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PURPOSE: HER2-targeted therapies have dramatically improved outcomes of patients with HER2-positive breast cancer (BC), as demonstrated in neoadjuvant trials. This study aims to provide real-world evidence on the use and effectiveness of combined pertuzumab, trastuzumab and chemotherapy (CT) in early-stage HER2-positive BC. METHODS: A retrospective, multicentre study was conducted on patients diagnosed with HER2-positive early BC treated with neoadjuvant pertuzumab and trastuzumab plus CT at 13 Spanish sites. The primary endpoint was pathological complete response (pCR). RESULTS: A total of 310 patients were included. Pertuzumab and trastuzumab were combined with anthracyclines and taxanes, carboplatin and docetaxel, and taxane-based CT in 77.1%, 16.5%, and 6.5% of patients, respectively. Overall, the pCR rate was 62.2%. The pCR was higher amongst patients with hormone receptor-negative tumours and with tumours expressing higher levels of Ki-67 (> 20%). After postoperative adjuvant treatment, 13.9% of patients relapsed. Those patients who did not achieve pCR, with tumours at advanced stages (III), and with node-positive disease were more likely to experience distant relapse. Median overall survival (OS) and distant disease-free survival (D-DFS) were not reached at the study end. The estimated mean OS and D-DFS times were 7.5 (95% CI 7.3-7.7) and 7.3 (95% CI 7.1-7.5) years, respectively (both were significantly longer amongst patients who achieved pCR). Grade 3-4 anti-HER2 related toxicities were reported in six (1.9%) patients. CONCLUSION: Neoadjuvant pertuzumab and trastuzumab plus CT achieve high pCR rates in real-life patients with HER2-positive early BC, showing an acceptable safety profile. Innovative adjuvant strategies are essential in patients at high risk of distant disease recurrence.
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Antecedentes y objetivo: La universalización del cribado mamográfico ha incrementado el diagnóstico de cánceres de mama con pronóstico excelente. La ausencia de tumor palpable les confiere un riesgo muy bajo de mortalidad por cáncer de mama. El objetivo del estudio fue identificar subgrupos con muy buena evolución a largo plazo.Pacientes y métodosIdentificamos pacientes con muy buena evolución mediante estudio descriptivo, observacional y retrospectivo. Los criterios de riesgo muy bajo fueron la procedencia del cribado mamográfico, sin tumor palpable, el fenotipo tumoral y la afectación ganglionar.ResultadosDe 746 pacientes con carcinoma de mama, con ganglios negativos, entre 2001 y 2015, 110 (14,75%) procedían del cribado con tumores no palpables. Ochenta y ocho (80%) eran hormonosensibles, 10 (9,10%) triples negativos y 11 (10%) HER2. La mediana de seguimiento fue 10 años (3,5-17). Solo tres pacientes desarrollaron metástasis, no hubo recidivas loco-regionales, siete presentaron segundos tumores primarios y hubo cuatro muertes, dos por cáncer de mama y dos por otras causas. El intervalo libre de metástasis a distancia (ILMD) fue 95,60% (intervalo de confianza (IC) 95% 90,70-100,50); 96,30% (IC 95% 91,21-99,39) en 88 tumores hormonosensibles, 100% en 34 hormonosensibles de grado histológico 1 (aproximación a luminales A) y 94,40% (IC 95% 86,76-102,04) en 54 de grado 2-3 (luminales B). En los triples negativos y HER2 fue 100%. En tumores menores y mayores de 1 cm fue 100% y 95,50% (IC 95% 89, 42-101,58).ConclusionesLas pacientes con tumores no palpables, detectados en el cribado mamográfico tienen un riesgo de recurrencia muy bajo. La buena evolución en los subgrupos luminal A, triple negativo, HER2 y menores de 1 cm puede explicar la eficacia del tratamiento, pero también los hace candidatos a desescalar su tratamiento. (AU)
