bluuebunny/crossref_metadata_2025 huggingface dataset:
Hormone replacement therapy (HRT) prescribing patterns among gynecologic oncologists.
Authors: Huang Marilyn , Sun Charlotte C. , Westin Shannon Neville , Bodurka Diane C.
Published: March 2020

e20637

Background: Gynecologic cancer survivors have indicated inadequate treatment of their menopausal symptoms; and while HRT can significantly improve quality of life (QOL) its safety is still debated. Our objective was to evaluate HRT practice patterns and identify potential barriers to prescribing HRT among gynecologic oncologists (GO). Methods: SGO members with active electronic mail (n=823) were queried with single answer and Likert-style questions using an internet-based program. Email reminders were sent at 3, 6, and 9 weeks. Results: Of 207 respondents (25%), 123 (59%) were male and 84 (41%) female. Providers identified personal history of blood clot (81.5%) or breast cancer (75.6%) as contraindications to prescribing HRT. More women than men cited breast cancer and personal history of a blood clot (p=0.038, p=0.08) as contraindications. HRT candidates were women with vasomotor symptoms (sx)(96.1%), those at risk for osteoporosis (55.1%), and postmenopausal women (47.8%). Sx considered amenable to HRT were hot flashes (98.5%), vaginal atrophy (89.3%) and osteoporosis (60%). Fewer women than men (p=0.02) thought HRT was acceptable treatment for vaginal atrophy. Most practitioners would recommend HRT for sexual dysfunction (61.5%). Physicians indicated that they would prescribe HRT for ovarian (55.1%) and endometrial (58.7%) cancer survivors in surveillance. Compared to females, males were more likely to prescribe HRT to ovarian cancer patients who were newly diagnosed (p=0.005), disease-free after adjuvant chemotherapy (p=0.004), on surveillance (p<0.001), or with recurrent disease (p=0.008). Similar trends occurred with endometrial cancer patients. 75% of physicians would prescribe HRT for women with cervical, vaginal, or vulvar cancer following definitive treatment. There was no consensus regarding the duration of HRT once initiated for any cancer. Interestingly, 56-71% of respondents cited evidence- based medicine as the basis for their recommendations. Conclusions: Our survey demonstrated a wide spectrum in HRT prescribing patterns of GO. As more emphasis is placed on QOL and survivorship, rigorous study of the outcomes of HRT use in our patients is of paramount importance.
Basic needs of pediatric oncology patients, families, and their psychosocial adjustment.
Authors: Uphold Heatherlun , Peterson Amy , Harper Felicity W. K. , Fox Jennifer , Foster Tanina , Phipps Sean , Taub Jeffrey Warren , Albrecht Terrance Lynn , Penner Louis
Published: March 2020

e20646

Background: Children are surviving cancer at increasing rates, but dealing with pediatric cancer creates substantial need for services among the families of patients. This study examined the fiscal/material/social needs of families with children in treatment, the relationship between the extent of these needs, and the psychosocial adjustment of primary caregivers. Methods: Participants included 105 pediatric cancer patients (ages 3-12), receiving outpatient cancer treatments at two large children’s hospitals, and their adult caregivers. About one year after treatment began, caregivers completed a questionnaire assessing their fiscal/material/social needs and whether the hospital offered assistance. Caregivers also completed several measures of psychosocial adjustment: satisfaction with life (Diener, 1985), perceived stress (Cohen, 1994), psychiatric symptoms (Derogatis, 1983), and post-traumatic stress symptoms (Weiss, 1996). This non-clinical study is still accruing patients, but it has reached a sample size that is large enough (90% of final sample) to justify data analysis. Results: The top 5 identified needs were: social work services, play activities during treatment, help with insurance to cover their child’s medical care, educational activities to help their child cope, and help obtaining cancer-related medical services. An analysis of the demographic correlates of these needs showed the total number of needs was significantly and negatively correlated with income, and Black families reported more needs than White families; there were no other significant demographic correlates. Total number of needs was significantly associated with caregivers’ psychosocial adjustment. Specifically, total number of needs was negatively correlated with life satisfaction, and positively associated with: caregiver perceived stress, depression, and symptoms of post-traumatic stress. Conclusions: Caregivers of pediatric cancer patients have substantial needs for basic services and the extent of these needs is associated with their psychosocial adjustment. Unmet needs may be a risk factor for patients and families. Programs that address these needs may benefit the adult caregivers and their children.
Τhe modulatory role of psychological distress in the relationship between illness perception and quality of life in patients with breast cancer.
Authors: Gercovich Daniela , Lopez Pablo , Bortolato Diego , Margiolakis Patricia , Morgenfeld Mirta , Rosell Laura , Acuna Claudia Lorena , Gil Deza Ernesto
Published: March 2020

