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

Name: Adcurare Rigor Record — Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.
Item: Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.
Rating: 59
Author: Adcurare

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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Adcurare Rigor Review — 4.25★ (Strong), 0 critical, 6 high issues for “Atezolizumab plus FOLFOX for Stage III Mismatch Repair-Deficient Colon Cancer.”

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Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · July 6, 2026

Adcurare Rigor Review

Rigor Reviewed

4.25 / 5

Strong — minor issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

ReportingBiological variables partially met−0.25★
ReportingKey resources partially met−0.25★
ReportingData & code availability partially met−0.25★

Model-reported confidence: highReviewer agreement: moderateEngine: 7.6.0Source: full text

Problems surfaced3 types

Biological variables underreported (sex, age, strain)
Data/code availability incomplete
Key resources under-identified (antibodies, cell lines, RRIDs)

This Adcurare Rigor Review uses AI 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 methodologically rigorous phase 3 RCT with strong scientific premise, clear design, adequate statistical analysis, and transparent reporting of limitations and funding. The main weaknesses are missing elements in demographic reporting (race/ethnicity, weight) and drug manufacturer details, and the absence of a data availability statement, which are all fixable reporting gaps.

All eight dimensions were applicable and evaluated. The reviewers largely converged; minor divergence on data code availability (warn vs fail) and key resources (pass vs warn) was resolved by weighing the specific evidence for missing items. The statistical verification component covered only 5 tests with consistent results — all unrecomputed statistics are unverified. No retracted or unresolved references were found.

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

Recomputed 5 tests: 5 consistent, 0 inconsistent, 5 via agent-written checks.

Reporting

Eight Dimensions5 pass · 3 warn

The introduction cites prior evidence on dMMR colon cancer biology, resistance to fluoropyrimidines, the KEYNOTE-177 trial in metastatic disease, and the rationale for the ATOMIC trial. The premise—that adding atezolizumab to adjuvant chemotherapy may improve outcomes—is logically linked from these prior data. The limitations of prior research (e.g., lack of adjuvant checkpoint inhibitor data in dMMR) are implicitly addressed by the study design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The paper clearly establishes the scientific foundation, citing prior work on dMMR colon cancer, immune checkpoint inhibition, and the rationale for combining atezolizumab with FOLFOX.

Evidence

direct quote[Introduction, paragraph 1]

“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).”

direct quote[Introduction, paragraph 2]

“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.”

direct quote[Discussion, paragraph 1]

“While colon cancers with dMMR have shown resistance to fluoropyrimidines, a benefit of oxaliplatin is suggested by data from a retrospective, observational cohort study and a pooled analysis.”

PASSReviewer 2· 95% conf

The paper clearly establishes its scientific foundation by citing prior research on dMMR biology, resistance to fluoropyrimidines, and efficacy of checkpoint inhibitors in metastatic disease, providing a logical rationale for the trial.

Evidence

direct quote[Introduction, paragraph 2]

“Colorectal cancer with dMMR has shown intrinsic resistance to fluoropyrimidines… In patients with metastatic dMMR colorectal cancer… pembrolizumab was shown to be superior to fluoropyrimidine-based chemotherapy.”

direct quote[Introduction, paragraph 3]

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

paraphrase[Introduction, paragraph 1-2]

“Approximately 30% of stage III patients recur despite adjuvant chemotherapy, and dMMR tumors show intrinsic resistance to fluoropyrimidines but not to oxaliplatin-containing regimens.”

PASSReviewer 3· 95% conf

The scientific premise is well-established, citing prior work on dMMR colon cancer, resistance to fluoropyrimidines, and the rationale for immune checkpoint inhibition.

Evidence

direct quote[Introduction, paragraph 1]

“Evidence indicates that 10-15% of localized colon cancers show deficient DNA mismatch repair (MMR) that results in microsatellite instability-high (MSI-H) characterized by hypermutation immune checkpoint up-regulation, and abundant predicted neoantigens.”

direct quote[Introduction, paragraph 2]

paraphrase[Discussion, paragraph 5]

“The paper discusses that while dMMR colon cancers show resistance to fluoropyrimidines, a benefit of oxaliplatin is suggested by data from retrospective studies and a pooled analysis, justifying the control arm.”

