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/㎡ Ⅳ, d1-5 and carboplatin AUC 5/d Ⅳ, d2 performed at 4 week intervals for a total of 6 cycles. RT (54 ㏉/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 ㏉ 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.