Background

In the phase 3 KEYNOTE-426 (NCT02853331) trial, pembrolizumab + axitinib demonstrated improvement in overall survival, progression-free survival, and objective response rate over sunitinib monotherapy for advanced renal cell carcinoma (RCC).

Objective

To evaluate health-related quality of life (HRQoL) in KEYNOTE-426.

Design, setting, and participants

A total of 861 patients were randomly assigned to receive pembrolizumab + axitinib (n = 432) or sunitinib (n = 429). HRQoL data were available for 429 patients treated with pembrolizumab + axitinib and 423 patients treated with sunitinib.

Outcome measurements and statistical analysis

HRQoL end points were measured using the European Organisation for the Research and Treatment of Cancer Core (EORTC) Quality of Life Questionnaire (QLQ-C30), EQ-5D visual analog rating scale (VAS), and Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index—Disease-Related Symptoms (FKSI-DRS) questionnaires.

Results and limitations

Better or not different overall improvement rates from baseline between pembrolizumab + axitinib and sunitinib were observed for the FKSI-DRS (–0.79% improvement vs sunitinib; 95% confidence interval [CI] –7.2 to 5.6), QLQ-C30 (7.5% improvement vs sunitinib; 95% CI 1.0–14), and EQ-5D VAS (9.9% improvement vs sunitinib; 95% CI 3.2–17). For time to confirmed deterioration (TTcD) and time to first deterioration (TTfD), no differences were observed between arms for the QLQ-C30 (TTcD hazard ratio [HR] 1.0; 95% CI 0.82–1.3; TTfD HR 0.82; 95% CI 0.69–0.97) and EQ-5D VAS (TTcD HR 1.1; 95% CI 0.87–1.3; TTfD HR 0.98; 95% CI 0.83–1.2). TTfD was not different between treatment arms (HR 1.1; 95% CI 0.95–1.3) for the FKSI-DRS, but TTcD favored sunitinib (HR 1.4; 95% CI 1.1–1.7). Patients were assessed during the off-treatment period for sunitinib, which may have underestimated the negative impact of sunitinib on HRQoL.

Conclusions

Overall, patient-reported outcome scales showed that results between the pembrolizumab + axitinib and sunitinib arms were not different, with the exception of TTcD by the FKSI-DRS.

Patient summary

Compared with sunitinib, pembrolizumab + axitinib delays disease progression and extends survival, while HRQoL outcomes were not different between groups.

中文翻译：

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KEYNOTE-426 的健康相关生活质量分析：帕博利珠单抗联合阿昔替尼与舒尼替尼治疗晚期肾细胞癌

背景

在 3 期 KEYNOTE-426 (NCT02853331) 试验中，pembrolizumab + axitinib 在晚期肾细胞癌 (RCC) 的总生存期、无进展生存期和客观缓解率方面优于舒尼替尼单药治疗。

客观的

评估 KEYNOTE-426 中与健康相关的生活质量 (HRQoL)。

设计、设置和参与者

共有 861 名患者被随机分配接受派姆单抗 + 阿西替尼（n  = 432）或舒尼替尼（n  = 429）。429 名接受派姆单抗 + 阿西替尼治疗的患者和 423 名接受舒尼替尼治疗的患者的 HRQoL 数据可用。

结果测量和统计分析

HRQoL 终点使用欧洲癌症研究与治疗组织 (EORTC) 生活质量问卷 (QLQ-C30)、EQ-5D 视觉模拟量表 (VAS) 和癌症治疗肾癌症状功能评估进行测量索引——疾病相关症状 (FKSI-DRS) 问卷。

结果和局限性

对于 FKSI-DRS（与舒尼替尼相比改善 –0.79%；95% 置信区间 [CI] –7.2 至 5.6）、QLQ-C30（改善 7.5%），在派姆单抗 + 阿西替尼和舒尼替尼之间观察到相对于基线的整体改善率更好或没有不同与舒尼替尼相比；95% CI 1.0–14）和 EQ-5D VAS（与舒尼替尼相比改善 9.9%；95% CI 3.2–17）。对于确认恶化时间 (TTcD) 和首次恶化时间 (TTfD)，QLQ-C30 组之间没有观察到差异（TTcD 风险比 [HR] 1.0；95% CI 0.82–1.3；TTfD HR 0.82；95% CI 0.69–0.97）和 EQ-5D VAS（TTcD HR 1.1；95% CI 0.87–1.3；TTfD HR 0.98；95% CI 0.83–1.2）。对于 FKSI-DRS，TTfD 在治疗组之间没有差异（HR 1.1；95% CI 0.95-1.3），但 TTcD 更倾向于舒尼替尼（HR 1.4；95% CI 1.1-1.7）。在舒尼替尼停药期间对患者进行了评估，

结论

总体而言，患者报告的结果量表显示，除 FKSI-DRS 的 TTcD 外，派姆单抗 + 阿西替尼和舒尼替尼组之间的结果没有差异。

患者总结

与舒尼替尼相比，派姆单抗 + 阿西替尼可延缓疾病进展并延长生存期，而 HRQoL 结果在各组之间没有差异。