Evidence map›Paper›PMID 35805034›Full record

ReviewCancers2022

Tumour Burden Reporting in Phase III Clinical Trials of Metastatic Lung, Breast, and Colorectal Cancers: A Systematic Review.

Mariachiara Santorsola, Vincenzo Di Lauro, Guglielmo Nasti, Michele Caraglia, Maurizio Capuozzo, Francesco Perri, Marco Cascella, Gabriella Misso, Alessandro Ottaiano

Open access · goldAbstract readReview
In one paragraph

Review in Cancers, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 23% 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

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

  1. Global trends, risk factors, and therapeutic associations of fungal pulmonary infections in lung cancer: A systematic review and meta-analysis.Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2025
    Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
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 2 institutions in 1 country.

Mariachiara SantorsolaIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.
Vincenzo Di LauroIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.
Guglielmo NastiIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.
Michele CaragliaDepartment of Precision Medicine, University of Campania "L. Vanvitelli", Via L. De Crecchio 7, 80138 Naples, Italy.ORCID 0000-0003-2408-6091
Maurizio CapuozzoDepartment of Pharmacy, ASL-Naples-3, 80056 Ercolano, Italy.
Francesco PerriIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.ORCID 0000-0001-8158-7509
Marco CascellaIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.ORCID 0000-0002-5236-3132
Gabriella MissoDepartment of Precision Medicine, University of Campania "L. Vanvitelli", Via L. De Crecchio 7, 80138 Naples, Italy.ORCID 0000-0002-7787-2531
Alessandro OttaianoIstituto Nazionale Tumori di Napoli, IRCCS "G. Pascale", Via M. Semmola, 80131 Naples, Italy.ORCID 0000-0002-2901-3855
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRandomised phase III clinical trials represent a methodological milestone to select effective drugs against metastatic cancers. In this context, and particularly in the efficacy assessment of biologic drugs, the initial metastatic tumour burden is a strong prognostic factor.

methodsA systematic literature review of randomised, phase III, first-line, clinical trials in metastatic breast, colorectal, and lung cancers, published from 2016 to 2021, was performed. Three groups of variables were collected: identity-, method- (including tumour burden assessment) and outcome-related.

resultsSeventy trials were selected. A large portion of studies (41.4%) focused on the effects of biologic agents (signal inhibitors and immuno-therapies). A definition of low-burden disease based predominantly on the number of involved organs was reported in 28.6% of studies. No explicit reference to oligo-metastatic disease was found either in inclusion/exclusion criteria or in final descriptive data analyses. Disease extent, heterogeneously defined, was a stratification factor for randomisation in only 25.7% of studies. In two studies, a significant imbalance between arms in patients with low-burden disease was revealed.

conclusionsAttention to initial tumour burden in designing future clinical trials (including the harmonisation of definitions and the reporting of eventual oligo-metastatic disease, complete estimates of tumour volume, and its consideration as a stratification factor) should be increased.

Indexed as

breast cancercolorectal cancernon-small-cell lung cancerphase III studiestumour burden

Identifiers

PMID35805034
PMCPMC9264965
OpenAlexW4283801309

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.