DUBLINHarnessing MIC chemotherapy to radiotherapy is more effective than radiotherapy alone in patients with locally advanced inoperable non-small-cell lung cancer (NSCLC), according to the findings of a multicenter randomized UK trial reported at the 8th World Conference on Lung Cancer.
In addition, a companion trial has shown that the MIC regimen, which combines mitomycin(Drug information on mitomycin) (Mutamycin), ifosfa-mide (Ifex), and cisplatin(Drug information on cisplatin) (Platinol), represents a life-prolonging alternative to palliative care in patients with extensive disease.
These studies extend and confirm the results of an earlier phase II trial that spotlighted the high response rate and low toxicity of the MIC regimen.
The first of the MIC trials assigned 461 patients with locally advanced, inoperable NSCLC to receive either standard radical radiotherapy, at least 40 Gy in 15 fractions, or four courses of MIC (mitomycin, 6 mg/m2, plus ifosfamide(Drug information on ifosfamide), 3 mg/m2, plus cisplatin, 50 mg/m2 IV every 21 days) followed by radiotherapy. All trial enrollees were 75 years of age or younger and had a WHO performance status of 0, 1, or 2.
Nearly two thirds of patients received all four courses of chemotherapy, reported investigator Michael Cullen, MD, of Queen Elizabeth Hospital, Birmingham. In addition, he noted that 87% of courses could be given without delay, suggesting good patient tolerance. Similarly, two thirds of participants in both study arms completed radical radiotherapy.
The pairing of MIC and radiotherapy significantly improved the response rate relative to radical radiotherapy alone, Dr. Cullen said. Combined therapy yielded a complete response rate of 20% and an overall objective response rate of 56%, whereas radiotherapy alone achieved a complete response in only 9% of patients, with an overall response of 46%.
Median survival was 11.7 months in the chemotherapy plus radiotherapy group, compared with 9.7 months in the radiotherapy alone group (see table). The difference reached borderline significance when deaths unrelated to the disease or treatment were excluded, he said.
MIC Plus Palliative Care
In the second MIC study, 359 patients with extensive NSCLC and good performance status were randomized to receive either standard palliative care alone or four courses of MIC plus palliative care. In this trial, half the study participants received their full four courses, with delays documented for only 9% of courses. Dr. Cullen stressed that the intensity of nonchemotherapeutic palliation was identical in both study groups.
More than a third of patients showed at least a partial response to MIC, Dr. Cullen said, and median survival was significantly longer in the chemotherapy arm than in the palliative care group (6.7 months vs 4.8 months, P = .03). At one year, 28% of MIC-treated patients were still alive, compared with 18% of patients who received palliation only.
Further trials may not be necessary, Dr. Cullen said, emphasizing that this conclusion is reinforced by quality of life data collected in the study.