bluuebunny/crossref_metadata_2025_split huggingface dataset:
iMETX (Individualized Metabolic RX): An environmental intervention to increase energy expenditure in breast cancer survivors.
Authors: Ballinger Tarah Jean , Althouse Sandra K. , Olsen Timothy P. , Miller Kathy , Sledge Jeffrey 
Published: May 2019

e23060 Background: Despite survival and quality of life benefits associated with physical activity (PA), many breast cancer survivors remain inactive. Effective, sustainable PA interventions must account for individual differences in capability, motivation, and environment. iMETX evaluated the feasibility, mechanics, and efficacy of delivering an individualized, dynamic intervention to increase energetic capacity and energy expenditure in breast cancer survivors. Methods: Stage 0-III breast cancer pts who had completed primary treatment were enrolled. Baseline PA patterns were collected using a wearable GPS/accelerometer for 4 weeks pre- intervention. Detailed movement data collection continued throughout the 12- week intervention, during which pts received tailored PA “prescriptions” every 1-3 days from an interactive web application, adjusted based on individual capability and environment to achieve pre- determined energy endpoints. Baseline and post- intervention, energetic capacity was assessed by power generation using a stationary bicycle protocol feasible in the clinic setting over a range of physical capabilities. Body composition by DEXA and quality of life questionnaires were collected. Results: 56 of 57 enrolled pts completed the intervention (98%). Median age was 60 (range 38 – 82), and pts were an average of 5.25 yrs from diagnosis (range 0.5 – 21 yrs). In the total population, energetic capacity (Watts/kg lean mass) increased significantly from 1.75 to 1.99 W/kg (p < 0.01) post- intervention. Separated by baseline energetic capacity, the lowest performing tertile improved significantly (0.76 to 1.12 W/kg, p < 0.01), while the highest performing tertile did not (2.75 to 2.96 W/kg, p = 0.30). Physical and functional well-being also improved (FACT-B TOI, pre: 72.26, post: 74.66, p = 0.02). Conclusions: iMETx is a feasible PA intervention with high adherence rates. Individualized PA prescriptions allowing pts to move in their typical environment resulted in improved energetic capacity and well- being. Results were particularly significant in those with the lowest baseline energetic capacity, a population most in need of effective and accessible PA interventions. Clinical trial information: NCT03158519.
Cutaneous eruption as a prognosis indicator for cancer patients treated with EGFR tyrosine kinase inhibitors: A systematic review and meta-analysis.
Authors: Wang Yensheng , Wu Jennifer , Wang Shi-Yi , Lacouture Mario E. , Wu Mei , Chung Wen-Hung 
Published: May 2019

e23063 Background: Clinical symptom is often a direct method to evaluate the treatment effects. With the emergence of EGFR-targeted drugs on market, it is unclear to apply cutaneous toxicity in evaluating treatment effects and outcomes in cancer patients. This study aimed to determine whether adverse skin event as a survival indicator for patients treated with EGFR tyrosine kinase inhibitors. Methods: PubMed, EMBASE, Scopus, trial register and Cochrane Library were searched on November 11, 2018 to identify studies reporting survivals outcomes. The following search/exploded terms were used: “ EGFR-TKIs: gefitinib/erlotinib/afatinib/osimertinib ”, “ cutaneous toxicity”, “ survival”. Two investigators performed study selection independently and assessed risk of bias with ROBINS-I method. Data were pooled with random effects models and further subgroup by cancer types. Funnel plot, Egger test and Begg test were performed for detection of publication bias. Sensitivity analysis was performed by excluding potential outliers. Results: There were 24 studies identified with 4696 patients included. Skin adverse event was found to be significantly associated overall survival rate (HR, 0.48; 95% CI, 0.43-0.53; P < 0.00001; I2 = 83%) and progression free survival rate (HR, 0.59; 95% CI, 0.41-0.85; P= 0.004; I2 = 88%). Subgroup analysis suggested among non-small cell lung cancer patients, skin adverse event was significantly associated with overall survival (HR, 0.39; 95% CI, 0.25-0.60; P < .0001; I2 = 86%) but not progression free survival (HR, 0.65; 95% CI, 0.29-1.45; P= 0.29; I2 = 95%). Among other cancer types patients, skin adverse event was significantly associated with overall survival (HR, 0.59; 95% CI, 0.41-0.84; P= 0.004; I2 = 70%) and progression free survival (HR, 0.61; 95% CI, 0.41-0.91; P= 0.02; I2 = 80%). Begg test and Egger test suggested no evidence of publication bias. Sensitivity analysis also showed similar results. Conclusions: Skin eruption had 52% lower risk of death and 41% lower risk of progression in cancer patients treated with EGFR-TKIs. This association should be further incorporated with cancer survivorship care planning.
Fatigue in long-term survivors of acute promyelocytic leukemia (APL) and its association with other symptoms and functional limitations.
Authors: Efficace Fabio , Breccia Massimo , Avvisati Giuseppe , Cottone Francesco , Intermesoli Tamara , Borlenghi Erika , Carluccio Paola , Rodeghiero Francesco , Fabbiano Francesco , Luppi Mario , Romani Claudio , Sborgia Marco , D'Ardia Stefano , Nobile Francesco , Cantore Nicola , Crugnola Monica , Nadali Gianpaolo , Amadori Sergio , Vignetti Marco , Lo-Coco Francesco 
Published: May 2019

