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

Fingerprint

Pemetrexed
Cisplatin
Neoplasms
Carcinoma
Disease-Free Survival
Febrile Neutropenia
Phase II Clinical Trials
Survival
Neutropenia
Neoplasm Metastasis
Safety

Keywords

  • Bladder cancer
  • Cisplatin
  • Pemetrexed
  • Urothelial carcinoma

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer : The PECULIAR study (KCSG 10-17). / Choi, Yoon Ji; Lee, S. H.; Lee, J. L.; Ahn, J. H.; Lee, K. H.; You, D.; Hong, B.; Hong, J. H.; Ahn, H.

In: British Journal of Cancer, Vol. 112, No. 2, 01.01.2015, p. 260-265.

Research output: Contribution to journalArticle

Choi, Yoon Ji ; Lee, S. H. ; Lee, J. L. ; Ahn, J. H. ; Lee, K. H. ; You, D. ; Hong, B. ; Hong, J. H. ; Ahn, H. / Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer : The PECULIAR study (KCSG 10-17). In: British Journal of Cancer. 2015 ; Vol. 112, No. 2. pp. 260-265.
@article{6d9c681681f14772a727636d7c20c7a5,
title = "Phase II study of pemetrexed in combination with cisplatin in patients with advanced urothelial cancer: The PECULIAR study (KCSG 10-17)",
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.",
keywords = "Bladder cancer, Cisplatin, Pemetrexed, Urothelial carcinoma",
author = "Choi, {Yoon Ji} and Lee, {S. H.} and Lee, {J. L.} and Ahn, {J. H.} and Lee, {K. H.} and D. You and B. Hong and Hong, {J. H.} and H. Ahn",
year = "2015",
month = "1",
day = "1",
doi = "10.1038/bjc.2014.591",
language = "English",
volume = "112",
pages = "260--265",
journal = "British Journal of Cancer",
issn = "0007-0920",
publisher = "Nature Publishing Group",
number = "2",

}

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, Yoon Ji

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.

PY - 2015/1/1

Y1 - 2015/1/1

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

UR - http://www.scopus.com/inward/citedby.url?scp=84922337376&partnerID=8YFLogxK

U2 - 10.1038/bjc.2014.591

DO - 10.1038/bjc.2014.591

M3 - Article

C2 - 25429526

AN - SCOPUS:84922337376

VL - 112

SP - 260

EP - 265

JO - British Journal of Cancer

JF - British Journal of Cancer

SN - 0007-0920

IS - 2

ER -