A novel haemocytometric COVID-19 prognostic score developed and validated in an observational multicentre European hospital-based study
- Sysmex Europe GMBH, Germany
- Amphia Hospital, Netherlands
- Elisabeth-Tweesteden Hospital, Netherlands
- Hospital Papa Giovanni XXIII Bergamo, Italy
- Erasmus MC, University Medical Center, Netherlands
- Leiden University Medical Center, Netherlands
- Albert Schweitzer Hospital, Netherlands
- Canisius Wilhelmina Hospital, Netherlands
- Catharina Hospital, Netherlands
- University Hospital Antwerp, Belgium
- University Medical Center Groningen, University of Groningen, Netherlands
- Zuyderland Medical Center, Netherlands
- Radboud University Medical Center, Netherlands
Abstract
COVID-19 induces haemocytometric changes. Complete blood count changes, including new cell activation parameters, from 982 confirmed COVID-19 adult patients from 11 European hospitals were retrospectively analysed for distinctive patterns based on age, gender, clinical severity, symptom duration and hospital days. The observed haemocytometric patterns formed the basis to develop a multi-haemocytometric-parameter prognostic score to predict, during the first three days after presentation, which patients will recover without ventilation or deteriorate within a two-week timeframe, needing intensive care or with fatal outcome. The prognostic score, with ROC curve AUC at baseline of 0.753 (95% CI 0.723-0.781) increasing to 0.875 (95% CI 0.806-0.926) on day 3, was superior to any individual parameter at distinguishing between clinical severity. Findings were confirmed in a validation cohort. Aim is that the score and haemocytometry results are simultaneously provided by analyser software, enabling wide applicability of the score as haemocytometry is commonly requested in COVID-19 patients.
Data availability
All data analysed during this study are included in the manuscript and supportinng files . Source data files have been provided for figures 3, 4, 5, 6, 7, 8, 9, 10 and 12, and tables 2, 3, 5, 6 and 7.
Article and author information
Author details
Simone van der Sar-van der Brugge
Lucas Joost Van Pelt
Andre J van der Ven
Funding
Sysmex Europe GMBH provided free of charge reagents for the study. No monetary payments were made to any of the investigators. Joachim Linssen, Jarob Saker and Marion Münster are full-time employees of Sysmex Europe GMBH and Andre van der Ven has an ad hoc consultancy agreement with Sysmex Europe GMBH.
Ethics
Human subjects: The study was reviewed by all participating centre ethics committees with approval granted in Italy (Registration Number 54/20) and Belgium (Registration Number 3002020000105) and exemption in the Netherlands, with need for informed consent waived by all.
Copyright
© 2020, Linssen et al.
This article is distributed under the terms of the Creative Commons Attribution License permitting unrestricted use and redistribution provided that the original author and source are credited.
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A novel haemocytometric COVID-19 prognostic score developed and validated in an observational multicentre European hospital-based study
eLife 9:e63195.
https://doi.org/10.7554/eLife.63195
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Background:
Approximately one-third of patients with HER2-positive breast cancer experienced recurrence within 10 years after receiving 1 year of adjuvant trastuzumab. The ExteNET study showed that 1 year of extended adjuvant neratinib after trastuzumab-based adjuvant therapy could reduce invasive disease-free survival (iDFS) events compared with placebo. This study investigated the efficacy and safety of pyrotinib, an irreversible pan-HER receptor tyrosine kinase inhibitor, after trastuzumab-based adjuvant therapy in patients with high-risk, HER2-positive early or locally advanced breast cancer.
Methods:
This multicenter phase II trial was conducted at 23 centers in China. After enrollment, patients received 1 year of extended adjuvant pyrotinib (400 mg/day), which should be initiated within 6 months after the completion of 1-year adjuvant therapy (trastuzumab alone or plus pertuzumab). The primary endpoint was 2-year iDFS rate.
Results:
Between January 2019 and February 2022, 141 eligible women were enrolled and treated. As of October 10, 2022, the median follow-up was 24 (interquartile range, 18.0–34.0) months. The 2-year iDFS rate was 94.59% (95% confidence interval [CI]: 88.97–97.38) in all patients, 94.90% (95% CI: 86.97–98.06) in patients who completed 1-year treatment, 90.32% (95% CI: 72.93–96.77) in patients who completed only 6-month treatment, 96.74% (95% CI: 87.57–99.18) in the hormone receptor (HR)-positive subgroup, 92.77% (95% CI: 83.48–96.93) in the HR-negative subgroup, 96.88% (95% CI: 79.82–99.55) in the lymph node-negative subgroup, 93.85% (95% CI: 86.81–97.20) in the lymph node-positive subgroup, 97.30% (95% CI: 82.32–99.61) in patients with adjuvant trastuzumab plus pertuzumab, and 93.48% (95% CI: 86.06–97.02) in patients with adjuvant trastuzumab. The most common adverse events were diarrhea (79.4%), fatigue (36.9%), lymphocyte count decreased (36.9%), nausea (33.3%), and hand-foot syndrome (33.3%).
Conclusions:
Extended adjuvant pyrotinib administrated after trastuzumab-based adjuvant therapy showed promising efficacy in patients with high-risk HER2-positive breast cancer. The follow-up is ongoing to determine the long-term benefit.
Funding:
No external funding was received for this work.
Clinical trial number:
ClinicalTrials.gov: NCT05880927
