Evidence map›Paper›PMID 26195720›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project.

Youn H Kim, Mahkam Tavallaee, Uma Sundram, Katrin A Salva, Gary S Wood, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 107 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 3 pooled it
32.8field-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

107 citing papers in PubMed, 3 syntheses or guidelines pooled it, 278 citations in OpenAlex.

  1. Pooled it
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  3. Interventions for mycosis fungoides.The Cochrane database of systematic reviews · 2020
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47 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Youn H KimYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY. younkim@stanford.edu.
Mahkam TavallaeeYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Uma SundramYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Katrin A SalvaYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Gary S WoodYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Shufeng LiYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Sima RozatiYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Seema NagpalYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Michael KrathenYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Sunil ReddyYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Richard T HoppeYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Annie Nguyen-LinYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Wen-Kai WengYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Randall ArmstrongYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Melissa PulitzerYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Ranjana H AdvaniYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Steven M HorwitzYoun H. Kim, Mahkam Tavallaee, Uma Sundram, Shufeng Li, Sima Rozati, Seema Nagpal, Michael Krathen, Sunil Reddy, Richard T. Hoppe, Annie Nguyen-Lin, Wen-Kai Weng, Randall Armstrong, and Ranjana H. Advani, Stanford University, Stanford, CA; Katrin A. Salva and Gary S. Wood, University of Wisconsin and William S. Middleton Memorial Veterans Hospital, Madison, WI; and Melissa Pulitzer and Steven M. Horwitz, Memorial Sloan Kettering Cancer Center, New York, NY.
Stanford Medicine · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
FAS Pathway Abnormalities in MF and SSI01BX002204 · VA · WM S. MIDDLETON MEMORIAL VETERANS HOSP · PI WOOD, GARY S · 2015 to 2018
–
BLRD VA I01 BX002204NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeIn contrast to Hodgkin lymphoma and systemic anaplastic large-cell lymphoma, CD30 expression of malignant lymphocytes in mycosis fungoides (MF) and Sézary syndrome (SS) is quite variable. Clinical activity and safety of brentuximab vedotin, a CD30 targeting antibody-drug conjugate, was evaluated in MF and SS. Tissue and blood biomarkers of clinical response were explored. PATIENTS AND

methodsIn this phase II study, patients with MF or SS with negligible to 100% CD30 expression levels were treated with brentuximab vedotin (1.8 mg/kg) every 3 weeks for a maximum of sixteen doses. The primary end point was overall global response rate. Secondary end points included correlation of tissue CD30 expression level with clinical response, time to response, duration of response, progression-free and event-free survivals, and safety.

resultsOf the 32 patients enrolled and treated, 30 patients had available efficacy evaluations. Objective global response was observed in 21 (70%) of 30 patients (90% CI, 53% to 83%). CD30 expression assessed by immunohistochemistry was highly variable, with a median CD30max of 13% (range, 0% to 100%). Those with <5% CD30 expression had a lower likelihood of global response than did those with 5% or greater CD30 expression (P < .005). CD163 positive tumor-associated macrophages, many of which coexpress CD30, were abundant in tissue. Peripheral neuropathy was the most common adverse event.

conclusionBrentuximab vedotin demonstrated significant clinical activity in treatment-refractory or advanced MF or SS with a wide range of CD30 expression levels. Additional biomarker studies may help optimize rational design of combination therapies with brentuximab vedotin.

Indexed as

AdultAgedAged, 80 and overAntigens, CDAntigens, Differentiation, MyelomonocyticAntineoplastic AgentsBiomarkers, TumorBrentuximab VedotinCD163 AntigenCD8 AntigensCooperative BehaviorDrug Administration ScheduleFemaleGene Expression Regulation, NeoplasticHumansImmunoconjugatesAntigens, CDAntigens, Differentiation, MyelomonocyticAntineoplastic AgentsBiomarkers, TumorBrentuximab VedotinCD163 AntigenCD8 AntigensImmunoconjugatesKi-1 AntigenReceptors, Cell Surface

Identifiers

PMID26195720
PMCPMC5089160
OpenAlexW2119799189

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.