Capecitabine/cisplatin versus 5‐fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re‐analysis of efficacy and safety data from the ML17032 phase III clinical trial

Aim To confirm non‐inferiority and test potential superiority of capecitabine/cisplatin (XP) over 5‐fluorouracil (5‐FU)/cisplatin (FP) as first‐line treatment for advanced gastric cancer (AGC) in Chinese patients. Methods In open‐label phase III ML17032 trial, AGC (stage IIIA–IV) patients with or without metastases were randomized 1:1 to receive cisplatin (80 mg/m2/day intravenous [IV] day 1) with either capecitabine (1000 mg/m2/day oral [PO] twice daily [BID], days 1–14; XP) or 5‐FU (800 mg/m2/day continuous IV days 1–5; FP) every 3 weeks. The primary objective was to confirm the non‐inferiority of XP over FP for progression‐free survival (PFS). Results The intent‐to‐treat (ITT) population included 126 Chinese patients (XP–62, FP–64; 67.5% male, mean age 54.7 years). The primary analysis was performed on the per‐protocol (PP) population (105 patients; XP–51, FP–54; 65.7% male). Median PFS in the XP and FP groups was 7.2 and 4.5 months, respectively. The adjusted hazard ratio (HR) for PFS was 0.52 (95% confidence interval [CI]: 0.32–0.83, P = 0.006). Unadjusted HR for PFS in the ITT population was 0.63 (95% CI, 0.42–0.94, P = 0.022). The most frequent drug‐related grade 3/4 adverse events (AEs) were neutropenia (XP–20.7%, FP–17.7%) and gastrointestinal disorders (XP–19.0%, FP–19.4%). The overall incidence of grade 3/4 AEs (XP–43.1%, FP–46.8%), serious AEs (XP–1.7%, FP–3.2%), and AEs related to treatment discontinuation (XP–10.3%, FP–16.1%) were comparable. Conclusion XP had a similar safety profile and may demonstrate superiority for PFS compared to FP as first‐line treatment of Chinese patients with AGC (NCT02563054).