Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent and/orMetastatic Squamous Cell Carcinoma of the Head and Neck Previously treated With Platinum-Based Therapy

Machiels, Jean-Pascal;Van Maanen, Aline;Vandenbulcke , Jean-Marie;Filleul, Bertrand;Schoonjans, Joelle;et.al.
(2016) The Oncologist — Vol. 21, n° 12, p. 1416-e17 (2016)

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Authors
  • Machiels, Jean-PascalUCLouvain
    Author
  • Van Maanen, AlineUCLouvain
    Author
  • Vandenbulcke , Jean-Marie
    Author
  • Filleul, Bertrand
    Author
  • Henry, StéphanieUCLouvain
    Author
  • D'hondt, LionelUCLouvain
    Author
  • Schmitz, SandraUCLouvain
    Author
  • Gillain, AlineUCLouvain
    Author
  • Schoonjans, Joelle
    Author
  • et. al.
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Abstract
Background. Cabazitaxel is a second-generation taxane that improves the survival of patients with etastatic castrateresistant 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 patientswith 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/m2, increased to 25 mg/m2 for subsequent cycles in the absence of nonhematological adverse events [AEs] greater than grade 2 and hematological AEs greater than grade 3) or methotrexate (40mg/m2/week).Thepatientswere 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 58.0years(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 progressionfree survival was 1.9 months in both arms. The median overall survival was 5.0 and 3.6months 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 lowactivity in recurrent SCCHN.
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Machiels, J.-P., Van Maanen, A., Vandenbulcke, J.-M., Filleul, B., Seront, E., Henry, S., D’hondt, L., Lonchay, C., Holbrechts, S., Boegner, P., Brohee, D., Dequanter, D., Louviaux, I., Sautois, B., Whenham, N., Berchem, G., Vanderschueren, B., Fontaine, C., Schmitz, S., et al. (2016). Randomized Phase II Study of Cabazitaxel Versus Methotrexate in Patients With Recurrent and/orMetastatic Squamous Cell Carcinoma of the Head and Neck Previously treated With Platinum-Based Therapy. The Oncologist, 21(12), 1416-e17. https://doi.org/10.1634/theoncologist.2016-0296 (Original work published 2016)