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

Date

08 Oct 2016

Session

Poster Display

Presenters

Gerold Meinhardt

Citation

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

Authors

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
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Background

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 

Methods

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.

Results

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.

Conclusions

SHARP Trial AP Trial
PLC SOR PLC SOR
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

N/A

Funding

Bayer Healthcare Pharmaceuticals

Disclosure

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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