728P - Final analysis of overall survival per subgroups of HCC patients in the prospective, non-interventional INSIGHT study treated with sorafenib

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter Tom Ganten
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors T. Ganten1, R. Stauber2, E. Schott3, P. Malfertheiner4, R. Buder5, P.R. Galle6, T. Goehler7, I. Bernard8, G. Gerken9
  • 1Medical Clinic For Gastroenterology, Hepatology, Infectiology, University Hospital Heidelberg, 69120 - Heidelberg/DE
  • 2Department For Gastroenterology And Heptaology, Medical University Graz, Graz/AT
  • 3Department For Gastroenterology And Heptaology, Charité Campus-Virchow Clinic, Berlin/DE
  • 4University Hospital For Gastroenterology, Hepatology And Infectiology, Otto-von-Guericke University Magdeburg, Magdeburg/DE
  • 5Department Internal Medicine, Konventspital Barmherzige Brüder, Linz/AT
  • 6Medical Clinic, Johannes Gutenberg University Hospital Mainz, Mainz/DE
  • 7Oncology, Medical Practice, Dresden/DE
  • 8Antiinfectives / Oncology, Bayer Vital GmbH, 51366 - Leverkusen/DE
  • 9Department For Gastroenterology And Heptaology, University Hospital Essen, Essen/DE

Abstract

Aim

INSIGHT is a prospective, non-interventional study, conducted in Germany and Austria in pts with hepatocellular carcinoma HCC. The objectives of this study are the evaluation of safety and efficacy under practice conditions in both hospitals and private practices. Enrollment into INSIGHT is not restricted to a particular tumor stage.

Methods

This final analysis evaluated overall survival and safety data incluling relevant subgroups. All patients with HCC were observed for the duration of their sorafenib therapy. In addition to baseline data the performance status, tumor status (clinical and/or radiological), and overall survival time are documented. Documentation of adverse events comprises relationship with drug, seriousness, grade (CTCAE version 3.0), and outcome.

Results

791 pts have been enrolled; 788 of which are evaluable for safety and 782 for efficacy analyses. The table summarises major baseline characteristics together with median overall survival (mOS) data for relevant subpopulations.

Patients recruited n, Male n (%) 782, 668 (85)
ECOG PS, n (%), 0, 1, 2 243 (31); 404 (52); 192 (16)
BCLC-Stage n (%), A, B, C, D 101 (13); 194 (25); 392 (50); 14 (2)
Child Pugh Stage, n (%), A(<7), B(7-9), C (>9), Missing 443 (57); 182 (23); 26 (3); 131 (17)
MOS total population (Events n = 278) 14.8 months
mPFS total population (Events n = 633) 4.1 months
MOS according to BCLC A, B, C, D 29.1; 19.5; 13.6; 3.1 months
MOS according to Child Pugh A, B, C 17.5; 8.1; 5.6 months
MOS Child Pugh B: 7, 8, 9 points 8.1; 9.4; 2.4 months
mOS Duration of therapy > 24 weeks (n = 352); >40 weeks (n = 209) 25.1; 31.8 months
MOS according to age <65, ≥65 years 16.8; 14.5 months (p = 0.5625)
MOS according to etiology: Hep C, Hep B, NASH, alcohol 23.3; 10.8; 11.8; 14.3 months
AEs (all grades), n (%); Drug-related AEs (all grades), n (%) 688 (87.3); 511 (64.9)
SAEs (all grades), n (%); Drug-related SAEs (all grades), n (%) 394 (50); 77 (9.8)

Conclusions

Results of mOS in pts with HCC treated under daily practice conditions in hospitals and private practices confirms the general efficacy of Sorafenib and gives further insight into survival of pts with CHILD B, BCLC stage A/B, age ≥65, etiology of HCC and a relevant subgroup of patients treated longer than 40 weeks. Further demographic data, efficacy and safety results will be presented.

Disclosure

T.M. Ganten: - Advisor Bayer Healthcare - holding Bayer stocks - fees for Advisor and corporate; sponsored research funding from Bayer Healthcare - other fees from Novartis; R. Stauber: - Fees for Advisory Boards for Abbvie, BMS, Gilead, MSD - corporate sponsored research funding from MSD; R. Buder: - corporate sponsored research funding from Bayer Healthcare; P.R. Galle: - Advisor and Consultant for Bayer, Lilly, Jennerex and BMS; I. Bernard: - Bayer Employee. All other authors have declared no conflicts of interest.