Evidence map›Paper›PMID 31532724›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020

Pembrolizumab in Relapsed and Refractory Mycosis Fungoides and Sézary Syndrome: A Multicenter Phase II Study.

Michael S Khodadoust, Alain H Rook, Pierluigi Porcu, Francine Foss, Alison J Moskowitz, Andrei Shustov, Satish Shanbhag, Lubomir Sokol, Steven P Fling, Nirasha Ramchurren and 23 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 132 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
132citing papers in PubMed, 3 pooled it
24.2field-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

132 citing papers in PubMed, 3 syntheses or guidelines pooled it, 218 citations in OpenAlex.

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72 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

33 authors at 12 institutions in 1 country.

Michael S KhodadoustStanford University, Stanford, CA.
Alain H RookUniversity of Pennsylvania, Philadelphia, PA.
Pierluigi PorcuThomas Jefferson University, Philadelphia, PA.
Francine FossYale University, New Haven, CT.
Alison J MoskowitzMemorial Sloan Kettering Cancer Center, New York, NY.
Andrei ShustovSeattle Cancer Care Alliance, Seattle, WA.
Satish ShanbhagJohns Hopkins University, Baltimore, MD.
Lubomir SokolMoffitt Cancer Center, Tampa, FL.
Steven P FlingFred Hutchinson Cancer Research Center, Seattle, WA.
Nirasha RamchurrenFred Hutchinson Cancer Research Center, Seattle, WA.
Robert PierceFred Hutchinson Cancer Research Center, Seattle, WA.
Asa DavisFred Hutchinson Cancer Research Center, Seattle, WA.
Richard ShineFred Hutchinson Cancer Research Center, Seattle, WA.
Shufeng LiStanford University, Stanford, CA.
Sophia FongStanford University, Stanford, CA.
Jinah KimStanford University, Stanford, CA.
Yi YangFred Hutchinson Cancer Research Center, Seattle, WA.
Wendy M BlumenscheinMerck Research Laboratories, Kenilworth, NJ.
Jennifer H YearleyMerck Research Laboratories, Kenilworth, NJ.
Biswajit DasFrederick National Laboratory for Cancer Research, Frederick, MD.
Rajesh PatidarFrederick National Laboratory for Cancer Research, Frederick, MD.
Vivekananda DattaFrederick National Laboratory for Cancer Research, Frederick, MD.
Erin CantuFrederick National Laboratory for Cancer Research, Frederick, MD.
Justine N McCutcheonFrederick National Laboratory for Cancer Research, Frederick, MD.
Chris KarlovichFrederick National Laboratory for Cancer Research, Frederick, MD.
P Mickey WilliamsFrederick National Laboratory for Cancer Research, Frederick, MD.
Priyanka B SubrahmanyamStanford University, Stanford, CA.
Holden T MaeckerStanford University, Stanford, CA.
Steven M HorwitzMemorial Sloan Kettering Cancer Center, New York, NY.
Elad SharonNational Cancer Institute, Bethesda, MD.
Holbrook E KohrtStanford University, Stanford, CA.
Martin A CheeverFred Hutchinson Cancer Research Center, Seattle, WA.
Youn H KimStanford University, Stanford, CA.
Stanford University · USFrederick National Laboratory for Cancer Research · USFred Hutch Cancer Center · USMemorial Sloan Kettering Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USJohns Hopkins University · USMoffitt Cancer Center · USNational Cancer Institute · USSeattle Cancer Care Alliance · USThomas Jefferson University · USUniversity of Pennsylvania · USYale University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Cancer Immunotherapy Trials Network Central Operations and Statistical CenterUM1CA154967 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DAVIDSON, NANCY ELLEN · 2017 to 2022
$20.7M
CCR NIH HHS HHSN261200800001CNCATS NIH HHS UL1 TR001863NCI NIH HHS HHSN261200800001ENCI NIH HHS P30 CA008748NCI NIH HHS UM1 CA154967
6 · The paper itself

Abstract

purposeTo assess the efficacy of pembrolizumab in patients with advanced relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS). PATIENTS AND

methodsCITN-10 is a single-arm, multicenter phase II trial of 24 patients with advanced MF or SS. Patients were treated with pembrolizumab 2 mg/kg every 3 weeks for up to 24 months. The primary end point was overall response rate by consensus global response criteria.

resultsPatients had advanced-stage disease (23 of 24 with stage IIB to IV MF/SS) and were heavily pretreated with a median of four prior systemic therapies. The overall response rate was 38% with two complete responses and seven partial responses. Of the nine responding patients, six had 90% or more improvement in skin disease by modified Severity Weighted Assessment Tool, and eight had ongoing responses at last follow-up. The median duration of response was not reached, with a median response follow-up time of 58 weeks. Immune-related adverse events led to treatment discontinuation in four patients. A transient worsening of erythroderma and pruritus occurred in 53% of patients with SS. This cutaneous flare reaction did not result in treatment discontinuation for any patient. The flare reaction correlated with high PD-1 expression on Sézary cells but did not associate with subsequent clinical responses or lack of response. Treatment responses did not correlate with expression of PD-L1, total mutation burden, or an interferon-γ gene expression signature.

conclusionPembrolizumab demonstrated significant antitumor activity with durable responses and a favorable safety profile in patients with advanced MF/SS.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorDrug Administration ScheduleFemaleHumansInfusions, IntravenousMaleMiddle AgedMycosis FungoidesNeoplasm StagingRecurrenceAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorCD274 protein, humanpembrolizumab

Identifiers

PMID31532724
PMCPMC6943974
OpenAlexW2974710297

What OpenQuestion holds

Textmetadata
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.