Randomization used a permuted block design with block size of 4, and patients were randomized 1:1. The unit of randomization is the individual patient. Blinding is not described, but this is standard for an open-label chemo-immunotherapy trial. A prospective power analysis is reported (700 patients, 165 events, 90% power to detect HR 0.6). Inclusion/exclusion criteria are detailed (age ≥12, R0 resection, stage III, dMMR, ECOG 0-2). The primary analysis is ITT; a post-hoc per-protocol analysis is also described. Outlier handling is not explicitly discussed, but adverse events are graded per CTCAE; the analysis population for safety is defined.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsINADEQUATE

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study design for a phase 3 RCT is rigorous: randomization method and unit are stated, blinding is not applicable (open-label), power analysis is described, inclusion/exclusion criteria are specified, and the analysis population (ITT) is defined.

Evidence

direct quote[Methods, Trial Design and Treatment, paragraph 1]

“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 … versus mFOLFOX6 … alone for 12 cycles (6 months total).”

direct quote[Methods, Statistical Analysis, paragraph 1]

“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.”

direct quote[Methods, Patients, paragraph 1]

“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.”

PASSReviewer 2· 90% conf

Study design is rigorous for a phase 3 RCT with clear randomization, power analysis, and ITT analysis, but blinding is not mentioned (open-label design without stated rationale).

Evidence

direct quote[Methods, Trial Design and Treatment]

“Patients were randomized (1:1), via permuted block design with block size of 4…”

direct quote[Methods, Statistical Analysis]

absence[Methods, Trial Design and Treatment and Trial Oversight sections]

Blinding is not mentioned.

PASSReviewer 3· 85% conf

The study design is rigorous for a phase 3 RCT, with clear randomization, power analysis, and inclusion criteria, but blinding is not reported.

Evidence

direct quote[Methods, Trial Design and Treatment]

“Patients were randomized (1:1), via permuted block design with block size of 4, within 10 weeks after surgery to atezolizumab plus mFOLFOX6 versus mFOLFOX6.”

direct quote[Methods, Statistical Analysis]

absence[Methods, Trial Design and Treatment]

Blinding is not reported.

Sex and age are reported in Table 1 (55.1% female, median age 64 years). Health status is captured via ECOG performance status (0,1,2). Body weight, which is relevant for BSA-based drug dosing (5-FU, oxaliplatin), is not reported. Race/ethnicity data are absent from the baseline table; the paper only states demographics are similar to NCDB cohort without providing actual numbers. Since both sexes are enrolled, sex justification is not applicable.

Sub-criteria

demographicsINADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthINADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Patient demographics (age, sex, tumor stage, sidedness) are reported and well-balanced between arms. Sex is reported and both sexes are included; no single-sex justification is needed.

Evidence

direct quote[Results, paragraph 1]

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

direct quote[Table 1]

“T-Stage ... N stage ... Clinical Risk Group ... ECOG Performance Status”

direct quote[Discussion, last paragraph]

“Baseline demographic and clinical features were also similar to those of a large NCDB cohort of patients with dMMR stage III colon cancer, further reinforcing the representativeness of the study population.”

WARNReviewer 2· 85% conf

Sex and age are reported, but health status is limited to ECOG performance score (weight not reported), and race/ethnicity is not reported in the provided tables.

Evidence

direct quote[Results, Table 1]

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

absence[Results, Table 1 and surrounding text]

Race/ethnicity is not reported in the baseline table.

absence[Results, Table 1]

Weight is not reported; only ECOG performance status for health.

WARNReviewer 3· 80% conf

Sex and age are reported, but weight and race/ethnicity are missing, and demographics are incomplete.

Evidence

direct quote[Table 1]

“Female Sex, n (%) : 186 (52.4%) [Arm 1] ... 206 (57.7%) [Arm 2] ... 392 (55.1%) [Total]”

absence[Table 1]

Weight is not reported.

absence[Table 1 and Results]

Race/ethnicity is not reported.

