RT Journal Article
T1 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.
A1 Di Cosimo, Serena
A1 Pérez-García, José Manuel
A1 Bellet, Meritxell
A1 Dalenc, Florence
A1 Gil Gil, Miguel J
A1 Ruiz Borrego, Manuel
A1 Gavilá, Joaquín
A1 Sampayo-Cordero, Miguel
A1 Aguirre, Elena
A1 Schmid, Peter
A1 Marmé, Frederik
A1 Gligorov, Joseph
A1 Schneeweiss, Andreas
A1 Albanell, Joan
A1 Zamora, Pilar
A1 Wheatley, Duncan
A1 Martínez-De Dueñas, Eduardo
A1 Carañana, Vicente
A1 Amillano, Kepa
A1 Mina, Leonardo
A1 Malfettone, Andrea
A1 Cortés, Javier
A1 Llombart-Cussac, Antonio
K1 advanced breast cancer
K1 endocrine therapy
K1 interstitial lung disease
K1 neutropenia
K1 palbociclib
K1 pneumonitis
K1 venous thromboembolism
AB 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. 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. 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  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. NCT02491983; https://clinicaltrials.gov/ct2/show/NCT02491983).
YR 2023
FD 2023
LK http://hdl.handle.net/10668/19828
UL http://hdl.handle.net/10668/19828
LA en
DS RISalud
RD Apr 19, 2025