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Record W4376613897 · doi:10.1016/j.esmoop.2023.101392

203P Clinical effectiveness of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer (mBC) by ER expression level: Subgroup analysis from phase IIIb LUCY trial

2023· article· en· W4376613897 on OpenAlexaff
Karen A. Gelmon, PA Fasching, Suzette Delaloge, Y.H. Park, Andrea Eisen, Hugues Bourgeois, Zoe Kemp, Tomasz Jankowski, Joohyuk Sohn, Sercan Aksoy, Constanta Timcheva, TW Park-Simon, A. Antón Torres, Ellie John, Ian Gibson, Natalia Lukashchuk, Katherine Baria, Judith Balmañà

Bibliographic record

VenueESMO Open · 2023
Typearticle
Languageen
FieldMedicine
TopicAdvanced Breast Cancer Therapies
Canadian institutionsSunnybrook Health Science CentreHealth Sciences CentreUniversity of British Columbia
FundersYonsei University College of MedicineMerck Sharp and DohmeFundació Institut de Recerca Hospital Universitari Vall d’HebronUniversitat de BarcelonaMedizinischen Hochschule HannoverHacettepe ÜniversitesiGilead SciencesMerckAstraZeneca
KeywordsMedicineOlaparibInternal medicineOncologyMetastatic breast cancerTaxaneEribulinBreast cancerPopulationVinorelbineCancerChemotherapyCisplatin

Abstract

fetched live from OpenAlex

In the OlympiAD phase III trial, olaparib significantly prolonged progression-free survival (PFS) vs chemotherapy in patients (pts) with germline-BRCA-mutated (gBRCAm), HER2-negative mBC regardless of hormone receptor (HR) status. In a study population that reflects clinical practice, the phase IIIb LUCY trial similarly showed clinical effectiveness of olaparib regardless of HR status. ASCO/CAP guidelines highlight the lack of data on the best treatment approach for breast tumors that are estrogen receptor (ER)-low (1–10% ER+ stained cells). We examined olaparib clinical effectiveness by ER expression in pts with HER2-negative gBRCAm mBC from the LUCY trial. In this open-label trial, pts with germline or somatic BRCAm, HER2-negative mBC received olaparib (300 mg BID). Pts had received ≤2 chemotherapy lines for mBC and a taxane and/or anthracycline in the (neo)adjuvant or mBC setting. Pts with ER+ BC had received endocrine therapy. In this post hoc subgroup analysis (data cut-off Sept 1, 2021), pts with gBRCAm were grouped by ER expression (ER <1%; 1–10%; >10% by IHC) and analysed for PFS, overall survival, clinical response rate (CRR; i.e. the proportion of pts assessed as responding by the investigator [radiological or symptomatic] at ≥1 visit), and duration of clinical response. 251/252 pts in the gBRCAm cohort were included (ER <1% n=117; 1–10% n=29; >10% n=105). At baseline, pts in the ER <1% group had shorter median times from their original diagnosis (29.7 vs 52.0 vs 58.6 mo) and from diagnosis of mBC (4.8 vs 11.1 vs 12.5 mo) vs pts in the ER 1–10% and >10% groups, respectively. Efficacy outcomes with olaparib were consistent across ER expression subgroups (Table).Table: 203PEfficacy results by ER expressionER <1%ER 1–10%ER >10%Median PFS, months (95% CI)92/117*6.8 (5.5–9.0)24/29*8.3 (4.5–12.6)89/105*8.4 (7.6–11.0)Median OS, months (95% CI)67/117*20.1 (16.5–26.9)20/29*22.9 (13.0–35.1)54/105*27.4 (23.0–NR)CRR, % (95% CI)59/116*50.9 (41.4–60.3)12/28*42.9 (24.5–62.8)51/104*49.0 (39.1–59.0)Median DOCR, months (IQR)59/116*8.3 (3.8–26.5)12/28*7.2 (5.3–14.1)51/104*7.4 (4.3–17.7)∗number of events or responses/number of evaluable pts.CI, confidence interval; CRR, clinical response rate; DOCR, duration of clinical response; IQR, interquartile range; NR, not reached; OS, overall survival; PFS, progression-free survival. Open table in a new tab ∗number of events or responses/number of evaluable pts. CI, confidence interval; CRR, clinical response rate; DOCR, duration of clinical response; IQR, interquartile range; NR, not reached; OS, overall survival; PFS, progression-free survival. Real-world results of the phase IIIb LUCY trial support the clinical effectiveness of olaparib in pts with gBRCAm, HER2-negative mBC, regardless of ER expression level.

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)0.002
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesMeta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.452
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0020.000
Bibliometrics0.0000.002
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.000

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 head0.090
GPT teacher head0.462
Teacher spread0.372 · 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.

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

Citations1
Published2023
Admission routes1
Has abstractyes

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