e20657

Background: In a previous study (Gercovich et al., 2011) we found that several dimensions of Illness Perception predicted some aspects of Quality of Life. The present study introduces Psychological Distress as a variable to assess the modulatory role it plays in the association between Illness Perception dimensions and Quality of Life in patients with breast cancer, identifying which of these two variables explain further variability in the different aspects of Quality of Life. Methods: A cohort of seventy-five patients was evaluated with the Brief Illness Perception Questionnaire, the Hospital Anxiety and Depression Scale and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-30). We calculated bivariate and partial correlations to evaluate the associations between the illness perception dimensions and different aspects of quality of life, controlling these associations by the psychological distress measure. Subsequently, we performed linear regression analysis to evaluate which of these two variables better explains the variability in the quality of life scores. Results: Although significant associations between subscales of perception of illness and quality of life were found, most of them lost their significance when controlled by distress. In the regression models, variables that predicted the variability in the quality of life best were psychopathological diagnostic and distress. Conclusions: According to the study results, psychological distress and psychopathological diagnostic were the two variables that better explained the variability in the quality of life. For this reason it is essential to learn more about the role these variables play on the quality of life and on the morbidity and mortality associated to them.
Biweekly combination therapy with gemcitabine and carboplatin compared with gemcitabine monotherapy in patients over 80 years old with advanced non-small-cell lung cancer: Subgroup analysis of the prospective randomized phase II study.
Authors: Kusagaya Hideki , Inui Naoki , Karayama Masato , Ozawa Yuichi , Nakamura Yutaro , Kuroishi Shigeki , Yokomura Koshi , Toyoshima MIkio , Shirai Toshihiro , Masuda Masafumi , Yamada Takashi , Yasuda Kazumasa , Suda Takafumi , Chida Kingo
Published: March 2020

e20658

Background: Chemotherapy regimens for the elderly with non-small-cell lung cancer (NSCLC) are still controversial, especially for patients over 80 years. We previously reported that biweekly combination therapy with gemcitabine and low-dose carboplatin was well tolerated and active in elderly patients aged ≥76 years with NSCLC (Lung Cancer 77, 2012). Here we present a subanalysis of more elder patients aged ≥80 years. Methods: We conducted a phase II trial comparing biweekly combination therapy with gemcitabine (1000mg/m2) plus carboplatin (AUC 3) and monotherapy with weekly gemcitabine (1000mg/m2) in chemotherapy-naïve NSCLC patients aged ≥76 years. We performed a retrospective subgroup analysis comparing patients aged < 80 and those ≥ 80 years. We focused on patients treated with combination therapy. The primary endpoint was overall response rate and secondary endpoints were safety and progression free survival (PFS). Results: Sixteen patients were aged < 80 years (median 77.5, range, 76-79 years) and 15 patients were aged ≥80 years (median 83, range 81-88 years). Overall response rates were 25% (95% CI: 7.3-52.4%) for patients aged <80 years and 20% (95% CI: 4.3-48.1%) for patients aged ≥80 years. The median PFS in patients aged <80 years was 3.5 months (95% CI: 3.2-5.6), compared with 3.6 months (95% CI: 2.8-5.0) in patients aged ≥80 years. Additionally, the prevalence of grade 3 or 4 hematologic and non-hematologic toxicity, the completion of four cycles chemotherapy, and the need for withdrawing treatment were not significantly different between the two groups. Conclusions: In elderly patients with NSCLC, even aged ≥80 years, combination therapy with biweekly gemcitabine and low-dose carboplatin may be an efficacious treatment with a favorable toxicity profile. Clinical trial information: NCT00881296.
Assuring dietary supplement quality for cancer patients: An integrated formulary systems approach.
Authors: Markman Maurie , Levin Michael , Reilly Paul , Coyne Joseph W. , Lammersfeld Carolyn , Birdsall Timothy C.
Published: March 2020

e20663

Background: Studies reveal up to 80% of cancer patients use some form of dietary supplements (DS). Despite the need for additional research, evidence exists that some DS may be of clinical value. In order to provide safe DS recommendations to patients, we created a Dietary Supplement Formulary Committee (DSFC). Methods: Twelve manufacturers (marketing 19 DS brands) with a reasonable reputation among providers for quality were selected. A survey tool was created to measure critical quality, GMP and FDA compliance practices; information was obtained via non-disclosure agreements; manufacturing documents were audited and compared to survey responses; FDA audit reports were obtained under Freedom of Information requests; site audits were conducted; and third party analytical testing was performed. Results: All 12 companies claimed to be operating in full compliance with FDA regulations. However, 3 had received Warning Letters from FDA for GMP violations; 2 performed a product recall within the last 5 years; 4 reported products that failed Consumerlab.com for potency or purity; 1 did not have product specifications; 1 was found by FDA to have inadequate testing; 1 was found to have a lack of sufficient controls throughout the supply chain to guard against microbiological contamination; and 2 had confirmed melamine contamination or lack of melamine testing on protein powders. Additional concerns included the use of subcontractors for certain operations, lack of stability data to support expiration dates, material discrepancies between claims and actual practice, and failure to change UPC (Universal Product Code) numbers when active ingredient formulas change. Conclusions: We observed considerable variation in the quality of DS, and in the level of compliance, which raises concerns for patient safety. One company met all quality standards. The combined use of the measures described above allowed for informed product selection. The variable quality practices identified here emphasize the need for careful formulary oversight. The USP (United States Pharmacopeial Convention), ConsumerLab.com, and the NSF International’s certification programs are current resources available to help identify quality DS.
The integration of cancer survivorship training in the curriculum of hematology/oncology fellows and radiation oncology residents.
Authors: Shayne Michelle , Culakova Eva , Milano Michael T. , Dhakal Sughosh , Constine Louis S.
Published: March 2020

e20667

Background: The population of cancer survivors is steadily increasing. Cancer specialists require an understanding of survivors’ needs to insure optimal delivery of post-treatment care. Residency and fellowship training traditionally focus on cancer therapy, while survivorship care is often not emphasized. As a paradigm shift in our training programs, we instituted a Cancer Survivorship Workshop. Methods: In academic year 2011-2012 a Cancer Survivorship Workshop course was held at the James P. Wilmot Cancer Center/University of Rochester, a comprehensive cancer center with accredited training programs in Hematology Oncology (HO) and Radiation Oncology (RO). Course objectives included 1) learning about survivorship from patient, primary care physician, and oncologist perspectives using an evidenced-based curriculum; 2) designing treatment summaries (TS) and survivorship care plans (SCP) for 5 malignancies (lung, breast, prostate, colon, lymphoma) for integration into the electronic medical record and dissemination to patients; 3) establishing collaboration between HO and RO trainees by working together in assigned teams. Course impact was assessed pre- and post- training with a 13 question survey. Questions were answered using a 10 point scale, with a pre-defined rating system for each question. Results: Significant differences in responses to several survey questions were observed comparing pre- and post-course experience. Improvement in comfort level when discussing survivorship issues with patients (median pre-course score=6, post-course=8; p=.001), reported knowledge of survivorship care for 5 types of cancer (5 to 7; p=.002), confidence in ability to explain a SCP to a patient (5 to 8; p=.001), and comfort discussing late effects of treatment with patients (5 to 8; p=.001). The number of articles read regarding cancer survivorship increased. Five unique sets of TS and SCP’s were completed. Conclusions: This study demonstrates the feasibility of implementing cancer survivorship education into the curriculum of HO and RO training. This represents, to our knowledge, the first documented educational undertaking of its kind nationally in HO and RO Programs.
Current approaches in the treatment of malignant ascites in Germany and Austria.
Authors: Lueftner Diana , Küpferling Susanne , Oskay-Özcelik Gülten , Jehn Christian
Published: March 2020

e20670

Background: Malignant Ascites (MA) is a common manifestation of advanced cancer associated with a poor prognosis and decreased quality of life. Currently there are no evidence based guidelines for the management of MA and only one agent is approved for its treatment. We conducted a survey with physicians throughout Germany and Austria, to get an overview of current approaches and opinions in the treatment of MA. Methods: 128 medical oncologists (MO), gastroenterologists (GE) and gynecologists (GYN) completed an electronic questionnaire consisting of 33 questions. Answers were evaluated with descriptive statistics. Results: 90% of the physicians were from Germany, 10% from Austria. 48% of those were MO, 30% were GYN and 14% were GE. Most physicians treated an average of 34 pts/year with MA. 26% of these pts suffered from ovarian, 20% from pancreatic, 17% from gastric and 14% from colorectal cancer. The majority of the physicians associated MA with poor prognosis (92%) and significant reduction in quality of life (87%). One third felt MA was a contraindication for full dosing of systemic chemotherapy. Paracentesis (P) was performed in 70% of pts with with symptom relieve and quality of life being the main reasons. Almost half of the pts required 3-5 P, 50% even more than 5 P during the course of their disease. Only 15% of pts needed multiple P per week, the majority (79%) needed the procedure either once a week or every 14 days. In 61% of pts 3-5 l ascites fluid was drained. Only in 8%, 5 l and more were removed. Volume substitution with IV albumin was performed in 40% of pts. Most pts (55%) had to stay 1-3h in a healthcare facility for the procedure. However 21% had to stay > 1 day. While almost all physicians (89%) performed a P at some point in the treatment of MA, 75% felt that a systemic chemotherapy and 55% thought a concomitant diuretic therapy were a necessary adjunct. 7% of the pts received a targeted treatment with catumaxomab. Conclusions: Even though repeated P is the main pillar of treatment of MA, its effect is only temporary, must be performed multiple times, requiring hospital resources. Further treatment strategies have to be evaluated in prospective studies. Targeted therapies like catumaxomab should be integrated into these.
Role of pre-operative serum magnesium (Mg) concentration on post-operative pain intensity and opioid usage in gynecologic surgery.
Authors: Azari Laleh , Stelts Sundae , Santoso Joseph T , Kocak Mehmet
Published: March 2020

e20673

Background: Hypomagnesemia is a common problem, occurring in nearly 12% of hospitalized patients. Due to the link of hypomagnesemia with surgery and the potential antinociceptive effects of Mg multiple trials have been conducted. Unfortunately, the role of IV and epidural Mg supplementation in pain management perioperatively remains controversial. An unanswered question from the literature to date is whether low serum Mg concentrations correlate with pain intensity. This review of patients undergoing gynecological surgeries examines whether pre-operative serum Mg level can affect pain scores and opioid use postoperatively. Methods: This was a retrospective study of the electronic medical record at Methodist University Hospital from October 1st, 2011 to July 31st, 2012. Included for analysis are all cases that underwent a gynecologic surgery and were performed under one attending surgeon. Each patient included in the study had perioperative serum Mg levels, resting and moving pain intensity scores, and amount of opioids used. Patients were excluded for any of the following criteria: missing data, discharge in less than 24 hours, robotic surgery, and use of ketamine in anesthesia. Statistical analysis included descriptive statistics, Spearman’s rank correlation coefficient, and logistic regression. Results: The analysis included 121 patients; 54% were Caucasian, the mean age was 51.7 years and 89% of surgeries were for oncologic indications. Pre-operative serum Mg level was not significantly associated with resting or moving pain intensity scores on post operative day (POD) 1 (p=0.66; p=0.68) or POD 2 (p=0.58, p=0.83). Pre-operative Mg level was not significantly associated with opioid use on POD 1 or 2. Two variables had a possible correlation with opioid usage, on average older patients used a lower level of opioid on average and patients with higher BMI used a higher level of opioids. Conclusions: Preoperative magnesium level has no correlation with pain scores or opioid use. While repletion maybe warranted and magnesium supplementation has minimal toxicity and cost, effect on post-operative pain is uncertain. Larger randomized trials may be warranted.
Care cycle on advanced cancer: Reforming a value-based system.
Authors: Tsukuda Hiroshi , Suzumura Tomohiro , Yonesaka Kimio , Fukuoka Masahiro
Published: March 2020

e20682

Background: In Japan, reconstruction of medical service system for cancer patients is urgent necessity. On medical service system, economist Michael E. Porter and Elizabeth Olmsted Teisberg advocated that value in health care is determined in addressing the patient's particular medical condition over the full cycle of care. In our facility, we adopted their concept to our cancer care system. Methods: In our facility, the cancer care team conducted by medical oncologists provides the best value across the full span of care services. In order to manage our care delivery value chain (CDVC) for advanced cancer, we innovated 'Annshin Card' system. 'Annshin means comfort in Japan. This card functions as a key among the patients, home nursing teams and us. We analyzed 772 patients from the tumor registry of our hospital from 7/12/2010 to 12/31/2012. The following factors were evaluated: (1) the overall incidence rate of emergency visit among patients with an 'Annshin cards', (2) the length of hospitalization and the rate of mortality at our palliative care unit (PCU) as hospitalizing indicators and (3) the medical profession income and expenditure rate as an indicator of cost-benefit. Results: (1) Of 772 patients, 419 patients were adopted 'Annshin card' system. Among patients with an 'Annshin card', the overall incidence rate of an emergency visit was 2.0 visits per 100 patients per month (/100/month). (2) Of 772 patients, 411 patients have been hospitalized in PCU and 748 events of hospitalization to PCU occurred. On 748 events, the average length of hospitalization was 19.8 [ 0-263 ] days; leaving hospital mortality was 274 events (36.6%). (3) On the medical profession income and expenditure rate, before vs. after launching our system, 85.3% vs. 95.8%, respectively. Conclusions: Our CDVC for advanced cancer not only reduced the emergency visit rate, but improved the indicators of hospitalization. Furthermore this system brought cost-benefit. We suppose that the concept of care cycles is effective for cancer patient management.
Symptom burden among metastatic cancer patients receiving palliative chemotherapy.
Authors: Luna Herdee Gloriane Cristal , Montoya Jose Enrique , Morelos Amherstia , Amparo Jose Roberto , Marbella Leo , Lesaca Reynaldo , Cristal-Luna Gloria R.
Published: March 2020

e20696

Background: Cancer-related symptoms are less investigated but frequently reported patient-experienced symptom clusters. In palliative oncology, focus is on recognizing and addressing these symptoms, and giving quality of life. The purpose of this study is to determine the severity of cancer related symptoms among metastatic cancer patients on palliative chemotherapy using the MD Anderson Symptom Inventory (Filipino) [MDASI-F]. Methods: A cross-sectional study among metastatic cancer patients undergoing palliative chemotherapy at the National Kidney and Transplant Institute, Philippines, was performed using MDASI-F. Results: A total of 114 patients were included with a mean age of 55.5 years. 61% were female, and 39% were male. 81.6% were married, while 14% were single and 4.4% were widowed. Highest educational level attained were college (78.1%), high school (19.3%) and primary school (2.6%). Average Body Mass Index fall on 23 kg/m2. Majority of the patients have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 1 (54.4%), followed by ECOG 2 (19.3%), ECOG 0 (18.4%), and ECOG 3 (7.9%). The most common cancer site is breast (30.7%), followed by colon (21.9%), and lungs (16.7%), while the remaining 30.7% belong to other cancer sites. Majority of the patients have one metastatic site (68.4%), 22.8% have two, while 8.8% have 3 metastatic sites. Mean duration of illness from the time of diagnosis was 13.67 months. The most severe cancer related symptoms were sleep disturbance (mean 3.48), fatigue (mean 3.36) and pain (mean 3.14). Interestingly, all Filipino metastatic cancer related severity symptoms and interference items belong to the mild severity score (scores of 0-3) using the MDSAI-F. Conclusions: Among Filipino metastatic cancer patients on palliative chemotherapy, cancer-related symptom severity items and interference items were shown to have mild severity scores based on the MDASI-F.
Carbamazepine for the prevention of chemotherapy-induced nausea and vomiting: A pilot study using the Simon's optimal two-stage design.
Authors: Santana Thaiana ARAGAO
Published: March 2020

e20699

Background: Nausea and vomiting have been a major drawback to patients undergoing chemotherapy. Despite standard preventive treatment, chemotherapy-induced nausea and vomiting (CINV) still occurs in approximately 50% of patients. Because of its high cost, this treatment is unavailable in centers where health assistance is provided by the government. As an effort to ameliorate prevention of CINV at lower costs, we studied the efficacy of the addition of carbamazepine to a regimen of corticosteroid plus 5-hidroxitriptamine-3 receptor antagonist for prevention of CINV as well as its side effects and influence on patients’ quality of life. Methods: This is a prospective open label phase II nonrandomized study carried out in a Brazilian public Oncology service. Patients scheduled to receive the first cycle of highly emetogenic chemotherapy were continuously recruited. Besides the current standard antiemetic treatment, patients received carbamazepine, p.o., according to the following schedule: 200 mg QD on the third day before chemotherapy; 200 mg BID on the second day before chemotherapy; 200 mg TID from one day before until the fifth day after chemotherapy. Considering sparse evidence about the anticonvulsants’ efficacy in CINV prevention, we adopted Simon’s optimal two-stage design which should include 43 patients unless overall complete prevention was not achieved in 9 out of the first 15 entries. Functional Living Index-Emesis (FLIE) questionnaire was used to measure impact on quality of life. Results: None of ten studied patients (0%) had overall complete prevention and nine needed rescue medication. Three quitted carbamazepine therapy because of somnolence and vomiting before chemotherapy infusion. Seven were able to take medication for the entire period and none were responsive, so the study was closed. There was no impact on patients´ quality of life. Conclusions: Carbamazepine was not effective for prevention of CINV and should not be used for this purpose out of experimental settings. The Simon optimal design allowed us to reach this data and stop the trial for futility, minimising the number of patients possibly exposed to an inactive agent.
Prevalence of self-reported cognitive dysfunction in breast cancer patients.
Authors: Skirbe Heidi , Hohn Gabriela , Klein Paula , Juliano Mary Ann , Winell Jeremy , Rosenwald Victoria , Festa Joanne
Published: March 2020

e20701

Background: A series of four time-limited, psycho-educational workshops was piloted by a neuropsychologist at an urban academic medical center, providing information, coping strategies, and resources to women who had been treated for breast cancer (BrCa) and who then sought cognitive treatment. Based on positive evaluations of these workshops, we assessed the prevalence of self-reported cognitive dysfunction in BrCa patients with the goal of assessing the need for and interest in the expansion of cognitive services to affected patients. Methods: The study was IRB approved. A convenience sample of 50 BrCa patients in a medical oncology waiting area completed a 16 item questionnaire which assessed potential cognitive problems on a 4-point Likert scale, with responses ranging from 0 (no problem) to 3 (serious problem). Results: Fifty patients completed the survey, of whom 46% requested further information on cognitive services. Conclusions: An unexpectedly large proportion of BrCa patients perceived cognitive difficulties, possibly compounded by fatigue and emotional dysfunction, and expressed interest in cognitive supportive services. Others may have failed to report cognitive difficulties, unaware of their onset. Quality of life of cancer patients is diminished by cognitive decline. Our data indicate a need for and interest in formal assessment and intervention programs to identify patients with cognitive and emotional dysfunction and offer remediation via workshops and therapy. Formal neuropsychological assessment and treatment resourcestargeting cognitive changes associated with cancer should be expanded to meet documented need. Further research will optimize the scheduling and structure of interventions. [Table: see text]
Epidemiology, risk factors, and outcomes in malignant bowel obstruction.
Authors: Vieito Maria , Martinez Lago Nieves , Campos Marta Carmona , Rodriguez Lopez Carmela , Barón Francisco J. , Candamio Sonia , Galrisa Neto Isabel , Lopez Rafael
Published: March 2020

e20708

Background: Malignant bowel obstruction is a complex syndrome that needs a multidisciplinary management and a better definition of prognostic risk factors. Methods: Information of patients with known history of cancer, admitted for a first episode of suspected malignant bowel obstruction, between 2008 and 2010 with consultation by a medical oncologist or palliative care specialist was reviewed and epidemiological variables like sex, age, localization, histology, and clinical stage treatments received, presence of infiltrating abdominal tumors, and peritoneal carcinomatosis were recorded at diagnosis and at the time of admission. Results: The basal characteristics of the 115 patients are resumed in the Table. At admission patients had in their majority known stage IV disease (75%) with previous evidence of peritoneal carcinomatosis in 63% of cases and of intra abdominal infiltrating masses in 49%, but only half of the patients were receiving active chemotherapy. Nearly all patients presented symptoms like pain (98%) and nausea (91%), followed by vomit and abdominal distension and a deterioration of their performance score (9% PS0-1, 43% PS2, 33% PS3, 13% PS4). Palliative prognostic index (PPI) altered items were mainly oral intake (64%) and edema (21%). They were treated with antisecretors (octreotide 58%, butylscopolamine 26%), anti-emetics, (ondasetron 65%, metoclopramide 46%) neuroleptics (60%), corticosteroids (59%) and analgesics (opioids in 66%). Conclusions: The episode of obstruction could be resolved in a median of 12 days in more than half of our patients(59%), this led to an acceptable rate of outpatient management of 61%, nerveless the prognosis of this patients is still very poor. with a median survival from the moment of obstruction of only 42 days and a rate of reobstruction of 52%. [Table: see text]
Interobserver correlation of morphometric data obtained from routine preoperative abdominal CT scans in pancreatic surgery.
Authors: Shelton Tiffani Dawn , Franko Jan , Goldman Charles David , Grimm Shawna
Published: March 2020

