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Abstract P6-18-34: Treat ER+ight Canadian prospective observational study in HR+ advanced breast cancer: <i>3rd interim analysis</i>

2019· article· en· W4248668221 on OpenAlexaffabout
C Doyle, N Califaretti, Susan Dent, N Iqbal, Mihaela Mates, Sadhana V. Kulkarni, P. Bains, Vivian Glenns, SR Perri, S. Chia

Bibliographic record

VenueCancer Research · 2019
Typearticle
Languageen
FieldMedicine
TopicAdvanced Breast Cancer Therapies
Canadian institutionsNovartis (Canada)Lions Gate HospitalWindsor Regional HospitalSaskatchewan Cancer AgencyBC Cancer AgencyKingston General HospitalOttawa HospitalNorth York General Hospital
Fundersnot available
KeywordsMedicinePalbociclibExemestaneFulvestrantLetrozoleEverolimusInternal medicineInterim analysisBreast cancerOncologyAdverse effectCancerAnastrozoleDiscontinuationMetastatic breast cancerHazard ratioTamoxifenClinical trialConfidence interval

Abstract

fetched live from OpenAlex

Abstract Treat ER+ight is the 1st prospective observational study in Canadian HR+ HER2– advanced breast cancer patients currently receiving endocrine therapy (ET) alone or in combination with targeted therapy (TT) in the first, second or third line setting (NCT02753686). Methods: This pre-planned interim analysis describes baseline characteristics, treatment patterns and safety/toxicity of patients enrolled in ET and ET+TT cohorts. At data cut-off (November 2017), 200 patients were enrolled from 24 sites since March 2016. The median follow-up time at data cut-off was 8.1 months and 182 patients were evaluable for this analysis. Results: ET (n=73)ET + TT (n=109)Baseline Patient and Disease Characteristics Median age, years (range)71 (37-92)65 (39-87), p=0.017ECOG 0-1 (%)6274Median time since primary BC diagnosis, years (range)5 (0-37)6 (0-31)Median time with advanced BC diagnosis, years (range)1 (0-16)1 (0-8)Sites of Metastases (%) Bone only4027Visceral6073Location of Metastases (%) Lungs5747Liver2348, p=0.006Bone4846Lymph Nodes2735Enrollment Therapy (%) Everolimus+exemestane-29Fulvestrant17-Palbociclib+letrozole-16Palbociclib+fulvestrant-12Tamoxifen11-Exemestane6-Letrozole3-Anastrozole2-Palbociclib+exemestane-1Everolimus+tamoxifen-0.5Unknown11Start Dose of Targeted Therapy Everolimus (n=53); 10, 7.5, 5mg (%)-72, 4, 24Palbociclib (n=54); 125, 100mg, unknown (%)-89, 9, 2On-Study Adverse Events ≥15% (all-grade, %) Fatigue2332Nausea1224Diarrhea1120Cough815Alopecia316Neutropenia017 Conclusions: The majority of patients enrolled (64%) were receiving endocrine-based targeted therapy (CDK4/6 inhibitor or mTOR inhibitor) combinations. ET+TT patients were younger with more visceral disease and liver metastases compared to patients receiving endocrine therapy alone. Real-world starting dose of targeted therapies appears to be lower than the approved full dose for 11% of patients receiving palbociclib and 28% of patients receiving everolimus. Incidence of reported all-grade adverse events appears to be lower than previously reported in randomized trials and may be a consequence of real-world under-reporting of adverse events as well as the heterogeneous nature of the treatment cohorts. There does however appear to be a trend toward increased incidence of adverse events in the ET+TT cohort compared to the ET cohort. Citation Format: Doyle C, Califaretti N, Dent S, Iqbal N, Mates M, Kulkarni S, Bains P, Glenns V, Perri SR, Chia S. Treat ER+ight Canadian prospective observational study in HR+ advanced breast cancer: 3rd interim analysis [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-34.

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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 categoriesMeta-epidemiology (narrow), Insufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.305
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0010.004
Science and technology studies0.0000.000
Scholarly communication0.0000.001
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0080.000

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 head0.126
GPT teacher head0.455
Teacher spread0.330 · 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
Published2019
Admission routes2
Has abstractyes

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