Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer
Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer
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DOI：
10.1016/j.annonc.2020.02.003
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发表时间：
2020-05-01
影响因子：
50.5
通讯作者：
Schmid, P.
中科院分区：
文献类型：
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作者：
Adams, S.;Dieras, V.;Schmid, P.
背景：转移性三阴性乳腺癌（mTNBC）是不可治愈的。一个关键的治疗目标是提供缓解，同时维持患者的健康相关生活质量（HRQoL）。IMpassion 130证明了atezolizumab + nab-紫杉醇（A + paclitaxel）与安慰剂+nab-紫杉醇（Pl + paclitaxel）在程序性死亡配体1阳性（PD-L1+）肿瘤mTNBC患者的一线治疗中的无进展生存获益。患者和方法：未经治疗的晚期或mTNBC患者每2周接受atezolizumab（840 mg）或安慰剂联合白蛋白结合型紫杉醇（100 mg/m2），在每个28天周期的第1，8和15天，直到进展或不耐受。患者在每个周期的第1天、治疗结束时以及1年随访期间每4周填写一次欧洲癌症研究和治疗组织生活质量问卷（QLQ-C30）及其乳腺癌模块（QLQ-BR 23）。HRQoL的恶化时间（TTD）（首次从基线下降≥ 10分，持续2个周期）是次要终点。探索性终点包括功能的TTD以及HRQoL、功能以及疾病和治疗相关症状评分较基线的平均和平均变化。结果：PRO的基线完成率为92%（QLQ-C30）和89%（QLQ-BR 23），并且在意向治疗（ITT）和PD-L1+患者中，到第20周期仍保持>80%。在PD-L1+患者的HRQoL {风险比（HR）0.94 [95%置信区间（CI）0.69-1.28]}或身体[HR 1.02（95% CI 0.76-1.37）]或角色[HR 0.77（95% CI 0.57-1.04）]功能方面，未观察到两组间中位TTD的差异。两组之间和整个治疗过程中，A + RQOL与Pl + RQOL的HRQoL（67.5与65.0）、身体（82.8与79.4）和角色（73.7与71.7）功能的平均基线评分相当，在患者停止治疗前，与基线相比无临床意义（>= 10分）的变化。两组之间未观察到治疗症状（疲乏、腹泻或恶心/呕吐）有临床意义的恶化差异。ITT患者的结果相似。结论：A +顺铂作为一线治疗mTNBC延迟进展，而不影响患者的日常功能或HRQoL或恶化的治疗症状。
Background: Metastatic triple-negative breast cancer (mTNBC) is incurable. A key treatment goal is providing palliation while maintaining patients' health-related quality of life (HRQoL). IMpassion130 demonstrated progression-free survival benefit with atezolizumab + nab-paclitaxel (A + nP) versus placebo + nab-paclitaxel (Pl + nP) in first-line treatment of mTNBC patients with programmed death-ligand 1 positive (PD-L1+) tumors. We report data on patient-reported outcomes (PROs), which capture patient perspectives of treatment.Patients and methods: Patients with untreated advanced or mTNBC received atezolizumab (840 mg) or placebo every 2 weeks in combination with nab-paclitaxel (100 mg/m(2)) on days 1, 8, and 15 of each 28-day cycle until progression or intolerance. Patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) and its Breast Cancer Module (QLQ-BR23) on day 1 of each cycle, at end of treatment, and every 4 weeks during 1 year of follow-up. Time-to-deterioration (TTD) in HRQoL (first >= 10-point decrease from baseline lasting two cycles) was a secondary end point. Exploratory end points included TTD in functioning and mean and mean change from baseline scores in HRQoL, functioning, and disease- and treatment-related symptoms.Results: Baseline completion of PROs was 92% (QLQ-C30) and 89% (QLQ-BR23) and remained >80% through cycle 20 in intent-to-treat (ITT) and PD-L1+ patients. No differences between arms in median TTD in PD-L1+ patients were observed for HRQoL {hazard ratio (HR) 0.94 [95% confidence interval (CI) 0.69-1.28]} or physical [HR 1.02 (95% CI 0.76-1.37)] or role [HR 0.77 (95% CI 0.57-1.04)] functioning. Mean baseline scores for A + nP versus Pl + nP for HRQoL (67.5 versus 65.0) and physical (82.8 versus 79.4) and role (73.7 versus 71.7) functioning were comparable between arms and throughout the course of treatment, with no clinically meaningful (>= 10 point) changes from baseline until patients discontinued treatment. No differences in clinically meaningful worsening in treatment symptoms (fatigue, diarrhea, or nausea/vomiting) were observed between arms. Results in ITT patients were similar.Conclusions: A + nP as first-line treatment for mTNBC delayed progression without compromising patients' day-to-day functioning or HRQoL or worsening treatment symptoms.