Originally published by 2 Minute Medicine^® (view original article). Reused on AccessMedicine with permission.

1. The median follow-up period for health-related quality-of-life (HRQOL) outcomes analyses was 12.9 months

2. For all FKSI-DRS, EORTC QLQ-C30 GHS/QOL and EQ-5D visual analogue scale, the scores were similar between lenvatinib plus pembrolizumab versus sunitinib.

Evidence Rating Level: 1 (Excellent)

Study Rundown:

Based on the primary endpoint data from the CLEAR study, lenvatinib plus pembrolizumab showed promising efficacy safety data compared to sunitinib for patients with advanced renal cell carcinoma. This study presents the health-related quality-of-life (HRQOL) outcomes of the CLEAR study. The 3 HRQOL tools that this study utilized were the Functional Assessment of Cancer Therapy Kidney Cancer Symptom Index – Disease Related Symptoms (FKSI-DRS), European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ – C30) global health status/quality of life (GHS/QOL) and EQ-5D-3. The mean change from baseline and time to definitive deterioration favoured the combination group. The time to first deterioration was similar between both study arms. Limitations to this study included the open-label nature of the study, no adjustments for multiple comparisons and the timing of sunitinib assessment at the end of the cycle coincided with off-treatment periods and could have led to better patient-reported health outcomes. Overall, this study demonstrated support the lenvatinib plus pembrolizumab as it has similar quality of life outcomes compared to standard of care.

Click to read the study in The Lancet Oncology

Relevant Reading: Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma

In-Depth [randomized controlled trial]:

This was an open label, randomized, phase III study. Patients were eligible if they had advanced clear-cell renal cell carcinoma and scored 70% or higher on the Karnofsky performance status. Patients were excluded if they had previously received systemic anticancer therapy for renal cell carcinoma. A total of 1069 patients were enrolled to receive lenvatinib plus pembrolizumab (n=355) or lenvatinib plus everolimus (n=357) or sunitinib (n=357). The demographic of all study groups was well-balanced. The median follow-up period for the health-related quality-of-life analysis (HRQOL) was 12.9 months (interquartile range [IQR]: 5.6-22.3). There were differences in the mean change from baseline between lenvatinib plus pembrolizumab versus sunitinib group (FKSI-DRS: -1.75 vs. -2.19; EORTC QLQ-C30 GHS/QOL: -5.93 vs.-6.73); EQ-5D-3: -4.96 vs. -6.64). For median time to deterioration between lenvatinib plus pembrolizumab versus sunitinib group, the values were 9.14 weeks versus 12.4 weeks (FKSI-DRS), 12.00 weeks versus 9.14 weeks (EORTC QLQ-C30 GHS/QOL) and 9.43 weeks versus 9.13 weeks (EQ-5D-3). For median time to definitive deterioration between lenvatinib plus pembrolizumab versus sunitinib group, the values were 134.14 weeks versus 117.43 weeks (FKSI-DRS), 114.29 weeks versus 75.14 weeks (EORTC QLQ-C30 GHS/QOL) and 124.86 weeks versus 74.86 weeks (EQ-5D-3).

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