bluuebunny/crossref_metadata_2025_split huggingface dataset:
Level of burden of supportive care-relevant pharmacogenetic markers in general population.
Authors: McLeod Howard L. , Patel Jai Narendra , Wei Min , Rosenberg Zeil 
Published: November 2017

221 Background: Precision medicine has become part of oncology, with implications for therapy selection, treatment avoidance, dosing, and risk prediction. The presence of clinically predictive germline variants has also opened the hope that objective predictors of patient toxicity will be in the future. This is an opportunity for oncology, where selection from amongst apparently equal supportive care treatment options can be subjective. Methods: The incidence of genetic risk for untoward drug effect was characterized in 1193 consecutive patients submitted for clinical pharmacogenetics testing using a 50 gene panel. Not all were cancer patients, so this reflects a potential patient population. For each patient, the need to stop/avoid, adjust dose, and select an alternate medication was determined for the treatment of pain (CYP2D6, CYP1A2, OPRM1), nausea/vomiting (CYP2D6), antifungal prophylaxis (CYP2C19) or depression (CYP2D6, CYP2C`9). It is recognized that there are many sources of variation in the response and toxicity to these classes of medications. Results: Of the 1193 patients, 173 (14.5%) would have a recommendation to avoid oxycodone, codeine, or tramadol therapy and a non-standard dosage for 893 patients (75%). A change in antiemetic would be suggested for 35 patients (3%). If voriconazole antifungal prophylaxis was clinical required, 289 (24%) would need a dose increase, while 45 (3.8%) should be switched to a different regimen. The majority (759 patients; 64%) should avoid some of the commonly used agents for depression because of lack of efficacy or heightened risk of toxicity, while 195 patients would need a dose adjustment. Conclusions: Pharmacogenetics markers that put patients at risk for lack of efficacy or toxicity to supportive care medications was commonly observed. Thankfully there are many options for most supportive care areas, allowing genetic information to help focus treatment selection. In addition, for number of supportive care medications we do not know the sources of variable response, genetic or otherwise. There are opportunities to apply precision oncology principles to patient management now, while research helps toward the goal of objective medication selection.
Off-label drug use in home palliative care: A non-evidence-based established practice.
Authors: Velutti Laura , Pavesi Carlotta , Lopane Diego , Arcanà Concetta , Saetta Annalisa , De Maio Ana Paula , Speciale Tatiana , Rimassa Lorenza , Santoro Armando 
Published: November 2017

225 Background: Advanced cancer patients (pts) often present with multiple concomitant symptoms and off-label use of drugs (indications doses formulations administration route) is a common practice. Drugs mixture (DM) solutions by continuous administration are frequently used. However, evidence-based data in this setting is scarce. Methods: We performed a retrospective analysis of 576 consecutive care pathways provided by our Home Palliative Care (HC) Service from Jul 2010 to Jun 2017. Infusions were administered subcutaneously (sc) or by a venous (iv) access, by elastomeric pumps (EP) (5 days - 2 mL/h) with drugs diluted in 0.9% NaCl with no light protection. We analyzed: treated symptoms, drugs, doses/concentrations, solution transparency, administration route, infusion duration, clinical response, adverse events (AEs), compliance/treatment acceptability, device proper functioning, and treatment interruptions. Results: We analyzed 266 pts out of 576 care pathways treated with DM infusions, M/F 143/123, median age 70 yrs (21-92); treated symptoms: pain (50%), nausea/vomiting (20%), dyspnea/agitation (20%), dysphagia/mucositis (18%); infused drugs: morphine, midazolam, dexamethasone, ranitidine, metoclopramide, scopolamine, alizapride, haloperidol, furosemide, and ketorolac. Median number of drugs in the DM was 3 (1-6). Administration route was sc in 214 pts/80%, iv in 52 pts/20%. Median infusion duration was 5 days (0-64). Symptoms control was achieved within 72 h in 69% of pts. No AEs related to the infusion devices were observed. Compliance was good in 92% of pts, poor/inadequate in 8%. 5 EP malfunctions were observed: 1 human error, 1 device obstruction due to furosemide flocculation, 3 unexplained. Also, 3 pts required sc infusion interruption due to fluid accumulation near the injection site. Conclusions: This retrospective analysis on a large number of pts shows efficacy and tolerability of DM administration by EP in the HC setting. Treatment compliance was high, no AEs were observed, EP malfunction and therapy discontinuation were rare. However, there are still many open questions about the off-label use of drugs in this setting, and prospective trials are strongly suggested.
Opioid switch and change of route of administration in palliative care cancer patients treated by morphine: Update of French guidelines.
Authors: Poulain Philippe , Michenot Nathalie , Rostaing Sylvie , Baron Laurent , Krakowski Ivan 
Published: November 2017

