Evidence map›Paper›PMID 32781104›Full record

Trial reportInternational journal of radiation oncology, biology, physics2021

A Randomized Phase 2 Study of Pembrolizumab With or Without Radiation in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.

Umair Mahmood, Andrew Bang, Yu-Hui Chen, Raymond H Mak, Jochen H Lorch, Glenn J Hanna, Mizuki Nishino, Claire Manuszak, Emily M Thrash, Mariano Severgnini and 13 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 7 pooled it
12.9field-weighted citation impact, top 1% of its field
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

66 citing papers in PubMed, 7 syntheses or guidelines pooled it, 109 citations in OpenAlex.

  1. Pooled it
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  8. Trial
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  13. Phase II Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  14. Article
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  16. Review
  17. YTHDFs as radiotherapy checkpoints in tumor immunity.The Journal of experimental medicine · 2025
    Review
  18. Article
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  20. Article

6 more citing papers are in PubMed but not listed here.

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

23 authors at 2 institutions in 1 country.

Umair MahmoodDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Andrew BangDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Yu-Hui ChenDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Raymond H MakDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Jochen H LorchDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Glenn J HannaDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Mizuki NishinoDepartment of Imaging, Dana-Farber Cancer Institute, Boston, Massachusetts.
Claire ManuszakCenter for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Emily M ThrashCenter for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Mariano SevergniniCenter for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Matthew SanbornDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Vishwajith SridharanDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Danielle N MargalitDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Roy B TishlerDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Paul M BusseDepartment of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.
Henning WillersDepartment of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.
Harvey J MamonDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Hyung-Jin YooDivision of Vascular and Endovascular Surgery, Massachusetts General Hospital, Boston, Massachusetts.
Sara I PaiDivision of Surgical Oncology, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts.
Lori J WirthDepartment of Medical Oncology, Massachusetts General Hospital, Boston, Massachusetts.
Robert I HaddadDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Nicole G ChauDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Jonathan D SchoenfeldDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: jonathan_schoenfeld@dfci.harvard.edu.
Dana-Farber Cancer Institute · USMassachusetts General Hospital · US

Funding

Strategies to Overcome Immune Resistance in Head and Neck CancersP01CA240239 · NCI · YALE UNIVERSITY · PI PAI, SARA ISABEL · 2019 to 2023
$8.4M
Phase II Trial of Anti-PD1 Therapy for HPV-associated Recurrent Respiratory Papillomatosis (IND#128874)R01FD006341 · FDA · MASSACHUSETTS GENERAL HOSPITAL · PI PAI, SARA ISABEL · 2019 to 2021
$1.1M
FDA HHS R01 FD006341NCI NIH HHS P01 CA240239
6 · The paper itself

Abstract

purposeWe evaluated the safety and efficacy of pembrolizumab (pembro) ± radiation therapy (RT) in a phase 2 study among patients with progressive, metastatic adenoid cystic carcinoma (ACC). METHODS AND MATERIALS: Eligible patients had metastatic ACC with progression within the last year and ≥1 measurable lesion. Patients were randomized to pembro alone or with RT to 30 Gy in 5 fractions (pembroRT). The primary endpoint was objective response rate outside the RT field. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and local RT responses.

resultsWe randomized 20 patients (10 per arm) from 2017 to 2018. We did not observe objective response outside of the radiation treatment field; stable disease (SD) was the best response in 12 (60%) patients and was not different per arm (7 pembro, 5 pembroRT, P = .65). A tumor growth rate decrease (TGR) of >25% was noted among 7 of 12 patients and >75% in 4 patients. There were local responses in the irradiated field among all evaluable pembroRT patients. Median PFS and OS were 4.5/not reached for pembroRT and 6.6 / 27.2 months for pembro patients. One patient developed grade 3 liver enzyme elevation after 27 cycles of therapy. Correlative analyses confirm low levels of programmed death-ligand 1 expression (PD-L1), and CD8 infiltrating T-cells. We identified associations between local response and both MYB/NFIB translocation and PD-L1 expression and between changes in systemic immune populations and RT.

conclusionsPembrolizumab and pembroRT were well tolerated. We observed no objective responses, but 60% of patients with PD before the study achieved SD, the majority with decreased TGR and half (n = 10) with clinical benefit (SD >6 months). We observed favorable local responses within the RT field. Additional strategies are needed to further delay progression and effect response.

Indexed as

AgedAntibodies, Monoclonal, HumanizedCarcinoma, Adenoid CysticCombined Modality TherapyFemaleHumansMaleMiddle AgedNeoplasm MetastasisRecurrenceSurvival AnalysisTreatment OutcomeAntibodies, Monoclonal, Humanizedpembrolizumab

Identifiers

PMID32781104
PMCPMC9361179
OpenAlexW3048357540

What OpenQuestion holds

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Registered trials

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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.