J Guigay1, J Fayette2, A F Dillies3, C Sire4, J N Kerger5, I Tennevet6, J P Machiels7, S Zanetta8, Y Pointreau9, L Bozec Le Moal10, S Henry11, A Schilf12, J Bourhis13. 1. Department of Medical Oncology, Centre Antoine Lacassagne, Nice; Gustave Roussy, UMR 8126/CNRS, Villejuif. Electronic address: joel.guigay@nice.unicancer.fr. 2. Department of Medical Oncology, University of Lyon, Centre Léon Bérard, and Hospices Civils de Lyon, Lyon. 3. Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand. 4. Department of Medical Oncology, Hôpital Bretagne Sud, Lorient, France. 5. Department of Medical Oncology, CHU Dinant Godinne UCL, Namur, Belgium. 6. Department of Medical Oncology, Centre Henri Becquerel, Rouen, France. 7. Department of Medical Oncology, Institut Roi Albert II, Cliniques Universitaires St-Luc and Institut de Recherche Clinique et Expérimentale (Pôle Miro), Université Catholique de Louvain, Brussels, Belgium. 8. Department of Medical Oncology, Centre Georges François Leclerc, Dijon. 9. Department of Medical Oncology, CHRU de Tours, Tours. 10. Department of Medical Oncology, Institut Curie-Hôpital René Huguenin, Saint-Cloud, France. 11. Department of Medical Oncology, Clinique Sainte-Elisabeth, Namur, Belgium. 12. Department of Head and Neck Oncology, Gustave Roussy, Villejuif, France. 13. GORTEC, Lausanne, Switzerland.
Abstract
BACKGROUND: Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab and taxane combinations have shown promising activity. This study evaluated the efficacy and safety of four cycles of docetaxel associated with cisplatin and cetuximab (TPEx), followed by maintenance with cetuximab every 2 weeks. PATIENTS AND METHODS: Patients with a histologically confirmed HNSCC with metastasis or recurrence unsuitable for locoregional curative treatment received docetaxel and cisplatin (75 mg/m(2) both) at day 1 and weekly cetuximab 250 mg/m(2) (loading dose of 400 mg/m(2)), repeated every 21 days for four cycles, followed by maintenance cetuximab 500 mg/m(2) every 2 weeks until progression or unacceptable toxicity. Prophylactic administration of granulocyte colony-stimulating factor was done systematically after each chemotherapy cycle. Patients had a good general status (performance status ≤1) and were under 71 years. Prior total doses of cisplatin exceeding 300 mg/m(2) were not allowed. The primary end point was objective response rate (ORR) after four cycles. RESULTS: Fifty-four patients were enrolled. The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3-17.3) and 6.2 months (95% CI 5.4-7.2). The most common grade 3/4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). There were one pulmonary embolism and two infectious events leading to death. CONCLUSIONS: The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. Further studies are needed to compare the TPEx versus EXTREME regimen in this population. CLINICALTRIALGOV: NCT01289522.
BACKGROUND: Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab and taxane combinations have shown promising activity. This study evaluated the efficacy and safety of four cycles of docetaxel associated with cisplatin and cetuximab (TPEx), followed by maintenance with cetuximab every 2 weeks. PATIENTS AND METHODS: Patients with a histologically confirmed HNSCC with metastasis or recurrence unsuitable for locoregional curative treatment received docetaxel and cisplatin (75 mg/m(2) both) at day 1 and weekly cetuximab 250 mg/m(2) (loading dose of 400 mg/m(2)), repeated every 21 days for four cycles, followed by maintenance cetuximab 500 mg/m(2) every 2 weeks until progression or unacceptable toxicity. Prophylactic administration of granulocyte colony-stimulating factor was done systematically after each chemotherapy cycle. Patients had a good general status (performance status ≤1) and were under 71 years. Prior total doses of cisplatin exceeding 300 mg/m(2) were not allowed. The primary end point was objective response rate (ORR) after four cycles. RESULTS: Fifty-four patients were enrolled. The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3-17.3) and 6.2 months (95% CI 5.4-7.2). The most common grade 3/4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). There were one pulmonary embolism and two infectious events leading to death. CONCLUSIONS: The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. Further studies are needed to compare the TPEx versus EXTREME regimen in this population. CLINICALTRIALGOV: NCT01289522.
Authors: I Pajares Bernad; J Martínez Trufero; L Calera Urquizu; R A Pazo Cid; A Cebollero de Miguel; M J Agustin; M Lanzuela; A Antón Journal: Clin Transl Oncol Date: 2017-01-24 Impact factor: 3.340