A phase II study of Docetaxel and Oxaliplatin combination as first-line chemotherapy in recurrent gastric cancer patients after Fluoropyrimidine and/or Cisplatin adjuvant treatment

초록

Background: After two important randomised trials of the East (S-1 as adjuvant treatment; Sakuramoto S et al, N Engl J Med 2007) and the West (MAGIC trial; Cunningham D et al, N Engl J Med 2006), surgery alone is no longer the standard treatment for patients with resectable gastric cancer. Therefore, urgent investigation is demanded which regimen is more effective for patients with recurrent gastric cancer after combined treatment with surgery and perioperative or adjuvant chemotherapy. Materials and Methods: Patients with histologically confirmed and measurable advanced gastric cancer that had relapsed after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy received docetaxel 35 mg/m2 i.v. on day 1, 8 plus oxaliplatin 100 mg/m2 i.v. on day 1 every 3 weeks until disease progression or unacceptable toxicities. Results: Between Feb 2007 and Mar 2009, total 27 patients (pts) who had received adjuvant chemotherapy for median 5.7 months (range, 0.1−49.1) were enrolled. A total of 18 pts (66.7%) had exposed all two drugs for fluoropyrimidine and cisplatin. The median age was 58 years (range, 40−68). After a median 4 (range, 1−13; total, 123) cycles of chemotherapy, 25 pts and 120 cycles were evaluable for response and toxicity, respectively. In intention-to-treat analysis, the overall response rate was 44.0% (95% C.I., 24.6−63.4%), including 1 CR, 10 PRs. After a median follow-up of 8.5 months (range, 2.0−20.6), median time to progression was 6.9 months (95% C.I., 3.4−10.4) and median overall survival was 12.8 months (95% C.I., 8.7−16.7). Commonly observed grade 3/4 adverse events were neutropenia (52.2% of pts), diarrhea (20.0%), anorexia (8.0%), stomatitis (8.0%) and motor neuropathy (4.0%). Treatment was delayed in 29 cycles (24.2%). The dose of docetaxel on D1, 8 and oxaliplatin were reduced during 22 (18.3%), 25 (20.8%) and 23 cycles (19.2%), respectively. Major causes for treatment delay and dose reduction of two drugs were neutropenia and diarrhea. There were three pts of neutropenic fever, and one pt of treatment-related death. Conclusions: Docetaxel and oxaliplatin combination chemotherapy was active and tolerable except grade 3 diarrhea as first-line treatment in patients with recurrent gastric cancer after fluoropyrimidine and/or cisplatinbased adjuvant chemotherapy.