Evidence map›Paper›PMID 31492988›Full record

ArticleInternational journal of colorectal disease2019

Impact of age on toxicity and efficacy of 5-FU-based combination chemotherapy among patients with metastatic colorectal cancer; a pooled analysis of five randomized trials.

Omar Abdel-Rahman, Hatim Karachiwala

5 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in International journal of colorectal disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT00115765 phase3completednot on this map

PACCE: A Randomized, Open-Label, Controlled, Clinical Trial of Chemotherapy and Bevacizumab With and Without Panitumumab in the First-Line Treatment of Subjects With Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2005 to 2009Enrolled1,053ConditionsColorectal CancerArmsOxaliplatin Based Chemotherapy, Panitumumab, Irinotecan Based Chemotherapy, Bevacizumab
NCT00272051 phase3completednot on this map

A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)

TypeinterventionalSponsorSanofiRan2002 to 2004Enrolled620ConditionsMetastases, Colorectal Neoplasms, Colorectal CarcinomaArmsSR57746A
NCT00305188 phase3completednot on this map

A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV

TypeinterventionalSponsorSanofiRan2005 to 2009Enrolled879ConditionsMetastases, Colorectal Neoplasms, Colorectal CarcinomaArmsXaliproden (SR57746A), Placebo, Oxaliplatin, 5-Fluorouracil, Leucovorin
NCT00364013 phase3completednot on this map

A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of Panitumumab in Combination With Oxaliplatin/ 5-fluorouracil/ Leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ Leucovorin Alone in Patients With Previously Untreated Metastatic Colorectal Cancer

TypeinterventionalSponsorAmgenRan2006 to 2013Enrolled1,183ConditionsMetastatic Colorectal CancerArmsPanitumumab, FOLFOX regimen
NCT00384176 phase2 / phase3completednot on this map

A Randomised, Double-blind, Multicentre Phase II/III Study to Compare the Efficacy of Cediranib (RECENTIN™, AZD2171) in Combination With 5-fluorouracil, Leucovorin, and Oxaliplatin (FOLFOX), to the Efficacy of Bevacizumab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer

TypeinterventionalSponsorAstraZenecaRan2006 to 2015Enrolled1,814ConditionsColorectal CancerArmsCediranib, Bevacizumab, 5-fluorouracil ( in FOLFOX), Leucovorin (in FOLFOX), Oxaliplatin (in FOLFOX)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Cumulative frailty impact on unplanned hospitalization in older patients with cancer and excellent Eastern Cooperative Oncology Group performance.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Observational
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Molecules (Basel, Switzerland) · 2021
    Article
  8. Review
  9. Article
  10. Outcomes of metastatic colorectal cancer patients in relationship to prior and concurrent antibiotics use; individual patient data analysis of three clinical trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Article
  11. Review
  12. Article
  13. Article
  14. 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

2 authors.

Omar Abdel-RahmanDepartment of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, T4G1Z2, Canada. omar.abdelsalam@ahs.ca.ORCID http://orcid.org/0000-0002-5117-2502
Hatim KarachiwalaDepartment of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, T4G1Z2, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the impact of age on toxicity and efficacy outcomes of metastatic colorectal cancer treated with 5FU-based combination chemotherapy.

methodsProject Data Sphere (PDS) platform has been accessed and de-identified datasets of the following clinical trials were downloaded (NCT00272051; NCT00305188; NCT00115765; NCT00364013; and NCT00384176). Multivariable logistic regression analysis was used to assess the impact of age (< 70 years versus ≥ 70 years) on the probability of different toxicities. Multivariable Cox regression analysis was additionally used to evaluate the impact of age (< 70 years versus ≥ 70 years) on overall and progression-free survival.

resultsAmong a total of 3223 patients included in the current analysis, 2488 patients were < 70 years; while 735 patients were ≥ 75 years at randomization. Older age was associated with a higher probability of serious adverse events (OR (odds ratio) 0.649; 95% CI 0.545-0.772; P < 0.001), fatal adverse events (OR 0.416; 95% CI 0.299-0.579; P < 0.001), all-grade diarrhea (OR 0.834; 95% CI 0.699-0.994, P = 0.043), high-grade diarrhea (OR 0.734; 95% CI 0.577-0.933, P = 0.012), high-grade stomatitis (OR 0.500, 95% CI 0.290-0.861, P = 0.012), high-grade thrombocytopenia (OR 0.578; 95% CI 0.359-0.930, P = 0.024), all-grade neutropenia (OR 0.690; 95% CI 0.578-0.824, P < 0.001), and high-grade neutropenia (OR 0.661; 95% CI 0.549-0.796, P < 0.001). In a multivariable Cox regression analysis for factors affecting overall survival, older age was associated with worse overall survival (hazard ratio for younger age versus older age 0.848; 95% CI 0.754-0.954, P = 0.006). On the hand, older age was not associated with worse progression-free survival (hazard ratio for younger age versus older age 0.933; 95% CI 0.843-1.032, P = 0.179).

conclusionMetastatic colorectal cancer patients ≥ 70 years of age who are treated with 5FU-based combination chemotherapy are more likely to have serious adverse events, fatal adverse events as well as worse overall survival compared to younger patients.

Indexed as

Randomized Controlled Trials as TopicAge FactorsAntineoplastic Combined Chemotherapy ProtocolsColorectal NeoplasmsFemaleFluorouracilHumansIncidenceMaleMultivariate AnalysisProbabilityRegression AnalysisSurvival AnalysisTreatment OutcomeFluorouracilAgeColon cancerOutcomesPrognosisRectal cancer

Identifiers

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Registered trials

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.