10. Qualitätsindikatoren – Breast Cancer
Quality indicators (QI) are measured variables whose collection serves to assess the quality of the underlying structures, processes or results [1632]. Quality indicators are an important instrument of quality management. The aim of their use is the continuous improvement of care by presenting the results of care, reflecting them critically and improving them if necessary. The present selection of quality indicators was prepared according to the methodology of the Oncology Guidelines Programme [1633]. For the derivation process a working group "Working Group Quality Indicators" was constituted. This group created the final set of quality indicators based on the existing quality indicators of the 2012 guideline and the new strong recommendations (strength of recommendation A, "should") of the updated guideline. The compilation took into account the results of the existing quality indicators from the certified breast cancer centers of the German Cancer Society and the German Society for Senology [1551], the quality indicators of the external inpatient quality assurance [1634] and the results of the research for existing national and international QIs. The results of the guideline-based quality indicators, which are measured and evaluated in the certification procedure, were already presented at the kick-off meeting of the present update in order to be able to make changes to recommendations and background texts based on the results from the care system, if necessary. Changes were made for some of the recommendations underlying the existing indicators. The changes are mainly due to new study results. The exact procedure for selecting potential QIs and the composition of the working group is described in the guideline report (http://leitlinienprogramm-onkologie.de/index.php?id=67ype=0).
After a face-to-face meeting, a written evaluation of the indicators positively prioritized there and a concluding conference call of the working group, 2 new indicators were adopted (supplement for QI 5 "Indication for sentinel lymph node biopsy" and QI 6 "Therapy of axillary lymph drainage areas in pN1"). The already existing QI 5 "Indication for sentinel lymph node biopsy" will in future be calculated separately for female (5 a)) and male patients (5 b)) on the basis of the data of the QA procedure for breast surgery of the Institute for Quality Assurance and Transparency in Health Care (IQTIG), so that only 1 QI will be added to the already existing QI. Of the 12 QIs from Guideline 2012, 4 QIs were deleted and 2 QIs (QI 2: Intraoperative preparation radio/sonography, QI 4: Endocrine therapy as the first therapeutic option in steroid-receptor-positive metastatic breast cancer) were adjusted in the numerator or denominator. The justifications are described in detail in the Methods Report. The final set thus consists of 9 quality indicators.
Based on the recommendation "3.9 Diagnosis and care chain breast cancer early detection", the Working Group QI has defined a QI that is intended to record and improve the further treatment of patients secured in screening in certified breast cancer centres.
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Counter |
Number of patients receiving treatment in a certified breast cancer center (DKG/DGS, NRW) |
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Denominator |
All patients with histologically confirmed invasive breast cancer u/o DCIS |
The data required for this QI are exclusively available to the Mammography Screening Cooperative and cannot be generated by the cancer registries or the certified centres. In this respect, the members of the Working Group QI could not positively evaluate criterion 5 to be evaluated "The data are routinely documented by the service provider or an additional survey requires a justifiable effort" for this QI, since the group members can only access data from certified centres, cancer registries and IQTIG. However, there was consensus in the group to include the QI in the list of QIs and to name and contact the Mammography Cooperative as the addressee of the recording of this QI.
The WG did not derive any new quality indicators for the field of palliative care, but referred to the existing QIs of the guideline on palliative care, especially the QI "Foresighted care planning" and "Screening using MIDOS and IPOS" of the guideline. The latter QI is recorded in the oncological centers of the German Cancer Society.
In the case of QIs that consider small populations, the detailed processing of cases, e.g. within the framework of on-site audit procedures, should be more important than a quantitative evaluation,. This is to prevent conspicuous QI results, which are mainly caused by small populations ("small number problem"), from leading to a negative evaluation. In these cases, the QI's main aim is to identify conspicuous developments, to address these specifically and to initiate improvement measures, e.g. through on-site auditing. Due to the small population, no valid data in the sense of a defined reference value can be provided.
