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
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...
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | Breast |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S0960977622001886 |
| _version_ | 1828114401388920832 |
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| author | Hope S. Rugo Seock-Ah Im Anil A. Joy Yaroslav Shparyk Janice M. Walshe Bethany Sleckman Sherene Loi Kathy Puyana Theall Sindy Kim Xin Huang Eustratios Bananis Reshma Mahtani Richard S. Finn Véronique Diéras |
| author_facet | Hope S. Rugo Seock-Ah Im Anil A. Joy Yaroslav Shparyk Janice M. Walshe Bethany Sleckman Sherene Loi Kathy Puyana Theall Sindy Kim Xin Huang Eustratios Bananis Reshma Mahtani Richard S. Finn Véronique Diéras |
| author_sort | Hope S. Rugo |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-04-11T12:25:02Z |
| format | Article |
| id | doaj.art-a722b0955acd4472b01e048a4c0096ba |
| institution | Directory Open Access Journal |
| issn | 1532-3080 |
| language | English |
| last_indexed | 2024-04-11T12:25:02Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Breast |
| spelling | doaj.art-a722b0955acd4472b01e048a4c0096ba2022-12-22T04:23:59ZengElsevierBreast1532-30802022-12-0166324331Effect 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-3Hope S. Rugo0Seock-Ah Im1Anil A. Joy2Yaroslav Shparyk3Janice M. Walshe4Bethany Sleckman5Sherene Loi6Kathy Puyana Theall7Sindy Kim8Xin Huang9Eustratios Bananis10Reshma Mahtani11Richard S. Finn12Véronique Diéras13University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Department of Medicine (Hematology/Oncology), 1825 4th Street, 3rd Floor, Box 1710, San Francisco, CA, 94158, USA; Corresponding author. University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, Department of Medicine (Hematology/Oncology), 1825 4th Street, 3rd Floor, Box 1710, San Francisco, CA, 94158-1710, USA.Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, 101 Daehak-ro, Jonro-gu, Seoul 03080, Republic of KoreaCross Cancer Institute, University of Alberta, 11560 University Ave NW, Edmonton, AB T6G1Z2, CanadaLviv State Oncologic Regional Treatment and Diagnostic Center, Lviv, UkraineCancer Trials Ireland, St Vincent's University Hospital, Elm Park, Dublin 4, IrelandMercy Hospital St. Louis, 607 S New Ballas Road, Suite 3300, St. Louis, MO, 63141, USAPeter MacCallum Cancer Centre, University of Melbourne, AustraliaPfizer Oncology, 300 Technology Square, Cambridge, MA 02139, USAPfizer Inc, 10555 Science Center Dr, San Diego, CA 92121, USAPfizer Inc, 10555 Science Center Dr, San Diego, CA 92121, USAPfizer Inc, 235 E 42nd St, New York, NY, 10017, USAMiami Cancer Institute, Baptist Health South Florida, Member, Memorial Sloan Kettering Cancer Alliance, 1228 South Pine Island Road, Plantation, FL, 33324, USADavid Geffen School of Medicine, 2825 Santa Monica Blvd, Suite 200, Santa Monica, CA, 90404, USAUnicancer Centre Eugène Marquis, Avenue de la Bataille Flandres-Dunkerque, CS 44229, 35042, Rennes Cedex, FranceBackground: 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).http://www.sciencedirect.com/science/article/pii/S0960977622001886Advanced breast cancerChemotherapyPalbociclibProgression-free survivalSafety |
| spellingShingle | Hope S. Rugo Seock-Ah Im Anil A. Joy Yaroslav Shparyk Janice M. Walshe Bethany Sleckman Sherene Loi Kathy Puyana Theall Sindy Kim Xin Huang Eustratios Bananis Reshma Mahtani Richard S. Finn Véronique Diéras 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 Breast Advanced breast cancer Chemotherapy Palbociclib Progression-free survival Safety |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Advanced breast cancer Chemotherapy Palbociclib Progression-free survival Safety |
| url | http://www.sciencedirect.com/science/article/pii/S0960977622001886 |
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