Browse by author
Lookup NU author(s): Dr Charles Kelly
Full text for this publication is not currently held within this repository. Alternative links are provided below where available.
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.
Author(s): Pivot X, Wadler S, Kelly C, Ruxer R, Tortochaux J, Stern J, Belpomme D, Humblet Y, Domenge C, Clendeninn N, Johnston A, Penning C, Schneider M
Publication type: Article
Publication status: Published
Journal: Annals of Oncology
Print publication date: 01/01/2001
ISSN (print): 0923-7534
ISSN (electronic): 1569-8041
Publisher: Oxford University Press
Altmetrics provided by Altmetric