期刊
JOURNAL OF THORACIC ONCOLOGY
卷 10, 期 2, 页码 387-391出版社
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/JTO.0000000000000360
关键词
Malignant pleural mesothelioma; mTOR inhibitor; Everolimus; Modified RECIST
资金
- National Cancer Institute, DHHS [CA32102, CA38926, CA105409, CA14028, CA13612, CA58723, CA35090, CA63848, CA45808, CA27057, CA45377, CA42777, CA67575, CA86780, CA11083, CA45807, CA35261, CA20319, CA76462, CA16385, CA77429, CA114047]
- Novartis Pharmaceuticals, Inc.
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.
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