Unknown

Dataset Information

0

Phase II trial of ribociclib and letrozole in patients with relapsed oestrogen receptor-positive ovarian or endometrial cancers.


ABSTRACT: OBJECTIVE:We describe a phase II clinical trial of the combination of ribociclib and letrozole for treatment of relapsed oestrogen receptor (ER)-positive ovarian cancer (OC) and endometrial cancer (EC). The primary endpoint was the proportion of patients alive, progression-free survival (PFS), and still on treatment at 12 weeks (PFS12), with 45% or greater considered positive. METHODS:Patients with measurable, relapsed ER-positive OC or EC (platinum-sensitive or resistant) were eligible and treated with 400?mg of oral ribociclib and 2.5?mg of oral letrozole daily. Patient-derived xenografts (PDXs) were created from imaging-guided tumour biopsies. RESULTS:Forty patients (20 OC and 20 EC) were enrolled. A PFS12 of 55% was observed in the EC cohort and 50% in the OC cohort. A PFS greater or equal to 24 weeks (PFS24) was seen in 20% (4/20) of the OC cohort and 35% (7/20) of the EC cohort. The greatest benefit was seen in low-grade serous OC (LGSOC) (3/3, 100% PFS24) and grades 1 and 2 EC (5/11, 45% PFS24). All three LGSOC patients obtained at least a partial response lasting for over 2 years, with two of the three patients still on treatment. PDX tumour engraftment was feasible in 45% of patients. Positive survival effects of the combination of ribociclib and letrozole were observed in two of three EC PDX models. CONCLUSION:Ribociclib and letrozole have promising clinical activity in relapsed ER-positive OC and EC, particularly in LGSOC and relapsed ER-positive grade 1 and 2 EC. Generation of PDX models is feasible with positive survival effects observed in EC models. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov registry (NCT02657928).

SUBMITTER: Colon-Otero G 

PROVIDER: S-EPMC7592247 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

altmetric image

Publications


<h4>Objective</h4>We describe a phase II clinical trial of the combination of ribociclib and letrozole for treatment of relapsed oestrogen receptor (ER)-positive ovarian cancer (OC) and endometrial cancer (EC). The primary endpoint was the proportion of patients alive, progression-free survival (PFS), and still on treatment at 12 weeks (PFS12), with 45% or greater considered positive.<h4>Methods</h4>Patients with measurable, relapsed ER-positive OC or EC (platinum-sensitive or resistant) were el  ...[more]

Similar Datasets

| S-EPMC4348638 | biostudies-literature
| S-EPMC7222485 | biostudies-literature
| S-EPMC10982620 | biostudies-literature
| S-EPMC5807486 | biostudies-literature
| S-EPMC3984742 | biostudies-literature
| S-EPMC6448015 | biostudies-literature
| S-EPMC10050005 | biostudies-literature
| S-EPMC6817898 | biostudies-literature
| S-EPMC5105193 | biostudies-literature
| S-EPMC9675476 | biostudies-literature