Trials with mitomycin, ifosfamide and cisplatin in non-small cell lung cancer

In 1988, we reported a Phase II study of mitomycin, ifosfamide and cisplatin (MIC) in inoperable non-small cell lung cancer. The overall objective response rate was 56% in 66 evaluable cases. An improvement in performance status was observed in responding patients and toxicity was acceptable. Consequently we then embarked upon two major, multicentre randomised trials to test this regimen in cases with localised disease (MIC 1--chemotherapy plus radical radiotherapy versus radical radiotherapy alone) and advanced disease (MIC 2--chemotherapy plus palliative care versus palliative care alone). These trials are still in progress with targets of 500 and 300 randomised cases, respectively. The present interim analysis is based on 317 cases randomised in MIC 1 and 193 in MIC 2. The overall response rate (CR + PR) in the MIC 1 trial is 52% with 10% CRs and in the MIC 2 trial is 42% with 5% CRs. Formal symptomatic assessments are monitored in both trials and the present interim analysis indicates symptom improvement in cases randomised to chemotherapy, including patients who fail to achieve an objective PR or CR. Other Phase II studies employing MIC are also reviewed.