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Bending the Curve Trial by Trial
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CARMENA

Clinical Trial to Assess the Importance of Nephrectomy

Phase 3N = 450NCT00930033

Population
Metastatic clear-cell renal cell carcinoma at presentation, MSKCC intermediate or poor risk, suitable candidates for nephrectomy
Design
Randomised 1:1 non-inferiority phase 3 trial in patients with confirmed metastatic clear-cell renal cell carcinoma at presentation who were suitable for nephrectomy: nephrectomy then sunitinib (standard therapy) versus sunitinib alone. Randomisation was stratified by MSKCC risk (intermediate or poor); sunitinib 50 mg daily in cycles of 28 days on and 14 days off every 6 weeks. Primary end point overall survival; the reported analysis was a planned interim analysis.
Primary endpoint
OS
Arms
  • Nephrectomy then sunitinib (control): Cytoreductive nephrectomy followed by sunitinib
  • Sunitinib alone (experimental): Sunitinib alone (nephrectomy not part of the protocol treatment)
People
Méjean A, senior author Escudier B
OSHR 0.89 (95% CI 0.71–1.10)Δ median OS+4.5 months
Show the numbers
Results reported for CARMENA
EndpointAnalysisSunitinib aloneNephrectomy then sunitinibEffect
OSEnrolled patients (450); analysis population not stated in the abstractinterimmedian follow-up 50.9 monthsMéjean 2018median 18.4 monthsmedian 13.9 monthsHR 0.89 (95% CI 0.71–1.10)Stratified hazard ratio for death; the non-inferiority criterion was an upper boundary of the 95% confidence interval of 1.20 or less. Planned interim analysis with 326 deaths. Median follow-up 50.9 months. The abstract reports no significant differences in response rate or progression-free survival.
Results reported for CARMENA
EndpointAnalysisSunitinib aloneNephrectomy then sunitinibEffect
OSEnrolled patients (450); analysis population not stated in the abstractinterimmedian follow-up 50.9 monthsMéjean 2018median 18.4 monthsmedian 13.9 monthsHR 0.89 (95% CI 0.71–1.10)Stratified hazard ratio for death; the non-inferiority criterion was an upper boundary of the 95% confidence interval of 1.20 or less. Planned interim analysis with 326 deaths. Median follow-up 50.9 months. The abstract reports no significant differences in response rate or progression-free survival.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.890.71–1.1
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%010203040Months (modelled)
  • Sunitinib alone (experimental)
  • Nephrectomy then sunitinib (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSunitinib aloneNephrectomy then sunitinib
0100.0%100.0%
1263.6%55.0%
2342.0%31.8%
3526.8%17.5%
4617.7%10.1%
Primary publication: Méjean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, et al. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018;379(5):417-427. PubMedDOI

Appears in

Sources

  1. Méjean A, Ravaud A, Thezenas S, Colas S, Beauval JB, Bensalah K, et al. Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma. N Engl J Med. 2018;379(5):417-427.

    PubMedDOI