📃 Paper Title: Sunitinib Alone or after Nephrectomy in Metastatic Renal-Cell Carcinoma
🧍 Author: MéJean
🕒 Year: 2018
📚 Journal: NEJM
🌎 Country: France
ㅤContext to the study:
Can you tell me about the role of Sunitinib in metastatic renal cell carcinoma?
ㅤ✅ Take-home message of study:
For patients with metastatic renal-cell carcinoma classified as having intermediate or poor risk of disease, giving Sunitinib chemotherapy agent alone was not inferior to performing a nephrectomy followed by Sunitinib.
ㅤ Multi-center open-label randomized phase 3 prospective trial
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Study participants:
450 patients were enrolled in 79 centres in UK, Norway, France and Sweden
Patients were assigned in a 1:1 ratio to receive Sunitinib treatment after a nephrectomy or Sunitinib alone
Inclusion Criteria:
Adults > 18 years old with clear cell renal cell carcinoma confirmed by biopsy
Participants had documentation of metastatic disease
Participants had an ECOG performance status of 0 or 1
Suitable candidates for nephrectomy and eligible for treatment with Sunitinib
Exclusion Criteria:
Previous systemic treatment for kidney cancer (VEGF-targeted therapy/anticoagulants)
A medical condition including cardiovascular disease that excluded them for either treatment arms
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Key study outcomes:
Primary endpoint: overall survival
The results in the sunitinib alone group were noninferior to
those in the nephrectomy sunitinib group with regards to overall survival (stratified hazard ratio for death, 0.89; 95% confidence interval, 0.71 to 1.10). The median
overall survival was 18.4 months in the sunitinib-alone group and 13.9 months in
the nephrectomy-sunitinib group.
Secondary endpoint: progression free survival and response rate
No significant differences in response rate or progression-free survival were observed
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Study Limitations:
The study excluded patients with low metastatic burden.
Patient's had poor risk features (using MSKCC risk groups instead of IMDC for risk stratification) with substantial metastatic tumour burdens.
Recruitment of fewer patients that planned (450 patients rather than 576) which reduced statistical power.
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