Original article Phase II study of pegylated liposomal doxorubicin: Inactive in recurrent small-cell lung cancer A Hellenic Cooperative Oncology Group Study

Purpose: Although clinical experience with liposomal doxo-rubicin is still limited in solid tumours, single agent Caelyx (pegylated liposomal doxorubicin) treatment has shown promis-ing results in AIDS-related Kaposi's sarcoma, metastatic breast and ovarian cancer and anecdotally in other solid tumours. This is the first report of its use in small-cell lung cancer (SCLQ. The objective of this multicenter phase II study was to evaluate the safety, tolerance and anti-tumour activity of Caelyx as mono-therapy in patients with recurrent SCLC. Patients and methods: A total of 14 patients with recur-rent SCLC who had not received prior treatment with doxo-rubicin, were accrued into this phase II study. All patients had progressed or relapsed after first-line chemotherapy. All but one had achieved objective responses to first-line treatment with median duration of five months (range 2-18 months) bu