Economic evaluation of adjuvant therapy with osimertinib in patients with early-stage non-small cell lung cancer and mutated EGFR.

PURPOSE: The ADAURA trial demonstrated the superiority of osimertinib over a placebo with regard to disease-free survival, showing it to be indicated as an adjuvant therapy for treatment of non-small cell lung cancer with mutated epidermal growth factor receptor (EGFR). The aim of the present study was to conduct a cost-utility analysis and an analysis of the budgetary impact of adjuvant therapy with osimertinib in patients with non-small cell lung cancer with mutated EGFR who had undergone resection surgery with curative intent. METHODS: Analyses were based on the outcomes of the ADAURA clinical trial and were conducted through a Spanish National Health Service perspective. The outcome measures used were quality-adjusted life years (QALY). RESULTS: The average overall cost of adjuvant treatment with osimertinib over a period of 100 months in the overall sample of trial patients (stages IB-IIIA) was 220,961 €, compared with 197,849 € in the placebo group. Effectiveness, estimated according to QALY, was 6.26 years in the osimertinib group and 5.96 years in the placebo group, with the incremental cost-utility ratio being 77,040 €/QALY. With regard to the budgetary impact, it was estimated that, in 2021, approximately 1130 patients would be subsidiaries to receive osimertinib. This pertains to a difference of 17,375,330 € over 100 months to fund this treatment relative to no treatment. CONCLUSION: Taking into account a Spanish threshold of 24,000 €/QALY, the reduction in the acquisition cost of osimertinib will have to be greater than 10%, to obtain a cost-effective alternative.

Evaluación del riesgo clínico, no genómico y resultados de supervivencia en el carcinoma de mama hormonosensible, HER-2 negativo, con ganglios negativos / Evaluation of non-genomic, clinical risk and survival results in endocrine-sensitive, HER-2 negative, lymph node negative breast cancer

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

How a deliberative approach includes women in the decisions of screening mammography: a citizens' jury feasibility study in Andalusia, Spain.

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.

Evaluation of non-genomic, clinical risk and survival results in endocrine-sensitive, HER-2 negative, lymph node negative breast cancer. / Evaluación del riesgo clínico, no genómico y resultados de supervivencia en el carcinoma de mama hormonosensible, HER-2 negativo, con ganglios negativos.

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.

¿Qué piensan las mujeres sobre la mamografía de cribado? Encuesta en el programa de diagnóstico precoz de cáncer de mama / What do women think about screening mammography? Survey in a breast cancer screening programme

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

Using an informed consent in mammography screening: a randomized trial.

Spanish women do not make an informed choice regarding breast cancer screening (BCS). Our aim was to evaluate the impact of receiving information regarding real BCS benefits and risks on knowledge, attitude, decision, feelings, and worries about cancer. Randomized controlled clinical trial of 355 women aged between 45 and 67 years, 177 and 178 assigned to the intervention group (IG) and control group (CG), respectively. After breast screening, women received either Nordic Cochrane Centre information on BCS or standard information. The primary outcome (knowledge) was determined from questionnaire administered at baseline and after a month. Answers were scored from 0 to 10 and scores of 5 or more indicated that women were well informed (had "good knowledge"). Questionnaires regarding attitudes, future screening intentions, and psychosocial impact were also administered. The Chi-squared and Student's t-tests were used to compare qualitative and quantitative variables, respectively. Good knowledge was acquired by 32 (18.10%) IG women and 15 (8.40%) CG women (P = 0.008). Mean scores from first to second interview increased from 2.97 (SD 1.16) to 3.43 (SD 1.39) in the CG and from and from 2.96 (SD 1.23) to 3.95 (SD 1.78) (P = 0.002) in the IG. No differences were found in the secondary endpoints. Women receiving information based on the Nordic Cochrane Centre document were better informed. This means of providing information is not very efficacious, nor does it modify attitude, decision, feelings, or worries about cancer.

Women's perceptions of breast cancer screening. Spanish screening programme survey.

OBJECTIVES: Participants in breast cancer screening programmes may benefit from early detection but may also be exposed to the risks of overdiagnosis and false positives. We surveyed a sample of Spanish women to assess knowledge, information sources, attitudes and psychosocial impact. MATERIALS AND METHODS: A total of 434 breast cancer screening programme participants aged 45-69 years were administered questionnaires regarding knowledge, information sources, attitudes and psychosocial impact. Scores of 5 or more (out of 10) and 12 or less (out of 24) were established as indicating adequate knowledge and a positive attitude, respectively. Psychosocial impact was measured using the Hospital Anxiety and Depression Scale and the Cancer Worry Scale. RESULTS: Only 42 women (9.7%) had adequate knowledge. The mean (SD) knowledge score was 2.97 (1.16). Better educated women and women without previous false positives had higher scores. The main sources of information were television, press, Andalusian Health Service documentation and family and friends. Most participants (99.1%) had a positive attitude, with a mean (SD) score of 3.21 (2.66). Mean (SD) scores for anxiety, depression and cancer worry were 1.86 (3.26), 0.72 (1.99) and 9.4 (3.04), respectively. CONCLUSION: Women have a very positive attitude to breast cancer screening, but are poorly informed and use television as their main information source. They experience no negative psychosocial impact from participation in such programmes.

