Results of a phase II protocol for evaluation of new chemotherapeutic regimens in patients with inoperable non-small cell lung carcinoma (EST-2575, generation I).

Two hundred and eighty-four patients with inoperable non-small cell lung carcinoma were randomized by the Eastern Cooperative Oncology Group to receive one of seven primary chemotherapy regimens: cyclophosphamide and methotrexate; Baker's antifol; vincristine, bleomycin, and methotrexate; melphalan; cyclophosphamide and CCNU (control arm); 5-FU procarbazine; and hexamethylmelamine, doxorubicin, and methotrexate (HAM). Patients with disease progression were eligible for treatment with VM-26 or ascorbic acid. HAM resulted in higher response rates than cyclophosphamide and CCNU in patients with adenocarcinoma (32%) and large cell carcinoma (23%). It was not tested in patients with squamous cell carcinoma. In terms of survival, HAM was significantly better than cyclophosphamide and CCNU in patients with limited disease. Its toxicity was predominantly hematologic and gastrointestinal. This regimen is being further evaluated by the Eastern Cooperative Oncology Group in patients with inoperable non-small cell lung carcinoma. Crossover therapy with VM-26 or ascorbic acid had no therapeutic benefit.

RCT Entities:   Population Interventions Outcomes