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A randomized phase II trial of ridaforolimus, dalotuzumab, and exemestane compared with ridaforolimus and exemestane in patients with advanced breast cancer

Authors
Rugo, Hope S.Tredan, OlivierRo, JungsilMorales, Serafin M.Campone, MarioMusolino, AntoninoAfonso, NoemiaFerreira, MartaPark, Kyong HwaCortes, JavierTan, Antoinette R.Blum, Joanne L.Eaton, LamarGause, Christine K.Wang, ZhenIm, EllieMauro, David J.Jones, Mary BethDenker, AndrewBaselga, Jose
Issue Date
10월-2017
Publisher
SPRINGER
Keywords
Breast cancer; Ridaforolimus; mTOR; Dalotuzumab; IGF1R; Exemestane
Citation
BREAST CANCER RESEARCH AND TREATMENT, v.165, no.3, pp.601 - 609
Indexed
SCIE
SCOPUS
Journal Title
BREAST CANCER RESEARCH AND TREATMENT
Volume
165
Number
3
Start Page
601
End Page
609
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/81993
DOI
10.1007/s10549-017-4375-5
ISSN
0167-6806
Abstract
To evaluate whether adding humanized monoclonal insulin growth factor-1 receptor (IGF-1R) antibody (dalotuzumab) to mammalian target of rapamycin (mTOR) inhibitor (ridaforolimus) plus aromatase inhibitor (exemestane) improves outcomes in patients with estrogen receptor (ER)-positive advanced/metastatic breast cancer. This randomized, open-label, phase II trial enrolled 80 postmenopausal women with high-proliferation (Ki67 index staining ae<yen>15%), ER-positive breast cancer that progressed after a non-steroidal aromatase inhibitor (NCT01605396). Randomly assigned patients were given oral ridaforolimus 10 mg QD 5 x/week, intravenous dalotuzumab 10 mg/kg/week, and oral exemestane 25 mg/day (R/D/E, n = 40), or ridaforolimus 30 mg QD 5 x/week and exemestane 25 mg/day (R/E; n = 40). Primary end point was progression-free survival (PFS). Median PFS was 23.3 weeks for R/D/E versus 31.9 weeks for R/E (hazard ratio 1.18; 80% CI 0.81-1.72; P = 0.565). Grade 3-5 adverse events were reported in 67.5% of patients in the R/E arm and 59.0% in the R/D/E arm. Stomatitis (95.0 vs. 76.9%; P = 0.021) and pneumonitis (22.5 vs. 5.1%; P = 0.027) occurred more frequently in the R/E than the R/D/E arm; hyperglycemia (27.5 vs. 28.2%) occurred at a similar rate. R/D/E did not improve PFS compared with R/E. Because the PFS reported for R/E was similar to that reported for everolimus plus exemestane in patients with advanced breast cancer, it is possible that lower-dose ridaforolimus in the R/D/E arm (from overlapping toxicities with IGF1R inhibitor) contributed to lack of improved PFS.
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