MESOTHELIOMA CLINICAL TRIALS

Feasibility Of Induction Chemotherapy, Extrapleural Pneumonectomy (EPP), And Adjuvant Hemithoracic Radiation For Locally Advanced Malignant Pleural Mesothelioma (MPM).

The year was 2004 and the venue was Memorial Sloan-Kettering Cancer Center, New York, NY. The subject of the study was to examine the feasibility of effectiveness of Induction chemotherapy, extrapleural pneumonectomy (EPP), and adjuvant hemithoracic radiation for treating Malignant Pleural Mesothelioma (MPM) in its locally advanced state.

The background of the study was based on certain facts. Surgery had proved to be hopeless for approximately 25 percent of the patients suffering from malignant Pleural Mesothelioma. Patients with Stage III MPM had shown a median survival time of less than a year even after they had undergone an extrapleural pneumonectomy (EPP). This led the specialists to opt for Induction Chemotherapy followed by EPP and adjuvant hemithoracic radiation (RT) with the aim of assessing the feasibility of this treatment and estimating survival.

From Jan, 2002 to December, 2003 patients who had been detected T3-4 or N2 MPM via CT or PET scans were admitted for Phase II Clinical Trial. The Induction Therapy consisted of variable doses of Gemcitabine and Cisplatin. For Gemcitabine the dosage was : 1250mg/m2days 1, 8 and for Cisplatin it was : 75mg/m2 day 8 and this one was for 2.4 cycles. EPP followed the induction therapy after three weeks and then the patients underwent 54 Gy RT after 4-6 weeks of the surgery. After every three months, Ct scans were arranged and RECIST criteria were used to evaluate the Chemotherapy response. The overall survival was estimated by Kaplan-Meier.

No Grade 4 toxicity was found among 21 patients of which 15 were men with 60 as the median age. Of the 19 patients with epithelial and sarcomatoid types who received chemotherapy had to complete 4 cycles. 8-9 patients subjected to EPP faced to postoperative death. The patients were also treated with planned adjuvant RT. A survival rate of 75 percent at 18 months was observed among the patients treated with EPP.

It was concluded from observations that multimodality therapy can be well accepted to treat patients with MPM.


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