The Safety and Efficacy of the Combination of Sacituzumab Govitecan and Palliative Radiotherapy-A Retrospective Multi-Center Cohort Study.

Sacituzumab govitecan (SG) is a new treatment option for patients with metastatic triple-negative and hormone receptor-positive, HER2-negative breast cancer. This antibody-drug conjugate is currently approved as monotherapy. Palliative radiotherapy is frequently used to treat symptomatic metastases locally. Concurrent use of SG and irradiation was excluded in clinical trials of SG, and there are currently limited published data. We report here a systematic review, as well as a retrospective multi-center study of 17 patients with triple-negative breast cancer who received concurrent SG and radiotherapy. In these patients, concurrent use was found to be efficient, safe and well tolerated. There were no apparent differences in moderate or severe acute toxicity according to the timing of SG administration.

Palliative Radiotherapy for Symptomatic Locally Advanced Breast Cancer.

Objective: Women with locally advanced breast cancer (LABC) or inoperable local recurrence often suffer from a significantly reduced quality of life (QOL) due to local tumor-associated pain, bleeding, exulceration, or malodorous discharge. We aimed to further investigate the benefit of radiotherapy (RT) for symptom relief while weighing the side-effects. Materials and methods: Patients who received symptom-oriented RT for palliative therapy of their LABC or local recurrence in the Department of Radiation Oncology at Heidelberg University Hospital between 2012 and 2021 were recorded. Clinical, pathological, and therapeutic data were collected and the oncological and symptomatic responses as well as therapy-associated toxicities were analyzed. Results: We retrospectively identified 26 consecutive women who received palliative RT with a median total dose of 39 Gy or single dose of 3 Gy in 13 fractions due to (impending) exulceration, pain, local hemorrhage, and/or vascular or plexus compression. With a median follow-up of 6.5 months after initiation of RT, overall survival at 6 and 12 months was 60.0% and 31.7%, and local control was 75.0% and 47.6%, respectively. Radiation had to be discontinued in 4 patients due to oncological clinical deterioration or death. When completed as initially planned, symptom improvement was achieved in 95% and WHO level reduction of analgesics in 28.6% of patients. In 36% (16%) of patients, local RT had already been indicated >3 months (>6 months) before the actual start of RT, but was delayed or not initiated among others in favor of drug alternatives or systemic therapies. RT-associated toxicities included only low-grade side-effects (CTCAE I°-II°) with predominantly skin erythema and fatigue even in the context of re-RT. Conclusion: Palliative RT in symptomatic LABC or locoregional recurrence is an effective treatment option for controlling local symptoms with only mild toxicity. It may thus improve QOL and should be considered early in palliative patient care management.

Age-Dependent Hematologic Toxicity Profiles and Prognostic Serologic Markers in Postoperative Radiochemotherapy Treatment for Uterine Cervical Cancer.

Introduction: In the adjuvant setting for cervical cancer, classical risk factors for postoperative radiochemotherapy have been established. However, data on laboratory changes during therapy and the prognostic value of serological markers are limited and further knowledge is needed to optimize the toxic trimodal regimen. Methods: We retrospectively identified 69 women who underwent weekly postoperative radiochemotherapy with 40 mg/m2 of cisplatin for cervical cancer between 2010 and 2021 at a single center. Laboratory parameters were recorded before, at each cycle and after radiochemotherapy. Kaplan-Meier and log-rank analyses were used to calculate and compare survival, groups were compared using the Mann-Whitney U, χ2, and variance tests. Results: With a median follow-up of 17.7 months, the 1- and 5-year local control rates were 94.0% and 73.7%, respectively, with significantly better rates for more chemotherapy cycles and negative resection margins. Only 68.1% of patients completed all cycles. The most common reasons for early discontinuation were persistent asymptomatic leukopenia in women aged ≤ 50 years, and limiting infections in women aged > 50 years. Leukopenia was more likely to occur after the third cycle. Significantly worse survival was observed for post-radiochemotherapy elevated C-reactive-protein and lactate dehydrogenase levels, low pre-radiochemotherapy nutritional index, and raised C-reactive-protein-levels; the latter were also predictable for local control. The Glasgow prognostic score did not reliably predict survival. Conclusion: Incomplete application of simultaneous chemotherapy leads to inferior local control, and age-dependent limiting factors should be identified at an early stage. In addition to classical risk factors, serological markers (C-reactive-protein, lactate dehydrogenase, nutritional index) show prognostic significance.

Stereotactic radiosurgery for brain metastases from pelvic gynecological malignancies: oncologic outcomes, validation of prognostic scores, and dosimetric evaluation.

INTRODUCTION: Stereotactic radiosurgery is a well-established treatment option in the management of brain metastases. Multiple prognostic scores for prediction of survival following radiotherapy exist, but are not disease-specific or validated for radiosurgery in women with primary pelvic gynecologic malignancies metastatic to the brain. The aim of the present study is to evaluate the feasibility, safety, outcomes, and impact of established prognostic scores. METHODS: We retrospectively identified 52 patients treated with radiotherapy for brain metastases between 2008 and 2021. Stereotactic radiosurgery was utilized in 31 patients for an overall number of 75 lesions; the remaining 21 patients received whole-brain radiotherapy. Kaplan-Meier survival analysis and the log-rank test were used to calculate and compare survival curves and univariate and multivariate Cox regression to assess the influence of cofactors on recurrence, local control, and prognosis. RESULTS: With a median follow-up of 10.7 months, overall survival rates post radiosurgery were 65.3%, 51.3%, and 27.7% for 1, 2, and 5 years, respectively, which were significantly higher than post whole-brain radiotherapy (p=0.049). Five local failures (6.7%) were detected, resulting in 1 and 2 year local cerebral control rates of 97.4% and 94.0%, respectively. Univariate factors for prediction of superior overall survival were high performance status (p=0.030) and application of three prognostic scores, especially the Recursive Partitioning Analysis score (p=0.028). Uni- and multivariate analysis revealed that extracranial progression prior to radiosurgery was significant for inferior overall survival (p<0.0001). Radionecrosis was diagnosed in five women (16%); long-term neurotoxicity was significantly worse after whole-brain radiotherapy compared with radiosurgery (p=0.023). CONCLUSION: Stereotactic radiosurgery for brain metastases from pelvic gynecologic malignancies appears to be safe and well tolerated, achieving promising local cerebral control. Prognostic scores were shown to be transferable and radiosurgery should be recommended as primary intracranial treatment, especially in women with no prior extracranial progression and Recursive Partitioning Analysis class I.

CATCH: A Prospective Precision Oncology Trial in Metastatic Breast Cancer.

PURPOSE: CATCH (Comprehensive Assessment of clinical feaTures and biomarkers to identify patients with advanced or metastatic breast Cancer for marker driven trials in Humans) is a prospective precision oncology program that uses genomics and transcriptomics to guide therapeutic decisions in the clinical management of metastatic breast cancer. Herein, we report our single-center experience and results on the basis of the first 200 enrolled patients of an ongoing trial. METHODS: From June 2017 to March 2019, 200 patients who had either primary metastatic or progressive disease, with any number of previous treatment lines and at least one metastatic site accessible to biopsy, were enrolled. DNA and RNA from tumor tissue and corresponding blood-derived nontumor DNA were profiled using whole-genome and transcriptome sequencing. Identified actionable alterations were brought into clinical context in a multidisciplinary molecular tumor board (MTB) with the aim of prioritizing personalized treatment recommendations. RESULTS: Among the first 200 enrolled patients, 128 (64%) were discussed in the MTB, of which 64 (50%) were subsequently treated according to MTB recommendation. Of 53 evaluable patients, 21 (40%) achieved either stable disease (n = 13, 25%) or partial response (n = 8, 15%). Furthermore, 16 (30%) of those patients showed improvement in progression-free survival of at least 30% while on MTB-recommended treatment compared with the progression-free survival of the previous treatment line. CONCLUSION: The initial phase of this study demonstrates that precision oncology on the basis of whole-genome and RNA sequencing is feasible when applied in the clinical management of patients with metastatic breast cancer and provides clinical benefit to a substantial proportion of patients.

Adjuvant Radiation Therapy for Male Breast Cancer-A Rare Indication?

