bluuebunny/crossref_metadata_2025_split huggingface dataset:
OrienX010 oncolytic viral therapy in phase Ic trial of intralesional injection in liver metastases among patients with stage IV melanoma after standard treatment.
Authors: Cui Chuanliang , Lian Bin , Chi Zhihong , Si Lu , Sheng Xinan , Li Dan , Li Si Ming , Tang Bixia , Mao Li Li , Wang Xuan , Zhou Li , Yan Xieqiao , Bai Xue , Guo Jun 
Published: September 2018

e21013 Background: The liver is one of the most common metastases in melanoma pts and associated with extremely poor prognosis. However, effective treatment has not been found. The safety and efficacy of OrienX010, a herpes simplex virus type 1-derived oncolytic immunotherapy with expression of gene encoding human GM-CSF, was tested in phaseⅠc trial of intralesional injection in liver metastases among patients with stage IV melanoma after standard treatment. Methods: We studied safety and efficacy of OrienX010 (8×107pfu/ml, 10ml per injection) q2w by ultrasound guided puncture. Efficacy was evaluated q8w by CT scan. The primary endpoint was toxicity. Secondary endpoints included Objective Response Rate (ORR), Disease Control Rate (DCR) as well as PFS time. Treatment continued until intolerance, or disease progression per Immune Related Response Criteria. Results: From May 2016, 15 pts received OrienX010 intralesional therapy. The median age was 47 y (32, 61), and 53.3% were female. The primary anatomic sites were: 40.0% (6 pts) from ocular, 33.3% (5 pts) from acral, 26.7% (4 pts) from mucosal. Only 1 patient with c-Kit mutation, 14 pts were wide-type in genotype. All pts had received at least one prior therapy, 53.3% (8 pts) had received transcatheter hepatic arterial chemoembolization. 73.3% (11 pts) had multiple liver metastases, 60.0% (9 pts) had extrahepatic metastases such as lung, bone, abdominal, distant lymph node. 60.0% (9 pts) had an elevation of serum LDH. Mean injection times were 6 (4-18). Mean size of all injectable lesions was 30.4mm (10.0-59.0). AEs were all grade 1/2, pyrexia 80.0%, fatigue 33.3%, injection site pain 26.7%, nausea/vomiting 20.0%, hepatotoxicity 20.0%, leucopenia 6.7%. 12 pts were eligible for evaluation till Jan 2017, and the median follow-up time was 6.0 months. ORR was 8.3% (1 PR), DCR was 41.7% (1 PR, 4 SD). Time to response was 8-16 wks, median PFS was 13.3 wks (95%CI 8.3-18.4), OS was not reached. Conclusions: This is the first trial for evaluating OrienX010 of intralesional injection in liver metastases among melanomas. It appears to be tolerable and with a potentially beneficial effect. Phase 2 and combination trial are pending.
Efficacy and tolerability of vemurafenib in BRAF-mutant acral and mucosal melanoma.
Authors: Bai Xue , Si Lu , Chi Zhihong , Sheng Xinan , Cui Chuanliang , Kong Yan , Dai Jie , Mao Li Li , Wang Xuan , Li Si Ming , Tang Bixia , Lian Bin , Zhou Li , Yan Xieqiao , Guo Jun 
Published: September 2018

