Is there a "trial effect" on outcome of patients with metastatic renal cell carcinoma treated with sunitinib?

Daniel Keizman, Keren Rouvinov, Avishay Sella, Maya Gottfried, Natalie Maimon, Jenny J. Kim, Mario A. Eisenberger, Victoria Sinibaldi, Avivit Peer, Michael A. Carducci, Wilmosh Mermershtain, Raya Leibowitz-amit, Rony Weitzen, Raanan Berger

Research output: Contribution to journalArticle

Abstract

Purpose Studies suggested the existence of a 'trial effect,' in which for a given treatment, participation in a clinical trial is associated with a better outcome. Sunitinib is a standard treatment for metastatic renal cell carcinoma (mRCC). We aimed to study the effect of clinical trial participation on the outcome of mRCC patients treated with sunitinib, which at present, is poorly defined. Materials and Methods The records of mRCC patients treated with sunitinib between 2004-2013 in 7 centers across 2 countries were reviewed. We compared the response rate (RR), progression free survival (PFS), and overall survival (OS), between clinical trial participants (n=49) and a matched cohort of non-participants (n=49) who received standard therapy. Each clinical trial participant was individually matched with a non-participant by clinicopathologic factors. PFS and OS were determined by Cox regression. Results The groups were matched by age (median, 64), sex (male, 67%), Heng risk (favorable, 25%; intermediate, 59%; poor, 16%), prior nephrectomy (92%), RCC histology (clear cell 86%), pre-treatment neutrophil to lymphocyte ratio (> 3 in 55%, n=27), sunitinib induced hypertension (45%), and sunitinib dose reduction/treatment interruption (41%). In clinical trial participants versus non-participants, RR was partial response/stable disease 80% (n=39) versus 74% (n=36), and progressive disease 20% (n=10) versus 26% (n=13) (p=0.63; odds ratio, 1.2). The median PFS was 10 versus 11 months (hazard ratio [HR], 0.96; p=0.84), and the median OS 23 versus 24 months (HR, 0.97; p=0.89). Conclusion In mRCC patients treated with sunitinib, the outcome of clinical trial participants was similar to that of non-participants who received standard therapy.

Original languageEnglish (US)
Pages (from-to)281-287
Number of pages7
JournalCancer Research and Treatment
Volume48
Issue number1
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

Keywords

  • Clinical trial participation
  • Metastatic renal cell carcinoma
  • Outcome
  • Sunitinib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Keizman, D., Rouvinov, K., Sella, A., Gottfried, M., Maimon, N., Kim, J. J., Eisenberger, M. A., Sinibaldi, V., Peer, A., Carducci, M. A., Mermershtain, W., Leibowitz-amit, R., Weitzen, R., & Berger, R. (2016). Is there a "trial effect" on outcome of patients with metastatic renal cell carcinoma treated with sunitinib? Cancer Research and Treatment, 48(1), 281-287. https://doi.org/10.4143/crt.2014.289