Phase II study of raltitrexed ('Tomudex') for patients with advanced soft tissue sarcomas refractory to doxorubicin-containing regimens

Advanced soft tissue sarcomas (ASTS) refractory to therapy with doxorubicin and/or ifosfamide are highly resistant to therapy with other cytotoxic age nts,The efficacy and safety of raltitrexed ('Tomudex') was assessed in pati ents with ASTS refractory to one or two doxorubicin- and/or ifosfamide-cont aining regimens in eight centers of the EORTC STBSG group, Raltitrexed was given at 3 mg/m(2) as a 15 min i.v. infusion once every 3 weeks. Among the 23 patients [mean age 54 (range 25-73) years] included, 22 patients (15 mal es and seven females) were eligible and evaluable for response to therapy a nd 21 were evaluable for toxicity, Patients had previously received chemoth erapy in metastatic phase (n=16), as adjuvant treatment (n=5) or both (n=1) , The primary tumor was located in the trunk (n=11), in the limbs (n=8) or in the head and neck (n=3). Most patients (n=13) received two courses of ra ltitrexed (range 1-8),The best response was stable disease in five (23%) pa tients, while disease progression was noted in 17 patients (77%); the media n time to disease progression was 6 weeks. The treatment was well tolerated with only one patient experiencing grade 4 neutropenia and thrombocytopeni a, one patient experiencing grade 3 nausea, one lethargy, one headache, and one asthenia, Only one patient experienced febrile neutropenia, Raltitrexe d as monotherapy is not an effective treatment for patients with ASTS who f ailed conventional chemotherapy with doxorubicin and ifosfamide. [(C) 1999 Lippincott Williams & Wilkins.].