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Recommendation of adjuvant trastuzumab treatment in HER-2-positive breast cancer patients: insights from quality indicator data collected in certified breast cancer centers in Germany, Italy, Austria, and Switzerland

  • Gynecologic Oncology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

In 2003, a certification system was introduced to ensure high standards of oncological care in breast cancer patients in Germany. Certified breast cancer centers (BCCs) must fulfill specific requirements including quality indicators (QI) derived from the clinical guidelines that are evaluated in annual audits. When target values for QIs are not fulfilled, centers need to give explanations. We analyzed data from BCCs for a selected indicator: the recommendation of trastuzumab for patients with early HER-2-positive invasive breast cancer. We investigated explanations given in cases when trastuzumab was not recommended to see whether this was justified.

Methods

Patient data from 274 BCCs treating 53,777 primary cases in 2015 were analyzed using descriptive statistics.

Results

In the 274 BCC sites, 5700 primary patients with early HER-2-positive breast cancer were treated in 2015. 128 sites (46.7%) did not reach the target value of 95% trastuzumab recommendation and thus had to give explanations. In these 128 sites, 2663 primary HER-2-positive breast cancer patients were treated, 343 (12.9%) of whom did not receive a recommendation for adjuvant trastuzumab treatment. All 128 sites delivered explanations. Overall, 450 explanations were given, allowing multiple explanations for single patients. No explanation was given for 8 of the 343 patients (2.3%). The most common given explanation was multi-/comorbidity (45.5%).

Conclusions

The analysis suggests thorough decision-making when quality indicator target values for a trastuzumab recommendation were not fulfilled. Our data do not provide information on whether such decisions have an impact on treatment outcome for these patients.

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Acknowledgements

English-language editorial services were provided by Michael Robertson.

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Author notes

  1. E. C. Inwald and C. Kowalski contributed equally to this paper.

Authors and Affiliations

  1. Department of Gynecology and Obstetrics, University Medical Center Regensburg, Landshuter Straße 65, 93053, Regensburg, Germany

    E. C. Inwald & O. Ortmann

  2. Department for Certification, German Cancer Society, Kuno-Fischer-Strasse 8, 14057, Berlin, Germany

    C. Kowalski & S. Wesselmann

  3. OnkoZert, Certification Institute of the German Cancer Society, Gartenstrasse 24, 89231, Neu-Ulm, Germany

    J. Ferencz

Authors
  1. E. C. Inwald
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  2. C. Kowalski
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  3. S. Wesselmann
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  4. J. Ferencz
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  5. O. Ortmann
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Contributions

OO conceptualized the research design. JF and SW collected data and checked these for plausibility. CK and ECI developed the plan of analysis, analyzed the data and drafted the manuscript. All of the authors contributed in writing the manuscript during several rounds of discussion. All of the authors have read and approved the final manuscript.

Corresponding author

Correspondence to E. C. Inwald.

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Conflict of interest

SW and CK are employees of the German Cancer Society and JF is an employee of the OnkoZert certification institute. OO is the President of the German Cancer Society. OO has received research funding and advisory board honoraria from pharmaceutical companies that are not related to the research presented here. A full list will be provided by the corresponding author upon request. ECI declares that she has no conflict of interest.

Ethical approval

The study used data from the oncological certification program of the German Cancer Society. Data are collected during the certification process using anonymized data regarding clinical parameters as well as quality indicators. Informed consent is automatically obtained from the patients by signing the hospital treatment contract. Therefore, the Local Ethical Committee of the University of Regensburg stated that an ethical vote was not necessary.

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Inwald, E.C., Kowalski, C., Wesselmann, S. et al. Recommendation of adjuvant trastuzumab treatment in HER-2-positive breast cancer patients: insights from quality indicator data collected in certified breast cancer centers in Germany, Italy, Austria, and Switzerland. Arch Gynecol Obstet 300, 383–388 (2019). https://doi.org/10.1007/s00404-019-05185-x

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  • DOI: https://doi.org/10.1007/s00404-019-05185-x

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