Kaimen Rigor reviewed

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Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

Name: Kaimen Rigor review — Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.
Item: Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.
Rating: 96
Author: Alpha1

Sinicrope FA, Ou FS, Arnold D, Peters WR, Behrens RJ, Lieu CH, Matin K, Cohen DJ, Potter SL, Nixon AB, Kottschade LA, Kathol E, Frankel WL, Shergill A, Hsu D, Reinacher-Schick A, Mehan P, Gold PJ, Khalil MF, Zemla T, Gatten C, O'Reilly EM, Meyerhardt JA

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Kaimen Rigor review — 3.75★ (Adequate), 0 critical, 2 high issues for “Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.”

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Alpha1 Editorial

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

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Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

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DOI

10.1056/NEJMoa2507874

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

Paper source

Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

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

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★

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

Biggest issues

01Reported statistic does not recompute
highArithmeticrecomputedFull detail
Check the p-value for the primary DFS analysis from the reported HR and CI.
“hazard ratio (HR) for recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.0001”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 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 phase 3 randomized trial with rigorous design, clear reporting of methods and results, and appropriate ethical approvals. The main weaknesses are the lack of an explicit data availability statement and minor reporting inconsistencies (e.g., CI bound discrepancy, blinding not explicitly stated).

Both reviewers agreed on all dimensions; no divergence. The study is an interventional trial; all non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only 2 tests, one of which showed a minor p-value discrepancy; this does not affect the overall assessment.

Numerical inconsistencies

2 findings · worst high

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.

Reported statistics do not recomputeRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 1 consistent, 1 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

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.

Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

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

Data authenticity concerns

None found

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.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

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.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites prior evidence on dMMR/MSI-H colon cancer, the role of immune checkpoint inhibitors, and the rationale for combining atezolizumab with FOLFOX. It acknowledges the resistance of dMMR tumors to fluoropyrimidines and the benefit of oxaliplatin. The hypothesis follows logically from the cited evidence. Limitations of prior work are implicitly addressed by the design of a randomized phase 3 trial.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with adequate citation of prior work and a logical rationale for the study.

Evidence

“In patients with metastatic dMMR colorectal cancer which encompasses those with microsatellite instability (MSI-H), the immune checkpoint inhibitor pembrolizumab was shown to be superior to fluoropyrimidine-based chemotherapy where it produced significantly longer progression-free survival with fewer adverse events as first-line therapy (KEYNOTE-177).”

Introduction ¶1Find in source

“The phase 3 ATOMIC study was designed to investigate whether the addition of atezolizumab, an anti-PD-L1 antibody, to standard FOLFOX chemotherapy can improve disease-free survival in patients with curatively resected, dMMR stage III colon cancer.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

Randomization method (permuted block design with block size 4) and unit (patient) are reported. Blinding is not described, but the paper states the trial was open-label (implied by the design and the lack of blinding mention; however, the paper does not explicitly state open-label, but the design of an adjuvant trial with different treatment durations makes blinding infeasible; the paper does not provide a rationale for lack of blinding, but this is not a major issue for a phase 3 trial). Power analysis is reported with effect size, alpha, and power. Inclusion/exclusion criteria are pre-specified. Outlier handling is not explicitly described, but the analysis population (ITT and per-protocol) is defined. Controls are the mFOLFOX6 arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

“Patients were randomized (1:1), via permuted block design with block size of 4, within 10 weeks after surgery to atezolizumab (840 mg intravenously every 2 weeks for 12 cycles) (6 months) plus modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) followed by atezolizumab monotherapy for 13 cycles (12 months total) versus mFOLFOX6 [(5-fluorouracil 400 mg/m 2 bolus and 2400 mg/m 2 continuous infusion over 46 hours), oxaliplatin (85 mg/m 2 ), and leucovorin (400 mg/m 2 )] alone for 12 cycles (6 months total).”

MethodsFind in source

“The trial was designed to randomize 700 patients, with 165 events providing an overall 90% power to detect a hazard ratio (HR) of 0.6 favoring the atezolizumab plus mFOLFOX6 arm at the one-sided significance level of 0.025.”

Statistical analysisFind in source

“Eligible patients were ≥ 12 years of age with completely resected (R0), histologically confirmed, stage III colon adenocarcinoma (any T, N1-2 M0) and dMMR status determined by local site-directed immunohistochemistry or at a site-selected reference laboratory; retrospective central confirmation was also performed.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding considerations, power analysis, and pre-specified analysis populations.

Evidence

“Patients were randomized (1:1), via permuted block design with block size of 4, within 10 weeks after surgery”

MethodsFind in source

Statistical analysisFind in source

absence[Methods, Trial Design and Treatment]

Blinding is not explicitly addressed.

