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, Olivier; Ro, Jungsil; Morales, Serafin M.; Campone, Mario; Musolino, Antonino; Afonso, Noemia; Ferreira, Marta; Park, Kyong Hwa; Cortes, Javier; Tan, Antoinette R.; Blum, Joanne L.; Eaton, Lamar; Gause, Christine K.; Wang, Zhen; Im, Ellie; Mauro, David J.; Jones, Mary Beth; Denker, Andrew; Baselga, 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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