Complementary and alternative medicine in cancer patients: characteristics of use and interactions with antineoplastic agents.

PURPOSE: Our objectives were to analyze the use of complementary and alternative medicine (CAM) in cancer patients and to describe the incidence and characteristics of interactions between CAM and antineoplastic agents. METHODS: We performed an observational study in cancer outpatients at a university hospital. Variables were collected through a 22-item questionnaire. Potential interactions between CAM and antineoplastic agents were analyzed using the Lexicomp®, the About Herbs®, and the summary of product characteristics. Mechanism of action, reliability, and the potential clinical effect of interactions were analyzed. RESULTS: The study population comprised 937 patients, of whom 65% used CAM (70.6% herbal products, 25.8% dietary supplements, and 3.6% homeopathy). Female sex, younger age, and breast cancer were associated with more frequent use of CAM. The primary source of information about CAM was friends and family (43.5%). A total of 335 (57.1%) patients did not tell their doctor that they took CAM. The five most common CAM were chamomile, green tea, pennyroyal mint, linden, and rooibos. At least one interaction between CAM and antineoplastic agents was reported by 65.0% of CAM users (33.9% of all patients). Depending on the mechanism of action, 80% of CAM diminished the metabolism of the antineoplastic agents. CONCLUSION: Our results reveal a high incidence of interactions between CAM and antineoplastic agents. The most frequent CAM were herbal products. Family and friends were the primary sources of information that led patients to start taking CAM, and more than half of the patients did not tell their doctor that they were taking CAM.

Smartphone-Based Ecological Momentary Assessment for the Measurement of the Performance Status and Health-Related Quality of Life in Cancer Patients Under Systemic Anticancer Therapies: Development and Acceptability of a Mobile App.

Background: We have defined a project to develop a mobile app that continually records smartphone parameters which may help define the Eastern Cooperative Oncology Group performance status (ECOG-PS) and the health-related quality of life (HRQoL), without interaction with patients or professionals. This project is divided into 3 phases. Here we describe phase 1. The objective of this phase was to develop the app and assess its usability concerning patient characteristics, acceptability, and satisfaction. Methods: The app eB2-ECOG was developed and installed in the smartphone of cancer patients who will be followed for six months. Criteria inclusion were: age over 18-year-old; diagnosed with unresectable or metastatic lung cancer, gastrointestinal stromal tumor, sarcoma, or head and neck cancer; under systemic anticancer therapies; and possession of a Smartphone. The app will collect passive and active data from the patients while healthcare professionals will evaluate the ECOG-PS and HRQoL through conventional tools. Acceptability was assessed during the follow-up. Patients answered a satisfaction survey in the app between 3-6 months from their inclusion. Results: The app developed provides a system for continuously collecting, merging, and processing data related to patient's health and physical activity. It provides a transparent capture service based on all the available data of a patient. Currently, 106 patients have been recruited. A total of 36 patients were excluded, most of them (21/36) due to technological reasons. We assessed 69 patients (53 lung cancer, 8 gastrointestinal stromal tumors, 5 sarcomas, and 3 head and neck cancer). Concerning app satisfaction, 70.4% (20/27) of patients found the app intuitive and easy to use, and 51.9% (17/27) of them said that the app helped them to improve and handle their problems better. Overall, 17 out of 27 patients [62.9%] were satisfied with the app, and 14 of them [51.8%] would recommend the app to other patients. Conclusions: We observed that the app's acceptability and satisfaction were good, which is essential for the continuity of the project. In the subsequent phases, we will develop predictive models based on the collected information during this phase. We will validate the method and analyze the sensitivity of the automated results.

Medication guide for the perioperative management of oral antineoplastic agents in cancer patients.

