{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:05:23Z","timestamp":1787508323175,"version":"build-2736575974"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,12,14]],"date-time":"2021-12-14T00:00:00Z","timestamp":1639440000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Asia-Pac J Clncl Oncology"],"published-print":{"date-parts":[[2022,12]]},"abstract":"Abstract<\/jats:title>\n \n Aim<\/jats:title>\n \n Palbociclib was approved in the United States in 2015 to treat estrogen receptor\n \u2013<\/jats:bold>\n positive\/human epidermal growth factor receptor 2\n \u2013<\/jats:bold>\n negative (HER2\n \u2013<\/jats:bold>\n ) advanced breast cancer (ABC). This study evaluated outcomes and safety in patients treated with palbociclib in Australia and India with hormone receptor\n \u2013<\/jats:bold>\n positive (HR+)\/HER2\n \u2013<\/jats:bold>\n ABC before palbociclib became commercially available.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Postmenopausal women (\u226518 years) with HR+\/HER2\n \u2013<\/jats:bold>\n ABC who were appropriate candidates for letrozole therapy received palbociclib 125\u00a0mg once daily for 21 days followed by 7 days off, and letrozole 2.5\u00a0mg once daily (continuous). Safety, tumor response, and patient\u2010reported outcomes (Australian cohort) were evaluated.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In total, 252 patients received palbociclib plus letrozole (Australia,\n n<\/jats:italic>\n \u00a0=\u00a0152; India,\n n\u00a0<\/jats:italic>\n =\u00a0100). More patients in the Australian versus Indian cohort had received prior chemotherapy (advanced\/metastatic setting: 45.9%\u00a0vs. 32.0%), endocrine therapy (advanced\/metastatic setting: 63.2%\u00a0vs. 54.3%), and advanced\/metastatic therapies (61.8%\u00a0vs. 31.0%). The most frequently reported all\u2010grade palbociclib\u2010related treatment\u2010emergent adverse events were neutropenia (66.7%), fatigue (35.3%), and stomatitis (26.6%); grade 3\/4 neutropenia was reported as palbociclib\u2010related 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%\u201324.9%) overall and 2.3% in Australian patients with \u22652 lines of prior therapy for metastatic disease. Patient\u2010reported quality of life scores were maintained throughout the study.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n In an expanded access setting in Australia and India, palbociclib plus letrozole was well tolerated in patients with HR+\/HER2\u2013 ABC, with a safety profile consistent with previous reports.<\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/ajco.13653","type":"journal-article","created":{"date-parts":[[2021,12,15]],"date-time":"2021-12-15T01:07:01Z","timestamp":1639530421000},"page":"560-569","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Palbociclib plus letrozole as treatment for postmenopausal women with hormone receptor\u2013positive\/human epidermal growth factor receptor 2\u2013negative advanced breast cancer for whom letrozole therapy is deemed appropriate: An expanded access study in Australia and India"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6137-9171","authenticated-orcid":false,"given":"Sherene","family":"Loi","sequence":"first","affiliation":[{"name":"Peter MacCallum Cancer Centre Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christos S.","family":"Karapetis","sequence":"additional","affiliation":[{"name":"Flinders Medical Centre and Flinders University Adelaide Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"McCarthy","sequence":"additional","affiliation":[{"name":"Icon Cancer Centre Wesley Auchenflower Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Oakman","sequence":"additional","affiliation":[{"name":"Sunshine Hospital Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Redfern","sequence":"additional","affiliation":[{"name":"Fiona Stanley Hospital Murdoch Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle","family":"White","sequence":"additional","affiliation":[{"name":"Monash Health Clayton Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustafa","family":"Khasraw","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dinesh Chandra","family":"Doval","sequence":"additional","affiliation":[{"name":"Rajiv Gandhi Cancer Institute and Research Centre New Delhi India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vinod","family":"Gore","sequence":"additional","affiliation":[{"name":"Sahyadri Super Specialty Hospital Pune Maharashtra India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahmood","family":"Alam","sequence":"additional","affiliation":[{"name":"Pfizer Australia Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Binko","sequence":"additional","affiliation":[{"name":"Pfizer Australia Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dongrui Ray","family":"Lu","sequence":"additional","affiliation":[{"name":"Pfizer Inc San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sindy","family":"Kim","sequence":"additional","affiliation":[{"name":"Pfizer Inc San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Boyle","sequence":"additional","affiliation":[{"name":"Patricia Ritchie Centre for Cancer Care and Research Mater Hospital North Sydney Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,12,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy192"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-15-1185"},{"key":"e_1_2_10_5_1","unstructured":"IBRANCE\u00aecapsules (palbociclib). Full Prescribing Information Pfizer Inc New York NY 2019."},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)71159-3"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10549-018-05125-4"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1607303"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2018.08.011"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1505270"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2020.0016"},{"key":"e_1_2_10_12_1","unstructured":"Cancer Australia Statements \u2013 Influencing best practice in cancer care. Available at:https:\/\/thestatement.canceraustralia.gov.au\/metastaticAccessed November 5 2020."},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cpcardiol.2018.11.002"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdy012"}],"container-title":["Asia-Pacific Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ajco.13653","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ajco.13653","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ajco.13653","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,21]],"date-time":"2023-08-21T16:21:43Z","timestamp":1692634903000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ajco.13653"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,14]]},"references-count":13,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1111\/ajco.13653"],"URL":"https:\/\/doi.org\/10.1111\/ajco.13653","archive":["Portico"],"relation":{},"ISSN":["1743-7555","1743-7563"],"issn-type":[{"value":"1743-7555","type":"print"},{"value":"1743-7563","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12,14]]},"assertion":[{"value":"2021-06-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}