Kristeleit, R;
Moreno, V;
Boni, V;
Guerra, EM;
Kahatt, C;
Romero, I;
Calvo, E;
... Forster, M; + view all
(2021)
Doxorubicin plus lurbinectedin in patients with advanced endometrial cancer: Results from an expanded phase i study.
International Journal of Gynecological Cancer
, 31
(11)
pp. 1428-1436.
10.1136/ijgc-2021-002881.
Preview |
PDF
Forster_Doxorubicin plus lurbinectedin in patients with advanced endometrial cancer_VoR.pdf - Published Version Download (1MB) | Preview |
Abstract
Objective: Second-line treatment of endometrial cancer is an unmet medical need. We conducted a phase I study evaluating lurbinectedin and doxorubicin intravenously every 3 weeks in patients with solid tumors. The aim of this study was to characterise the efficacy and safety of lurbinectedin and doxorubicin for patients with endometrial cancer. Methods: Thirty-four patients were treated: 15 patients in the escalation phase (doxorubicin 50 mg/m2 and lurbinectedin 3.0-5.0 mg) and 19 patients in the expansion cohort (doxorubicin 40 mg/m2 and lurbinectedin 2.0 mg/m2). All histological subtypes were eligible and patients had received one to two prior lines of chemotherapy for advanced disease. Antitumor activity was evaluated every two cycles according to the Response Evaluation Criteria in Solid Tumors version 1.1. Adverse events were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 4. Results: Median age (range) was 65 (51-78) years. Eastern Cooperative Oncology Group performance status was up to 1 in 97% of patients. In the escalation phase, 4 (26.7%) of 15 patients had confirmed response: two complete and two partial responses (95% CI 7.8% to 55.1%). Median duration of response was 19.5 months. Median progression-free survival was 7.3 (2.5 to 10.1) months. In the expansion cohort, confirmed partial response was reported in 8 (42.1%) of 19 patients (95% CI 20.3% to 66.5%). Median duration of response was 7.5 (6.4 to not reached) months, median progression-free survival was 7.7 (2.0 to 16.7) months and median overall survival was 14.2 (4.5 to not reached) months. Fatigue (26.3% of patients), and transient and reversible myelosuppression (neutropenia, 78.9%; febrile neutropenia, 21.1%; thrombocytopenia, 15.8%) were the main grade 3 and higher toxicities in the expanded cohort. Conclusions: In patients with recurrent advanced endometrial cancer treated with doxorubicin and lurbinectedin, response rates (42%) and duration of response (7.5 months) were favorable. Further evaluation of doxorubicin and lurbinectedin is warranted in this patient population.
Type: | Article |
---|---|
Title: | Doxorubicin plus lurbinectedin in patients with advanced endometrial cancer: Results from an expanded phase i study |
Location: | England |
Open access status: | An open access version is available from UCL Discovery |
DOI: | 10.1136/ijgc-2021-002881 |
Publisher version: | https://doi.org/10.1136/ijgc-2021-002881 |
Language: | English |
Additional information: | This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
Keywords: | Endometrial neoplasms, endometrium, Aged, Antibiotics, Antineoplastic, Antineoplastic Combined Chemotherapy Protocols, Carbolines, Doxorubicin, Endometrial Neoplasms, Female, Heterocyclic Compounds, 4 or More Rings, Humans, Middle Aged, Neoplasm Recurrence, Local, Progression-Free Survival |
UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Cancer Institute > Research Department of Oncology |
URI: | https://discovery.ucl.ac.uk/id/eprint/10176177 |
Archive Staff Only
View Item |