Sex is reported (55.1% female). Age is reported (median 64 years). Demographics include sex, age, and tumor characteristics. Health status is implied by ECOG performance status. Species/strain and housing conditions are not applicable for a human trial. Sex justification is not applicable because both sexes are enrolled.

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

Biological variables are adequately reported for a human trial, including sex, age, and demographics.

Evidence

paraphrase[Results, Patients]

“Median patient age was 64 years, 55.1% were female, and 83.7% had proximal tumors.”

paraphrase[Table 1]

“ECOG Performance Status , n (%) | 0 | 238 (67.0%) | 225 (63.0%) | 463 (65.0%)”

PASSReviewer 2· 90% conf

Key biological variables such as sex, age, and tumor characteristics are reported, but some details like health status are limited.

Evidence

“Median patient age was 64 years, 55.1% were female”

ResultsFind in source

paraphrase[Table 1]

“ECOG Performance Status , n (%) | 0 | 238 (67.0%) | 225 (63.0%) | 463 (65.0%)”

The trial was approved by the NCI central institutional review board (IRB). All patients provided written informed consent. Regulatory compliance is stated with adherence to Good Clinical Practice and the Declaration of Helsinki.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are adequately reported with a named IRB and informed consent.

Evidence

“The protocol was approved by the NCI central institutional review board (IRB).”

MethodsFind in source

“All the patients provided written informed consent before enrollment.”

MethodsFind in source

“The trial was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and the principles of the Declaration of Helsinki.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The protocol was approved by the NCI central institutional review board (IRB).”

MethodsFind in source

“All the patients provided written informed consent before enrollment.”

MethodsFind in source

Atezolizumab is identified as an anti-PD-L1 antibody with dose and regimen. mFOLFOX6 components are specified with doses. Statistical software (SAS version 9.04) is identified. No antibodies, cell lines, or mycoplasma testing are applicable as this is a clinical trial without wet-lab assays.

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 product (atezolizumab) and chemotherapy are adequately identified, and statistical software is identified.

Evidence

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles) (6 months) plus modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) followed by atezolizumab monotherapy for 13 cycles (12 months total)”

MethodsFind in source

“Statistical analyses were performed using SAS software, version 9.04 (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (atezolizumab) and chemotherapy agents are identified with dosing details, and statistical software is named.

Evidence

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles) (6 months) plus modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin)”

MethodsFind in source

“Statistical analyses were performed using SAS software, version 9.04 (SAS Institute).”

Statistical analysisFind in source

Tests are named (stratified log-rank, stratified Cox proportional-hazards). Assumptions are handled by design (Cox model). Exact p-values are reported (e.g., P<0.0001, p=0.0002). Effect sizes with CIs are reported. Software is identified. Data presentation includes Kaplan-Meier curves and forest plots. Mathematical plausibility is not applicable for large-N continuous outcomes.

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· 90% conf

Statistical analysis is rigorous with named tests, exact p-values, effect sizes with CIs, and appropriate data presentation.

Evidence

“Disease-free and overall survival were compared between treatment groups using stratified log-rank tests; their hazard ratios were estimated using a stratified Cox proportional-hazards model without covariates adjustment.”

Statistical analysisFind in source

“The stratified log-rank p-value was 0.0002.”

ResultsFind in source

“hazard ratio (HR) for recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.0001”

AbstractFind in source

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Abstract]

“P<0.0001”

“stratified HR, 0.50; 95% confidence interval [CI] , 0.35 to 0.73”

ResultsFind in source

No data availability statement is present. The paper mentions supplementary material but does not specify where data are deposited. For a clinical trial, a data availability statement is required. The trial is registered, but data access is not described.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability is not explicitly stated; the paper mentions supplementary material but no data repository or access mechanism.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no data repository or code sharing is mentioned.

Evidence

absence[Entire paper]

No explicit data availability statement is found.

“protocol available with the full text of this article at NEJM.org”

Statistical analysisFind in source

The trial is registered (NCT02912559). Methods are detailed. Limitations are discussed (e.g., overall survival immature, subsequent therapy confounds). Conclusions are proportional to the evidence. Funding and COI are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, limitations discussed, and proportional conclusions.

Evidence

“NCT02912559 (https://clinicaltrials.gov/ct2/show/NCT02912559)”

MethodsFind in source

“No difference in overall survival has been observed between the study arms at this first analysis with a median follow-up of 40.9 months, and longer follow-up is required for mature estimates.”

