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Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.

Name: Kaimen Rigor review — Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.
Item: Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.
Rating: 100
Author: Alpha1

Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM

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Kaimen Rigor review — 4★ (Strong), 0 critical, 0 high issues for “Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.

Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM

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DOI

10.1136/bmj-2025-085457

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.

Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM

Paper source

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported phase 3 randomized trial. The methodology is rigorous, with proper randomization, blinding of assessors, pre-specified power analysis, and appropriate statistical handling of non-proportional hazards. Minor reporting gaps (e.g., missing CONSORT flow diagram details, exact p-values for piecewise analyses) and a few copyedit issues do not undermine the core findings.

Both reviewers classified the study as interventional, and this was adopted. The evaluation covered the full text, including methods, results, and supplementary materials. Non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of reported tests; the absence of detected errors does not confirm overall statistical correctness.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 5 via agent-written checks.

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

5 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The paper cites multiple prior studies (ECOG E1199, CALGB 9741, GIM-2, EBCTCG meta-analysis) to establish the standard of care and the rationale for dose-dense regimens. It acknowledges the controversy regarding platinum agents' long-term survival benefit and the limited evidence in the adjuvant setting, directly motivating the trial. The hypothesis follows logically from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear scientific rationale for evaluating carboplatin in the adjuvant setting, citing prior studies and identifying the evidence gap.

Evidence

“The Eastern Cooperative Oncology Group (ECOG) E1199 study optimised the administration of taxanes and suggested that weekly paclitaxel, after anthracyclines, improves disease-free survival and overall survival in patients with triple negative breast cancer.”

Introduction ¶2Find in source

“Nevertheless, significant controversy remains regarding whether platinum agents can improve patients’ long term survival and the association between the efficacy of platinum agents and the germline BRCA mutation status.”

Introduction ¶3Find in source

“In this context, we did a phase 3 trial (carboplatin intensified chemotherapy for triple negative breast cancer or CITRINE) to evaluate the efficacy and safety of epirubicin and cyclophosphamide, followed by weekly paclitaxel, with or without carboplatin, as adjuvant therapy for patients with high risk, early stage, triple negative breast cancer.”

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear rationale for the trial, citing prior studies and identifying the gap in adjuvant platinum therapy.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“The ECOG E1199 study optimised the administration of taxanes and suggested that weekly paclitaxel, after anthracyclines, improves disease-free survival and overall survival in patients with triple negative breast cancer.”

IntroductionFind in source

Introduction ¶4Find in source

Randomization used a computer-generated block method with block size eight, and allocation was concealed through a central office. The trial was open-label, but outcome assessors, data collectors, and analysts were blinded. A power analysis was pre-specified, assuming 83% vs 89% three-year disease-free survival, requiring 144 events for 80% power. Inclusion/exclusion criteria were detailed in the protocol. Outlier handling is addressed through the pre-specified analysis population (ITT for efficacy, safety population for toxicity).

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessors, pre-specified power analysis, and clear inclusion/exclusion criteria.

Evidence

“Randomisation was done using a block randomisation method with a block size of eight, generated through a computer based allocation sequence created by an independent statistician.”

MethodsFind in source

“Neither patients nor investigators were blinded to the treatment assignments, whereas all outcome assessors, data collectors, and analysts were blinded to the allocation.”

MethodsFind in source

“A total of 144 disease-free survival events would provide 80% power to detect the difference between the two arms at a two sided significance level of 5%, on the basis of a 1:1 randomisation ratio.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous with adequate randomization, blinding of assessors, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Randomisation was done using a block randomisation method with a block size of eight, generated through a computer based allocation sequence created by an independent statistician.”

MethodsFind in source

“Neither patients nor investigators were blinded to the treatment assignments, whereas all outcome assessors, data collectors, and analysts were blinded to the allocation.”

MethodsFind in source

Statistical analysisFind in source

The paper reports sex (all female), age (median 47, range 22-70), and detailed baseline characteristics in Table 1, including menopausal status, histological grade, pathological T/N stage, lymphovascular invasion, Ki-67 index, and BRCA/HRR status. Since the study is human, species/strain and housing conditions are not applicable.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Patient demographics and key clinical characteristics are reported in detail, including age, menopausal status, tumor stage, and Ki-67 index.

