Adjuvant 5-FU/cisplatin (FP) chemotherapy in curatively resected stage IIIA-IV M0 gastric cancer

Abstract

4214 Background: After a curative resection for gastric cancer, loco-regional and systemic relapse were more frequently observed with advanced stage. To date, no definitive conclusions concerning the efficacy of adjuvant chemotherapy for gastric cancer have been reached. FP chemotherapy is one of the most widely used regimen for treating patients with advanced gastric cancer. The aim of this phase II study is to evaluate the efficacy of adjuvant FP in terms of relapse rate and survival and to assess prognostic factors affecting relapse and survival. Methods: From November 1995 to November 2003, 80 patients with AJCC stage III-IV (M0) were given adjuvant FP chemotherapy after curative gastric resection with D2 dissection. Cisplatin (60mg/m2 as 15min i.v infusion) followed by 5-FU (1,200mg/m2 as 12 hours continuous i.v infusion for 4days) was given in cycles of 21days. Results: Among 80 patients who were treated as above, a total of 79 patients were available for the analysis. The male to female ratio was 2.2:1 (54:25) and median age was 51.7 (range 29–71). 46 patients were given total gastrectomy and 33 patients were given subtotal gastrectomy. Pathologic stages were as follows: IIIA 30(38%), IIIB 19(24.1%), and IV 30(38%). 68 patients (79.1%) finished 6 cycles of chemotherapy. During median follow-up of 25.3 months (4.3–108.3 months), a total of 41 patients (51.9%) relapsed. (locoregional 29.3% vs. systemic 70.7%) Advanced stage and nodal status were significant risk factor for relapse (hazard ratio for IV (M0): 2.60 and N3: 7.44). Relapse rates according to stage were as follows: IIIA 40.0%, IIIB 42.1%, and IV 70.0%. 3-year disease free survival rate and overall survival rate were 33.6% and 57.3%, respectively. Grade 3–4 leucopenia (15.1%) and neutropenia (62.9%) were most common toxicities, and 2 patients died of febrile neutropenia. Conclusions: In patients with stage III-IV (M0) gastric cancer, adjuvant FP chemotherapy was tolerable. N status was the most powerful predictor of relapse. Adjuvant FP apparently did not confer survival advantage in curatively resected stage III-IV gastric cancer. Clinical trial using more active chemotherapeutic agents is mandatory. No significant financial relationships to disclose.