Oxaliplatin-based regimen as neoadjuvant chemotherapy for Chinese patients with advanced gastric cancer: Preliminary results of a phase II study

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Abstract
4184 Background: Gastric cancer is the first cause of death per cancer in China, with more than 160,000 deaths/year. At time of resection, 75–85% of gastric cancer (GC) patients (pts) are expected to have nodal involvement and are at high risk of postoperative relapse. A Phase-II trial was conducted to evaluate the benefits of surgery combined with Oxaliplatin (OXA)-based regimen as neoadjuvant and adjuvant chemotherapy, on the survival of pts with locally advanced disease. Methods: 15 pts (Stage IIIb or IV) have been enrolled by now. All pts had histologically proven gastric adenocarcinoma and no previous palliative chemotherapy. Median age: 59 years (33–69 years), male/female ratio: 10/5, performance status: 0–2. Pts received OXA 130 mg/m2 3H-infusion day 1, leucovorin (LV) 200 mg/m2 (2H-infusion) followed by 5FU 400mg/m2 (bolus) and 5FU 2.5g/m2 (22h-continuous infusion) day 1, repeated every 3 weeks. Efficacy was evaluated after 2 cycles. Results: All pts are evaluable for response with a more than 50% tumor reduction in 7 of 15 (46.7%)pts, SD was observed in 6 pts (40.0%) and PD in 2(13.3%).14 of 15 pts received a total 6 cycles (pre-op +or- post-op) of chemotherapy and all 15 pts came to surgery after receiving 2–6 cycles. OXA-5FU/LV was general well tolerated. The most common toxicity was Grade (Gr) 2 or 3 neutropenia and diarrhea or Gr 2 nausea/vomiting, No patients experienced Gr 4 toxicity. Neutropenic fever was not observed. An R0 curative resection was possible in 7 pts. There were no postoperative mortalities and no treatment related deaths; 14 of 15 pts are surviving (2 to 24 months) and one PD pt died of disease 2 months after surgery. Pathologic examinations of operative samples showed significant chemotherapy-induced changes in 6 pts. The trial is still open and more mature data will be available at the meeting. Conclusions: In view of the favorable response rate and toxicity profile, this protocol will be further assessed in a multicenter phase II trial. No significant financial relationships to disclose.