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

Y. J. 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 journalArticlepeer-review

8 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 20
Externally publishedYes

Bibliographical note

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.

Keywords

  • Bladder cancer
  • Cisplatin
  • Pemetrexed
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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