The numerator is always a partial quantity of the denominator. The quality indicators apply to female and male patients unless otherwise described.
Further treatment of breast cancer detected by mammographic screening in certified breast cancer centers
Numerator
Number of patients treated in a certified breast cancer center (DKG/DGS, NRW)
Denominator
All patients detected during mammographic screening with histologically confirmed invasive breast cancer and/or DCIS
Quality target / reference range
Quality objective:
As often as possible, further treatment of the breast carcinomas and/or DCIS detected in screening in a certified breast cancer centre
Notes
The QI can be evaluated with data from the Mammography Cooperation Group.
Reference recommendations
QI 1: Pretherapeutic histological confirmation (since 2012, formerly: Breast CA 1)
Numerator
Patients with pretherapeutic histological confirmation of diagnosis by core needle biopsy or vacuum-assisted biopsy
Denominator
Patients with primary intervention and histology “invasive breast cancer (primary tumor) or DCIS" as primary disease
Quality target / reference range
LOE 3a, recommendation level A
Quality objective:
As many patients as possible with pre-therapeutic histological confirmation by punch or vacuum biopsy in case of initial intervention and primary disease invasive breast cancer and/or DCIS
Reference recommendations
The histological clarification of findings should be carried out by punch biopsy, vacuum biopsy and, in exceptional cases which must be justified, by open excision biopsy.
Intraoperative specimen radiography/sonography (since 2012, formerly: Breast CA 2)
Numerator
Surgeries using intraoperative specimen X-ray or intraoperative specimen ultrasound
Denominator
Surgeries with preoperative wire marking guided by mammography or ultrasound
Quality target / reference range
Quality objective:
As often as possible intraoperative preparation sonography or radiography after preoperative marking
Reference recommendations
Pre-operative or intraoperative marking should be carried out using the method that allows the findings to be clearly visualized, especially in the case of non-palpable changes.
Proof of adequate resection must be provided intraoperatively by means of specimen radiography or specimen sonography. If MR-guided marking has been performed, an MR control should be performed within 6 months in case of histologically unspecific benign findings.
- Consensus
- Strong consensus
Axillary lymph node biopsy in DCIS (since 2012, formerly: Breast CA 3)
Numerator
Patients who have undergone axillary lymphadenectomy (primary axillary dissection or SLNB)
Denominator
Patients with "DCIS" histology who have completed surgical treatment for their primary disease after breast-conserving treatment
Quality target / reference range
LOE 1b, recommendation level A
Quality objective:
As few patients as possible with primary axilla dissection or sentinel node biopsy (SNB) in DCIS with breast-conserving therapy
Notes
Quality objective <5%
Reference recommendations
An axillary dissection should not be performed in DCIS. A sentinel node biopsy should only be performed if a secondary sentinel node biopsy is not possible for technical reasons, e.g. in the case of a mammary ablatio.
Endocrine therapy as the first therapeutic option for steroid-receptor-positive metastatic breast cancer (since 2012, formerly: Breast CA 11)
Numerator
Patients who have received endocrine therapy as first-line therapy in the metastatic stage
Denominator
All patients with steroid-receptor-positive breast cancer and HER2- negative breast cancer and primary diagnosis of metastasis
Quality target / reference range
LOE 1b, recommendation level A
Quality objective:
To perform endocrine-based therapy as a first-line therapy as often as possible for Pat with breast cancer, positive hormone receptor status, negative HER2 status and initial diagnosis of metastasis.
Reference recommendations
In pre- and perimenopausal patients, endocrine therapy, possibly combined with targeted therapy, shall be offered if hormone receptor status is positive and HER2 status is negative.
Endocrine-only monotherapy is not indicated in patients with the need to achieve rapid remission to avert marked symptoms of the affected organ.
