Open AccessRandomized 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
Author(s) -
Machiels JeanPascal,
Van Maanen Aline,
Vandenbulcke JeanMarie,
Filleul Bertrand,
Seront Emmanuel,
Henry Stéphanie,
D'Hondt Lionel,
Lonchay Christophe,
Holbrechts Stéphane,
Boegner Petra,
Brohee Dany,
Dequanter Didier,
Louviaux Ingrid,
Sautois Brieuc,
Whenham Nicolas,
Berchem Guy,
Vanderschueren Brigitte,
Fontaine Christel,
Schmitz Sandra,
Gillain Aline,
Schoonjans Joelle,
Rottey Sylvie
Publication year - 2016
Publication title -
the oncologist
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.176
H-Index - 164
eISSN - 1549-490X
pISSN - 1083-7159
DOI - 10.1634/theoncologist.2016-0296
Subject(s) - cabazitaxel , medicine , taxane , docetaxel , oncology , clinical endpoint , population , cancer , prostate cancer , randomized controlled trial , breast cancer , androgen deprivation therapy , environmental health
Lessons LearnedCabazitaxel 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.