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Breast Cancer Research and Treatment
Published in: Breast Cancer Research and Treatment 2/2019

01-09-2019 | Metastasis | Clinical trial

Non-sentinel axillary tumor burden applying the ACOSOG Z0011 eligibility criteria to a large routine cohort

Authors: Fabian Riedel, Jörg Heil, Manuel Feißt, Mahdi Rezai, Mareike Moderow, Christof Sohn, Florian Schütz, Michael Golatta, André Hennigs

Published in: Breast Cancer Research and Treatment | Issue 2/2019

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Abstract

Purpose

In the ACOSOG Z0011 trial, patients with primary breast cancer (BC) and 1–2 tumor-involved sentinel lymph nodes (SLN) undergoing breast-conserving surgery gained no benefit from completing axillary lymph node dissection (cALND). This paper reports cALND rates performed in clinical routine on patients who would meet the Z0011 criteria. Further, patients still received cALND were analyzed concerning the number of non-sentinel metastases (NSM) to estimate occult axillary tumor burden.

Methods

Data were retrospectively analyzed from patients treated in 179 German breast centers between 2008 and 2015. Time-trend rates were determined for cALND regarding the presence of axillary macrometastases or micrometastases. Descriptive statistics were used to report the number of NSM depending on the number of SLN removed, tumor-involved SLN, tumor stage (pT1–2), and immunohistochemical subtype. Factors associated with NSM were identified using multivariable logistic regression.

Results

Altogether, data for 188,909 patients were available, of whom 13,741 (7.3%) were identified eligible for the Z0011 criteria. For these patients, the cALND rate for macrometastases declined from 96.4% in 2008 to 49.7% in 2015, for micrometastases from 86.7 to 5.9%. In total 9773 patients still received cALND, 33.4% of whom had NSM. The NSM rates were: 38.8% for pN(1/1sn), 28.6% for pN(1/2sn), and 50.9% for pN(2/2sn). Hormone receptor (HR) positive/HER2+ showed the highest NSM rate (41.6%), HR−/HER2− the lowest rate (29.4%).