Discussion ¶1Find in source

paraphrase[Support]

“This manuscript is the result of funding in whole or in part by the National Cancer Institute of the National Institutes of Health (NIH) under Award Numbers U10CA180821 and U10CA180882, and U24CA196171; (to the Alliance for Clinical Trials in Oncology); ... Also supported in part by funds from Genentech, a member of the Roche group.”

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, detailed methods, and discussion of limitations.

Evidence

paraphrase[Methods, Trial Design and Treatment]

“NCT02912559”

“No difference in overall survival has been observed between the study arms at this first analysis with a median follow-up of 40.9 months, and longer follow-up is required for mature estimates.”

DiscussionFind 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 24 references by DOI: 24 verified.

1 of 2 data/code links checked; 1 live; 1 not probed.

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and methodologically sound. An informed reader should weigh the minor data availability gap and the small CI inconsistency, but these do not undermine the primary conclusions. No erratum is warranted for the p-value discrepancy, but the authors should consider clarifying data access and the CI bound.

1.
HIGHdata code
Add a data availability statement in the Methods or a dedicated section, specifying how de-identified patient data can be accessed (e.g., via the Alliance for Clinical Trials in Oncology data access committee) and any conditions or timeframe.
The absence of a data availability statement is a reporting gap that readers and reviewers will expect for a clinical trial.
2.
HIGHreporting
Explicitly state whether the trial was open-label and provide a rationale for not blinding in the Methods (Trial Design and Treatment).
Blinding status is not explicitly described, which is a minor but important reporting detail for a randomized trial.
3.
MEDIUMcopyedit
Reconcile the 3-year DFS upper CI bound between the Abstract (89.9) and Results (89.8) to ensure consistency.
The internal contradiction is a minor but visible inconsistency that could confuse readers.
4.
MEDIUMcopyedit
Change 'mFOLFOX arm' to 'mFOLFOX6 arm' in the Results, Safety section for terminology consistency.
Consistent terminology is expected in a clinical trial report.
5.
MEDIUMreporting
Mention adherence to CONSORT reporting guidelines explicitly in the Methods or a footnote, and provide the completed checklist as supplementary material.
Explicit reporting guideline adherence enhances transparency and is often required by journals.
6.
MEDIUMdata code
Consider depositing the statistical analysis code (e.g., SAS programs) in a public repository with a DOI to enhance reproducibility.
Sharing analysis code supports reproducibility, though it is not mandatory for clinical trials.
7.
LOWcopyedit
Break the long sentence in Methods, Trial Design and Treatment into shorter sentences for readability.
The sentence is complex and could be clearer for readers.
8.
LOWcopyedit
Clarify in Methods, Statistical Analysis whether the interim efficacy two-sided boundary of 0.0006 applies to overall survival or disease-free survival.
The ambiguity could lead to misinterpretation of the interim analysis design.

Full text (31,271 chars)Analyzed: Aug 15, 2026

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Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.

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DOI

10.1056/NEJMoa2507874

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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

3.75 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsStatistic did not reproduce−0.5★
IntegrityIntegrity concern−0.5★
ReportingData & code availability partially met−0.25★

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

Biggest issues

01Reported statistic does not recompute
highArithmeticrecomputedFull detail
Check the p-value for the primary DFS analysis from the reported HR and CI.
“hazard ratio (HR) for recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.0001”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit5 minor suggestions

Numerical inconsistencies

2 findings · worst high

Reported statistics do not recomputeRecomputed
Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 1 consistent, 1 inconsistent; 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with adequate citation of prior work and a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the study.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, blinding, power analysis, and inclusion/exclusion criteria.

Evidence

MethodsFind in source

Statistical analysisFind in source

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding considerations, power analysis, and pre-specified analysis populations.

Evidence

“Patients were randomized (1:1), via permuted block design with block size of 4, within 10 weeks after surgery”

MethodsFind in source

Statistical analysisFind in source

absence[Methods, Trial Design and Treatment]

Blinding is not explicitly addressed.

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

Biological variables are adequately reported for a human trial, including sex, age, and demographics.

Evidence

paraphrase[Results, Patients]

“Median patient age was 64 years, 55.1% were female, and 83.7% had proximal tumors.”

paraphrase[Table 1]

“ECOG Performance Status , n (%) | 0 | 238 (67.0%) | 225 (63.0%) | 463 (65.0%)”

PASSReviewer 2· 90% conf

Key biological variables such as sex, age, and tumor characteristics are reported, but some details like health status are limited.

Evidence

“Median patient age was 64 years, 55.1% were female”

ResultsFind in source

paraphrase[Table 1]

“ECOG Performance Status , n (%) | 0 | 238 (67.0%) | 225 (63.0%) | 463 (65.0%)”

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals are adequately reported with a named IRB and informed consent.

