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Palbociclib plus letrozole as first-line therapy in postmenopausal Asian women with metastatic breast cancer: Results from the phase III, randomized PALOMA-2 study
DC Field | Value | Language |
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dc.contributor.author | Im, Seock-Ah | - |
dc.contributor.author | Mukai, Hirofumi | - |
dc.contributor.author | Park, In Hae | - |
dc.contributor.author | Masuda, Norikazu | - |
dc.contributor.author | Shimizu, Chikako | - |
dc.contributor.author | Kim, Sung-Bae | - |
dc.contributor.author | Im, Young-Hyuck | - |
dc.contributor.author | Ohtani, Shoichiro | - |
dc.contributor.author | Bartlett, Cynthia Huang | - |
dc.contributor.author | Lu, Dongrui R. | - |
dc.contributor.author | Iyer, Shrividya | - |
dc.contributor.author | Mori, Yuko | - |
dc.contributor.author | Mori, Ave | - |
dc.contributor.author | Gauthier, Eric | - |
dc.contributor.author | Finn, Richard S. | - |
dc.contributor.author | Toi, Masakazu | - |
dc.date.accessioned | 2022-03-22T09:10:22Z | - |
dc.date.available | 2022-03-22T09:10:22Z | - |
dc.date.created | 2020-03-26 | - |
dc.date.created | 2020-03-26 | - |
dc.date.issued | 2019-05 | - |
dc.identifier.citation | Journal of Global Oncology, Vol.2019 No.5, pp.1-19 | - |
dc.identifier.issn | 2378-9506 | - |
dc.identifier.other | 93738 | - |
dc.identifier.uri | https://hdl.handle.net/10371/177192 | - |
dc.description.abstract | PURPOSE In PALOMA-2, palbociclib plus letrozole significantly improved progression-free survival (PFS) as initial treatment of estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. We assessed the benefit of palbociclib plus letrozole in Asians. PATIENTS AND METHODS Of 666 enrolled postmenopausal women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (no prior treatment of advanced disease), 95 were Asian. Patients were randomly assigned 2:1 to receive palbociclib plus letrozole or placebo plus letrozole. The primary end point was investigator-assessed PFS. Secondary end points were overall survival, objective response, patient-reported outcomes, pharmacokinetics, and safety. RESULTS Median PFS was significantly longer in Asian patients who received palbociclib plus letrozole versus placebo plus letrozole (25.7 months [95% CI, 19.2 months to not estimable] v 13.9 months [95% CI, 7.4 to 22.0 months]; hazard ratio, 0.49; 95% CI, 0.27 to 0.87; P= .007). The most common toxicities with palbociclib were hematologic and more frequent among Asians versus non-Asians: neutropenia (any grade, 95.4% v 76.8%; grade 3/4, 89.2% v 62.5%), leukopenia (43.1% v 38.3%; 32.3% v 23.5%), and thrombocytopenia (27.7% v13.5%; 4.6% v 1.1%). No Asians had febrile neutropenia. Discontinuation rates as a result of adverse events were similar among Asian and non-Asian patients who received palbociclib plus letrozole (10.8% and 9.5%). In Asians, quality of life (QOL) was maintained with no significant differences observed between treatments from baseline in breast cancer-specific QOL and general health status scores. Change from baseline in EuroQol five dimensions index scores was significantly higher with palbociclib plus letrozole (0.013 v-0.069; P= .0132). Geometric mean palbociclib trough concentration values were higher in Asians versus non-Asians (93.8 v 61.7 ng/mL). CONCLUSION Consistent with the overall study population, the addition of palbociclib to letrozole significantly improved PFS in Asians. Hematologic toxicities were more frequent in Asians versus non-Asians but manageable with early dose modifications while maintaining QOL. (C) 2019 by American Society of Clinical Oncology | - |
dc.language | 영어 | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.title | Palbociclib plus letrozole as first-line therapy in postmenopausal Asian women with metastatic breast cancer: Results from the phase III, randomized PALOMA-2 study | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1200/JGO.18.00173 | - |
dc.citation.journaltitle | Journal of Global Oncology | - |
dc.identifier.wosid | 000470156800001 | - |
dc.identifier.scopusid | 2-s2.0-85066946116 | - |
dc.citation.endpage | 19 | - |
dc.citation.number | 5 | - |
dc.citation.startpage | 1 | - |
dc.citation.volume | 2019 | - |
dc.identifier.sci | 000470156800001 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | SAFETY | - |
dc.subject.keywordPlus | FULVESTRANT | - |
dc.subject.keywordPlus | MULTICENTER | - |
dc.subject.keywordPlus | PLACEBO | - |
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