Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3. (December 2022)

• Record Type: Journal Article
• Authors: Rugo, Hope S.; Im, Seock-Ah; Joy, Anil A.; Shparyk, Yaroslav; Walshe, Janice M.; Sleckman, Bethany; Loi, Sherene; Theall, Kathy Puyana; Kim, Sindy; Huang, Xin; Bananis, Eustratios; Mahtani, Reshma; Finn, Richard S.; Diéras, Véronique
• Is Part Of: Breast. Volume 66(2022)
• Page Start: 324
• Page End: 331
• Publication Date: 2022-12
• Subjects: Advanced breast cancer -- Chemotherapy -- Palbociclib -- Progression-free survival -- Safety; Breast -- Diseases -- Periodicals; Breast -- Tumors -- Periodicals; Breast -- Periodicals; Electronic journals; Periodicals; 616
• DOI: 10.1016/j.breast.2022.11.005
• Languages: English
• ISSNs: 0960-9776

Abstract

Abstract: Background: Previous analyses from the PALOMA-2 and PALOMA-3 studies showed that palbociclib (PAL) plus endocrine therapy (ET) prolongs time to first subsequent chemotherapy (TTC) versus placebo (PBO) plus ET in the overall population of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative (HR+/HER2−) advanced breast cancer (ABC). Here, we evaluated TTC in relevant patient subgroups. Methods: These post hoc analyses evaluated TTC by subgroup using data from 2 randomized, phase 3 studies of women with HR+/HER2− ABC. In PALOMA-2, postmenopausal patients previously untreated for ABC were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus letrozole (LET; 2.5 mg/day; n = 444) or PBO plus LET (n = 222). In PALOMA-3, premenopausal or postmenopausal patients whose disease had progressed after prior ET were randomized 2:1 to receive PAL (125 mg/day, 3/1-week schedule) plus fulvestrant (FUL; 500 mg; n = 347) or PBO plus FUL (n = 174). Results: First subsequent chemotherapy was received by 35.5% and 56.2% in PALOMA-2 and PALOMA-3 after progression on palbociclib plus ET or placebo plus ET. Across all subgroups analyzed, the median progression-free survival (PFS) was longer in the PAL plus ET arm than the PBO plus ET arm. TTC was longer with PAL plus ET versus PBO plus ET across the same patient subgroups in both studies. Conclusions: Across all subgroups, PAL plus ET versus PBO plus ET had longer median PFS and resulted in prolonged TTC in both the PALOMA-2 and PALOMA-3 studies. Pfizer Inc (NCT01740427, NCT01942135). Highlights: Palbociclib + endocrine therapy prolongs time to chemotherapy in HR+/HER2– cancer. We analyzed palbociclib efficacy data from 2 clinical trials across subgroups. Patient subgroups were based on demographics and baseline disease characteristics. Palbociclib increased progression-free survival versus placebo across all subgroups. Palbociclib increased time to chemotherapy versus placebo across all subgroups.