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      Call for Papers: Digital Diagnostic Techniques

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      Sex-Specific Differences in the Risk of Heart Failure following Anti-HER2 Monoclonal Antibody Therapy

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          Abstract

          Background

          Anti-HER2 monoclonal antibody is associated with a greater risk of heart failure (HF) in female breast cancer patients. In recent years, the indication of anti-HER2 monoclonal antibodies was further expanded to stomach, colorectal, and salivary gland cancers regardless of sex in Japan. However, there have been no data on sex difference in the risk of HF after the anti-HER2 monoclonal antibody treatment.

          Objectives

          We compared the risk of HF between male and female cancer patients treated with anti-HER2 monoclonal antibody using a nationwide population-based database.

          Method

          We analyzed 4,608 cancer patients (230 men, median age; 52 years, breast cancer; 4,333) treated with HER2 monoclonal antibody enrolled in the JMDC Claims Database. The primary outcome was the incidence of HF.

          Results

          Over a mean follow-up of 917 ± 835 days, 559 HF events were documented. Kaplan-Meier curves showed no significant difference in the incidence of HF between men and women. Multivariable Cox regression analysis showed that male sex was not associated with a risk of HF compared with women (HR, 0.76; 95% CI: 0.39–1.49).

          Conclusions

          Our analysis of a nationwide population-based database firstly revealed that no significant sex difference existed in the risk of HF among cancer patients treated with anti-HER2 monoclonal antibody. Our findings suggest that the use of anti-HER2 monoclonal antibodies in male patients may be associated with similar risks observed in female patients.

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          Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

          Dennis J Slamon, Brian Leyland-Jones, Steven Shak … (2001)
          The HER2 gene, which encodes the growth factor receptor HER2, is amplified and HER2 is overexpressed in 25 to 30 percent of breast cancers, increasing the aggressiveness of the tumor. We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer that overexpressed HER2. We randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive standard chemotherapy plus trastuzumab. Patients who had not previously received adjuvant (postoperative) therapy with an anthracycline were treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women). The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs. 4.6 months; P<0.001), a higher rate of objective response (50 percent vs. 32 percent, P<0.001), a longer duration of response (median, 9.1 vs. 6.1 months; P<0.001), a lower rate of death at 1 year (22 percent vs. 33 percent, P=0.008), longer survival (median survival, 25.1 vs. 20.3 months; P=0.01), and a 20 percent reduction in the risk of death. The most important adverse event was cardiac dysfunction of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although the cardiotoxicity was potentially severe and, in some cases, life-threatening, the symptoms generally improved with standard medical management. Trastuzumab increases the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.
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            Validity of diagnoses, procedures, and laboratory data in Japanese administrative data

            Hayato Yamana, Mutsuko Moriwaki, Hiromasa Horiguchi … (2017)
            Background Validation of recorded data is a prerequisite for studies that utilize administrative databases. The present study evaluated the validity of diagnoses and procedure records in the Japanese Diagnosis Procedure Combination (DPC) data, along with laboratory test results in the newly-introduced Standardized Structured Medical Record Information Exchange (SS-MIX) data. Methods Between November 2015 and February 2016, we conducted chart reviews of 315 patients hospitalized between April 2014 and March 2015 in four middle-sized acute-care hospitals in Shizuoka, Kochi, Fukuoka, and Saga Prefectures and used them as reference standards. The sensitivity and specificity of DPC data in identifying 16 diseases and 10 common procedures were identified. The accuracy of SS-MIX data for 13 laboratory test results was also examined. Results The specificity of diagnoses in the DPC data exceeded 96%, while the sensitivity was below 50% for seven diseases and variable across diseases. When limited to primary diagnoses, the sensitivity and specificity were 78.9% and 93.2%, respectively. The sensitivity of procedure records exceeded 90% for six procedures, and the specificity exceeded 90% for nine procedures. Agreement between the SS-MIX data and the chart reviews was above 95% for all 13 items. Conclusion The validity of diagnoses and procedure records in the DPC data and laboratory results in the SS-MIX data was high in general, supporting their use in future studies.
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              Sex differences in cardiovascular risk factors and disease prevention.