BACKGROUND: Oral antineoplastic agents (OAAs) are high-risk drugs that may increase the risk of bleeding, difficulty in wound healing, or produce alterations in coagulation and/or platelet aggregation. These aspects had to be highly considered throughout the entire perioperative process. Our aim was to create a comprehensive management medication guide based on reconciliation and dose adjustment recommendations for OAAs in patients undergoing a surgical intervention. RESEARCH DESIGN AND METHODS: We analyzed all OAAs approved by the EMA in November 2020. We assessed data related to dose adjustment, drug reconciliation, coagulation disturbances, or anticoagulant interactions from the FDA and EMA summary of product characteristics. RESULTS: We analyzed 67 OAAs. We identified that 51 (76.2%) OAAs can produce alteration in the platelet count, 12 (17.9%) affect the wound healing and recovery process, and 32 (47.8%) require control and monitoring in case of combination with anticoagulants. Only 13 (19.4%) OAAs, most of them antiangiogenics, have specific recommendations for temporary suspension before surgery. CONCLUSIONS: Most OAAs require perioperative monitoring. This review can serve as an easy (simple, effective) tool to help healthcare professionals involved in patient care to manage OAAs during the perioperative process.

DPYD Exome, mRNA Expression and Uracil Levels in Early Severe Toxicity to Fluoropyrimidines: An Extreme Phenotype Approach.

Dihydropyrimidine dehydrogenase deficiency is a major cause of severe fluoropyrimidine-induced toxicity and could lead to interruption of chemotherapy or life-threatening adverse reactions. This study aimed to characterize the DPYD exon sequence, mRNA expression and in vivo DPD activity by plasma uracil concentration. It was carried out in two groups of patients with extreme phenotypes (toxicity versus control) newly treated with a fluoropyrimidine, during the first three cycles of treatment. A novel nonsense gene variant (c.2197insA) was most likely responsible for fluoropyrimidine-induced toxicity in one patient, while neither DPYD mRNA expression nor plasma uracil concentration was globally associated with early toxicity. Our present work may help improve pharmacogenetic testing to avoid severe and undesirable adverse reactions to fluoropyrimidine treatment and it also supports the idea of looking beyond DPYD.

Assessment of diarrhea as side effect of oral targeted antineoplastic agents in clinical practice.

BACKGROUND: Diarrhea is one of the most frequent class adverse events associated with targeted oral antineoplastic agents (OAAs). Our objective was to analyze the incidence, characteristics, and severity of diarrhea in cancer patients in clinical practice. METHODS: An observational, longitudinal, and prospective study of cancer outpatients treated with targeted OAAs was carried out in a tertiary hospital. Targed OAAs analyzed were anaplastic lymphoma kinase inhibitors, BCR-ABL inhibitors, cyclin-dependent kinase inhibitors, epidermal growth factor receptor inhibitors, mTOR inhibitors, poly (ADP-ribose) polymerase inhibitors, and vascular endothelial growth factor receptor inhibitors. Patients were given a data collection form to record daily the number, severity (CTCAE version 5.0), and characteristics of stools during the first 30 days of treatment with OAAs. Multivariate analysis was performed to identify risk factors associated with the incidence of diarrhea. RESULTS: We analyzed 240 patients, of whom 28.7% experienced diarrhea (25.4% grades 1-2 and 3.3% grades 3-4). Patients treated with EGFR and VEGFR inhibitors had a higher incidence of diarrhea. The multivariate analysis revealed that taking the OAA with food was associated with a lower risk of diarrhea (OR = 0.404 [0.205-0.956], p = 0.038). CONCLUSIONS: More than a third of patients in treatment with OAAs presented diarrhea (any grade), and 22.1% of stools were semi-liquid/liquid. In multivariate analysis, taking the OAA on an empty stomach was associated with a statistically significant increase in the incidence of diarrhea.

Aggressiveness of end-of-life cancer care: what happens in clinical practice?

