Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: Results of an international randomized phase II trial (JASINT1)

Maria De Santis, P. J. Wiechno, J. Bellmunt, C. Lucas, W. C. Su, L. Albiges, C. C. Lin, E. Senkus-Konefka, A. Flechon, L. Mourey, A. Necchi, W. C. Loidl, M. M. Retz, N. Vaissière, S. Culine

研究成果: Article

30 引文 斯高帕斯(Scopus)

摘要

Background: There is no standard first-line chemotherapy for advanced urothelial carcinoma (aUC) in cisplatin-ineligible (cisplatin-unfit) patients. The study assessed the efficacy and tolerability profile of two vinflunine-based cytotoxic regimens in this setting. Patients and methods: Patients with aUC a creatinine clearance (CrCl) of <60 but ≥30 ml/min, performance status 0 or 1 and no prior chemotherapy for advanced disease were randomized (1: 1). They received vinflunine 250 or 280 mg/m2 (based on baseline CrCl) on day 1, plus either gemcitabine [750 mg/m2 escalated to 1000 mg/m2 in cycle 2 if no toxicity grade (G) ≥ 2 on days 1 and 8 (VG) or plus carboplatin area under the curve 4.5 day 1 (VC) every 21 days]. To detect a 22% improvement in each arm compared with H0 (41%) in the primary end point, disease control rate (DCR = complete response + partial response + stable disease), 31 assessable patients per arm were required (α = 5%, β = 20%). Results: Sixty-nine patients were enrolled (34 VG, 35 VC). Less G3/4 haematological adverse events (AEs) were reported with VG: Neutropaenia was seen in 38% (versus 68% with VC) and febrile neutropaenia in 3% (versus 14% with VC) of patients. No major differences were observed for non-haematological AEs. DCR was 77% in both groups; overall response rate (ORR) was 44.1% versus 28.6%, with a median progression-free survival of 5.9 versus 6.1 months and median OS of 14.0 versus 12.8 months with VG and VC, respectively. Conclusion: Both vinflunine-based doublets offer a similar DCR, ORR and OS. The better haematological tolerance favours the VG combination, which warrants further study. ClinicalTrials.gov protocol identifier: NCT 01599013.

原文English
文章編號mdv609
頁(從 - 到)449-454
頁數6
期刊Annals of Oncology
27
發行號3
DOIs
出版狀態Published - 2016 三月 1

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology

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    De Santis, M., Wiechno, P. J., Bellmunt, J., Lucas, C., Su, W. C., Albiges, L., Lin, C. C., Senkus-Konefka, E., Flechon, A., Mourey, L., Necchi, A., Loidl, W. C., Retz, M. M., Vaissière, N., & Culine, S. (2016). Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: Results of an international randomized phase II trial (JASINT1). Annals of Oncology, 27(3), 449-454. [mdv609]. https://doi.org/10.1093/annonc/mdv609