This document summarizes a clinical trial comparing sunitinib alone to nephrectomy followed by sunitinib in patients with metastatic renal cell carcinoma. The trial was a prospective, multicenter, randomized phase 3 trial that enrolled 450 patients between 2009-2017. The primary endpoint was overall survival and secondary endpoints included progression-free survival, objective response rate, and clinical benefit. The results showed that sunitinib alone was not inferior to nephrectomy followed by sunitinib for overall survival and progression-free survival. Nephrectomy is still recommended for symptomatic patients.

1. Dr Mebanshanbor Garod
(MS General Surgery, FMAS,
FEBS Surgical Oncology)
Surgical Oncology Dept.,
NEIGRIHMS, Shillong
.

11. 1. Karnofsky performance status<80
2. LDH> 1.5 upper limit of normal
3. Calcium>10 mg/dl
4. Hmg <lower limit of normal range
5. Time from Dx to Rx <1yr

13. OBJECTIVE: Non inferiority trial comparing
Sunitinib alone to Nephrectomy followed
by Sunitinib

14. Trial design:
Prospective , multicentric, open label,
randomized phase 3 trial.
Stratified according to risk group (using
MSKCC prognostic model): intermediate
and poor risk groups included.

15. End points:
Primary: overall survival
Secondary :PFS, objective response rate,
clinical benefit

16. Inclusion criteria:
 >/ 18 years
Proven clear cell RCC
ECOG 0 or 1
No brain mets
MSKCC intermediate and poor risk groups

17. Exclusion Criteria:
Prev. Systemic treatment or anti-
coagualtion
Medical conditions
Poor ECOG

20. Sept. 2009- Sept. 2o17
450 pts enrolled from 79 centres
• 226 nephrectomy f/b sunitinib
• 224 sunitinib alone
Median folllow up 50.9 months

21. Men 74.7%
Median age 62 years
56% patients: ECOG-0
Intermediate and poor risk groups

26. Prospective , randomized, multi-centric
trial
Pharmaceutical company not involved
Primary endpoint :OS
Intention to treat analysis
Adverse effects monitored independently
usingCTCAE

27. Fewer patients included than planned
MSKCC risks groups not as relevant as IMDC
risk groups
Underestimate the benefits of nephrectomy
Good risk groups (low metastatic burden) not
included-different survival outcome
Cost related issues.

28. Sunitinib alone not inferior to nephrectomy
f/b sunitinib: OS/PFS
Nephrectomy indicated in symptomatic
patients

29. Thank you…

30. Rini et al JCO 2005, 2009