The Trial Oversight section states the protocol was approved by the NCI central IRB, all patients provided written informed consent, and the trial was conducted in accordance with ICH GCP guidelines and the Declaration of Helsinki. This meets all applicable sub-criteria for a human trial.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial reports approval by the NCI central IRB, written informed consent, and regulatory compliance with GCP and the Declaration of Helsinki.

Evidence

direct quote[Methods, Trial Oversight, paragraph 1]

“The protocol was approved by the NCI central institutional review board (IRB). All the patients provided written informed consent before enrollment.”

direct quote[Methods, Trial Oversight, paragraph 1]

“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.”

PASSReviewer 2· 98% conf

Ethics approval from a named institutional review board (NCI central IRB), written informed consent, and regulatory compliance (ICH GCP, Declaration of Helsinki) are all explicitly stated.

Evidence

direct quote[Methods, Trial Oversight]

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

direct quote[Methods, Trial Oversight]

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

direct quote[Methods, Trial Oversight]

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

PASSReviewer 3· 95% conf

Ethical approvals are clearly documented with a named IRB, informed consent, and regulatory compliance.

Evidence

direct quote[Methods, Trial Oversight]

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

direct quote[Methods, Trial Oversight]

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

direct quote[Methods, Trial Oversight]

Atezolizumab is named with dose (840 mg IV q2w) and regimen, but the manufacturer (Genentech) is only implied via funding. mFOLFOX6 components (5-FU, oxaliplatin, leucovorin) are listed with doses but no vendor information. For a clinical trial, the reagent sub-criterion requires naming the manufacturer/source. Statistical software (SAS 9.04) is adequately identified. No other resource sub-criteria apply (antibodies, cell lines, etc.).

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The investigational products (atezolizumab, FOLFOX components) are identified with doses and regimens; statistical software is identified. No cell lines, antibodies, or laboratory reagents were used.

Evidence

direct quote[Methods, Trial Design and Treatment, paragraph 1]

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles) (6 months) plus modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) ... versus mFOLFOX6 [(5-fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours), oxaliplatin (85 mg/m2), and leucovorin (400 mg/m2)] alone for 12 cycles (6 months total).”

direct quote[Methods, Statistical Analysis, last paragraph]

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

WARNReviewer 2· 80% conf

The investigational product (atezolizumab, mFOLFOX6 components) is described with dose/regimen but without explicit manufacturer/source; statistical software is adequately identified.

Evidence

direct quote[Methods, Trial Design and Treatment]

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles)”

direct quote[Methods, Trial Design and Treatment]

“modified (m)FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) … (5-fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours), oxaliplatin (85 mg/m2), and leucovorin (400 mg/m2)”

direct quote[Methods, Statistical Analysis]

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

WARNReviewer 3· 75% conf

The investigational product (atezolizumab) and chemotherapy regimen are described but without manufacturer details, while statistical software is adequately identified.

Evidence

direct quote[Methods, Trial Design and Treatment]

“atezolizumab (840 mg intravenously every 2 weeks for 12 cycles)”

direct quote[Methods, Trial Design and Treatment]

“modified (m) FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin)”

direct quote[Methods, Statistical Analysis]

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

The primary analysis uses stratified log-rank test and Cox proportional-hazards model. Exact p-values (e.g., P<0.0001 for DFS) and 95% CIs are reported. Effect sizes (HR 0.50) with 95% CI are given. SAS version 9.04 is identified. Data presentation includes Kaplan-Meier curves (Figures 2, 3) and per-group n and event counts. Assumptions for Cox regression (proportional hazards) are not explicitly verified, but the analysis is standard. Exact p-values are reported (0.0002 for DFS). Mathematical plausibility: cell counts and percentages appear consistent; no arithmetic errors are apparent. The p-value reported for DFS (P<0.0001) is from the stratified log-rank test and is consistent with the reported HR and CI.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedINADEQUATE

mathematical plausibilityN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

Statistical tests are named (stratified log-rank, Cox proportional-hazards), exact p-values and confidence intervals are reported, effect sizes (HR) with CIs are given, software is identified, and data presentation includes Kaplan-Meier curves and per-group event counts.