e23073 Background: Despite cancer survivorship research for patients with solid tumours is increasing, there is paucity of data for patients with hematologic malignancies. We aimed to: 1) investigate factors associated with development of fatigue in long-term APL survivors; 2) describe prevalence of other key symptoms and functional limitations by fatigue severity. Methods: The current analysis is based on 244 APL survivors with a median follow-up from diagnosis of 14.3 years, who were recruited in a large multicenter study. Fatigue was evaluated with the validated FACIT-Fatigue scale. Multivariate linear regression analysis was used to investigate factors associated with self-reported fatigue and key clinical and treatment-related variables were also considered in the analysis. Patients were also divided into two groups based on the FACIT-Fatigue median score identifying a low fatigue (LF) and a high fatigue (HF) group. Prevalence (i.e., not present, mild and moderate to severe) of key symptoms and functional limitations, measured with the EORTC QLQ-C30, were also analyzed by fatigue severity. Results: Multivariate analysis showed that a lower age at diagnosis (p = .002), absence of comorbidities (p = .001) and a greater social support (p = .004) were independently associated with lower fatigue. Patients in the HF group had a significantly higher prevalence of many symptoms, including: pain (p < .001), dyspnea (p < .001), insomnia (p < .001), appetite loss (p = .010), nausea and vomiting (p = .026) and diarrhea (p = .002) than patients in the LF group. As an example, whilst in the HF group there were 61% of patients also reporting pain (with any level of concern), in the LF group there were only 26% of patients reporting pain. Also, HF patients reported a significantly higher prevalence of functional limitations including: physical, role, social, emotional and cognitive functioning (each with p < .001). Conclusions: Our data provides novel information of factors that are independently associated with fatigue severity in long-term APL survivors. Greater fatigue is also associated with a substantial burden of other symptoms and functional limitations.
The impact of chemotherapy on sleep quality in women undergoing cytotoxic treatment for breast, ovarian, and endometrial cancer.
Authors: Cantillo Evelyn , Beffa Lindsay , Luis Christine , Raker Christina , Robison Katina , Sikov William M. 
Published: May 2019

e23077 Background: To determine changes in sleep quality among women with breast, ovarian, and endometrial cancer during chemotherapy and to assess the impact of sleep quality on quality of life (QOL). Methods: A prospective cohort study was performed at The Program in Women’s Oncology among chemotherapy naïve women diagnosed with breast, ovarian, or endometrial cancer scheduled to begin treatment. Ovarian and endometrial patients were combined into one group (Gyn) for analysis. Two validated questionnaires: the Pittsburgh Sleep Quality Index (PSQI) and the Functional Assessment of Cancer Therapy (FACT), which measure sleep quality and QOL, respectively, were administered prior to-, halfway through-, completion of-, and 6 months after chemotherapy completion. Descriptive statistics were used to summarize baseline characteristics. Categorical variables were compared by Chi-square (χ2) test and continuous variables by T-test. The PSQI and FACT scores were analyzed by linear or logistic regression with GEEs. Results: Of the 99 women enrolled, 27 had ovarian, 23 had endometrial, and 49 had breast cancer. 97 were included in the analysis. The breast cohort was younger than their Gyn counterparts: 50 vs. 62, (p < .001), and more likely to identify as Hispanic (p = .012). 56% of women endorsed poor sleep quality at baseline. By mid-treatment, both cohorts reported a significant reduction in sleep quality (p = .008) and QOL (p = .0003) that did not persist at end of- or 6 months post-treatment. Increased need for sleep medications (p = .012) and reduction in sleep efficiency (p = .002) were identified mid-treatment. No significant changes in PSQI or FACT-G were seen by end of treatment. At 6 months post treatment, less Gyn patients reported poor sleep quality when compared to baseline (46 vs 53%) while experiencing a significant improvement in QOL (p = .03). Poor sleep quality was correlated with worse QOL at all time points (p < .001). Conclusions: There is a sparsity of research on sleep disturbances in gynecologic malignancies. In this study, three quarters of all women reported poor sleep quality by mid-treatment with concomitant decrease in QOL. Poor sleep was reported by nearly 50% of women at all other time points. Larger studies need to be done to further define the problem and identify areas suitable for interventions.
Long-term symptom burden and quality of life in metastatic melanoma patients treated with checkpoint inhibitors.
Authors: Mamoor Maha , Lavery Jessica A. , Sidlow Robert , Rogak Lauren J. , Thom Bridgette , Khan Niloufer , Baxi Shrujal S. , Wolchok Jedd D. , Postow Michael A. , Korenstein Deborah 
Published: May 2019

e23090 Background: Patients with metastatic melanoma (MMel) who achieve durable long-term responses to checkpoint inhibitors (CI) represent a new type of cancer survivor, but their long-term quality of life (QOL) is poorly described. We measured symptom burden and long-term QOL in MMel patients treated with CIs at Memorial Sloan Kettering Cancer Center (MSK). Methods: Between February and August 2018 we performed a cross-sectional survey of adult patients with MMel treated with CI at MSK beginning at least 12 months prior to this study. Surveys were self-administered online using RedCap. We assessed patient treatment experience and QOL using the PRO-CTCAE bank, EORTC, EQ-5D, and Fatigue Severity Scale. We performed chart abstraction to assess extent of cancer burden, ECOG status, Charlson Comorbidity Index (CCI), concurrent medical conditions, and immune-related adverse events (irAEs) developing during or after treatment. For analysis, we dichotomized age (< 65 vs ≥65) and months from CI initiation (< 25 vs ≥25). Results: We enrolled 107 patients (39% survey response rate); 106 completed surveys. Participants were 57.0% male and 93.5% white, with median age 60.5 years (IQR: 51.1, 67.5 years). 79.4% had a CCI of 0 at start of CI; preexisting autoimmune disorders were rare. Median time since CI initiation was 36.4 months (range: 14.2, 133.9 months). Median length of CI treatment was 7.3 months (IQR: 2.1, 24.3 months); 15 patients were on treatment at the time of survey completion. Among those off treatment at the time of survey completion, median time off treatment was 27.1 months (IQR: 16.7, 40.4 months). The most common irAEs were rash (34.6%), colitis (24.3%), thyroiditis (19.6%), hepatitis (18.7%), and hypophysitis (13.1%). irAEs did not differ by age. Few patients reported symptoms at time of survey, most commonly aching joints (18%), fatigue (14%), aching muscles (13%), and difficulty sleeping (11%). Few (< 12%) had difficulty with physical, role, emotional, cognitive, or social functioning and almost none (1%) reported anxiety, depression or pain on the EQ-5D. QOL was excellent, with a median of 83.3% on the EQ-5D global health score and no differences based on toxicities or time from treatment. Conclusions: Long-term survivors of MMel patients report few burdensome symptoms after CI therapy and have excellent QOL.
Cognitive impairment and treatment effects among gastrointenstinal stromal tumor survivors: Results of a large online survey.
Authors: Ferguson Robert J. , Manculich Jessica , Snitz Beth E. , Bovbjerg Dana H. , Duensing Anette 
Published: May 2019

e23092 Background: Cancer-related cognitive impairment (CRCI) is chronic and negatively affects quality of life (QOL) for a large portion of cancer survivors. To date, no studies have exclusively examined CRCI among gastrointestinal stromal tumor (GIST) survivors. Tyrosine kinase inhibitors (TKI), such as imatinib mesylate, have greatly increased median survival of individuals with GIST, so evaluating CRCI for this group is important. We report results of a large online survey of GIST survivors to ascertain prevalence, course and features of CRCI. Methods: A web-based survey utilizing validated patient reported outcomes (PRO’s) and de-identified demographic questions was developed. Respondents answered questions on age, gender, education, medical/cancer history and treatment. Estimated IQ was derived from demographic indexing. The FACT-Cog V3 and PROMIS Short Forms 8a assessed cognitive complaints, fatigue, mood, and anxiety. The survey was distributed through GIST Support International, the GIST Cancer Research Fund, Sarcoma Patients EuroNet and the Life Raft Group. Results: Across 4 continents, 485 adult GIST survivors (median age = 59 years, 71.8% female, 88.7% Caucasian) completed the survey. Respondents were 6.29 (sd = 5.19) years post-diagnosis with 88.0% percent on, or at least having started, imatinib. A majority (63.9%) indicated significant negative QOL impact as assessed by FACT-Cog Perceived Cognitive Impairments scale (PCI). PCI did not correlate with emotional distress or fatigue, as in other cancer samples. Type of surgery, current use/non-use of imatinib or other therapy was not associated with PCI. However, GIST survivors ≥ 5 years post-diagnosis had significantly worse PCI scores than survivors < 5 years post-diagnosis (p < 0.05). No differences between survivors with/without B12 deficiency or anemia were found and PCI did not correlate with cognitive reserve (years of education or IQ). Conclusions: Nearly two-thirds of GIST survivors report significant QOL impact of CRCI. Those with ≥ 5 year survival report worse cognitive symptoms, regardless of being on or off current TKI and cognitive symptoms do not appear associated with emotional distress or fatigue. CRCI among GIST survivors appears long term but further research to objectively determine CRCI magnitude and trajectory is warranted.
Novel smartphone app for daily symptom reporting for active chemotherapy patients.
Authors: Marshall John , Wiebe Lauren Allison , Isenstein Howard 
Published: May 2019

e23119 Background: Clinicians, payors and patients are recognizing the value of enhanced symptom monitoring for ambulatory patients between chemotherapy encounters. However, enabling technologies to do so are nascent. Methods: A patient-facing Smartphone app and a clinician-facing dashboard were developed for providers to easily monitor key symptoms in ambulatory patients. Both EHR-integrated and standalone versions were available by provider preference. 250 patients with breast, lung or gastrointestinal cancer in active chemotherapy and their paired clinicians were recruited at three hospital-based practices to test the feasibility and usability of our system. Patients were prompted to report symptoms once per day Monday-Friday. Patients could also track their symptoms and obtain standardized self-care guidance at any time. Clinicians could access their patients’ data via the dashboard at any time. The treating team ould also receive e-mail alerts based on a pre-approved symptom triage protocol. Results: All enrolled clinicians and patients were able to access and use the technology. Clinicians accessed the symptom management dashboard at least once per weekday on average. 75% of clinicians indicated that the technology reduced their workflow somewhat or had no effect on it. The majority (71.5%) of clinicians indicated that the frequency of alerts they received was acceptable. 100% of clinicians who accessed the tool when integrated into the EHR indicated that the it was very convenient to use vs. only 20% of the clinicians who accessed the standalone version. 39.4% of patients reported using our technology on a daily basis. 77.9% of patients said that they would recommend the Smartphone App. Conclusions: The CarePrompter electronic patient-reported outcomes (ePRO) monitoring system demonstrated high technical feasibility and usability, particularly when integrated with the EHR, suggesting that technical barriers to providing robust real-time and historical symptom data are less formidable than they appear.
Cachexia in head and neck squamous cell carcinoma (HNSCC) patients (pts) after cisplatin-based chemoradiation (CRT): A cross-sectional study.
Authors: Castro Gilberto , das Neves Willian , Rivelli Thomás Giollo , Simao Eduardo Furquim , Martins Renata Eiras , Kulcsar Marco Aurelio Vamondes 
Published: May 2019

