Evidence map›Paper›PMID 30315379›Full record

ArticleInvestigational new drugs2019

Survival outcome and prognostic model of patients with colorectal cancer on phase 1 trials.

Audrey E Kam, Gopichand Pendurti, Umang H Shah, Mohammad H Ghalib, Imran Chaudhary, Jennifer Chuy, Lakshmi Rajdev, Andreas Kaubisch, Santiago Aparo, Ioannis Mantzaris and 1 more

Open access · greenAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 37% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. 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

11 authors at 3 institutions in 1 country.

Audrey E KamMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Gopichand PendurtiJacobi Medical Center, 1400 Pelham Pkwy S, Bronx, NY, 10461, USA.
Umang H ShahMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Mohammad H GhalibMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Imran ChaudharyMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Jennifer ChuyMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Lakshmi RajdevMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Andreas KaubischMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Santiago AparoMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Ioannis MantzarisMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA.
Sanjay GoelMontefiore Medical Center, 1695 Eastchester Road, Bronx, NY, 10461, USA. sgoel@montefiore.org.
Montefiore Medical Center · USAlbert Einstein College of Medicine · USJacobi Medical Center · US

Funding

COMPARATIVE EFFECTIVENESS OF BIOLOGIC AGENTS IN ETHNIC MINORITIES WITH COLORECTAL CANCERR21AG058027 · NIA · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI GOEL, SANJAY, NEGASSA, ABDISSA · 2018 to 2019
$397k
NIA NIH HHS R21 AG058027
6 · The paper itself

Abstract

Background Patients with metastatic colorectal cancer (mCRC) who progress on standard therapies may be eligible for phase I trials. To better delineate the risk-benefit ratio, we assessed toxicities, clinical outcomes and prognostic factors. Methods Records of mCRC patients on phase I trials at our institution over 18 years were reviewed. Univariable (UVA) and multivariable analyses (MVA) were undertaken and a prognostic model developed. Results There were 187 enrollments on 37 phase I trials. Median age was: 59 (29-83) years and number of prior therapies: 3 (0-8). The clinical benefit rate (CBR): response (5.6%) + stable disease, was 43.1%. Median progression free survival (PFS) and overall survival (OS) was 7.7 weeks and 43.7 weeks, respectively. The MVA identified age > 60 years (HR 1.63, p < 0.004), albumin<3.5 g/dL (HR 3.69, p < 0.001), direct bilirubin>ULN (HR1.69, p < 0.01), and WBC ≥ 5.2 k/uL (HR 1.97, p < 0.001) as negative prognostic factors. A risk score based on the MVA revealed that patients with a score of 0-1 had an improved OS (58.7 weeks) compared to a score of 2 (49.9 weeks, p < 0.01) and 3 (14.1 weeks, p < 0.001). Conclusions Phase 1 trials may offer similar or better clinical outcome for mCRC patients than standard third line therapies; the prognostic model could assist in selecting appropriate patients.

Indexed as

Models, StatisticalAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsFemaleFollow-Up StudiesHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisPatient SelectionPrognosisRetrospective StudiesColorectal cancerPhase I trialsSurvival

Identifiers

PMID30315379
PMCPMC6461536
OpenAlexW2896909095

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.