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Poster Display

4103 - Analysis of tumor growth rate for advanced hepatocellular cancer patients receiving placebo or sorafenib in the phase 3 SHARP and Asia Pacific trials


08 Oct 2016


Poster Display


Gerold Meinhardt


Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371


G. Meinhardt1, J. Bruix2, J. Llovet3, A. Cheng4, C. Kappeler5

Author affiliations

  • 1 Global Clinical Development Oncology, Bayer Healthcare Pharmaceuticals, 07981 - Whippany/US
  • 2 Hepatic Oncology Unit, BCLC Hospital Clínic Barcelona, IDIBAPS, University of Barcelona CIBERehd, Barcelona, Spain University of Barcelona, Barcelona/ES
  • 3 Mount Sinai Liver Cancer Program, Icahn School of Medicine, Mount Sinai, New York/US
  • 4 Department Of Oncology, National Taiwan University Hospital, Taipei/TW
  • 5 Clinical Statistics Eu, Bayer Pharma Aktiengesellschaft, 13353 - Berlin/DE


Abstract 4103


In the phase 3 SHARP and AP trials, sorafenib (SOR) significantly improved overall survival (OS) vs placebo (PLC) in patients with hepatocellular carcinoma (HCC) (SHARP: HR 0.69; p 


In both trials, tumors were assessed at baseline and every 6 weeks. Early TGR, defined as the relative change per month in the sum of target lesion diameters (SLD) from start of treatment, determined at start of treatment, was derived with a parabola-like 3-parametric model describing the SLDs as a function of time during the treatment period. TGR was examined both for prognostic and predictive characteristic for OS with uni- (UV) and multivariate (MV) models. Baseline SLD was included to compare the roles of a tumor-related baseline and post baseline variable.


544/602 patients (90%)/SHARP and 190/226 (84%)/AP patients were evaluable for TGR and OS. Mean early TGR was significantly different between treatment arms (SHARP: PLC 0.042, SOR 0.007, p = 0.035; AP: PLC 0.115, SOR 0.028, p = 0.005). Early TGR as categorical covariate in a Cox model analysis of OS was a strong prognostic factor for time to death of similar strength in both treatment arms. The table shows hazard ratios (HR) and p-values in UV and MV analyses of OS with TGR for PLC and SOR separately and for TGR together with treatment. Interaction terms with treatment were always non-significant; thus, TGR is prognostic in both treatment arms, but does not predict whether patients respond differentially to SOR and PLC.


SHARP Trial AP Trial
TGR categorical, HR (p-value)
HR by treatment 0.717 (0.001) 0.685 (0.017)
HR by TGR 0.518 (

Clinical trial identification

Legal entity responsible for the study



Bayer Healthcare Pharmaceuticals


G. Meinhardt: Employee of Bayer Healthcare Pharmaceuticals.

J. Bruix: Research support: Daichi, Arquile, Bayer Healthcare Pharma.; honoraria: Bayer Healthcare Pharma., Biocompatibles, BMS, Novartis; consulting support: Daichi, Arquile, Bayer Healthcare Pharma., Biocompatibles, BMS, Novartis, and Roche.

J. Llovet: Bayer Healthcare, BMS, Lilly, GSK, Nanostring, Biosphere Medical, and Boehringer Ingelheim.

C. Kappeler: Employee of Bayer Pharma AG.

All other authors have declared no conflicts of interest.

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