e23138 Background: Cachexia is a wasting syndrome that may affect HNSCC pts, contributing to their dismal prognosis. We aimed to study the frequency of cachexia in HNSCC survivors treated with CRT with curative intent. Methods: Cross-sectional study that included 120 consecutive pts from Jan/2014 to Feb/2017, over 18 y.o. and who were previously treated with definitive or adjuvant CRT for HNSCC (nasopharynx, oropharynx [OP], oral cavity [OC], hypopharynx and larynx [L]). Eligible pts were in regular follow-up for at least 2 years in the multidisciplinary team, with no evidence of disease. Medical history, body weight, height, mid-arm muscle circumference (MAMC) and muscle strength (MS, handgrip dynamometer) were measured, and laboratory tests (hemoglobin [Hb], albumin and C-reactive protein [CRP]) were obtained. Cachexia was diagnosed when there was any weight loss in the previous year, and at least 3 of the following: reduced grip muscle strength, fatigue, anorexia, low lean body mass, or laboratorial alterations (Hb < 12 g/dL, serum albumin < 3.2 g/dL or CRP > 5.0 mg/L). A subjective assessment of nutritional status was made based on the Patient-Generated Subjective Global Assessment (PG-SGA) in its short form. Results: Median age 59 y.o. (21-78), 88 male (73%). Most common primary sites were OP (42%), L (24%) and OC (19%). Median follow-up was 42 mo. (24-125). There was a predominance of locally advanced disease at diagnosis: 73% T3/T4 and 72% N+. The mean weight was 64.5 kg (±14.6) pre-CRT, 57.8 kg (±12.2) post-CRT (p 0.02) and 63 kg (±11.8) in the present evaluation (p NS). Dysphagia was a complaint in 88 pts (73%). Cachexia was diagnosed in 42 pts (35%). As expected, cachectic pts (CP) presented lower MAMC (25.1 vs. 27.2 cm, p 0.0002) and MS (24.3 vs. 29.5 kgf, p 0.004). Higher mean CRP (12.7 vs. 4.2 mg/L, p 0.0001) and lower Hb (13.1 vs.13.9 g/dL, p 0.01) were also seen in CP. The PG-SGA score was higher in CP (7.9 vs. 5.7, p 0.006). Conclusions: Cachexia was frequently diagnosed in HNSCC pts with NED after CRT in a long-term follow-up, without evident weight loss. More effective preventive and therapeutic strategies are warranted. Supported in part by FAPESP grant 2014/00172-9.
Mutational status and thromboembolic risk in lung, gastrointestinal and breast cancer patients.
Authors: Platania Marco , Nichetti Federico , De Braud Filippo G. 
Published: May 2019

e23147 Background: Cancer-Associated Thrombosis (CAT) is one of the most threatening complications of cancer. Recent evidences suggested a link between the molecular profile of solid tumors and the incidence of CAT. The aim of this study was to explore the relationship between the mutational status of breast, lung and gastrointestinal cancer patients and the risk of CAT. Methods: We retrospectively evaluated the molecular profile, analysed as per clinical practice, of all consecutive patients hospitalized at the National Cancer Institute’s Department in Milan from October 2017 to November 2018. Patients with previous thromboembolic events and patients under anticoagulant therapy at cancer diagnosis were excluded. Due to death as competing risk, the Fine and Gray proportional regression model was used to detect statistical association and estimate relative risk. Results: The resulting cohort consisted of 484 patients, of whom 47% had gastrointestinal cancers, 18% had lung cancer and 15% had breast cancer. Molecular investigations were available for 375 (77%) patients; in particular, a 50-gene Next Generation Sequencing (NGS) panel was performed on 148 (31%) patients. After a median follow up of 17 months, 118 patients (24%) exhibited clinical manifestations of thrombosis (i.e. deep vein thrombosis, pulmonary thromboembolism, splanchnic thrombosis, disseminated intravascular coagulation, arterial thrombosis) and 117 (24%) patients deceased without thrombotic events. A statistically significant association was observed between incidence of CAT and presence of TP53 (HR 0.50, p = 0.04), c-KIT (HR 4.30, p = 0.041), and SMAD4 (HR 3.19, p = 0.029) mutations. No significant association was detected for KRAS and MET gene mutations, even if HRs were >2. Conclusions: In this study, the mutational status of TP53, SMAD4 and c-KIT genes was statistically associated to the risk of thrombosis. Due to methodological limits and low prevalence of mutations, large prospective studies are warranted, with the aim of better defining the role of oncogenes in CAT risk.