e21017 Background: Vemurafenib has substantially impressive clinical efficacy in cutaneous melanoma (CM). However, compared with their cutaneous counterpart, acral melanoma (AM) and mucosal melanoma (MM) have distinct genetic patterns and worse prognosis. The efficacy and safety profiles of vemurafenib in AM and mm remain unclear. Methods: Clinical, pathological, and therapeutic data were collected and reviewed of patients (pts) with metastatic or unresectable BRAF-mutant AM and mm hospitalized and administrated vemurafenib during January 2011 and January 2017. Responses were evaluated by RECIST v1.1, survival data were analyzed by Kaplan-Meier survival curve, and adverse effects were assessed by CTCAE v4.0. Results: 24 pts were identified, 13 (54.2%) with AM, 11 (45.8%) with mm (1 patient without available radiology data). All 13 AM pts harbored BRAF V600E mutation (1 with simultaneous C-KIT E861K mutation); 10/11 (90.9%) mm pts carried BRAF V600E mutation (1 with simultaneous PDGFRA V824I mutation), 1/11 (9.1%) had BRAF D594N mutation. Median PFS were 5.4 (95%CI 3.5-8.7) and 4.5 (95%CI 1.5-15.0) months, median OS were 11.7 (95%CI 8.1-23.6) and 7.9 (95%CI 4.6-26.2) months; ORRs were 61.5% (8/13) and 40.0% (4/10), DCRs were 92.3% (12/13) and 90.0% (9/10) in AM and MM, respectively. Vemurafenib was well tolerated. The most common adverse effects (AEs) were hand-foot syndrome in AM and elevation of total cholesterol in MM, with the incidence of 23.1% (3/13) and 18.2% (2/11), respectively. Grade 3/4 AEs have not been observed. No patient discontinued vemurafenib because of treatment related toxicity. Conclusions: Vemurafenib yields substantial response in pts with AM and MM. Compared with in CM, vemurafenib has similar efficacy and safety profiles in BRAF-mutant AM and MM.
Can checkpoint inhibitor therapy improve response to chemotherapy?
Authors: Kirchberger Michael Constantin , Schilling Bastian , Haferkamp Sebastian , Bosserhoff Anja , Schuler Gerold , Heinzerling Lucie 
Published: September 2018

e21024 Background: Even though immune checkpoint inhibitors (ICPI) are very effective with the wider use of single or combination treatment an increasing number of patients show resistance to treatment. If patients with metastatic melanoma progress and targeted therapy has also failed or is not feasible due to the lack of targetable mutations chemotherapy remains a treatment option. There is strong evidence that high mutational load leading to formation of so-called neoantigens is a major determinant of ICPI benefit. Additionally, chemotherapy has been described to modulate the microenvironment and the immune system. Here, we assess the efficacy of chemotherapy after checkpoint inhibitor failure in a series of advanced melanoma patients. Methods: We evaluated overall survival and response to chemotherapy of patients with progressive disease under previous treatment with the immune checkpoint inhibitors anti-CTLA4 and anti-PD1. Three skin cancer centers included a total of 17 patients. All BRAF-mutated patients had also progressed under previous BRAF/MEK-inhibitor therapy. Of all patients, 71% showed an elevated LDH, 41% had brain metastases and 35% an ECOG of 2 at initiation of chemotherapy. Results: Tumor control, defined as complete response, partial response, mixed response or stable disease was achieved in 53% (n = 9) of the patients who had previously been clearly progressive. The mean overall survival was 13.1 months with 65% (n = 11) of the patients still being alive. The choice of chemotherapy did not seem to influence the overall survival or tumor control rate. Conclusions: Immune checkpoint inhibitors could increase response to chemotherapy. The combination of chemotherapy and immunotherapy might be beneficial and increase tumor control.
Analysis of the impact of body mass index in the treatment of metastatic melanoma with ipilimumab.
Authors: Gomes Jessica Ribeiro 
Published: September 2018

e21044 Background: Recently observational and retrospective studies have been observing a higher incidence of melanoma among patients with over normal body mass index (BMI), as well as a higher melanoma-specific mortality. However, no study has analyzed the impact of BMI in patients with metastatic melanoma treated with immunotherapy. We aim to evaluate whether BMI could influence the treatment of patients with metastatic melanoma receiving Ipilimumab. Methods: Patients diagnosed with metastatic melanoma treated with Ipilimumab at Centro Oncológico Antônio Ermírio de Moraes - Brazil were identified. Patients were stratified according to BMI value at the beginning of Ipilimumab therapy (BMI ≥ 25 and BMI < 25). Progression free survival (PFS) was compared between the groups. Results: We evaluated 187 patients with metastatic melanoma treated with Ipilimumab. About fifty eight percent were male and median age was 58 years (range 27-89). About 88.8% had cutaneous melanoma (42.6% BRAF mutated), 5.3% mucosal melanoma, and 5.9% choroid melanoma. The overall PFS was 3.13 months (95% CI 2.84 – 3.41). Median BMI was 25.8% (range 15.2 - 47.9), and 37.4% of the patients had BMI < 25. The group with BMI ≥ 25 had higher median PFS when compared to those with BMI < 25 (3.5 versus 2.9 months, p = 0.037). In the group of BMI < 25, 16 (22.8%) and 4 (5.7%) patients had PFS > 6 months and 12 months, respectively, versus 35 (30%) and 16 (13.6%) patients in the group of BMI ≥ 25. Conclusions: We have observed a superior PFS on Ipilimumab among overweight patients with metastatic melanoma . Further studies are necessary to confirm whether activity of Ipilimumab is greater among patients with higher BMI.
Symptom distribution of terminally ill cancer patients in a palliative care unit of a developing country.
Authors: Tiwari Shristi 
Published: September 2018

