Evidence map›Paper›PMID 31105345›Full record

ArticleJournal of the Royal Statistical Society. Series C, Applied statistics2019

Optimizing natural killer cell doses for heterogeneous cancer patients on the basis of multiple event times.

Juhee Lee, Peter F Thall, Katy Rezvani

Abstract read
In one paragraph

Article in Journal of the Royal Statistical Society. Series C, Applied statistics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. 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
  7. Article
  8. Review
  9. Innovative trial design in precision oncology.Seminars in cancer biology · 2022
    Review
  10. Article
  11. Article
  12. Article
  13. Adaptive Enrichment Designs in Clinical Trials.Annual review of statistics and its application · 2021
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
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.

Juhee LeeDepartment of Applied Mathematics and Statistics, University of California at Santa Cruz, Santa Cruz, CA.
Peter F ThallDepartment of Biostatistics, M.D. Anderson Cancer Center, Houston, TX.
Katy RezvaniDepartment of Stem Cell Transplantation and Cellular Therapy, M.D. Anderson Cancer Center, Houston, TX.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
STATISTICAL METHODS FOR COMPLEX CANCER TRIALSR01CA083932 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI THALL, PETER F · 2000 to 2017
$2.3M
Off-the-shelf engineered NK cells for the treatment of AMLR01CA211044 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI REZVANI, KATY · 2017 to 2021
$2.0M
NCATS NIH HHS UL1 TR000371NCI NIH HHS P30 CA016672NCI NIH HHS R01 CA083932NCI NIH HHS R01 CA211044
6 · The paper itself

Abstract

A sequentially adaptive Bayesian design is presented for a clinical trial of cord blood derived natural killer cells to treat severe hematologic malignancies. Given six prognostic subgroups defined by disease type and severity, the goal is to optimize cell dose in each subgroup. The trial has five co-primary outcomes, the times to severe toxicity, cytokine release syndrome, disease progression or response, and death. The design assumes a multivariate Weibull regression model, with marginals depending on dose, subgroup, and patient frailties that induce association among the event times. Utilities of all possible combinations of the nonfatal outcomes over the first 100 days following cell infusion are elicited, with posterior mean utility used as a criterion to optimize dose. For each subgroup, the design stops accrual to doses having an unacceptably high death rate, and at the end of the trial selects the optimal safe dose. A simulation study is presented to validate the design's safety, ability to identify optimal doses, and robustness, and to compare it to a simplified design that ignores patient heterogeneity.

Indexed as

Cellular TherapyDose FindingNatural Killer CellsPhase I–II Clinical TrialPrecision Medicine

Identifiers

PMID31105345
PMCPMC6521706

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.