Abstract 1771
Background
Early tumor shrinkage (eTS) of 10% has been identified as a putative prognostic marker in mRCC, which could serve as an early read-out in clinical trials. We aimed to validate the prognostic role of eTS in first line TKI treatment using data from the COMPARZ study (NCT00720941).
Methods
A retrospective analysis on data of 1100 1st line patients treated with sunitinib or pazopanib was performed. Tumor response was measured according to RECIST 1.1. eTS was a priori defined as tumor shrinkage by ≥10%. The Kaplan-Meier method was used to estimate time-to-event outcomes. A landmark analysis was performed on day (d) 42 and d 90 after randomization. Cox proportional hazards regression was performed to evaluate the effect of prognostic factors on overall survival after d 42 and d 90.
Results
ConclusionsSimilar results were found for eTS at the 42 and 90 days landmarks. eTS ≥10% has prognostic relevance in mRCC and reflects a valid early endpoint in clinical trials. Clinical trial identificationNCT00720941 Legal entity responsible for the studyGSK sponsored study. Current analysis is retrospective on the initial data set. FundingMedical School Hannover, McMaster University DisclosureV. Grünwald: Honoraria: Novartis, Pfizer, BMS Consultation: Novartis, Pfizer, BMS. All other authors have declared no conflicts of interest. Resources from the same session4099 - A first-in-human (FIH) phase I/II, dose escalation, pharmacokinetic (PK) study to assess the safety and tolerability of VAL-201 in patients with advanced prostate cancer (APC) and other advanced solid tumoursPresenter: Rebecca Kristeleit Session: Poster display Resources: Abstract 4130 - Response to savolitinib (AZD6094/HMPL-504, a potent and selective MET inhibitor) in a papillary renal cell carcinoma patient harbouring a novel MET activating mutationPresenter: Melanie Frigault Session: Poster display Resources: Abstract 4141 - Qualitative and quantitative differences in a set of criteria for histological grading of colorectal cancerPresenter: Taras Savchyn Session: Poster display Resources: Abstract 4167 - The comparison between TP53 gene polymorphisms (c.[215G > C]) homozygotes and heterozygotes in breast cancer patients: a clinicopathological analysisPresenter: Joanna Huszno Session: Poster display Resources: Abstract 4205 - MicroRNAs as biomarkers of resistance to HER2 inhibitors in combination with chemotherapy in gastro-oesophageal cancer cell linesPresenter: Hazel Lote Session: Poster display Resources: Abstract 4208 - Initial first-in-human phase 1 results of PTC596, a novel small molecule that targets cancer stem cells (CSCs) by reducing BMI1 protein levelsPresenter: Geoffrey Shapiro Session: Poster display Resources: Abstract 4276 - Phase II studies of AZD1775, a WEE1 kinase inhibitor, and chemotherapy in non-small-cell lung cancer (NSCLC): Lead-in cohort resultsPresenter: David Spigel Session: Poster display Resources: Abstract 4313 - Survival patterns of T2 & T3 breast cancer according to different modalities of treatment in the United StatesPresenter: Mohamed Ramadan Session: Poster display Resources: Abstract 4322 - Suppression of oncogene transcription - PNA as targeted cancer therapy for BRAF-V600E mutant melanomaPresenter: Jeffrey Rothman Session: Poster display Resources: Abstract 4326 - Phase 1 dose-escalation study of the folic acid-tubulysin small-molecule drug conjugate (SMDC) folate-tubulysin EC1456: Study updatePresenter: Jasgit Sachdev 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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