Locoregional effects of pegylated liposomal doxorubicin (Caelyx) in irradiated area: a phase I-II study in patients with recurrent squamous cell carcinoma of the head and neck.

Aim of this study was to determine the antitumour activity and toxicity of pegylated liposomal doxorubicin (Caelyx) in pretreated patients with locally recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Caelyx was administrated as 1 h infusion every 3 weeks at doses of 35 mg/m2 (group A) and then subsequently given at 45 mg/m2 (group B). 26 patients received a total of 87 cycles. The median number of cycles was 3 (range 1-7). Four out of 24 evaluable patients (17%, 95% confidence interval (CI) 0.5-32%) showed significant evidence of antitumour activity, with tumour necrosis being observed in 2 patients. Grade 3-4 neutropenia was observed in only 2 patients. There were no grade 3-4 mucosal, skin, digestive, cardiac or hepatic toxicities. Caelyx has activity against locally recurrent SCCHN and is well tolerated up to 45 mg/m2, but a careful utilisation of this drug is required for tumours relapsing in irradiated areas.