dc.contributor.author | Oza, A | |
dc.contributor.author | Kaye, S | |
dc.contributor.author | Van Tornout, J | |
dc.contributor.author | Sessa, C | |
dc.contributor.author | Gore, M | |
dc.contributor.author | Naumann, RW | |
dc.contributor.author | Hirte, H | |
dc.contributor.author | Colombo, N | |
dc.contributor.author | Chen, J | |
dc.contributor.author | Gorla, S | |
dc.contributor.author | Poondru, S | |
dc.contributor.author | Singh, M | |
dc.contributor.author | Steinberg, J | |
dc.contributor.author | Yuen, G | |
dc.contributor.author | Banerjee, S | |
dc.date.accessioned | 2019-03-04T15:36:58Z | |
dc.date.issued | 2018-05 | |
dc.identifier.citation | Gynecologic oncology, 2018, 149 (2), pp. 275 - 282 | |
dc.identifier.issn | 0090-8258 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3126 | |
dc.identifier.eissn | 1095-6859 | |
dc.identifier.doi | 10.1016/j.ygyno.2018.01.019 | |
dc.description.abstract | BACKGROUND:Linsitinib, an oral, dual inhibitor of insulin-like growth factor-1 receptor and insulin receptor, in combination with weekly paclitaxel, may improve clinical outcomes compared with paclitaxel alone in patients with refractory or platinum-resistant ovarian cancer. PATIENTS AND METHODS:This open-label phase 1/2 clinical trial (NCT00889382) randomized patients with refractory or platinum-resistant ovarian cancer (1:1:1) to receive either oral intermittent linsitinib (600mg once daily on Days 1-3 per week) combined with paclitaxel (80mg/m2 on Days 1, 8, and 15; Arm A) or continuous linsitinib (150mg twice daily) in combination with paclitaxel (Arm B), or paclitaxel alone (Arm C). Primary endpoint was progression-free survival (PFS); secondary endpoints included overall survival (OS), overall response rate (ORR), disease control rate (DCR), and safety/tolerability. RESULTS:A total of 152 women were randomized to treatment (n=51 Arm A; n=51 Arm B, n=50 Arm C). In combination with paclitaxel, neither intermittent linsitinib (median PFS 2.8months; 95% confidence interval [CI]:2.5-4.4) nor continuous linsitinib (median PFS 4.2months; 95% CI:2.8-5.1) improved PFS over weekly paclitaxel alone (median PFS 5.6months; 95% CI:3.2-6.9). No improvement in ORR, DCR, or OS in either linsitinib dosing schedule was observed compared with paclitaxel alone. Adverse event (AE) rates, including all-grade and grade 3/4 treatment-related AEs, and treatment-related AEs leading to discontinuation, were higher among patients receiving intermittent linsitinib compared with the other treatment arms. CONCLUSION:Addition of intermittent or continuous linsitinib with paclitaxel did not improve outcomes in patients with platinum-resistant/refractory ovarian cancer compared with paclitaxel alone. | |
dc.format | Print-Electronic | |
dc.format.extent | 275 - 282 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Neoplasms, Glandular and Epithelial | |
dc.subject | Ovarian Neoplasms | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Paclitaxel | |
dc.subject | Organoplatinum Compounds | |
dc.subject | Imidazoles | |
dc.subject | Pyrazines | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Treatment Outcome | |
dc.subject | Drug Administration Schedule | |
dc.subject | Drug Resistance, Neoplasm | |
dc.subject | Adolescent | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Young Adult | |
dc.subject | Carcinoma, Ovarian Epithelial | |
dc.title | Phase 2 study evaluating intermittent and continuous linsitinib and weekly paclitaxel in patients with recurrent platinum resistant ovarian epithelial cancer. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-01-19 | |
rioxxterms.versionofrecord | 10.1016/j.ygyno.2018.01.019 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2018-05 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Gynecologic oncology | |
pubs.issue | 2 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Closed research teams | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Closed research teams/Medicine Drug Development Unit (Kaye) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Closed research teams | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Closed research teams/Medicine Drug Development Unit (Kaye) | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published | |
pubs.volume | 149 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Medicine Drug Development Unit (Kaye) | en_US |
dc.contributor.icrauthor | Gore, Martin | |
dc.contributor.icrauthor | Banerjee, Susana | |
dc.contributor.icrauthor | Kaye, Stanley Bernard | |