Evidence map›Paper›PMID 40571773›Full record

Trial reportJournal of gastrointestinal cancer2025

Adjuvant Chemotherapy for Gastric Cancer may Worsen Prognosis in Elderly Women: Retrospective Analysis of Individual Patient Data from the CLASSIC Study.

Fumitaka Noji, Hideki Yoshioka, Ryota Jin, Hiroto Hatakeyama, Hiromi Sato, Akihiro Hisaka

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gastrointestinal cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00411229 (A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT00411229 phase3completednot on this map

A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin vs Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4NO), and IIIb (T3N2) Gastric Adenocarcinoma

TypeinterventionalSponsorSanofiRan2006 to 2012Enrolled1,035ConditionsStomach NeoplasmsArmsCapecitabine, Oxaliplatin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

6 authors.

Fumitaka NojiClinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan.
Hideki YoshiokaClinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan.
Ryota JinClinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan.
Hiroto HatakeyamaDesign and Drug Disposition, Graduate School of Medical and Pharmaceutical Sciences, Chiba University, Chiba, Japan.
Hiromi SatoClinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan.
Akihiro HisakaClinical Pharmacology and Pharmacometrics, Graduate School of Pharmaceutical Sciences, Chiba University, Chiba, Japan. hisaka@chiba-u.jp.

Funding

Agency for Cultural Affairs, Government of Japan JP21mk0101159
6 · The paper itself

Abstract

purposeThis research aimed to identify significant prognostic factors that interact with the treatment effect of capecitabine and oxaliplatin (CapeOX), based on individual patient data from the CLASSIC study (NCT00411229), which evaluated the efficacy of adjuvant chemotherapy for gastric cancer.

methodsStepwise variable selection of prognostic factors was performed using the Cox proportional hazards model, with patient data from 519 CapeOX-treated and 514 untreated patients.

resultsFor all-cause mortality, older women (≥ 55 years) with a serum albumin level ≥ 4.0 g/dL were identified as significant prognostic factors interacting with CapeOX treatment, and unexpectedly, the treatment was associated with poor outcomes in this group. The prognostic significance of serum albumin levels was primarily attributed to the particularly poor survival outcomes observed in untreated patients with serum albumin < 4.0 g/dL. Tumor stage and lymph node status were prognostic factors that interacted with treatment for disease-free survival (DFS). The results showed that in patients with tumor stage (T) ≥ T3 and lymph node metastasis (N) < N2, improvement in DFS with CapeOX was not significant.

conclusionAs this was a post-hoc analysis, the results should be interpreted as hypothesis-generating rather than definitive. Nevertheless, the findings suggest the need for a more detailed consideration of patient baseline characteristics when determining the adjuvant chemotherapy strategy for gastric cancer.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsStomach NeoplasmsAgedAged, 80 and overCapecitabineChemotherapy, AdjuvantDisease-Free SurvivalFemaleHumansMiddle AgedNeoplasm StagingOrganoplatinum CompoundsOxaliplatinPrognosisRetrospective StudiesSerum AlbuminCapecitabineOrganoplatinum CompoundsOxaliplatinSerum AlbuminAdjuvantCapecitabineGastric cancerIndividual dataOxaliplatinPrognostic factor

Identifiers

PMID40571773
PMCPMC12202623

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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.