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Molecular-integrated risk profile to determine adjuvant radiotherapy in endometrial cancer: Evaluation of the pilot phase of the PORTEC-4a trial.
- Source :
-
Gynecologic oncology [Gynecol Oncol] 2018 Oct; Vol. 151 (1), pp. 69-75. Date of Electronic Publication: 2018 Aug 03. - Publication Year :
- 2018
-
Abstract
- Objective: The Post-Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-4a trial is a randomized trial for women with high-intermediate risk endometrial cancer (EC), comparing individualized adjuvant treatment based on a molecular-integrated risk profile to standard adjuvant treatment; vaginal brachytherapy. To evaluate patient acceptability and pathology logistics of determining the risk profile, a pilot phase was included in the study.<br />Methods: PORTEC-4a is ongoing and the first 50 patients enrolled were included in the pilot phase. Primary endpoints of the pilot phase were patient acceptance, evaluated by analyzing the screening logs of the participating centers, and logistical feasibility of determination of the risk profile within 2 weeks, evaluated by analyzing the pathology database.<br />Results: In the first year, 145 eligible women were informed about the trial at 13 centers, of whom 50 (35%) provided informed consent. Patient accrual ranged from 0 to 57% per center. Most common reasons for not participating were: not willing to participate in any trial (43.2%) and not willing to risk receiving no adjuvant treatment (32.6%). Analysis of the pathology database showed an average time between randomization and determination of the molecular-integrated risk profile of 10.2 days (1-23 days). In 5 of the 32 patients (15.6%), pathology review took >2 weeks.<br />Conclusions: The PORTEC-4a trial design was proven feasible with a satisfactory patient acceptance rate and an optimized workflow of the determination of the molecular-integrated risk profile. PORTEC-4a is the first randomized trial to investigate use of a molecular-integrated risk profile to determine adjuvant treatment in EC.<br /> (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Brachytherapy adverse effects
Disease-Free Survival
Endometrial Neoplasms genetics
Endometrial Neoplasms mortality
Endometrial Neoplasms pathology
Endometrium pathology
Endometrium radiation effects
Endometrium surgery
Feasibility Studies
Female
Humans
Middle Aged
Neoplasm Grading
Neoplasm Recurrence, Local genetics
Neoplasm Recurrence, Local mortality
Neoplasm Recurrence, Local pathology
Neoplasm Staging
Pilot Projects
Quality of Life
Radiotherapy, Adjuvant methods
Research Design
Risk Assessment methods
Treatment Outcome
Workflow
Brachytherapy methods
Endometrial Neoplasms therapy
Neoplasm Recurrence, Local therapy
Patient Satisfaction
Subjects
Details
- Language :
- English
- ISSN :
- 1095-6859
- Volume :
- 151
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Gynecologic oncology
- Publication Type :
- Academic Journal
- Accession number :
- 30078506
- Full Text :
- https://doi.org/10.1016/j.ygyno.2018.07.020