Breast cancer research : BCR · 2026
Real-world data for a CDK4/6 inhibitor, palbociclib, as 1st- or 2nd-line therapy in HR+/HER2- metastatic breast cancer: a multicenter prospective cohort study.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Ishikawa Takashi, Uemura Yukari, Seki Hirohito, Kitada Masahiro, Saito Tsuyoshi, Yamada Kimito, Takao Shintaro, Takabatake Daisuke, Yokota Toru, Kitahara Miyuki, Kikawa Yuichiro, Yamada Akimitsu, Toh Uhi, Nishimura Hideki, Kaise Hiroshi, Yamagami Kazuhiro, Nishimura Reiki, Taira Naruto, Narui Kazutaka, Mukai Hirofumi
Аннотация
BACKGROUND: Palbociclib (PAL), the first CDK4/6 inhibitor approved for breast cancer, improves progression-free survival (PFS) in hormone receptor-positive (HR+)/HER2-negative (HER2-) metastatic breast cancer (MBC) when added to an aromatase inhibitor or fulvestrant, but also increases toxicity compared to endocrine therapy alone. Use of PAL in 1st-line treatment increases the burden on patients and adds to costs compared to use as 2nd-line treatment, due to the longer period of 1st-line treatment. Therefore, data on use of PAL in a real-world setting are required to assess the merits of 1st- and 2nd-line therapy in the sequence of treatment for MBC.
METHODS: A prospective observational study was performed in patients with postmenopausal metastatic or unresectable breast cancer using PAL in 1st-, 2nd-, or 3rd-line treatment. The primary endpoint was PFS (start of PAL to progression or death). Secondary endpoints included PFS2 (start of 1st-line endocrine treatment to second progression) and adverse events.
RESULTS: The study included 593 patients treated with PAL (246 1st-line, 282 2nd-line, 65 3rd-line) from April 2019 to January 2023. Median PFS was 25.8 (95%CI: 21.4), 18.0 (14.0-22.7), and 12.0 (7.7-17.4) months, for 1st-, 2nd- and 3rd-line use respectively. Median PFS2 was 36.9 (27.7-not reached) and 57.9 (43.4-65.3) months in the 1st- and 2nd-line cohorts. Neutropenia of grade ≥ 3 occurred in 70% of patients, and > 80% required dose reductions.
CONCLUSIONS: PFS for the 1st-line cohort was similar to that in PALOMA-2, while the 2nd-line cohort had better outcomes than those in PALOMA-3, even when modelled for potential bias since some patients on 1st-line endocrine monotherapy would have received chemotherapy rather than 2nd-line PAL. Overall, the findings in this study of real-life treatment of patients with HR+/HER2- MBC support randomized control trial data that challenge the need to use a CDK4/6 inhibitor in the 1st-line setting for all patients.
CLINICAL TRIAL REGISTRATION: UMIN000035863.
METHODS: A prospective observational study was performed in patients with postmenopausal metastatic or unresectable breast cancer using PAL in 1st-, 2nd-, or 3rd-line treatment. The primary endpoint was PFS (start of PAL to progression or death). Secondary endpoints included PFS2 (start of 1st-line endocrine treatment to second progression) and adverse events.
RESULTS: The study included 593 patients treated with PAL (246 1st-line, 282 2nd-line, 65 3rd-line) from April 2019 to January 2023. Median PFS was 25.8 (95%CI: 21.4), 18.0 (14.0-22.7), and 12.0 (7.7-17.4) months, for 1st-, 2nd- and 3rd-line use respectively. Median PFS2 was 36.9 (27.7-not reached) and 57.9 (43.4-65.3) months in the 1st- and 2nd-line cohorts. Neutropenia of grade ≥ 3 occurred in 70% of patients, and > 80% required dose reductions.
CONCLUSIONS: PFS for the 1st-line cohort was similar to that in PALOMA-2, while the 2nd-line cohort had better outcomes than those in PALOMA-3, even when modelled for potential bias since some patients on 1st-line endocrine monotherapy would have received chemotherapy rather than 2nd-line PAL. Overall, the findings in this study of real-life treatment of patients with HR+/HER2- MBC support randomized control trial data that challenge the need to use a CDK4/6 inhibitor in the 1st-line setting for all patients.
CLINICAL TRIAL REGISTRATION: UMIN000035863.
Предметные рубрики MeSH
HumansFemalePyridinesBreast NeoplasmsPiperazinesErb-b2 Receptor Tyrosine KinasesProspective StudiesAgedCyclin-Dependent Kinase 6Middle AgedCyclin-Dependent Kinase 4Receptors, EstrogenReceptors, ProgesteroneProtein Kinase InhibitorsAntineoplastic Combined Chemotherapy ProtocolsProgression-Free SurvivalNeoplasm MetastasisAged, 80 and over