HEALTH-RELATED QUALITY OF LIFE (HRQOL) AND DISEASE SYMPTOMS IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) TREATED WITH LENVATINIB (LEN) OR SORAFENIB (SOR)

Author(s)

Vogel A1, Qin S2, Kudo M3, Hudgens S4, Yamashita T5, Yoon J6, Fartoux L7, Simon K8, Lopez C9, Sung M10, Dutcus C11, Kraljevic S12, Tamai T11, Grunow N4, Meier G11, Breder V13
1Hannover Medical School, Hannover, Germany, 2Nanjing Bayi Hospital, Nanjing, China, 3Kindai University Faculty of Medicine, Osaka, Japan, 4Clinical Outcomes Solutions, Tucson, AZ, USA, 5Kanazawa University Hospital, Kanazawa, Japan, 6Seoul National University Hospital, Seoul, Korea, Republic of (South), 7Hôpital Saint-Antoine, Paris, France, 8NZOZ Centrum, Badan Klinicznych, Wroclaw, Poland, 9Hospital Universitario Marques de Valdecilla, Santander, Spain, 10Tisch Cancer Institute at Mount Sinai, New York, NY, USA, 11Eisai Inc., Woodcliff Lake, NJ, USA, 12Eisai Co. Ltd., Hatfield, UK, 13FSBSI N. N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation

Presentation Documents

OBJECTIVES: A recent phase 3, randomized, open-label, noninferiority trial compared efficacy and safety of LEN to SOR as first-line systemic treatment in unresectable HCC (954 patients). The study included analyses to evaluate the impact of therapy for HCC on HRQOL.

METHODS: HRQOL was assessed using the EORTC QLQ-C30, the HCC-specific module (EORTC QLQ-HCC18), and the European Quality of Life (EQ‑5D-3L) at baseline, Day 1 of each cycle, and off-treatment visit. Changes from baseline in both treatment arms were assessed using linear-mixed models with selected covariates (baseline score, geographical region, macroscopic portal vein invasion and/or extrahepatic spread, ECOG-PS, body weight). Time to worsening for each domain was represented as months to deterioration defined by a minimally important difference (MID).

RESULTS: CONCLUSIONS: Most domains met the noninferiority assumption between LEN and SOR. The additional evidence of significant HRQOL benefits further support LEN in terms of functional deterioration delays.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PCN236

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Gastrointestinal Disorders, Oncology

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