCR or pathPR had a significantly longer median survival time (63.9 months) than those achieving less than pathPR (12.6 months; P = .03). There were two treatment-related deaths. Conclusion Our data suggest that the three-step strategy of preoperative induction chemotherapy followed by chemoradiotherapy resulted in substantial pathologic response that resulted in durable survival time. This strategy is worthy of a direct comparison with postoperative adjuvant chemoradiotherapy. (C) 2004 by American Society of Clinical Oncology.