IMpassion031: Efficacy, safety and patient (pts)-reported outcomes/quality of life (QoL) - Results from a Ph 3 study of neoadjuvant (neoadj) atezolizumab + chemo in early stage triple-negative breast cancer (eTNBC)
Bibliographic record
Abstract
Background IMpassion031 is a randomised, placebo-controlled Ph3 study in high-risk primary invasive eTNBC evaluating neoadj atezolizumab (A) or placebo (P) with nab -paclitaxel (nP) followed by A or P with dose-dense doxorubicin + cyclophosphamide. Methods Pts with untreated stage II-III eTNBC > 2 cm were randomized to receive A 840 mg (n = 165) or P (n = 168) q2w + nP 125 mg/m 2 qw for 6 doses followed by A 840 mg or P q2w + doxorubicin 60 mg/m 2 + cyclophosphamide 600 mg/m 2 q2w for 4 doses of A before surgery. Pathologic complete response (pCR; ypT0/isN0) was assessed (stratified by PD-L1 expression on tumour-infiltration immune cells, cut-off 1 %). QoL was measured by EORTC-QLQ-C30 and single-item GP5 from the FACT-G questionnaire at baseline and day1 of each neo- and adjuvant cycle (C). Results Median follow-up was 20.6 mos (A-chemo)/19.8 (P-chemo). pCR was seen in 57.6 % (A-chemo) and 41.1 % (P-chemo) ( P = 0.0044). pCR benefit with A-chemo was observed regardless of PD-L1 status. In the neoadj phase, Grade 3/4 AEs were balanced, treatment (Tx)-related serious AEs occurred in 22.6 % (A-chemo) and 15.6 % (P-chemo). One pt/arm had an unrelated Grade 5 AE. QoL mean values were similar between arms across on-Tx assessments to C16 and through follow up. In both arms, HRQoL declined during neoadj therapy from C3-C5, rebounding in the adj period, and stabilizing from C6. Conclusions In pts with eTNBC, atezolizumab + neoadj chemo significantly improved pCR rates independent of PD-L1 status with an acceptable safety profile, without added Tx burden to pts. (NCT03197935). Publication History Article published online: 01 June 2021 © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".