Premium
Phase II study of the effectiveness and safety of trastuzumab and paclitaxel for taxane‐ and trastuzumab‐naïve patients with HER2‐positive, previously treated, advanced, or recurrent gastric cancer (JFMC45‐1102)
Author(s) -
Nishikawa Kazuhiro,
Takahashi Tsunehiro,
Takaishi Hiromasa,
Miki Akira,
Noshiro Hirokazu,
Yoshikawa Takaki,
Nishida Yasunori,
Iwasa Satoru,
Miwa Hiroto,
Masuishi Toshiki,
Boku Narikazu,
Yamada Yasuhide,
Kodera Yasuhiro,
Yoshida Kazuhiro,
Morita Satoshi,
Sakamoto Junichi,
Saji Shigetoyo,
Kitagawa Yuko
Publication year - 2016
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.30383
Subject(s) - trastuzumab , medicine , taxane , gastroenterology , oncology , cancer , regimen , cardiotoxicity , paclitaxel , neutropenia , metastatic breast cancer , chemotherapy , breast cancer , surgery
Paclitaxel is a standard second‐line gastric cancer treatment in Japan. Trastuzumab could be active as second‐line chemotherapy for taxane/trastuzumab‐naïve patients with epidermal growth factor 2 (HER2)‐positive advanced gastric cancer. Patients aged ≥20 years with HER2‐positive, previously treated (except for trastuzumab and taxane), unresectable or recurrent gastric adenocarcinoma underwent combined trastuzumab (first and subsequent doses of 8 and 6 mg kg −1 , respectively, every 3 weeks) and paclitaxel (days 1, 8, 15, every 4 weeks) treatment. Study endpoints were best overall response, progression‐free survival, overall survival, and safety. From September 2011 to March 2012, 47 Japanese patients were enrolled. Forty patients discontinued treatment after a median of 128.5 (range 4–486) days. Complete and partial responses were obtained in one and 16 patients (response rate of 37% [95% CI 23–52]), respectively. Median progression‐free survival and overall survival were 5.1 (95% CI 3.8–6.5) and 17.1 (95% CI 13.5–18.6) months, respectively. Grade 3/4 adverse events were neutropenia (32.6%), leukopenia (17.4%), anemia (15.2%) and hypoalbuminemia (8.7%). There was no clinically significant cardiotoxicity or cumulative toxicity. Three (disturbed consciousness, pulmonary fibrosis, and rapid disease progression) grade 5 events occurred. In conclusion, trastuzumab combined with paclitaxel was well tolerated and was a promising regimen for patients with HER2‐positive, previously treated, advanced or recurrent gastric cancer.