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
304P - Survival outcomes and survival predictors in recurrent and metastatic head and neck squamous cell cancer (R/M-HNSCC) patients treated with chemotherapy (CT) plus cetuximab as first-line therapy in a real-world study
Presenter: Filipa Pontes
Session: Poster display session
Resources:
Abstract
305P - A retrospective study to evaluate patient characteristics for recurrent head and neck cancer after definitive treatment
Presenter: Tetsuro Wakasugi
Session: Poster display session
Resources:
Abstract
306P - Efficacy and safety of apatinib in heavily pretreated metastatic adenocarcinoma of the head and neck
Presenter: Lin Gui
Session: Poster display session
Resources:
Abstract
307P - Lacrimal gland tumours: Clinical and epidemiological patterns in the United States
Presenter: Mahmoud KhalafAllah
Session: Poster display session
Resources:
Abstract
308P - Dental prophylaxis and 5-fluorouracil related oral mucositis in head and neck cancer patients: A population-based cohort study
Presenter: Yi-Fang Huang
Session: Poster display session
Resources:
Abstract
309P - Evaluation of a pharmacist-led opioid de-escalation (PLODE) program after chemoradiotherapy completion in head and neck cancer patients
Presenter: Ai Horinouchi
Session: Poster display session
Resources:
Abstract
310P - Laser and PDT for the oral leukoplakia
Presenter: Sadykov Rasul
Session: Poster display session
Resources:
Abstract
311P - Incidence of thyroid carcinoma in the Philippines: A retrospective study from a tertiary university hospital
Presenter: Priscilla Caguioa
Session: Poster display session
Resources:
Abstract
312P - Oral health disparities among privileged and underprivileged tribes of south India - A study on precancerous oral lesions prevalence
Presenter: Shanavas Palliyal
Session: Poster display session
Resources:
Abstract
313P - Immunotherapy application for advanced cancers: One institution experiences since 2016 to 2019
Presenter: Jo Pai Chen
Session: Poster display session
Resources:
Abstract