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
| Autor: | Akihito Tsuji, Hiroshi Yabusaki, Kazumasa Fujitani, Toru Aoyama, Satoshi Morita, Masazumi Takahashi, Shigefumi Yoshino, Tsutomu Namikawa, Kazuaki Tanabe, Yasushi Rino, Kazuhiro Nishikawa, Junji Kawada, Yoshinori Hirashima, Takaki Yoshikawa, Yutaka Kimura, Akira Tsuburaya, Junichi Sakamoto, Koichi Taira, Yumi Miyashita, Kensei Yamaguchi, Yasuhiro Kodera, Naoki Hirabayashi |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty medicine.medical_treatment Neutropenia Gastroenterology Capecitabine 03 medical and health sciences 0302 clinical medicine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols Clinical endpoint Adjuvant therapy Humans Medicine 030212 general & internal medicine Aged Tegafur Cisplatin Chemotherapy business.industry Standard treatment Cancer General Medicine Middle Aged medicine.disease Survival Analysis Drug Combinations Oxonic Acid Treatment Outcome Oncology Chemotherapy Adjuvant 030220 oncology & carcinogenesis Female Neoplasm Recurrence Local business medicine.drug |
| Zdroj: | Gastric Cancer. 21:811-818 |
| ISSN: | 1436-3305 1436-3291 |
| Popis: | 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). 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/m2 bid for 14 days plus cisplatin 80 mg/m2 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. 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 |
| Databáze: | OpenAIRE |
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