A phase II study of neoadjuvant chemotherapy with docetaxel, capecitabine and cisplatin (DXP) in patients with advanced unresectable or intra-abdominal metastatic gastric cancer

Abstract

4640 Background: The prognosis of gastric cancer is dismal once R0 resection is impossible due to local invasion or distant metastasis. Previous studies have suggested the possible efficacy of neoadjuvant chemotherapy for the patients with locally advanced gastric cancer (AGC). The aim of the present study was to evaluate the feasibility, the impact on R0 resection of neoadjuvant chemotherapy in locally advanced, unresectable or intra-abdominal metastatic gastric cancer Methods: Patients with advanced gastric cancer, clinically unresectable because of local invasion or intra-abdominal metastasis in paraaortic lymph nodes and/or peritoneum based on CT scan were entered into this study. Preoperative chemotherapy consisted of docetaxel 60 mg/m2 IV on day 1, cisplatin 60 mg/m2 IV on day 1, and capecitabine 1,875 mg/m2/day PO on days 1 - 14 every 21 days. After 2 cycles of chemotherapy, the tumors were evaluated. Unless disease progression was encountered, surgery was performed after total 3 - 6 cycles of chemotherapy and followed by two cycle of adjuvant therapy with the same regimen if R0 resection was done. Results: Total 49 patients were accrued. Among them, 36 (74%) could undergo surgery, and 31 (63%) had R0 resection. R0 resection was possible in 15 (71%) of 21 patients with initially unresectable T4 lesions and in 12 (70%) of 17 patients with paraaortic lymph node enlargement, while only in 3 (42%) of 7 patients with suspicious peritoneal seeding. After a median follow up of 18.2 months for the surviving patients, median overall survival and progression free survival of total enrolled patients were 19 months (95% C.I, 10.5 - 27.4) and 11.6 months (95% C.I, 9.6 - 13.7), respectively. Among 31 patients who underwent R0 resection, median OS was 33.4 months and median PFS was 18.2 months. Major toxicity was neutropenia and grade 3/4 neutropenia occurred in 77% of patients, but there was only 4% of neutropenic fever and no treatment related mortality. Postoperative morbidities were observed in 4 patients. Conclusions: These data suggested that neoadjuvant DXP chemotherapy could offer a reasonable chance for curative surgery in AGC patients with local invasion or paraaortic lymph node enlargement. No significant financial relationships to disclose.