Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide

Title
Multicenter phase II study of everolimus in patients with metastatic or recurrent bone and soft-tissue sarcomas after failure of anthracycline and ifosfamide
Author(s)
이경희유창훈[유창훈]이지윤[이지윤]라선영[라선영]박경화[박경화]김태민[김태민]안진희[안진희]이효진[이효진]김유정[김유정]
Keywords
DOUBLE-BLIND; TRIAL; EFFICACY; TUMORS; COMBINATION; GEMCITABINE; SORAFENIB; INHIBITOR; PAZOPANIB; IMATINIB
Issue Date
201312
Publisher
SPRINGER
Citation
INVESTIGATIONAL NEW DRUGS, v.31, no.6, pp.1602 - 1608
Abstract
This multicenter, phase II trial evaluated the efficacy and safety of everolimus, an mTOR inhibitor, in patients with metastatic or recurrent bone and soft-tissue sarcoma after the failure of anthracycline- and ifosfamide-containing regimens. Everolimus was administered orally as 10 mg once daily. The primary endpoint was the progression-free rate (PFR) at 16 weeks, assessed by computed tomography scan according to RECIST v1.0. Between July 2010 and May 2011, 41 patients were enrolled in this study. Among them, 83 % received two or more regimens of chemotherapy prior to study entry. In 38 patients who the primary endpoint was evaluable, 11 patients reached 16 weeks progression-free (one with partial response and 10 with stable disease), indicating a PFR at 16 weeks of 27 % (95 % confidence interval [CI], 16 -aEuro parts per thousand 42 %). The PFR at 16 weeks was highest in patients with angiosarcoma (2 of 3, 67 %). With a median follow-up of 10.9 months (range, 2.3-23.9 months) in living patients, the median progression-free survival was 1.9 months (95 % CI, 1.3-2.4 months) and the median overall survival was 5.8 months (95 % CI, 3.6-8.0 months). Most adverse events were generally mild and tolerable. Grade 3/4 toxicities included hyperglycemia (15 %), stomatitis (7 %), pain (5 %), and asthenia (5 %). Everolimus shows modest antitumor activity with manageable toxicities in heavily pretreated patients with bone and soft-tissue sarcoma.
URI
http://hdl.handle.net/YU.REPOSITORY/28052http://dx.doi.org/10.1007/s10637-013-0028-7
ISSN
0167-6997
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의과대학 > 내과학교실 > Articles
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