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
15P - Comparing the outcomes of the mastectomy using the tumescent technique by between the special and non-special surgeons
Presenter: Naoya Takeda
Session: Poster display session
Resources:
Abstract
16P - Risk factors and prognostic value of non-alcoholic fatty liver disease (NAFLD) in hormone positive, non-metastatic breast cancer receiving adjuvant hormonal therapy
Presenter: Kartika Taroeno Hariadi
Session: Poster display session
Resources:
Abstract
17P - Distance related outcome in indigenous and non-indigenous breast cancer women of Western Australia
Presenter: Azim Khan
Session: Poster display session
Resources:
Abstract
18P - Usefulness of neutrophil to lymphocyte ratio in early stage breast cancer as predictor of disease-free survival in a Babylon Oncology Center
Presenter: Yaala Raof Al-Bairmany
Session: Poster display session
Resources:
Abstract
19P - Silymarin functionalized quantum cores as selective inhibitor of polo-like kinase 1, and preclinical antitumor activity in human breast cancer xenografts
Presenter: Manickam Paulpandi
Session: Poster display session
Resources:
Abstract
20P - Diagnostic value of serum HER-2 level in compression with tissue HER-2 in breast cancer: A systematic review and meta-analysis
Presenter: Amir Shamshirian
Session: Poster display session
Resources:
Abstract
21P - Clinical outcome of treatment without trastuzumab in HER2 positive breast cancer patients
Presenter: Than Than Aye
Session: Poster display session
Resources:
Abstract
22P - Clinical outcomes after skin-sparing or nipple areolar complex-sparing mastectomy with sentinel lymph node biopsy in early breast cancer patients
Presenter: Hye Yoon Lee
Session: Poster display session
Resources:
Abstract
23P - The correlations between knowledge and attitudes of productive age women toward “SADARI” (breast self-assessment) as early detection of breast cancer in Pejeng Kaja Village, Ubud, Bali
Presenter: Yorky Brahmantya
Session: Poster display session
Resources:
Abstract
24TiP - KEYNOTE-756: A randomized, double-blind, phase III study of pembrolizumab or placebo with neoadjuvant chemotherapy and adjuvant endocrine therapy for high-risk, early-stage, ER+/HER2−breast cancer
Presenter: Fatima Cardoso
Session: Poster display session
Resources:
Abstract