title: 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.
abstract: 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.
authors.affiliation: Department of Medicine, Institut Gustave-Roussy, Villejuif Cedex, France. faivres@aol.com
authors.forename: Sandrine
authors.initials: S
authors.lastname: Faivre
authors.forename: Hassan
authors.initials: H
authors.lastname: Alsabe
authors.forename: Latifa
authors.initials: L
authors.lastname: Djafari
authors.forename: François
authors.initials: F
authors.lastname: Janot
authors.forename: Morbize
authors.initials: M
authors.lastname: Julieron
authors.forename: Christian
authors.initials: C
authors.lastname: Domenge
authors.forename: Kamel
authors.initials: K
authors.lastname: Djazouli
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Armand
authors.forename: Bernard
authors.initials: B
authors.lastname: Luboinski
authors.forename: Eric
authors.initials: E
authors.lastname: Raymond
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000556:secondary; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*
chemical_list: D000903:Antibiotics, Antineoplastic; D004317:Doxorubicin