LUMINA: A prospective trial omitting radiotherapy (RT) following breast conserving surgery (BCS) in T<sub>1</sub>N<sub>0</sub> luminal A breast cancer (BC).
Bibliographic record
Abstract
LBA501 Background: Adjuvant breast RT is usually prescribed following BCS to reduce the risk of local recurrence (LR). However, this treatment is inconvenient, costly, and associated with acute and late toxicity. Traditional clinical pathological factors (CPFs) alone are limited in their ability to identify women with a low enough risk of LR to omit RT. Molecular defined intrinsic subtypes of BC provide additional prognostic information with luminal A having the lowest risk of recurrence. A retrospective analysis of a previous trial suggested that women >60 years with luminal A grade 1-2 T 1 N 0 BC treated by BCS and endocrine therapy alone had a low rate of LR ( JCO 2015; 33:2035). The utility of identifying luminal A subtype combined with CPFs has not been prospectively evaluated for its ability to guide RT decision-making. Methods: A prospective multicenter cohort study was performed. Eligibility criteria were: women ≥ 55 years; having undergone BCS for grade 1-2 T 1 N 0 BC; ≥ 1mm margins of excision; luminal A subtype (defined as: ER ≥ 1%, PR>20%, HER2 negative and Ki67 ≤ 13.25%); and treated with adjuvant endocrine therapy. ER, PR and HER2 were performed locally as per ASCO guidelines. Patients meeting clinical eligibility with ER ≥ 1%, PR>20%, HER2 negative BC were registered and had Ki67 immunohistochemistry performed centrally in one of three Canadian laboratories using International Ki67 Working Group methods. Proficiency testing between laboratories was performed yearly. Patients with Ki67 ≤ 13.25% were enrolled in the trial and were assigned to not receive RT. The primary outcome was LR defined as time from enrollment to any invasive or non-invasive cancer in the ipsilateral breast. Assuming a 5-year LR rate of 3.5%, 500 patients were required to show that the upper bound of a two sided 90% (one-sided 95%) confidence interval (CI) was <5%. Patients were followed every six months for the first two years and then yearly. The probability of LR was estimated using the cumulative incidence function with death as a competing risk. Secondary outcomes were contralateral BC; relapse free survival (RFS) based on any recurrence; disease free survival (DFS) based on any recurrence, second cancer or death; and overall survival (OS). Results: From August 2013 to July 2017, 501 of 727 registered patients from 26 centers had a Ki67 ≤ 13.25% and were enrolled. Median follow-up was 5 years. Median age was 67 and 442 (88%) patients were <75 years. Median tumor size was 1.1 cm. The 5-year rate of LR satisfied our pre-specified boundary (see Table). Conclusions: Women ≥ 55 years with grade 1-2 T 1 N 0 luminal A BC following BCS treated with endocrine therapy alone had very low rates of LR at 5 years and are candidates for omission of RT. Clinical trial information: NCT01791829. [Table: see text]
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".