Multicenter phase II study of capecitabine plus cisplatin as first-line therapy for human epidermal growth factor receptor 2-negative advanced gastric cancer: Yokohama Clinical Oncology Group Study YCOG1107

• Published in: Cancer chemotherapy and pharmacology 2017-11, Vol.80 (5), p.939-943
• Main Authors: Sato, Kei, Kunisaki, Chikara, Kosaka, Takashi, Takagawa, Ryo, Takahashi, Masazumi, Izumisawa, Yusuke, Miyamoto, Hiroshi, Sato, Sho, Tanaka, Yusaku, Yamaguchi, Naotaka, Kimura, Jun, Ono, Hidetaka A., Makino, Hirochika, Akiyama, Hirotoshi, Endo, Itaru
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anemia; Anorexia; Antimetabolites, Antineoplastic - administration & dosage; Antimetabolites, Antineoplastic - pharmacology; Antimetabolites, Antineoplastic - therapeutic use; Cancer; Cancer Research; Capecitabine - administration & dosage; Capecitabine - pharmacology; Capecitabine - therapeutic use; Chemotherapy; Cisplatin; Cisplatin - administration & dosage; Cisplatin - pharmacology; Cisplatin - therapeutic use; Confidence intervals; Epidermal growth factor; ErbB-2 protein; Female; Gastric cancer; Humans; Lesions; Leukopenia; Male; Medicine; Medicine & Public Health; Middle Aged; Motivation; Nausea; Neutropenia; Oncology; Original Article; Patients; Pharmacology/Toxicology; Quality; Response rates; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Survival; Therapy; Toxicity
• ISSN: 0344-5704; 1432-0843
• DOI: 10.1007/s00280-017-3430-6

Purpose S-1 plus cisplatin therapy is the recommended standard first-line regimen for human epidermal growth factor receptor 2 (HER-2)-negative advanced unresectable or recurrent gastric cancer (AGC) in the Japanese Gastric Cancer Treatment Guidelines. By contrast, capecitabine plus cisplatin (XP) therapy has been second-line therapy for these patients. This prospective study aimed to evaluate the efficacy and safety of XP as a first-line regimen for HER2-negative patients with AGC. Methods In this multicenter, open-label, phase II study, patients received cisplatin (80 mg/m 2 i.v. day 1) plus capecitabine (1000 mg/m 2 orally, twice daily, days 1–14) at 3 week intervals until disease progression or non-continuation for various reasons. The primary endpoint was overall response rate; secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity profiles. Results Thirty-six patients with HER2-negative AGC were enrolled in this study. Of these, 16 patients with evaluable lesions were assessable for efficacy and 36 were assessable for toxicity. One patient achieved a complete response and five partial responses. The overall response rate was 37.5% [95% confidence interval (CI) 13.7–61.2%] calculated on an intention-to-treat basis. The median PFS and median OS were 5.2 months (95% CI 4.2–6.2 months) and 16.9 months (95% CI 5.8–27.9 months), respectively. Treatment-related adverse events were generally mild; the most common grade 3/4 adverse event was neutropenia (27.8%), followed by anorexia (19.4%), leucopenia (16.7%), anemia (16.7%), and nausea (13.9%). Conclusion XP as first-line therapy is effective and well tolerated by patients with HER2-negative AGC.