Due to its rarity, there are no randomized trials investigating the outcome of adjuvant radiotherapy in MBC. This study reports on patient and tumor characteristics of 41 consecutive MBC patients treated between 1990 and 2018 and on clinical outcomes after surgical resection of tumors and adjuvant radiotherapy of the chest wall or breast. Local control (LC), locoregional control (LRC), overall survival (OS), disease-free survival (DFS), and toxicity were evaluated. After a median follow-up of 80 months (95% CI: 14.6-213.8 months) there was only one recurrence, in a patient's locoregional lymph nodes 17 months after start of radiotherapy, resulting in an LC rate of 100% at 5 years and a 5-year LRC rate of 97.4% (standard deviation (SD): 0.025). Five-year DFS and OS rates were 64.6% (SD: 0.085) and 57.2% (SD: 0.082), respectively. Adjuvant radiotherapy was tolerated well without high-grade (CTCAE grade > II) adverse events. After tumor resection and adjuvant radiotherapy, LC and LRC rates in MBC patients are excellent and comparable to results found for female breast cancer (FBC) patients. However, as patients are often diagnosed with locally advanced, higher-risk tumors, distant recurrences remain the major failure pattern.

Immune Checkpoint Blockade in Patients with Triple-Negative Breast Cancer.

Triple-negative breast cancer constitutes ~ 15% of all breast cancer subtypes. Because of the negative hormone receptor and human epidermal growth factor receptor 2 status, therapy is mainly based on chemotherapy with a poor median overall survival in the metastatic setting of ~ 18 months. Compared to other breast cancer subtypes, triple-negative breast cancer is characterized by a higher mutational load, which renders the tumor immunogenic and amenable to immunotherapeutic intervention. Based on the promising results of immunotherapy in other cancer entities, including melanoma or non-small cell lung cancer, a vast number of studies are currently assessing immunotherapeutic approaches in patients with triple-negative breast cancer. While monotherapies with antibodies against programmed death-1 and programmed death ligand-1 have shown little efficacy in patients with heavily pretreated metastatic triple-negative breast cancer, treatment efficacy likely depends on the therapeutic setting, the treatment line, and the combination of immunotherapies with other anticancer drugs. Several studies are currently evaluating the safety and efficacy of immune checkpoint inhibition in combination with chemotherapy, angiogenesis inhibitors, poly(ADP-ribose) polymerase inhibitors, as well as radiotherapy in the metastatic and (neo-)adjuvant settings. The US Food and Drug Administration approval of nab-paclitaxel in combination with atezolizumab in 2019 presented a landmark therapeutic development for patients with triple-negative breast cancer, given the limited treatment options available for this highly aggressive disease. In this review, we provide an overview on important ongoing and completed immunotherapeutic studies in triple-negative breast cancer and their possible implications for clinical practice.

Atezolizumab for use in PD-L1-positive unresectable, locally advanced or metastatic triple-negative breast cancer.

Since the US FDA-approval of the first immune checkpoint inhibitor, anticytotoxic T-lymphocyte antigen-4 monoclonal antibody ipilimumab, for metastatic melanoma on 28 March 2011, another six agents have been granted use among a multitude of tumors, including renal cell cancer, Hodgkin lymphoma, urothelial carcinoma and non-small-cell lung cancer. The first anti-programmed cell death ligand-1 monoclonal antibody to receive the FDA approval, atezolizumab (Tecentriq®), has yielded promising results among international Phase III trials in triple-negative breast cancer and small-cell lung cancer, expanding the field of cancer immunotherapies. Herein, we review the pharmacodynamic and pharmacokinetic properties of atezolizumab, its safety and efficacy data from early clinical trials and summarize data from Phase III IMpassion130 trial, prompting FDA and EMA approval of atezolizumab in metastatic triple-negative breast cancer. Finally, implications for clinical use and ongoing research will be briefly discussed.

Locoregional risk assessment after neoadjuvant chemotherapy in patients with primary breast cancer: clinical utility of the CPS + EG score.

PURPOSE: Locoregional control is a prerequisite to cure primary breast cancer but the prediction of locoregional recurrence to guide further local therapy following neoadjuvant chemotherapy remains a challenge. The CPS + EG score was designed to predict distant recurrences. Here we examine its ability to predict both not only distant but also locoregional recurrences with respect to accuracy and clinical applicability. METHODS: Clinical data from 432 patients with primary breast cancer treated with neoadjuvant chemotherapy between 2003 and 2011 were prospectively collected. Using the Kaplan-Meier method we analyzed the risk of local and distant recurrences according to individual CPS + EG scores, stratified by type of surgery. Possible confounding of the relationship between recurrence risk and CPS + EG score by established risk factors was accounted for in multiple survival regression models. Additionally, we analyzed the performance of the CPS + EG score to predict isolated locoregional recurrence by censoring patients with prior or simultaneous distant metastases. RESULTS: 5-year locoregional recurrence-free survival was 90%, and 5-year distant metastases-free survival was 82%. The CPS + EG score stratified patients into six prognostic groups with distinct 5-year locoregional recurrence-free survival, ranging from 100 to 41% (p = 0.02) and 5-year distant metastases-free survival, ranging from 96 to 35% (p < 0.0001). 8 patients (17%) with CPS + EG scores ≥ 4 experienced locoregional recurrence-5 of them presented with simultaneous distant disease. CONCLUSION: The CPS + EG score, originally designed to predict distant relapse, is also valuable for assessing local recurrence risks. Our data demonstrate that distant and locoregional recurrence risks are closely related. As prognosis of patients with high risk of locoregional failure based on CPS + EG is dominated by distant recurrences, escalating local therapies may have limited impact on overall prognosis.

Prediction of local recurrence risk after neoadjuvant chemotherapy in patients with primary breast cancer: Clinical utility of the MD Anderson Prognostic Index.

BACKGROUND: Locoregional recurrence after neoadjuvant chemotherapy for primary breast cancer is associated with poor prognosis. It is essential to identify patients at high risk of locoregional recurrence who may benefit from extended local therapy. Here, we examined the prediction accuracy and clinical applicability of the MD Anderson Prognostic Index (MDAPI). METHODS: Prospective clinical data from 456 patients treated between 2003 and 2011 was analyzed. The Kaplan-Meier method was used to examine the probabilities of locoregional recurrence, local recurrence and distant metastases according to individual prognosis score, stratified by type of surgery (breast conserving therapy or mastectomy). The possible confounding of the relationship between recurrence risk and MDAPI by established risk factors was accounted for in multiple survival regression models. To define the clinical utility of the MDAPI we analyzed its performance to predict locoregional recurrence censoring patients with prior or simultaneous distant metastases. RESULTS: Mastectomized patients (42% of the patients) presented with more advanced tumor stage, lower tumor grade, hormone-receptor positive disease and consequently lower pathological complete response rates. Only a few patients presented with high-risk scores (2,7% MDAPI≥3). All patients with high-risk MDAPI score (MDAPI ≥3) who developed locoregional recurrence were simultaneously affected by distant metastases. CONCLUSION: Our data do not support a clinical utility of the MDAPI to guide local therapy.

COOLHAIR: a prospective randomized trial to investigate the efficacy and tolerability of scalp cooling in patients undergoing (neo)adjuvant chemotherapy for early breast cancer.

PURPOSE: Chemotherapy-induced alopecia (CIA) is a distressing side effect for women with breast cancer undergoing chemotherapy. Scalp cooling is a method aiming to prevent CIA, but its efficacy is not well defined. Randomized trials until recently and at the time this trial was designed have been lacking. METHODS: Patients undergoing (neo)adjuvant chemotherapy for early breast cancer (EBC) were randomized to scalp cooling (CAP) or observation (NoCAP). All patients received 18-24 weeks of anthracycline- and/or taxane-based chemotherapy. The primary endpoint was patient-reported rate of alopecia according to a modified version of the Dean Scale. Hair preservation was defined as hair loss ≤ grade 2 (≤ 50%). Secondary endpoints were rate of alopecia determined by medical staff, rate of wig/scarf use, tolerability as well as quality of life (QoL). RESULTS: Seventy-nine patients were randomized. Hair preservation was observed in 39.3% of patients in the CAP arm versus 0% in the NoCAP arm (p < 0.001). Wig/scarf use was significantly less frequent in the CAP group (40.7% vs 95.5% outside home before cycle 3, p < 0.001). The drop-out rate was 31.7% and 34.2% in the CAP and NoCAP arm, respectively. Main reasons for drop-out were hair loss, adverse events (CAP), and randomization into control arm. We observed no differences in efficacy between anthracycline-based and non-anthracycline-based regimens. QoL did not differ between the study arms. CONCLUSIONS: This trial adds to the evidence that scalp cooling effectively prevents CIA in a meaningful number of patients. This option should be made available for patients undergoing (neo)adjuvant chemotherapy for EBC.

Exam preparation course in obstetrics and gynecology for the German Medical State Examination: proof of concept and implications for the recruitment of future residents.