Background and objective: To identify subgroups with good progress over an extended period, we used diagnostic screening, tumour palpability, tumour phenotype, and node involvement.Patients and methodsWe identified patients with good progress by means of a descriptive, observational and retrospective study.ResultsOf 746 patients diagnosed with node-negative breast cancer between 2001 and 2015: 110 (14.75%) had non-palpable screening-diagnosed tumours; 88 (80%) were endocrine-sensitive, 10 (9.10%) were triple-negative and 11 (10%) were HER2. Only 3 patients developed metastases, and there were 4 deaths: 2 from breast cancer and 2 from other causes. The distant recurrence-free interval (DRFI) was 95.60%: 100% in 34 endocrine-sensitive histological grade 1 (equivalent to luminal A) tumours, and 94.40% (95% CI 86.76102.04) in 54 grade 23 (luminal B) tumours. In triple-negative and HER2 cases, it was 100%. In tumours <1 cm it was 100%, and >1 cm it was 95.50% (95% CI 79.42100.98).ConclusionsPatients with non-palpable tumours detected by mammogram screening have ultralow risk. The good progress in the luminal A, triple-negative, HER2, and less than 1 cm subgroups may explain the efficacy of the treatment but it also makes them candidates to de-escalation of their treatment. (AU)
Subject(s)
Humans , Mammography , Neoplasms , Prognosis , Receptor, ErbB-2 , Retrospective StudiesABSTRACT
BACKGROUND AND OBJECTIVE: To identify subgroups with good progress over an extended period, we used diagnostic screening, tumour palpability, tumour phenotype, and node involvement. PATIENTS AND METHODS: We identified patients with good progress by means of a descriptive, observational and retrospective study. RESULTS: Of 746 patients diagnosed with node-negative breast cancer between 2001 and 2015: 110 (14.75%) had non-palpable screening-diagnosed tumours; 88 (80%) were endocrine-sensitive, 10 (9.10%) were triple-negative and 11 (10%) were HER2. Only 3 patients developed metastases, and there were 4 deaths: 2 from breast cancer and 2 from other causes. The distant recurrence-free interval (DRFI) was 95.60%: 100% in 34 endocrine-sensitive histological grade 1 (equivalent to luminal A) tumours, and 94.40% (95% CI 86.76-102.04) in 54 grade 2-3 (luminal B) tumours. In triple-negative and HER2 cases, it was 100%. In tumours <1 cm it was 100%, and >1 cm it was 95.50% (95% CI 79.42-100.98). CONCLUSIONS: Patients with non-palpable tumours detected by mammogram screening have ultralow risk. The good progress in the luminal A, triple-negative, HER2, and less than 1 cm subgroups may explain the efficacy of the treatment but it also makes them candidates to de-escalation of their treatment.
Subject(s)
Mammography , Neoplasms , Early Detection of Cancer , Prognosis , Receptor, ErbB-2 , Retrospective StudiesABSTRACT
Background: The most important decision after diagnosing terminal cancer is whether to provide active therapy or withhold treatment. Objective: To analyze the aggressiveness of care by evaluating systemic anticancer therapy (SACT) given near to death, describing this care and identifying factors that determine its use. Design: This involves retrospective observational cohorts study. Setting/Subjects: This involves patients with metastatic tumors who died at a University Hospital in Spain between 2015 and 2016. Measurements: Data obtained from prescribing oncologists and patients' clinical records, type of cancer, and information on treatment. The dependent variable used was the interval between the date of the last dose and date of death. Results: Ninety-four (32.60%) of 288 patients received SACT in the last month of life. This cohort had a higher frequency of lung cancer (OR: 1.58; CI 95%: 1.14-2.18), received more care from oncologist 2 (OR: 1.50; CI 95%: 1.08-2.08), had fewer last-line treatment cycles (OR: 1.28; CI 95%: 1.13-1.45), a lower subjective response (OR: 3.13; CI 95%: 1.34-7.29), less clinical benefit (OR: 2.38; CI 95%: 1.04-5.55), more visits to the Emergency Department (OR: 1.59; CI 95%: 1.06-2.38), and less care from the Palliative Care Unit (OR: 4.55; CI 95%: 2.69-7.70). In multivariate analysis, the predictors of having received SACT close to death remained: receiving fewer cycles of treatment (OR: 1.28; CI 95%: 1.12-1.47) and less palliative care (OR: 4.54; CI 95%: 2.56-7.69). Conclusions: A third of cancer patients received SACT in the last month of life with less efficacy and poorer quality of care than patients not receiving it.
