Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER(+)HER2(-) breast cancer: a randomized phase 2 trial.

Name: Αlpha¹ Rigor Record — Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER(+)HER2(-) breast cancer: a randomized phase 2 trial.
Item: Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER(+)HER2(-) breast cancer: a randomized phase 2 trial.
Rating: 59
Author: Αlpha¹

De Caluwé A, Desmoulins I, Cao K, Remouchamps V, Baten A, Longton E, Peignaux K, Joaquin Garcia A, Venet D, Arecco L, Agostinetto E, Nader-Marta G, Denis Z, Dhont J, Kristanto P, Catteau X, Larsimont D, Salgado R, Poortmans P, Stagg J, Sotiriou C, Piccart M, Ignatiadis M, Romano E, Buisseret L

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Αlpha¹ Rigor Review — 3★ (Adequate), 0 critical, 3 high issues for “Neoadjuvant stereotactic body radiation therapy with durvalumab and oleclumab in ER(+)HER2(-) breast cancer: a randomized phase 2 trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern−0.5★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×10−0.25★
CitationsUnresolved reference−0.25★

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

Problems surfaced6 types

Numerical inconsistencies2

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.

Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions3

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.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

Broken references and links1

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.

References not resolvable to a published paperRecomputed

This Αlpha¹ 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 well-conducted and transparently reported randomized phase 2 trial. The paper excels in ethical approvals, data/code availability, and biological variable reporting, with minor gaps in power analysis reporting, exact p-values for exploratory analyses, and explicit reporting guideline adherence.

Both reviewers classified the study as interventional and agreed on all dimension statuses; minor divergences in checklist ratings (power analysis, sex justified, assumptions verified, exact p_values, reporting guideline) were resolved conservatively. The statistics verification covered only 12 tests with test statistics/CI; threshold-only p-values and resampling-based tests were not machine-verifiable, so the absence of detected errors does not confirm overall statistical correctness.

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.

Premise concern: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks. 10 printed percentages that do not match their own count.

1 integrity concern flagged (0 high).

Reporting

Eight Dimensions8 pass

The introduction cites prior studies on ICI in breast cancer, the immune-cold TME of ER+ HER2- tumors, and the immunomodulatory effects of RT and CD73 blockade. The rationale for combining iSBRT with ICI and anti-CD73 is logically developed. Limitations of prior work (e.g., low pCR in ER+ HER2-, limited ICI benefit in PD-L1-negative tumors) are explicitly addressed as the motivation for the 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 extensive prior work and a logical rationale linking immune-cold tumors, iSBRT, and CD73 blockade to the study hypothesis.

Evidence

direct quote[Introduction, paragraph 2]

“In triple-negative BC, the addition of anti-PD-1 to NACT increased pCR by 13.6% and improved overall survival by 5.0% at 5 years”