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A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer.

Sun, J M; Kim, J R; Do, I G; Lee, S Y; Lee, J; Choi, Y L; Ahn, J S; Ahn, M J; Park, K.
Br J Cancer; 109(6): 1482-7, 2013 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-23963141

BACKGROUND:

The mammalian target of rapamycin (mTOR) pathway is dysregulated in small-cell lung cancer (SCLC) and everolimus is an oral mTOR inhibitor.

METHODS:

This phase-1b study assessed everolimus safety at the levels of 2.5, 5, or 10 mg once daily in combination with paclitaxel (175 mg m(-2)) once every 3 weeks in previously treated SCLC patients. The primary end point was to determine the maximum tolerated dose of everolimus.

RESULTS:

Among 21 enrolled patients, common drug-related adverse events were anaemia, neutropenia, thrombocytopenia, pain, hyperglycemia, and stomatitis. Out of 11 evaluable patients treated with everolimus at the level of 5 mg, 1 patient experienced dose-limiting toxicity (DLT) of grade 4 febrile neutropenia and grade 3 thrombocytopenia. The other two DLTs (grade 4 thrombocytopenia and grade 3 hyperglycemia) occurred in two out of three patients receiving everolimus 10 mg. The overall objective response rate was 28%.

CONCLUSION:

Everolimus showed an acceptable safety profile and preliminary antitumour activity at the dose of 5 mg once daily when combined with 3-weekly paclitaxel 175 mg m(-2) in patients with SCLC.
Selo DaSilva