A phase 3 study (PATHWAY) of palbociclib plus tamoxifen in patients with HR-positive/HER2-negative advanced breast cancer.
Journal
NPJ breast cancer
Journal Volume
10
Journal Issue
1
Start Page
論文號碼 76
ISSN
2374-4677
Date Issued
2024-12
Author(s)
Noguchi, Emi
Yamanaka, Takashi
Mukai, Hirofumi
Yamamoto, Naohito
Chung, Chi-Feng
Sohn, Joohyuk
Kim, Gun Min
Lee, Kyung-Hun
Lee, Soo-Chin
Iwasa, Tsutomu
Iwata, Hiroji
Watanabe, Kenichi
Jung, Kyung Hae
Tanabe, Yuko
Kang, Seok Yun
Yasojima, Hiroyuki
Aogi, Kenjiro
Tokunaga, Eriko
Sim, Sung Hoon
Yap, Yoon Sim
Matsumoto, Koji
Tseng, Ling-Ming
Umeyama, Yoshiko
Sudo, Kazuki
Kojima, Yuki
Hata, Tomomi
Kuchiba, Aya
Shibata, Taro
Nakamura, Kenichi
Fujiwara, Yasuhiro
Tamura, Kenji
Yonemori, Kan
Abstract
Palbociclib combined with endocrine therapy is approved for treating patients with hormone-receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer; however, data on palbociclib combined with tamoxifen are limited. We investigated the efficacy and safety of palbociclib-tamoxifen in patients with HR+/HER2- advanced breast cancer. This double-blind phase 3 study included 184 women who were randomly assigned 1:1 to receive palbociclib-tamoxifen or placebo-tamoxifen. Pre/perimenopausal women also received goserelin. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Median PFS was 24.4 months (95% confidence interval [CI], 13.1-32.4) with palbociclib-tamoxifen and 11.1 months (95% CI, 7.4-14.6) with placebo-tamoxifen (hazard ratio [HR], 0.60; 95% CI, 0.43-0.85; P = 0.002). Palbociclib-tamoxifen improved PFS in patients who were treated with first-line or second-line endocrine therapy and pre-, peri-, and postmenopausal patients. Though OS data are still immature (median not reached in both groups), an overall risk reduction of 27% (HR, 0.73; 95% CI, 0.44-1.21) with palbociclib-tamoxifen was observed at the time of PFS analysis. The most common grade 3/4 adverse event with palbociclib-tamoxifen was neutropenia (89.0% [none were febrile] versus 1.1% with placebo-tamoxifen). There were no deaths owing to adverse events in either group. Among patients with HR+/HER2- advanced breast cancer, palbociclib-tamoxifen resulted in significantly longer PFS than tamoxifen alone. Early OS data showed a trend favoring palbociclib-tamoxifen. Trial registration: ClinicalTrials.gov number, NCT03423199. Study registration date: February 06, 2018.
SDGs
Type
journal article