SEOM clinical guidelines in early stage breast cancer (2018)

Breast cancer is the most common cancer in women in our country and it is usually diagnosed in the early and potentially curable stages. Nevertheless, around 20-30% of patients will relapse despite appropriate locoregional and systemic therapies. A better knowledge of this disease is improving our ability to select the most appropriate therapy for each patient with a recent diagnosis of an early stage breast cancer, minimizing unnecessary toxicities and improving long-term efficacy

No disponible

Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer: results of phase IIIb BALLET trial in Spain

Background: Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. Patients and methods: Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain. Results: Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE. Conclusion: The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trials

No disponible

Papel pronóstico del volumen metabólico tumoral y de la glucólisis tumoral total en los estudios 18F-FDG PET/TC de estadificación del cáncer localmente avanzado de mama / Prognostic value of metabolic tumour volume and total lesion glycolysis in 18F-FDG PET/CT scans in locally advanced breast cancer staging

Objetivo. Conocer si el volumen metabólico tumoral (VMT) y la glucólisis tumoral total (GTT) pueden predecir el riesgo de recurrencia en cáncer localmente avanzado de mama (CLAM). Material y métodos. Estudio retrospectivo de pacientes con CLAM tratados con tratamiento neoadyuvante, local y adyuvante; en seguimiento. Se realizó una 18F-FDG PET/TC para estadificar la enfermedad, midiéndose diferentes parámetros metabólicos (VMT, GTT, SUVmáx y SUVmed), tanto en el tumor primario (T) como en los ganglios metastásicos (N) y en el cuerpo entero (CE). Resultados. Se incluyeron 40 mujeres entre enero de 2010-2011; seguimiento hasta enero de 2015. Con una mediana de seguimiento de 46 meses el 20% tuvieron recidiva, local (n=2) o a distancia (n=6); fallecieron 3 (38% de aquellas con recidiva y 7,5% del total). EL SUVmáx, VMT y GTT, tanto en T, como N y CE, fue mayor en aquellas que presentaron recidiva. En el T tanto el VMT como la GTT se relacionaron con la recidiva de la enfermedad (p=0,020 y p=0,028, respectivamente), mientras que en la N fue el SUVmáx (p=0,008). Los puntos de corte óptimos para predecir recurrencia fueron: VMT T≥19,3cm3, GTT T≥74,4g y SUVmáx N≥13,8, existiendo 10-12 veces más probabilidad de experimentar progresión tumoral cuando superaban estos umbrales. El grado tumoral fue la única variable clínico-patológica asociada con la recidiva (p=0,035). Conclusiones. En este estudio de CLAM los parámetros metabólicos que más se asocian con la tasa de recidiva son el VMT y la GTT en el tumor primario, el SUVmáx en la enfermedad ganglionar regional y los 3 índices PET en el cuerpo entero. Estos parámetros podrían utilizarse en la práctica asistencial para identificar a las pacientes con mayor riesgo (AU)

Objective. To determine whether metabolic tumour volume (MTV) and total lesion glycolysis (TLG) are able to predict recurrence risk in locally advanced breast cancer (LABC) patients. Material and methods. Retrospective study of LABC patients who undertook neoadjuvant, local and adjuvant treatment and follow up. A 18F-FDG PET/CT study for initial staging was performed analysing in this study different metabolic parameters (MTV, TLG, SUVmax and SUVmed) both in the primary tumour (T) as well as in axillary nodes (N) and whole-body (WB). Results. Forty females were included between January 2010-2011; follow up until January 2015 was completed. The average follow-up was 46 months. Twenty percent presented recurrence: local disease (n=2) and distant metastasis (n=6); 3 patients died (38% of the patients which recurred and 7.5% from the total). SUVmax, MTV and TLG, in T, N and WB, were higher in those patients with recurrence. The MTV and TLG parameters in the tumour (T) were related to the recurrence rate (P=.020 and P=.028, respectively); whereas SUVmax in the lymph nodes (N) was significantly related (P=.008) to the recurrence rate. The best cut-off points to predict recurrence where: MTV T ≥19.3cm3, TLG T≥74.4g and SUVmax N≥13.8, being 10-12 times more likely to recidivate when these thresholds where exceeded. Tumour grade was the only clinical-pathological variable which was related to recurrence probability (p=.035). Conclusions. In this study of LABC patients the metabolic parameters which have a better relationship with recurrence rate are: MTV and TLG in the primary tumour, SUVmax in the regional lymph node disease and whole-body PET data (AU)

Review: circulating tumor cells in the practice of breast cancer oncology

The primary cause of tumor-related death in breast cancer is still represented by distant metastasization. The dissemination of tumor cells from the primary tumor to distant sites through bloodstream cannot be early detected by standard imaging methods. Circulating tumor cells (CTCs) play a major role in the metastatic spread of breast cancer. Different analytical systems for CTCs isolation and detection have been developed and novel areas of research are directed towards developing assays for CTCs molecular characterization. This review describes the current state of art on CTCs detection techniques and the present and future clinical implications of CTCs enumeration and characterization (AU)

No disponible

SEOM clinical guidelines in early-stage breast cancer 2015

Breast cancer is a major public health problem. Despite remarkable advances in early diagnosis and treatment, one in three women may have metastases since diagnosis. Better understanding of prognostic and predictive factors allows us to select the most appropriate adjuvant therapy in each patient. In these guidelines, we summarize current evidence for the medical management of early-stage breast cáncer (AU)

No disponible

Respuesta patológica en la axila tras quimioterapia neoadyuvante en el cáncer de mama localmente avanzado con afectación axilar / Axillary pathologic response after neoadjuvant chemotherapy in locally advanced breast cancer with axillary involvement

Objetivo. Comparar la afectación axilar (N+) al diagnóstico en el cáncer de mama localmente avanzado (CMLA), con el resultado histopatológico en la axila tras el tratamiento quimioterápico neoadyuvante (QTN). Material y métodos. Estudio retrospectivo entre noviembre de 2011 y septiembre de 2013 de los CMLA tratadas con QTN basada en docetaxel (asociando trastuzumab en los casos HER2 positivos y carboplatino/adriamicina si HER2 negativos). Los casos con sospecha clínica/radiológica de N+ se confirmaron histológicamente. Si no existía sospecha, se estadificó con la técnica de biopsia radioguiada del ganglio centinela (BRGC), mediante la inyección de 99mTc-nanocoloide de albúmina, previa a la QTN. En los casos N+ se realizó linfadenectomía axilar (LA) tras QTN. Clasificamos la respuesta patológica final como completa (RCp) cuando no hubo evidencia de enfermedad tumoral y como no respuesta patológica (NRp) en caso contrario. Resultados. Revisamos 346 pacientes tratados con docetaxel, donde identificamos 105 CMLA. En 70 (67%) se evidenció infiltración tumoral axilar antes de iniciar la QTN. De estas, el 73% (n = 51) presentaban N+ por punción-aspiración con aguja fina (PAAF) y/o biopsia ganglionar, y las restantes 19 (27%) presentaban N+ oculta demostrada por la BRGC. La LA evidenció RCp axilar en el 56% (39/70); aumentando hasta un 84% cuando el estatus inicial N+ se alcanzó por BRGC, frente a un 45% cuando se llegó al diagnóstico de N+ por PAAF/biopsia ganglionar. Conclusión. Más de la mitad de las mujeres con cáncer de mama localmente avanzado con afectación tumoral axilar al diagnóstico presentan axilas libres de enfermedad metastásica tras el efecto terapéutico de la quimioterapia neoadyuvante. Esto aumenta hasta casi el 90% cuando se trata de axilas metastásicas ocultas detectadas mediante el ganglio centinela antes de iniciar la quimioterapia neoadyuvante (AU)

Aim. To compare axillary involvement (N+) at initial staging in locally advanced breast cancer (LABC) with axillary lymphadenectomy histologic results after neoadjuvant chemotherapy treatment (NeoChemo). Material and methods. Retrospective study between November 2011 and September 2013 of LABC cases treated with neoadjuvant chemotherapy based on docetaxel (associated with trastuzumab in HER2 positive cases and carboplatin/adriamycin in HER2 negative cases). Those clinically or radiologically suspected cases of axillary involvement were histologically confirmed. When there was no suspicion of axillary involvement, sentinel lymph node radioguided biopsy (SLNRB) was performed using intradermal injection of 99mTc-nanocolloid albumin prior to neoadjuvant treatment. Axillary lymphadenectomy after NeoChemo was undertaken in all cases with positive axilla. Final pathologic response was classified as complete (pCR) when there was no evidence of tumoral disease and as non-pathologic complete response (no pCR) in the opposite case. Results. A total of 346 patients treated with docetaxel were reviewed, identifying 105 LABC. Axillary involvement at initial staging was detected in 70 (67%) before starting NeoChemo. From these 70, 73% (n = 51) were N+ (fine needle biopsy and/or biopsy) and the remaining 19 (27%) were occult N+ detected by SLNRB. Axillary lymphadenectomy detected pCR in 56% (39/70), increasing up to 84% pCR when initial N+ status was reached using SNLB. On the other hand, when N+ was detected using fine needle biopsy/lymph biopsy, pCR was only 45%. Conclusion. More than 50% of women affected by locally advanced breast cancer with tumoral axillary involvement at initial diagnosis present free metastatic axilla after therapeutic neoadjuvant chemotherapy effect. This increases up to almost 90% in case of occult metastatic axilla detected with sentinel node biopsy prior starting neoadjuvant chemotherapy (AU)

