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
3993 - Prophylaxis with Lipegfilgrastim in patients with primary breast cancer receiving dose dense chemotherapy: results from the German NIS NADENS
Presenter: Marion Kiechle
Session: Poster Display session 1
Resources:
Abstract
3471 - Randomized phase 2 trial evaluating the safety of peripherally inserted central catheters vs implanted port catheters during adjuvant chemotherapy in early breast cancer patients.
Presenter: Florian Clatot
Session: Poster Display session 1
Resources:
Abstract
1327 - Simultaneous intravenous fluid infusion to prevent oxaliplatin infusion-related venous pain
Presenter: Stefan Van Ravensteijn
Session: Poster Display session 1
Resources:
Abstract
5004 - Clinical practice evaluation of opioids induced constipation management in cancer patients: The EIO-Praxis project.
Presenter: Enrique Aranda Aguilar
Session: Poster Display session 1
Resources:
Abstract
2222 - Analysis of the efficacy of naloxegol in a real-world 12 weeks of follow-up study, in patients with cancer and opioid-induced constipation with laxative-inadequate response.
Presenter: Manuel Cobo Dols
Session: Poster Display session 1
Resources:
Abstract
5556 - Consensus on strategies in the management of opioid-induced constipation in cancer patients
Presenter: Regina Girones Sarrio
Session: Poster Display session 1
Resources:
Abstract
3913 - Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial
Presenter: Yanni Lou
Session: Poster Display session 1
Resources:
Abstract
2208 - A prospective study about the complementary medicine among patients with cancers
Presenter: Wala Ben Kridis
Session: Poster Display session 1
Resources:
Abstract
1082 - Prevalence and management of Potentially Inappropriate Medication use and Potential Omissions in Medication in older cancer patients - the PIM POM study
Presenter: Fianne van Loveren
Session: Poster Display session 1
Resources:
Abstract
1701 - Immunogenicity and optimal timing of 13-valent pneumococcal conjugate vaccination during adjuvant chemotherapy in gastric and colorectal cancer : A randomized controlled trial
Presenter: Wonyoung Choi
Session: Poster Display session 1
Resources:
Abstract