Abstract 4518
Background
Patients with cancer who are refractory to standard treatments may participate in phase I clinical trials. Despite stringent eligibility criteria for trial participation, early discontinuation often occurs. These patients do not benefit from study treatment and may experience additional burden from participation, while adequate evaluation of novel treatment strategies is hampered. The aim of this study was to identify predictors for early discontinuation of phase I clinical trials.
Methods
Data from patients with solid tumors who participated in phase I trials in our center were pooled for the current analysis. Early trial discontinuation was defined as (i) trial discontinuation within 28 days after administration of the first dose of the investigated drug or (ii) discontinuation before administration of the first dose in patients who were found to be eligible. Based on the literature, the following potential predictors were examined: opioid use, number of metastatic sites, body mass index, ECOG/WHO performance status, comorbidity history of thromboembolism, hemoglobin level, platelet count, leukocytes, lymphocytes, absolute neutrophil count, serum sodium level, creatinine clearance, serum albumin level, serum alkaline phosphatase level, serum aspartate aminotransferase level (AST), serum lactate dehydrogenase level and. Multilevel logistic regression analyses were conducted and Odds ratio (OR) and 95% confidence interval (95%CI) were reported.
Results
Data from 154 patients recruited in 8 phase I clinical trials were analyzed. Thirty-six (23%) participants discontinued the trial early. Baseline hyponatremia (OR = 3.69, 95%CI=1.09-12.47) and an elevated AST level (OR = 2.57, 95%CI=1.10-6.01) were independent predictors for early trial discontinuation.
Conclusions
Hyponatremia and an elevated serum AST level were identified as significant independent predictors for early trial discontinuation in patients with cancer participating in phase I clinical trials. These predictors will be further investigated in a prospective study, to determine their added value in minimizing early trial discontinuation of patients participating in phase I oncology trials.
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
4079 - Triggering anti-GBM immune response with EGFR-mediated photoimmunotherapy
Presenter: Gabriela Kramer-marek
Session: Poster Display session 1
Resources:
Abstract
4364 - Upregulation of sFRP3 circulating expression levels correlates survival outcomes in glioblastoma
Presenter: Gema Bruixola
Session: Poster Display session 1
Resources:
Abstract
2327 - Characterization and pre-clinical modeling of genetic aberrations in pediatric gliomas
Presenter: Itai Moshe
Session: Poster Display session 1
Resources:
Abstract
3154 - Preclinical Study of Novel Tetracyclic Small Molecule, CC12, for Brain Cancer
Presenter: Liyun Fann
Session: Poster Display session 1
Resources:
Abstract
5759 - CHLOROBRAIN phase IB trial: The addition of chloroquine, an autophagy inhibitor, to concurrent radiation and temozolomide for newly diagnosed glioblastoma
Presenter: Inge Compter
Session: Poster Display session 1
Resources:
Abstract
1382 - A Phase II Clinical Trial Evaluating the Efficacy and Safety of Apatinib Combined with dose-dense Temozolomide in Recurrent Glioblastoma
Presenter: Yong Wang
Session: Poster Display session 1
Resources:
Abstract
4407 - Phase 0 Trial of Ceritinib in Brain Metastases and Recurrent Glioblastoma
Presenter: Shwetal Mehta
Session: Poster Display session 1
Resources:
Abstract
1469 - Pembrolizumab (Pem) in recurrent high-grade glioma (HGG) patients with mismatch repair deficiency (MMRd): an observational study
Presenter: Mario Caccese
Session: Poster Display session 1
Resources:
Abstract
4217 - Outcome of high-grade gliomas (HGGs) treated into immunotherapeutic early-phase clinical trials (ieCTs): a single-center experience
Presenter: Matteo Simonelli
Session: Poster Display session 1
Resources:
Abstract
5107 - Tolerability of PCV in Low Grade Glioma: a Real World Experience
Presenter: Razia Aslam
Session: Poster Display session 1
Resources:
Abstract