SynthesisBMC cancer2021
Optimal biological dose: a systematic review in cancer phase I clinical trials.
Synthesis in BMC cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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
28 citing papers in PubMed, 43 citations in OpenAlex.
- The value of target-site physiologically-based pharmacokinetics for high-affinity small molecules: a mechanistic foundation for precision dosing in oncology and hematology.Cancer chemotherapy and pharmacology · 2026Article
- Generalized Pairwise Comparisons in Dose Optimization Oncology Trials: Beyond Safety to Multi-outcome Dose Selection.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Landscape of T-cell bispecific antibodies in cancer therapy: therapeutic strategies, challenges and future prospection.Molecular cancer · 2026Review
- Clinical Development of Novel-Novel Multi-Company Combination Therapies in Oncology.Current oncology reports · 2026Review
- Personalized pharmacokinetic-pharmacodynamic guided therapy via an induced pluripotent stem cell-derived multi-organoid platform in NF1-mutant breast cancer.Signal transduction and targeted therapy · 2026Article
- Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) N-of-1 Precision Oncology Study: Molecular Profiling to Match Individually Dosed, Personalized Drug Combinations.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Observational
- A short review of dose-finding adaptive trial designs for clinical pharmacologists and non-statisticians in oncology.European journal of clinical pharmacology · 2026Review
- Impact of Dose-Escalation Design on the Safety and Development of Anticancer Drugs in Clinical Trials.Clinical and translational science · 2025Article
- Contemporary Characteristics and Outcomes of Pediatric Oncology Patients Participating in Early Phase Clinical Trials.Cancer medicine · 2025Article
- Understanding the Role of Patient-Reported Outcomes for Decision-Making in Early-Phase Dose-Finding Clinical Trials.Current oncology (Toronto, Ont.) · 2025Article
- A phase I study of MLN4924 and belinostat in relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome.Cancer chemotherapy and pharmacology · 2025Article
- Clinical Pharmacology of Cytokine Release Syndrome with T-Cell-Engaging Bispecific Antibodies: Current Insights and Drug Development Strategies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Review
- Safety of unconventional antibody-drug conjugate L-DOS47 in a phase I/II monotherapy study targeting advanced NSCLC.Frontiers in oncology · 2025Article
- Population Pharmacokinetic and Pharmacodynamic Modeling Analysis of rhIL-7-hyFc, a Hybrid Fc-Fused Long-Acting Interleukin-7, to Support Optimal Dosing Regimens in Patients with Solid Cancer.Drug design, development and therapy · 2025Article
- Targeting PI3Kδ in cancer: a setback or the end.Frontiers in oncology · 2025Article
- Application of machine learning in breast cancer survival prediction using a multimethod approach.Scientific reports · 2024Article
- Resistance Management for Cancer: Lessons from Farmers.Cancer research · 2024Review
- REDOMA: Bayesian random-effects dose-optimization meta-analysis using spike-and-slab priors.Statistics in medicine · 2024Article
- Dose-limiting mucositis: friend or foe?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Article
- Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundClassical phase 1 dose-finding designs based on a single toxicity endpoint to assess the maximum tolerated dose were initially developed in the context of cytotoxic drugs. With the emergence of molecular targeted agents and immunotherapies, the concept of optimal biological dose (OBD) was subsequently introduced to account for efficacy in addition to toxicity. The objective was therefore to provide an overview of published phase 1 cancer clinical trials relying on the concept of OBD.
methodsWe performed a systematic review through a computerized search of the MEDLINE database to identify early phase cancer clinical trials that relied on OBD. Relevant publications were selected based on a two-step process by two independent readers. Relevant information (phase, type of therapeutic agents, objectives, endpoints and dose-finding design) were collected.
resultsWe retrieved 37 articles. OBD was clearly mentioned as a trial objective (primary or secondary) for 22 articles and was traditionally defined as the smallest dose maximizing an efficacy criterion such as biological target: biological response, immune cells count for immunotherapies, or biological cell count for targeted therapies. Most trials considered a binary toxicity endpoint defined in terms of the proportion of patients who experienced a dose-limiting toxicity. Only two articles relied on an adaptive dose escalation design.
conclusionsIn practice, OBD should be a primary objective for the assessment of the recommended phase 2 dose (RP2D) for a targeted therapy or immunotherapy phase I cancer trial. Dose escalation designs have to be adapted accordingly to account for both efficacy and toxicity.
Indexed as
Identifiers
What OpenQuestion holds
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.