Multicenter phase II study of sunitinib in patients with non-clear cell renal cell carcinoma.
BACKGROUND
Retrospective and molecular biologic data suggest that sunitinib may be effective in patients with non-clear cell renal cell carcinoma (nccRCC).


METHODS
Eligibility criteria included advanced nccRCC except for collecting duct carcinoma and sarcomatoid carcinoma without identifiable renal cell carcinoma subtypes. Patients were treated with 50 mg/day oral sunitinib for 4 weeks, followed by 2 weeks of rest. The primary end point was overall response rate (RR).


RESULTS
Thirty-one eligible patients were enrolled. Twenty-four patients (77%) had prior nephrectomy. By Memorial Sloan-Kettering Cancer Center criteria, 8 patients (26%) had poor risk and 14 (45%) had intermediate risk. Twenty-two patients had papillary renal cell carcinoma (RCC), and three had chromophobe RCC. Eleven patients had partial response with a RR of 36% (95% confidence interval (CI) 19% to 52%) and an additional 17 patients (55%) had stable disease. Median duration of response was 12.7 months (95% CI 6.3-19.1 months), and median progression-free survival was 6.4 months (95% CI 4.2-8.6 months). At a median follow-up duration of 18.7 months (95% CI 13.7-23.7 months), 13 patients (42%) had died, resulting in an estimated median survival of 25.6 months (95% CI 8.4-42.9 months). Toxicity profiles were commensurate with prior reports.


CONCLUSIONS
Sunitinib has promising activity in patients with nccRCC (NCT01219751).
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul. Electronic address: jaelyun@amc.seoul.kr.
J-L
JL
Lee
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
J-H
JH
Ahn
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
H Y
HY
Lim
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul.
S H
SH
Park
Department of Internal Medicine, Seoul National University College of Medicine, Seoul.
S H
SH
Lee
Department of Internal Medicine, Seoul National University College of Medicine, Seoul.
T M
TM
Kim
Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
D-H
DH
Lee
Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Y M
YM
Cho
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
C
C
Song
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
J H
JH
Hong
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
C-S
CS
Kim
Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
H
H
Ahn
D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D000077210:Sunitinib; D055815:Young Adult
D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib