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Silicone gel-filled implants exist in a wide range of shapes and textures, and yet there are relatively few long-term large-scale studies, particularly on recently developed "semi-smooth" implants. The present study fills this gap by presenting the 3-year findings from an ongoing 10-year multicenter prospective study on breast implants with four different surface types: smooth, semi-smooth, microtextured, and macrotextured. A total of 908 patients were recruited in 15 investigational sites across Europe and divided into three groups: 653 primary augmentations in Group 1, 144 revision augmentations in Group 2, and 111 reconstructions in Group 3. All 4 types of implant shells were manufactured by the same company using the same silicone material. Surgeons were free to choose their preferred technique and implant surface, but data were collected using a standardized software and included all complications, and satisfaction levels reported by the patients at each visit. The incidence of post-operative complications was estimated based on Kaplan-Meier risk rates, on a per patient basis. At 3 years post implantation, capsular contracture (Baker grade III/IV) was the most common complication, with a per-patient risk rate of 1.5% in Group 1. Interestingly, there was no capsular contracture in this group when semi-smooth implants were used. The risk of implant rupture in Group 1 was 0.2%. The preliminary findings of this 10-year prospective study indicate that, 3 years after the operation, the four types of silicone gel-filled implants investigated were safe, with a low complication rate in comparison with the most favorable results published in other similar studies.

In der Gruppe der Mammakarzinome hat das triple-negative Mammakarzinom (TNBC, „triple-negative breast cancer“) das heterogenste Outcome und die schlechteste Prognose. Durch das Fehlen von Hormonrezeptoren und des HER2/neu(„human epidermal growth factor receptor 2“)-Rezeptor bestehen in der aktuellen klinischen Routine keine Zielstrukturen fur eine spezifische Therapie. Es erfolgte eine Literaturrecherche zur aktuellen Studienlage und vielversprechenden Therapieansatzen. In der kurativen Situation finden sich neue Ansatze in der Hinzunahme von Checkpointinhibitoren zusatzlich zur Standardchemotherapie. Ebenfalls gibt es mit Capecitabin analog der CREATE-X-Studie bei non-PCR eine postneoadjuvante Therapie. In der palliativen Situation findet man neben verschiedenen Chemotherapien einen Ansatz in der Testung von Tumorgewebe und der Keimbahn. Bei PD-L1(„programmed cell death 1 ligand 1“)-Positivitat kann auf den bereits zugelassenen Checkpointinhibitor Atezolizumab zuruckgegriffen werden. Bevacizumab ist auch bei manchen Patientinnen eine Option. Weitere mogliche Antikorpertherapien umfassen in Zukunft Pembrolizumab sowie die Antikorper-drug-Konjugate Sacituzumab-Govitecan und Trastuzumab-Deruxtecan. Bei einer Aktivierung des AKT/PI3K(Phosphoinositid-3-Kinase)-Signalwegs scheinen AKT-Inhibitoren wie Capivasertib oder Ipatasertib eine Option darzustellen. Bei BRCA-Positivitat stehen PARP(Poly[ADP-ribose]-Polymerasen)-Inhibitoren zur Verfugung. Trotz Fehlens der Hormonrezeptoren und des HER2/neu-Rezeptors bestehen mittlerweile mit der PD-L1-Testung, der Keimbahnanalyse und auch der Testung auf eine Aktivierung des AKT/PI3K-Signalwegs weitere zielgerichtete Therapieoptionen fur das TNBC sowohl in der kurativen als auch in der palliativen Situation.

Das metastasierte Mammakarzinom gilt allgemein als nicht kurabel; dennoch hat die Lebenserwartung der betroffenen Patientinnen durch den Einsatz moderner Systemtherapien in den letzten Jahrzehnten zugenommen. Zum aktuellen Zeitpunkt stellt die primare operative Resektion des Brusttumors keine Standardtherapie dar, und ihr Effekt auf ein langeres Uberleben ist bislang nicht eindeutig geklart. In diesem Ubersichtsartikel werden Argumente pro und kontra eine primare Brustoperation beim metastasierten Mammakarzinom herausgearbeitet und validiert. Literaturrecherche retro- und prospektiver Studien in Bezug auf eine Operation bei Patientinnen mit Erstdiagnose eines Stadium-IV-Mammakarzinoms Viele retrospektive Studien legen fur Patientinnen mit metastasiertem Mammakarzinom einen Uberlebensvorteil durch die Operation des Primarius dar. Diese Untersuchungen weisen jedoch methodische Limitationen und Selektionsbias auf. Neuere prospektive Daten konnen den Uberlebensvorteil empirisch nicht bestatigen. Dennoch deuten Subgruppenanalysen auf einen Vorteil fur junge Patientinnen mit hormonrezeptorpositiver Tumorbiologie und Oligometastasierung in den Knochen hin. Ausgehend von der aktuellen Datenlage ist es nicht moglich, eine eindeutige Schlussfolgerung pro oder kontra Brustoperation in der metastasierten Erkrankungssituation zu treffen. Junge hormonrezeptorpositive Patientinnen mit Knochenmetastasen scheinen am meisten von der Resektion des Primartumors zu profitieren. Die Wertigkeit einer solchen Operation sollte allerdings immer interdisziplinar fur den Einzelfall gepruft werden.

Die Komplexitat und Vielfalt an plastisch-operativen und rekonstruktiven Eingriffsmoglichkeiten an der Mamma erfordert eine operative Spezialisierung des chirurgisch tatigen Gynakologen auf diesem Gebiet. Eine gute und facherubergreifende Zusammenarbeit mit der plastischen Chirurgie ist zwingende Voraussetzung, um den Wunschen und Bedurfnissen der Patientinnen gerecht werden zu konnen. Ein Schwerpunkt der operativen Therapiemoglichkeiten liegt heute in der onkoplastischen Mammachirurgie, die neben der onkologisch sicheren In-sano-Resektion des Karzinoms eine asthetisch fur die Patientin zufriedenstellende Wiederherstellung der Brust zum Ziel hat. Von verschiedenen brusterhaltenden Ansatzen kommen hier u. a. Verfahren mit auto- und heterologen Rekonstruktionsmoglichkeiten nach Mastektomie zum Einsatz. In diesem Zusammenhang ist auch die prophylaktische Mastektomie bei Hochrisikopatientinnen (BRCA-Mutationstragerinnen) zu nennen. Weitere Indikationen fur plastisch-operative Eingriffe sind angeborene oder erworbene Fehlbildungen, z. B. Aplasie/Hypoplasie, eine tubulare Brust oder eine deutliche Makromastie mit entsprechenden korperlichen Beschwerden. Besonders bei rekonstruktiven und plastisch-asthetischen Operationen muss vorher umfassend uber den Eingriff, mogliche Komplikationen und Alternativen aufgeklart werden.

Hematologic toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematologic parameters and fatigue in patients with breast cancer during chemotherapy.In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 × 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 × epirubicin and cyclophosphamide followed by 4 × docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after one-half of the chemotherapy.In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41; P .001) were affected by treatment regimen. Fatigue during chemotherapy was mostly affected by the level of fatigue before the start of chemotherapy (B = 0.41; P .001). Patients with G-CSF application in the preceding cycle showed an increased fatigue score (B = 5.43; P = .02).We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.

Background: A recent meta-analysis has reported benefits of adjuvant bisphosphonate treatment in early breast cancer patients with improved breast cancer survival and reduced rate of breast cancer recurrences in the bone, especially in postmenopausal patients. However, a comparison between bisphosphonate treatments duration is lacking. Therefore, we examined 2 and 5 years of zoledronate treatment following adjuvant chemotherapy in the SUCCESS A trial. Methods: The SUCCESS A trial is a randomized, open-label, 2x2 factorial design Phase III study in high-risk early breast cancer patients that were randomized to adjuvant chemotherapy treatment with 3 cycles of FEC followed by either 3 cycles of docetaxel or 3 cycles of gemcitabine-docetaxel. After chemotherapy, patients were subject to a second randomization of 5 years of zoledronate treatment (4 mg i.v. every 3 months for 2 years, followed by 4 mg i.v. every 6 months for 3 years) vs. 2 years of zoledronate treatment (4 mg i.v. every 3 months for 2 years). Outcome was analyzed using adapted disease-free survival (DFS) and adapted overall survival (OS), with survival times measured as of 2 years after the start of zoledronate treatment. Maximal observation time was set to 4 years. Median observation time was 2.95 years for DFS and 3 years for OS. Results: Overall, 3421 of the 3754 patients randomized in the SUCCESS A study received at least one zoledronate dose. 434 patients had a DFS event or were lost to follow up in the first two years after the start of zoledronate treatment; thus, 2987 patients were available for analysis (1540 and 1447 patients in the 5-year and 2-year zoledronate treatment arm, respectively). Both adapted DFS and adapted OS did not differ between the two treatment arms (5 vs. 2 years) as shown by multivariate cox regressions adjusted for patient and tumor characteristics as well as chemotherapy (DFS: hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.75 – 1.25, p = 0.81; OS: HR 0.98, 95% CI 0.67 – 1.42, p = 0.90). In addition, subgroup analyses according to menopausal status revealed no difference in DFS or OS between the two treatment arms in premenopausal women (DFS: HR 1.21, 95% CI 0.81 – 1.81, p = 0.35; OS: HR 0.93, 95% CI 0.57 – 1.53, p = 0.78) or postmenopausal women (DFS: HR 0.85, 95% CI 0.62 – 1.16, p = 0.30; OS: HR 0.96, 95% CI 0.67 – 1.39, p = 0.84). Conclusions: Our study showed no difference in DFS or OS between 5-years and 2-years of adjuvant zoledronate treatment in early breast cancer patients, irrespectively of menopausal status. Thus, our results indicate that extended treatment with zoledronate does not improve DFS or OS in high-risk early breast cancer patients. Citation Format: Janni W, Friedl TWP, Fehm T, Müller V, Lichtenegger W, Blohmer J, Lorenz R, Forstbauer H, Bauer E, Fink V, Bekes I, Jückstock J, Schneeweiss A, Tesch H, Mahner S, Brucker SY, Heinrich G, Beckmann MW, Coleman R, Rack B. Extended adjuvant bisphosphonate treatment over five years in early breast cancer does not improve disease-free and overall survival compared to two years of treatment: Phase III data from the SUCCESS A study [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr GS1-06.