Assignment of tumor subtype by genomic testing and pathologic-based approximations: implications on patient's management and therapy selection

BACKGROUND: Breast cancer subtypes can be identified by genomic testing or pathology-based approximations. However, these classifications are not equivalent and the clinical relevance of both classifications needs to be fully explored. METHODS: Ninety-four patients were randomized to neoadjuvant single agent doxorubicin or docetaxel. Tumor subtype was assessed by pathology-based classification and by gene expression using the PAM50 plus the claudin-low predictor (CLP). Kappa Cohen's coefficient (κ) was used to test the agreement between methods. Multivariate Cox proportional hazards analyses were used to determine the significance of each methodology in the prediction of prognosis. Likelihood ratio statistics of both classifications were evaluated. RESULTS: The agreement between pathology-based classification and PAM50 was moderate [κ = 0.551, 95 % confidence interval (95 % CI) 0.467-0.641]. Tumor subtype assessed by both classifications were prognostic for overall survival (OS) and relapse-free survival (P < 0.05). However, PAM50 + CLP provided more prognostic information, in terms of OS, than the pathology-based classification (P < 0.05). Patients with triple negative tumors as well as basal-like tumors had worse OS when first treated with doxorubicin (HR = 5.98, 95 % CI 1.25-28.67, and HR = 5.02, 95 % CI 0.96-26.38, respectively). However, claudin-low tumors did not show significant differences in OS according to neoadjuvant treatment branch. Indeed, we found that claudin-low tumors treated with pre-operative doxorubicin had significantly better OS than basal-like tumors treated with neoadjuvant doxorubicin (adjusted HR = 0.16, 95 % CI 0.04-0.69, P = 0.014). CONCLUSIONS: The assignment of tumor subtype can differ depending on the methodology, which might have implications on patient's management and therapy selection (AU)

No disponible

Nuevas estrategias de mejora en la accesibilidad a las pruebas de laboratorio de los pacientes en oncología / New strategies to improve accessibility to laboratory tests in cancer patients

Objetivo. Desarrollo de modelos que mejoren la accesibilidad de los pacientes oncológicos para la realización de las pruebas analíticas, flexibilizando la elección del centro de obtención de la muestra tanto en atención primaria como en especializada. Material y métodos. Análisis del circuito de los pacientes oncológicos. Estudio de la accesibilidad del paciente a la realización de sus analíticas. Desarrollo del modelo de consulta de alta resolución (MCAR) y del modelo de accesibilidad analítica del paciente (MAAP). Resultados. El porcentaje de pacientes oncológicos que están en tratamiento ha sufrido un incremento bianual de un 8,76%. Se evidencia la utilización de ambos modelos por el paciente. El modelo MAAP sufrió un incremento progresivo de su utilización alcanzando hasta un 32% a los 2 años de su implantación. La causa principal de su elección ha sido en un 74% de los casos debido a una mayor accesibilidad. Un 8% de los pacientes han utilizado ambos modelos según sus necesidades. Conclusiones. La implantación de circuitos asistenciales optimizados y preferentes en ambos modelos mejoran la accesibilidad y la flexibilidad para la realización de pruebas diagnósticas del laboratorio en los pacientes estudiados(AU)

Objective. To develop models to improve accessibility of performing laboratory tests on chronic oncology patients, as well as a more flexible choice of sample collection in both primary and specialized care. Material and methods. Circuit analysis of cancer patients. Patient survey to study access to laboratory tests. High Resolution Consultation Development Model (MCAR) and Patient Access Analytical Model (MAAP). Results. The percentage of cancer patients on treatment has increased by 8.76% in the past two years. There was a 32% increased in the use of the MAAP model in the two years of its implementation, and has been the choice of 74% due to greater accessibility, with 8% of the patients having used both models to suit their needs. Conclusions. The implementation of optimized and preferred care systems has shown that both models improve accessibility and flexibility of the diagnostic testing laboratory in the patients studied(AU)

Is trastuzumab-induced cardiotoxicity involved in onco-cardiology outcome?