226 Background: In 2002 guidelines for the treatment of cancer pain (National Federation of French Cancer Centers) were adapted to the availability of drugs in France. In 2015, a group of experts nominated by the 3 French Societies involved in cancer pain (AFSOS, SFAP, SFETD: Supportive Care, Palliative Care and Pain Societies), reviewed these guidelines and established new ratios for morphine switching and/or changing the route of administration in patients whose pain was not adequately controlled. Methods: A review of the literature via Pubmed (key words: morphine, oxycodone, fentanyl, hydromorphone, methadone, tapentadol, pain, cancer, palliative care, opioid rotation, opioid switching, equianalgesic ratios) plus a manual search, led us to retain 43 original works containing good scientific evidence (methodology French Health Authority).Final approval for publishing was obtained from each of the aforementioned three scientific committees of the societies. Results: Experts explained why the theory of opioid rotation using fixed ratios was no longer appropriate for a secure practice. In the light of recent publications enhancing our knowledge on the efficacy of new drug switching ratios and for changing the route of administration of morphine, the group of experts recommended to use reconsidered switching ratios favoring security over efficacy, to minimize overdosing and adverse effects. Consequently, after the new conversion ratio (using slow release opioids) was applied, a second titration should be done by using normal release rescue formulations for breakthrough pain episodes. Conclusions: This work can be apply to an international situation (despite different drug availability amongst countries). A smartphone app is available for rapid and secure dose conversions and will be translated into English. The adequate opioid dose is obtained from a theoretical dose calculation adapted to patient’s personal situation and needs (second titration). Continuous updating of good practice guidelines may provide security and adequacy of prescription for adequate and safe pain relief for our patients, limiting overconsumption and risk of misuse.
Efficacy and side effect profile of olanzapine versus haloperidol for symptoms of delirium in hospitalized patients with advanced cancer: A multicenter, investigator-blinded, randomized, controlled trial (RCT).
Authors: Van Der Vorst Maurice , Neefjes Elisabeth C.W. , Boddaert Manon S.A. , Verdegaal Bertha A.T.T. , Beeker Aart , Teunissen Saskia C.C. , Beekman Aartjan TF , Wilschut Janneke A. , Berkhof Johannes , Verheul Henk M.W. 
Published: November 2017

231 Background: Delirium is highly prevalent in patients with advanced cancer. Patients experiencing delirium may require pharmacological treatment to reduce distressing symptoms. Atypical antipsychotics, like olanzapine, are potentially safer and more effective than haloperidol, but no phase III RCTs are reported in patients with advanced cancer. Methods: Hospitalized patients with advanced cancer diagnosed with delirium ( DSM-IV-TR criteria) were randomly assigned centrally (1:1) to olanzapine or haloperidol. Dosages were up-titrated. Primary endpoint was delirium resolution rate (DRR), defined as Delirium Rating Scale-Revised-98 (DRS-R-98) total severity score < 15.25 points and ≥ 4.5 points reduction. Secondary endpoints: time to recovery, grade ≥ 3 side effects (Common Terminology Criteria for Adverse Events version 3.0), and distress (Delirium Experience Questionnaire). The study was powered to increase DRR with 25% for olanzapine compared to haloperidol. Results: Between January 2010 and June 2016, 100 of the anticipated 200 patients were enrolled in the study from 6 sites in the Netherlands and randomly assigned to olanzapine (n = 50) or haloperidol (n = 50). Baseline characteristics were well balanced. Interim analysis showed a difference in DRR of -12.2% (95% confidence interval (CI) = -32.0%- 7.4%); 45% for olanzapine (95% CI 31.0-58.8) vs 57% for haloperidol (95% CI 43.3-71.0), P = 0.22).Time to recovery was 4.5 days in the olanzapine arm vs 2.8 days in the haloperidol arm (P = 0.20). There was no difference in grade ≥ 3 side effects between both arms (OR 0.44, 95% CI 0.14-1.40; P = 0.16). Mean level of distress in patients was 2.1 (SD 1.4) for olanzapine vs 2.3 (SD 1.4) for haloperidol (P = 0.80). Formal interim futility analysis indicated a conditional power of 0.086, implying a very low likelihood (8.6%) of reaching the expected DRR superiority rate of 25% for olanzapine. Therefore, the study was prematurely terminated. Conclusions: No difference in efficacy and side effect profile was observed between haloperidol or olanzapine treatment for delirium in patients with advanced cancer. Clinical trial information: NCT01539733.
Development of a digital tool to assess the risk of thromboembolic disease and prescription of prophylactic anti-thrombotic therapy in oncologic patients.
Authors: Garcia Montes Lizbett Vanessa 
Published: November 2017

