Pembrolizumab plus eribulin in hormone-receptor-positive, HER2-negative, locally recurrent or metastatic breast cancer (KELLY): An open-label, multicentre, single-arm, phase â ¡ trial.

BACKGROUND: Pembrolizumab has modest activity if used in patients with hormone-receptor-positive (HR+), HER2-negative, previously treated metastatic breast cancer (BC). Our study investigated whether there would be any clinical benefit in combining chemotherapy with pembrolizumab in a similar patient population. METHODS: This single-arm, phase Ⅱ trial enrolled women aged ≥18 years with HR+, HER2-negative, inoperable, locally recurrent or metastatic BC. Patients were previously treated with hormonal therapy and 1-2 chemotherapy regimens for locally recurrent and/or metastatic BC. On each 21-day cycle, patients received intravenous pembrolizumab 200 mg on day 1 and eribulin 1∙23 mg/m2 on days 1 and 8. The primary endpoint was the clinical benefit rate. Analysis of safety and activity was carried out in all patients who met the screening criteria and received at least 1 dose of study treatment. The trial is registered at ClinicalTrials.gov, NCT03222856. RESULTS: Of the 44 patients enrolled between January 29 and October 17, 2018, clinical benefit was achieved in 25 (56∙8%, 95% confidence interval [CI]: 41∙0-71∙7), objective response in 18 (40∙9%, 95% CI: 26∙3-56∙8), median progression-free survival was 6∙0 months (95% CI: 3∙7-8∙4), and 1-year overall survival was 59∙1% (95% CI: 45∙8-76∙2). The most common treatment-emergent adverse events (AEs) of any grade were neutropenia (20 [45∙5%]), anaemia (17 [38∙6%]), alopecia (19 [43∙2%]), asthenia (19 [43∙2%]), diarrhoea (14 [31∙8%]), fatigue (14 [31∙8%]), and peripheral neuropathy (12 [27∙3%]). Serious AEs occurred in 14 (31∙8%) patients including febrile neutropenia (3 [6∙8%]), neutropenia (2 [4∙5%]), fever (2 [4∙5%]) and peripheral neuropathy (2 [4∙5%]). Immune-related AEs occurred in 11 (25∙0%) patients. One (2∙3%) patient died of cardiac arrest unrelated to study treatment. CONCLUSION: Pembrolizumab plus eribulin demonstrates encouraging antitumour activity in patients with heavily pre-treated, HR+, HER2-negative, locally recurrent or metastatic BC. The safety and tolerability of the combination is similar to eribulin or pembrolizumab monotherapy.

Complementary medicine use in cancer patients receiving intravenous antineoplastic treatment.

OBJECTIVE: Complementary and alternative medicine (CAM) use has grown considerably, although there is little research on the topic in Spain. The aim of this study was to determine the prevalence of complementary medicine use in adult cancer patients at the same time as they were receiving conventional treatment in a Spanish referral cancer centre. METHOD: An observational, descriptive, cross-sectional study was conducted in the Ambulatory Treatment Unit during 2 consecutive weeks in March 2015. Adult patients who were receiving intravenous chemotherapy were included. Study variables were obtained from a questionnaire and medical records. RESULTS: 316 patients were included. 32.3% of the patients reported complementary medicine use during this period and 89% were ingesting products by mouth, herbs and natural products being the most commonly used. 81% of patients started to use complementary medicine after diagnosis, and family/friends were the main source of information. 65% of the patients reported improvements, especially in their physical and psychological well-being. Significant predictors of CAM use were female gender (P=0.028), younger age (P<0.001), and secondary education (P=0.009). CONCLUSIONS: A large proportion of cancer patients receiving intravenous chemotherapy also use complementary medicine, which they mainly take by mouth. Due to the risk of chemotherapy-CAM interactions, it is important for health-professionals to keep abreast of research on this issue, in order to provide advice on its potential benefit and risks.

Objetivo: La popularidad de la medicina alternativa y complementaria entre los pacientes oncológicos ha incrementado, pero aún se dispone de poca información acerca de su empleo en España. El objetivo principal de este estudio fue determinar la prevalencia del uso de medicina complementaria en pacientes oncológicos adultos que reciben tratamiento en un centro autonómico español de referencia.Método: Estudio observacional, descriptivo y transversal llevado a cabo en un Hospital de Día de oncología durante 2 semanas de marzo de 2015. Se incluyeron pacientes adultos que recibían tratamiento con quimioterapia intravenosa. Las variables del estudio se obtuvieron a través de un cuestionario y de la historia clínica.Resultados: Fueron incluidos 316 pacientes; el 32,3% estaba usando algún tipo de medicina complementaria en ese momento, y el 89% de ellos lo hacía a base de una ingesta oral de sustancias, principalmente hierbas y productos naturales. El 81% de los pacientes inició la medicina complementaria tras el diagnóstico, siendo la fuente de información principal familiares/amigos. El 65% refirió sentir mejoría, principalmente bienestar físico y psíquico. Los predictores significativos de uso de MAC fueron: ser mujer (p=0,028), edad joven (p<0,001) y un nivel educativo medio (p=0,009).Conclusiones: Una proporción importante de los pacientes oncológicos que reciben quimioterapia intravenosa usan simultáneamente medicina complementaria, y esta consiste principalmente en una ingesta oral de preparados. Debido al riesgo de interacción con el tratamiento, es importante la formación de los profesionales sanitarios en este ámbito, con el fin de poder aconsejar a los pacientes acerca de sus potenciales beneficios y riesgos.