000150342 001__ 150342 000150342 005__ 20251017144648.0 000150342 0247_ $$2doi$$a10.1016/j.ejca.2022.03.006 000150342 0248_ $$2sideral$$a142526 000150342 037__ $$aART-2022-142526 000150342 041__ $$aeng 000150342 100__ $$aMartín, Miguel 000150342 245__ $$aOverall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study 000150342 260__ $$c2022 000150342 5060_ $$aAccess copy available to the general public$$fUnrestricted 000150342 5203_ $$aBackground An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. Methods Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). Results OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81–1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81–1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. Conclusions Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. Trial registration NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT). 000150342 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttps://creativecommons.org/licenses/by-nc-nd/4.0/deed.es 000150342 590__ $$a8.4$$b2022 000150342 591__ $$aONCOLOGY$$b37 / 241 = 0.154$$c2022$$dQ1$$eT1 000150342 592__ $$a2.898$$b2022 000150342 593__ $$aOncology$$c2022$$dQ1 000150342 593__ $$aCancer Research$$c2022$$dQ1 000150342 594__ $$a11.1$$b2022 000150342 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000150342 700__ $$aZielinski, Christoph 000150342 700__ $$aRuiz-Borrego, Manuel 000150342 700__ $$aCarrasco, Eva 000150342 700__ $$aCiruelos, Eva M. 000150342 700__ $$aMuñoz, Montserrat 000150342 700__ $$aBermejo, Begoña 000150342 700__ $$aMargelí, Mireia 000150342 700__ $$aCsöszi, Tibor 000150342 700__ $$0(orcid)0000-0002-9159-4988$$aAntón, Antonio$$uUniversidad de Zaragoza 000150342 700__ $$aTurner, Nicholas 000150342 700__ $$aCasas, María I. 000150342 700__ $$aMorales, Serafín 000150342 700__ $$aAlba, Emilio 000150342 700__ $$aCalvo, Lourdes 000150342 700__ $$ade la Haba-Rodríguez, Juan 000150342 700__ $$aRamos, Manuel 000150342 700__ $$aMurillo, Laura 000150342 700__ $$aSantaballa, Ana 000150342 700__ $$aAlonso-Romero, José L. 000150342 700__ $$aSánchez-Rovira, Pedro 000150342 700__ $$aCorsaro, Massimo 000150342 700__ $$aHuang, Xin 000150342 700__ $$aThallinger, Christiane 000150342 700__ $$aKahan, Zsuzsanna 000150342 700__ $$aGil-Gil, Miguel 000150342 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000150342 773__ $$g168 (2022), 12-24$$pEur. j. cancer$$tEuropean Journal of Cancer$$x0959-8049 000150342 8564_ $$s2636690$$uhttps://zaguan.unizar.es/record/150342/files/texto_completo.pdf$$yVersión publicada 000150342 8564_ $$s2097050$$uhttps://zaguan.unizar.es/record/150342/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000150342 909CO $$ooai:zaguan.unizar.es:150342$$particulos$$pdriver 000150342 951__ $$a2025-10-17-14:35:13 000150342 980__ $$aARTICLE