Sunitinib Alone or After Nephrectomy for Patients with Metastatic Renal Cell Carcinoma: Is There Still a Role for Cytoreductive Nephrectomy?
- Study type
- Clinical trial
- Study name
- CARMENA
- Phase
- Phase 3
- Design
- Randomised non-inferiority trial (updated overall survival analysis)
- Sample size
- 450 patients
- Source
- Eur Urol · 2021
- Trial registration
- NCT00930033
In plain words
In people whose kidney cancer had already spread at diagnosis and who needed drug treatment, starting the drug straight away without removing the kidney was no worse for survival than surgery followed by the drug. In some patients at lower risk, surgery may still be helpful.
Key results
Treatment arms and regimens
Cytoreductive nephrectomy, then sunitinib 50 mg orally daily in cycles of 28 days on and 14 days off (every 6 weeks), until disease progression or unacceptable toxicity (226 patients).
Sunitinib 50 mg orally daily in cycles of 28 days on and 14 days off (every 6 weeks), without nephrectomy (224 patients).
Source of the regimen details: Abstract of the original CARMENA paper (NEJM 2018; PMID 29860937) and ClinicalTrials.gov NCT00930033
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with biopsy-confirmed metastatic clear-cell renal-cell carcinoma at diagnosis who were suitable candidates for nephrectomy in the urologist's judgement; intermediate or poor risk by the MSKCC model (a randomisation stratification factor); ECOG performance status 0 to 1; no prior systemic therapy; brain metastases only if treated and stable. 450 patients were enrolled between 2009 and 2017.
Endpoints
Primary endpoint: overall survival (updated data cut-off October 2018).
Safety and side effects
Safety data are not reported in the abstract.
Clinical significance and place in guidelines
This updated analysis confirmed the main CARMENA result and underpins guideline recommendations against immediate cytoreductive nephrectomy in poor-risk patients and in most intermediate-risk patients who need systemic therapy.
Limitations
The trial was conducted in the era of anti-VEGF drugs, before immunotherapy combinations; subgroup analyses were post hoc.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.