Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021

Burstein, Harold J.; Curigliano, Giuseppe; Thürlimann, Beat; Weber, Walter; Poortmans, Philip; Regan, Meredith M.; Senn, Hans; Winer, Eric P.; Gnant, Michael

doi:10.1016/j.annonc.2021.06.023

Cited by 522 publications

(419 citation statements)

References 130 publications

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“…We conducted a clinical trial of neoadjuvant chemotherapy (NCT) versus neoadjuvant endocrine therapy (NET) in premenopausal patients with hormone-responsive, HER2-, LN+ breast cancer. As we previously reported, in a phase III trial (NEST; NCT01622361), conventional NCT yielded a significantly better response than NET in premenopausal patients with ER+/ HER2-, LN+ breast cancer, supporting the ASCO and St. Gallen international consensus guidelines (15,17,18). The present study aimed to evaluate the surgical impact of neoadjuvant treatment and compare the ALND rates and prognosis in terms of axillary recurrence-free survival (ARFS), disease-free survival (DFS), and overall survival (OS) between patients treated with NET and NCT in the NEST trial.…”

Section: Introductionsupporting

confidence: 66%

Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer

et al. 2021

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In this study, we aimed to evaluate axillary lymph node dissection (ALND) rates and prognosis in neoadjuvant chemotherapy (NCT) compare with neoadjuvant endocrine therapy (NET) in estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), lymph node (LN)-positive, premenopausal breast cancer patients (NCT01622361). The multicenter, phase 3, randomized clinical trial enrolled 187 women from July 5, 2012, to May 30, 2017. The patients were randomly assigned (1:1) to either 24 weeks of NCT including adriamycin plus cyclophosphamide followed by intravenous docetaxel, or NET involving goserelin acetate and daily tamoxifen. ALND was performed based on the surgeon’s decision. The primary endpoint was ALND rate and surgical outcome after preoperative treatment. The secondary endpoint was long-term survival. Among the 187 randomized patients, pre- and post- neoadjuvant systemic therapy (NST) assessments were available for 170 patients. After NST, 49.4% of NCT patients and 55.4% of NET patients underwent mastectomy after treatment completion. The rate of ALND was significantly lower in the NCT group than in the NET group (55.2% vs. 69.9%, P=.046). Following surgery, the NET group showed a significantly higher mean number of removed LNs (14.96 vs. 11.74, P=.003) and positive LNs (4.84 vs. 2.92, P=.000) than the NCT group. The axillary pathologic complete response (pCR) rate was significantly higher in the NCT group (13.8% vs. 4.8%, P=.045) than in the NET group. During a median follow-up of 67.3 months, 19 patients in the NCT group and 12 patients in the NET group reported recurrence. The 5-year ARFS (97.5%vs. 100%, P=.077), DFS (77.2% vs. 84.8%, P=.166), and OS (97.5% vs. 94.7%, P=.304) rates did not differ significantly between the groups. In conclusion, although survival did not differ significantly, more NCT patients might able to avoid ALND, with fewer LNs removed with lower LN positivity.Clinical Trial Registrationhttps://clinicaltrials.gov/ct2/show/NCT01622361, identifier NCT01622361.

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Section: Introductionsupporting

confidence: 66%

Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer

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“…Re-conservation should also include BCS and re-irradiation of the tumor bed and be discussed as an alternative to mastectomy after multidisciplinary evaluation [64] (Figure 2). The 2021 St Gallen Consensus Conference further confirmed the role of re-irradiation compared to mastectomy in case of IBTR after 5 years from BCT, especially in selected classes of patients [65].…”

Section: Second Breast Conservative Surgery For Ipsilateral Breast Tumor Recurrence: the New Standard Of Treatmentmentioning

confidence: 90%

Breast Cancer Surgery: New Issues

et al. 2021

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Since ancient times, breast cancer treatment has crucially relied on surgeons and clinicians making great efforts to find increasingly conservative approaches to cure the tumor. In the Halstedian era (mid-late 19th century), the predominant practice consisted of the radical and disfiguring removal of the breast, much to the detriment of women’s psycho-physical well-being. Thanks to enlightened scientists such as Professor Umberto Veronesi, breast cancer surgery has since impressively progressed and adopted a much more conservative approach. Over the last three decades, a better understanding of tumor biology and of its significant biomarkers has made the assessment of genetic and molecular profiles increasingly important. At the same time, neo-adjuvant treatments have been introduced, and great improvements in genetics, imaging technologies and in both oncological and reconstructive surgical techniques have been made. The future of breast cancer management must now rest on an ever more precise and targeted type of surgery that, through an increasingly multidisciplinary and personalized approach, can ensure oncological radicality while offering the best possible quality of life.

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“…RNI may be a potentially acceptable alternative to ALND in patients with micrometastatic disease or isolated tumor cells. Importantly, systemic treatment options such as capecitabine or trastuzumab emtansine for residual invasive cancer are not considered equivalent alternatives to ALND [52].…”

Section: Tablementioning

confidence: 99%

“…The only exception was the 2019 St. Gallen Consensus, in which RNI in case of cN1 patients converting to ypN0 was recommended only in the presence of additional adverse factors [73]. This, however, is being changed back in the 2021 edition to a strong recommendation against omitting RNI for patients whose presented with a clinically positive axillary node(s), even when pCR is achieved [52].…”

Section: Tablementioning

confidence: 99%

De-escalation of axillary irradiation for early breast cancer – Has the time come?

Senkus

Cardoso

Kaidar‐Person

et al. 2021

Cancer Treatment Reviews

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Introduction of sentinel lymph node biopsy, initially in clinically node-negative and subsequently in patients presenting with involved axilla and downstaged by primary systemic therapy, allowed for significant decrease in morbidity compared to axillary lymph node dissection. Concurrently, regional nodal irradiation was demonstrated to improve outcomes in most node-positive patients. Additionally, over the last decades, introduction of more effective systemic therapies has resulted in improvements not only at distant sites, but also in locoregional control, creating space for de-escalation of locoregional treatments. We discuss the data on de-escalation in axillary surgery and irradiation, both in patients undergoing upfront surgery and primary systemic therapy, with special emphasis on the feasibility of omission of nodal irradiation in patients undergoing primary systemic therapy. In view of the accumulating evidence, omission of axillary irradiation may be considered in clinically node-positive patients converting after primary systemic therapy to pathologically negative nodes on sentinel lymph node biopsy (preferably also with in-breast pCR), presenting with lower initial nodal stage, older age and were treated with breast-conserving surgery followed by whole breast irradiation. Omission of regional nodal irradiation in patients with aggressive tumor phenotypes achieving a pCR is under investigation. In patients undergoing preoperative endocrine therapy the adoption of axillary management strategies utilized in case of upfront surgery seems more suitable than those used in post chemotherapy-based primary systemic therapy setting.

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Customizing local and systemic therapies for women with early breast cancer: the St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021

Cited by 522 publications

References 130 publications

Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer

Axillary Lymph Node Dissection Rates and Prognosis From Phase III Neoadjuvant Systemic Trial Comparing Neoadjuvant Chemotherapy With Neoadjuvant Endocrine Therapy in Pre-Menopausal Patients With Estrogen Receptor-Positive and HER2-Negative, Lymph Node-Positive Breast Cancer

Breast Cancer Surgery: New Issues

De-escalation of axillary irradiation for early breast cancer – Has the time come?

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