ArticleOncotarget2015
Predictors of early treatment discontinuation in patients enrolled on Phase I oncology trials.
Article in Oncotarget, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Order of patient entry and outcomes in phase II clinical trials: A meta-analysis of individual patient data.Contemporary clinical trials · 2023Pooled it
- Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma.Advances in therapy · 2022Trial
- Smartphone measurements of physical activity and fitness are associated with early trial discontinuation of patients in (hemato)oncology phase I/II clinical trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Trial
- Use of supportive care services and advance care planning among early phase oncology clinical trial participants.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Serum protein and electrolyte imbalances are associated with chemotherapy induced neutropenia.Heliyon · 2022Article
- Clinical Predictors of Early Trial Discontinuation for Patients Participating in Phase I Clinical Trials in Oncology.Cancers · 2021Article
- A phase I study of HER1, HER2 dual kinase inhibitor lapatinib plus the proteasome inhibitor bortezomib in patients with advanced malignancies.Cancer chemotherapy and pharmacology · 2019Article
- Early disease progression and treatment discontinuation in patients with advanced ovarian cancer receiving immune checkpoint blockade.Gynecologic oncology · 2019Article
- Hypoalbuminemia: Pathogenesis and Clinical Significance.JPEN. Journal of parenteral and enteral nutrition · 2019Review
- A DREAM Challenge to Build Prediction Models for Short-Term Discontinuation of Docetaxel in Metastatic Castration-Resistant Prostate Cancer.JCO clinical cancer informatics · 2017Article
- Article
- Evaluation of the Safety and Benefit of Phase I Oncology Trials for Patients With Primary CNS Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2015Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
purposePatients who do not complete one cycle of therapy on Phase I trials for reasons other than dose limiting toxicity (DLT) are considered inevaluable for toxicity and must be replaced.
methodsIndividual records from patients enrolled to NCI-sponsored Phase I trials activated between 2000 and 2010 were used. Early discontinuation was defined as the failure to begin cycle 2 for reasons other than a DLT during cycle 1. A multinomial logistic regression with a 3-level nominal outcome (early discontinuation, DLT during cycle 1, and continuation to cycl1e 2) was used with continuation to cycle 2 serving as the reference category. The final model was used to create two risk scores. An independent external cohort was used to validate these models.
resultsData from 3079 patients on 127 Phase I trials were analyzed. ECOG performance status (1, ≥ 2, two-sided P = .0315 and P = .0007), creatinine clearance (<60 ml/min, P = .0455), alkaline phosphatase (>2.5xULN, P = .0026), AST (>ULN, P = .0076), hemoglobin (<10 g/dL, P < .0001), albumin (<3.5 g/dL, P < .0001), and platelets (<400x109/L, P = .0732) were predictors of early discontinuation. The c-index of the final model was 0.63.
conclusionKnowledge of risk factors for early treatment discontinuation in conjunction with clinical judgment can help guide Phase I patient selection.
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Registered trials
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