Clinical response to trimetrexate as sole therapy for nonsmall cell lung cancer.

Trimetrexate glucuronate was evaluated in 70 nonsmall cell lung cancer patients with incurable disease and/or demonstrated progression following surgery/radiotherapy and no prior cytotoxic chemotherapy. Trimetrexate was initially administered at 8 mg/m2 intravenously (IV) daily for 5 days and repeated every 3 to 4 weeks with dose adjustments depending on patient tolerance. A median of two courses of trimetrexate therapy was administered (range 1 to 12). Fifty-nine (84%) patients were evaluable for response. Eleven patients (19%) achieved a partial response with a median duration of 15.3 weeks. The median time to response was 4.6 weeks. Twenty-three patients (39%) had stable disease with a median time to progression of 15.7 weeks. The median survival for evaluable patients was 26.4 weeks. Trimetrexate was well tolerated with manageable myelosuppression as the dose limiting toxicity. Trimetrexate was shown to have activity in nonsmall cell lung cancer.