Targeted therapies alone or combined with chemotherapy have improved response rates as well as the progression-free survival and overall survival in several solid tumors. Trastuzumab is a monoclonal antibody with a revolutionary effect on tumoral breast cells, but also on the myocardium, as has been identified recently, following the inherent cascade signaling shared between both cells. Instead of decreasing the use of trastuzumab, investigations based on the results of Metastatic and Adjuvant Breast Cancer Trials tend to develop monitoring schemes as well as risk factor identification and prophylactic applications in order to improve the number of patients receiving full treatment instead of restricting it. Moreover, the largely reversible trastuzumab effect (different from anthracyclines) allows its reintroduction or its later withdrawal with cardiologic directed therapy. In conclusion, every action is aiming at optimizing trastuzumab's application instead of abandoning (AU)

Platinum-based adjuvant chemotherapy on moderate- and high-risk stage I and II epithelian ovarian cancer patients. Long-term single institution experience and literature review

BACKGROUND: Although the optimal management of women with FIGO stages I and II epithelial ovarian cancer (EOC) is still controversial, platinum-based adjuvant chemotherapy (CT) is the mainstay of treatment. Suboptimal survival results have led to major efforts to identify prognostic factors, improve surgical staging and develop adjuvant therapies to improve patients' outcomes. PATIENTS AND METHODS: We evaluate in a retrospective study clinical efficacy and the toxicity profile of a platinum-based adjuvant CT in FIGO stages I and II EOC treated at our institution from March 1984 to December 2006. Grade I FIGO stages IA-IB were excluded from the analysis. In the first period (1984-1997), patients received a platinum-based regimen without taxanes. In the second period from 1997 onwards, patients were treated with carboplatin and paclitaxel. Four to six cycles of adjuvant CT were administered. Potential predictive factors of efficacy and the role of paclitaxel addition were also analysed. RESULTS: One hundred and fifty-eight patients (60 treated with paclitaxel) met inclusion criteria and were evaluable. Median age at diagnosis was 53.7 years (range 19-81) and most patients had an Eastern Cooperative Oncology Group performance status score (ECOG) of 0-1 (91.8%); 82.9% patients had pathological stage I and 17.1% pathological stage II. With a median follow up of 8.34 years (range 4.4-11.6), 103 patients (74.1%) were free of disease and 110 of them were alive (79.1%). Median relapse-free survival (RFS) and median overall survival (OS) had not been reached at the time of the analysis. No survival difference was found between paclitaxel and carboplatin combination or non-paclitaxel-containing regimens. Statistically significant prognostic factors for better RFS in the multivariate analysis were: ECOG 0 (p=0.023; HR 0.32; 95% CI 0.17-0.57); FIGO I stage (p<0.001; HR 0.30; 95% CI 0.15-0.58); I-II histological grade (p=0.005; HR 0.38; 95% CI 0.19-0.75); mucinous histology (p=0.013; HR 0.28; 95% CI 0.13-0.53); non-surgical adherences (p<0.002, HR 0.32; 95% CI 0.15-0.54); paracolic gutters inspection (p=0.033; HR 0.50; 95% CI 0.26-0.95) and liver surface biopsies (p=0.048; HR 0.64; 95% CI 0.41-0.98).Toxicity was generally mild and non-haematologic events were the most commonly found (62.9% of the total). The most frequent haematologic toxicities were neutropenia (41.7% in all grades, 9.5% grade 3-4) and anaemia (29.1% in all grades, 3.2% grade 3-4). CONCLUSIONS: The long-term outcome of this series is comparable to the published evidence and reflects the limited activity of platinum-based CT in the adjuvant setting. The potential survival advantage of the addition of paclitaxel to carboplatin cannot be definitively answered due to the small number of patients, the limited follow-up and the retrospective nature of the study. More effective and specific treatments are clearly required, in particular for those patients with stage II and undifferentiated tumours. Quality of surgery entails prognostic value (AU)

Circulating tumour cells in locally advanced breast cancer

MATERIAL AND METHODS: A prospective study was conducted to determine the value of changes in circulating tumour cell (CTC) levels prior to and after the first cycle of neoadjuvant treatment in early prediction of pathologic response in locally advanced breast cancer (LABC). Two blood samples were obtained from 72 eligible LABC patients to isolate and enumerate CTCs before neoadjuvant chemotherapy started on day 1, and on day 21, immediately before second cycle administration. RESULTS: Sixty patients (83.3%) had <1 CTC in the first sample and response rates in this cohort were pathologic complete response (PCR) in 2 patients (5%), partial response (PR) in 35 (87.5%), stable disease (SD) in 2 (5%) and progressive disease (PD) in 1 (2.5%). Twelve patients (16.7%) had >2 CTCs in the first sample; these patients were more likely to have triple negative tumours. All 12 had fewer CTCs in the second sample. Response rates in this second cohort of 12 patients were PCR in 4 (34%), PR in 6 (50%), SD in 1 (8%) and PD in 1 (8%). PCR rate was markedly better in this second cohort (p<0.0042; OR 14.5, 95% CI 2.3-92). DISCUSSION: This study suggests that the presence of CTCs prior to neoadjuvant therapy might be a predictor of response to this therapy (AU)