Phase II Study of Consolidation Amrubicin After Concurrent Chemoradiotherapy in Patients With Limited-stage Small-cell Lung Cancer

Background: Concurrent chemoradiotherapy (CCRT) is the gold standard for limited-stage small-cell lung cancer (LS-SCLC); however, most patients inevitably experience relapse. We hypothesized consolidation amrubicin following CCRT to be a potential treatment for LS-SCLC. Patients and Methods: All enrolled patients were treated using induction CCRT consisting of four cycles of etoposide and cisplatin plus concurrent thoracic radiotherapy. Eligible patients then received three cycles of amrubicin as consolidation therapy ( consolidation population). The primary endpoint was the 2-year progression-free survival rate in the consolidation population. Results: Of the 36 intention-to-treat patients, 28 (78%) received amrubicin and 24 ( 67%) completed all planned treatments. The 2-year progression-free survival rate and overall response rate were 35.7% and 86%, respectively. The median progression-free and overall survival were 14.3 and 60.9 months, respectively. There were no treatment-related deaths in the intention-to-treat population. Conclusion: This study was terminated due to slow patient accrual; however, this treatment strategy was feasible and demonstrated promising efficacy.