The long-term results of a pilot study of three times a day radiotherapy and escalating doses of daily cisplatin for locally advanced non-small-cell lung cancer

Purpose: This analysis was performed to determine the long-term results of a Phase I trial that included 3-times-a-day radiotherapy (TIDRT) and concurrent daily cisplatin (CDDP) for Stage III non-small-cell lung cancer. Methods and Materials: Twenty patients with Stage III non-small-cell lung cancer were treated with TIDRT delivered over 12 weekdays that included 57.6 Gy administered in 1.5 Gy fractions at 8 a.m. and 4 p.m., and 1.8 Gy fractions at noon. AP-PA fields were used at 8 a.m. and 4 p.m. Opposed oblique off cord fields were used at noon. The first 5 patients were given no CDDP, the second 5 patients received 5 mg/m² of CDDP, and the remaining 10 patients received 7.5 mg/m² of CDDP. All survivors were followed for greater than 5 years. Results: The maximum tolerated dose of daily CDDP during this program of radiation therapy was 7.5 mg/m². None of the patients died as a result of toxicity. The median survival was 19.2 months, and the 5-year survival rate was 25%. Tumor response and patterns of failure were also evaluated. Conclusions: This study was performed to determine the maximum tolerated dose of CDDP when administered daily during an aggressive program of TIDRT. The survival results were promising, suggesting that the combination of TIDRT and systemic therapy deserves further study.