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Record W4393166351 · doi:10.1016/j.esmoop.2024.102985

LBA2 Clinical outcomes with perioperative nivolumab (NIVO) in patients (PTS) with resectable NSCLC from the phase III CheckMate 77T study

2024· article· en· W4393166351 on OpenAlexaff
Mark M. Awad, Tina Cascone, Jonathan Spicer, Jie He, Shun Lü, Fumihiro Tanaka, Robin Cornelissen, N. Karaseva, Luboš Petruželka, Lin Wu, J-L. Pujol, Hiroyuki Ito, T-E. Ciuleanu, L.D.O.M. Koch, Annelies Janssens, C. Coronado Erdmann, Padma Sathyanarayana, S. Meadows–Shropshire

Bibliographic record

VenueESMO Open · 2024
Typearticle
Languageen
FieldMedicine
TopicGastric Cancer Management and Outcomes
Canadian institutionsMcGill University Health Centre
Fundersnot available
KeywordsMedicineNivolumabPerioperativeOncologyInternal medicinePhases of clinical researchSurgeryClinical trialCancerImmunotherapy

Abstract

fetched live from OpenAlex

In CheckMate 77T, perioperative NIVO demonstrated statistically significant and clinically meaningful EFS benefit vs neoadjuvant (neoadj) chemo followed by adjuvant (adj) placebo (PBO) in pts with resectable NSCLC (HR 0.58, 97.36% CI 0.42–0.81; P = 0.00025). pCR and MPR rates were also improved with perioperative NIVO. Here, we report clinical outcomes by number of neoadj treatment (tx) cycles. Adults with untreated, resectable stage IIA–IIIB NSCLC (AJCC 8th ed) were randomized 1:1 to NIVO 360 mg Q3W + chemo (4 cycles) followed by adj NIVO 480 mg Q4W (1 y) or PBO Q3W + chemo (4 cycles) followed by adj PBO Q4W (1 y). Primary endpoint: EFS. Exploratory analyses: pCR, MPR, EFS, TTDM, and safety by number of completed neoadj tx cycles (< 4 and 4); TTDM in randomized pts (prespecified) and by pathologic response. Of 461 randomized pts (median f/u 25.4 mo), 191 (83%; NIVO) and 205 (88%; chemo) completed 4 cycles of neoadj tx; the majority of pts who discontinued neoadj tx did so due to study drug toxicity. Baseline characteristics were similar for pts who completed < 4 or 4 cycles of neoadj tx in both tx arms, except that a higher proportion of pts who completed < 4 cycles were from Asia. In pts who completed < 4 cycles of neoadj tx (NIVO, 38; chemo, 27), pCR, MPR, and EFS favored NIVO vs chemo (table); 53% and 37% had surgery, respectively, and among these pts, pCR rates were 35% vs 0% and MPR rates were 40% vs 0%. In pts who completed 4 cycles of neoadj tx, pCR, MPR, and EFS were improved with NIVO vs chemo (table). TTDM favored NIVO vs chemo in all randomized pts (HR 0.62, 95% CI 0.44–0.85) and regardless of number of completed neoadj tx cycles or pCR/MPR status (data to be presented). No new safety signals were seen.Table: LBA2< 4 cycles4 cyclesNIVO (n = 38)chemo (n = 27)NIVO (n = 191)chemo (n = 205)pCR, % (95% CI)18.4 (7.7-34.3)0 (0-12.8)26.7 (20.6-33.6)5.4 (2.7-9.4)MPR, % (95% CI)21.1 (9.6-37.3)0 (0-12.8)38.2 (31.3-45.5)13.7 (9.3-19.1)Pts who received surgery, n (%)20 (53)10 (37)158 (83)168 (82) pCR, % (95% CI)35.0 (15.4–59.2)032.3 (25.1–40.2)6.5 (3.3–11.4) MPR, % (95% CI)40.0 (19.1–63.9)046.2 (38.2–54.3)16.7 (11.4–23.2)mEFS, mo (95% CI)NR (10.8–NR)7.8 (2.2–NR)NR (28.9–NR)19.8 (14.4–28.2) HR (95% CI)0.51 (0.23–1.11)0.57 (0.42–0.79) 12-mo EFS rate, %62367661mTTDM, mo (95% CI)NR (16.5–NR)10.9 (3.4–22.2)NR (NR–NR)38.8 (22.3–NR) HR (95% CI)0.46 (0.22–0.98)0.61 (0.42–0.88) Open table in a new tab In these exploratory analyses from CheckMate 77T, perioperative NIVO showed clinical benefit in pts with resectable NSCLC, including those who received < 4 cycles of neoadj NIVO + chemo, further supporting perioperative NIVO as a tx option for this pt population.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.038
Threshold uncertainty score0.992

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.001
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0010.000

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.

Opus teacher head0.044
GPT teacher head0.387
Teacher spread0.343 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

Quick stats

Citations4
Published2024
Admission routes1
Has abstractyes

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