Evidence map›Paper›PMID 29119354›Full record

ArticleBreast cancer research and treatment2018

Characteristics and outcomes of breast cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase I clinical trials.

Filipa Lynce, Matthew J Blackburn, Ling Cai, Heping Wang, Larry Rubinstein, Pamela Harris, Claudine Isaacs, Paula R Pohlmann

Abstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
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

6 citing papers in PubMed.

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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

8 authors.

Filipa LynceLombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, 3800 Reservoir Rd NW, Podium B Room 404, Washington, 20007, DC, USA. filipa.c.lynce@gunet.georgetown.edu.ORCID http://orcid.org/0000-0001-6615-7076
Matthew J BlackburnLombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, 3800 Reservoir Rd NW, Podium B Room 404, Washington, 20007, DC, USA.
Ling CaiDepartment of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University, Washington, USA.
Heping WangDepartment of Biostatistics, Bioinformatics, and Biomathematics, Georgetown University, Washington, USA.
Larry RubinsteinBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, USA.
Pamela HarrisInvestigational Drug Branch Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, USA.
Claudine IsaacsLombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.
Paula R PohlmannLombardi Comprehensive Cancer Center, MedStar Georgetown University Hospital, 3800 Reservoir Rd NW, Podium B Room 404, Washington, 20007, DC, USA.

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI STEPHEN W BYERS · 1990 to 2026
$71.5M
NCI NIH HHS P30 CA051008
6 · The paper itself

Abstract

purposeBreast cancer (BC) is the most commonly diagnosed cancer and the second leading cause of cancer-related death among women. Given the availability of approved therapies and abundance of phase II and III clinical trials, historically few BC patients have been referred for consideration of participation on a phase I trial. We were interested in determining whether clinical benefit rates differed in patients with BC from other patients enrolled in phase I trials.

methodsWe performed a retrospective analysis of all Cancer Therapy Evaluation Program (CTEP) sponsored phase I trials from 1993 to 2012. We report an analysis of demographic variables, rates of response to treatment, grade 4 toxicities, and treatment-related deaths.

resultsDe-identified data from 8087 patients were analyzed, with 1,376 having a diagnosis of BC. The median time from initial cancer diagnosis to enrollment in a CTEP-sponsored phase I clinical trial was 614 days for all patients. Breast cancer patients were enrolled on average 790 days after initial diagnosis, while non-BC patients had a median enrollment time of 582 days (p < 0.001). Breast cancer patients had more clinical responses than non-BC patients (18.3% vs. 4.3%, respectively). Along with the higher rate of response, BC patients remained on phase I trials longer than non-BC patients with a median of 70 days while the latter were on trial for a median of 57 days. The overall rate of death related to the treatment drugs was 0.47%.

conclusionsOur data confirm our hypothesis that when compared to a general population of patients with cancer enrolled on phase I clinical trials, BC patients tend to derive clinical benefit from these therapies with similar toxicity profile. This evidence further supports enrollment of BC patients on phase I trials.

Indexed as

Patient SelectionResponse Evaluation Criteria in Solid TumorsAdultAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsClinical Trials, Phase I as TopicDrug-Related Side Effects and Adverse ReactionsFemaleHumansMiddle AgedNational Cancer Institute (U.S.)Retrospective StudiesTime FactorsUnited StatesAntineoplastic AgentsBreast cancerClinical trialsOutcomesPhase IToxicity

Identifiers

PMID29119354
PMCPMC5940334

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Registered trials

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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.