e21500 Background: Palliative care is new concept in developing countries like Nepal, It encompasses physical, psychosocial and spiritual aspects. Methods: This is a retrospective study of symptom patterns of 668 terminal cancer patients (median age: 51 years; 58% female), admitted to the Palliative Care Unit of Nepal Cancer hospital, Kathmandu Nepal from Jan 1st 2015 to Dec 31st 2016 Results: The most common primary cancer sites in these patients were lung (41%), GI (28%), ovarian (20%) and liver (10%). Physical and psychological symptoms were assessed using different scales. The median number of symptoms was 13.5 (range: 9-18) on admission, among which pain, nausea, vomiting, dyspnea, fatigue and depression were the most common. There was 23% mortality during palliative care ward stay. Anorexia-cachexia and dyspnea symptoms showed highest mortality association with in ward mortality Conclusions: A very rational approach in regards to socioeconomic beliefs and symptom presentation is required for relief of these incurable symptoms at the end stage of life for these patients.
Evaluating the utility of the QUAL-EC in the clinical care of patients with advanced cancer.
Authors: Wilkinson Anne , Slatyer Susan , Nowak Anna K. , Pienaar Cathy , Tandon Anil , Wallace Mark 
Published: September 2018

e21507 Background: We piloted the Quality of Life at the End of Life (QUAL-E) in Australian palliative care in-patients (N = 52) and demonstrated feasibility, acceptability and face validity. An unexpected finding was the potential for the QUAL-E to prompt psycho-social-spiritual discussion when conducted as an interview, indicating opportunities for enhanced support. We compared a 17-item QUAL-E-Cancer (QUAL-EC) to the Distress Thermometer Screening Tool (DT) and participants’ experience when the QUAL-EC was conducted as an interview. Methods: A cross-sectional, mixed methods design was used. Convenience sampling recruited patients (N = 50) with advanced cancer and a prognosis of less than 12 months from a tertiary hospital. Participants completed the DT, followed by the QUAL-EC which was digitally recorded as an interview. Results: Correlational and thematic analysis found that 39.6% of participants reported severe distress (score ≥ 7) while 40% reported moderate distress (score 4-6) on the DT. Levels of distress significantly correlated with two QUAL-EC domains: symptom control ( r= 0.52, p < 0.001) and preparation for end of life ( r= 0.32, p < 0.05). Qualitative analysis identified six themes: the health care team; family issues; approaching death; worry; coping and QUAL-EC experience. Feasibility: completion of the QUAL-EC ranged from 3-14 minutes (M = 7.37 minutes, SD 3.05 minutes). Acceptability: Participants overwhelmingly found the questions to be clear and did not find the questions hard to understand, hard to answer or stressful. Ninety per cent of participants agreed or strongly agreed that they were glad they took part. Conclusions: Patient distress was associated with either symptom burden or concerns about their family/loved ones. When distress is identified on screening, the QUAL-EC offers good potential for nuanced, versus vague, assessment of globalised distress (e.g., DT) as an aid in targeting patient-centered clinical/psycho-social interventions.
Risk factors for hospitalizations (HOS) among older adults with gastrointestinal (GI) cancers receiving chemotherapy.
Authors: Li Daneng , Sun Can-Lan , Levi Abrahm , Klepin Heidi D. , Elias Rawad , Mohile Supriya Gupta , Tew William P. , Lim Dean , Chung Vincent M. , Chao Joseph , Owusu Cynthia , Muss Hyman B. , Lichtman Stuart M. , Gross Cary Philip , Chapman Andrew E. , Gajra Ajeet , Cohen Harvey Jay , Katheria Vani , Hurria Arti 
Published: September 2018

