618O - Health-related Quality of Life (HRQOL) and Disease Symptoms in Patients With Unresectable Hepatocellular Carcinoma (HCC) Treated With Lenvatinib (L...

Date 10 September 2017
Event ESMO 2017 Congress
Session Gastrointestinal tumours, non-colorectal 2
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Gastrointestinal Cancers
Presenter Arndt Vogel
Citation Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369
Authors A. Vogel1, S. Qin2, M. Kudo3, S. Hudgens4, T. Yamashita5, J. Yoon6, L. Fartoux7, K. Simon8, C. López López9, M. Sung10, C. Dutcus11, S. Kraljevic12, T. Tamai11, N. Grunow4, G. Meier11, V. Breder13
  • 1Department Of Gastroenterology, Hepatology And Endocrinology, Hannover Medical School, 30625 - Hannover/DE
  • 2Department Of Medical Oncology, Nanjing Bayi Hospital, 210002 - Nanjing/CN
  • 3Faculty Of Medicine, Kindai University Faculty of Medicine, Osaka/JP
  • 4Clinical Outcome, Solutions, 85719 - Tucson/US
  • 5Department Of Gastroenterology, Kanazawa University Hospital, 920-8641 - Kanazawa/JP
  • 6Department Of Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 7Oncology, Hopital Saint-Antoine, Paris/FR
  • 8Nzoz Centrum, Badan Klinicznych, Wroclaw/PL
  • 9Department Of Medicine, Hospital Universitario Marqués de Valdecilla, Santander/ES
  • 10Department Of Oncology, Tisch Cancer Institute at Mount Sinai, New York/US
  • 11Eisai, Inc., NJ 07677 - Woodcliff Lake/US
  • 12Eisai Co., Ltd, Hatfield/GB
  • 13Department Of Oncology, FSBSI N. N. Blokhin Russian Cancer Research Center, Moscow/RU

Abstract

Background

A recent phase 3, randomized, open-label, noninferiority trial compared the 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 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) 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

A total of 954 patients (LEN treatment n = 478; SOR treatment n = 476) were randomized and included in the intent-to-treat population. Baseline HRQOL scores were similar for patients receiving LEN or SOR across all domains. Significant changes from baseline HRQOL scores were noted for Nutrition, Diarrhea, Role Function (RF), Pain, and Body Image (BI). In the QLQ-HCC18 Nutrition domain, lower adjusted mean scores in favor of LEN were reported at most time points with significant differences at Cycle 6 and Cycle 9 (p 

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.

Clinical trial identification

NCT01761266

Legal entity responsible for the study

Eisai Inc

Funding

Eisai Inc

Disclosure

M. Kudo: Honoraria: Bayer, Eisai, MSD, EA Pharma. S. Hudgens: Consultant to Eisai. J-H. Yoon: Research grants from Bayer HealthCare Pharmaceuticals, Daewoong Pharmaceuticals, and Bukwang Pharmaceuticals. C. López López: Grants, personal fees, non-financial support and other from Eisai, Bayer, Lilly, Daiichi Sankyo. C. Dutcus: Employee of Eisai Inc. S. Kraljevic: Employee of Eisai Co Ltd. T. Tamai, G. Meier: Employee of Eisai Inc. V. Breder: Consulting: BMS, MSD, Bayer, Boehringer-Ingelheim. Lectures: BMS, MSD, Bayer, Boehringer-Ingelheim. All other authors have declared no conflicts of interest.