Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: the PECULIAR study (KCSG 10-17)
- Authors
- Choi, Y. J.; Lee, S. H.; Lee, J-L; Ahn, J-H; Lee, K-H; You, D.; Hong, B.; Hong, J. H.; Ahn, H.
- Issue Date
- 20-1월-2015
- Publisher
- SPRINGERNATURE
- Keywords
- urothelial carcinoma; bladder cancer; pemetrexed; cisplatin
- Citation
- BRITISH JOURNAL OF CANCER, v.112, no.2, pp.260 - 265
- Indexed
- SCIE
SCOPUS
- Journal Title
- BRITISH JOURNAL OF CANCER
- Volume
- 112
- Number
- 2
- Start Page
- 260
- End Page
- 265
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/94624
- DOI
- 10.1038/bjc.2014.591
- ISSN
- 0007-0920
- Abstract
- 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 500 mg m(-2) with cisplatin 70 mg m(-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.
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