Palbociclib plus letrozole as treatment for postmenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An expanded access study in Australia and India
- Author(s)
- Loi, S; Karapetis, CS; McCarthy, N; Oakman, C; Redfern, A; White, M; Khasraw, M; Doval, DC; Gore, V; Alam, M; Binko, J; Lu, DR; Kim, S; Boyle, F;
- Details
- Publication Year 2022-12,Volume 18,Issue #6,Page 560-569
- Journal Title
- Asia-Pacific Journal of Clinical Oncology
- Publication Type
- Research article
- Abstract
- AIM: Palbociclib was approved in the United States in 2015 to treat estrogen receptor-positive/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC). This study evaluated outcomes and safety in patients treated with palbociclib in Australia and India with hormone receptor-positive (HR+)/HER2- ABC before palbociclib became commercially available. METHODS: Postmenopausal women (>/=18 years) with HR+/HER2- ABC who were appropriate candidates for letrozole therapy received palbociclib 125 mg once daily for 21 days followed by 7 days off, and letrozole 2.5 mg once daily (continuous). Safety, tumor response, and patient-reported outcomes (Australian cohort) were evaluated. RESULTS: In total, 252 patients received palbociclib plus letrozole (Australia, n = 152; India, n = 100). More patients in the Australian versus Indian cohort had received prior chemotherapy (advanced/metastatic setting: 45.9% vs. 32.0%), endocrine therapy (advanced/metastatic setting: 63.2% vs. 54.3%), and advanced/metastatic therapies (61.8% vs. 31.0%). The most frequently reported all-grade palbociclib-related treatment-emergent adverse events were neutropenia (66.7%), fatigue (35.3%), and stomatitis (26.6%); grade 3/4 neutropenia was reported as palbociclib-related in 62.7% of patients. Febrile neutropenia was reported in six patients (2.4%). Eight patients (3.2%) discontinued because of an adverse event. The objective response rate was 19.4% (95% CI, 14.7%-24.9%) overall and 2.3% in Australian patients with >/=2 lines of prior therapy for metastatic disease. Patient-reported quality of life scores were maintained throughout the study. CONCLUSIONS: In an expanded access setting in Australia and India, palbociclib plus letrozole was well tolerated in patients with HR+/HER2- ABC, with a safety profile consistent with previous reports.
- Keywords
- Humans; Female; Letrozole/therapeutic use; *Breast Neoplasms/pathology; Receptors, Estrogen/metabolism; Postmenopause; Quality of Life; Antineoplastic Combined Chemotherapy Protocols/adverse effects; Australia; Receptor, ErbB-2/metabolism; *Neutropenia/etiology; Hr+/her2-; India; advanced breast cancer; letrozole; palbociclib
- Department(s)
- Medical Oncology; Laboratory Research
- PubMed ID
- 34908235
- Publisher's Version
- https://doi.org/10.1111/ajco.13653
- Open Access at Publisher's Site
https://doi.org/10.1111/ajco.13653- Terms of Use/Rights Notice
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Creation Date: 2025-01-24 05:57:04
Last Modified: 2025-01-24 05:58:22