A randomized phase II trial of amonafide or trimetrexate in patients with advanced non-small cell lung cancer. A trial of the North Central Cancer Treatment Group.

BACKGROUND

In an effort to identify new active chemotherapeutic agents against non-small cell lung cancer (NSCLC), the authors conducted a randomized Phase II trial to evaluate the efficacy of amonafide or trimetrexate in patients with Stage IV disease.

METHODS

This was a multicenter Cooperative Oncology Group trial. All patients had advanced NSCLC and were previously untreated with chemotherapy. Patients were randomized to treatment after enrollment. Amonafide was administered as a 24-hour continuous infusion (1600 mg/m2) every 21 days. Trimetrexate (150 mg/m2) was administered intravenously over 30 minutes every 2 weeks. The primary endpoints of the study were clinical response and toxic effects. All patients were observed for survival.

RESULTS

Thirty-five patients received amonafide and were assessable. There were no complete responses and two partial responses (6%). Thirty-seven patients were treated with trimetrexate. There were no complete responses and five (14%) partial responses. Myelosuppression was the primary toxic effect observed with amonafide treatment. Trimetrexate was associated infrequently with clinically significant side effects.

CONCLUSIONS

Amonafide is inactive against NSCLC, and no additional studies with this agent are planned. Trimetrexate has some activity against NSCLC, but its role in the future therapy of this disease is questionable.