Importance Bisphosphonate treatment in patients with early breast cancer has become part of care, but the optimal treatment duration is still unclear. Objective To compare 2 vs 5 years of zoledronate treatment following adjuvant chemotherapy in patients with early breast cancer. Design, Setting, and Participants The SUCCESS A phase 3 multicenter randomized open-label clinical trial with a 2 × 2 factorial design enrolled 3754 patients from September 21, 2005, to March 12, 2007 (last patient out, May 7, 2014). Final data analysis was conducted from September 2019 to October 2020. In 250 German study centers, patients were eligible for participation in the SUCCESS A trial if they had either node-positive or high-risk node-negative (defined as at least 1 of the following: tumor size ≥ pT2, histologic grade 3, negative hormone receptor status, or age ≤35 years) primary invasive breast cancer. Interventions Patients were first randomized to adjuvant chemotherapy with 3 cycles of fluorouracil, epirubicin, and cyclophosphamide followed by 3 cycles of docetaxel with or without gemcitabine (not presented in this report). After chemotherapy, patients underwent a second randomization of 5 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years, followed by 4 mg intravenously every 6 months for 3 years) vs 2 years of zoledronate treatment (4 mg intravenously every 3 months for 2 years). Main Outcomes and Measures The primary end point of the study was disease-free survival; secondary end points were overall survival, distant disease-free survival, and the incidence of skeletal-related adverse events. Survival times were measured from 2 years after the start of zoledronate treatment (landmark analysis). Results Overall, data on 2987 patients were available for analysis; median age was 53 (range, 21-86) years. Disease-free survival, overall survival, and distant disease-free survival did not differ significantly between the 2 treatment arms (5 vs 2 years) as shown by adjusted multivariable Cox proportional hazards regression models (disease-free survival: hazard ratio [HR], 0.97; 95% CI, 0.75-1.25;P = .81; overall survival: HR, 0.98; 95% CI, 0.67-1.42;P = .90; distant disease-free survival: HR, 0.87; 95% CI, 0.65-1.18;P = .38). Adverse events were observed more often in the 5-year (46.2%) vs 2-year (27.2%) zoledronate treatment arm, which was particularly true for the skeletal-related events bone pain (5 years, 8.3% vs 2 years, 3.7%) and arthralgia (5 years, 5.1% vs 2 years, 3.1%). Conclusions and Relevance The results of this phase 3 randomized clinical trial indicate that extending the zoledronate treatment beyond 2 years does not improve the prognosis of high-risk patients with early breast cancer receiving chemotherapy, suggesting that the currently recommended bisphosphonate treatment duration of 3 to 5 years could be reduced. Trial Registration ClinicalTrials.gov Identifier:NCT02181101

Elderly breast cancer patients are affected by poorer quality of life (QoL) compared to younger patients. Because QoL has a relevant impact on guideline-adherent treatment, elderly breast cancer patients are often undertreated, especially with regard to adjuvant chemotherapy, and overall survival is decreased. Thus, understanding the impact of chemotherapy on QoL in elderly patients is crucial. This study compared QoL in patients aged 65 years and 65 to 70 years receiving adjuvant chemotherapy as a secondary outcome in the prospective randomized multicenter ADEBAR trial.Patients with lymph node-positive breast cancer were prospectively randomized for either sequential anthracycline-taxane or epirubicin/fluorouracil/cyclophosphamid chemotherapy (FEC) therapy. QoL was assessed at baseline (t1), before cycle 4 FEC, and cycle 5 epirubicin/cyclophosphamid-docetaxel (EC-DOC) (t2), 4 weeks after chemotherapy (t3), and 6 weeks after radiation (t4) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). We compared patients aged 65 years and 65 to 70 years with respect to QoL and discontinuation of chemotherapy.A total of 1363 patients were enrolled onto the ADEBAR trial, with 16.7% of the patients aged 65 to 70 years. In elderly patients, Eastern Cooperative Oncology Group performance status was higher and global health status and physical functioning were lower at baseline. Global health status decreased between t1 and t3 by 7 points in patients 65 years and by 11 points in patients 65 to 70 years, and physical functioning decreased in the same period by 13.4 points in patients aged 65 years and by 15.9 points in patients 65 to 70 years. In both groups, at t4 global health status exceeded baseline by 6 points, and physical functioning was 1.3 points under baseline in patients 65 years old and 3 points under baseline in patients 65 to 70 years. There was a trend to more fatigue in elderly patients and to more nausea and vomiting while receiving chemotherapy in younger patients at t3. There was a higher dropout rate in patients aged 65 to 70 years (25.7%) than in patients aged 65 years (16.2%).There were only small or trivial differences in QoL in patients aged 65 years versus 65 to 70 years who were receiving adjuvant chemotherapy, although the dropout rate from chemotherapy was notably higher in elderly breast cancer patients.

BackgroundIn this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes.MethodsIn this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes.ResultsIn our study population, patients had a good to excellent prognosis (5-year RFS: 91% and tumorspecific 5-year OS 96.5%). There was no significant difference in RFS stratified by patients with only endocrine therapy and with endocrine plus chemo-therapy. Patients with 1-3 affected lymph nodes had no significant differences in OS treated only with endocrine therapy or with endocrine plus chemotherapy, independent of tumor size. Patients with large tumors and more than 3 affected lymph nodes had a significant worse survival as compared to the small tumors. However, despite the worse prognosis of those, adjuvant chemotherapy failed in order to improve RFS.ConclusionsAccording to our data, nodal positive patients with luminal A breast cancer have, if any, a limited benefit of adjuvant chemotherapy. Tumor size and nodal status seem to be of prognostic value in terms of survival, however both tumor size as well as nodal status were not predictive for a benefit of adjuvant chemotherapy.

Tumorbefallene Resektionsrander beim Mammakarzinom und beim duktalen Carcinoma in situ (DCIS) haben einen negativen Effekt auf die Prognose und gehen nachweislich mit einem erhohten Lokalrezidivrisiko einher, sodass tumorfreie Resektionsrander eingefordert werden mussen. Ein mikroskopisch freier Schnittrand bei invasiven Karzinomen – „no cells on ink“ – auch mit begleitendem DCIS wird inzwischen als ausreichend angesehen. Dies gilt fur alle Tumortypen und ist unabhangig vom Alter der Patientin. Die Voraussetzung stellt eine leitliniengerechte adjuvante Strahlen- und Systemtherapie dar. Dieses Vorgehen wird in den amerikanischen Leitlinien sowie von der Arbeitsgemeinschaft Gynakologische Onkologie (AGO) bereits empfohlen, ist in der aktuell gultigen deutschen S3-Leitlinie von 2012 jedoch noch nicht verankert. Beim reinen DCIS sollte aktuell noch ein tumorfreier Schnittrand von 2 mm erreicht werden, wenn nach brusterhaltender Operation nachbestrahlt wird.

One of the most common complications in breast conserving surgery is seroma formation. The origin of seroma formation remains unclear. While intraoperative radiotherapy (IORT) has been shown to be an alternative to whole breast irradiation, the influence on seroma production is unclear. Therefore, this analysis compares seroma production in patients with breast conserving surgery with or without IORT as tumour bed boost during breast conserving surgery. A retrospective analysis of seroma production in patients with nodal-negative (pN0sn) pT1/2 primary breast cancer treated between September 2010 and October 2013 at the Breast Cancer Centre, University Hospital Ulm was performed. Patients with neoadjuvant chemotherapy, previous breast/axillary surgery or more than one intervention were excluded. IORT was applied as a tumour bed boost with 50-kV X-rays (Intra beam®) delivering 9 Gy at the applicator surface. Seroma formation was measured using wound drains placed in breast and in axilla. Data of 152 patients (99 −IORT; 53 +IORT) were available for analysis. No significant differences between patients with or without IORT with regard to seroma production and number of days until drain removal were found (all p > 0.05). Patients with IORT encountered no increased seroma production and removal of the drains was not delayed compared to patients with breast conserving surgery only. Our results indicate that IORT does not increase the seroma production compared to surgery alone.

In den letzten Jahrzehnten ist die Pravalenz von Krebserkrankungen in Deutschland deutlich angestiegen, wahrend die Mortalitat bei vielen Entitaten gesunken ist. Dieser Trend fuhrt zu einer wachsenden Anzahl an Patientinnen in der onkologischen Nachsorge. Wahrend die Therapien heutzutage im Allgemeinen auf evidenzbasierten Masnahmen beruhen, stutzen sich die Empfehlungen zur Nachsorge mangels groser randomisierter Studien meist auf Konsensempfehlungen. Wahrend ein Lokalrezidiv haufig kurativ behandelt werden kann, besteht nach Detektion von Fernmetastasen meist nur die Moglichkeit einer palliativen Therapie. Die Herausforderung besteht daher in der Verknupfung sinnvoller medizinischer Masnahmen zur Erkennung eines Rezidivs bzw. symptomatischer Fernmetastasen unter Berucksichtigung der Bedurfnisse und der Lebensqualitat der Patientin. Der Artikel gibt einen Uberblick uber die aktuellen Empfehlungen zur Nachsorge von Patientinnen mit gynakologischen Tumoren, einschlieslich des Mammakarzinoms.

In high-risk early breast cancer, adjuvant taxane-Gemcitabine combinations result in a recurrence-free survival similar to single-agent taxanes. However, haematologic toxicities and need for dose reductions are more frequent in combinations. Which option ultimately provides a better quality of life (QoL) is unknown. We compared the QoL curves before, during, and up to one year after three cycles of Fluorouracil–epirubicin–cyclophosphamide followed by three cycles of Docetaxel–Gemcitabine or Docetaxel. Overall, 3691 women with recent R0-resection of a primary epithelial breast cancer participated in the nationwide SUCCESS A clinical trial. The centres sent QoL questionnaires of the European Organisation for Research and Treatment of Cancer before and up to 15 months after randomisation to Docetaxel–Gemcitabine versus Docetaxel. Multilevel analysis by chemotherapy arm estimated the QoL time curves, questionnaire return, and dropout. The combination caused one-point higher global QoL (95% confidence ±1; p = 0.05) and 1.1 lower odds of adherence to the outcome (95% confidence 1.0–1.1; p = 0.23) than the monotherapy. In both groups, a 10-point decrease during therapy preceded a 16-point increase after chemotherapy (p

Health-related quality of life (QoL) is a self-assessed construct indicating how people feel in regard to aspects of their health. Performance status (PS) is evaluated by the treating physician. We examined whether pretreatment QoL and PS are related to subsequent treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy. We conducted a prospective cohort study with data from a randomized phase III trial comparing FEC- and EC-DOC-chemotherapy in patients with primary breast cancer (ADEBAR). We examined the patient’s request to discontinue the study, discontinuation due to toxicity, the prolongation of therapy, and dose reduction. Baseline QoL was assessed using the EORTC QLQ-C30. PS was evaluated using the Eastern Cooperative Oncology Group Scale (ECOG). Four QoL scales were selected prior to analysis as outcomes: global health, physical functioning, emotional functioning, and fatigue. Multivariate binary logistic regression analyses were used to test for differences within the independent variables. 1322 patients were included. 1094 (82.8 %) patients completed therapy according to protocol. 6.3 % stopped therapy due to toxicity and 4.4 % refused treatment. Global health was not related to any of the four QoL outcomes. Physical functioning had the strongest impact on QoL, when comparing the fittest group to the lowest quintile [OR 2.14 (95 % CI 1.00–4.60)]. ECOG 0 compared to worse than 1 was strongly correlated to therapy discontinuation due to toxicity [OR 20.15 (95 % CI 9.48–42.83)] and treatment refusal [OR 8.32 (95 % CI 3.81–18.14)]. Pretreatment QoL, especially physical functioning, is associated with subsequent therapy discontinuation due to toxicity and with changes of the treatment protocol. Pretreatment performance status is strongly associated with therapy discontinuation due to toxicity and with treatment refusal.

Circulating tumor cells (CTCs) represent the liquid component of solid tumors and are a surrogate marker for residual cancer burden. Although CTC status is prognostic of recurrence and death in breast cancer, its role in guiding clinical management remains unknown.To determine whether CTC status is predictive of radiotherapeutic benefit in early-stage breast cancer.The cohort studies in the present analysis included patients with stages pT1 to pT2 and pN0 to pN1 breast cancer and known CTC status from the National Cancer Database (NCDB) and the multicenter phase 3 SUCCESS clinical trial. Multivariable parametric accelerated failure time models were used to evaluate the association of CTC status and radiotherapy (RT) with survival outcomes. Data were collected from January 1, 2004, through December 31, 2014, from the NCDB cohort. The SUCCESS trial collected data from September 1, 2005, through September 30, 2013. The analyses were completed from November 1, 2016, through December 17, 2017.Adjuvant RT.Overall survival (OS), local recurrence-free survival (LRFS), and disease-free survival (DFS).A total of 1697 patients from the NCDB (16 men [0.9%] and 1681 women [99.1%]; median age, 63 years; interquartile range, 53-71 years) and 1516 patients from the SUCCESS clinical trial (median age, 52 years; interquartile range, 45-60 years) were identified. Circulating tumor cells were detected in 399 patients (23.5%) in the NCDB cohort and 294 (19.4%) in the SUCCESS cohort. The association of RT with survival was dependent on CTC status within the NCDB cohort (4-year OS, 94.9% for CTC-positive RT vs 88.0% for CTC-positive non-RT vs 93.9% for CTC-negative RT vs 93.4% for CTC-negative non-RT groups; P .001) and 5-year DFS within the SUCCESS cohort (88.0% for CTC-positive RT vs 75.2% for CTC-positive non-RT vs 92.3% for CTC-negative RT vs 88.3% for CTC-negative non-RT; P = .04). In the NCDB cohort, RT was associated with longer OS in patients with CTCs (time ratio [TR], 2.04; 95% CI, 1.55-2.67; P .001), but not in patients without CTCs (TR, 0.80; 95% CI, 0.52-1.25; P = .33). In the SUCCESS cohort, CTC-positive patients treated with RT exhibited longer LRFS (TR, 2.73; 95% CI, 1.62-4.80; P .001), DFS (TR, 3.03; 95% CI, 2.22-4.13; P .001), and OS (TR, 1.83; 95% CI, 1.23-2.72; P = .003). Among patients from both cohorts who underwent breast-conserving surgery, RT was associated with longer OS in patients with CTCs (TR, 4.37; 95% CI, 2.71-7.05; P .001) but not in patients without CTCs (TR, 0.87; 95% CI, 0.47-1.62; P = .77). Radiotherapy was not associated with OS after mastectomy in CTC-positive or CTC-negative patients.Treatment with RT was associated with longer LRFS, DFS, and OS in patients with early-stage breast cancer and detectable CTCs. These results are hypothesis generating; a prospective trial evaluating CTC-based management for RT after breast-conserving surgery in women with early-stage breast cancer is warranted.

Background The recommendation for adjuvant dose-dense chemotherapy in high risk primary breast cancer is heterogeneous among guidelines. Understanding the impact on QoL is thereby a crucial factor, especially if the benefit is potentially low. This study aims to assess QoL as a secondary outcome in the prospective randomized multi-center ADEBAR trial. Methods QoL was assessed at baseline (t1), before cycle 4 FEC and cycle 5 EC-DOC (t2), 4 weeks after chemotherapy (t3) and 6 weeks after radiation (t4) using the European Organization for Research and Treatment for Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) and the Breast Cancer-Specific Module (QLQ-BR23). Results 1306 patients were enrolled into the ADEBAR trial. 675 were assigned to the FEC and 688 to the EC-DOC arm. After the beginning of treatment, global QoL dropped in both arm by 3–4 points. In the EC-DOC arm, QoL dropped further at t3 by 7 points and stayed stable in the FEC arm. 6 weeks after radiation, QoL exceeded baseline in both arms by 6–8 points. The differences between treatment arms were strongest at t3 (53.0 vs. 49.5) but did not reach clinical relevance at any point in time. Physical functioning, nausea and vomiting, fatigue and systemic therapy side effects followed with some minor exceptions similar patterns but showed higher amplitudes. Conclusion In conclusion, we could not detect a clinically relevant difference between the two treatment arms in global QoL, although the results consistently show that patients on EC-DOC report worse scores during the treatment.