ABSTRACT
PURPOSE: To evaluate prospectively the combination of radiotherapy with low doses of carboplatin given as radiosensitizer in patients with locally advanced non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients enrolled in this trial were randomly allocated in two groups. The study group consisted of 67 patients with stage IIIA/B NSCLC who were treated initially with a tumor dose (TD) of 30 Gy in 10 fractions, 5 fractions per weeks, in 2 weeks. Carboplatin was administered simultaneously as radiosensitizer at a dose of 20 mg/m(2) i.v. bolus just prior to each radiotherapy fraction. After a 2-week rest an additional 25 Gy were given in 10 fractions, with carboplatin as previously described. The total tumor dose (TTD) was 55 Gy (30+25 Gy) in 20 fractions in 6 weeks and the total dose of carboplatin was 600 mg. The study group was compared with a control group of 70 NSCLC patients who were treated with radical conventional radiotherapy (60 Gy in 30 fractions, 2 Gy per fraction, 5 fractions per week). RESULTS: Haematological toxicity and oesophagitis were statistically more often seen in the study group. There was no statistically significant difference in the response rate between the 2 groups (53.7% versus 62.8%). The 2-year survival was 27% in the study group and 33% in the control group (p >0.05). CONCLUSION: The results showed no response and survival benefit of concomitant chemoradiotherapy compared with conventional radiotherapy. We believe that further prospective, multicenter trials are required to evaluate the concurrent combination of new cytotoxic agents used as radiosensitizers with conventional radiotherapy or radiotherapy with different fractionation schedules and high-technology equipment which enables the application of higher tumor doses.