PURPOSE: End-of-life cancer care varies widely, and very few centers evaluate it systematically. Our objective was to assess indicators of the aggressiveness of end-of-life cancer care in clinical practice. METHODS: An observational, longitudinal, and retrospective cohort study was conducted at a tertiary hospital. Eligible patients were at least 18 years old, had a solid tumor, were followed up by the Oncology Department, and had died because of cancer or associated complications during 2017. We used the criteria of Earle et al. (J Clin Oncol 21(6):1133-1138, 2003) to assess the aggressiveness of care. Multivariate logistic regression analyses were performed to characterize factors associated with aggressiveness of therapy. RESULTS: The study population comprised 684 patients. Eighty-eight patients (12.9%) received anti-cancer treatment during the last 14 days of their lives, and 62 patients (9.1%) started a new treatment line in the last 30 days. During the last month of life, 102 patients (14.9%) visited the ER, 80 patients (11.7%) were hospitalized more than once, and 26 (3.8%) were admitted to the ICU. A total of 326 patients (47.7%) died in the acute care unit. A total of 417 patients (61.0%) were followed by the Palliative Care Unit, and in 54 cases (13.0%), this care started during the last 3 days of life. CONCLUSIONS: The use of anti-cancer therapies and health care services in our clinical practice, except for the ICU, did not meet the Earle criteria for high-quality care. Concerning hospice care, more than half of the patients received hospice services before death, although in some cases, this care started close to the time of death.

Development and Evaluation of a Clinical Decision Support System to Improve Medication Safety.

BACKGROUND: Clinical decision support systems (CDSSs) are a good strategy for preventing medication errors and reducing the incidence and severity of adverse drug events (ADEs). However, these systems are not very effective and are subject to multiple limitations that prevent their implementation in clinical practice. OBJECTIVES: The objective of this study was to evaluate the effectiveness of an advanced CDSS, HIGEA, which generates alerts based on predefined clinical rules to identify patients at risk of an ADE. METHODS: A multidisciplinary team defined the system and the clinical rules focusing on medication errors commonly encountered in clinical practice. Four intervention programs were defined: (1) dose adjustment in renal impairment; (2) adjustment of anticoagulation/antiplatelet therapy; (3) detection of biochemical/hematologic toxicities; and (4) therapeutic drug monitoring. We performed a 6-month observational prospective study to analyze the effectiveness of these clinical rules by calculating the positive predictive value (PPV). RESULTS: The team defined 211 clinical rules. During the study period, HIGEA generated 1,086 alerts (8.9 alerts per working day), which were reviewed by pharmacists. Fifty-one percent (554/1,086) of alerts generated an intervention to prevent a possible ADE; of these, 66% (368/554) required a documented modification to therapy owing to a real prescription error intercepted. The intervention program that induced the highest number of modifications to therapy was the dose adjustment in renal impairment program (PPV = 0.51), followed by the adjustment of anticoagulation/antiplatelet therapy program (PPV = 0.24). The percentage of accepted interventions was similar in surgical units (68%), medical units (67%), and critical care units (63%). CONCLUSION: Our study offers evidence that HIGEA is highly effective in preventing potential ADEs at the prescription stage.

Oral antineoplastic agents: assessment of safety and dose adjustments in clinical practice.

Objectives: Although the safety profile of oral antineoplastic agents (OAAs) is better than that of classic chemotherapy, the rate of severe adverse events (AEs) is high. The objective was to assess the reasons for adjustments to treatment with OAAs during the first 100 days of treatment. Methods: The authors performed a prospective observational study of cancer outpatients who initiated OAAs between November 2015 and October 2017. Dose reductions and treatment interruptions were closely followed-up during the first 100 days after the beginning of treatment with an OAA. The authors described the different safety profile of different OAA classes. Results: The authors included 443 patients (31 different OAA assessed), of whom 53.0% required their OAA to be adjusted during the first 100 days of treatment. A total of 151 patients required dose reductions and/or interruptions of OAAs owing to AEs. The authors identified 203 AEs in these patients. Treatment with sorafenib, lower ECOG performance status, and first-line treatment were associated with a higher proportion of treatment adjustments due to AEs. Conclusion: These results in clinical practice could be a first approach to help healthcare professionals to design patient monitoring programs by identifying priority patients and drugs, and remarks the importance of pharmacovigilance in OAAs.