              Yolande Appelman, Bas van Rijn, Monique Ten Haaf … (2015)
              Cardiovascular disease (CVD) has been seen as a men's disease for decades, however it is more common in women than in men. It is generally assumed in medicine that the effects of the major risk factors (RF) on CVD outcomes are the same in women as in men. Recent evidence has emerged that recognizes new, potentially independent, CVD RF exclusive to women. In particular, common disorders of pregnancy, such as gestational hypertension and diabetes, as well as frequently occurring endocrine disorders in women of reproductive age (e.g. polycystic ovary syndrome (PCOS) and early menopause) are associated with accelerated development of CVD and impaired CVD-free survival. With the recent availability of prospective studies comprising men and women, the equivalency of major RF prevalence and effects on CVD between men and women can be examined. Furthermore, female-specific RFs might be identified enabling early detection of apparently healthy women with a high lifetime risk of CVD. Therefore, we examined the available literature regarding the prevalence and effects of the traditional major RFs for CVD in men and women. This included large prospective cohort studies, cross-sectional studies and registries, as randomised trials are lacking. Furthermore, a literature search was performed to examine the impact of female-specific RFs on the traditional RFs and the occurrence of CVD. We found that the effects of elevated blood pressure, overweight and obesity, and elevated cholesterol on CVD outcomes are largely similar between women and men, however prolonged smoking is significantly more hazardous for women than for men. With respect to female-specific RF only associations (and no absolute risk data) could be found between preeclampsia, gestational diabetes and menopause onset with the occurrence of CVD. This review shows that CVD is the main cause of death in men and women, however the prevalence is higher in women. Determination of the CV risk profile should take into account that there are differences in impact of major CV RF leading to a worse outcome in women. Lifestyle interventions and awareness in women needs more consideration. Furthermore, there is accumulating evidence that female-specific RF are of influence on the impact of major RF and on the onset of CVD. Attention for female specific RF may enable early detection and intervention in apparently healthy women. Studies are needed on how to implement the added RF's in current risk assessment and management strategies to maximize benefit and cost-effectiveness specific in women. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Oncology
                Journal ID (iso-abbrev): Oncology
                Journal ID (hwp): OCL
                Journal ID (publisher-id): OCL
                Title: Oncology
                Publisher: S. Karger AG (Basel, Switzerland )
                ISSN (Print): 0030-2414
                ISSN (Electronic): 1423-0232
                Publication date (Electronic): 20 March 2023
                Publication date (Print): June 2023
                Volume: 101
                Issue: 6
                Pages: 358-361
                Affiliations
                [a ]The Department of Cardiovascular Medicine, The University of Tokyo, Tokyo, Japan
                [b ]Center for Outcomes Research and Economic Evaluation for Health, National Institute of Public Health, Saitama, Japan
                [c ]The Department of Advanced Cardiology, The University of Tokyo, Tokyo, Japan
                [d ]Department of Cardiology, International University of Health and Welfare School of Medicine, Narita, Japan
                [e ]Department of Prevention of Diabetes and Lifestyle-Related Diseases, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan
                [f ]The Department of Health Services Research, The University of Tokyo, Tokyo, Japan
                [g ]Department of Cardiovascular Medicine, Saga University, Saga, Japan
                [h ]The Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Tokyo, Japan
                Author notes
                Correspondence to: Hidehiro Kaneko, kanekohidehiro@ 123456gmail.com

                Yuta Suzuki and Yuichi Tamura contributed equally and share the first authorship.

                Article
                Publisher ID: 530215
                DOI: 10.1159/000530215
                PMC ID: 11251645
                PubMed ID: 36940681
                SO-VID: 2c9b3f09-3558-4105-bb5d-7cd6785d070e
                Copyright © © 2023 The Author(s). Published by S. Karger AG, Basel
                License:

                This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC) ( http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes requires written permission.

                History
                Date received : 20 November 2022
                Date accepted : 7 March 2023
                Date: 2023
                Page count
                Figures: 1, References: 7, Pages: 4
                Funding
                This work was supported by grants from the Ministry of Health, Labour and Welfare, Japan (21AA2007), and the Ministry of Education, Culture, Sports, Science and Technology, Japan (20H03907, 21H03159, and 21K08123). The funder had no role in the design of this study, data collection, statistical analysis, interpretation of the data, writing of the manuscript, and final decision to submit this manuscript for publication.
                Categories
                Subject: Clinical Study

                Keywords: anti-her2 monoclonal antibody,heart failure,sex difference
                Data availability:
                Keywords: anti-her2 monoclonal antibody, heart failure, sex difference

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