232 Background: Thromboprophylaxis for oncologic patients represents a huge challenge. The existence of more specific guidelines for anti-thrombotic therapy in hospitalized and ambulatory oncologic patients is an unmet need. Methods: We present an observational, descriptive, retrospective and transversal study, from January 2012 to December 2016, all the oncologic patients hospitalized for any cause in the Hospital Español de México were included. We reviewed clinical files and obtained demographic and disease characteristics necessary to stratify the risk of thromboembolism using the Khorana score. A bivariate analysis was done between the risk of thromboembolism and the use of thromboprophylaxis and a multivariate analysis to identify the reproducibility of Khorana score in Mexican patients. Results: Of the 1048 patients included in the study, 65.6% (688 patients) were categorized by the Khorana score with intermediate risk of thromboembolism, 26% (273 patients) with low risk and 8.4% (87 patients) with high risk. In the low risk group 80.6% used some kind of prophylaxis, in the intermediate risk group 83.2% and in the high risk group 87%, nevertheless only 19.7% met the recommendations published by international guidelines (ASCO, ESMO) and the Khorana score and also this data confirmed the reproducibility of Khorana score in Mexican patients. Conclusions: The 80.3% of all the patients didn’t obey the recommendations stablished by the American and European guidelines. We propose a digital tool to monitor and manage the risk of thrombosis as a health condition associated with cancer. This could be use in an easy way of each member of the multidisciplinary team, to stratify cancer patients by risk to receive the correct prophylactic anti-thrombotic therapy. This is nowadays an unmet need for oncologic patients, and in our country this type of tool, will help to save resources and re-direct them to patients who will actually benefit from the prophylactic treatment.
Cancer-related fatigue in cancer survivors (CS) with no active treatment.
Authors: Soriano Maria , Alvarez-Bustos Alejandro , Ramos Javier , Piquin Carmen , Osorio Pablo , Ros Javier , Ramírez Miguel , Gutierrez Sanz Lourdes , Nuñez García Beatriz , Gomez-Bravo Raquel , Brea Lidia , Fiuza-Luces Carmen , Lucia Alejandro , Pagola Itziar , Cebolla Hector , Ruiz-Casado Ana 
Published: November 2017

238 Background: Fatigue is a subjective experience that should be systematically assessed at the initial visit, at regular intervals and as clinically indicated. Quality of fatigue management should be included in institutional continuous quality improvement projects. The PERFORM questionnaire (PQ) was developed among Spanish speaking patients for the assessment of fatigue. Methods: Outpatients recruited for projects in which physical condition and physical activity (PA) were evaluated, rated their fatigue severity on the PQ (12-60, being 60 no fatigue). PHUEM-01 evaluated early colon CS after finishing adjuvant treatment (AT). PHUEM-02 early breast CS at the end of AT. PH-UEM-03 evaluated colorectal CS (localized and metastatic) at the time of diagnosis. MS-04 evaluated fatigue at the time of diagnosis of different tumors (localized and metastatic). Physical condition was evaluated through the one-mile walk test (VO2MAX) and handgrip dynamometer. Heart rate was measured as a sign of autonomic dysfunction. PA was objectively evaluated through accelerometers generating weekly MVPA information. Results: 262 CS (63% women) were recruited, (110 breast, 119 colorectal, 14 other), mean age 60. 30% of survivors reported no fatigue. Mean PERFORM score 48,34; VO2max 25.5 ml/kg/min; handgrip 29,14 kg; HR 75 bpm. Women, younger CS, CS with worse physical condition, higher BMI, higher HR and less active CS reported more fatigue (only sex, handgrip strength and weekly PA were statistically significant for the overall population). Breast CS reported higher scores of fatigue than colorectal CS (p < 0.000). For breast CS there was an association between fatigue and HR which was not seen in the overall population. Metastatic colorectal did not report worse scores of fatigue than CS with localized tumors. Conclusions: As a subjective symptom, fatigue is unpredictable and its severity and interference with daily activities can be bothersome in an unexpected population (young CS, early stages) with no active treatment. More physically active and fitter CS are less fatigued. Mechanisms underlying cancer-related fatigue could be different for different tumors. More research in prevalence, evaluation, mechanisms and management of fatigue is needed.
Clinical assessment of emotions in patients with cancer: Diagnostic accuracy compared to two reference standards.
Authors: Verheul Henk M.W. , Braamse Annemarie , Aerts W , Hoogendoorn A W , Snoek F J , Van Linde Myra Ellen , Dekker Joost 
Published: November 2017