- Recommendation grade
- A: Starke Empfehlung für oder gegen ein Maßnahme - verwendete Ausdrucksweise = soll/soll nicht
- Level of evidence
- 1b
- Consensus
- Strong consensus
- References
- [28] [989] [990] [991] [992] [993] [994]
Change note
Endocrine therapy +/- targeted therapy is the therapy of choice for positive hormone receptor status and negative HER2 status. Endocrine therapy is not indicated in patients where there is a need to achieve rapid remission in order to avert pronounced symptoms of the affected organ.Indication for sentinel lymph node biopsy (since 2012, formerly: Breast CA 4)
Numerator
Patients with sentinel node biopsy alone
Denominator
Patients with primary disease of invasive breast cancer and negative pN staging and without preoperative tumor-specific therapy
Quality target / reference range
Quality objective:
As many patients as possible with sentinel node biopsy in lymph node negative (pN0) invasive breast cancer without preoperative tumour-specific therapy
Notes
The quality indicator should be calculated separately for female and male patients (see introduction)
Reference recommendations
The axillary staging is intended to be a component of the surgical therapy of invasive breast cancer.
- Consensus
- Consent
This is to be carried out with the help of sentinel lymph node removal (SLNB) for lymph node status that is inconspicuous on palpation and sonography.
Therapie der axillären Lymphabflussgebiete bei pN1mi (neu 2017)
Numerator
Anzahl Pat. mit Therapie (= Axilladissektion o. Radiatio) der axillären Lymphabflussgebiete
Denominator
Alle Pat. mit Primärerkrankung invasives Mammakarzinom, pN1mi
Quality target / reference range
LoE 1b, Empfehlungsgrad B
Qualitätsziel:
Möglichst selten Therapie der axillären Lymphabflussgebiete bei Mikrometastasierung
Notes
Qualitätsziel <5%
Reference recommendations
In the case of exclusive micrometastasis, a targeted therapy of the lymph drainage areas (surgery, radiotherapy) should be avoided.
Radiotherapy performed after BCT (since 2012, formerly: Breast CA 6)
Numerator
Patients with invasive cancer and BCT who have undergone irradiation of the breast
Denominator
Patients with primary disease of invasive breast cancer and BCT
Quality target / reference range
LOE 1a, recommendation level A
Quality objective:
Adequate rate of irradiation after BET in patients with the first disease invasive breast cancer.
Reference recommendations
After breast-conserving surgery due to invasive carcinoma, radiation of the affected breast should be performed.
For patients with clearly limited life expectancy (<10 years) and a small (pT1), node-negative (pN0), hormone receptor-positive HER2-negative tumor receiving endocrine adjuvant therapy, conditional upon free excision margins and taking an increased risk of local recurrence into account.
Note for all recommendations: All individual items are "or" combinations. "And" links are represented by an "and".
Endocrine therapy in patients with receptor-positive findings (since 2012, formerly: Breast CA 7)
Numerator
Patients who have received adjuvant endocrine therapy.
Denominator
Steroid-receptor-positive patients with invasive breast cancer as primary disease
Quality target / reference range
LOE 1a, recommendation level A
Quality objective:
Endocrine therapy should be carried out as often as possible in receptor-positive patients with the first disease invasive mammary carcinoma
Reference recommendations
Patients with estrogen- and/or progesterone receptor-positive (°) invasive tumors should receive endocrine therapy.
° (>/=10% progesterone receptor-positive tumor cell nuclei)
Trastuzumab therapy in patients with HER2-positive findings (since 2012, formerly: Breast CA 8)
Numerator
All patients who have received (neo)adjuvant treatment with trastuzumab for one year
Denominator
All HER2-positive (immuno-histochemical score 3+ and/or ISH-positive) patients with invasive breast cancer as primary disease ≥ pT1c
Quality target / reference range
LOE 1b, recommendation level A
Quality objective:
Trastuzumab therapy as often as possible over 1 year in HER2-positive patients with first diagnosis of invasive breast cancer >= pT1c
Reference recommendations
Patients with HER2-overexpressing tumours with a diameter of ≥ 1 cm (immunohistochemical score 3+ and/or ISH-positive) should receive (neo-)adjuvant treatment with anthracycline followed by a taxane in combination with trastuzumab. Trastuzumab should be administered over a total period of one year.
