Details

Autor(en) / Beteiligte

• Takahashi, Masanobu
• Sakamoto, Yasuhiro
• Otsuka, Kazunori
• Kanbe, Mariko
• Ohori, Hisatsugu
• Shindo, Yoshiaki
• Honda, Hiroshi
• Saijo, Ken
• Ouchi, Kota
• Murakawa, Yasuko
• Takahashi, Hidekazu
• Kawai, Sadayuki
• Tanaka, Yuichi
• Yamaguchi, Takuhiro
• Shimodaira, Hideki
• Yoshioka, Takashi
• Ishioka, Chikashi

Titel

Phase II Study of the Reuse of Trastuzumab with Docetaxel beyond Progression after First-Line Treatment in Second-Line Treatment for Unresectable, Metastatic Gastric Cancer (T-CORE1203)

Ist Teil von

• The Tohoku Journal of Experimental Medicine, 2021, Vol.254(1), pp.49-55

Ort / Verlag

Tohoku University Medical Press

Erscheinungsjahr

2021

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• Whether 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.