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
164P - Multi-centered phase II trial of weekly 5-FU plus l-LV regimen as salvage line chemotherapy for oral fluorouracil resistant advanced gastric cancer (HGCSG1502)
Presenter: Yusuke Sasaki
Session: Poster display session
Resources:
Abstract
165P - Lenvatinib treatment for advanced hepatocellular carcinoma: The relationship between efficacy and safety
Presenter: Takayoshi Oikawa
Session: Poster display session
Resources:
Abstract
166P - The comparison between UGT1A1 single heterozygous and wild type regarding the clinical outcomes of fixed dose irinotecan monotherapy for advanced gastric cancer: Multicenter retrospective study
Presenter: Takahide Sasaki
Session: Poster display session
Resources:
Abstract
167P - Prognostic impact of the C-reactive protein/albumin ratio in advanced pancreatic cancer treated with GEM plus nab-PTX or FOLFIRINOX: Based on the results of a multicenter retrospective study (the NAPOLEON study)
Presenter: Akitaka Makiyama
Session: Poster display session
Resources:
Abstract
168P - A retrospective multicenter study evaluating the efficacy and safety of irinotecan in patients with advanced gastric cancer: Analysis of Glasgow Prognostic Score (GPS)
Presenter: Takuya Honda
Session: Poster display session
Resources:
Abstract
169P - M-phase phosphoprotein 8 promotes gastric cancer growth and metastasis via p53/Bcl-2 and EMT-related signalling pathways
Presenter: Yizhuo Wang
Session: Poster display session
Resources:
Abstract
170P - Surgery alone versus surgery combined with Chemotherapy: Survival patterns among patients with fibrolamellar hepatocellular carcinoma
Presenter: Yasmine Ashraf
Session: Poster display session
Resources:
Abstract
171P - The clinical value of prognostic nutritional index in patients with anastomotic leakage after minimally invasive esophagectomy
Presenter: Yan Wang
Session: Poster display session
Resources:
Abstract
172P - Preoperative neutrophil‐to‐lymphocyte ratio (NLR) predicts recurrence after surgery in patient with pancreatic neuroendocrine neoplasm (PanNEN)
Presenter: Takayuki Miura
Session: Poster display session
Resources:
Abstract
173P - Cancer stem-like phenotypes including immune surveillance and its responsible genes in induced liver cancer stem-like cells
Presenter: Ryouichi Tsunedomi
Session: Poster display session
Resources:
Abstract