Abstract:
Objective This study aimed to investigate the curative effect and safety of capecitabine maintenance chemotherapy after the first-line oxaliplatin/capecitabine chemotherapy for patients with advanced gastric cancer (AGC).
Methods A total of 62 chemotherapy-naïve AGC patients were enrolled into this study. They received 2 h of intravenous infusion of oxapliplatin (130 mg/m2) on day 1, and an oral administration of capecitabine (2 000 mg/m2) given in two daily doses on days 1–14 (XELOX regimen). The therapeutic regimen was repeated every 21 days. A maximum six-cycle dosage was given. A total of 49 patients who responded to the therapy were assigned to either the group with capecitabine maintenance chemotherapy (G1; 2 000 mg/m2 given in two daily doses on days 1–14) or with clinical observation (G2). Among the 49 patients, 32 were in G1 and 17 patients were in G2. The maintenance therapy continued until disease progression or intolerable toxicity.
Results A total of 315 cycles of the chemotherapy were completed in 62 AGC patients, with a median of five cycles per patient. All patients were evaluated for the therapeutic efficacy. The response rate (RR) was 51.6% in the patients. Among the 49 patients who responded to the XELOX regimen, 32 received capecitabine maintenance chemotherapy. The RR and disease control rate were 28.1% and 78.1% in G1, and 0% and 47.1% in G2, respectively (P < 0.05). At a median follow-up of 17 months, the median time to progression was longer in G1 (7.9 months) than in G2 (5.7 months) (P < 0.05). The median overall survival time was 14.9 and 13.4 months in G1 and G2, respectively (P>0.05). The most common adverse events included nausea/vomiting, diarrhea, myelosuppression, and hand-foot syndrome.
Conclusion Capecitabine maintenance chemotherapy can benefit the RR and median time to progression, but not the overall survival time in AGC patients who respond to oxaliplatin/capecitabine induction chemotherapy. However, further evaluation of the efficacy of capecitabine maintenance chemotherapy is needed