Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naïve Metastatic Renal Cell Carcinoma.
Patient-Reported Outcomes from the Phase III Randomized IMmotion151 Trial: Atezolizumab + Bevacizumab versus Sunitinib in Treatment-Naïve Metastatic Renal Cell Carcinoma.
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DOI：
10.1158/1078-0432.ccr-19-2838
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发表时间：
2020-06-01
期刊：
影响因子：
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通讯作者：
Escudier B
中科院分区：
文献类型：
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作者：
Atkins MB;Rini BI;Motzer RJ;Powles T;McDermott DF;Suarez C;Bracarda S;Stadler WM;Donskov F;Gurney H;Oudard S;Uemura M;Lam ET;Grüllich C;Quach C;Carroll S;Ding B;Zhu QC;Piault-Louis E;Schiff C;Escudier B
在 3 期 IMmotion151 试验 (NCT02420821) 中评估了患者报告的结果 (PRO)，以了解阿替利珠单抗加贝伐单抗与舒尼替尼在既往未经治疗的转移性肾细胞癌 (mRCC) 患者中的总体治疗/疾病负担。患者以 1:1 的比例随机接受阿特珠单抗 1200 mg IV q3w 加贝伐单抗 15 mg/kg IV q3w 或舒尼替尼 50 mg PO QD 治疗 4 周/停药 2 周。患者在基线、治疗期间、治疗结束时和生存随访期间完成 MD 安德森症状调查表 (MDASI)、国家综合癌症网络癌症治疗功能评估 - 肾脏症状指数 (FKSI-19) 和简要疲劳调查表 (BFI)。对核心症状和肾细胞癌症状及其对日常生活的干扰、治疗副作用以及健康相关生活质量（HRQOL）进行纵向和恶化时间（TTD）分析。 ITT 人群分别包括阿特珠单抗加贝伐单抗组和舒尼替尼组的 454 名患者和 461 名患者。每种仪器的完成率在基线时为 83%−86%，到第 54 周≥ 70%。与舒尼替尼相比，阿特朱单抗加贝伐单抗的症状更轻、症状干扰和治疗副作用更少、大多数就诊时的 HRQOL 更好。对于核心症状（HR，0.50 [0.40，0.62]）和 RCC 症状（HR，0.45 [0.37，0.55]），TTD HR（95% CI）倾向于阿特珠单抗加贝伐单抗；症状干扰（HR，0.56 [0.46，0.68]）；和 HRQOL（HR，0.68 [0.58，0.81]）。 IMmotion151 中的 PRO 表明，对于初治 mRCC 患者，与舒尼替尼相比，atezolizumab 加贝伐单抗的总体治疗负担较低，并为该方案的临床益处提供了进一步的证据。
Patient-reported outcomes (PROs) were evaluated in the phase 3 IMmotion151 trial (NCT02420821) to inform overall treatment/disease burden of atezolizumab plus bevacizumab versus sunitinib in patients with previously untreated metastatic renal cell carcinoma (mRCC). Patients were randomized 1:1 to receive atezolizumab 1200 mg IV q3w plus bevacizumab 15 mg/kg IV q3w or sunitinib 50 mg PO QD 4 weeks on/2 weeks off. Patients completed the MD Anderson Symptom Inventory (MDASI), National Comprehensive Cancer Network Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19), and Brief Fatigue Inventory (BFI) at baseline, q3w during treatment, at end-of-treatment, and during survival follow-up. Longitudinal and time to deterioration (TTD) analyses for core and RCC symptoms and their interference with daily life, treatment side-effect bother, and health-related quality of life (HRQOL) were evaluated. The ITT population included 454 and 461 patients in the atezolizumab plus bevacizumab and sunitinib arms, respectively. Completion rates for each instrument were 83%−86% at baseline and ≥ 70% through week 54. Milder symptoms, less symptom interference and treatment side-effect bother, and better HRQOL at most visits were reported with atezolizumab plus bevacizumab versus sunitinib. The TTD HR (95% CI) favored atezolizumab plus bevacizumab for core (HR, 0.50 [0.40, 0.62]) and RCC symptoms (HR, 0.45 [0.37, 0.55]); symptom interference (HR, 0.56 [0.46, 0.68]); and HRQOL (HR, 0.68 [0.58, 0.81]). PROs in IMmotion151 suggest lower overall treatment burden with atezolizumab plus bevacizumab compared with sunitinib in patients with treatment-naive mRCC and provide further evidence for clinical benefit of this regimen.