Amrubicin hydrochloride for relapsed small-cell lung cancer

Introduction: Despite small-cell lung cancer often being very sensitive to chemotherapy treatment, duration of response is often short-lived in patients who are diagnosed with extensive disease at the onset. To improve survival in these patients and provide alternative treatment options, new chemotherapeutic agents have been evaluated, including amrubicin, a recent second-line treatment for patients with relapsed small-cell lung cancer. Areas covered: The authors reviewed the pharmacodynamics and pharmacokinetics of amrubicin and evaluated it versus other currently available chemotherapeutic agents. Existing Phases I, II, and III clinical data were reviewed. In Phase I trials, amrubicin was shown to be a safe and tolerable agent. Results from Phase II studies appeared promising, suggesting that patients treated with amrubicin had a better overall response rate and a longer progression-free survival versus topotecan. Unfortunately, the randomized Phase III trial, designed to definitively compare amrubicin to topotecan as second-line treatment for relapsed small-cell lung cancer, failed to show an improvement in overall survival. Expert opinion: Options for second-line therapy in relapsed small-cell lung cancer continue to be limited. The current role of amrubicin remains uncertain, and predictive biomarkers may be necessary to better establish its role. Further basic and clinical research studies are needed to expand treatment options and improve overall survival in patients with relapsed small-cell lung cancer.