Originally published as JCO Early Release 10.1200/JCO.2008.20.3943 on April 13 2009

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Multicenter Phase II Trial of Neoadjuvant Pemetrexed Plus Cisplatin Followed by Extrapleural Pneumonectomy and Radiation for Malignant Pleural Mesothelioma

From the Memorial Sloan-Kettering Cancer Center; New York University School of Medicine, New York, NY; University of Chicago, Chicago, IL; Brigham and Women's Hospital, Boston, MA; University of Pennsylvania Medical Center, Philadelphia, PA; The University of Texas M. D. Anderson Cancer Center, Houston, TX; Eli Lilly, Indianapolis, IN; and Nevada Cancer Institute, Las Vegas, NV.

Corresponding author: Lee M. Krug, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, Box 327, New York, NY 10065; e-mail: krugl{at}mskcc.org.

Purpose Neoadjuvant pemetrexed plus cisplatin was administered, followed by extrapleural pneumonectomy (EPP) and hemithoracic radiation (RT), to assess the feasibility and efficacy of trimodality therapy in stage I to III malignant pleural mesothelioma.

Patients and Methods Requirements included stage T1-3 N0-2 disease, no prior surgical resection, adequate organ function (including predicted postoperative forced expiratory volume in 1 second 35%), and performance status 0 to 1. Patients received pemetrexed 500 mg/m² plus cisplatin 75 mg/m² for four cycles. Patients without disease progression underwent EPP followed by RT (54 Gy). The primary end point was pathologic complete response (pCR) rate.

Results Seventy-seven patients received chemotherapy. All four cycles were administered to 83% of patients. The radiologic response rate was 32.5% (95% CI, 22.2 to 44.1). Fifty-seven patients proceeded to EPP, which was completed in 54 patients. Three pCRs were observed (5% of EPP). Forty of 44 patients completed irradiation. Median survival in the overall population was 16.8 months (95% CI, 13.6 to 23.2 months; censorship, 33.8%). Patients completing all therapy had a median survival of 29.1 months and a 2-year survival rate of 61.2%. Radiologic response of complete or partial response was associated with a median survival of 26.0 months compared with 13.9 months for patients with stable disease or progressive disease (P = .05).

Conclusion This multicenter trial showed that trimodality therapy with neoadjuvant pemetrexed plus cisplatin is feasible with a reasonable long-term survival rate, particularly for patients who completed all therapy. Radiologic response to chemotherapy, but not sex, histology, disease stage, or nodal status, was associated with improved survival.

Supported by Eli Lilly.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL; and 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00087698 [ClinicalTrials.gov] .

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