Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: The PECULIAR study (KCSG 10-17)

Yoon Ji Choi, S. H. Lee, J. L. Lee, J. H. Ahn, K. H. Lee, D. You, B. Hong, J. H. Hong, H. Ahn

Research output: Contribution to journalArticle

7 Citations (Scopus)

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 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.

Original languageEnglish
Pages (from-to)260-265
Number of pages6
JournalBritish Journal of Cancer
Volume112
Issue number2
DOIs
Publication statusPublished - 2015 Jan 1

Keywords

  • Bladder cancer
  • Cisplatin
  • Pemetrexed
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Fingerprint Dive into the research topics of 'Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: The PECULIAR study (KCSG 10-17)'. Together they form a unique fingerprint.

  • Cite this