A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association 2018-09, Vol.21 (5), p.811-818
• Main Authors: Nishikawa, Kazuhiro, Tsuburaya, Akira, Yoshikawa, Takaki, Takahashi, Masazumi, Tanabe, Kazuaki, Yamaguchi, Kensei, Yoshino, Shigefumi, Namikawa, Tsutomu, Aoyama, Toru, Rino, Yasushi, Kawada, Junji, Tsuji, Akihito, Taira, Koichi, Kimura, Yutaka, Kodera, Yasuhiro, Hirashima, Yoshinori, Yabusaki, Hiroshi, Hirabayashi, Naoki, Fujitani, Kazumasa, Miyashita, Yumi, Morita, Satoshi, Sakamoto, Junichi
• Format: Article
• Language: English
• Subjects: Abdominal Surgery; Adjuvant therapy; Adult; Aged; Anorexia; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Cancer therapies; Capecitabine - administration & dosage; Chemotherapy; Chemotherapy, Adjuvant - methods; Cisplatin; Cisplatin - administration & dosage; Creatinine; Diarrhea; Drug Combinations; ErbB-2 protein; Fatigue; Female; Gastric cancer; Gastroenterology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neutropenia; Oncology; Original Article; Oxonic Acid; Platinum; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach Neoplasms - pathology; Surgical Oncology; Survival Analysis; Tegafur; Treatment Outcome
• ISSN: 1436-3291; 1436-3305
• DOI: 10.1007/s10120-018-0815-0

Backgrounds In Japan, standard regimens for advanced gastric cancer (AGC) include S-1 chemotherapy. The standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine alone is platinum-based chemotherapy, while the standard treatment for early relapse after adjuvant chemotherapy with fluoropyrimidine plus platinum is second-line chemotherapy. To evaluate the efficacy and safety of capecitabine plus cisplatin (XP) treatment for AGC patients who relapse within 6 months after S-1-based therapy, we conducted a multicenter phase II trial (NCT01412294). Methods HER2-negative gastric cancer patients treated with adjuvant chemotherapy including S-1 for more than 12 weeks and relapsed within 6 months were treated with capecitabine 1000 mg/m 2 bid for 14 days plus cisplatin 80 mg/m 2 on day 1 of a 3-week cycle. The primary endpoint was PFS; secondary endpoints were OS, time to treatment failure, overall response rate (ORR) and safety. Results Forty patients (median age 64) were enrolled; of those, 37 (92.5%) received adjuvant S-1 monotherapy. Median PFS was 4.4 months (95% CI 3.6–5.1), which was longer than the 2-month protocol-specified threshold ( p