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Multicenter phase II trial of neoadjuvant pemetrexed plus cisplatin followed by extrapleural pneumonectomy and radiation for malignant pleural mesothelioma
Journal of Clinical Oncology, 06/24/09
Krug LM et al. - In a study to assess the use of neoadjuvant pemetrexed plus cisplatin followed by extrapleural pneumonectomy (EPP) and hemithoracic radiation (RT) in stage I to III malignant pleural mesothelioma, it was shown that trimodality therapy is feasible with a reasonable long-term survival rate, particularly for pts who completed all therapy. Radiologic response to chemotherapy, but not sex, histology, disease stage, or nodal status, was associated with improved survival.
Methods- Requirements included stage T1-3 N0-2 disease, no prior surgical resection, adequate organ function (including predicted postoperative forced expiratory volume in 1 sec 35%), and performance status 0 to 1.
- Pts received pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 for 4 cycles.
- Pts without disease progression underwent EPP followed by RT (54 Gy).
- The primary endpoint was pathologic complete response (pCR) rate.
- 77 pts received chemotherapy.
- All 4 cycles were administered to 83% of pts.
- Radiologic response rate was 32.5%.
- 57 pts proceeded to EPP, which was completed in 54 pts.
- 3 pCRs were observed (5% of EPP).
- 40 of 44 pts completed irradiation.
- Median survival in the overall population was 16.8 mos.
- Pnts completing all therapy had a median survival of 29.1 mos and a 2-yr survival rate of 61.2%.
- Radiologic response of complete or partial response was associated with median survival of 26.0 mos vs 13.9 mos for pts with stable disease or progressive disease.
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