Assessment of Survival and Clinical Benefit in Malignant Pleural Mesothelioma (MPM) Patients Treated with Gemcitabine and Carboplatin.
OBJECTIVE
To evaluate the efficacy, safety, and clinical benefit of combined gemcitabine and carboplatin in patients with previously untreated malignant pleural mesothelioma (MPM).


METHODS
This prospective phase II study was performed on 42 eligible patients with histologically or cytologically proven MPM presenting to Ain Shams University hospitals and Sohag Cancer Center between January 2002 and April 2006. They were assigned to receive combined gemcitabine (1250mg/m2) on days, 1 and 8 and carboplatin (AUC 6) on day 1. The regimen was repeated every 21 days. The treatment continued until disease progression or intolerable drug toxicity.


RESULTS
The patients received a total of 227 cycles of chemotherapy (median 5.4 cycles and range from 2 to 9 cycles). The chemotherapy was generally well tolerated. Neutropenia, thrombocytopenia and anemia were the most severe (Grade 3 or 4) toxicities recorded during therapy and were reported in (14%), (9.5%), and (9.5%), respectively. Twelve patients (29%) achieved partial response, 18 patients (42%) had stable disease and the disease progressed in the remaining 12 patients (29%). The median follow-up duration was 11 months (range 5 from 20 months). The overall survival (OS) and progression free survival (PFS) at one year was 44.5% and 33.2%, respectively. The median survival and time to disease progression were 11 months and 8.5 months respectively. Of 32 patients assessed for clinical benefit, 20 patients (62.5%) were considered clinical benefit responders.


CONCLUSIONS
The combination of gemcitabine and carboplatin is a safe and tolerable treatment with reasonable response rate, OS, and PFS compared with the historical phase II single agents and combined chemotherapy studies in patients with MPM. Key Words: Mesothelioma , Gemcitbine , Carboplatin.
The Departments of Radiation Oncology&Nuclear Medicine, Ain Shams University.
Atef Yousef
AY
Ryad
Ehab
E
Mostafa
Dina A
DA
Salem
Eman Ramzy
ER
Al-Adwy
Maha
M
Margerges