Oncology Patient Interest in the Use of New Technologies to Manage Their Disease: Cross-Sectional Survey.

BACKGROUND: Information and communication technologies (ICTs) in oncology can revolutionize the medical care of cancer patients. ICTs can promote patients' empowerment and real-time disease monitoring. There is limited information about the impact of ICTs in cancer patients or their level of interest in using these tools for greater management of their condition. OBJECTIVE: This study aimed to understand the ICT usage profile in hematology-oncology patients to identify their needs and determine their level of interest in these technologies as a means of managing their disease. METHODS: A 28-item questionnaire was drawn up by a multidisciplinary team including pharmacists and oncologists. The questions were organized into 3 blocks, which were as follows: block A-sociodemographic characteristics; block B-use of ICTs when searching for health-related information; and block C-usage preferences for health apps. Hematology-oncology patients receiving treatment between May and July 2017 were included. A paper copy of the questionnaire was handed over to patients in either the day hospital or the pharmaceutical care consultancy in pharmacy services. RESULTS: A total of 650 questionnaires were handed out, with a participation of 94.0% (611/650). Patient sociodemographic characteristics were as follows: mean age was 57.8 years (age range: 19-91). Of 611 participants, 40.7% (249/611) had a university education, and 45.1% (276/611) of participants reported their overall state of health to be good. Results from use of ICTs when searching for health-related information were as follows: 87.1% (532/611) of participants were interested in being informed about health-related matters. Of all participants, 75.5% (532/611) sought information from health professionals and 61.3% (375/611) on the internet. Before going to their doctor's appointment, 21.8% (133/611) of patients looked up information about their disease or treatment on the internet. This access to the internet rose to 50.9% (311/611) after their first medical appointment with their oncologist. Usage preferences for health apps were as follows: 82.7% (505/611) had a smartphone, whereas 20.3% (124/611) had a health app installed. Overall, 81.5% (498/611) would use an app if their health professional recommended it to them, but 39.6% (242/611) were not willing to pay for it. CONCLUSIONS: The hematology-oncology patients showed a great deal of interest in searching for health-related information by means of ICTs, especially using smartphones and apps. The issues that drew the most interest in terms of apps were appointment management, advice on disease management, and communication with health professionals. Free access to these features and the recommendation by a health professional are important factors when it comes to their use. Therefore, the health care provider is a key element in the recommendation of ICTs, providing their knowledge and experience concerning their correct usage.

Level of concordance between two risk-assessment models for predicting venous thromboembolism in medical patients at admission.

OBJECTIVES: To evaluate the level of concordance between the 2007 PRETEMED guidelines and the 2012 American College of Chest Physicians (ACCP) guidelines in medical patients at admission. METHODS: A cross-sectional, observational and descriptive study was designed and included all adult medical patients admitted from an emergency department. Firstly, patients classified as low-moderate risk and high risk according to PRETEMED were compared to those classified by ACCP as low and high risk. Secondly, the same analysis was performed but this time low and moderate-high risk patients according to PRETEMED were compared to ACCP low and high risk patients. The level of concordance was calculated using the kappa concordance index. The study was approved by the Ethics Committee for Clinical Research of the hospital. RESULTS: The analysis was performed with 207 patients; 53.1% were male and the median age was 75.3 years (minimum 18, maximum 100 years old). The most common diagnosis at admission was related to a respiratory disease (37.2%). The level of concordance was 0.59 (95% CI 0.48 to 0.70) when moderate risk patients were grouped with low-risk patients and 0.53 (95% CI 0.42 to 0.65) when moderate risk patients were grouped with high-risk patients. CONCLUSIONS: The level of concordance between both guides is moderate. It would be helpful to confirm whether the level of agreement improves when the patient's condition stabilises after several days of hospitalisation.