| Autor: |
Emi Noguchi, Takashi Yamanaka, Hirofumi Mukai, Naohito Yamamoto, Chi-Feng Chung, Yen-Shen Lu, Dwan-Ying Chang, Joohyuk Sohn, Gun Min Kim, Kyung-Hun Lee, Soo-Chin Lee, Tsutomu Iwasa, Hiroji Iwata, Kenichi Watanabe, Kyung Hae Jung, Yuko Tanabe, Seok Yun Kang, Hiroyuki Yasojima, Kenjiro Aogi, Eriko Tokunaga, Sung Hoon Sim, Yoon Sim Yap, Koji Matsumoto, Ling-Ming Tseng, Yoshiko Umeyama, Kazuki Sudo, Yuki Kojima, Tomomi Hata, Aya Kuchiba, Taro Shibata, Kenichi Nakamura, Yasuhiro Fujiwara, Kenji Tamura, Kan Yonemori |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
npj Breast Cancer, Vol 10, Iss 1, Pp 1-10 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2374-4677 |
| DOI: |
10.1038/s41523-024-00684-w |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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Full text from SpringerLink