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

被引：6

作者：

Loi, Sherene ^{[1
]}

Karapetis, Christos S. ^{[2
,3
]}

McCarthy, Nicole ^{[4
]}

Oakman, Catherine ^{[5
]}

Redfern, Andrew ^{[6
]}

White, Michelle ^{[7
]}

Khasraw, Mustafa ^{[8
]}

Doval, Dinesh Chandra ^{[9
]}

Gore, Vinod ^{[10
]}

Alam, Mahmood ^{[11
]}

Binko, Justin ^{[11
]}

Lu, Dongrui Ray ^{[12
]}

Kim, Sindy ^{[12
]}

Boyle, Frances ^{[13
]}

机构：

[1] Peter MacCallum Canc Ctr, 305 Grattan St, Melbourne, Vic 3000, Australia

[2] Flinders Med Ctr, Adelaide, SA, Australia

[3] Flinders Univ S Australia, Adelaide, SA, Australia

[4] Icon Canc Ctr Wesley, Auchenflower, Qld, Australia

[5] Sunshine Hosp, St Albans, Vic, Australia

[6] Fiona Stanley Hosp, Murdoch, WA, Australia

[7] Monash Hlth, Clayton, Vic, Australia

[8] Duke Canc Inst, Durham, NC USA

[9] Rajiv Gandhi Canc Inst & Res Ctr, New Delhi, India

[10] Sahyadri Super Specialty Hosp, Pune, Maharashtra, India

[11] Pfizer Australia, Sydney, NSW, Australia

[12] Pfizer Inc, San Diego, CA USA

[13] Mater Hosp, Patricia Ritchie Ctr Canc Care & Res, Sydney, NSW, Australia

来源：

ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 18卷 / 06期

关键词：

advanced breast cancer; Australia; HR plus; HER2-; India; letrozole; palbociclib;

D O I：

10.1111/ajco.13653

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：560 / 569

页数：10

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