Evidence map›Paper›PMID 32404970›Full record

ReviewScientific reports2020

First-In-Human Phase 1 Clinical Trials - A Single-Center Experience In The Era Of Modern Oncotherapeutics.

Ravi K Paluri, Peng Li, Ashley Anderson, Lakshminarayana Nandagopal, Traci McArdle, Matthew Young, Franscisco Robert, Gurudatta Naik, Mansoor Saleh

Open access · goldAbstract readReview
In one paragraph

Review in Scientific reports, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
5.2field-weighted citation impact, top 3% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Article
  5. Article
  6. Article
  7. Article
  8. 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

9 authors at 1 institution in 1 country.

Ravi K PaluriThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US. rpaluri@uabmc.edu.ORCID http://orcid.org/0000-0002-2317-7082
Peng LiThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Ashley AndersonThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Lakshminarayana NandagopalThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Traci McArdleThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Matthew YoungThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Franscisco RobertThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Gurudatta NaikThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
Mansoor SalehThe University Of Alabama at Birmingham, O'Neal Comprehensive Cancer Center, Department of Medicine, Division of Hematology Oncology, Birmingham, US.
University of Alabama at Birmingham · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the era of precision medicine the treatment options for cancer patients and subsequent outcomes are expected to improve. We present a review of patients enrolled in first-in-human Phase1 trials at University of Alabama at Birmingham. Between 1/2015-6/2017, 162 cancer patients (whole cohort, WC) were enrolled on phase1 studies receiving either targeted therapy (TT) or immuno-therapy (IOT). We assessed 90 day mortality (90DM) and time to treatment failure (TTF) to determine the predictors. Of the WC (122 (TT), 40 (IOT)), 90 (56%) received ≥ 2 prior therapies and 38 (24%) ⩾ 5 prior therapies. Overall, Grade 3 or 4 events were observed in 33% (WC) vs 31% (TT) vs 38% (IOT). The 90DM was 9.3% (WC) vs 7.4% (TT) vs 15% (IOT). The median TTF was 4.2 months vs 4.5 m vs 3.6 m. The number of lines of prior therapy and performance status were identified as outcome predictors. Our data reflects the new trend in precision oncology where majority received non-cytotoxic therapeutic interventions. The observation that number of lines of prior therapy and performance status predictive of PFS and 90DM emphasizes the need to consider phase1 trials earlier, preferably upon progression following definitive therapy.

Indexed as

Precision MedicineAdultAgedAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase I as TopicDrug DevelopmentFemaleHumansMaleMiddle AgedMolecular Targeted TherapyNeoplasm GradingNeoplasmsNeoplasm StagingPrognosisTreatment Failure

Identifiers

PMID32404970
PMCPMC7220914
OpenAlexW3024827652

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.