Subject(s)
Antineoplastic Agents/therapeutic use , Neoplasms/drug therapy , Neoplasms/mortality , Palliative Care/methods , Palliative Care/statistics & numerical data , Terminal Care/methods , Terminal Care/statistics & numerical data , Adult , Aged , Aged, 80 and over , Cohort Studies , Decision Making , Female , Humans , Male , Middle Aged , Retrospective Studies , Spain , Time FactorsABSTRACT
Antecedentes y objetivos: En el cáncer de mama hormonosensible, HER-2 negativo, con ganglios negativos, la presencia de un riesgo genómico bajo permite tratar solo con hormonoterapia adyuvante, obteniendo unas excelentes tasas de supervivencia. La justificación de este estudio es demostrar que también se obtienen unas excelentes tasas de supervivencia tratando solo con hormonoterapia adyuvante mediante la evaluación del riesgo clínico. Pacientes y métodos: Estudio descriptivo, observacional y retrospectivo entre 2006 y 2016 de la cohorte de cáncer de mama hormonosensible, HER-2 negativo, con ganglios negativos, tamaño del tumor mayor de 1cm o entre 0,6 y 1cm con características desfavorables. Revisión retrospectiva de los registros de salud. Datos de mortalidad del Registro Nacional de Defunciones. Resultados: Un total de 203 pacientes fueron evaluables para la supervivencia. Ciento veintitrés (60,50%) fueron tratadas solo con hormonoterapia adyuvante, 77 (37,90%) con quimioterapia-hormonoterapia, una (0.50%) solo con quimioterapia y 2 (1%) no recibieron ningún tratamiento. La tasa de supervivencia global a los 5 años fue del 97% (intervalo de confianza [IC] del 95% 94-100). La tasa de intervalo libre de metástasis a distancia fue del 94% (IC 95% 90-98). En el subgrupo de pacientes tratadas solo con hormonoterapia la tasa de supervivencia global y del intervalo libre de metástasis a distancia a los 5 años fue del 98% (IC 95% 95-100) y 97% (IC 95% 93-100), respectivamente. Conclusiones: Las pacientes con cáncer de mama hormonosensible, HER-2-negativo, con ganglios negativos, tratadas solo con hormonoterapia según su riesgo clínico, obtienen resultados de supervivencia similares a los descritos cuando son tratadas solo con hormonoterapia según su riesgo genómico
Background and objectives: In endocrine-sensitive, HER-2 negative, node negative breast cancer, the presence of a low genomic risk allows treatment with adjuvant endocrine therapy alone, obtaining excellent survival rates. The justification for this study is to show that excellent survival rates are also obtained by treating with adjuvant hormone therapy alone, based on clinical risk assessment. Patients and methods: A descriptive, observational and retrospective study was performed between 2006 and 2016 with endocrine-sensitive, HER-2 negative, node negative breast cancer, greater than 1cm or between 0.6 and 1cm with unfavourable features. Retrospective review of health records. Mortality data of the National Registry of Deaths. Results: A total of 203 patients were evaluable for survival. One hundred and twenty-three (60.50%) were treated with adjuvant endocrine therapy alone, 77 (37.90%) with chemotherapy and endocrine therapy, one (0.50%) with chemotherapy alone and 2 (1%) were not treated. The overall survival rate at 5 years was 97% (95% confidence interval [CI] 94-100). Distant recurrence-free interval was 94% (95% CI 90-98). In the subgroup of patients treated with endocrine therapy alone, overall survival and distant recurrence-free interval rates at 5 years were 98% (95% CI 95-100) and 97% (95% CI 93-100), respectively. Conclusions: Patients with endocrine-sensitive, HER-2-negative, node negative breast cancer treated with endocrine therapy alone according to their clinical risk have similar survival outcomes as those treated with endocrine therapy according to their genomic risk
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Breast Neoplasms/diagnosis , Genes, erbB-2 , Chemotherapy, Adjuvant/methods , Survival Analysis , Breast Neoplasms/drug therapy , Retrospective Studies , Receptor, ErbB-2/geneticsABSTRACT
