mRCC: cabozantinib efficacy extends to non-clear-cell disease

  • Martínez Chanzá N & al.
  • Lancet Oncol
  • 28 Feb 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Real-world data support cabozantinib efficacy and safety in non-clear-cell metastatic renal cell carcinoma (mRCC).

Why this matters

  • Cabozantinib is approved for mRCC based on studies in patients with clear-cell histology.
  • A large-scale prospective study in non-clear-cell mRCC is difficult because of its rarity.

Study design

  • Multicenter, international, retrospective cohort study of 112 patients with non-clear-cell mRCC treated with oral cabozantinib during any treatment line.
  • Funding: None.

Key results

  • Median follow-up, 11 months.
  • Objective response rate, 27% (95% CI, 19%-36%).
  • Median time to treatment failure was 6.7 (95% CI, 5.5-8.6) months, median PFS was 7.0 (95% CI, 5.7-9.0) months, and median OS was 12.0 (95% CI, 9.2-17.0) months.
  • The most common any grade adverse events (AEs) were fatigue (52%), diarrhea (34%), skin toxicity (rash and palmar-plantar erythrodysesthesia; 31%), nausea (29%), and hypertension (28%).
  • The most common grade 3 AEs were skin toxicity (4%) and hypertension (4%).
  • No treatment-related deaths reported.
  • Next-generation sequencing data were available for 48% of patients.
    • Most common somatic gene alterations were CDKN2A (22%), MET (20%), and TP53 (11%).

Limitations

  • Retrospective design.

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