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- Dokumenttyp:
- Clinical Trial, Phase II; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Article
- Autor(en):
- 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
- Titel:
- 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).
- Abstract:
- 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 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/m(2) (based on baseline CrCl) on day 1, plus either gemcitabine [750 mg/m(2) escalated to 1000 mg/m(2) 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 (? = 5%, ? = 20%).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.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.
- Zeitschriftentitel:
- Ann Oncol
- Jahr:
- 2016
- Band / Volume:
- 27
- Heft / Issue:
- 3
- Seitenangaben Beitrag:
- 449-54
- Sprache:
- eng
- Volltext / DOI:
- doi:10.1093/annonc/mdv609
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/26673352
- Print-ISSN:
- 0923-7534
- TUM Einrichtung:
- Urologische Klinik und Poliklinik
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