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Title: SWOG S0722: phase II study of mTOR inhibitor everolimus (RAD001) in advanced malignant pleural mesothelioma (MPM).

Authors: Ou, Sai-Hong Ignatius; Moon, James; Garland, Linda L; Mack, Philip C; Testa, Joseph R; Tsao, Anne S; Wozniak, Antoniette J; Gandara, David R

Published In J Thorac Oncol, (2015 Feb)

Abstract: INTRODUCTION: The PI3K/Akt/mammalian target of rapamycin pathway is activated in a majority of malignant pleural mesotheliomas (MPM). We evaluated the activity of everolimus, an oral mammalian target of rapamycin inhibitor, in patients with unresectable MPM. METHODS: MPM patients who had received at least one but no more than two prior chemotherapy regimens, which must have been platinum-based, were treated with 10 mg of everolimus daily. The primary endpoint was 4-month progression-free survival (PFS) by RECIST 1.1. RESULTS: A total of 59 evaluable patients were included in the analysis. The median duration of treatment was 2 cycles (56 days). Overall response rate was 2% [95% confidence interval (CI): 0-12%] by RECIST 1.1 and 0% (0-10%) by modified RECIST for MPM. The 4-month PFS rate was 29% (95% CI: 17-41%) by RECIST 1.1, and 27% (95% CI: 16-39%) by modified RECIST. The median PFS was 2.8 months (95% CI: 1.8-3.4) by RECIST 1.1. The median overall survival was 6.3 months (95% CI: 4.0-8.0). There was no difference in PFS among patients who received one or two prior chemotherapy regimens (p = 0.74). There was no difference in overall survival between patients with epithelioid histology versus other types (p = 0.47). The most common toxicities were fatigue (59%), hypertriglyceridemia (44%), anemia (42%), oral mucositis (34%), nausea (32%), and anorexia (32%). The most common grade 3 to 4 toxicities were fatigue (10.2%), anemia (6.8%), and lung infection (6.8%). CONCLUSION: Everolimus has limited clinical activity in advanced MPM patients. Additional studies of single-agent everolimus in advanced MPM are not warranted.

PubMed ID: 25611229 Exiting the NIEHS site

MeSH Terms: Aged; Aged, 80 and over; Antineoplastic Agents/therapeutic use*; Disease-Free Survival; Everolimus; Female; Humans; Lung Neoplasms/drug therapy*; Lung Neoplasms/pathology; Male; Mesothelioma, Malignant; Mesothelioma/drug therapy*; Mesothelioma/pathology; Middle Aged; Pleural Neoplasms/drug therapy*; Pleural Neoplasms/pathology; Sirolimus/analogs & derivatives*; Sirolimus/therapeutic use; TOR Serine-Threonine Kinases/antagonists & inhibitors

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