e20714

Background: Quantification of frailty is necessary for estimation of therapy tolerance. Sarcopenia is a recognized measure of frailty and predicts long-term survival in both non-surgical and surgical cohorts. Here we set to evaluate interobserver agreement for certain sarcopenia parameters on routine abdominal CT scans among patients undergoing Whipple procedure for suspicion of neoplasm. Methods: Two observers using a standardized protocol for measurements of linear and surface morphometric parameters independently reviewed thirty abdominal CT scans. Results: Mean morphometric data for the entire group were: total psoas area 2237±868 mm2, mean psoas muscle density 46±9 HU, mean psoas antero-posterior diameter 40±8mm, mean psoas latero-lateral diameter 36±8 mm, mean rectus muscle thickness 9.2±2.6 mm, mean distance between anterior vertebral L4 surface and linea alba 115±28 mm (L4-alba distance), mean subcutaneous fat thickness 23.7 ±11.5mm, mean L4 vertebra antero-posterior diameter 37.6±5.2 mm. Excellent inter-observer correlation was observed for total psoas area is R2=0.788, p<0.001. Similarly good correlation was detected between observers for rectus muscle thickness (R2=0.6019, p<0.001), subcutaneous fat thickness (R2=0.731, p<0.001), and L4-alba distance (R2=0.601, p<0.001). Poor correlation was observed for L4 diameter (R2=0.392,p=0.0014). No interobserver correlation was observed for psoas muscle density (R2=0.005, p=0.743). Conclusions: Excellent degree of interobserver correlation was observed for the following morphometric data obtained from abdominal CT scans: Total psoas muscle area, L4-alba distance, rectus muscle and subcutaneous fat thickness. Further studies are needed to evaluate utility of morphometric parameters for prediction of surgical outcomes.
AVAST-M: Adjuvant bevacizumab as treatment for melanoma patients at high risk of recurrence.
Authors: Corrie Philippa , Marshall Andrea , Goonewardena Madusha , Dunn Janet A. , Middleton Mark R. , Nathan Paul D. , Gore Martin Eric , Davidson Neville , Nicholson Steve , Kelly Charles G. , Marples Maria , Danson Sarah , Marshall Ernest , Houston Stephen , Board Ruth E. , Waterston Ashita Marie , Nobes Jenny , Harries Mark , Barber Jim , Lorigan Paul
Published: March 2020

LBA9000

The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Saturday, June, 1, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.
An open-label, randomized, phase II study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) given sequentially with ipilimumab in patients (pts) with advanced or metastatic melanoma (MEL).
Authors: Hodi F. Stephen , Baudelet Christine , Chen Allen C. , Weber Jeffrey S.
Published: March 2020

TPS9107^

Background: Programmed death-1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4) are immune checkpoint receptors that attenuate T-cell responses and contribute to immune evasion by tumor cells. Nivolumab is a PD-1 receptor blocking monoclonal antibody that has shown clinical activity in phase 1 trials with various tumor types including MEL. Ipilimumab is an anti-CTLA-4 monoclonal antibody approved for advanced or metastatic MEL. Preclinical data suggest that combined PD-1 and CTLA-4 receptor blockade may improve antitumor activity in MEL, with PD-1 blockade upregulating CTLA-4 expression and CTLA-4 blockade upregulating PD-1 expression on tumor-infiltrating T cells. We describe a phase II study evaluating nivolumab administered sequentially with ipilimumab in pts with advanced (unresectable stage III) or metastatic (stage IV) MEL. Methods: This open-label, phase II study will enroll approximately 80 pts. During the induction period, pts will be randomized 1:1 to either nivolumab (3 mg/kg, q2w) from Weeks (Wk) 1-13 followed by ipilimumab (3 mg/kg, q3w) from Wks 14-25, or ipilimumab followed by nivolumab at the same doses and schedules. All pts will then receive nivolumab (3 mg/kg, q2wk) during the continuation period until disease progression or unacceptable toxicity, for ≤2 years from initial study treatment. Pts may be treatment-naive or have disease recurrence or progression after one prior systemic therapy, excluding prior anti-PD-1, anti-CTLA-4, or a BRAF inhibitor. The primary endpoint is the incidence of treatment-related Grade 3–5 adverse events (AEs) during the induction period. Secondary endpoints are response rate at Wk 25 and progression rates at Wks 13 and 25. Exploratory endpoints include safety and tolerability; overall survival; pt-level time course of treatment-related grade 3–5 AEs, response, progression, treatment discontinuation, and death; the association of changes in pharmacodynamic immune markers from baseline to Wk 13 and Wk 25 and clinical response; the association between baseline immunological parameters and clinical response; and immune-related single nucleotide polymorphisms. Clinical trial information: NCT01783938.
Exercise for cancer-related fatigue and putative functional, inflammatory, and metabolic mechanisms in patients receiving chemotherapy: A URCC CCOP research base phase III RCT.
Authors: Mustian Karen Michelle , Janelsins Michelle Christine , Peppone Luke Joseph , Sprod Lisa , Palesh Oxana , Kamen Charles Stewart , Peoples Anita Roselyn , Heckler Charles E. , Kasbari Samer S. , Scalzo Anthony Joseph , Reddy Pavan S. , Esparaz Benjamin , Morrow Gary R.
Published: March 2020

