Evidence map›Paper›PMID 32534809›Full record

Trial reportGynecologic oncology2020

Phase II study of pembrolizumab efficacy and safety in women with recurrent small cell neuroendocrine carcinoma of the lower genital tract.

Michael Frumovitz, Shannon N Westin, Gloria Salvo, Abdulrazzak Zarifa, Mingxuan Xu, Timothy A Yap, Ahnert J Rodon, Daniel D Karp, Abdulrahman Abonofal, Amir A Jazaeri and 1 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02721732 (Phase II Study for the Evaluation of Efficacy of Pembrolizumab), which is not on this map. Cited by 43 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 1 pooled it
6.5field-weighted citation impact, top 2% 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.

NCT02721732 phase2active not recruitingnot on this map

Phase II Study for the Evaluation of Efficacy of Pembrolizumab (MK-3475) in Patients With Rare Tumors

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2016 to 2028Enrolled157ConditionsAdvanced Malignant Solid Neoplasm, Carcinoma of Unknown Primary, Metastatic Adrenal Gland Pheochromocytoma, Metastatic Kidney Medullary CarcinomaArmsLaboratory Biomarker Analysis, Pembrolizumab, Questionnaire Administration
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 1 synthesis or guideline pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  12. Advances in cervical cancer: current insights and future directions.Cancer communications (London, England) · 2025
    Review
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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

11 authors at 1 institution in 1 country.

Michael FrumovitzDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: mfrumovitz@mdanderson.org.
Shannon N WestinDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: swestin@mdanderson.org.
Gloria SalvoDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: GSalvo@mdanderson.org.
Abdulrazzak ZarifaDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: azarifa@mdanderson.org.
Mingxuan XuDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: mxu2@mdanderson.org.
Timothy A YapDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: tyap@mdanderson.org.
Ahnert J RodonDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: jrodon@mdanderson.org.
Daniel D KarpDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: dkarp@mdanderson.org.
Abdulrahman AbonofalDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States.
Amir A JazaeriDepartment of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: aajazaeri@mdanderson.org.
Aung NaingDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States. Electronic address: anaing@mdanderson.org.
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of pembrolizumab in women with recurrent small cell neuroendocrine tumors of the lower genital tract.

methodsWe conducted an open-label, investigator-initiated phase II basket trial of pembrolizumab 200 mg intravenously every 3 weeks in patients with rare tumors (ClinicalTrials.gov: NCT02721732). The trial had prespecified cohorts, including small cell malignancies of extrapulmonary origin. Eligibility criteria included disease progression during standard treatment in the 6 months before study enrollment. Patients were enrolled from February 2017 to February 2019. The primary endpoint was the proportion of patients alive without progression at 27 weeks. Response to pembrolizumab was evaluated every 9 weeks (3 cycles) with radiographic imaging.

resultsSeven women with gynecologic extrapulmonary small cell carcinoma were enrolled, 6 with cervical and 1 with vulvar carcinoma. No patient was progression free at 27 weeks. At first radiologic assessment, 1 patient had stable disease, while 6 had progression. The single patient with stable disease at 6 weeks had disease progression at 14 weeks. The median progression-free interval was 2.1 months (range 0.8-3.3 months). Severe treatment-related adverse events (≥grade 3) were seen in 2 of 7 patients (29%); 1 patient had grade 3 asymptomatic elevation of serum alkaline phosphatase, and 1 had grade 3 asymptomatic elevation of serum alanine aminotransferase.

conclusionsPembrolizumab alone showed minimal activity in women with recurrent small cell neuroendocrine tumors of the lower genital tract. Treatment was well tolerated in the majority of study participants, and the rate of severe adverse events was low.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalCarcinoma, NeuroendocrineCarcinoma, Small CellFemaleHumansMiddle AgedNeoplasm Recurrence, LocalProgression-Free SurvivalResponse Evaluation Criteria in Solid TumorsUterine Cervical NeoplasmsVulvar NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalpembrolizumabCervical cancerCheckpoint inhibitorImmunotherapyNeuroendocrinePhase IISmall cell

Identifiers

PMID32534809
PMCPMC7486997
OpenAlexW3034229498

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

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.