Background: There is not more treatment selection for advanced nonsmall-cell lung cancer (NSCLC) patients who had disease progression after two previous treatments. Everolimus is an oral inhibitor of the mammalian target of rapamycin pathway, which is aberrantly activated in NSCLC.
Patients and methods: Stage IV NSCLC patients, with one or multiple prior chemotherapy regimens, received everolimus 5-10 mg/day with or without chemotherapy until progression or unacceptable toxicity. The primary objective were toxicity of everolimus and overall disease control rate (DCR).
Results: 22 patients were enrolled. Common ≥ grade 3 events were stomatitis, dyspnea, vomiting, thrombocytopenia. Overall disease control rate was 54.5% among 22 patients, 1 had a partial response, and 11 had disease stabilization. Common ≥ Grade 3 events were stomatitis, dyspnea, vomiting, and thrombocytopenia.
Conclusion: Everolimus was well tolerated, showing the modest clinical activity in heavily pretreated advanced NSCLC.