TPS9651

Background: Up to 100% of cancer patients report cancer-related fatigue (CRF) during chemotherapy which co-occurs with impaired cardiopulmonary (CPF) and neuromuscular function (NMF), chronically up-regulated inflammatory responses, and low metabolic energy expenditure. CRF interferes with completion of treatment, increases cancer morbidity and mortality, and impairs quality of life (QOL). Exercise is one of the most promising treatments available for CRF, but no large multicenter phase III RCTs have confirmed these findings and little is known about the mechanisms through which exercise may impact CRF. Methods: We are conducting a nationwide multicenter phase III RCT (N=692) through the URCC CCOP Research Base with 23 CCOP affiliates. The primary aim is to determine if exercise will significantly improve CRF, and secondarily, CPF, NMF, inflammation, energy expenditure, and QOL compared to standard care in cancer patients receiving chemotherapy. The exercise intervention is our standardized, individually-tailored, home-based walking and progressive resistance program, “Exercise for Cancer Patients” (EXCAP, 7 days/wk, 6wks). To be eligible, patients must: 1) have a confirmed diagnosis of cancer with no leukemia or metastasis, 2) be chemotherapy naïve and scheduled to start, 3) not be receiving concurrent radiation, 4) have a KPS of >70, 5) be ≥21 years of age, 6) have no contraindications to exercise or functional testing, and 7) not be currently exercising. CRF and all secondary outcomes are assessed at baseline (pre-chemotherapy), 3 weeks (mid-intervention), and 6 weeks (post-intervention). Measures include: 1) CRF-Brief Fatigue Inventory, 2) CPF-6-minute walk test, 3) NMF-handgrip dynamometry, 4) inflammation-serum ELISA levels, 5) energy expenditure-actigraphy, and 6) quality of life-Functional Assessment of Chronic Illness Therapy. The DSMC reviewed the trial in October of 2012 and suggested it continue as planned. 532 participants have been enrolled in 36 months. Funding: NCI U10CA037420, U10CA37402-28, K07CA120025, K07CA132916, 1R25CA102618, ACS MRSG1300101CCE. Clinical trial information: NCT00924651.
Gender-based analysis of pre-residency research productivity among a current United States radiation oncology resident class.
Authors: McClelland Shearwood , Murphy Blair , Jaboin Jerry Jeff , Zellars Richard C.
Published: March 2020

10504

Background: The increasing proportion of women in medicine has not been adequately reflected in the gender distribution of residents, particularly in highly competitive subspecialties such as neurosurgery and radiation oncology. The presence of at least one pre-residency peer-reviewed publication (PRP) was found to be associated with future resident choice of academic over private practice career in a recent radiation oncology resident graduating class, with no significant gender difference in the likelihood of having a PRP (McClelland et al., Practical Radiation Oncology 2017). We sought to pursue a gender-based analysis of PRP productivity in a current junior resident class. Methods: A list of radiation oncology residents from the graduating class of 2022 (PGY-2 academic year of 2018-2019) was obtained through internet investigation. In addition to gender, demographics included dual degree status and presence/absence of a PhD. Research productivity was calculated using PRP number, defined as the number of a resident’s publications listed in PubMed (pubmed.gov) through the calendar year of residency application (2016 for the class of 2022), as previously described. Fisher’s exact test was used for statistical analysis. Results: Of 179 residents examined from the 2022 class, 55 (31%) were women, representing a nine percent increase from the resident class of 2016. Four-fifths had at least one PRP, 33% had dual degrees, and 18% had a PhD. These percentages were comparable to their male counterparts, 73% of whom had at least one PRP, 28% who had dual degrees, and 15% who had a PhD. Specific analyses revealed no statistically significant differences by gender in any of these benchmarks (p>0.05). Conclusions: While slower than the overall trend of increased female representation in medicine, the proportion of women in radiation oncology residency has increased by approximately 1.4% per year over a recent six year span. There remain no significant differences in PRP productivity between male and female residents, and there are no significant gender differences in the likelihood of dual degree status or PhD status. Further study will be needed to determine how these findings manifest in career choice following graduation.
Mindful fellows: Study results from a pilot wellness curriculum in hematology oncology.
Authors: Chatwal Monica Sheila , Vinci Christine , Reich Richard R. , McDowell Marc , Reagan Angela , Gray Jhanelle Elaine
Published: March 2020