Evidence

“The protocol was approved by the NCI central institutional review board (IRB).”

MethodsFind in source

“All the patients provided written informed consent before enrollment.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and consent are adequately reported.

Evidence

“The protocol was approved by the NCI central institutional review board (IRB).”

MethodsFind in source

“All the patients provided written informed consent before enrollment.”

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 product (atezolizumab) and chemotherapy are adequately identified, and statistical software is identified.

Evidence

MethodsFind in source

“Statistical analyses were performed using SAS software, version 9.04 (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (atezolizumab) and chemotherapy agents are identified with dosing details, and statistical software is named.

Evidence

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles) (6 months) plus modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin)”

MethodsFind in source

“Statistical analyses were performed using SAS software, version 9.04 (SAS Institute).”

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· 90% conf

Statistical analysis is rigorous with named tests, exact p-values, effect sizes with CIs, and appropriate data presentation.

Evidence

Statistical analysisFind in source

“The stratified log-rank p-value was 0.0002.”

ResultsFind in source

“hazard ratio (HR) for recurrence or death, 0.50; 95% CI, 0.35 to 0.73; P<0.0001”

AbstractFind in source

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Abstract]

“P<0.0001”

“stratified HR, 0.50; 95% confidence interval [CI] , 0.35 to 0.73”

ResultsFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

Data availability is not explicitly stated; the paper mentions supplementary material but no data repository or access mechanism.

Evidence

absence[Entire paper]

No data availability statement is present.

WARNReviewer 2· 80% conf

A data availability statement is present but vague, and no data repository or code sharing is mentioned.

Evidence

absence[Entire paper]

No explicit data availability statement is found.

“protocol available with the full text of this article at NEJM.org”

Statistical analysisFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with trial registration, limitations discussed, and proportional conclusions.

Evidence

“NCT02912559 (https://clinicaltrials.gov/ct2/show/NCT02912559)”

MethodsFind in source

“No difference in overall survival has been observed between the study arms at this first analysis with a median follow-up of 40.9 months, and longer follow-up is required for mature estimates.”

Discussion ¶1Find in source

paraphrase[Support]

PASSReviewer 2· 90% conf

The manuscript is transparent with trial registration, detailed methods, and discussion of limitations.

Evidence

paraphrase[Methods, Trial Design and Treatment]

“NCT02912559”

“No difference in overall survival has been observed between the study arms at this first analysis with a median follow-up of 40.9 months, and longer follow-up is required for mature estimates.”

DiscussionFind 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 24 references by DOI: 24 verified.

1 of 2 data/code links checked; 1 live; 1 not probed.

Copyediting

5 minor

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

No major wording or formatting errors. 5 minor suggestions below.

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

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHdata code
Add a data availability statement in the Methods or a dedicated section, specifying how de-identified patient data can be accessed (e.g., via the Alliance for Clinical Trials in Oncology data access committee) and any conditions or timeframe.
The absence of a data availability statement is a reporting gap that readers and reviewers will expect for a clinical trial.
2.
HIGHreporting
Explicitly state whether the trial was open-label and provide a rationale for not blinding in the Methods (Trial Design and Treatment).
Blinding status is not explicitly described, which is a minor but important reporting detail for a randomized trial.
3.
MEDIUMcopyedit
Reconcile the 3-year DFS upper CI bound between the Abstract (89.9) and Results (89.8) to ensure consistency.
The internal contradiction is a minor but visible inconsistency that could confuse readers.
4.
MEDIUMcopyedit
Change 'mFOLFOX arm' to 'mFOLFOX6 arm' in the Results, Safety section for terminology consistency.
Consistent terminology is expected in a clinical trial report.
5.
MEDIUMreporting
Mention adherence to CONSORT reporting guidelines explicitly in the Methods or a footnote, and provide the completed checklist as supplementary material.
Explicit reporting guideline adherence enhances transparency and is often required by journals.
6.
MEDIUMdata code
Consider depositing the statistical analysis code (e.g., SAS programs) in a public repository with a DOI to enhance reproducibility.
Sharing analysis code supports reproducibility, though it is not mandatory for clinical trials.
7.
LOWcopyedit
Break the long sentence in Methods, Trial Design and Treatment into shorter sentences for readability.
The sentence is complex and could be clearer for readers.
8.
LOWcopyedit
Clarify in Methods, Statistical Analysis whether the interim efficacy two-sided boundary of 0.0006 applies to overall survival or disease-free survival.
The ambiguity could lead to misinterpretation of the interim analysis design.

Full text (31,271 chars)Analyzed: Aug 15, 2026