Evidence map›Paper›PMID 25595934›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2015

Impact of age and medical comorbidity on adjuvant treatment outcomes for stage III colon cancer: a pooled analysis of individual patient data from four randomized, controlled trials.

D G Haller, M J O'Connell, T H Cartwright, C J Twelves, E F McKenna, W Sun, M W Saif, S Lee, G Yothers, H-J Schmoll

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
4.3field-weighted citation impact, top 4% 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

49 citing papers in PubMed, 119 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Article
  7. Oxaliplatin-Based Adjuvant Chemotherapy in Older Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 12 Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  8. Update on the management of elderly patients with colorectal cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Article
  9. Review
  10. Article
  11. Guidance for Treating the Older Adults with Colorectal Cancer.Current treatment options in oncology · 2023
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

10 authors at 7 institutions in 3 countries.

D G HallerAbramson Cancer Center at the University of Pennsylvania, Philadelphia. Electronic address: daniel.haller@uphs.upenn.edu.
M J O'ConnellNational Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh.
T H CartwrightDepartment of Oncology, Florida Cancer Affiliates, Ocala, USA.
C J TwelvesLeeds Institute of Cancer and Pathology and St James's University Hospital, Leeds, UK.
E F McKennaUS Medical Affairs, Genentech, Inc., South San Francisco.
W SunUniversity of Pittsburgh Cancer Institute, Pittsburgh.
M W SaifTufts University School of Medicine, Boston.
S LeeUS Medical Affairs, Genentech, Inc., South San Francisco.
G YothersBiostatistical Center and University of Pittsburgh Graduate School of Public Health Department of Biostatistics, Pittsburgh, USA.
H-J SchmollUniversity Clinic, Martin Luther University, Halle, Germany.
Martin Luther University Halle-Wittenberg · DENSABP Foundation · USSt James's University Hospital · GBTufts University · USUniversity of Pennsylvania · USUniversity of Pittsburgh · USUPMC Hillman Cancer Center · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
PRIMARY CANCER THERAPY GROUP--NSABP (HEADQUARTERS)U10CA012027 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2012
$117.2M
NSABP Foreign AccrualsU10CA037377 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI WOLMARK, NORMAN · 1985 to 2014
$116.5M
STUDY TO ASSESS RALOXIFENE FOR PREVENTING BREAST CANCERU10CA069974 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2013
$62.4M
PRIMARY BREAST CANCER THERAPY--BIOSTATISTICS CENTERU10CA069651 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI COSTANTINO, JOSEPH P. · 1995 to 2012
$52.1M
NCI NIH HHS U10 CA012027NCI NIH HHS U10 CA037377NCI NIH HHS U10 CA 12027NCI NIH HHS U10 CA180868NCI NIH HHS U10-CA-37377NCI NIH HHS U10 CA 69651NCI NIH HHS U10 CA-69974NCI NIH HHS UG1 CA189867
6 · The paper itself

Abstract

backgroundAdjuvant oxaliplatin plus capecitabine or leucovorin/5-fluorouracil (LV/5-FU) (XELOX/FOLFOX) is the standard of care for stage III colon cancer (CC); however, there is disagreement regarding oxaliplatin benefit in patients aged >70. In most analyses, the impact of medical comorbidity (MC) has not been assessed. Efficacy and safety of adjuvant XELOX/FOLFOX versus LV/5-FU were compared with respect to age and MC using pooled data from four randomized, controlled trials, selected for access to patient-level MC data and including commonly endorsed and utilized regimens. PATIENTS AND

methodsIndividual data from patients with stage III CC in NSABP C-08, XELOXA, X-ACT, and AVANT were pooled, excluding bevacizumab-treated patients. Patients were grouped by treatment, MC (low versus high), or age (<70 versus ≥70), and compared for disease-free survival (DFS), overall survival (OS), and adverse events (AEs). Multivariable Cox proportional hazards regression controlled for gender, T stage, and N stage.

resultsDFS benefits were shown for XELOX/FOLFOX versus LV/5-FU regardless of age or MC, although benefits were modestly attenuated for patients aged ≥70. Hazard ratios were 0.68 (P < 0.0001) and 0.77 (P < 0.014) for <70 and ≥70 age groups; 0.69 (P < 0.0001) and 0.59 (P < 0.0001) for Charlson Comorbidity Index ≤1 and >1 groups; and 0.70 (P < 0.0001) and 0.58 (P < 0.0001) for National Cancer Institute Combined Index ≤1 and >1 groups. OS was also significantly improved in all groups. Grade 3/4 serious AE rates were comparable across cohorts and MC scores and higher in patients aged ≥70. Oxaliplatin-relevant grade 3/4 AEs, including neuropathy, were comparable across ages and MC scores.

conclusionsResults further support consideration of XELOX or FOLFOX as standard treatment options for the adjuvant management of stage III CC in all age groups and in patients with comorbidities, consistent with those who were eligible for these clinical trials.

Indexed as

Clinical Trials as TopicAdultAgedAged, 80 and overAge FactorsAntineoplastic Combined Chemotherapy ProtocolsChemotherapy, AdjuvantColonic NeoplasmsComorbidityFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm StagingPrognosisadjuvant chemotherapyage groupscapecitabinecolon cancercomorbidityoxaliplatin

Identifiers

PMID25595934
PMCPMC4374386
OpenAlexW2138309253

What OpenQuestion holds

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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.