Cabazitaxel in recurrent/metastatic squamous cell carcinoma of the head and neck: Phase II UNICANCER trial ORL03
| Autor: | Marie Paule Sablin, Béata Juzyna, Frederic Peyrade, Jérôme Fayette, Carine Bellera, Christophe Le Tourneau, Joël Guigay, Florence Orlandini, Caroline Even, Eve Marie Neidhardt, Marian Degardin |
|---|---|
| Přispěvatelé: | Centre Léon Bérard [Lyon], Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Risques cliniques et sécurité en santé des femmes et en santé périnatale (RISCQ), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, CRLCC Paul Strauss, UNICANCER - Centre Léon Bérard Lyon (Rhône), Epidemiologie-Biostatistique [Bordeaux], Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux Ségalen [Bordeaux 2], Université Lille Nord de France (COMUE)-UNICANCER |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
[SDV]Life Sciences [q-bio] 03 medical and health sciences 0302 clinical medicine Clinical endpoint medicine Basal cell 030212 general & internal medicine Head and neck Head and neck cancer Cabazitaxel Platinum failure business.industry General surgery medicine.disease 3. Good health Surgery Oncology 030220 oncology & carcinogenesis Clinical Research Paper business Recurrent Febrile neutropenia medicine.drug |
| Zdroj: | Oncotarget Oncotarget, 2017, 8 (31), pp.51830-51839. ⟨10.18632/oncotarget.15901⟩ Oncotarget, Impact journals, 2017, 8 (31), pp.51830-51839. ⟨10.18632/oncotarget.15901⟩ |
| ISSN: | 1949-2553 |
| Popis: | International audience; 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 nonprogressions 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|