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