Salvage-line of Capecitabine Plus Oxaliplatin Therapy (XELOX) for Patients With Inoperable/Advanced Gastric Cancer Resistant/Intolerant to Cisplatin (OGSG1403).

[BACKGROUND/AIM] No prospective study has evaluated salvage chemotherapy with capecitabine plus oxaliplatin (XELOX) in patients with gastric cancer who are resistant to or intolerant of cisplatin.

[PATIENTS AND METHODS] This multicenter, open-label, single-arm, phase II study was conducted at six centers in Japan, enrolling patients with metastatic or advanced gastric cancer resistant to or intolerant of fluoropyrimidine, cisplatin, taxane, and irinotecan. Capecitabine 1,000 mg/m was administered orally twice daily for 14 days, followed by a 7-day rest period. Oxaliplatin 130 mg/m was administered intravenously on day one. The primary endpoint was disease control rate (DCR). Secondary endpoints included response rate (RR), progression-free survival (PFS), overall survival (OS), time to treatment failure (TTF), and safety.

[RESULTS] The study was terminated prematurely due to poor accrual, with 12 patients enrolled. Eight patients demonstrated resistance to prior cisplatin, while four experienced unacceptable toxicity. The median age was 64 years, and eight were male. Four, six, and two patients had Eastern Cooperative Oncology Group performance status 0, 1, and 2, respectively. Among 10 evaluable patients, DCR was 90%, with an RR of 30%. Median PFS, TTF, and OS were 4.2 months [95% confidence interval (CI)=1.4-5.3], 4.1 months (95%CI=1.4-4.4), and 7.1 months (95%CI=2.3-10.1), respectively. The most frequently reported grade 3-4 adverse events were fatigue (20%) and hypokalemia (20%). No treatment-related deaths occurred.

[CONCLUSION] Salvage chemotherapy with XELOX may offer clinical benefits for patients with metastatic or advanced gastric cancer resistant to or intolerant of cisplatin.