Palbociclib with fulvestrant or letrozole in endocrine-sensitive patients with HR-Positive/HER2-Negative advanced breast cancer: A detailed safety analysis of the randomized PARSIFAL trial

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  • dc.contributor.author Di Cosmo, Serena
  • dc.contributor.author Albanell Mestres, Joan
  • dc.contributor.author Llombart-Cussac, Antonio
  • dc.date.accessioned 2023-05-12T06:21:43Z
  • dc.date.available 2023-05-12T06:21:43Z
  • dc.date.issued 2023
  • dc.description.abstract Background: Palbociclib has gained a central role in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). Despite its manageable toxicity profile, venous thromboembolism (VTE) or interstitial lung disease (ILD)/pneumonitis may infrequently occur. Therefore, we provide a comprehensive summary of the safety and tolerability of the combination of endocrine therapy and palbociclib among patients included in the randomized phase 2 PARSIFAL study. Materials and methods: Patients with endocrine-sensitive HR+/HER2- ABC and no prior therapy in an advanced setting (n = 486) were randomly assigned 1:1 to receive fulvestrant-palbociclib (FP) or letrozole-palbociclib (LP). Laboratory tests and the incidence of adverse events (AEs) were recorded at baseline and day 1 of each cycle. Progression-free survival (PFS) was estimated for patients with and without VTE. Results: A total of 483 patients were analyzed. Neutropenia, leukopenia, anemia, asthenia, arthralgia, fatigue, and diarrhea were the most frequent AEs in both groups. Febrile neutropenia occurred in 3 (1.2%) patients of the FP group and in 1 (0.4%) patient in the LP group. Six (2.5%; 0.4% grade 3) patients in the FP group and 6 patients (2.5%; 0.4% grade 3) in the LP group experienced ILD/pneumonitis. Pulmonary embolism was reported in 12 (5.0%) patients in the FP group and 6 (2.5%) patients in the LP group. Advanced age at baseline was the only factor significantly associated with an increased risk of pulmonary embolism (P < .01). Conclusion: The PARSIFAL data confirmed the favorable safety profile of both palbociclib regimens. VTE and ILD/pneumonitis were occasionally reported, and their early detection allowed patients to continue treatment effectively without detriment to efficacy. Clinicaltrials.gov identifier: NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983).
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Di Cosimo S, Pérez-García JM, Bellet M, Dalenc F, Gil Gil MJ, Ruiz Borrego M, et al. Palbociclib with fulvestrant or letrozole in endocrine-sensitive patients with HR-Positive/HER2-Negative advanced breast cancer: A detailed safety analysis of the randomized PARSIFAL trial. Oncologist. 2023 Jan 18;28(1):23-32. DOI: 10.1093/oncolo/oyac205
  • dc.identifier.doi http://dx.doi.org/10.1093/oncolo/oyac205
  • dc.identifier.issn 1083-7159
  • dc.identifier.uri http://hdl.handle.net/10230/56789
  • dc.language.iso eng
  • dc.publisher Oxford University Press
  • dc.relation.ispartof Oncologist. 2023 Jan 18;28(1):23-32
  • dc.rights © The Author(s) 2022. Published by Oxford University Press. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
  • dc.subject.keyword Advanced breast cancer
  • dc.subject.keyword Endocrine therapy
  • dc.subject.keyword Interstitial lung disease
  • dc.subject.keyword Neutropenia
  • dc.subject.keyword Palbociclib
  • dc.subject.keyword Pneumonitis
  • dc.subject.keyword Venous thromboembolism
  • dc.title Palbociclib with fulvestrant or letrozole in endocrine-sensitive patients with HR-Positive/HER2-Negative advanced breast cancer: A detailed safety analysis of the randomized PARSIFAL trial
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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