PALOMA-3：在既往内分泌治疗后进展的激素受体阳性、人表皮生长因子受体2阴性的绝经前和绝经后转移性乳腺癌患者中，来曲唑联合或不联合帕博西尼的III期试验——亚洲患者的安全性和疗效
PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy-Safety and Efficacy in Asian Patients.
作者信息
Iwata Hiroji, Im Seock-Ah, Masuda Norikazu, Im Young-Hyuck, Inoue Kenichi, Rai Yoshiaki, Nakamura Rikiya, Kim Jee Hyun, Hoffman Justin T, Zhang Ke, Giorgetti Carla, Iyer Shrividya, Schnell Patrick T, Bartlett Cynthia Huang, Ro Jungsil
机构信息
, Aichi Cancer Center Hospital, Nagoya; , National Hospital Organization, Osaka National Hospital, Osaka; , Saitama Cancer Center, Saitama; , Sagara Hospital, Kagoshima City; , Chiba Cancer Center, Chiba, Japan; , Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine; , Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul; , Seoul National University Bundang Hospital, Seongnam; , National Cancer Center, Goyang, Republic of Korea; and , Pfizer, La Jolla, CA; , , and , Pfizer, New York, NY; and , Pfizer, Collegeville, PA.
出版信息
J Glob Oncol. 2017 Apr 11;3(4):289-303. doi: 10.1200/JGO.2016.008318. eCollection 2017 Aug.
PURPOSE
To assess efficacy and safety of palbociclib plus fulvestrant in Asians with endocrine therapy-resistant metastatic breast cancer.
PATIENTS AND METHODS
The Palbociclib Ongoing Trials in the Management of Breast Cancer 3 (PALOMA-3) trial, a double-blind phase III study, included 521 patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer with disease progression on endocrine therapy. Patient-reported outcomes (PROs) were assessed on study treatment and at the end of treatment.
RESULTS
This preplanned subgroup analysis of the PALOMA-3 study included premenopausal and postmenopausal Asians taking palbociclib plus fulvestrant (n = 71) or placebo plus fulvestrant (n = 31). Palbociclib plus fulvestrant improved progression-free survival (PFS) compared with fulvestrant alone. Median PFS was not reached with palbociclib plus fulvestrant (95% CI, 9.2 months to not reached) but was 5.8 months with placebo plus fulvestrant (95% CI, 3.5 to 9.2 months; hazard ratio, 0.485; 95% CI, 0.270 to 0.869; = .0065). The most common all-cause grade 3 or 4 adverse events in the palbociclib arm were neutropenia (92%) and leukopenia (29%); febrile neutropenia occurred in 4.1% of patients. Within-patient mean trough concentration comparisons across subgroups indicated similar palbociclib exposure between Asians and non-Asians. Global quality of life was maintained; no statistically significant changes from baseline were observed for patient-reported outcome scores with palbociclib plus fulvestrant.
CONCLUSION
This is the first report, to our knowledge, showing that palbociclib plus fulvestrant improves PFS in asian patients. Palbociclib plus fulvestrant was well tolerated in this study.
目的
评估帕博西尼联合氟维司群治疗对内分泌治疗耐药的亚洲转移性乳腺癌患者的疗效和安全性。
患者与方法
乳腺癌管理中帕博西尼正在进行的试验3（PALOMA-3）试验是一项双盲III期研究，纳入了521例激素受体阳性/人表皮生长因子受体2阴性的转移性乳腺癌患者，这些患者在内分泌治疗中疾病进展。在研究治疗期间和治疗结束时评估患者报告的结局（PROs）。
结果
PALOMA-3研究的这项预先计划的亚组分析包括接受帕博西尼联合氟维司群（n = 71）或安慰剂联合氟维司群（n = 31）的绝经前和绝经后亚洲人。与单独使用氟维司群相比，帕博西尼联合氟维司群改善了无进展生存期（PFS）。帕博西尼联合氟维司群未达到中位PFS（95%CI，9.2个月至未达到），而安慰剂联合氟维司群为5.8个月（95%CI，3.5至9.2个月；风险比，0.485；95%CI，0.270至0.869；P = 0.0065）。帕博西尼组最常见的全因3级或4级不良事件是中性粒细胞减少（92%）和白细胞减少（29%）；4.1%的患者发生发热性中性粒细胞减少。各亚组患者内平均谷浓度比较表明，亚洲人和非亚洲人之间帕博西尼的暴露相似。总体生活质量得以维持；帕博西尼联合氟维司群治疗的患者报告结局评分与基线相比无统计学显著变化。
结论
据我们所知，这是首份表明帕博西尼联合氟维司群可改善亚洲患者PFS的报告。本研究中帕博西尼联合氟维司群耐受性良好。
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