OBJECTIVES: Today´s written part of the medical state examination requires students to retrieve a comprehensive amount of knowledge in a limited period of time. Therefore, the main study objectives were to implement and to evaluate a two-day exam preparation course for the German Medical State Examination in obstetrics and gynecology. The project evaluation focused on acceptability, satisfaction and the gain of knowledge for the participants of such a face-to-face course. STUDY DESIGN: The two-day intensive training for senior medical students offered a review of the entire exam-relevant content in the field of obstetrics and gynecology in combination with interactive discussions along selected exam questions. Skill gains were assessed using pre- and post-course multiple choice tests. In addition, a qualitative questionnaire assessed attitudes and satisfaction of course participants. RESULTS: A total of 101 fifth year senior medical students from Heidelberg University Medical School participated in the two pilot courses (summer 2014 and winter 2015). Pre- and post-course tests showed a significant skill-gain from 14.9 to 18.0 points [of a maximum of 20; pre-post difference 95 % CI (2.21; 3.98), t test: p < 0.001]. Furthermore, the qualitative results showed high satisfaction with the course, with an average Likert scale grading of 5.63 (2014) and 5.44 (2015) on a scale from 1 ("extraordinary bad") to 6 ("extraordinary good"). CONCLUSIONS: This study shows that a two-day intensive course in obstetrics and gynecology is feasible, effective and highly appreciated by senior medical students preparing for the Second German Medical State Examination. It further suggests surplus value for academic clinical departments to recruit future residents. Methods and tools presented in this paper are intended to inspire and guide clinical colleagues in implementing the format at their respective universities.

Do Patients After Reexcision Due to Involved or Close Margins Have the Same Risk of Local Recurrence as Those After One-Step Breast-Conserving Surgery?

PURPOSE: To explore whether patients after a reexcision due to involved or close margins have the same risk of local recurrence (LR) than those after a one-step breast-conserving surgery (BCS); to learn whether the presence of residual cancer in the reexcision specimen influences the probability of LR. METHODS: We reviewed demographic, clinical, radiologic, and pathologic records of a cohort of women diagnosed with invasive cancer or carcinoma-in situ who underwent BCS surgery as final surgical treatment between January 1, 2003, and December 31, 2011. Univariable and multivariable Cox regression analyses were used to evaluate influencing factors of LR. RESULTS: A total of 2657 patients were eligible for inclusion onto this study. LR was observed in 67 patients (2.5 %) after a median follow-up of 52 months. Reexcision surgery was performed in 486 patients (18.3 %). The 5-year LR-free survival rate was 94.5 % in the reexcision group and 98.0 % in the group with one-step BCS surgery (p < 0.001). In multivariable Cox regression analyses including different covariates patients with a reexcision had a two to eightfold higher risk of LR. Residual cancer in the reexcision specimen did not influence the LR rate (hazard ratio 1.1, p = 0.779). CONCLUSIONS: This study suggests the importance of a complete tumor resection ideally within one surgical procedure. Therefore, rigorous preoperative planning, multidisciplinary decision making, and additional intraoperative techniques (e.g., ultrasound, specimen radiography, and/or cavity shaved margin) should be used to avoid the need for reexcision.

Efficacy of nab-paclitaxel does not seem to be associated with SPARC expression in metastatic breast cancer.

AIM: To evaluate the predictive value of the expression of the secreted protein acidic and rich in cysteine (SPARC) for nab-paclitaxel in metastatic breast cancer (MBC). PATIENTS AND METHODS: Forty-four patients with progressive MBC were prospectively treated with nab-paclitaxel. Expression of SPARC in tumor cells was assessed by an immunoreactive score, integrating staining intensity and percentage of positive tumor cells; expression in stroma based on staining intensity. SPARC serum levels were determined before 1st and 2nd cycle of nab-paclitaxel and at progression. By applying several cut-offs the association between SPARC expression or serum levels and clinical end-points was analyzed. RESULTS: No clear association between expression of SPARC in primary or metastatic tumor tissue or in serum and any clinical end-point could be detected regardless of the various cut-offs applied. CONCLUSION: Efficacy of nab-paclitaxel in MBC does not seem to be associated with expression of SPARC in tumor tissues or serum.

Efficacy and toxicity profile of pegylated liposomal doxorubicin (Caelyx) in patients with advanced breast cancer.

