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Abstract PD12-01: Evaluation of sleep problems and their association with febrile neutropenia, leucopenia and infections in women receiving adjuvant chemotherapy for breast cancer in the Canadian Cancer Trials Group MA.21 trial

2021· article· en· W3130516758 on OpenAlexaffabout
Audreylie Lemelin, Josée Savard, Michelle Chen, Margot J. Burnell, Mark N. Levine, Lois E. Shepherd, Bingshu E. Chen, Julie Lemieux

Bibliographic record

VenueCancer Research · 2021
Typearticle
Languageen
FieldMedicine
TopicNeutropenia and Cancer Infections
Canadian institutionsMcMaster UniversityQueen's UniversityDalhousie UniversityUniversité Laval
Fundersnot available
KeywordsMedicineLeukopeniaBreast cancerInternal medicineFebrile neutropeniaNeutropeniaCancerChemotherapyClinical endpointSleep disorderOncologyClinical trialInsomniaPsychiatry

Abstract

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Abstract BackgroundInsomnia is a frequent complaint in patients with cancer. Sleep problems can affect immune functioning in healthy individuals. Our aim was to evaluate the association between sleep disturbance and the risk of febrile neutropenia, leukopenia and infections in patients treated with chemotherapy in an adjuvant setting for breast cancer.MethodologyThis is a retrospective study using the Canadian Cancer Trial Group data collected for the MA.21 trial, in which three adjuvant chemotherapy regimens (CEF, EC-T dose dense or AC-T) were compared in 2104 patients with node positive or high-risk node negative breast cancer. A total of 1731 patients had completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and 1727 patients had completed the Breast Cancer Chemotherapy Questionnaire (BCQ) quality of life questionnaires, which both include a question about sleep difficulties. The primary definition for patients with insomnia was a score of three (quite a bit) or greater at Question 11 (Have you had trouble sleeping? with answers ranging from one (not at all) to four (very much)) on the EORTC QLQ-C30 questionnaire. We compared patients classified as having “clinical insomnia” based on their response to this question with patients considered “good sleepers”. The primary endpoint was the risk of febrile neutropenia. Secondary endpoints were the risks of grade one or more leukopenia, neutropenia and infection. ResultsFebrile neutropenia was more frequent in patients with sleep problems compared with those without, with 16.3% and 12.2% of patients having at least one episode in each group respectively (p value = 0.01 in the univariate analysis (table 1)). However, after adjustment for potential confounders in the multi-variate analysis, it was not statistically significant with an odds ratio of 1.07, a 95% confidence interval of 0.76-1.50 and a p value of 0.71. Similarly, no statistically significant difference in the risk of leukopenia could be demonstrated in the multi-variate analysis for patients with sleep problems with an odds ratio of 0.92 a 95% confidence interval of 0.69-1.24 and a p value of 0.59. No significant association could be found between sleep problems and neutropenia and infections. In an unplanned exploratory analysis, chemotherapy dose reductions were significantly more frequent in patients with sleep problems with 30.6% in this group compared to 21.8% in good sleepers, with a p value <0.0001. ConclusionWhile our univariate analysis suggested an increased risk of febrile neutropenia and leucopenia in patients with sleep problems, after adjustment for confounders, we could not show a statistically significant association in women undergoing adjuvant chemotherapy for high-risk locoregional breast cancer. Table 1: Univariate analysis of primary and secondary outcomes in patients with sleep problems and good sleepersCharacteristicsSleep problem= yesSleep problem = noFebrile neutropeniaNo781 (83.7%)701 (87.8%)Yes152 (16.3%)97 (12.2%)P-value0.01White blood cell count (WBC)Grade 0157 (16.8%)141 (17.7%)Grade 1135 (14.5%)138 (17.3%)Grade 2184 (19.7%)186 (23.3%)Grade 3214 (22.9%)173 (21.7%)Grade 4243 (26.1%)160 (20.1%)P-value0.02NeutropeniaGrade 0778 (83.4%)700 (87.7%)Grade 10 (0%)1 (0.1%)Grade 22 (0.2%)0 (0%)Grade 3152 (16.3%)96 (12.0%)Grade 41 (0.1%)1 (0.1%)P-value0.014InfectionGrade 0619 (66.4%)564 (70.7%)Grade 168 (7.3%)62 (7.8%)Grade 2158 (16.9%)110 (13.8%)Grade 387 (9.3%)61 (7.6%)Grade 41 (0.1%)1 (0.1%)P-value0.24Chemotherapy delayNo1 (0.1%)12 (1.5%)Yes932 (99.9%)786 (98.5%)P-value0.0008Chemotherapy dose reductionNo648 (69.4%)624 (78.2%)Yes285 (30.6%)174 (21.8%)P-value< 0.0001 Citation Format: Audreylie Lemelin, Josée Savard, Michelle Chen, Margot Burnell, Mark N Levine, Lois Shepherd, Bingshu E Chen, Julie Lemieux. Evaluation of sleep problems and their association with febrile neutropenia, leucopenia and infections in women receiving adjuvant chemotherapy for breast cancer in the Canadian Cancer Trials Group MA.21 trial [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD12-01.

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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)0.008
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: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.614
Threshold uncertainty score1.000

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0080.000
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 integrity0.0000.001
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 head0.111
GPT teacher head0.412
Teacher spread0.301 · 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".

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Citations0
Published2021
Admission routes2
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