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Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma
M E Gore1, C Szczylik2, C Porta3
1Royal Marsden Hospital NHS Trust, Fulham Road, London SW3 6JJ, UK.
Background:
We report final results with extended follow-up from a global, expanded-access trial that pre-regulatory approval provided sunitinib to metastatic renal cell carcinoma (mRCC) patients, ineligible for registration-directed trials.
Methods:
Patients ⩾18 years received oral sunitinib 50 mg per day on a 4-weeks-on-2-weeks-off schedule. Safety was assessed regularly. Tumour measurements were scheduled per local practice.
Results:
A total of 4543 patients received sunitinib. Median treatment duration and follow-up were 7.5 and 13.6 months. Objective response rate was 16% (95% confidence interval (CI): 15-17). Median progression-free survival (PFS) and overall survival (OS) were 9.4 months (95% CI: 8.8-10.0) and 18.7 months (95% CI: 17.5-19.5). Median PFS in subgroups of interest: aged ⩾65 years (33%), 10.1 months; Eastern Cooperative Oncology Group performance status ⩾2 (14%), 3.5 months; non-clear cell histology (12%), 6.0 months; and brain metastases (7%), 5.3 months. OS was strongly associated with the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model (n=4065). The most common grade 3/4 treatment-related adverse events were thrombocytopenia (10%), fatigue (9%), and asthenia, neutropenia, and hand-foot syndrome (each 7%).
Conclusion:
Final analysis of the sunitinib expanded-access trial provided a good opportunity to evaluate the long-term side effects of a tyrosine kinase inhibitor used worldwide in mRCC. Efficacy and safety findings were consistent with previous results.
Insights
Sunitinib demonstrated consistent efficacy and safety in metastatic renal cell carcinoma (mRCC) patients during an expanded-access trial. Long-term follow-up confirmed these findings, providing valuable data for this tyrosine kinase inhibitor.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Expanded-access trial of sunitinib for metastatic renal cell carcinoma (mRCC) patients ineligible for registration trials.
- Global trial providing pre-regulatory approval access to sunitinib.
Purpose of the Study:
- Report final results with extended follow-up.
- Evaluate long-term side effects of sunitinib in mRCC.
Main Methods:
- 4543 patients received oral sunitinib (50 mg/day, 4-weeks-on-2-weeks-off).
- Safety assessed regularly; tumor measurements per local practice.
- Extended follow-up for long-term data collection.
Main Results:
- Objective response rate: 16%. Median progression-free survival (PFS): 9.4 months. Median overall survival (OS): 18.7 months.
- Subgroup PFS varied: 10.1 months (age ≥65), 3.5 months (ECOG PS ≥2), 6.0 months (non-clear cell), 5.3 months (brain metastases).
- Common grade 3/4 adverse events: thrombocytopenia (10%), fatigue (9%), asthenia, neutropenia, hand-foot syndrome (7% each). OS associated with IMDC prognostic model.
Conclusions:
- Final analysis confirms consistent efficacy and safety of sunitinib in mRCC.
- Extended follow-up provides valuable long-term safety data for this tyrosine kinase inhibitor.
- Findings align with previous trial results, supporting worldwide use in mRCC.
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