Title |
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
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Published in |
Gastric Cancer, February 2018
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DOI | 10.1007/s10120-018-0815-0 |
Pubmed ID | |
Authors |
Kazuhiro Nishikawa, Akira Tsuburaya, Takaki Yoshikawa, Masazumi Takahashi, Kazuaki Tanabe, Kensei Yamaguchi, Shigefumi Yoshino, Tsutomu Namikawa, Toru Aoyama, Yasushi Rino, Junji Kawada, Akihito Tsuji, Koichi Taira, Yutaka Kimura, Yasuhiro Kodera, Yoshinori Hirashima, Hiroshi Yabusaki, Naoki Hirabayashi, Kazumasa Fujitani, Yumi Miyashita, Satoshi Morita, Junichi Sakamoto |
Abstract |
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/m2bid for 14 days plus cisplatin 80 mg/m2on 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 < 0.001). Median OS was 13.7 months (95% CI 9.0-17.7) and ORR was 8/30 (26.7%) (95% CI 14.2-44.4). Most common grade ≥ 3 adverse events were neutropenia (23%), anemia (18%), elevated serum creatinine (18%), fatigue (13%), diarrhea (7.5%), and anorexia (7.5%). XP was safe and effective in patients with early relapse after S-1 adjuvant chemotherapy for curatively resected gastric cancers. XP may be a good option for the treatment of patients after early failure after adjuvant S-1. NCT01412294. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Japan | 1 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 35 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 5 | 14% |
Student > Doctoral Student | 5 | 14% |
Other | 4 | 11% |
Student > Master | 3 | 9% |
Student > Ph. D. Student | 3 | 9% |
Other | 6 | 17% |
Unknown | 9 | 26% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 12 | 34% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 6% |
Nursing and Health Professions | 2 | 6% |
Agricultural and Biological Sciences | 2 | 6% |
Sports and Recreations | 2 | 6% |
Other | 5 | 14% |
Unknown | 10 | 29% |