Evidence

direct quote[Results, Efficacy, paragraph 1]

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

direct quote[Results, Efficacy, paragraph 1]

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

direct quote[Methods, Statistical Analysis, last paragraph]

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

PASSReviewer 2· 90% conf

Statistical methods are well-described with named tests, exact p-values, effect sizes with CIs, and data presentation appropriate for a clinical trial, but verification of model assumptions (e.g., proportional hazards) is not reported.

Evidence

direct quote[Methods, Statistical Analysis]

“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.”

direct quote[Results, Efficacy]

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

absence[Methods, Statistical Analysis]

Model assumptions (e.g., proportional hazards) are not discussed.

PASSReviewer 3· 90% conf

Statistical methods are clearly described and appropriate for the trial design, with exact p-values, effect sizes, and software identified.

Evidence

direct quote[Methods, Statistical Analysis]

direct quote[Results, Efficacy]

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

direct quote[Results, Efficacy]

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

The paper does not include a data availability statement. The clinical trial registration number is provided, but the underlying data are not mentioned as accessible. No code sharing is reported. For a clinical trial, a data availability statement is required; the absence is a reporting gap.

Sub-criteria

code sharingNOT REPORTED

accession numbersN/A

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 85% conf

The data availability statement is vague ('protocol available at NEJM.org'), and no mention of individual patient data sharing or code sharing is made. A trial registration number is provided, but this does not constitute a data availability statement.

Evidence

direct quote[Methods, Statistical Analysis, last paragraph]

“Adverse events were graded and attributed by site investigators (protocol available with the full text of this article at NEJM.org).”

absence[Overall manuscript]

No mention of data sharing in the main manuscript

absence[Overall manuscript]

Code sharing not mentioned

FAILReviewer 2· 75% conf

No data availability statement is present in the provided manuscript; no repository deposit, accession numbers, or code sharing are mentioned.

Evidence

absence[Entire manuscript (including Supplementary Material, footnotes)]

No data availability statement is present.

absence[Entire manuscript]

No repository deposit or code sharing is mentioned.

WARNReviewer 3· 90% conf

No data availability statement is provided, and no data repository or code sharing is mentioned.

Evidence

absence[Entire paper]

No data availability statement is present.

absence[Entire paper]

No repository deposit URL is provided.

Methods include full eligibility criteria, treatment schedule, statistical analysis plan. Trial registration number (NCT02912559) is given. A CONSORT diagram (Figure 1) is referenced. Limitations are discussed (e.g., no OS difference yet, potential for overstaging in dMMR). Conclusions are measured ('significant improvement in disease-free survival'). Funding and COI are disclosed. Reporting guideline is not explicitly named, but the paper follows CONSORT structure and includes a flow diagram. All expected outcomes are reported.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 95% conf

The methods are detailed, the trial is registered, the CONSORT diagram is provided, limitations are discussed, conclusions are proportional, and funding/COI are disclosed.

Evidence

direct quote[Methods, Trial Design and Treatment, paragraph 1]

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

direct quote[Discussion, paragraph 4]

“ATOMIC was not designed to test the benefit of atezolizumab in the absence of standard chemotherapy.”

direct quote[Support section and Footnotes]

“Supported ... by the National Cancer Institute of the National Institutes of Health ... and in part by funds from Genentech. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.”

PASSReviewer 2· 85% conf

Overall reporting is transparent with complete methods, trial registration, limitations discussed, and proportional conclusions, but some secondary endpoints (PRO-CTCAE, QoL) are deferred and CONSORT guideline adherence is not explicitly stated.

Evidence

direct quote[Abstract and Methods]

“NCT02912559”

direct quote[Methods, Statistical Analysis]

“The secondary endpoints of patient-reported outcome-CTCAE (PRO-CTCAE) and quality of life will be reported separately.”

absence[Methods]

CONSORT guideline is not explicitly referenced.

PASSReviewer 3· 80% conf

The manuscript is well-structured with detailed methods, trial registration, limitation discussion, and proportional conclusions, but lacks a reporting guideline and does not report all secondary outcomes in this paper.

