Effects of adjuvant sorafenib and sunitinib on cardiac function in renal cell carcinoma patients without overt metastases: Results from ASSURE, ECOG 2805

Naomi B. Haas, Judith Manola, Bonnie Ky, Keith T. Flaherty, Robert G. Uzzo, Christopher J. Kane, Michael Jewett, Lori Wood, Christopher G. Wood, Michael B. Atkins, Janice J. Dutcher, George Wilding, Robert S. DiPaola

Research output: Contribution to journalArticlepeer-review

51 Scopus citations

Abstract

Purpose: Sunitinib and sorafenib are used widely in the treatment of renal cell carcinoma (RCC). These agents are associated with a significant incidence of cardiovascular (CV) dysfunction and left ventricular ejection fraction (LVEF) declines, observed largely in the metastatic setting. However, in the adjuvant population, the CV effects of these agents remain unknown. We prospectively defined the incidence of cardiotoxicity among resected, high-risk RCC patients treated with these agents. Experimental Design: Sunitinib, sorafenib, or placebo was administered for up to 12 months in patients with high-risk, resected RCC. LVEF was measured by multigated acquisition (MUGA) scans at standard intervals. Additional CV adverse events were reported according to NCI Common Terminology Criteria for Adverse Events (CTCAE). Results: Among 1,943 patients randomized, 1,599 hadatleast 1 post-baseline MUGA. Within 6 months, 21 patients (1.3%) experienced a cardiac event, defined as an LVEF decline from baseline that was >15% and below the institutional lower limit of normal. Nine of 513 patients (1.8%) were on sunitinib, 7 of 508 (1.4%) on sorafenib, and 5 of 578 (0.9%) on placebo (P = 0.28 and 0.56 comparing sunitinib and sorafenib to placebo, respectively). With dose interruption or adjustment, 16 of the 21 recovered their LVEF to >50%. The incidence of symptomatic heart failure, arrhythmia, or myocardial ischemia did not differ among groups. Conclusions: In the adjuvant setting, we prospectively define low incidence of cardiotoxicity with sunitinib and sorafenib. These findings may be related to close CV monitoring, or potentially to fewer CV comorbidities in our nonmetastatic population.

Original languageEnglish
Pages (from-to)4048-4054
Number of pages7
JournalClinical Cancer Research
Volume21
Issue number18
DOIs
StatePublished - Sep 15 2015

Bibliographical note

Publisher Copyright:
© 2015 American Association for Cancer Research.

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint

Dive into the research topics of 'Effects of adjuvant sorafenib and sunitinib on cardiac function in renal cell carcinoma patients without overt metastases: Results from ASSURE, ECOG 2805'. Together they form a unique fingerprint.

Cite this