Evidence map›Paper›PMID 31172405›Full record

Trial reportBreast cancer research and treatment2019

Phase II study of irinotecan and temozolomide in breast cancer patients with progressing central nervous system disease.

Michelle E Melisko, Michael Assefa, Jimmy Hwang, Amy DeLuca, John W Park, Hope S Rugo

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.4field-weighted citation impact, top 10% 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

17 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
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  8. Advances in the Diagnosis and Treatment of Leptomeningeal Disease.Current neurology and neuroscience reports · 2022
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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

6 authors at 2 institutions in 1 country.

Michelle E MeliskoDepartment of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA, USA. michelle.melisko@ucsf.edu.ORCID http://orcid.org/0000-0002-8729-4667
Michael AssefaWellstar Atlanta Medical Center, Atlanta, GA, USA.
Jimmy HwangEmeritus Professor, Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
Amy DeLucaDepartment of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA, USA.
John W ParkDepartment of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA, USA.
Hope S RugoDepartment of Medicine, Division of Hematology and Oncology, University of California San Francisco, San Francisco, CA, USA.
University of California, San Francisco · USAtlanta Medical Center · US

Funding

Merck A105089Pfizer 2005-0811
6 · The paper itself

Abstract

purposeBreast cancer patients with progressing central nervous system (CNS) disease have limited treatment options. Few chemotherapy drugs with activity in breast cancer have well-documented CNS penetration. This phase 2 trial evaluated efficacy and safety of irinotecan 125 mg/m

methodsBreast cancer patients of any biological subtype and progressing brain metastases and/or leptomeningeal disease (LMD) were eligible. The primary endpoint was CNS response rate. Secondary endpoints were clinical benefit rate (CBR), time to progression (TTP), and overall survival (OS). Imaging studies evaluating intracranial and extracranial response were performed every 8 weeks.

resultsThirty patients were evaluable for safety and efficacy. The most common hematologic and non-hematologic adverse events were neutropenia, and nausea and fatigue, respectively. There were two confirmed CNS partial responses (PR) and five patients with stable disease in the CNS ≥ 16 weeks, resulting in a 7% PR and 23% CBR. Median TTP was 2.3 months (range 13-444 days), and median OS from treatment initiation until death was 4.9 months (range 20-1023 days). Excluding patients with LMD, median TTP and OS were 3.1 and 5.6 months, respectively. Only one patient progressed systemically before CNS progression.

conclusionsThe combination of irinotecan and temozolomide was well tolerated, demonstrated some clinical activity across multiple breast cancer subtypes with progressing CNS disease, and offers a reasonable option for patients who are not candidates for further radiation or clinical trials.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCentral Nervous System NeoplasmsFemaleHumansIrinotecanMiddle AgedRetreatmentSurvival AnalysisTemozolomideTreatment OutcomeBiomarkers, TumorIrinotecanTemozolomideBrain metastasesBreast cancerChemotherapyClinical trialIrinotecanTemozolomide

Identifiers

PMID31172405
OpenAlexW2948257396

What OpenQuestion holds

Textmetadata
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.