Randomized Trial of Early Versus Late Alternating Radiotherapy/ Chemotherapy in Limited-Disease Patients with Small Cell Lung Cancer

Lee, Chang Geol; Kim, Joo Hang; Kim, Sung Kyu; Kim, Sei Kyu; Kim, Gwi Eon; Suh, Chang Ok

Abstract

PURPOSE: A randomized prospective study was conducted to compare the efficacy of early or late alternating schedules of radiotherapy, and carboplatin and ifosfamide chemotherapy in patients with limited-disease small cell lung cancer.
MATERIALS AND METHODS
From August 1993 to August 1996, a total of 44 patients with newly diagnosed, limited-disease small cell lung cancer, PS H0~2, wt loss<10% were enrolled in a randomized trial which compared early alternating radiotherapy (RT)/chemotherapy (CT) and late alternating RT/CT. The CT regimen included ifosfamide 1.5 g/m(2) IV, d1-5 and carboplatin AUC 5/d IV, d2 performed at 4 week intervals for a total of 6 cycles. RT (54 Gy/30 fr) was started after the first cycle of CT (early arm, N=22) or after the third cycle of CT (late arm, N=22) with a split course of treatment.
RESULTS
The pretreatment characteristics between the two arms were well balanced. The response rates in the early (86%) and late (85%) arm were similar. The median survival durations and 2-year survival rates were 15 months and 22.7% in the early arm, and 17 months and 14.9% in the late arm ( p=0.47 by the log-rank test). The two-year progression free survival rates were 19.1% in the early arm and 19.6% in the late arm ( p=0.52 by the log-rank test). Acute grade 3 or 4 hematologic and nonhematologic toxicities were similar between the two arms. Eighteen patients (82%) completed 6 cycles of CT in the early arm and 17 (77%) in the late arm. Four patients received less than 45 Gy of RT in the early arm and two in the late arm. There was no significant difference in the failure patterns. The local failure rate was 43% in the early arm and 45% in the late arm. The first site of failure was the brain in 24% of the early arm patients compared to 35% in the late arm (p=0.51).
CONCLUSION
There were no statistical differences in the overall survival rate and the pattern of failure between the early and late alternating RT/CT in patients with limited-disease small cell lung cancer.