24 Background: Previous research has suggested that clinical assessment of emotions in patients with cancer is suboptimal. Since well-trained and experienced doctors and nurses may differentiate between emotions that do or do not necessitate professional mental health care, we hypothesized that clinical assessment may be more accurate than previously concluded. This study aimed to evaluate the diagnostic accuracy of clinical assessment of emotions. Methods: The study was designed as a retrospective cohort study at a department of medical oncology. The clinical assessment of emotions by medical oncologists and nurses was derived from the patient file. Emotional distress and need for emotional care was assessed using the Distress Thermometer and Problem List. The sensitivity, specificity and diagnostic odds ratio of clinical assessment was calculated, with either (i) emotional distress or (ii) need for professional mental health care as a reference standard. Results: Clinical assessment resulted in notes on emotions in 42.2% of the patient files (n =185), with 36.2% of patients experiencing emotional distress and 10.8% expressing a need for professional mental health care. As expected, the sensitivity of clinical assessment of emotions was higher with ‘need for professional mental health care’ as reference standard, compared to ‘emotional distress’ as reference standard (0.85 versus 0.54, p < 0.001). The diagnostic odds ratio showed a similar pattern (9.66 versus 2.10, p = 0.02). For specificity, equivalent results were obtained with the two reference standards (0.63 versus 0.64, p =0.63). Conclusions: Medical oncologists and nurses seem to differentiate between emotions that do or do not necessitate professional mental health care, resulting in a high sensitivity of clinical assessment of emotions in patients with cancer.
Utilization of gabapentin for cough in cancer: A case series.
Authors: Feliciano Josephine Louella , Razzak A. Rab , Waldfogel Julie , Doberman Danielle J , Smith Thomas J. 
Published: November 2017

241 Background: Refractory cough is a significant problem for cancer patients. Therapeutic options are suboptimal and based on low quality of evidence. Gabapentin is a gamma aminobutyric acid analog that may regulate neurotransmitter release via activity at the alpha-2-delta subunit of voltage dependent calcium channels. It is hypothesized to ameliorate cough through a central mechanism and is effective in relieving chronic refractory idiopathic cough. However, gabapentin has not been studied in cancer patients with cough. We report the use of gabapentin for chronic, refractory cough in adult cancer patients. Methods: We identified 3 male patients with metastatic cancer evaluated by palliative care for refractory cough. Data regarding diagnosis previous treatments for cough, dosage of gabapentin, and symptomatic outcomes are reported. Results: Case 1 is a 68 y.o. male with NSCLC and malignant pleural effusion had chronic cough despite thoracentesis that was associated with fatigue, sleep disturbance, and worsened with movement, pain, and sitting upright. Previous treatment for cough included benzonatate, codeine, dextromethorphan, albuterol inhaler, and ranitidine, without relief. He received gabapentin 300 mg three times a day. Case 2 was a 68 y.o. with NSCLC and a left mainstem bronchus obstructive mass not amenable to stent. Cough was associated with eating and sleep disturbance, and he could not lie flat for radiation planning. He received gabapentin 300 mg at night. Case 3 was a 48 y.o. with salivary duct carcinoma and a cavitary S. Pyogenes pneumonia treated with antibiotics and chest tube drainage and had persistent cough. He received gabapentin 300 at night. All patients had cough relief within 24 hours and were controlled until death. Conclusions: Gabapentin at doses up to 1800 mg per day has been studied in refractory chronic idiopathic cough and found effective relative to placebo with significantly more improvement in cough frequency, severity, and quality of life. Chronic cough in cancer patients can be a debilitating symptom and interventions are inadequately effective, with little quality evidence to support their use. Our case series suggests that further studies of gabapentin in cancer-related chronic cough are warranted.
Patient engagement with a smartphone mobile app for adherence to oral chemotherapy.
Authors: Ream Molly , Jacobs Jamie M. , Fishbein Joel N , Pensak Nicole , Nisotel Lauren Ellen , MacDonald James J , Buzaglo Joanne S. , Lennes Inga Tolin , Safren Steven A. , Pirl William F. , Temel Jennifer S. , Greer Joseph 
Published: November 2017