Follow-up of long-term survivors of breast cancer in primary care versus specialist attention.

BACKGROUND: Hospitals have traditionally been the place where the follow-up of breast cancer patients occurs in Spain. OBJECTIVE: To describe the evolution of long-term survivors of breast cancer according to type of follow-up received (in primary or specialist/hospital care), measuring impact of care type on health, cost, health-related quality of life (HRQL) and satisfaction results. METHOD: Retrospective study of cohorts with disease-free patients followed up for at least 5 years in Oncology. Using personal questionnaires, the type and cost of the follow-up, events, HRQL and satisfaction were analysed. RESULTS: Ninety-eight women were surveyed, 60 in primary and 38 in specialist care. There were no differences between groups in diagnosis of metastasis or new primary tumours. The number of annual visits per patient was 0.98 (0.48) in primary and 1.11 (0.38) in specialist care (P = 0.19). In primary, 44.6% were programmed and 55.4% on demand; in specialist, 94.6% were programmed and 5.4% on demand (P = 0.0001). The costs of follow-up in primary care were lower--€112.86 (77.54) versus €184.61 (85.87) per patient and year (P = 0.0001). No differences were reported in HRQL. Preference for specialist care was expressed by 80%, versus 10% for primary, with 10% indifferent. Patients showed greater satisfaction with specialist care in all questionnaire dimensions. CONCLUSIONS: Compliance with follow-up protocol was high in both groups. In specialist care nearly all the visits were programmed and in primary almost half were on demand. In our locality, primary is more cost-effective than specialist care, but patients express greater satisfaction with specialist follow-up and hence prefer it.

Influencia de los factores clínicos y biográficos en el retraso en iniciar la quimioterapia adyuvante en las pacientes con cáncer de mama / Influence of clinical and biographical factors on the delay in starting adjuvant chemotherapy treatment among breast cancer patients

Background and objetive: Previous studies have related the delay in starting chemotherapy (>3 months from date of surgery) with worse survival. The study objective is to analyse the delay in the start of chemotherapy and associated biomedical, sociodemographic and cultural factors. Patients and methods: A cohort of women operated on for breast cancer, candidates for receiving adjuvant chemotherapy and participants in a clinical trial of non-pharmacological intervention, were surveyed regarding the delay in starting their chemotherapy, measured by the number of days from date of surgery. Differences in function of the clinical and biographical variables were studied. Results: In 197 women, mean delay was 42.32 (15.29) days; this was associated with tumour stage ( i , 40.06 days; ii , 44.76 days; iii , 38.7 days; P=.049), age (≤35, 37.36 days; 36-64, 41.49 days; ≥65, 52.61 days; P=.007) and occupational situation (active, 36.91 days; unemployed, 45.5 days; pensioner, 40.07 days; housewife, 43.17 days; P=.038). F r patients older than 65 years, the delay in starting adjuvant chemotherapy was longer than for those in the 2 lower age groups -less than 35 years, and between 35 and 65 years- (P=.023 and P=.009 respectively). In the multivariate analysis, the variables associated independently with the delay in starting chemotherapy were again age (P=.019), tumour stage (P=.037) and occupational situation (P=.022). Conclusion: Patients began receiving adjuvant chemotherapy within the time period (3 months from surgery) defined as appropriate, and during which no evidence exists of worse survival results. Length of delay varied according to age, tumour stage and occupational situation (AU)

