Evidence map›Paper›PMID 35438782›Full record

Trial reportThe oncologist2022

Phase II Clinical and Translational Study of Everolimus ± Paclitaxel as First-Line Therapy in Cisplatin-Ineligible Advanced Urothelial Carcinoma.

Tomi Jun, Noah M Hahn, Guru Sonpavde, Constantine Albany, Gary R MacVicar, Ralph Hauke, Mark Fleming, Theodore Gourdin, Bagi Jana, William K Oh and 5 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01215136 (Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 25% 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.

NCT01215136 phase2terminatednot on this map

Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients With Advanced Urothelial Carcinoma: Hoosier Cancer Research Network GU10-147

TypeinterventionalSponsorMatthew GalskyRan2010 to 2018Enrolled36ConditionsTransitional Cell Carcinoma, Bladder Carcinoma, Urothelial CarcinomaArmsEverolimus, Paclitaxel
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. The Role of Natural Compounds in Bladder Urothelial Carcinoma Treatment.International journal of molecular sciences · 2026
    Review
  3. Article
  4. Review
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

15 authors at 10 institutions in 1 country.

Tomi JunSema4, Stamford, CT, USA.
Noah M HahnIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Guru SonpavdeUniversity of Alambama at Birmingham, Birmingham, AL Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
Constantine AlbanyIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN, USA.
Gary R MacVicarRobert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL Illinois CancerCare, Peoria, IL, USA.
Ralph HaukeNebraska Cancer Specialists/ Nebraska Methodist Hospital, Omaha, NE, USA.
Mark FlemingVirginia Oncology Associates, Norfolk, VA, USA.
Theodore GourdinMedical University of South Carolina Hollings Cancer Center, Charleston, SC, USA.
Bagi JanaUniversity of Texas Medical Branch at Galveston, Galveston, TX, USA.
William K OhSema4, Stamford, CT, USA.
Patricia TaikSema4, Stamford, CT, USA.
Huan WangSema4, Stamford, CT, USA.
Ajay Ramakrishnan VaradarajanSema4, Stamford, CT, USA.
Andrew UzilovSema4, Stamford, CT, USA.
Matthew D GalskyThe Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Sema4 (United States) · USIcahn School of Medicine at Mount Sinai · USDana-Farber Cancer Institute · USIllinois CancerCare · USIndiana University Health · USMedical University of South Carolina · USNebraska Cancer Specialists · USSidney Kimmel Comprehensive Cancer Center · USThe University of Texas Medical Branch at Galveston · USVirginia Oncology Associates · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment options have been historically limited for cisplatin-ineligible patients with advanced urothelial carcinoma (UC). Given the need for alternatives to platinum-based chemotherapy, including non-chemotherapy regimens for patients with both impaired renal function and borderline functional status, in 2010 (prior to the immune checkpoint blockade era in metastatic UC), we initiated a phase II trial to test the activity of everolimus or everolimus plus paclitaxel in the cisplatin-ineligible setting.

methodsThis was an open-label phase II trial conducted within the US-based Hoosier Cancer Research Network (ClinicalTrials.gov number: NCT01215136). Patients who were cisplatin-ineligible with previously untreated advanced UC were enrolled. Patients with both impaired renal function and poor performance status were enrolled into cohort 1; patients with either were enrolled into cohort 2. Patients received everolimus 10 mg daily alone (cohort 1) or with paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle (cohort 2). The primary outcome was clinical benefit at 4 months. Secondary outcomes were adverse events, progression-free survival (PFS), and 1-year overall survival (OS). Exploratory endpoints included genomic correlates of outcomes. The trial was not designed for comparison between cohorts.

resultsA total of 36 patients were enrolled from 2010 to 2018 (cohort 1, N = 7; cohort 2, N = 29); the trial was terminated due to slow accrual. Clinical benefit at 4 months was attained by 0 (0%, 95% confidence interval [CI] 0-41.0%) patients in cohort 1 and 11 patients (37.9%, 95% CI 20.7-57.7%) in cohort 2. Median PFS was 2.33 (95% CI 1.81-Inf) months in cohort 1 and 5.85 (95% CI 2.99-8.61) months in cohort 2. Treatment was discontinued due to adverse events for 2 patients (29%) in cohort 1 and 11 patients (38%) in cohort 2. Molecular alterations in microtubule associated genes may be associated with treatment benefit but this requires further testing.

conclusionEverolimus plus paclitaxel demonstrates clinical activity in cisplatin-ineligible patients with metastatic UC, although the specific contribution of everolimus cannot be delineated. Patients with both impaired renal function and borderline functional status may be difficult to enroll to prospective trials. (ClinicalTrials.gov Identifier NCT01215136).

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellUrinary Bladder NeoplasmsCisplatinEverolimusHumansPaclitaxelProspective StudiesTreatment OutcomeCisplatinEverolimusPaclitaxelcisplatin-ineligibleeverolimusgenomicpaclitaxelurothelial cancer

Identifiers

PMID35438782
PMCPMC9177111
OpenAlexW4210261725

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.