References
[1632] (ÄZQ), Ärztliches Zentrum für Qualität in der Medizin, E, Gramsch, JD, Hoppe, G, Jonitz, A, Köhler, al., Ollenschläger G et, Kompendium Q-M-A. Qualitätsmanagement in der ambulanten VersorgungDt. Ärzte-Verl., 2008.
[1633] Entwicklung von Leitlinien basierten Qualitätsindikatoren. Methodenpapier für das Leitlinienprogramm OnkologieLeitlinienprogramm Onkologie (Deutsche Krebsgesellschaft (DKG), Deutsche Krebshilfe (DKH), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF)), 2017.
[1551] Deutsche Krebsgesellschaft, Deutsche Gesellschaft für Senologie., Jahresbericht der zertifizierten Brustkrebszentren. Kennzahlenauswertung 2017., 2017.
[1634] Gesundheitswesen, IQTIG - Institut für Qualitätssicherung und Transparenz im, Bundesauswertung zum Erfassungsjahr 2016 Mammachirurgie. Qualitätsindikatoren., 2017.
[28] NICE, The National Institute for Health and Care Excellence (NICE). Advanced breast cancer: diagnosis and treatment, 2009 [addendum 2014].
[223] Dahabreh, I. J., Wieland, L. S., Adam, G. P., Halladay, C., Lau, J., Trikalinos, T. A., AHRQ Comparative Effectiveness Reviews, in Core Needle and Open Surgical Biopsy for Diagnosis of Breast Lesions: An Update to the 2009 Report, 2014, Agency for Healthcare Research and Quality (US): Rockville (MD).
[185] NZGG, Management of Early Breast Cancer - Evidence-based Best Practice Guideline, New Zealand Guidelines Group, 2009.
[275] Lyman, G. H., Temin, S., Edge, S. B., Newman, L. A., Turner, R. R., Weaver, D. L., et.al. Sentinel lymph node biopsy for patients with early-stage breast cancer: American Society of Clinical Oncology clinical practice guideline update, J Clin Oncol, 2014. 32(13): p. 1365-83.
[989] Fossati, R., Confalonieri, C., Torri, V., Ghislandi, E., Penna, A., Pistotti, V., et.al. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women, J Clin Oncol, 1998. 16(10): p. 3439-60.
[990] Stockler, M, Wilcken, N, Ghersi, D, Simes, RJ, The management of advanced breast cancer: systemic reviews of randomised controlled trials regarding the use of cytotoxic chemotherapy and endocrine therapy, Woolloomooloo, NHMRC National Breast Cancer Centre, 1997.
[991] Stockler, M., Wilcken, N. R., Ghersi, D., Simes, R. J., Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer, Cancer Treat Rev, 2000. 26(3): p. 151-68.
[992] Rugo, H. S., Rumble, R. B., Macrae, E., Barton, D. L., Connolly, H. K., Dickler, M. N., et.al. Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline, J Clin Oncol, 2016. 34(25): p. 3069-103.
[993] Cancer Australia. Recommendations for the management of early breast cancer in women with an identified BRCA1 or BRCA2 gene mutation or at high risk of a gene mutation, 2014.
[994] Partridge, A. H., Rumble, R. B., Carey, L. A., Come, S. E., Davidson, N. E., Di Leo, A., et.al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline, J Clin Oncol, 2014. 32(29): p. 3307-29.
[363] Committee, National Clinical Effectiveness, Diagnosis, staging and treatment of patients with breast cancer: national clinical guideline no. 7, 2015.
[403] Krag, D. N., Anderson, S. J., Julian, T. B., Brown, A. M., Harlow, S. P., Costantino, J. P., et.al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial, Lancet Oncol, 2010. 11(10): p. 927-33.
