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 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.

Elucidation of Novel Molecular Targets for Therapeutic Strategies in Urothelial Carcinoma: A Literature Review

“…The phase II PECULIAR study involved 42 advanced UC patients, treated with pemetrexed and cisplatin combination therapy; the ORR was 64.3%, median PFS was 6.9 months, and median OS was 14.4 months. 33.33% of the patients experienced grade 3-4 neutropenia ( 96 ). Cao et al.’s phase I 2018 trial compared the outcomes of gemcitabine-cisplatin versus pemetrexed-cisplatin in patients with advanced or metastatic UC.…”