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)

Kazuhiro Nishikawa, Tsunehiro Takahashi, Hiromasa Takaishi, Akira Miki, Hirokazu Noshiro, Takaki Yoshikawa, Yasunori Nishida, Satoru Iwasa, Hiroto Miwa, Toshiki Masuishi, Narikazu Boku, Yasuhide Yamada, Yasuhiro Kodera, Kazuhiro Yoshida, Satoshi Morita, Junichi Sakamoto, Shigetoyo Saji, Yuukou Kitagawa

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Abstract

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.

Original languageEnglish
Pages (from-to)188-196
Number of pages9
JournalInternational Journal of Cancer
Volume140
Issue number1
DOIs
Publication statusPublished - 2017 Jan 1

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Keywords

  • human epidermal growth factor receptor
  • paclitaxel
  • recurrence
  • stomach neoplasms
  • trastuzumab

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Cancer Research

Cite this

Nishikawa, K., Takahashi, T., Takaishi, H., Miki, A., Noshiro, H., Yoshikawa, T., Nishida, Y., Iwasa, S., Miwa, H., Masuishi, T., Boku, N., Yamada, Y., Kodera, Y., Yoshida, K., Morita, S., Sakamoto, J., Saji, S., & Kitagawa, Y. (2017). 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). International Journal of Cancer, 140(1), 188-196. https://doi.org/10.1002/ijc.30383