ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Nomogram to predict cycle-one serious drug-related toxicity in phase I oncology trials.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 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.
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Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.
- The role of age on dose-limiting toxicities in phase I dose-escalation trials.Clinical cancer research : an official journal of the American Association for Cancer Research · 2014Pooled it
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- Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants.The oncologist · 2020Trial
- Prediction of postoperative survival in patients with head and neck acinic cell carcinoma: a population-based study.Translational cancer research · 2025Article
- A retrospective study using the Surveillance Epidemiology and End Results (SEER) database to predict risk and prognostic factors for lung metastasis in cervical carcinoma: nomogram development and validation.Translational cancer research · 2025Article
- The Use of Artificial Intelligence in Predicting Chemotherapy-Induced Toxicities in Metastatic Colorectal Cancer: A Data-Driven Approach for Personalized Oncology.Diagnostics (Basel, Switzerland) · 2024Article
- Predictive Modeling for Adverse Events and Risk Stratification Programs for People Receiving Cancer Treatment.JCO oncology practice · 2022Review
- Prognostic Nomogram for Gastrointestinal Stromal Tumors after Surgery Based on the SEER Database.BioMed research international · 2022Article
- Development and Validation of a Nomogram to Predict the Individual Future Stroke Risk for Adult Patients With Moyamoya Disease: A Multicenter Retrospective Cohort Study in China.Frontiers in neurology · 2021Article
- Clinical implications of drug-induced liver injury in early-phase oncology clinical trials.Cancer · 2020Article
- Building a Clinically Relevant Risk Model: Predicting Risk of a Potentially Preventable Acute Care Visit for Patients Starting Antineoplastic Treatment.JCO clinical cancer informatics · 2020Article
- Improving survival prediction using a novel feature selection and feature reduction framework based on the integration of clinical and molecular data.Pacific Symposium on Biocomputing. Pacific Symposium on Biocomputing · 2020Article
- Development and External Validation of a Nomogram to Predict Recurrence-Free Survival After R0 Resection for Stage II/III Gastric Cancer: An International Multicenter Study.Frontiers in oncology · 2020Article
- Relationship between phase I study duration and symptom burden.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2018Article
- Do all patients in the phase I oncology trials need to be hospitalized? Domestic but outstanding issues for globalization of drug development in Japan.International journal of clinical oncology · 2017Article
- Analysis of esophagogastric cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase 1 trials.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017Article
- Predicting the survival of patients with small bowel neuroendocrine tumours: comparison of 3 systems.Endocrine connections · 2017Article
- Challenges Facing Early Phase Trials Sponsored by the National Cancer Institute: An Analysis of Corrective Action Plans to Improve Accrual.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Review
- Article
- Effect of Renal Dysfunction on Toxicity in Three Decades of Cancer Therapy Evaluation Program-Sponsored Single-Agent Phase I Studies.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 2 countries.
Funding
Abstract
purposeAll patients in phase I trials do not have equivalent susceptibility to serious drug-related toxicity (SDRT). Our goal was to develop a nomogram to predict the risk of cycle-one SDRT to better select appropriate patients for phase I trials. PATIENTS AND
methodsThe prospectively maintained database of patients with solid tumor enrolled onto Cancer Therapeutics Evaluation Program-sponsored phase I trials activated between 2000 and 2010 was used. SDRT was defined as a grade ≥ 4 hematologic or grade ≥ 3 nonhematologic toxicity attributed, at least possibly, to study drug(s). Logistic regression was used to test the association of candidate factors to cycle-one SDRT. A final model, or nomogram, was chosen based on both clinical and statistical significance and validated internally using a bootstrapping technique and externally in an independent data set.
resultsData from 3,104 patients enrolled onto 127 trials were analyzed to build the nomogram. In a model with multiple covariates, Eastern Cooperative Oncology Group performance status, WBC count, creatinine clearance, albumin, AST, number of study drugs, biologic study drug (yes v no), and dose (relative to maximum administered) were significant predictors of cycle-one SDRT. All significant factors except dose were included in the final nomogram. The model was validated both internally (bootstrap-adjusted concordance index, 0.60) and externally (concordance index, 0.64).
conclusionThis nomogram can be used to accurately predict a patient's risk for SDRT at the time of enrollment. Excluding patients at high risk for SDRT should improve the safety and efficiency of phase I trials.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.