e21523 Background: Older adults undergoing chemotherapy for GI cancers are at increased risk of HOS due to treatment related toxicity; however, there are limited data regarding which individuals are at greatest risk. We therefore sought to identify risk factors for HOS among older adults with GI cancers receiving chemotherapy. Methods: We performed a secondary analysis of patients age ≥ 65 years with GI cancer who participated in either of 2 prospective studies used to develop (n = 500) and validate (n = 250) a geriatric assessment (GA) based chemotherapy toxicity score for older adults with cancer. The incidence of HOS within 30 days post treatment was determined. The following patient characteristics were captured pre-chemotherapy: demographics, cancer type, stage, laboratory values, chemotherapy type, and GA measures (functional status, comorbidity, psychological state, cognitive function, nutritional status, and social support). Univariate and multivariate logistic regressions were used to estimate the odds ratio (OR) to identify risk factors. Results: A total of 199 adults age 65+ (median 73; range 65-94) with GI cancers (colorectal 43%, gastric/esophageal 25%, pancreas/biliary 32%; Stage I-III 42%, stage IV 58%) receiving chemotherapy (67% poly-chemotherapy) were included. 5-FU chemotherapy was administered alone or in combination in 126 (63%) patients. Sixty five (33%) patients had ≥1 HOS (1 HOS: 55, 2 HOS: 9, 3 HOS: 1). In univariate analysis, hospitalized patients were more likely to be female (p = 0.02), have stage IV disease (p = 0.03), have a diagnosis of non-colorectal GI cancer (p = 0.04), have poly-pharmacy (≥ 5 medications, p < 0.01), decreased hearing (p = 0.05), cardiac comorbidity (p < 0.01), and low serum albumin (p = 0.05). On multivariate analyses, patients who were female (OR = 2.06, 95% CI: 1.05-4.06), with cardiac comorbidity (OR = 3.73, 95% CI: 1.78-7.83), or a diagnosis of stage IV non-colorectal GI cancer (OR = 3.75, 95% CI: 1.50-9.39) were more likely to be hospitalized. Conclusions: HOS during chemotherapy treatment are common among older adults with GI cancers. Female sex, cardiac comorbidity, and a diagnosis of stage IV non-colorectal GI cancer are risk factors for HOS.
Nutritional risk as predictor for short-term outcomes in a prospective cohort of elderly patients with cancer.
Authors: Costa Jose Iran , Telles O Lima Jurema , Bergmann Anke , Mello Maria Julia Gonçalves , Bezerra Mirella Rebello , Cavalcanti Zilda , Sales Letícia telles , Thuler Luiz Claudio Santos 
Published: September 2018

e21533 Background: To determine if the nutritional risk according Mini Nutritional Assessment Short-Form (MNA®-SF) is an independent factor for short-term outcomes (infection, un programmed hospitalization and premature death) within the first six months after study entry. Methods:Prospective cohort study of elderly patients (≥ 60 years) with a recent diagnosis of cancer admitted to an outpatient oncology unit. At baseline sociodemographic and clinical variables were determined and comprehensive geriatric assessment (CGA) was conducted including MNA-SF. The outcomes were first Healthcare-associated Infection, un programmed hospitalization and death. Data were analyzed using multivariate Cox proportional hazards models; overall survival was estimated using the Kaplan–Meier method and survival curves were compared using the Log rank test. Results:The cohort consisted of 608 elderly patients followed for 180 days or until the censured data. Mean age was 71.9 years (range: 60‒96), 305 (50.2%) participants were at risk of malnutrition. During this period, 216 (35.5%) participants were hospitalized, 179 (29.4%) HAI and 100 (16.4%) died. After adjustment for age, site of cancer and cancer stage the multivariate regression Cox model showed that being undernourished was an independent predictor of infection (HR = 1.88, 95%CI 1.32-2.67, p < 0.001) hospitalization (HR = 1.5, 95% CI:1.10- 2.06, p = 0.012) and death (HR = 3.12, 95% CI: 1.74‒ 5.78, p < 0.001) Conclusions:Nutritional risk at admission was identified as a significant predictor of risk for premature death, infection, and need for hospitalization in elderly cancer patients. The use of MNA-SF should be incorporated into regular geriatric assessment of older patients with cancer
Integrative therapy use amongst patients and providers at an NCI-Designated Cancer Center.
Authors: Ross Masey Marie , Braun Sarah E. , Albrecht Tara A. 
Published: September 2018

