Evidence map›Paper›PMID 38794815›Full record

Trial reportHead & neck2024

Effect of time-of-day nivolumab and stereotactic body radiotherapy in metastatic head and neck squamous cell carcinoma: A secondary analysis of a prospective randomized trial.

James R Janopaul-Naylor, Lillian Boe, Yao Yu, Eric J Sherman, David G Pfister, Nancy Y Lee, Sean McBride

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Head & neck, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–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

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Timing matters: how mechanism-guided sequencing shapes the efficacy of radiotherapy-immunotherapy combinations : A systematic review.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. 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

7 authors.

James R Janopaul-NaylorDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Lillian BoeDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Yao YuDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Eric J ShermanDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
David G PfisterDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Nancy Y LeeDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Sean McBrideDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
American Society of Clinical OncologyMemorial Sloan-Kettering Cancer CenterNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPrior work documented circadian rhythm impacts on efficacy and toxicity of cancer therapies.

methodsSecondary analysis of prospective, phase II trial of metastatic HNSCC randomized to nivolumab+/-SBRT. Used cutoffs of 1100 and 1630. Timing classified by first infusion or majority of SBRT (e.g., PM SBRT defined by two or three fractions after 1630).

resultsOf 62 patients, there was no significant difference in median PFS between AM nivolumab (n = 7, 175 days), PM nivolumab (n = 21, 58 days), or Mid-Day nivolumab (n = 34, 67 days; p = 0.8). There was no significant difference in median PFS with AM SBRT (n = 4, 78 days), PM SBRT (n = 13, 111 days), or Mid-Day SBRT (n = 15, 63 days; p = 0.8). There was no significant difference in Grade 3-4 toxicity or ORR. Sensitivity analyses with other timepoints were negative.

conclusionsFurther work may elucidate circadian impacts on select patients, tumors, and therapies; however, we found no significant effect in this study.

Indexed as

Head and Neck NeoplasmsNivolumabRadiosurgerySquamous Cell Carcinoma of Head and NeckAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalCircadian RhythmCombined Modality TherapyDrug Administration ScheduleFemaleHumansMaleMiddle AgedProspective StudiesAntineoplastic Agents, ImmunologicalNivolumabchrono‐oncologycircadian rhythmhead and neck cancerimmunotherapystereotactic body radiotherapy

Identifiers

PMID38794815
PMCPMC11305937

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.