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Everolimus in metastatic renal cell carcinoma patients intolerant to previous VEGFr-TKI therapy: a RECORD-1 subgroup

S Bracarda1, T E Hutson, C Porta

  • 1Ospedale San Donato USL8, Istituto Toscano Tumori, Arezzo, Italy. sergio.bracarda@usl8.toscana.it

British Journal of Cancer
|March 24, 2012
PubMed
Abstract

Insights

Everolimus is safe and effective for metastatic renal cell carcinoma patients intolerant to vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFr-TKIs). This treatment offers improved progression-free survival without increased toxicity.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Metastatic renal cell carcinoma (mRCC) patients often develop intolerance to vascular endothelial growth factor receptor-tyrosine kinase inhibitors (VEGFr-TKIs).
  • Careful selection of subsequent therapies is crucial for patients experiencing VEGFr-TKI toxicity.
  • This study retrospectively analyzed everolimus in patients who discontinued prior VEGFr-TKI therapy due to adverse events.

Purpose of the Study:

  • To evaluate the safety and efficacy of everolimus in patients with mRCC who were intolerant to prior VEGFr-TKI therapy.
  • To compare progression-free survival (PFS) between everolimus and placebo in this specific patient population.

Main Methods:

  • Retrospective analysis of patients from the phase-III RECORD-1 trial.
  • Inclusion criteria: patients who discontinued previous VEGFr-TKI therapy due to an adverse event (AE).
  • Progression-free survival (PFS) estimated using Kaplan-Meier; hazard ratios (HR) calculated using Cox proportional hazard models.

Main Results:

  • In VEGFr-TKI-intolerant patients (n=58), median PFS was 5.4 months with everolimus versus 1.9 months with placebo (HR: 0.32; P=0.004).
  • In sunitinib-intolerant patients (n=26), median PFS was 5.1 months with everolimus versus 2.8 months with placebo (HR: 0.28; P=0.033).
  • Grade 3/4 adverse events with everolimus included infections (16%), fatigue (7%), and stomatitis (4%), with a similar toxicity profile to the overall study population.

Conclusions:

  • Everolimus demonstrates efficacy in improving PFS for patients intolerant to VEGFr-TKIs.
  • Everolimus is well-tolerated in this patient group, showing no increased toxicity.
  • The findings support everolimus as a viable treatment option for mRCC patients with prior VEGFr-TKI intolerance.

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