Palbociclib Rechallenge for Hormone Receptor–Positive/HER-Negative Advanced Breast Cancer: Findings from the Phase II BioPER Trial

帕博西利布 医学 内科学 养生 肿瘤科 乳腺癌 临床终点 癌症 临床试验 转移性乳腺癌
作者
Joan Albanell,José Manuel Peréz-García,Miguel Gil,Giuseppe Curigliano,Manuel Ruíz Borrego,Laura Comerma,Joan Gibert,Meritxell Bellet,Begoña Bermejo,Lourdes Calvo,Juan de la Haba-Rodriguez,Enrique Espinosa,Alessandro Marco Minisini,Vanesa Quiroga,Ana Santaballa,Leonardo Mina,Beatriz Bellosillo,Federico Rojo,Silvia Menéndez,Miguel Sampayo-Cordero,Crina Popa,Andrea Malfettone,Javier Cortes,Antonio Llombart-Cussac
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:: OF1-OF12
标识
DOI:10.1158/1078-0432.ccr-22-1281
摘要

To assess the efficacy and exploratory biomarkers of continuing palbociclib plus endocrine therapy (ET) beyond progression on prior palbociclib-based regimen in patients with hormone receptor-positive/HER2-negative (HR+/HER2-) advanced breast cancer (ABC).The multicenter, open-label, phase II BioPER trial included women who had experienced a progressive disease (PD) after having achieved clinical benefit on the immediately prior palbociclib plus ET regimen. Palbociclib (125 mg, 100 mg, or 75 mg daily orally for 3 weeks and 1 week off as per prior palbociclib-based regimen) plus ET of physician's choice were administered in 4-week cycles until PD or unacceptable toxicity. Coprimary endpoints were clinical benefit rate (CBR) and percentage of tumors with baseline loss of retinoblastoma (Rb) protein expression. Additional endpoints included safety and biomarker analysis.Among 33 patients enrolled, CBR was 34.4% [95% confidence interval (CI), 18.6-53.2; P < 0.001] and 13.0% of tumors (95% CI, 5.2-27.5) showed loss of Rb protein expression, meeting both coprimary endpoints. Median progression-free survival was 2.6 months (95% CI, 1.8-6.7). No new safety signals were reported. A signature that included baseline mediators of therapeutic resistance to palbociclib and ET (low Rb score, high cyclin E1 score, ESR1 mutation) was independently associated with shorter median progression-free survival (HR, 22.0; 95% CI, 1.71-282.9; P = 0.018).Maintaining palbociclib after progression on prior palbociclib-based regimen seems to be a reasonable, investigational approach for selected patients. A composite biomarker signature predicts a subset of patients who may not derive a greater benefit from palbociclib rechallenge, warranting further validation in larger randomized controlled trials.
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