243 Background: Patients prescribed oral chemotherapy receive minimal supervision and support for adherence. We developed a smartphone mobile app consisting of medication reminders, symptom reporting, clinician communication, and educational resources for improving adherence and symptom management. In this study, we sought to identify potential correlates of app usage. Methods: From 12/2014 to 08/2016, 181 patients with diverse malignancies prescribed oral chemotherapy enrolled in a randomized trial to test the efficacy of a smartphone mobile app to improve adherence and symptoms. Medication adherence was monitored using electronic pill caps (MEMScaps). At baseline and 12 weeks, participants completed a measure of treatment satisfaction (FACIT-TS). We gathered clinical and treatment data from the electronic health record. Through the app we collected data on engagement: total number of minutes, days of usage, and number of completed symptom reports. We calculated Pearson correlations to identify associations between app engagement, using a latent variable for overall engagement, with adherence, treatment satisfaction and healthcare utilization. Results: 91 patients were randomly assigned to receive the mobile app. Over the 12-week study period, participants used the mobile app for a mean of 59 minutes (SD = 68) and 21.75 discrete days (SD = 21.24 days), completing 15.92 symptom reports (SD = 14.15) on average. Higher app engagement was associated with having a lower proportion of missed doses (r = -.248, p = .035) over the study period. Patients who became less satisfied with their communication with physicians (r = -.278, p = .019) and nurses (r = -.238, p = .047) used the app more. Higher app engagement was associated with fewer emergency department visits resulting in hospitalizations (r = -.252, p = .029). Conclusions: Among patients prescribed oral chemotherapy, higher usage of a mobile app targeting adherence was related to fewer missed doses and ED visits leading to hospitalization. Fostering patient engagement with the app may also serve to buffer difficulties in patient-clinician communication about care. Clinical trial information: NCT02157519.
Biomarkers to evaluate distress in cancer patients.
Authors: Labbe-Coldsmith Elise , Butler Thomas Wayne , Naylor Paige , Aragon Ileana 
Published: November 2017

251 Background: Self-report assessments of stress are a popular, but limiting practice, particularly for underserved populations that may struggle with poor psychological insight and illiteracy. Assessment of stress via biomarkers may be a more inclusive approach to stress assessment for patients with cancer. However, as the rise in popularity regarding biomarker function as outcome data has risen, so to have questions regarding the validity of this endeavor. The current study aimed to explore the convergent validity of inflammatory biomarkers (C-Reactive Protein; CRP, Interleukin 6; IL-6, and Cortisol) while also exploring predictors of stress (e.g., sex, race, marital status) in an underserved, diverse cancer population. Methods: Upon IRB approval, patients ( N = 37) were consented and contributed plasma and serum for the examination of biomarkers (CRP, IL-6, and Cortisol). Next, patients completed the Calgary Symptoms of Stress Inventory (CSOSI; Carlson & Thomas, 2007) to assess for biopsychosocial stress levels. The C-SOSI produces one total score and eight subscales measuring physiological, psychological, and social domains of stress. Results: The mean age of patients was 59.6 ( SD= 13.3) and 56.8% were women. The majority of participants identified as White (56.8%), and a wide variety of cancer types was represented. Biomarkers were analyzed via Quantikine ELISA kits. Correlational analyses revealed that certain subscales showed a positive relationship via medium sized significant correlations. Aside from the Anger subscale, only the physiological subscales were correlated with the biomarkers. The Anger subscale was significantly correlated with Cortisol ( r = .348, p = .035), as was Muscle Tension ( r = .341, p = .039), and Upper Respiratory ( r = .382, p = .02). While Cardiopulmonary Arousal was correlated with CRP ( r = .437, p = .007) and IL-6 ( r = .340, p = .04). Interestingly, IL-6 and CRP were correlated, however, Cortisol was not correlated with IL-6 or CRP. Additional analyses demonstrated significant differences for stress between men and women, which will be discussed. Conclusions: It appears that the biomarkers capture physiological aspects of stress, which may serve in screening patients for psychological intervention.