Evidence

“The median age was 47 (range 22-70) years at the time of study entry.”

ResultsFind in source

“Median (range) age, years | 48 (24-70) | 47 (22-70)”

Table 1Find in source

PASSReviewer 2· 90% conf

Patient demographics and key clinical characteristics are well reported, including age, menopausal status, tumor stage, and Ki-67 index.

Evidence

“The median age was 47 (range 22-70) years at the time of study entry.”

ResultsFind in source

“Median (range) age, years | 48 (24-70) | 47 (22-70)”

Table 1Find in source

The paper states: 'The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki and was approved by the independent ethics committee at the participating institution.' It also states 'All participants gave written informed consent before their enrolment in the study.' The ethics statement in the supplementary section names the committee: 'This study was approved by the independent ethics committee of Fudan University Shanghai Cancer Center.'

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports approval by a named ethics committee and written informed consent from all participants, with compliance to Good Clinical Practice and the Declaration of Helsinki.

Evidence

“This study was approved by the independent ethics committee of Fudan University Shanghai Cancer Center.”

EthicsFind in source

“All participants gave written informed consent before their enrolment in the study.”

MethodsFind in source

“The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the independent ethics committee of Fudan University Shanghai Cancer Center.”

EthicsFind in source

“All participants gave written informed consent.”

EthicsFind in source

“The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki”

MethodsFind in source

The trial uses standard chemotherapeutic agents, which are identified by generic name with dosing regimens. The paper does not provide manufacturer or lot numbers, but for a drug trial, the investigational product is adequately identified by name, dose, and schedule. Statistical software is identified as SPSS version 22.0 and R 4.4.1.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational drugs (epirubicin, cyclophosphamide, paclitaxel, carboplatin) are identified with doses and schedules; statistical software is named.

Evidence

paraphrase[Methods, Procedures]

“Patients in the carboplatin arm received four cycles of epirubicin 90 mg/m2 and cyclophosphamide 600 mg/m2 on day 1 every two weeks, sequentially followed by four cycles of paclitaxel 80 mg/m2 and carboplatin (area under the curve=2) on days 1, 8, and 15 of each 28 day cycle.”

“We used SPSS version 22.0 and R 4.4.1 for statistical analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational drugs are adequately identified with doses and schedules; no other key biological resources are used.

Evidence

paraphrase[Methods, Procedures]

“We used SPSS version 22.0 and R 4.4.1 for statistical analyses.”

Statistical analysisFind in source

The paper names the tests used (log-rank, Cox proportional hazards, piecewise Cox, restricted mean survival analysis). It reports exact p-values (e.g., P=0.03) and effect sizes with 95% CIs. The proportional hazards assumption was tested and found violated, and the paper appropriately used piecewise models and restricted mean analyses. Statistical software is identified. Data presentation includes Kaplan-Meier curves and forest plots, appropriate for a clinical trial.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals; proportional hazards assumption was tested and addressed.

Evidence

“We used an unadjusted Cox proportional hazards model to estimate hazard ratios and confidence intervals, and we tested the comparison of survival between trial arms by log-rank testing.”

Statistical analysisFind in source

“We assessed the assumptions of proportional hazards by assessment of the Schoenfeld residuals. When proportional hazards assumption was not valid, we provided restricted mean survival analysis and the piecewise hazard ratio within pre-defined time periods (0-12, 12-36, and >36 months).”

Statistical analysisFind in source

“hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03”

AbstractFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“We used an unadjusted Cox proportional hazards model to estimate hazard ratios and confidence intervals, and we tested the comparison of survival between trial arms by log-rank testing.”

Statistical analysisFind in source

“We assessed the assumptions of proportional hazards by assessment of the Schoenfeld residuals.”

