A randomized phase II trial of ridaforolimus, dalotuzumab, and exemestane compared with ridaforolimus and exemestane in patients with advanced breast cancer
DC Field | Value | Language |
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dc.contributor.author | Rugo, Hope S. | - |
dc.contributor.author | Tredan, Olivier | - |
dc.contributor.author | Ro, Jungsil | - |
dc.contributor.author | Morales, Serafin M. | - |
dc.contributor.author | Campone, Mario | - |
dc.contributor.author | Musolino, Antonino | - |
dc.contributor.author | Afonso, Noemia | - |
dc.contributor.author | Ferreira, Marta | - |
dc.contributor.author | Park, Kyong Hwa | - |
dc.contributor.author | Cortes, Javier | - |
dc.contributor.author | Tan, Antoinette R. | - |
dc.contributor.author | Blum, Joanne L. | - |
dc.contributor.author | Eaton, Lamar | - |
dc.contributor.author | Gause, Christine K. | - |
dc.contributor.author | Wang, Zhen | - |
dc.contributor.author | Im, Ellie | - |
dc.contributor.author | Mauro, David J. | - |
dc.contributor.author | Jones, Mary Beth | - |
dc.contributor.author | Denker, Andrew | - |
dc.contributor.author | Baselga, Jose | - |
dc.date.accessioned | 2021-09-03T00:21:26Z | - |
dc.date.available | 2021-09-03T00:21:26Z | - |
dc.date.created | 2021-06-19 | - |
dc.date.issued | 2017-10 | - |
dc.identifier.issn | 0167-6806 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/81993 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER | - |
dc.subject | MONOCLONAL-ANTIBODY | - |
dc.subject | MAMMALIAN TARGET | - |
dc.subject | MTOR INHIBITOR | - |
dc.subject | RAPAMYCIN INHIBITION | - |
dc.subject | ANTITUMOR-ACTIVITY | - |
dc.subject | SOLID TUMORS | - |
dc.subject | RECEPTOR | - |
dc.subject | THERAPY | - |
dc.subject | COMBINATION | - |
dc.subject | PROGRESSION | - |
dc.title | A randomized phase II trial of ridaforolimus, dalotuzumab, and exemestane compared with ridaforolimus and exemestane in patients with advanced breast cancer | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Park, Kyong Hwa | - |
dc.identifier.doi | 10.1007/s10549-017-4375-5 | - |
dc.identifier.scopusid | 2-s2.0-85021784217 | - |
dc.identifier.wosid | 000411105800015 | - |
dc.identifier.bibliographicCitation | BREAST CANCER RESEARCH AND TREATMENT, v.165, no.3, pp.601 - 609 | - |
dc.relation.isPartOf | BREAST CANCER RESEARCH AND TREATMENT | - |
dc.citation.title | BREAST CANCER RESEARCH AND TREATMENT | - |
dc.citation.volume | 165 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 601 | - |
dc.citation.endPage | 609 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | MONOCLONAL-ANTIBODY | - |
dc.subject.keywordPlus | MAMMALIAN TARGET | - |
dc.subject.keywordPlus | MTOR INHIBITOR | - |
dc.subject.keywordPlus | RAPAMYCIN INHIBITION | - |
dc.subject.keywordPlus | ANTITUMOR-ACTIVITY | - |
dc.subject.keywordPlus | SOLID TUMORS | - |
dc.subject.keywordPlus | RECEPTOR | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | COMBINATION | - |
dc.subject.keywordPlus | PROGRESSION | - |
dc.subject.keywordAuthor | Breast cancer | - |
dc.subject.keywordAuthor | Ridaforolimus | - |
dc.subject.keywordAuthor | mTOR | - |
dc.subject.keywordAuthor | Dalotuzumab | - |
dc.subject.keywordAuthor | IGF1R | - |
dc.subject.keywordAuthor | Exemestane | - |
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