e21565 Background: Historically, use of integrative health (IH) therapies among patients with cancer is high. Less is known about provider use and provider perceptions. The study aim was to evaluate the use of IH approaches among patients and providers and to gauge provider knowledge, familiarity, and referrals. Methods: We conducted a single-institution patient and provider survey in the outpatient hematology/oncology clinics at a NCI designated cancer center. Results: In 145 patients surveyed (mean age 58±13, 64% female, 56% white), 66% reported use of at least one IH approach. Of these, the highest reported were vitamins/herbs/special diets (66%), physical activity (54%), and mindfulness/meditation/prayer (44%). In 53% of patients who used IH, the therapy was recommended by someone; of these, 58% of the recommendations came from their oncologist or PCP. In all, 37% of patients wished their provider would supply more information regarding IH approaches. In 87 providers surveyed (46% MD/DO, 30% RN, mean age 46±12, 61% male, 79% white), 89% reported prior personal use of an IH therapy. Seventy-four percent reported that they received IH inquiries from patients “sometimes” or more, with 9% receiving inquiries frequently. Thirty-six percent rated their knowledge of IH low, with 24% not feeling comfortable discussing IH approaches with patients. Provider comfort level with IH therapies was positively correlated with frequency of reported patient inquiries ( r= .391, p= .01). Overall, 85% of providers thought IH therapies had the potential to be beneficial and 77% had recommended their use. The highest reported barrier to referral was lack of knowledge (18%) followed by lack of resources (14%). Conclusions: Use of IH therapies among cancer patients and providers is high and most providers have recommended IH approaches to their patients. Patients would like more provider-directed education on IH, yet more than 1/3 of providers rate their knowledge of IH low with a correlation between provider comfort level and frequency of reported patient inquiries. These data suggest that efforts should be aimed at improving educational resources and programs for providers to increase their awareness and comfort level with IH approaches.
Prevalence and predicators of insomnia among cancer survivors.
Authors: Peppercorn Jeffrey M. , Jimenez Rachel , Rabin Julia , Quain Katharine , Chinn Garrett , McDonough Allison , O'Donnell Elizabeth , Park Elyse R. , Perez Giselle Katiria 
Published: September 2018

e21603 Background: Insomnia is prevalent among cancer survivors. However, screening and treatment is inconsistent across U.S. cancer centers. We sought to identify factors associated with moderate to severe insomnia (MSI) to inform the development of a screening and treatment program for survivors. Methods: As part of a comprehensive supportive care needs assessment, we evaluated the prevalence and correlates of insomnia among patients receiving follow-up cancer care. Patients reported on a 5 point Likert scale (0 = never to 5 = always) how often they have “problems falling or staying asleep”. MSI was defined as those who endorsed “4 = very often” or “5 = always,” and remaining responses were characterized as “No Insomnia” (NI). Descriptive statistics summarized patterns of insomnia and sleep hygiene. Chi-square and Fisher’s exact tests compared differences in sleep hygiene, fatigue, anxiety, depression, and other clinical and demographic characteristics between patients with and without insomnia. Results: Among 312 respondents, 83 (27%) endorsed MSI. Women were more likely to endorse MSI compared to men (32% vs. 19%, p = 0.02). Age was not associated with MSI. MSI was most common among patients with hematologic malignancy (36%), breast cancer (32%), gynecologic cancer (31%), and melanoma (29%). Regarding sleep hygiene: Most reported frequent exposure to bright light before sleep (89% MSI vs. 85% NI). Patients with MSI, compared to NI, were more likely to report watching the clock (86% vs. 75%, p = 0.04) and an irregular sleep schedule (47% vs. 32%, p = 0.02). Patients with MSI were also less likely to meet exercise guidelines (31% vs. 45% NI, p = 0.03) and more likely to report fatigue (29% vs. 14%, p = 0.004). Further, those with MSI were more likely to report anxiety (40% vs. 8%), fear of recurrence (74% vs. 46%), and financial concerns (35% vs. 15%) (all p < 0.001). 67% of patients with MSI were interested in supportive care to address insomnia. Conclusions: A simple one-item screener identified survivors susceptible to moderate to severe insomnia. Interventions beyond attention to sleep hygiene are needed to improve insomnia and its impact on fatigue and emotional distress. The relationships between insomnia, fitness, anxiety and distress merit further evaluation.