Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive,Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2 |
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| Institution: | 1. Department of Medicine (Hematology/Oncology), University of California San Francisco, Comprehensive Cancer Center, San Francisco, CA;2. Division of Hematology/Oncology, David Geffen School of Medicine at UCLA, Santa Monica, CA;3. Department of Medical Oncology, British Columbia Cancer, Vancouver, BC, Canada;4. Division of Medical Oncology, Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada;5. Department of OB&GYN, Brustzentrum, Frauenklinik der Universität München (LMU), Munich, Germany;6. Memorial Healthcare System, Breast Cancer Center, Pembroke Pines, FL;7. Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan;8. Department of Medical Oncology, St Vincent’s University Hospital and Cancer Trials Ireland, Dublin, Ireland;9. Global Product Development, Clinical, Pfizer S.r.l., Milan, Italy;10. Global Product Development, Clinical, Pfizer Inc, San Francisco, CA;11. Pfizer Inc, Clinical Statistics, La Jolla, CA;12. Pfizer Oncology, US Medical Affairs, New York, NY;13. Hospital Gregorio Maranon, Universidad Complutense, Madrid, Spain;14. Oncologie sénologique, Centre Eugene Marquis, Rennes, France, and Institut Curie, Paris, France |
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| Abstract: | BackgroundIn PALOMA-2, palbociclib + letrozole significantly prolonged progression-free survival (PFS) versus placebo + letrozole in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2−) advanced breast cancer (ABC). We investigated clinical outcomes of patients who achieved or did not achieve a confirmed objective response (OR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (data cutoff: May 31, 2017).Patients and MethodsPostmenopausal patients untreated for ER+/HER2− ABC were randomized 2:1 to palbociclib + letrozole or placebo + letrozole. Median PFS, median duration of OR, baseline characteristics, and palbociclib exposure were compared in patients with or without OR by treatment arm.ResultsIn the intent-to-treat population, OR was achieved by 194 (44%) of 444 and 77 (35%) of 222 patients in the palbociclib and placebo arms, respectively (odds ratio, 1.5; 95% confidence interval CI], 1.0-2.1; P = .0156). Regardless of treatment, more OR than non-OR patients had de novo metastatic disease (47%-50% and 28%-31%, respectively) and no prior endocrine therapy (55% and 35%-37%, respectively). Rates of palbociclib dose reduction owing to adverse events were similar regardless of OR (41% and 38%, respectively). Among the patients with OR during the study, approximately 50% achieved OR within the first 3 months regardless of treatment. The median PFS was significantly prolonged with palbociclib + letrozole versus placebo + letrozole in patients with measurable disease in both OR (37.2 months; 95% CI, 28.1 months to not estimable vs. 27.4 months; 95% CI, 22.2-31.1 months; hazard ratio, 0.66; 95% CI, 0.47-0.94; P = .009) and non-OR groups (10.9 months; 95% CI, 8.2-11.2 months vs. 5.6 months; 95% CI, 5.3-8.3 months; hazard ratio, 0.72; 95% CI, 0.54-0.97; P = .016).ConclusionsPalbociclib + letrozole provided significant clinical benefit versus placebo + letrozole to patients with ER+/HER2− ABC regardless of achieving RECIST-defined OR.Pfizer; ClinicalTrials.gov: NCT01740427 |
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| Keywords: | Cyclin-dependent kinase Inhibitor Metastatic breast cancer Tumor response |
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