Abstract 704P
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 identificationLegal entity responsible for the studyN/A FundingBayer Healthcare Pharmaceuticals DisclosureG. 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. Resources from the same sessionZUMA-3: A phase 1/2 multi-center study evaluation the safety and efficacy of KTE-C19 anti-CD19 CAR T cells in adult patients with relapsed/refractory B precursor acute lymphoblastic leukemia (R/R ALL)Presenter: Bijal Shah Session: Poster display Resources: Abstract ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)Presenter: Michael Wang Session: Poster Display Resources: Abstract ZUMA-1: A phase 2 multi-center study evaluating anti-CD19 chimeric antigen receptor (CAR) T cells in patients with refractory aggressive non-Hodgkin lymphoma (NHL)Presenter: Sattva Neelapu Session: Poster Display Resources: Abstract Younger age as a prognostic indicator in breast cancer: Correlation between clinical-pathologic factors and miRNAs and long-term follow-upPresenter: Maria Teresa Martinez Session: Poster display Resources: Abstract Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)Presenter: Christy Toms Session: Poster display Resources: Abstract Whole exome sequencing (WES) and RNA sequencing (RNA-seq) in routine clinical practice for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) patients (pts)Presenter: Géraldine Perkins Session: Poster display Resources: Abstract What is the optimal annual interpretive volume for a radiologist reading screening mammograms?Presenter: Asli Uluturk Session: Poster display Resources: Abstract What decides breast conservation versus mastectomy in the background of diverse sociocultural environment, an Indian studyPresenter: Poonamalle Padmanabhan Bapsy Session: Poster display Resources: Abstract Waiting time to diagnosis and treatment of the head and neck cancer in four institutions in PortugalPresenter: Ana Castro Session: Poster display Resources: Abstract Wait times for diagnosis and treatment of lung cancer: a single centre experiencePresenter: Catherine Labbe Session: Poster Display Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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