Statistical analysisFind in source

“hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03”

AbstractFind in source

The data availability statement states: 'The data underlying the findings in this paper are openly and publicly available and can be found at Fudan University Shanghai Cancer Center Clinical Trial Database ( http://117.72.180.52:8081 [search for CT2025-00002]).' This is a concrete route. The code is available in supplementary materials. For a clinical trial, repository deposit and accession numbers are not applicable for patient-level data, but the data are openly available.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability statement provides a concrete access route (openly available at a named database with a search identifier), and analytical code is provided in supplementary materials.

Evidence

“The data underlying the findings in this paper are openly and publicly available and can be found at Fudan University Shanghai Cancer Center Clinical Trial Database ( http://117.72.180.52:8081 [search for CT2025-00002]).”

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data and code availability are adequately addressed with a public repository and code in supplementary materials.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

The trial is registered at ClinicalTrials.gov (NCT04296175). The paper states it was reported according to the CONSORT 2025 statement. All pre-specified endpoints (primary and secondary) are reported, including negative/exploratory results. Limitations are explicitly discussed in the Discussion. Funding sources and competing interests are declared.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov NCT04296175 (https://clinicaltrials.gov/ct2/show/NCT04296175)”

AbstractFind in source

“The trial was reported according to the CONSORT 2025 statement.”

MethodsFind in source

“This study has several other limitations that warrant consideration.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, CONSORT adherence, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov NCT04296175”

AbstractFind in source

“The trial was reported according to the CONSORT 2025 statement.”

MethodsFind in source

“This study has several other limitations that warrant consideration.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 50 references by DOI: 50 verified.

1 data/code link checked; 1 live.

Copyediting

3 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and methodologically sound. An informed reader should weigh the non-proportional hazards and the modest effect size, but the paper's transparent reporting and appropriate statistical handling support its conclusions. Minor reporting gaps (e.g., missing CONSORT flow diagram, exact p-values for piecewise analyses) are worth noting but do not warrant a correction.

1.
MEDIUMreporting
Add a CONSORT flow diagram to the main text (currently referenced as Fig 1 but not shown in the provided text) and report the number of patients screened and excluded.
CONSORT requires a flow diagram to fully document participant flow and exclusions.
2.
MEDIUMstatistics
Report exact p-values for the piecewise hazard ratios (currently only CIs are given) and for the interaction tests in subgroup analyses.
Exact p-values allow readers to assess significance in each time period and subgroup.
3.
MEDIUMstatistics
Report the results of the Schoenfeld residual test for secondary endpoints in a supplementary table.
The proportional hazards assumption may also be violated for secondary endpoints, and reporting the test results would enhance transparency.
4.
MEDIUMdata code
Provide the analytical code in a public repository (e.g., GitHub) with a DOI, rather than only in supplementary materials.
A versioned public repository improves reproducibility and long-term access.
5.
MEDIUMdata code
Add a detailed data access procedure for the clinical trial database, including any conditions for access and a timeline.
A clear access procedure aligns with best practices for clinical data sharing.
6.
MEDIUMreporting
Add a statement about the availability of the study protocol in a public repository (e.g., ClinicalTrials.gov).
Public protocol availability enhances transparency and allows verification of pre-specified analyses.
7.
MEDIUMstatistics
Add a note on the handling of missing data for the primary analysis (e.g., censoring rules) in the statistical analysis section.
Clarifying missing data handling helps readers interpret the analysis.
8.
LOWreporting
Report the manufacturer and lot numbers for the chemotherapeutic agents used.
This is sometimes expected for investigational products to ensure traceability.
9.
LOWcopyedit
Fix the typo 'he KEYNOTE-522 trial' to 'the KEYNOTE-522 trial' in the Discussion, Limitations of study.
Correcting typos improves professionalism and readability.
10.
LOWcopyedit
Fix the grammar 'a continuous variables' to 'continuous variables' in Methods, Statistical analysis.
Correcting grammar improves clarity.
11.
LOWcopyedit
Ensure consistent use of 'hazard ratio' vs 'HR' throughout the manuscript; define at first use.
Consistent terminology avoids confusion for readers.

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Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.

