A phase 2 study for evaluating doxycycline 50 mg once daily and 100 mg once daily as preemptive treatment for skin toxicity in patients with metastatic colorectal cancer treated with an anti-EGFR and chemotherapy.

PURPOSE: To assess the efficacy, safety, and quality-of-life outcomes of doxycycline 50 or 100 mg once daily in the prevention of skin toxicity in patients undergoing chemotherapy plus anti-EGFR therapy as first-line treatment of metastatic colorectal cancer (mCRC). METHODS: Phase II, multicenter, single-arm, exploratory study was conducted in 7 Spanish hospitals. The primary study outcome was the incidence of ≥ grade 2 skin toxicities during the 6-week skin treatment period. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) questionnaire. Patients had to receive either doxycycline 50 mg once daily in a first stage with 10 patients, or, if more than three patients presented ≥ grade 2 skin toxicities, the next 30 patients had to receive 100 mg once daily. RESULTS: Thirty-four patients with RAS wild-type mCRC were enrolled in the study. Ten patients were first treated with doxycycline 50 mg once daily, and the following 24 were treated with doxycycline 100 mg once daily. A total of 60.0% (95% CI 29.6-90.0) and 20.8% (95% CI 4.6-37.0) of patients who received doxycycline 50 mg/day and 100 mg/day, respectively, had at least one ≥ grade 2 skin toxicity. Patients treated with doxycycline 100 mg once daily experienced less QoL deterioration. Only 1 patient reported a mild doxycycline-related gastrointestinal adverse event. CONCLUSION: Our results suggest that doxycycline doses as low as 100 mg once daily are efficacious and well tolerated for the prevention of skin toxicity in patients with mCRC who undergo treatment with chemotherapy plus EGFR-targeted therapies. TRIAL REGISTRATION: ClinicalTrials.gov NCT03448731.

Exercise in cancer patients: assistance levels and referral pathways-a position statement from the Spanish Society of Medical Oncology.

There is growing evidence about how physical activity can improve cancer care. Unfortunately, exercise is still not widely prescribed to oncology patients, despite the benefit it brings. For this to occur, it is necessary for a multidisciplinary approach involving different types of healthcare professionals, given that each treatment be tailored for each single case. Besides incorporating appropriate infrastructures and referral pathways, we need to integrate exercise into healthcare practice, which ameliorates patients' quality of life and treatment side effects. From the Spanish Society of Medical Oncology (SEOM), and through the Exercise and Cancer Working Group, we indicate considerations, analyze patient care scenarios, and propose a referral pathway algorithm for exercise prescription, taking in account the patient's needs. In later sections of this paper, we describe how this algorithm could be implemented, and how the exercise programs should be built, including the physical activity contents, the settings, and the delivery mode. We conclude that professionals, infrastructures, and organizations should be available at every assistance level to create programs providing adequate exercise training for cancer patients.

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.

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.

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.

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