Evidence map›Paper›PMID 31741544›Full record

ArticleJournal of the American Statistical Association2018

A Bayesian Phase I/II Trial Design for Immunotherapy.

Suyu Liu, Beibei Guo, Ying Yuan

Abstract read
In one paragraph

Article in Journal of the American Statistical Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed.

  1. Trial
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  14. Article
  15. Novel Clinical Trial Designs with Dose Optimization to Improve Long-term Outcomes.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Review
  16. Article
  17. Article
  18. Interval design to identify the optimal biological dose for immunotherapy.Contemporary clinical trials communications · 2022
    Article
  19. Combining cytotoxic agents with continuous dose levels in seamless phase I-II clinical trials.Journal of the Royal Statistical Society. Series C, Applied statistics · 2022
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Suyu LiuAssistant Professor, Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX 77030-4009.
Beibei GuoAssistant Professor, Department of Experimental Statistics, Louisiana State University, Baton Rouge, LA 70803.
Ying YuanProfessor, Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX 77030-4009, (yyuan@mdanderson.org).

Funding

Targeting the PI3K Signaling Pathway in Endometrial CarcinomaP50CA098258 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI BODURKA, DIANE · 2003 to 2020
$32.0M
Bayesian Adaptive Designs for Oncology Clinical Trials with Late-onset OutcomesR01CA154591 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI YUAN, YING · 2011 to 2014
$1.2M
NCI NIH HHS P50 CA098258NCI NIH HHS R01 CA154591
6 · The paper itself

Abstract

Immunotherapy is an innovative treatment approach that stimulates a patient's immune system to fight cancer. It demonstrates characteristics distinct from conventional chemotherapy and stands to revolutionize cancer treatment. We propose a Bayesian phase I/II dosefinding design that incorporates the unique features of immunotherapy by simultaneously considering three outcomes: immune response, toxicity and efficacy. The objective is to identify the biologically optimal dose, defined as the dose with the highest desirability in the risk-benefit tradeoff. An Emax model is utilized to describe the marginal distribution of the immune response. Conditional on the immune response, we jointly model toxicity and efficacy using a latent variable approach. Using the accumulating data, we adaptively randomize patients to experimental doses based on the continuously updated model estimates. A simulation study shows that our proposed design has good operating characteristics in terms of selecting the target dose and allocating patients to the target dose.

Indexed as

Bayesian adaptive designdose findingimmune responseImmunotherapyphase I/II trialrisk-benefit tradeoff

Identifiers

PMID31741544
PMCPMC6860919

What OpenQuestion holds

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Registered trials

None linked

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.