Abstract 233P
Background
Correlative science is an integral aspect to modern oncology clinical trial design. To adopt a personalized approach to oncology, correlative research is important at all stages of drug development. This study investigated the integration of correlative studies in ovarian cancer (OC).
Methods
A systematic review of phase I, II and III clinical trials in OC published from 2013-2017 was performed. Objectives were to assess type of test; safety and success with obtaining tissue; and reporting of correlative results. Correlative studies were defined as additional tests beyond standard of care, for example biopsies, circulating tumour DNA and immune studies. Changes with time and phase of trial were assessed.
Results
From 1073 abstracts, 175 trials with 30,674 patients were identified. 116 of these were early phase trials (I/II; 66%). Overall, 80 trials included at least one correlative study (46%), 35 included a biopsy (20%) and 28 archival tissue (16%). Other correlative studies were done in 45 studies (26%) with blood-based investigations being the most common (21%). In this review, 73 trials (42%) reported results of the correlative studies within the article. Only 19% published the results of the biopsy tissue analysis. One in ten (10.5%) patients enrolled had a biopsy. Only 3 (9%) trials required two or more biopsies. Biopsies were optional in 6 (3%) trials and mandatory in 29 (17%). 71% of the patient cohort underwent a biopsy in trials where the biopsy was mandatory compared to 55% when optional (p < 0.0001). Biopsies were more likely to be included in phase I/II trials compared to phase III (23 vs 14%; p = 0.16). Safety of biopsies was reported in one of the published trials (0.5%).
Conclusions
Based on this systematic review, less than 50% of the trials published had correlative studies, with only 1 in 5 including biopsies. Results of the studies were published in only 42% of the trials. Mandatory biopsies have higher sampling rates and may be needed to ensure adequate power to address the scientific hypothesis. Adequate sample size and timeliness of results of correlative studies are critical to ensure accountability to patient investment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
285TiP - Phase II, open-label study of pembrolizumab in children and young adults with newly diagnosed classical Hodgkin lymphoma (cHL) with slow early response (SER) to frontline chemotherapy: KEYNOTE-667
Presenter: Christine Mauz-koerholz
Session: Poster display session
Resources:
Abstract
294P - Validation of the 8th edition of AJCC/UICC staging system for nasopharyngeal carcinoma: Results from a non-endemic cohort with long-term follow-up
Presenter: Li-rong Wu
Session: Poster display session
Resources:
Abstract
295P - Development and validation of M1 substages for previously untreated metastatic nasopharyngeal carcinoma
Presenter: Sik Kwan Chan
Session: Poster display session
Resources:
Abstract
296P - Nasopharyngeal carcinoma: A retrospective review of outcome in a single institution
Presenter: Wan Ping Ch' ng
Session: Poster display session
Resources:
Abstract
297P - Global longitudinal assessment of treatment outcomes in nasopharyngeal carcinoma (GLANCE-NPC) study
Presenter: Myung-Ju Ahn
Session: Poster display session
Resources:
Abstract
298P - Long-term complication and outcomes after induction chemotherapy with TPF followed by chemoradiotherapy for nasopharyngeal cancer
Presenter: Sang-Hee Cho
Session: Poster display session
Resources:
Abstract
299P - Weekly versus triweekly concurrent chemoradiation for nasopharyngeal cancer
Presenter: Sudibio Sudibio
Session: Poster display session
Resources:
Abstract
300P - Endoscopic nasopharyngectomy for localized stage I nasopharyngeal carcinoma
Presenter: Ming-Yuan Chen
Session: Poster display session
Resources:
Abstract
301P - Oncological outcome following 3 Drug NACT for Bucco-Alveolar carcinoma with Supra-notch ITF extension
Presenter: Karan Gupta
Session: Poster display session
Resources:
Abstract
303P - Segmental mandibulectomy without reconstruction
Presenter: Yohei Morishita
Session: Poster display session
Resources:
Abstract