[406] Giuliano, A. E., Hunt, K. K., Ballman, K. V., Beitsch, P. D., Whitworth, P. W., Blumencranz, P. W., et.al. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial, Jama, 2011. 305(6): p. 569-75.
[407] Galimberti, V., Cole, B. F., Zurrida, S., Viale, G., Luini, A., Veronesi, P., et.al. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial, Lancet Oncol, 2013. 14(4): p. 297-305.
[580] Clarke, M., Collins, R., Darby, S., Davies, C., Elphinstone, P., Evans, V., et.al. Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials, Lancet, 2005. 366(9503): p. 2087-106.
[581] Darby, S., McGale, P., Correa, C., Taylor, C., Arriagada, R., Clarke, M., et.al. Effect of radiotherapy after breast-conserving surgery on 10-year recurrence and 15-year breast cancer death: meta-analysis of individual patient data for 10,801 women in 17 randomised trials, Lancet, 2011. 378(9804): p. 1707-16.
[582] Potter, R., Gnant, M., Kwasny, W., Tausch, C., Handl-Zeller, L., Pakisch, B., et.al. Lumpectomy plus tamoxifen or anastrozole with or without whole breast irradiation in women with favorable early breast cancer, Int J Radiat Oncol Biol Phys, 2007. 68(2): p. 334-40.
[583] Hughes, K. S., Schnaper, L. A., Bellon, J. R., Cirrincione, C. T., Berry, D. A., McCormick, B., et.al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343, J Clin Oncol, 2013. 31(19): p. 2382-7.
[584] Kunkler, I. H., Williams, L. J., Jack, W. J., Cameron, D. A., Dixon, J. M., Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial, Lancet Oncol, 2015. 16(3): p. 266-73.
[585] Blamey, R. W., Bates, T., Chetty, U., Duffy, S. W., Ellis, I. O., George, D., et.al. Radiotherapy or tamoxifen after conserving surgery for breast cancers of excellent prognosis: British Association of Surgical Oncology (BASO) II trial, Eur J Cancer, 2013. 49(10): p. 2294-302.
[586] Fyles, Anthony W, McCready, David R, Manchul, Lee A, Trudeau, Maureen E, Merante, Patricia, Pintilie, Melania, et.al. Tamoxifen with or without breast irradiation in women 50 years of age or older with early breast cancer, New England Journal of Medicine, 2004. 351(10): p. 963-970.
[587] Kauer-Dorner, D., Potter, R., Resch, A., Handl-Zeller, L., Kirchheiner, K., Meyer-Schell, K., et.al. Partial breast irradiation for locally recurrent breast cancer within a second breast conserving treatment: alternative to mastectomy? Results from a prospective trial, Radiother Oncol, 2012. 102(1): p. 96-101.
[729] Polychemotherapy for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group, Lancet, 1998. 352(9132): p. 930-42.
[730] Davies, C., Godwin, J., Gray, R., Clarke, M., Cutter, D., Darby, S., et.al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level meta-analysis of randomised trials, Lancet, 2011. 378(9793): p. 771-84.
[731] Fisher, B., Dignam, J., Wolmark, N., DeCillis, A., Emir, B., Wickerham, D. L., et.al. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer, J Natl Cancer Inst, 1997. 89(22): p. 1673-82.
[732] Thuerlimann, B, Price, KN, Castiglione, M, Coates, AS, Goldhirsch, A, Gelber, RD, et.al. Randomized controlled trial of ovarian function suppression plus tamoxifen versus the same endocrine therapy plus chemotherapy: Is chemotherapy necessary for premenopausal women with node-positive, endocrine-responsive breast cancer? First results of International Breast Cancer Study Group Trial 11–93, The Breast, 2001. 10: p. 130-138.
[817] Moja, L., Tagliabue, L., Balduzzi, S., Parmelli, E., Pistotti, V., Guarneri, V., et.al. Trastuzumab containing regimens for early breast cancer, Cochrane Database Syst Rev, 2012. p. Cd006243.