Caelyx in malignant mesothelioma: a phase II EORTC study.

Area of Science:

• Oncology
• Pharmacology

Background:

• Doxorubicin shows activity in malignant mesothelioma but causes cardiotoxicity.
• Caelyx, a pegylated liposomal formulation of doxorubicin, offers improved pharmacokinetics and a better toxicity profile.
• This study evaluated Caelyx in chemotherapy-naive malignant pleural mesothelioma patients.

Purpose of the Study:

• To assess the efficacy and toxicity of Caelyx in patients with malignant pleural mesothelioma.

Main Methods:

• A phase II study included 33 patients with measurable or evaluable malignant pleural mesothelioma.
• Caelyx (45 mg/m2) was administered intravenously every four weeks for up to nine cycles.
• Treatment continued until disease progression or unacceptable toxicity.

Main Results:

• Two partial responses (6%) were observed among 31 evaluable patients, with a median survival of 13 months.
• The most common toxicity was palmar plantar erythrodysesthesia (62% grade 1-2, 6% grade 3).
• Grade 3 anemia and thrombocytopenia occurred in 10% and 3% of patients, respectively; cardiac toxicity was rare and not drug-related.

Conclusions:

• Single-agent Caelyx at the studied dose is well-tolerated in chemotherapy-naive mesothelioma patients.
• The observed activity of Caelyx as a single agent does not support further investigation in this patient population.