Many patients with metastatic breast cancer (MBC) have been treated previously with taxanes and/or anthracyclines, which renders reinduction of anthracyclines in the palliative setting impossible because of the high cardiotoxicity of these drugs. Pegylated liposomal doxorubicin represents a means of reinducing anthracyclines without increasing cardiotoxicity. The aim of this retrospective study was to evaluate the efficacy and toxicity of Caelyx in patients with MBC. Patients with histologically confirmed MBC were eligible for this retrospective study if they had received palliative chemotherapy with pegylated liposomal doxorubicin between 1 January 2002 and 31 December 2006 at the Department for Gynecology and Obstetrics at the University of Heidelberg (Germany). The main endpoints were time to progression, overall survival, and safety of the treatment with pegylated liposomal doxorubicin. In all, 141 patients were included in this retrospective trial. The median age of the patients was 54 years (range 24-84 years). Of the patients, 43% had received five to six previous chemotherapy regimens before pegylated liposomal doxorubicin was recommended. In 33% of patients, more than three organs were involved. The most commonly involved organs were bones, liver, and lungs; 37 patients had received three or at least six cycles of Caelyx. During the treatment with pegylated liposomal doxorubicin, left ventricular ejection function was not reduced by more than 15%. The major effects (grade 4) were hematological toxicity (anemia, leukopenia, and thrombocytopenia), hand-foot syndrome, and stomatitis. In nine patients, the dose was reduced and in three patients chemotherapy with Caelyx was stopped owing to hematological toxicity. In 20 patients, the dose was reduced and in nine patients chemotherapy was stopped owing to nonhematological toxicity. The median time to disease progression was 6.5 months; the overall median survival was 13 months after the first course of pegylated liposomal doxorubicin was initiated. This retrospective study confirmed the efficacy and good tolerability of pegylated liposomal doxorubicin in patients with MBC who had been treated previously with anthracycline. A dosage of 40 mg/m² body surface every 4 weeks is equally effective with less toxicity.

Nab-Paclitaxel monotherapy as a treatment of patients with metastatic breast cancer in routine clinical practice.

AIM: To compare treatment results with use of nab-paclitaxel in routine clinical practice with data obtained from clinical trials. PATIENTS AND METHODS: A retrospective chart review of all 36 patients with metastatic breast cancer treated with nab-paclitaxel was performed. Nab-paclitaxel was given weekly and usually started at 150 mg/m(2). RESULTS: Thirteen (36.1%) patients received nab-paclitaxel as first-line, seven (19.4%) as second-line and 16 as third- or further line treatment. Overall, the response rate was 9.7%, disease control rate 64.5%, median progression-free survival 7.5 months and median overall survival 14.2 months. The most frequent non-hematological toxicities of grade 3 or more were fatigue (27.8%), dyspnea, rash and arthalgia (all 5.6%). Six (16.7%) patients developed peripheral neuropathy of grade 2 or more. Incidence of neutropenia grade 3 or more was 41.7% with no case of febrile neutropenia. CONCLUSION: According to our experience, weekly nab-paclitaxel is effective and tolerable, with results at least comparable to those from the prospective clinical trials.

Omission of axillary dissection according to ACOSOG Z0011: impact on adjuvant treatment recommendations.

OBJECTIVE: A recent, randomized trial (ACOSOG Z0011) has demonstrated that omission of completion axillary lymph node dissection (ALND) in patients with one or two sentinel lymph node (SLN) metastases treated with breast conserving therapy (BCT) does not have a negative impact on survival. This study evaluates the impact of omitting ALND on adjuvant treatment recommendations. METHODS: Performing a search of our clinical database, we identified patients meeting the main inclusion and exclusion criteria of ACOSOG Z0011 treated at the University of Heidelberg Breast Center. We performed blinded mock interdisciplinary tumor boards based on patient and tumor characteristics as well as (1) SLN information or (2) final nodal status after ALND. Differences between treatment recommendations were noted and analyzed. RESULTS: A total of 132 patients were included; 80.3 % of these had one and 19.7 % had two metastatic sentinel nodes with a rate of micrometastases only of 19.7 %, and 39.7 % of patients had additional nonsentinel node metastases upon ALND. Overall, there was a change in adjuvant chemotherapy in 18.2 % of cases. Treatment recommendations based on ALND lead to a more aggressive therapy in 16.6 % of cases, all of them with additional metastatic nonsentinel nodes. Chemotherapy was not recommended in only two cases (1.5 %) based on ALND. Based on ALND, irradiation of the supraclavicular and infraclavicular nodes was added in 5.3 % of patients. CONCLUSIONS: Completion ALND for patients with one or two metastatic sentinel nodes in pT1-2 cN0 PBC treated with BCT does have a relevant impact on adjuvant treatment. This should be considered in shared decision making.