PMID- 27903924
OWN - NLM
STAT- MEDLINE
DCOM- 20171103
LR  - 20190221
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 21
IP  - 12
DP  - 2016 Dec
TI  - Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With 
      Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck 
      Previously Treated With Platinum-Based Therapy.
PG  - 1416-e17
AB  - LESSONS LEARNED: Cabazitaxel has activity in squamous cell carcinoma of the head 
      and neck (SCCHN) and taxane-resistant cell lines. For the first time, cabazitaxel 
      was investigated in incurable patients with recurrent SCCHN. Patients were 
      randomly assigned to cabazitaxel every 3 weeks or weekly methotrexate.This phase 
      II study did not meet its primary endpoint.Cabazitaxel has low activity in 
      SCCHN.The toxicity profile in this population also was not favorable owing to the 
      high rate of febrile neutropenia observed (17%). BACKGROUND: Cabazitaxel is a 
      second-generation taxane that improves the survival of patients with metastatic 
      castrate-resistant prostate cancer following docetaxel therapy. Cabazitaxel has 
      activity in squamous cell carcinoma of the head and neck (SCCHN) and 
      taxane-resistant cell lines. In this randomized phase II trial, we investigated 
      cabazitaxel in patients with recurrent SCCHN. METHODS: Patients with incurable 
      SCCHN with progression after platinum-based therapy were randomly assigned to 
      cabazitaxel every 3 weeks (cycle 1, 20 mg/m(2), increased to 25 mg/m(2) for 
      subsequent cycles in the absence of nonhematological adverse events [AEs] greater 
      than grade 2 and hematological AEs greater than grade 3) or methotrexate (40 
      mg/m(2)/week). The patients were stratified according to their performance status 
      and previous platinum-based chemotherapy for palliation versus curative intent. 
      The primary endpoint was the progression-free survival rate (PFSR) at 18 weeks. 
      RESULTS: Of the 101 patients, 53 and 48, with a median age of 58.0 years (range, 
      41-80), were randomly assigned to cabazitaxel or methotrexate, respectively. The 
      PFSR at 18 weeks was 13.2% (95% confidence interval [CI], 5%-25%) for cabazitaxel 
      and 8.3% (95% CI, 2%-20%) for methotrexate. The median progression-free survival 
      was 1.9 months in both arms. The median overall survival was 5.0 and 3.6 months 
      for cabazitaxel and methotrexate, respectively. More patients experienced serious 
      adverse events with cabazitaxel than with methotrexate (54% vs. 36%). The most 
      common drug-related grade 3-4 AE in the cabazitaxel arm was febrile neutropenia 
      (17.3%). CONCLUSION: This study did not meet its primary endpoint. Cabazitaxel 
      has low activity in recurrent SCCHN.
CI  - (c)AlphaMed Press; the data published online to support this summary is the 
      property of the authors.
FAU - Machiels, Jean-Pascal
AU  - Machiels JP
AD  - Institut Roi Albert II, Department of Medical Oncology, Cliniques Universitaires 
      Saint-Luc and Institut de Recherche Clinique et Experimentale (Pole MIRO), 
      Universite Catholique de Louvain, Brussels, Belgium 
      jean-pascal.machiels@uclouvain.be.
FAU - Van Maanen, Aline
AU  - Van Maanen A
AD  - Statistical Support Unit, Institut Roi Albert II, Cliniques Universitaires 
      Saint-Luc, Universite Catholique de Louvain, Brussels, Belgium.
FAU - Vandenbulcke, Jean-Marie
AU  - Vandenbulcke JM
AD  - Department of Medical Oncology, Reseau Hospitalier de Medecine Sociale, Tournai, 
      Belgium.
FAU - Filleul, Bertrand
AU  - Filleul B
AD  - Department of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint-Paul, 
      Belgium.
FAU - Seront, Emmanuel
AU  - Seront E
AD  - Department of Medical Oncology, Centre Hospitalier de Jolimont, Haine Saint-Paul, 
      Belgium.
FAU - Henry, Stephanie
AU  - Henry S
AD  - Department of Medical Oncology, Centre de Maternite Sainte Elisabeth, Namur, 
      Belgium jean-pascal.machiels@uclouvain.be.