Liu Y, Gong Y, Zhu XZ, Liu GY, Yu KD, Yang F, Chen L, He M, Hu Z, Chen CM, Cao AY, Li JJ, Hou YF, Di GH, Wu J, Jiang YZ, Fan L, Wang ZH, Shao ZM

Read full text (PMC)

DOI

10.1136/bmj-2025-085457

Share this Kaimen Rigor review

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  <img src="https://alpha1science.com/verify/aba13e07-b54c-4a39-b4bf-3103322b1b03/badge" alt="Kaimen Rigor review — 4★ (Strong), 0 critical, 0 high issues for “Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trial.”" width="440" height="104" style="max-width:100%;height:auto" />
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Record fingerprint

50ac0763d016f783e9e9dd8be436845095cee2f59898a0fedf9f7b81990bfd65

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

4 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 103AuthenticityData authenticity concerns 04DisclosureNone found 05AvailabilityNone found 06Copyedit3 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 2 recomputed directly from the reported test statistics, 5 via agent-written checks.

Overstated conclusions

None found

Checked — nothing surfaced.

5 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The introduction establishes a clear scientific rationale for evaluating carboplatin in the adjuvant setting, citing prior studies and identifying the evidence gap.

Evidence

Introduction ¶2Find in source

Introduction ¶3Find in source

Introduction ¶4Find in source

PASSReviewer 2· 90% conf

The introduction establishes a clear rationale for the trial, citing prior studies and identifying the gap in adjuvant platinum therapy.

Evidence

paraphrase[Introduction, paragraphs 1-3]

IntroductionFind in source

Introduction ¶4Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with adequate randomization, blinding of outcome assessors, pre-specified power analysis, and clear inclusion/exclusion criteria.

Evidence

“Randomisation was done using a block randomisation method with a block size of eight, generated through a computer based allocation sequence created by an independent statistician.”

MethodsFind in source

“Neither patients nor investigators were blinded to the treatment assignments, whereas all outcome assessors, data collectors, and analysts were blinded to the allocation.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The trial design is rigorous with adequate randomization, blinding of assessors, power analysis, and pre-specified inclusion/exclusion criteria.

Evidence

“Randomisation was done using a block randomisation method with a block size of eight, generated through a computer based allocation sequence created by an independent statistician.”

MethodsFind in source

“Neither patients nor investigators were blinded to the treatment assignments, whereas all outcome assessors, data collectors, and analysts were blinded to the allocation.”

MethodsFind in source

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Patient demographics and key clinical characteristics are reported in detail, including age, menopausal status, tumor stage, and Ki-67 index.

Evidence

“The median age was 47 (range 22-70) years at the time of study entry.”

ResultsFind in source

“Median (range) age, years | 48 (24-70) | 47 (22-70)”

Table 1Find in source

PASSReviewer 2· 90% conf

Patient demographics and key clinical characteristics are well reported, including age, menopausal status, tumor stage, and Ki-67 index.

Evidence

“The median age was 47 (range 22-70) years at the time of study entry.”

ResultsFind in source

“Median (range) age, years | 48 (24-70) | 47 (22-70)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports approval by a named ethics committee and written informed consent from all participants, with compliance to Good Clinical Practice and the Declaration of Helsinki.

Evidence

“This study was approved by the independent ethics committee of Fudan University Shanghai Cancer Center.”

EthicsFind in source

“All participants gave written informed consent before their enrolment in the study.”

MethodsFind in source

“The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the independent ethics committee of Fudan University Shanghai Cancer Center.”

EthicsFind in source

“All participants gave written informed consent.”

EthicsFind in source

“The trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational drugs (epirubicin, cyclophosphamide, paclitaxel, carboplatin) are identified with doses and schedules; statistical software is named.

Evidence

paraphrase[Methods, Procedures]

“We used SPSS version 22.0 and R 4.4.1 for statistical analyses.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational drugs are adequately identified with doses and schedules; no other key biological resources are used.

Evidence

paraphrase[Methods, Procedures]

“We used SPSS version 22.0 and R 4.4.1 for statistical analyses.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals; proportional hazards assumption was tested and addressed.

