Evidence map›Paper›PMID 32601075›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Randomized Phase II Trial of Carboplatin-Paclitaxel Compared with Carboplatin-Paclitaxel-Trastuzumab in Advanced (Stage III-IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis.

Amanda N Fader, Dana M Roque, Eric Siegel, Natalia Buza, Pei Hui, Osama Abdelghany, Setsuko Chambers, Angeles Alvarez Secord, Laura Havrilesky, David M O'Malley and 14 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01367002 (Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab), which is not on this map. Cited by 140 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
140citing papers in PubMed, 3 pooled it
13.6field-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.

NCT01367002 phase2completednot on this map

Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma

TypeinterventionalSponsorYale UniversityRan2011 to 2022Enrolled61ConditionsEndometrial CancerArmsCarboplatin/Paclitaxel, Trastuzumab
3 · Its place in the literature

Who cites it

140 citing papers in PubMed, 3 syntheses or guidelines pooled it, 295 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Colombian consensus for the molecular diagnosis of endometrial cancerRevista colombiana de obstetricia y ginecologia · 2024
    Guideline
  4. p53 immunohistochemistry in endometrial cancer: clinical and molecular correlates in the PORTEC-3 trial.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022
    Trial
  5. Trial
  6. Review
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80 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

24 authors at 14 institutions in 2 countries.

Amanda N FaderJohn Hopkins School of Medicine, Baltimore, Maryland.
Dana M RoqueUniversity of Maryland, Baltimore, Maryland.ORCID 0000-0002-7098-6376
Eric SiegelUniversity of Arkansas for Medical Sciences, Little Rock, Arkansas.ORCID 0000-0001-9824-6612
Natalia BuzaYale University, New Haven, Connecticut.
Pei HuiYale University, New Haven, Connecticut.
Osama AbdelghanyYale University, New Haven, Connecticut.
Setsuko ChambersUniversity of Arizona, Tucson, Arizona.
Angeles Alvarez SecordDuke University School of Medicine, Durham, North Caroline.
Laura HavrileskyDuke University School of Medicine, Durham, North Caroline.
David M O'MalleyThe Ohio State University School of Medicine, Columbus, Ohio.
Floor J BackesThe Ohio State University School of Medicine, Columbus, Ohio.ORCID 0000-0002-9225-6913
Nicole NevadunskyAlbert Einstein College/Montefiore Medical Center, Bronx, New York.ORCID 0000-0001-5680-0670
Babak EdrakiJohn Muir Medical Center, Walnut Creek, California.
Dirk PikaartPenrose Cancer Center-St. Francis, Colorado Springs, Colorado.
William LoweryWalter Reed Medical Center, Bethesda, Maryland.
Karim ElSahwiHackensack Meridian Health, Neptune, New Jersey.
Paul CelanoGreater Baltimore Medical Center, Baltimore, Maryland.ORCID 0000-0002-1365-0411
Stefania BelloneYale University, New Haven, Connecticut.
Masoud AzodiYale University, New Haven, Connecticut.
Babak LitkouhiStanford Women's Cancer Center, Palo Alto, California.
Elena RatnerYale University, New Haven, Connecticut.
Dan-Arin SilasiYale University, New Haven, Connecticut.
Peter E SchwartzYale University, New Haven, Connecticut.
Alessandro D SantinYale University, New Haven, Connecticut. alessandro.santin@yale.edu.
Yale University · USDuke University · USThe Ohio State University · USGreater Baltimore Medical Center · USHackensack Meridian Health · USJohn Muir Health · USMontefiore Medical Center · USPenrose-St. Francis Health Services · USUniversity of Arizona · USUniversity of Arkansas for Medical Sciences · USUniversity of Baltimore · USUniversity of Maryland, Baltimore · USWalter Reed National Military Medical Center · USWomen's Cancer Center of Nevada · US

Funding

Integrated genomic analysis of racial disparities in endometrial cancerU01CA176067 · NCI · YALE UNIVERSITY · PI SANTIN, ALESSANDRO D · 2014 to 2018
$1.7M
NCI NIH HHS U01 CA176067
6 · The paper itself

Abstract

purposeUterine-serous-carcinoma (USC) is an aggressive variant of endometrial cancer. On the basis of preliminary results of a multicenter, randomized phase II trial, trastuzumab (T), a humanized-mAb targeting Her2/Neu, in combination with carboplatin/paclitaxel (C/P), is recognized as an alternative in treating advanced/recurrent HER2/Neu-positive USC. We report the updated survival analysis of NCT01367002. PATIENTS AND

methodsEligible patients had stage III to IV or recurrent disease. Participants were randomized 1:1 to receive C/P for six cycles ± T followed by maintenance T until progression or toxicity. Progression-free survival (PFS) was the primary endpoint; overall survival (OS) and toxicity were secondary endpoints.

resultsSixty-one patients were randomized. After a median-follow-up of 25.9 months, 43 progressions and 38 deaths occurred among 58 evaluable patients. Updated median-PFS continued to favor the T-arm, with medians of 8.0 months versus 12.9 months in the control and T-arms (HR = 0.46; 90% CI, 0.28-0.76;

conclusionsAddition of T to C/P increased PFS and OS in women with advanced/recurrent HER2/Neu-positive USC, with the greatest benefit seen for the treatment of stage III to IV disease.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinChemotherapy, AdjuvantCystadenocarcinoma, SerousCytoreduction Surgical ProceduresDrug Administration ScheduleEndometrial NeoplasmsEndometriumErb-b2 Receptor Tyrosine KinasesFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingCarboplatinERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesPaclitaxelTrastuzumab

Identifiers

PMID32601075
PMCPMC8792803
OpenAlexW3037541659

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.