Clinical Research Papers:
Cabazitaxel in recurrent/metastatic squamous cell carcinoma of the head and neck: phase II UNICANCER trial ORL03
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Jerome Fayette1, Joel Guigay2,3, Christophe Le Tourneau4,5, Marian Degardin6, Frederic Peyrade3, Eve-Marie Neidhardt1, Marie-Paule Sablin4, Caroline Even2, Florence Orlandini7, Béata Juzyna8 and Carine Bellera9
1 Léon Bérard Center, University of Lyon, Lyon, France
2 Gustave Roussy Institute, Villejuif, France
3 Antoine Lacassagne Center, Nice, France
4 Institut Curie, Saint-Cloud & Paris, France
5 EA7285, Versailles-Saint-Quentin-en-Yvelines University, Montigny-le-Bretonneux, France
6 Oscar Lambret Center, Lille, France
7 Paul Strauss Center, Starsbourg, France
8 H&N Unicancer Group, Paris, France
9 Bergonié Institute, Clinical and Epidemiological Research Unit & INSERM U897 & Data Center for Cancer Clinical Trials, Bordeaux, France
Jérôme Fayette, email:
Keywords: Cabazitaxel, head and neck cancer, recurrent, platinum failure
Received: August 25, 2016 Accepted: January 23, 2017 Published: March 04, 2017
Treatments are limited after platinum Cetuximab or anti-PD1 failure for patients with recurrent/metastatic head and neck squamous cell carcinoma. Cabazitaxel has increased overall survival in hormone-refractory metastatic prostate cancer after failure of Docetaxel. Our aim was to detect a signal of activity with Cabazitaxel in patients with head and neck cancer who had failed platinum-, Cetuximab- and taxanes-based chemotherapy.
This multicenter phase II trial included progressive patients with an ECOG ≤2. Cabazitaxel was given at 25 mg/m²/3 weeks (maximum of 10 cycles), with growth factors support. Efficacy was centralized and assessed every 6 weeks. The primary endpoint was control rate at six-weeks. A Simon’s two-stage optimal design (P0=0.10; P1=0.30) required 29 evaluable patients. At the end of trial, at least 6 non-progressions were required to consider the drug worthy of further study.
Out of the 31 enrolled patients, 29 were eligible; 42% had received at least three previous lines of chemotherapy. For the primary end point, 8 patients (27.6%; 95%CI 12.7%-47.2%) had a stable disease at six weeks. Median progression-free survival was 1.05 months (95%CI 0.69-2.07). All patients were analyzed for toxicity: 6 patients had febrile neutropenia.
During the 81 cycles administered, 49 grade 3-5 events were observed concerning 81% of the patients, including 35 severe adverse events of which 15 were related to Cabazitaxel.
Although Cabazitaxel met its primary endpoint to deserve further investigations, its toxicity makes it difficult to use in frail patients and new schemes are needed (20 mg/m2 for example) if further investigations are launched.
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