Result of two randomized trials comparing nolatrexed (Thymitaq™) versus methotrexate in patients with recurrent head and neck cancer
| Autor: | A. Johnston, C. Domenge, N. Clendeninn, S. Wadler, C. Penning, Y. Humblet, D. Belpomme, C. Kelly, J. Stern, J. Tortochaux, X. Pivot, M. Schneider, R. Ruxer |
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| Rok vydání: | 2001 |
| Předmět: |
Adult
Diarrhea Male Antimetabolites Antineoplastic medicine.medical_specialty Neutropenia medicine.medical_treatment Gastroenterology chemistry.chemical_compound Internal medicine Mucositis Humans Medicine Enzyme Inhibitors Aged Aged 80 and over Chemotherapy business.industry Thymidylate Synthase Hematology Middle Aged medicine.disease Chemotherapy regimen Surgery Methotrexate Treatment Outcome Oncology chemistry Epidermoid carcinoma Head and Neck Neoplasms Carcinoma Squamous Cell Quinazolines Nolatrexed Female Neoplasm Recurrence Local business Febrile neutropenia medicine.drug |
| Zdroj: | Annals of Oncology. 12:1595-1599 |
| ISSN: | 0923-7534 |
| Popis: | We report on two randomized trials performed in the USA and Europe, which compared methotrexate and nolatrexed as treatment for patients with recurrent head and neck cancer. Eligibility criteria included: histologically confirmed squamous-cell carcinoma, measurable disease, adequate hematological, renal and hepatic functions, failure of a first-line chemotherapy, and informed consent. Methotrexate 40 mg/m(2) was weekly given by short infusion, and nolatrexed 725 mg/m(2) per day was administered as a five-day continuous infusion, every three weeks. A total of 139 patients (63 in the USA, 76 in Europe) were randomized based on a ratio of 2/1: 93 and 46 received nolatrexed and methotrexate, respectively. Patient characteristics included 115 males and 24 females; median age 60 years. In the nolatrexed arm, the following grade 3-4 toxicities occurred: neutropenia (29.9%) with 3.1% of febrile neutropenia, mucositis (33.3%), and vomiting (10.3%). In the MTX arm, the grade 3-4 toxicities were neutropenia (7.1%) and mucositis (6.9%). There was no difference in activity between the nolatrexed and the methotrexate treatment: 3.3% and 10.8% of objective responses, 1.9 versus 1.5 months of disease-free progression and 3.5 versus 3.7 months of overall survival, respectively. Nolatrexed has demonstrated a similar activity to methotrexate. |
| Databáze: | OpenAIRE |
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