Background: This open-label, multicentre, phase 2 trial evaluated the efficacy and tolerability of the mammalian target of rapamycin inhibitor ridaforolimus in women with advanced endometrial cancer. Methods: Women with measurable recurrent or persistent endometrial cancer and documented disease progression were treated with ridaforolimus 12.5 mg intravenously once daily for 5 consecutive days every 2 weeks in a 4-week cycle. The primary end point was clinical benefit response, defined as an objective response or prolonged stable disease of 16 weeks or more.Results:In all, 45 patients were treated with single-agent ridaforolimus. Clinical benefit was achieved by 13 patients (29%), including 5 (11%) with confirmed partial responses and 8 (18%) with prolonged stable disease. All patients with clinical benefit response received ridaforolimus for more than 4 months. In this heavily pretreated population, the 6-month progression-free survival was 18%. Ridaforolimus was generally well tolerated: adverse events were predictable and manageable, consistent with prior studies in other malignancies. Overall, the most common adverse events were diarrhoea (58%) and mouth sores (56%); most common grade 3 or higher adverse events were anaemia (27%) and hyperglycaemia (11%). Conclusion: Single-agent ridaforolimus has antitumor activity and acceptable tolerability in advanced endometrial cancer patients. Further clinical evaluation of ridaforolimus is warranted. © 2013 Cancer Research UK. All rights reserved.

Colombo, N., Mcmeekin, D., Schwartz, P., Sessa, C., Gehrig, P., Holloway, R., et al. (2013). Ridaforolimus as a single agent in advanced endometrial cancer: Results of a single-arm, phase 2 trial. BRITISH JOURNAL OF CANCER, 108(5), 1021-1026 [10.1038/bjc.2013.59].

Ridaforolimus as a single agent in advanced endometrial cancer: Results of a single-arm, phase 2 trial

COLOMBO, NICOLETTA
;
2013

Abstract

Background: This open-label, multicentre, phase 2 trial evaluated the efficacy and tolerability of the mammalian target of rapamycin inhibitor ridaforolimus in women with advanced endometrial cancer. Methods: Women with measurable recurrent or persistent endometrial cancer and documented disease progression were treated with ridaforolimus 12.5 mg intravenously once daily for 5 consecutive days every 2 weeks in a 4-week cycle. The primary end point was clinical benefit response, defined as an objective response or prolonged stable disease of 16 weeks or more.Results:In all, 45 patients were treated with single-agent ridaforolimus. Clinical benefit was achieved by 13 patients (29%), including 5 (11%) with confirmed partial responses and 8 (18%) with prolonged stable disease. All patients with clinical benefit response received ridaforolimus for more than 4 months. In this heavily pretreated population, the 6-month progression-free survival was 18%. Ridaforolimus was generally well tolerated: adverse events were predictable and manageable, consistent with prior studies in other malignancies. Overall, the most common adverse events were diarrhoea (58%) and mouth sores (56%); most common grade 3 or higher adverse events were anaemia (27%) and hyperglycaemia (11%). Conclusion: Single-agent ridaforolimus has antitumor activity and acceptable tolerability in advanced endometrial cancer patients. Further clinical evaluation of ridaforolimus is warranted. © 2013 Cancer Research UK. All rights reserved.
Articolo in rivista - Articolo scientifico
clinical benefit response; endometrial cancer; mammalian target of rapamycin inhibitor; ridaforolimus; stable disease; Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Alkylating; Disease-Free Survival; Drug Administration Schedule; Endometrial Neoplasms; Female; Humans; Middle Aged; Retreatment; Sirolimus; TOR Serine-Threonine Kinases; Cancer Research; Oncology
English
2013
108
5
1021
1026
none
Colombo, N., Mcmeekin, D., Schwartz, P., Sessa, C., Gehrig, P., Holloway, R., et al. (2013). Ridaforolimus as a single agent in advanced endometrial cancer: Results of a single-arm, phase 2 trial. BRITISH JOURNAL OF CANCER, 108(5), 1021-1026 [10.1038/bjc.2013.59].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/72391
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