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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.

asia‐pacific journal of clinical oncology

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