10508

Background: Rates of physician burnout, depression, and career dissatisfaction are rising. It is imperative to develop solutions. Studies find mindfulness is an effective therapeutic means for physician burnout, but few programs address this in clinical trainees, specifically hematology oncology fellows. The aims of this pilot study were to determine the feasibility and acceptability of a mindfulness-based wellness curriculum. To our knowledge, this is the first study assessing this type of intervention in this population. Methods: In this single center, nonrandomized study, six monthly 30-45 minute sessions were integrated within the framework of existing didactic conferences. Each session had two parts – didactics on mindfulness and guided meditation exercises. Sessions were led by a social worker trained in mindfulness techniques. Participants completed pre and post intervention questionnaires, including Mindfulness Attention Awareness Scale (MAAS) (Carlson, 2005), Perceived Stress Scale (PSS) (Cohen, 1983), and reflection questions, with an opportunity for free responses. The primary endpoint was feasibility as determined through recruitment (target 70%) and treatment adherence defined as participation and questionnaire completion (target 80%). A secondary aim was acceptability determined through self-reflection questions (target 80%). Results: A total of 27 participants (59% female) enrolled with 37% in post-graduate year 6 (PGY-6). Of the eligible fellows, 96% enrolled and 96% of participants completed questionnaires. On self-reflection questions, 65% reported that the program was useful and 81% reported they would participate again in the future. Participants suggested modifications including location, timing, and a broader scope to include skills in addition to mindfulness (e.g. resiliency-focused). Data on self-reported levels of stress and self-awareness, an exploratory aim, will be presented at the meeting. Conclusions: Findings indicate that a mindfulness-based wellness curriculum was both feasible and acceptable for hematology oncology fellows. Modifications are being made to expand on this program, and incorporate it as a recurring component of the existing curriculum.
Evaluation of Colorado oncology providers on the use of medical marijuana.
Authors: Glode Ashley Elizabeth , Wright Garth C. , Leong Stephen
Published: March 2020

10511

Background: There is a lack of knowledge regarding medical marijuana use in cancer patients. More information is needed due to increase in both state approvals and access to medical marijuana. We hypothesized that variation in provider knowledge, attitudes, and behaviors exists across all professions in oncology, which contributes to a lack of both provider awareness of patient use and patient education on marijuana use. Methods: A survey was distributed to oncology providers in the state of Colorado. The primary objective was to describe provider knowledge, attitudes, and behaviors regarding medical marijuana use in cancer patients. Other objectives were identifying educational needs for oncology providers to feel comfortable recommending medical marijuana and reporting provider interest in future marijuana studies. Results: We received responses from 172 oncology providers; 48 advanced practice providers, 47 physicians, 53 registered nurses, 17 pharmacists, and 7 other. Most providers (73.3%) believe marijuana provides a medical benefit to cancer patients, and 81.5% believe it should be available as a prescription drug. Yet, 60.1% had not recommend its use to any cancer patient in the past 6 months, and 54.3% are not comfortable recommending or suggesting it to a patient to manage cancer related symptoms. Major concerns included uncertain dosing (83%), limited knowledge of available products and where to get them (73.1%), and interactions with other medications (64.9%). Providers reported that educational programs for healthcare providers (79.3%), more clinical data (74%), and endorsed clinical guidelines (67.5%) would increase their comfort level in recommending medical marijuana. The areas of research most interesting or important were specific product information and doses (77.6%), efficacy for specific side effects (77.6%), and drug-drug interactions (74.7%). Conclusions: Regardless of profession, the majority of oncology providers in Colorado do not recommend and do not feel comfortable recommending or suggesting medical marijuana to a cancer patient, yet most believe it provides medical benefit. Providers believe there is a need for education and research on the use of medical marijuana in oncology patients.
Burnout and level of mental functioning in oncology staff.
Authors: Alcorta-Garza Adelina , Alcorta-Nuñez Fernando , Vidal-Gutiérrez Oscar , Gonzalez-Guerrero Juan Francisco , Garza-Guerrero Antonio César , Gómez-Meza Marco Vinicio , Alcorta-Garza Ángel Enrique
Published: March 2020

10513

Background: The Burnout Syndrome takes relevance for its investigation since 1986, when Maslach developed a survey for its study with 3 subscales that include the symptoms generated by exhaustion and chronic labor stress. Health workers are especially vulnerable to the development of this syndrome, which is greater centers with exposure to patients with severe and/or chronic ailments. Thus, the mental structure maturity level with which the individual functions takes relevance, since it is linked to the quality of judgment of the clinician. Few studies consider this aspect because of the complexity of having the instruments and professionals to assess it. It has been questioned whether Burnout or this occupational exhaustion damages the quality of life of the individual, and if it also negatively impacts their work performance, and the quality of care provided to patients. Methods: Observational, cross-sectional and correlational study. It analyses the relationship between Burnout and the characteristics of the mental-structural functioning level in oncology staff, and its association with the level of functionality of the mental structures within the work environment. Prior validation of the instrument was conducted, FIAD-15, with acceptable Alpha of 0.81. Results: Data were obtained from 1,060 subjects, including administrative, nursing and medical members of the Oncology Service staff, as well as, students. Out of these, 1,036 subjects answered the questionnaire appropriately and were considered in the analysis. 413 (39.86%) presented Burnout. The prevalence was higher in men (45.17%) than in women (34.56%). A significant association was found between Burnout frequency and levels of mental functioning. On the functionality of the mental structures, 80% had functional, high and intermediate levels, while 20% of the total population showed a borderline level of functionality (severe). In women, Burnout frequency was higher in borderline levels, followed by those of functional and high level. In men, Burnout was higher in those at the borderline level, followed by functional and intermediate; it was much lower in high level subjects. Conclusions: The mental structure functionality levels found in the oncology staff are associated with Burnout; which is lower in men with structures with high functionality and in women in the intermediate level. Subjects with borderline structures suffer greater Burnout. Further studies should be carried out to support these findings in the future and open new lines of research.