[HTML][HTML] A phase-1b study of everolimus plus paclitaxel in patients with small-cell lung cancer
JM Sun, JR Kim, IG Do, SY Lee, J Lee, YL Choi… - British journal of …, 2013 - nature.com
JM Sun, JR Kim, IG Do, SY Lee, J Lee, YL Choi, JS Ahn, MJ Ahn, K Park
British journal of cancer, 2013•nature.comBackground: 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 …
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 …
Abstract
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.
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