PEARL研究中，帕博西尼联合内分泌治疗与卡培他滨用于激素受体阳性、HER2阴性的绝经后转移性乳腺癌患者的总生存期比较。
Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study.
作者信息
Martín Miguel, Zielinski Christoph, Ruiz-Borrego Manuel, Carrasco Eva, Ciruelos Eva M, Muñoz Montserrat, Bermejo Begoña, Margelí Mireia, Csöszi Tibor, Antón Antonio, Turner Nicholas, Casas María I, Morales Serafín, Alba Emilio, Calvo Lourdes, de la Haba-Rodríguez Juan, Ramos Manuel, Murillo Laura, Santaballa Ana, Alonso-Romero José L, Sánchez-Rovira Pedro, Corsaro Massimo, Huang Xin, Thallinger Christiane, Kahan Zsuzsanna, Gil-Gil Miguel
机构信息
Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; GEICAM, Spanish Breast Cancer Group, Madrid, Spain; Centro de Investigación Biomédica en Red de Oncología, CIBERONC-ISCIII, Madrid, Spain.
Vienna Cancer Center, Medical University Vienna and Vienna Hospital Association, Vienna, Austria; CECOG, Central European Cooperative Oncology Group, Vienna, Austria.
出版信息
Eur J Cancer. 2022 Jun;168:12-24. doi: 10.1016/j.ejca.2022.03.006. Epub 2022 Apr 13.
BACKGROUND
An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis.
METHODS
Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death).
RESULTS
OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed.
CONCLUSIONS
Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.
TRIAL REGISTRATION
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
背景
对PEARL III期研究的早期分析表明，在芳香化酶抑制剂耐药、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（MBC）患者中，与卡培他滨相比，哌柏西利联合内分泌治疗（ET）并未改善无进展生存期（PFS）。在此，我们报告最终的总生存期（OS）分析结果。
方法
绝经后患者（N = 601）按1:1随机分为卡培他滨组或哌柏西利联合ET组（依西美坦，队列1；氟维司群，队列2）。对队列2、野生型ESR1人群和总体人群进行OS分析。此外，我们分析了后续的全身治疗，并探讨了PFS2（从随机分组到首次后续治疗结束/死亡的时间）。
结果
哌柏西利联合氟维司群的OS为31.1个月，卡培他滨为32.8个月（校正风险比[aHR] 1.10，95%置信区间[CI] 0.81 - 1.50，P = 0.550）。在野生型ESR1人群中，哌柏西利联合ET的OS为37.2个月，卡培他滨为34.8个月（aHR 1.06，95% CI 0.81 - 1.37，P = 0.683）。在OS分析中，没有亚组显示哌柏西利联合ET比卡培他滨更具优势。总体人群中，哌柏西利联合ET的OS为32.6个月，卡培他滨为30.9个月（P = 0.995）。分别有79.8%和82.9%接受哌柏西利联合ET和卡培他滨治疗的患者接受了后续全身治疗。各研究组之间的中位PFS2相似（队列2，P = 0.941；野生型ESR1人群，P = 0.827）。未观察到新的安全性发现。
结论
在对芳香化酶抑制剂治疗进展的MBC患者中，与卡培他滨相比，哌柏西利联合ET在OS方面未显示出统计学上的优势。
试验注册
NCT02028507（ClinicalTrials.gov），2013 - 003170 - 27（EudraCT）
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