KEYNOTE-006研究中患者报告结局：帕博利珠单抗对比伊匹木单抗治疗晚期黑色素瘤的随机研究
Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma
该研究关注晚期黑色素瘤患者治疗期间的生活质量。研究在3期KEYNOTE-006试验中，让患者分别接受帕博利珠单抗（每2周或每3周）或伊匹木单抗治疗，并用EORTC QLQ-C30量表（一种评估癌症患者生活质量的标准问卷）定期测评。结果显示，12周时帕博利珠单抗组总体健康状况下降仅约2分，而伊匹木单抗组下降10分，差异显著；帕博利珠单抗组出现生活质量恶化的患者比例也更低。这说明帕博利珠单抗在延长疗效的同时，对生活质量影响更小。
为什么推荐给您：3期试验的患者报告结局二次分析，属常规增量，不涉及新疗法或新机制。
不需要生物学背景，多打比方
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摘要Abstract
OBJECTIVE: Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma.
PATIENTS AND METHODS: Patients received pembrolizumab 10 mg/kg every 2 (Q2W) or every 3 weeks (Q3W) for up to 2 years, or four cycles of ipilimumab 3 mg/kg Q3W. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was administered at baseline and throughout the study. Patient-reported outcome (PRO) analyses were pre-specified exploratory endpoints; the primary PRO assessment was the score change from baseline to week 12 in EORTC QLQ-C30 global health status (GHS)/HRQoL score between the arms using constrained longitudinal data analysis.
RESULTS: The PRO analysis population included 776 patients: pembrolizumab Q2W (n = 270); pembrolizumab Q3W (n = 266); ipilimumab (n = 240). Baseline GHS was similar across arms. QLQ-C30 compliance rates at week 12 were 87% (n = 214), 97% (n = 226), and 96% (n = 178), for the pembrolizumab Q2W, pembrolizumab Q3W, and ipilimumab arms, respectively. From baseline to week 12, GHS/HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of -1.9 and -2.5 for pembrolizumab versus -10.0 for ipilimumab; p < 0.001 for each pembrolizumab arm versus ipilimumab). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31% for pembrolizumab Q2W; 29% for Q3W and 44% for ipilimumab), with similar trends observed for individual functioning and symptoms scales.
CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with ipilimumab in patients with ipilimumab-naive advanced melanoma. CLINICALTRIALS.
GOV IDENTIFIER: NCT01866319.