FAU - D'Hondt, Lionel
AU  - D'Hondt L
AD  - Department of Medical Oncology, CHU Mont-Godinne, Universite Catholique de 
      Louvain, Belgium.
FAU - Lonchay, Christophe
AU  - Lonchay C
AD  - Department of Medical Oncology, Grand Hopital de Charleroi, Charleroi, Belgium.
FAU - Holbrechts, Stephane
AU  - Holbrechts S
AD  - Department of Medical Oncology, CHU Ambroise Pare, Mons, Belgium.
FAU - Boegner, Petra
AU  - Boegner P
AD  - Department of Medical Oncology Epicura, Baudour, Belgium.
FAU - Brohee, Dany
AU  - Brohee D
AD  - Department of Medical Oncology, Hopital Civil Marie Curie, Charleroi, Belgium.
FAU - Dequanter, Didier
AU  - Dequanter D
AD  - Department of Head and Neck Surgery, Hopital Civil Marie Curie, Charleroi, 
      Belgium.
FAU - Louviaux, Ingrid
AU  - Louviaux I
AD  - Department of Medical Oncology, Hopital de la Citadelle, Liege, Belgium.
FAU - Sautois, Brieuc
AU  - Sautois B
AD  - Department of Medical Oncology, CHU Sart Tilman, Liege, Belgium.
FAU - Whenham, Nicolas
AU  - Whenham N
AD  - Department of Medical Oncology, Clinique Saint Pierre Ottignies, Ottignies, 
      Belgium.
FAU - Berchem, Guy
AU  - Berchem G
AD  - Department of Medical Oncology, Centre Hospitalier de Luxembourg, Luxembourg 
      City, Luxembourg.
FAU - Vanderschueren, Brigitte
AU  - Vanderschueren B
AD  - Department of Medical Oncology RHMS-Clinique Louis Caty, Baudour, Belgium.
FAU - Fontaine, Christel
AU  - Fontaine C
AD  - Department of Medical Oncology, Free University of Brussels, Brussels, Belgium.
FAU - Schmitz, Sandra
AU  - Schmitz S
AD  - Institut Roi Albert II, Department of Medical Oncology, Cliniques Universitaires 
      Saint-Luc and Institut de Recherche Clinique et Experimentale (Pole MIRO), 
      Universite Catholique de Louvain, Brussels, Belgium.
FAU - Gillain, Aline
AU  - Gillain A
AD  - Institut Roi Albert II, Department of Medical Oncology, Cliniques Universitaires 
      Saint-Luc and Institut de Recherche Clinique et Experimentale (Pole MIRO), 
      Universite Catholique de Louvain, Brussels, Belgium.
FAU - Schoonjans, Joelle
AU  - Schoonjans J
AD  - Department of Radiology, Clinique Saint Pierre Ottignies, Ottignies, Belgium.
FAU - Rottey, Sylvie
AU  - Rottey S
AD  - Department of Medical Oncology, University Hospital Ghent, Ghent, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT01528163
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20161130
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Taxoids)
RN  - 51F690397J (cabazitaxel)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Carcinoma, Squamous Cell/*drug therapy/mortality
MH  - Female
MH  - Head and Neck Neoplasms/*drug therapy/mortality
MH  - Humans
MH  - Male
MH  - Methotrexate/adverse effects/*therapeutic use
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality
MH  - Squamous Cell Carcinoma of Head and Neck
MH  - Taxoids/adverse effects/*therapeutic use
PMC - PMC5153346
COIS- of potential conflicts of interest may be found at the end of this article.
EDAT- 2016/12/03 06:00
MHDA- 2017/11/04 06:00
PMCR- 2016/11/30
CRDT- 2016/12/02 06:00
PHST- 2016/07/17 00:00 [received]
PHST- 2016/08/29 00:00 [accepted]
PHST- 2016/12/03 06:00 [pubmed]
PHST- 2017/11/04 06:00 [medline]
PHST- 2016/12/02 06:00 [entrez]
PHST- 2016/11/30 00:00 [pmc-release]
AID - theoncologist.2016-0296 [pii]
AID - T16296CTR [pii]
AID - 10.1634/theoncologist.2016-0296 [doi]
PST - ppublish
SO  - Oncologist. 2016 Dec;21(12):1416-e17. doi: 10.1634/theoncologist.2016-0296. Epub 
      2016 Nov 30.