Lenvatinib May Delay Functional Deterioration in Hepatocellular Carcinoma
Patients had similar HRQOL scores by all measures at baseline, but experienced significant changes in scores for the HRQOL domains of Body Image, Diarrhea, Nutrition, Pain, and Role Function.
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Lenvatinib may delay deterioration and improve health-related quality of life (HRQOL) outcomes among patients with unresectable hepatocellular carcinoma (HCC) compared with sorafenib, according to a study presented at the European Society for Medical Oncology (ESMO) 2017 Congress.1
In the phase 3, non-inferiority REFLECT study (ClinicalTrials.gov Identifier: NCT01761266), researchers compared the safety and efficacy of lenvatinib with sorafenib. The purpose of this secondary analysis was to evaluate the effect the study treatments would have on HRQOL. Nine hundred and fifty-four patients with unresectable HCC were randomly assigned 1:1 to receive lenvatinib or sorafenib.
The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30), the HCC-specific module (EORTC QLQ-HCC18), and the European Quality of Life (EQ-5D-3L) assay were used to assess HRQOL at baseline, the first day of each treatment cycle, and at off-treatment visits. Patients had similar HRQOL scores by all measures at baseline, but experienced significant changes in scores for the HRQOL domains of Body Image, Diarrhea, Nutrition, Pain, and Role Function.
Lenvatinib had favorable lower adjusted mean scores in the Nutrition domain at most time points with significant differences at cycle 6 and cycle 9 (P < .05), as well as favorable lower adjusted mean scores in Diarrhea reported during cycles 3, 6, 9, and 12 (P < .01) on the QLQ-HCC18.
Median months to clinically meaningful worsening among was statistically significant, favoring lenvatinib for the QLQ-C30 domains of Role Function (2.0 vs 1.9; P = .0098), Pain (2.0 vs 1.8; P = .0060), and Diarrhea (4.6 vs 2.7; P < .0001).
The QLQ-HCC18 domains of Body Image (2.8 vs 1.9; P = .0041) and Nutrition (4.1 vs 2.8; P = .0060) were also significantly favorable for lenvatinib compared with sorafenib.
The authors concluded that “the additional evidence of significant HRQOL benefits further support lenvatinib in terms of functional deterioration delays.”
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- Vogel A, Qin S, Kudo M, et al. Health-related quality of Life (HRQOL) and disease symptoms in patients with unresectable hepatocellular carcinoma (HCC) treated with lenvatinib (LEN) or sorafenib (SOR). Presented at: ESMO 2017 Congress; Madrid, Spain: September 8-12, 2017. Abstract 618O.