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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)
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De Santis, Maria , 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. and Culine, S. (2015) 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). pp. 449-454. doi:10.1093/annonc/mdv609 ISSN 0923-7534.
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Official URL: http://dx.doi.org/10.1093/annonc/mdv609
Abstract
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.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Annals of Oncology | ||||||||
Publisher: | Oxford University Press | ||||||||
ISSN: | 0923-7534 | ||||||||
Official Date: | 16 December 2015 | ||||||||
Dates: |
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Volume: | 27 | ||||||||
Number: | 3 | ||||||||
Page Range: | pp. 449-454 | ||||||||
DOI: | 10.1093/annonc/mdv609 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
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