PMID- 31648851
OWN - NLM
STAT- MEDLINE
DCOM- 20200731
LR  - 20221207
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 127
DP  - 2020 Mar
TI  - Vinflunine/gemcitabine versus carboplatin/gemcitabine as first-line treatment in 
      cisplatin-ineligible patients with advanced urothelial carcinoma: A randomised 
      phase II trial (VINGEM).
PG  - 173-182
LID - S0959-8049(19)30726-9 [pii]
LID - 10.1016/j.ejca.2019.08.033 [doi]
AB  - 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/m(2) day 1, 
      gemcitabine 1000 mg/m(2) days 1 and 8, q21 days) or the control arm (carboplatin 
      AUC 4.5 day 1, gemcitabine 1000 mg/m(2) 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.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Holmsten, Karin
AU  - Holmsten K
AD  - PO Backencancer, Tema Cancer, Karolinska Universitetssjukhuset and Department of 
      Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. Electronic address: 
      karin.holmsten@ki.se.
FAU - Jensen, Niels Viggo
AU  - Jensen NV
AD  - Department of Oncology, Odense Universitetshospital, Odense, Denmark.
FAU - Mouritsen, Lene Sonne
AU  - Mouritsen LS
AD  - Department of Oncology, Herlev Gentofte Hospital, Herlev, Denmark.
FAU - Jonsson, Erika
AU  - Jonsson E
AD  - Department of Oncology, Norrlands Universitetssjukhus, Umea, Sweden.
FAU - Mellnert, Camilla
AU  - Mellnert C
AD  - Department of Oncology, Skanes Universitetssjukhus, Lund, Sweden.
FAU - Agerbaek, Mads
AU  - Agerbaek M
AD  - Department of Oncology, Aarhus Universitetshospital, Aarhus, Denmark.
FAU - Nilsson, Cecilia
AU  - Nilsson C
AD  - Department of Oncology, Vastmanlands Sjukhus, Vasteras, Sweden.
FAU - Moe, Mette
AU  - Moe M
AD  - Department of Oncology, Aalborg Universitetshospital, Aalborg, Denmark.
FAU - Carus, Andreas
AU  - Carus A
AD  - Department of Oncology, Aalborg Universitetshospital, Aalborg, Denmark.
FAU - Ofverholm, Elisabeth
AU  - Ofverholm E
AD  - Department of Oncology, Sahlgrenska Universitetssjukhuset, Goteborg, Sweden.
FAU - Lahdenpera, Outi
AU  - Lahdenpera O
AD  - Department of Oncology, Abo Universitetscentralsjukhus, Abo, Finland.
FAU - Brandberg, Yvonne
AU  - Brandberg Y
AD  - PO Backencancer, Tema Cancer, Karolinska Universitetssjukhuset and Department of 
      Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
FAU - Johansson, Hemming
AU  - Johansson H
AD  - PO Backencancer, Tema Cancer, Karolinska Universitetssjukhuset and Department of 
      Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
FAU - Hellstrom, Mats
AU  - Hellstrom M
AD  - PO Backencancer, Tema Cancer, Karolinska Universitetssjukhuset and Department of 
      Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
FAU - Maase, Hans von der
AU  - Maase HV
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
FAU - Pappot, Helle
AU  - Pappot H
AD  - Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
FAU - Ullen, Anders
AU  - Ullen A
AD  - PO Backencancer, Tema Cancer, Karolinska Universitetssjukhuset and Department of 
      Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.
LA  - eng
SI  - ClinicalTrials.gov/NCT02665039
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191022
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0W860991D6 (Deoxycytidine)
RN  - 5BF646324K (vinflunine)
RN  - 5V9KLZ54CY (Vinblastine)
RN  - BG3F62OND5 (Carboplatin)
RN  - Q20Q21Q62J (Cisplatin)
RN  - 0 (Gemcitabine)
SB  - IM
CIN - Eur J Cancer. 2020 Mar;127:158-159. PMID: 32014813
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carboplatin/administration & dosage
MH  - Cisplatin/administration & dosage
MH  - Deoxycytidine/administration & dosage/analogs & derivatives
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - Prognosis
MH  - Survival Rate
MH  - Urologic Neoplasms/*drug therapy/pathology
MH  - Vinblastine/administration & dosage/analogs & derivatives
MH  - Gemcitabine
OTO - NOTNLM
OT  - Bladder cancer
OT  - Carboplatin/gemcitabine
OT  - Cisplatin-unfit
OT  - Renal impairment
OT  - Urothelial carcinoma
OT  - Vinflunine
OT  - Vinflunine/gemcitabine
EDAT- 2019/10/28 06:00
MHDA- 2020/08/01 06:00
CRDT- 2019/10/26 06:00
PHST- 2019/05/06 00:00 [received]
PHST- 2019/08/06 00:00 [revised]
PHST- 2019/08/18 00:00 [accepted]
PHST- 2019/10/28 06:00 [pubmed]
PHST- 2020/08/01 06:00 [medline]
PHST- 2019/10/26 06:00 [entrez]
AID - S0959-8049(19)30726-9 [pii]
AID - 10.1016/j.ejca.2019.08.033 [doi]
PST - ppublish
SO  - Eur J Cancer. 2020 Mar;127:173-182. doi: 10.1016/j.ejca.2019.08.033. Epub 2019 
      Oct 22.