Published in:
01-01-2006 | Original Article
Phase II study of temozolomide plus pegylated liposomal doxorubicin in the treatment of brain metastases from solid tumours
Authors:
Michele Caraglia, Raffaele Addeo, Raffaele Costanzo, Liliana Montella, Vincenzo Faiola, Monica Marra, Alberto Abbruzzese, Giovannella Palmieri, Alfredo Budillon, Francesco Grillone, Salvatore Venuta, Pierosandro Tagliaferri, Salvatore Del Prete
Published in:
Cancer Chemotherapy and Pharmacology
|
Issue 1/2006
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Abstract
Objective: A combination regimen of temozolomide (TMZ) and pegylated liposomal doxorubicin has been evaluated in the treatment of brain metastases from solid tumours. Study design: Nineteen consecutive patients (pts) have been enrolled in a prospective phase II trial and treated with TMZ 200 mg/m2 (days 1–5) and pegylated liposomal doxorubicin 35 mg/m2 (day 1) every 28 days. The study was prospectively projected according to the Simon’s two-stage optimal design. Results: Major toxicities have been grade III neutropenia and thrombocytopenia in one patient (pt) and grade III erythrodisesthesia in two pts. Three pts achieved a complete response (CR) and four a partial response (PR), for an overall response rate of 36.8% (95% CI: 19.1–59.2), which exceeded the target activity in the study design. A significant improvement in quality of life was demonstrated by FACT-G analysis. The median Progression Free Survival (PFS) was 5.5 (95% CI: 2.7–8.2) months while the median Overall Survival (OS) was 10.0 months (95% CI: 6.3–13.7). Conclusions: The TMZ/pegylated liposomal doxorubicin regimen was well tolerated with an encouraging activity in brain metastases from solid tumours.