A phase II trial of alternating chemotherapy in patients with inoperable non-small cell lung cancer

We assessed the efficacy and toxicity of alternating non-cross-resistant chemotherapy in the treatment of advanced NSCLC. Cycles of cisplatin, methotrexate, doxorubicin, and cyclophosphamide were alternated monthly with cisplatin and etoposide. Patients had measurable disease, ECOG performance status 0-3, no previous chemotherapy, and stage II (inoperable), III, or IV disease without brain metastases. Between 1988 and 1990, 28 patients were entered in the study: 20 patients (71%) had stage IV disease, 19 (68%) were evaluable for response and toxicity; 4 (21%) responded. There were 3 partial responders (16%) and 1 complete responder (5%). The mean duration of response was 60.5 weeks (range: 32-105+ weeks), and the median time to progression was 12 weeks (range: 8-105+ weeks). The median survival time for all 28 patients was 24 weeks (range: 3-153+ weeks). The most significant toxicity was grade 3-4 leukopenia experienced by 63% of patients, but there were no episodes of sepsis and no treatment-related deaths. This regimen of alternating cycles of cisplatin-containing chemotherapy is safe, but its efficacy is not superior to other combination chemotherapy regimens.