Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Vinflunine/gemcitabine versus carboplatin/gemcitabine as first-line treatment in cisplatin-ineligible patients with advanced urothelial carcinoma: A randomised phase II trial (VINGEM)

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. The current epidemic of HPV-associated oropharyngeal cancer: An 18-year Danish population-based study with 2,169 patients

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. Initial treatment and survival in 4163 Danish patients with pancreatic cancer: A nationwide unselected real-world register study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Measured and genetically predicted plasma YKL-40 levels and melanoma mortality

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Phase II randomised discontinuation trial of brivanib in patients with advanced solid tumours

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Total burden of disease in cancer patients at diagnosis-a Danish nationwide study of multimorbidity and redeemed medication

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. eHealth-mind the gap

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Telemedicine and e-Health Solutions for COVID-19: Patients' Perspective

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • Karin Holmsten
  • Niels Viggo Jensen
  • Lene Sonne Mouritsen
  • Erika Jonsson
  • Camilla Mellnert
  • Mads Agerbæk
  • Cecilia Nilsson
  • Mette Moe
  • Andreas Carus
  • Elisabeth Öfverholm
  • Outi Lahdenperä
  • Yvonne Brandberg
  • Hemming Johansson
  • Mats Hellström
  • Hans von der Maase
  • Helle Pappot
  • Anders Ullén
Vis graf over relationer

BACKGROUND: The present study (VINGEM) is the first randomised trial comparing vinflunine/gemcitabine (VG) to standard carboplatin/gemcitabine (CG) in patients with advanced urothelial carcinoma (aUC) ineligible for treatment with cisplatin.

PATIENTS AND METHODS: Patients with aUC, creatinine clearance 30-60 ml/min, performance status ≤1 and no prior chemotherapy for metastatic disease were randomised to the experimental arm (vinflunine 280 or 250 mg/m2 day 1, gemcitabine 1000 mg/m2 days 1 and 8, q21 days) or the control arm (carboplatin AUC 4.5 day 1, gemcitabine 1000 mg/m2 days 1 and 8, q21 days). Primary end-point was progression-free survival (PFS).

RESULTS: Sixty-two patients were randomised; a total of 59 patients were treated (29 VG, 30 CG). There was no significant difference in PFS between the treatment arms: median 6.2 months for VG versus 6.3 months for CG (hazard ratio [HR]: 0.75, 95% confidence interval [CI]: 0.44-1.28; P = 0.293). Median overall survival was 12.5 months for VG versus 10.6 months for CG. The overall response rate (ORR) was higher in the VG arm than in the CG arm (63% versus 40%) but was not statistically significant in the intention-to-treat analysis. Furthermore, VG showed a high complete response (CR) rate, 22% versus 3% in CG. In the per-protocol group, both ORR and CR were significantly higher for VG than for CG. The most common adverse events (AEs) were fatigue, haematological toxicities, gastrointestinal disorders and nausea/vomiting. Common grade III/IV AEs were neutropenia (VG 62%, CG 43%), thrombocytopenia (VG 7%, CG 37%) and febrile neutropenia (VG 31%, CG 7%).

CONCLUSIONS: The combination of VG did not improve PFS compared with standard treatment with CG in patients unfit for cisplatin due to renal impairment. The response rate of VG indicates, however, an active regimen and warrants further studies. CLINICALTRIALS.

GOV NUMBER: NCT02665039.

OriginalsprogEngelsk
TidsskriftEuropean journal of cancer (Oxford, England : 1990)
Vol/bind127
Sider (fra-til)173-182
ISSN0959-8049
DOI
StatusUdgivet - mar. 2020

Bibliografisk note

Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

ID: 58931863