Discussion
carcinosarcoma, endometrial cancer, tumor, endometrioid tumors, endometrial carcinoma
CARCINOSARCOMA, ENDOMETRIAL CANCER, TUMOR, ENDOMETRIAL CARCINOMA, ENDOMETRIOID TUMOR
This cohort from a phase 2 exploratory Basket study included 73 patients with pretreated endometrial cancer who received therapy with single-agent lurbinectedin. ORR according to RECIST v.1.1 was 11.3% (95%CI, 5.0–21.0%). Responses were mostly observed in patients with endometrioid tumors and the median of prior lines was one. These results (eight objective responses) were lower than the threshold of ≥ 10 confirmed responses established in the statistical hypothesis for this endometrial carcinoma cohort. However, although the cohort did not meet the planned hypothesis, hints of antitumor activity were observed, with two patients achieving complete response and six patients with partial responses in a quite heterogeneous cohort that included patients with different number of prior lines administered (up to four previous lines), different histology subtypes (e.g., carcinosarcoma, endometrial stromal sarcoma), and not characterized molecularly at study entry according to current guidelines [Studies in small cohorts of patients of lurbinectedin in combination with other drugs have shown to increase the single-agent activity in pretreated endometrial cancer. For instance, in combination with doxorubicin (ORR = 42% and median DoR = 7.5 months) [Retrospective tumor molecular and genomic profiling have shown different lurbinectedin response depending on the presence of mutations on particular genes, protein levels and specific molecular subtypes, with better PFS and OS in the Lurbinectedin administered at 3.2 mg/mIn conclusion, the current efficacy results suggest that antitumor activity of lurbinectedin could be improved in patients with pretreated endometrial cancer when administered in combination with other agents and in populations with previous molecular classification. Immunotherapy added to chemotherapy has shown promising results in the first-line treatment of endometrial cancer [