Evidence map›Paper›PMID 26308485›Full record

Trial reportCancer2015

Multicenter phase 2 study of patupilone for recurrent or progressive brain metastases from non-small cell lung cancer.

Lakshmi Nayak, Lisa M DeAngelis, H Ian Robins, Ramaswamy Govindan, Shirish Gadgeel, Karen Kelly, James R Rigas, David M Peereboom, Steven S Rosenfeld, Alona Muzikansky and 5 more

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

Trial report in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
2.4field-weighted citation impact, top 11% 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

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Article
  2. Article
  3. Epothilones as Natural Compounds for Novel Anticancer Drugs Development.International journal of molecular sciences · 2023
    Review
  4. Article
  5. Leptomeningeal Metastases.Current treatment options in oncology · 2018
    Review
  6. Review
  7. Article
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 11 institutions in 1 country.

Lakshmi NayakCenter For Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Lisa M DeAngelisDepartment of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York.
H Ian RobinsDepartment of Human Oncology, University of Wisconsin Hospital and Clinics, Madison, Wisconsin.
Ramaswamy GovindanDivision of Oncology, Washington University School of Medicine in St. Louis, St. Louis, Missouri.
Shirish GadgeelKarmanos Cancer Institute/Wayne State University, Detroit, Michigan.
Karen KellyDivision of Hematology and Oncology, Davis Comprehensive Cancer Center, University of California, Sacramento, California.
James R RigasNorris Cotton Cancer Center/Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
David M PeereboomBurkhardt Brain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, Ohio.
Steven S RosenfeldDepartment of Neurology, Columbia University Medical Center/New York Presbyterian, New York, New York.
Alona MuzikanskyBiostatistics Center, Massachusetts General Hospital, Boston, Massachusetts.
Ming ZhengNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Patrick UrbanNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Lauren E AbreyDepartment of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York.
Antonio OmuroDepartment of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York.
Patrick Y WenCenter For Neuro-Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
Memorial Sloan Kettering Cancer Center · USNovartis (United States) · USCenter for Neuro-Oncology · USCleveland Clinic · USColumbia University Irving Medical Center · USDana-Farber Cancer Institute · USDartmouth–Hitchcock Medical Center · USMassachusetts General Hospital · USThe Barbara Ann Karmanos Cancer Institute · USUW Health University Hospital · USWashington University in St. Louis · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Participating Member Institution in NABTCU01CA105663 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI DEANGELIS, LISA M · 2004 to 2008
$811k
NCI NIH HHS P30 CA008748NCI NIH HHS U01 CA105663
6 · The paper itself

Abstract

backgroundTreatment options for patients with non-small cell lung cancer (NSCLC) with brain metastases are limited. Patupilone (EPO906), a blood-brain barrier-penetrating, microtubule-targeting, cytotoxic agent, has shown clinical activity in phase 1/2 studies in patients with NSCLC. This study evaluates the efficacy, pharmacokinetics, and safety of patupilone in NSCLC brain metastases.

methodsAdult patients with NSCLC and confirmed progressive brain metastases received patupilone intravenously at 10 mg/m(2) every 3 weeks. The primary endpoint of this multinomial 2-stage study combined early progression (EP; death or progression within 3 weeks) and progression-free survival at 9 weeks (PFS9w) to determine drug activity.

resultsFifty patients with a median age of 60 years (range, 33-74 years) were enrolled; the majority were men (58%), and most had received prior therapy for brain metastases (98%). The PFS9w rate was 36%, and the EP rate was 26%. Patupilone blood pharmacokinetic analyses showed mean areas under the concentration-time curve from time zero to 504 hours for cycles 1 and 3 of 1544 and 1978 ng h/mL, respectively, and a mean steady state distribution volume of 755 L/m(2) . Grade 3/4 adverse events (AEs), regardless of their relation with the study drug, included diarrhea (24%), pulmonary embolisms (8%), convulsions (4%), and peripheral neuropathy (4%). All patients discontinued the study drug: 31 (62%) for disease progression and 13 (26%) for AEs. Twenty-five of 32 deaths were due to brain metastases. The median time to progression and the overall survival were 3.2 and 8.8 months, respectively.

conclusionsThis is the first prospective study of chemotherapy for recurrent brain metastases from NSCLC. In this population, patupilone demonstrated activity in heavily treated patients.

Indexed as

Administration, IntravenousAdultAgedAntineoplastic AgentsBrain NeoplasmsCarcinoma, Non-Small-Cell LungDisease ProgressionDrug Administration ScheduleEpothilonesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesAntineoplastic Agentsepothilone BEpothilonesbrain metastaseschemotherapynon-small cell lung cancerpatupilonerecurrent metastases

Identifiers

PMID26308485
PMCPMC5941922
OpenAlexW1837134848

What OpenQuestion holds

Textmetadata
LicenceTDM
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.