• Masanobu Takahashi, Yasuhiro Sakamoto, Kazunori Otsuka, Mariko Kanbe, Hisatsugu Ohori, Yoshiaki Shindo, Hiroshi Honda, Ken Saijo, Kota Ouchi, Yasuko Murakawa, Hidekazu Takahashi, Sadayuki Kawai, Yuichi Tanaka, Takuhiro Yamaguchi, Hideki Shimodaira, Takashi Yoshioka, and Chikashi Ishioka.
• Department of Medical Oncology, Tohoku University Hospital.
• Tohoku J. Exp. Med. 2021 May 1; 254 (1): 49-55.

AbstractWhether trastuzumab use beyond disease progression is beneficial in second-line treatment for patients with unresectable human epidermal growth factor receptor 2 (HER2)-positive gastric cancer remains to be elucidated. We conducted this phase II study to assess whether trastuzumab plus docetaxel was effective for patients with previously treated advanced HER2-positive gastric cancer. This trial was a single-arm, open-label, multicenter, phase II study, conducted by Tohoku Clinical Oncology Research and Education Society (T-CORE). Patients aged 20 years or older who had advanced HER2-positive gastric cancer and were refractory to trastuzumab, fluoropyrimidine, and cisplatin were enrolled. Patients were treated with 6 mg/kg trastuzumab and 60 mg/m2 docetaxel every 3 weeks. The primary endpoint was the overall response rate. The threshold overall response rate was estimated to be at 15%. Secondary endpoints were progression-free survival, 6-month survival rate, overall survival, and toxicities. A total of 27 patients were enrolled from 7 hospitals. The median age was 67 years. Partial response was seen in 3 patients among the 26 evaluated patients. The overall response rate was at 11.5% (90% confidence interval 1.2%-21.8%). The median progression-free survival was 3.2 months, the 6-month survival rate was 85%, and the median overall survival was 11.6 months. Febrile neutropenia was observed in 14.8%. The most frequently observed grade 3 non-hematologic toxicity was anorexia (14.8%). The primary endpoint was not achieved. The results support a current consensus that the continuation of trastuzumab in second-line therapy for gastric cancer is not a recommended option.

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