Conclusions

The rate of cALND for ACOSOG Z0011 eligible patients has decreased substantially in routine care in our nationwide cohort. Our data reveal a relatively high prevalence of additional axillary NSM tumor burden.
Literature
1.
Whelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A et al (2015) Regional nodal irradiation in early-stage breast cancer. N Engl J Med 373(4):307–316CrossRefPubMedPubMedCentral
2.
Moebus V, Jackisch C, Lueck HJ, du Bois A, Thomssen C, Kurbacher C et al (2010) Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol 28(17):2874–2880CrossRefPubMed
3.
Network NCC (2016) NCCN clinical practice guidelines in oncology (NCCN Guidelines). Breast Cancer 2016. 1
4.
Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA et al (2000) Molecular portraits of human breast tumours. Nature 406(6797):747–752CrossRefPubMed
5.
Cardoso F, van’t Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S et al (2016) 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 375(8):717–729CrossRefPubMed
6.
Gluz O, Nitz UA, Christgen M, Kates RE, Shak S, Clemens M et al (2016) West German Study Group Phase III PlanB trial: first prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology assessment. J Clin Oncol 34(20):2341–2349CrossRefPubMed
7.
Veronesi U, Paganelli G, Viale G, Luini A, Zurrida S, Galimberti V et al (2003) A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer. N Engl J Med 349(6):546–553CrossRefPubMed
8.
Krag DN, Anderson SJ, Julian TB, Brown AM, Harlow SP, Costantino JP et al (2010) 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 11(10):927–933CrossRefPubMedPubMedCentral
9.
DiSipio T, Rye S, Newman B, Hayes S (2013) Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol 14(6):500–515CrossRefPubMed
10.
Giuliano AE, McCall L, Beitsch P, Whitworth PW, Blumencranz P, Leitch AM et al (2010) Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: the American College of Surgeons Oncology Group Z0011 randomized trial. Ann Surg 252(3):426–432 (discussion 32-3) PubMed
11.
Giuliano AE, Ballman K, McCall L, Beitsch P, Whitworth PW, Blumencranz P et al (2016) Locoregional recurrence after sentinel lymph node dissection with or without axillary dissection in patients with sentinel lymph node metastases: long-term follow-up from the American College of Surgeons Oncology Group (Alliance) ACOSOG Z0011 randomized trial. Ann Surg 264(3):413–420CrossRefPubMed
12.
Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR et al (2017) Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA 318(10):918–926CrossRefPubMedPubMedCentral
13.
14.
Guth U, Myrick ME, Viehl CT, Schmid SM, Obermann EC, Weber WP (2012) The post ACOSOG Z0011 era: does our new understanding of breast cancer really change clinical practice? Eur J Surg Oncol 38(8):645–650CrossRefPubMed
15.
Shah-Khan M, Boughey JC (2012) Evolution of axillary nodal staging in breast cancer: clinical implications of the ACOSOG Z0011 trial. Cancer Control 19(4):267–276CrossRefPubMed
16.
Morrow M, Giuliano AE (2011) To cut is to cure: can we really apply Z11 in practice? Ann Surg Oncol 18(9):2413–2415CrossRefPubMed
17.
Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P et al (2013) Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol 14(4):297–305CrossRefPubMedPubMedCentral
18.
Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M et al (2018) Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol 19(10):1385–1393CrossRefPubMed
19.
Donker M, van Tienhoven G, Straver ME, Meijnen P, van de Velde CJ, Mansel RE et al (2014) Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial. Lancet Oncol 15(12):1303–1310CrossRefPubMedPubMedCentral
20.
Savolt A, Peley G, Polgar C, Udvarhelyi N, Rubovszky G, Kovacs E et al (2017) Eight-year follow up result of the OTOASOR trial: the Optimal Treatment Of the Axilla - Surgery Or Radiotherapy after positive sentinel lymph node biopsy in early-stage breast cancer: a randomized, single centre, phase III, non-inferiority trial. Eur J Surg Oncol 43(4):672–679CrossRefPubMed
21.
Riedel F, Heil J, Golatta M, Schaefgen B, Hug S, Schott S et al (2018) Changes of breast and axillary surgery patterns in patients with primary breast cancer during the past decade. Arch Gynecol Obstet 299(4):1043–1053CrossRefPubMed
22.
Wockel A, Festl J, Stuber T, Brust K, Stangl S, Heuschmann PU et al (2018) Interdisciplinary screening, diagnosis, therapy and follow-up of breast cancer. Guideline of the DGGG and the DKG (S3-Level, AWMF Registry Number 032/045OL, December 2017) - Part 1 with Recommendations for the Screening, Diagnosis and Therapy of Breast Cancer. Geburtshilfe Frauenheilkd 78(10):927–948CrossRefPubMedPubMedCentral
23.
Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A et al (2017) NCCN guidelines insights: breast cancer, version 1.2017. J Natl Compr Cancer Netw 15(4):433–451CrossRef
24.
WBC, Westdeutsches Brust-Centrum GmbH (2015) Benchmarking WBC - 2014, Jahresbericht, Kennzahlen
25.
Hennigs A, Kopke M, Feisst M, Riedel F, Rezai M, Nitz U et al (2019) Which patients with sentinel node-positive breast cancer after breast conservation still receive completion axillary lymph node dissection in routine clinical practice? Breast Cancer Res Treat 173(2):429–438CrossRefPubMed