Evidence

“We used an unadjusted Cox proportional hazards model to estimate hazard ratios and confidence intervals, and we tested the comparison of survival between trial arms by log-rank testing.”

Statistical analysisFind in source

“hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03”

AbstractFind in source

PASSReviewer 2· 85% conf

Statistical methods are appropriate and well described, with exact p-values and effect sizes with confidence intervals.

Evidence

“We used an unadjusted Cox proportional hazards model to estimate hazard ratios and confidence intervals, and we tested the comparison of survival between trial arms by log-rank testing.”

Statistical analysisFind in source

“We assessed the assumptions of proportional hazards by assessment of the Schoenfeld residuals.”

Statistical analysisFind in source

“hazard ratio 0.64, 95% confidence interval (CI) 0.43 to 0.95; P=0.03”

AbstractFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Data availability statement provides a concrete access route (openly available at a named database with a search identifier), and analytical code is provided in supplementary materials.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Data and code availability are adequately addressed with a public repository and code in supplementary materials.

Evidence

Data availabilityFind in source

“The code used to analyse the data in the paper can be found in the supplementary materials.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial is registered, reported per CONSORT, all outcomes are reported, limitations are discussed, and funding/COI are disclosed.

Evidence

“ClinicalTrials.gov NCT04296175 (https://clinicaltrials.gov/ct2/show/NCT04296175)”

AbstractFind in source

“The trial was reported according to the CONSORT 2025 statement.”

MethodsFind in source

“This study has several other limitations that warrant consideration.”

LimitationsFind in source

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, CONSORT adherence, limitations, and funding/COI statements.

Evidence

“ClinicalTrials.gov NCT04296175”

AbstractFind in source

“The trial was reported according to the CONSORT 2025 statement.”

MethodsFind in source

“This study has several other limitations that warrant consideration.”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 50 references by DOI: 50 verified.

1 data/code link checked; 1 live.

Copyediting

3 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 3 minor suggestions below.

3 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
MEDIUMreporting
Add a CONSORT flow diagram to the main text (currently referenced as Fig 1 but not shown in the provided text) and report the number of patients screened and excluded.
CONSORT requires a flow diagram to fully document participant flow and exclusions.
2.
MEDIUMstatistics
Report exact p-values for the piecewise hazard ratios (currently only CIs are given) and for the interaction tests in subgroup analyses.
Exact p-values allow readers to assess significance in each time period and subgroup.
3.
MEDIUMstatistics
Report the results of the Schoenfeld residual test for secondary endpoints in a supplementary table.
The proportional hazards assumption may also be violated for secondary endpoints, and reporting the test results would enhance transparency.
4.
MEDIUMdata code
Provide the analytical code in a public repository (e.g., GitHub) with a DOI, rather than only in supplementary materials.
A versioned public repository improves reproducibility and long-term access.
5.
MEDIUMdata code
Add a detailed data access procedure for the clinical trial database, including any conditions for access and a timeline.
A clear access procedure aligns with best practices for clinical data sharing.
6.
MEDIUMreporting
Add a statement about the availability of the study protocol in a public repository (e.g., ClinicalTrials.gov).
Public protocol availability enhances transparency and allows verification of pre-specified analyses.
7.
MEDIUMstatistics
Add a note on the handling of missing data for the primary analysis (e.g., censoring rules) in the statistical analysis section.
Clarifying missing data handling helps readers interpret the analysis.
8.
LOWreporting
Report the manufacturer and lot numbers for the chemotherapeutic agents used.
This is sometimes expected for investigational products to ensure traceability.
9.
LOWcopyedit
Fix the typo 'he KEYNOTE-522 trial' to 'the KEYNOTE-522 trial' in the Discussion, Limitations of study.
Correcting typos improves professionalism and readability.
10.
LOWcopyedit
Fix the grammar 'a continuous variables' to 'continuous variables' in Methods, Statistical analysis.
Correcting grammar improves clarity.
11.
LOWcopyedit
Ensure consistent use of 'hazard ratio' vs 'HR' throughout the manuscript; define at first use.
Consistent terminology avoids confusion for readers.

Full text (48,073 chars)Analyzed: Aug 15, 2026