TY - JOUR
T1 - Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer
T2 - The PECULIAR study (KCSG 10-17)
AU - Choi, Y. J.
AU - Lee, S. H.
AU - Lee, J. L.
AU - Ahn, J. H.
AU - Lee, K. H.
AU - You, D.
AU - Hong, B.
AU - Hong, J. H.
AU - Ahn, H.
N1 - Funding Information:
We thank the patients and their families who took part in this study, the coordinators, and the investigators. We also thank Lilly Korea Co. for their kind donation of pemetrexed (Alimtas) for this study. This study was supported in part by a grant (HI12C17880300, HI14C1931) from the Korean Health Technology R&D Project, Ministry of Health and Welfare, Republic of Korea.
Publisher Copyright:
© 2015 Cancer Research UK. All rights reserved.
PY - 2015/1/20
Y1 - 2015/1/20
N2 - Background: Pemetrexed has shown a favourable response rate of about 30% with minimal toxicity when used as a single agent for treatment of advanced urothelial carcinoma. This phase II study evaluated the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma. Methods: This multicentre, single-arm, open-label, phase II clinical trial enrolled patients who had advanced urothelial carcinoma, ECOG PS 0-2, and measurable disease. Pemetrexed 500mgm-2 with cisplatin 70mgm-2 on day 1 were administered every 3 weeks. The primary endpoint was the objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. Results: A total of 42 patients were enrolled (median age, 66 years; ECOG 0-1, 100%; visceral metastasis, 54.8%; recurrent disease, 57.1%). Twenty-seven partial responses for an ORR of 64.3% (95% CI, 49.2%-77.0%) were documented. Seven patients had stable disease. Median PFS and OS were 6.9 (95% CI, 6.2-7.6) and 14.4 (95% CI, 10.4-18.4) months, respectively. Grade 3 or 4 neutropenia was observed in 28.6% of patients. No patients experienced febrile neutropenia. Conclusion: The combination of pemetrexed and cisplatin is active, and well tolerated in patients with advanced urothelial cancer as a first-line treatment.
AB - Background: Pemetrexed has shown a favourable response rate of about 30% with minimal toxicity when used as a single agent for treatment of advanced urothelial carcinoma. This phase II study evaluated the efficacy and safety of pemetrexed plus cisplatin in advanced urothelial carcinoma. Methods: This multicentre, single-arm, open-label, phase II clinical trial enrolled patients who had advanced urothelial carcinoma, ECOG PS 0-2, and measurable disease. Pemetrexed 500mgm-2 with cisplatin 70mgm-2 on day 1 were administered every 3 weeks. The primary endpoint was the objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity. Results: A total of 42 patients were enrolled (median age, 66 years; ECOG 0-1, 100%; visceral metastasis, 54.8%; recurrent disease, 57.1%). Twenty-seven partial responses for an ORR of 64.3% (95% CI, 49.2%-77.0%) were documented. Seven patients had stable disease. Median PFS and OS were 6.9 (95% CI, 6.2-7.6) and 14.4 (95% CI, 10.4-18.4) months, respectively. Grade 3 or 4 neutropenia was observed in 28.6% of patients. No patients experienced febrile neutropenia. Conclusion: The combination of pemetrexed and cisplatin is active, and well tolerated in patients with advanced urothelial cancer as a first-line treatment.
KW - Bladder cancer
KW - Cisplatin
KW - Pemetrexed
KW - Urothelial carcinoma
UR - http://www.scopus.com/inward/record.url?scp=84922337376&partnerID=8YFLogxK
U2 - 10.1038/bjc.2014.591
DO - 10.1038/bjc.2014.591
M3 - Article
C2 - 25429526
AN - SCOPUS:84922337376
SN - 0007-0920
VL - 112
SP - 260
EP - 265
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 2
ER -