Fundamento y objetivos: Estudios previos han relacionado el retraso en iniciar la quimioterapia adyuvante (>3 meses desde la cirugía) con peor supervivencia. El objetivo de este estudio es analizar el retraso en iniciar quimioterapia y la influencia de los factores biomédicos, sociodemográficos y culturales. Pacientes y método: En una cohorte de mujeres con cáncer de mama, candidatas a quimioterapia adyuvante y participantes en un ensayo clínico de intervención no farmacológica, se recogió la demora en el inicio de quimioterapia desde la cirugía. Se estudiaron las diferencias según variables clínicas y biográficas. Resultados: En 197 mujeres, la demora media (DE) entre cirugía y quimioterapia fue de 42,32 (15,29) días y estuvo asociada al estadio tumoral ( i , 40,06 días; ii , 44,76 días; iii , 38,7 días; p=0,049), la edad (≤35 años, 37,36 días; 36-64 años, 41,49 días; ≥65 años, 52,61 días; p=0,007) y la situación laboral (en activo, 36,91 días; en paro, 45,5 días; pensionistas, 40,07 días; amas de casa, 43,1 días; p=0,038). Las pacientes mayores de 65 años recibieron quimioterapia adyuvante con más demora que las menores de 35 o entre 35 y 65 años (p=0,023 y p=0,009, respectivamente). En el análisis multivariante, las variables asociadas de forma independiente con el retraso en recibir la quimioterapia continuaron siendo la edad (p=0,019), el estadio (p=0,037) y la situación laboral (p=0,022). Conclusiones: Las pacientes recibieron quimioterapia adyuvante dentro del tiempo (3 meses desde la cirugía) definido como apropiado y durante el cual no hay pruebas de peores resultados de supervivencia. El retraso varió según la edad, el estadio y la situación laboral (AU)

[Influence of clinical and biographical factors on the delay in starting adjuvant chemotherapy treatment among breast cancer patients]. / Influencia de los factores clínicos y biográficos en el retraso en iniciar la quimioterapia adyuvante en las pacientes con cáncer de mama.

BACKGROUND AND OBJECTIVE: Previous studies have related the delay in starting chemotherapy (>3 months from date of surgery) with worse survival. The study objective is to analyse the delay in the start of chemotherapy and associated biomedical, sociodemographic and cultural factors. PATIENTS AND METHODS: A cohort of women operated on for breast cancer, candidates for receiving adjuvant chemotherapy and participants in a clinical trial of non-pharmacological intervention, were surveyed regarding the delay in starting their chemotherapy, measured by the number of days from date of surgery. Differences in function of the clinical and biographical variables were studied. RESULTS: In 197 women, mean delay was 42.32 (15.29) days; this was associated with tumour stage (i, 40.06 days; ii, 44.76 days; iii, 38.7 days; P=.049), age (≤ 35, 37.36 days; 36-64, 41.49 days; ≥ 65, 52.61 days; P=.007) and occupational situation (active, 36.91 days; unemployed, 45.5 days; pensioner, 40.07 days; housewife, 43.17 days; P=.038). For patients older than 65 years, the delay in starting adjuvant chemotherapy was longer than for those in the 2 lower age groups -less than 35 years, and between 35 and 65 years- (P=.023 and P=.009 respectively). In the multivariate analysis, the variables associated independently with the delay in starting chemotherapy were again age (P=.019), tumour stage (P=.037) and occupational situation (P=.022). CONCLUSION: Patients began receiving adjuvant chemotherapy within the time period (3 months from surgery) defined as appropriate, and during which no evidence exists of worse survival results. Length of delay varied according to age, tumour stage and occupational situation.

Use of health-care services during chemotherapy for breast cancer.

AIM OF THE STUDY: The authors analyse the effect of chemotherapy on the use of additional health-care resources and report the clinical and demographic factors associated with such use. PATIENTS AND METHODS: In women with breast cancer, eligible to receive first-line (neo)-adjuvant or palliative chemotherapy, consultations with health-care practitioners (general practitioners [GPs] and specialists) and admissions to emergency department and to hospital were prospectively recorded. Differences were studied according to these clinical and demographic variables: age, tumour stage, performance status, weight, height, body mass index, surgery type, chemotherapy type, number of courses, comorbidity, marital status, educational level, social status and occupational status. RESULTS: Among 268 patients, 124 (42.2%) required one or more non-protocol health-care encounters. 180 visits were generated (GP 23.3%, specialist 35.5%, emergency department admission 21.1%, hospital admission 8.3%, others 3.3% and more than one resource 8.3%). Of total consultations 150 (83.3%) were chemotherapy-related. The number of visits was higher in the first courses. Fever and infection were the most frequent reasons for consultation in all resources. The dependent variable: 'need for non-protocol health-care encounter in any course' was statistically associated with age (p=0.002) and marital status (p=0.021); no association was found with other variables. In multivariate analysis, age (p=0.001) and marital status (p=0.009) remained statistically significant. Younger and married patients consumed less extra health resources. CONCLUDING STATEMENT: Many patients receiving chemotherapy consume health-care resources in addition to their routine visits, usually treatment-related. Patients consult less in the later courses. Older and unmarried women in particular need extra care during chemotherapy.