The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with i
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CLINICAL TRIAL
The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first‑line therapy in Japanese patients with inoperable or recurrent HER2‑positive breast cancer: the COMACHI study Masato Takahashi1 · Shoichiro Ohtani2 · Shigenori E. Nagai3 · Seiki Takashima4 · Miki Yamaguchi5 · Michiko Tsuneizumi6 · Yoshifumi Komoike7 · Tomofumi Osako8 · Yoshinori Ito9 · Masahiko Ikeda10 · Kazushige Ishida11 · Takahiro Nakayama12 · Tsutomu Takashima13 · Takashi Asakawa14 · Sho Matsumoto15 · Daisuke Shimizu16 · Norikazu Masuda17 Received: 8 June 2020 / Accepted: 2 September 2020 © The Author(s) 2020
Abstract Purpose In the CLEOPATRA study of patients with human epidermal growth factor receptor 2 (HER2)-positive recurrent or metastatic breast cancer, the Japanese patient subgroup did not demonstrate the improved progression-free survival (PFS) of pertuzumab plus trastuzumab and docetaxel vs. placebo that was seen in the overall population. Therefore, COMACHI was conducted to confirm the efficacy and safety of this treatment regimen in this patient subgroup. Methods This was a phase IV study of pertuzumab plus trastuzumab and docetaxel in Japanese patients with histologically/ cytologically confirmed inoperable or recurrent HER2-positive breast cancer. All patients received pertuzumab, trastuzumab, and docetaxel intravenously every 3 weeks until disease progression/unacceptable toxicity. The primary endpoint was investigator-assessed PFS. Secondary endpoints were overall survival (OS), investigator-assessed objective response rate, and duration of response (DoR). Safety was also assessed. Results At final analysis, median investigator-assessed PFS was 22.8 months (95% CI 16.9–37.5). From first dose, OS rate at 1 year was 97.7%; and at 2 and 3 years were 88.5% and 79.1%, respectively. Of the 118 patients with measurable disease at baseline, response rate was 83.9% (95% CI 77.3–90.5) and median investigator-assessed DoR was 26.3 months (95% CI 17.1–not evaluable). Treatment was well tolerated, with no new safety signals detected. Conclusions Our results suggest similar efficacy and safety for pertuzumab plus trastuzumab and docetaxel in Japanese patients compared with the overall population of CLEOPATRA, providing further support for this combination therapy as standard of care for Japanese patients with inoperable or recurrent HER2-positive breast cancer. Keywords Pertuzumab · Trastuzumab · Docetaxel · HER2-positive inoperable/recurrent/advanced/metastatic breast cancer · Prospective clinical trial · Japanese patients
Introduction Key data from COMACHI were previously presented as a poster at the European Society for Medical Oncology (ESMO) Congress 2019 (27 Sep–01 Oct 2019). Electronic supplementary material The online version of this article (https://doi.org/10.1007/s10549-020-05921-x) contains supplementary material, which is available to authorized users. * Norikazu Masuda [email protected] Extended author information available on the last page of the article
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