OBJECTIVES: To verify whether a citizens' jury study is feasible to the Andalusian population and to know if women, when better informed, are able to answer the research question of whether the Andalusian Public Health System must continue offering screening mammography to women aged 50-69. The reasons for the pertinent decision and recommendations to the political authorities will be stated. DESIGN: Qualitative research study with the methodology of citizens' jury. SETTING: Breast cancer screening programme in Andalusia (Spain). PARTICIPANTS: Thirteen women aged 50-69 with secondary school or higher education accepted to participate as a jury. Two epidemiologists were the expert witnesses. The main researcher was the neutral moderator. INTERVENTIONS: Jury met on Monday, 15 February 2016. The moderator indicated to the jury that it had to assess the screening programme's key benefits and main harm. On Tuesday, 16 February, the expert witnesses positioned for and against the programme. On Thursday, 18 February, the jury deliberated, reached final conclusions, submitted its vote and stated its recommendations to politicians. The deliberation session was transcribed and analysed with the support of ATLAS.ti.5.2 software. PRIMARY AND SECONDARY OUTCOME MEASURES: Feasibility in the Andalusian population, women's vote and opinion, reasons for votes and recommendations to political authorities. RESULTS: Eleven participants voted yes and two voted no. There are three reasons to vote 'yes': health, the test nature, and individual freedom. Some women invoke the lack of efficacy and the cost to justify their negative vote, at least in universal terms. On completion, they made suggestions to be submitted to the pertinent authorities for the improvement of information, psychology services and research. CONCLUSIONS: The deliberative strategy is feasible and causes a favourable positioning regarding screening mammography, although information changes the opinion of some women, who desire informed decision making and to keep or increase medicalisation in their lives.
Subject(s)
Breast Neoplasms/diagnosis , Decision Making , Mammography , Mass Screening , Patient Acceptance of Health Care , Patient Participation/methods , Public Opinion , Aged , Cost-Benefit Analysis , Early Detection of Cancer , Feasibility Studies , Female , Group Processes , Health Knowledge, Attitudes, Practice , Health Services Accessibility , Humans , Informed Consent , Judgment , Middle Aged , Public Health , Qualitative Research , SpainABSTRACT
BACKGROUND AND OBJECTIVES: In endocrine-sensitive, HER-2 negative, node negative breast cancer, the presence of a low genomic risk allows treatment with adjuvant endocrine therapy alone, obtaining excellent survival rates. The justification for this study is to show that excellent survival rates are also obtained by treating with adjuvant hormone therapy alone, based on clinical risk assessment. PATIENTS AND METHODS: A descriptive, observational and retrospective study was performed between 2006 and 2016 with endocrine-sensitive, HER-2 negative, node negative breast cancer, greater than 1cm or between 0.6 and 1cm with unfavourable features. Retrospective review of health records. Mortality data of the National Registry of Deaths. RESULTS: A total of 203 patients were evaluable for survival. One hundred and twenty-three (60.50%) were treated with adjuvant endocrine therapy alone, 77 (37.90%) with chemotherapy and endocrine therapy, one (0.50%) with chemotherapy alone and 2 (1%) were not treated. The overall survival rate at 5 years was 97% (95% confidence interval [CI] 94-100). Distant recurrence-free interval was 94% (95% CI 90-98). In the subgroup of patients treated with endocrine therapy alone, overall survival and distant recurrence-free interval rates at 5 years were 98% (95% CI 95-100) and 97% (95% CI 93-100), respectively. CONCLUSIONS: Patients with endocrine-sensitive, HER-2-negative, node negative breast cancer treated with endocrine therapy alone according to their clinical risk have similar survival outcomes as those treated with endocrine therapy according to their genomic risk.
Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/mortality , Adult , Aged , Aged, 80 and over , Aromatase Inhibitors/therapeutic use , Breast Neoplasms/chemistry , Breast Neoplasms/pathology , Breast Neoplasms, Male , Carcinoma, Ductal, Breast/chemistry , Carcinoma, Ductal, Breast/mortality , Carcinoma, Ductal, Breast/pathology , Carcinoma, Lobular/chemistry , Carcinoma, Lobular/mortality , Carcinoma, Lobular/pathology , Confidence Intervals , Female , Humans , Lymph Nodes , Male , Middle Aged , Receptor, ErbB-2/analysis , Retrospective Studies , Risk Assessment , Survival Analysis , Tamoxifen/therapeutic use , Time FactorsABSTRACT
Objetivos. En España las mujeres no toman una decisión informada sobre su participación en el programa de cribado mamográfico. Se analizó si proporcionar información individualizada y precisa sobre los beneficios y riesgos del programa de cribado mamográfico incrementaba su grado de conocimiento. Pacientes y método. Se realizó un ensayo clínico aleatorizado y controlado en el que participaron 434 mujeres de entre 45 y 69 años, convocadas a la mamografía de cribado. Doscientas dieciocho fueron aleatorizadas al grupo control y 216 al de intervención. Se evaluó el grado de conocimiento sobre beneficios y riesgos del cribado mamográfico mediante un cuestionario específico, en la segunda entrevista, al mes. Secundariamente se analizaron la actitud, la ansiedad y la depresión, así como la preocupación por el cáncer de las participantes. Resultados. Adquirieron un buen conocimiento 15 de 178 mujeres (8,4%) en el grupo control y 32 de 177 (18,1%) en el de intervención (p=0,008). Las mujeres del grupo de intervención tienen un riesgo relativo 2,39 veces mayor de adquirir un buen conocimiento que las del grupo control (IC 95% 1,24-4,60). No se hallaron diferencias en ninguno de los objetivos secundarios evaluados. Conclusiones. Las mujeres poseen un nivel de conocimientos muy pobre sobre el programa de cribado con mamografía, siendo la televisión su principal fuente de información. La información individualizada incrementó significativamente el grado de buen conocimiento, aunque persistió en porcentajes muy bajos. Tienen una actitud muy positiva sobre el mismo y no se aprecia un impacto negativo en la esfera psicosocial por su participación en este tipo de procedimientos
Objectives. Spanish women do not make an informed choice about their participation in breast cancer screening. Our study hypothesised that providing individualised and accurate information about the benefits and risks of the mammography screening programme in Spain would increase their knowledge. Patients and method. A randomised controlled clinical trial was conducted in 434 women aged between 45 and 69 years: 216 were assigned to the intervention group and 218 to the control group. The degree of knowledge about the benefits and risks of mammography screening was determined from questionnaires administered at baseline and after one month. Secondarily, the participants attitudes, anxiety and depression and cancer worry were analysed. Results. Good knowledge was acquired by 15 of 178 women (8.4%) in the control group and 32 of 177 (18.1%) in the intervention group (P=.008). The relative risk of acquiring a good level of knowledge about the programme was 2.39 times higher in women in the intervention group than in those in the control group (95% CI 1.24-4.60). No differences were found in the secondary endpoints. Conclusions. Women have a very poor level of knowledge about mammography screening, with their main information source being television. Individualized information significantly increased the proportion of women with good knowledge but the percentages remained very low. Women had a very positive attitude to screening and a negative impact in the psychosocial sphere due to their participation was not observed