26.
Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ (2011) Strategies for subtypes–dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol 22(8):1736–1747CrossRefPubMedPubMedCentral
27.
Hennigs A, Riedel F, Gondos A, Sinn P, Schirmacher P, Marmé F et al (2016) Prognosis of breast cancer molecular subtypes in routine clinical care: a large prospective cohort study. BMC Cancer 16(1):1–9CrossRef
28.
Dengel LT, Van Zee KJ, King TA, Stempel M, Cody HS, El-Tamer M et al (2014) Axillary dissection can be avoided in the majority of clinically node-negative patients undergoing breast-conserving therapy. Ann Surg Oncol 21(1):22–27CrossRefPubMed
29.
Yao K, Liederbach E, Pesce C, Wang CH, Winchester DJ (2015) Impact of the American College of Surgeons Oncology Group Z0011 randomized trial on the number of axillary nodes removed for patients with early-stage breast cancer. J Am Coll Surg 221(1):71–81CrossRefPubMed
30.
Poodt IGM, Spronk PER, Vugts G, van Dalen T, Peeters M, Rots ML et al (2018) Trends on axillary surgery in nondistant metastatic breast cancer patients treated between 2011 and 2015: a Dutch Population-based Study in the ACOSOG-Z0011 and AMAROS Era. Ann Surg 268(6):1084–1090CrossRefPubMed
31.
Gondos A, Jansen L, Heil J, Schneeweiss A, Voogd AC, Frisell J et al (2016) Time trends in axilla management among early breast cancer patients: persisting major variation in clinical practice across European centers. Acta Oncol 55(6):712–719CrossRefPubMed
32.
Naidoo K, Pinder SE (2017) Micro- and macro-metastasis in the axillary lymph node: a review. Surgeon 15(2):76–82CrossRefPubMed
33.
Bauerfeind I, Kümmel S. (Working Group Gynecological Oncology) (2011) Diagnosis and treatment of patients with primary and metastatic breast cancer: Guidelines of the AGO Breast Commission. 03/2011
34.
Yi M, Kuerer HM, Mittendorf EA, Hwang RF, Caudle AS, Bedrosian I et al (2013) Impact of the American College of Surgeons Oncology Group Z0011 criteria applied to a contemporary patient population. J Am Coll Surg 216(1):105–113CrossRefPubMed
35.
Tsao MW, Cornacchi SD, Hodgson N, Simunovic M, Thabane L, Cheng J et al (2016) A population-based study of the effects of a regional guideline for completion axillary lymph node dissection on axillary surgery in patients with breast cancer. Ann Surg Oncol 23(10):3354–3364CrossRefPubMed
36.
Freedman GM, Fowble BL, Li T, Hwang ES, Schechter N, Devarajan K et al (2014) Risk of positive nonsentinel nodes in women with 1-2 positive sentinel nodes related to age and molecular subtype approximated by receptor status. Breast J 20(4):358–363CrossRefPubMedPubMedCentral
37.
Millar EK, Graham PH, O’Toole SA, McNeil CM, Browne L, Morey AL et al (2009) Prediction of local recurrence, distant metastases, and death after breast-conserving therapy in early-stage invasive breast cancer using a five-biomarker panel. J Clin Oncol 27(28):4701–4708CrossRefPubMed
38.
Wiechmann L, Sampson M, Stempel M, Jacks LM, Patil SM, King T et al (2009) presenting features of breast cancer differ by molecular subtype. Ann Surg Oncol 16(10):2705–2710CrossRefPubMed
39.
Gangi A, Mirocha J, Leong T, Giuliano AE (2014) Triple-negative breast cancer is not associated with increased likelihood of nodal metastases. Ann Surg Oncol 21(13):4098–4103CrossRefPubMed
40.
Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A et al (2016) 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol 17(6):791–800CrossRefPubMed
41.
Hennigs A, Riedel F, Marme F, Sinn P, Lindel K, Gondos A et al (2016) Changes in chemotherapy usage and outcome of early breast cancer patients in the last decade. Breast Cancer Res Treat 160(3):491–499CrossRefPubMedPubMedCentral
42.
Savolt A, Polgar C, Musonda P, Matrai Z, Renyi-Vamos F, Toth L et al (2013) Does the result of completion axillary lymph node dissection influence the recommendation for adjuvant treatment in sentinel lymph node-positive patients? Clin Breast Cancer 13(5):364–370CrossRefPubMed
43.
Poodt IGM, Rots ML, Vugts G, van Dalen T, Kuijer A, Vriens BEPJ et al (2018) The administration of adjuvant chemo(-immuno) therapy in the post ACOSOG-Z0011 era; a population based study. Eur J Surg Oncol 44(8):1151–1156CrossRefPubMed
44.
Aigner J, Smetanay K, Hof H, Sinn HP, Sohn C, Schneeweiss A et al (2013) Omission of axillary dissection according to ACOSOG Z0011: impact on adjuvant treatment recommendations. Ann Surg Oncol 20(5):1538–1544CrossRefPubMed
45.
Lucci A, McCall LM, Beitsch PD, Whitworth PW, Reintgen DS, Blumencranz PW et al (2007) Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol 25(24):3657–3663CrossRefPubMed
Metadata
Title
Non-sentinel axillary tumor burden applying the ACOSOG Z0011 eligibility criteria to a large routine cohort
Authors
Fabian Riedel
Jörg Heil
Manuel Feißt
Mahdi Rezai
Mareike Moderow
Christof Sohn
Florian Schütz
Michael Golatta
André Hennigs
Publication date
01-09-2019
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 2/2019
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-019-05327-4

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