Evidence

direct quote[Abstract, Methods, Footnotes]

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

absence[Methods]

No reporting guideline is referenced.

direct quote[Methods, Statistical Analysis]

“The secondary endpoints of patient-reported outcome-CTCAE (PRO-CTCAE) and quality of life will be reported separately.”

6 copyedit issues flagged: mostly consistency, clarity, punctuation.

Checked 24 references: 24 verified.

Reproducibility

3 data/code links checked; 1 live.

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

Adcurare Rigor Action ItemsFinal pass before journal submission

The paper is ready to submit after minor edits. The three 'warn' dimensions (biological_variables, key_resources, data_code_availability) require specific additions before submission, but none threaten the validity of the results. The copyedit issues are minor and easily addressed. Addressing the pre-submission action items below will bring the paper to a standard suitable for a high-impact journal.

1.
HIGHdata code
Add a formal data availability statement in the Methods or a dedicated Data Sharing section specifying how to access de-identified individual patient data (e.g., via the Alliance for Clinical Trials in Oncology data-sharing portal or a managed-access repository).
There is no data availability statement in the manuscript; NEJM and most journals require one for clinical trials to ensure reproducibility.
2.
HIGHreporting
Report race and ethnicity of participants in Table 1 to fully characterize the study demographics and comply with NIH policy.
Race/ethnicity are standard demographic variables for assessing generalizability; their absence is a notable gap in Table 1.
3.
HIGHreporting
Report body weight or note that weight was not collected in Table 1, as it is relevant for BSA-based drug dosing (FOLFOX).
Weight is an important health status variable for a trial involving weight-based chemotherapy dosing.
4.
HIGHrigor
Include the manufacturer/source for atezolizumab and each mFOLFOX6 component (e.g., Genentech for atezolizumab, standard suppliers for fluorouracil, oxaliplatin, leucovorin) in the Methods section.
Reagent identification requires source for reproducibility; the current Methods list doses but not vendors.
5.
HIGHreporting
Explicitly state that the trial is open-label and provide a brief rationale for the lack of blinding (e.g., due to differing infusion schedules and the impracticality of placebo infusions).
Blinding status is a standard reporting item; omitting it entirely could raise reviewer questions.
6.
HIGHreporting
Explicitly reference adherence to CONSORT reporting guidelines (e.g., 'This study is reported in accordance with the CONSORT 2010 statement') in the Methods.
CONSORT is the standard guideline for RCTs; referencing it signals commitment to transparent reporting.
7.
MEDIUMreporting
Harmonize the p-value for the primary endpoint between the Abstract (P<0.0001) and the Results text (p=0.0002) so they are consistent.
Copyedit flagged this inconsistency; p-values must be identical in abstract and main text to avoid confusion.
8.
MEDIUMdata code
Consider depositing the SAS analysis code in a public repository (e.g., GitHub, Zenodo) or state where it can be accessed upon request.
Code sharing enhances reproducibility; for an NCI-funded trial, this is an emerging expectation.
9.
MEDIUMreporting
Include a brief statement on verification of proportional hazards assumptions for the Cox model, or note that it was assessed and satisfied.
This is a standard model assumption; its verification adds methodological rigor despite being commonly omitted.
10.
MEDIUMreporting
Provide a timeline or planned publication venue for the deferred secondary endpoints (PRO-CTCAE, quality of life) to fully report all pre-specified outcomes.
Deferring outcomes is acceptable but should be transparently linked to a future report to avoid concerns about selective reporting.
11.
LOWcopyedit
Remove the extraneous metadata header numbers from the Abstract (line beginning with '319 nihpa') before submission.
This appears to be a PMC metadata artifact and should be cleaned to present a clean manuscript.
12.
LOWcopyedit
Clarify the statement about NCCN guidelines in Discussion paragraph 3 by specifying whether the extension to T4bN0 stage II is a direct recommendation or a statement of applicability.
The current phrasing is slightly ambiguous; clarifying avoids potential misinterpretation.

Full text (31,727 chars)Analyzed: Jul 6, 2026

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

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Journal

DOI

10.1056/NEJMoa2507874

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