bluuebunny/crossref_metadata_2025_split huggingface dataset:
Sex differences in adverse event reporting in SWOG chemotherapy, biologic/immunotherapy, and targeted agent cancer clinical trials.
Authors: Unger Joseph M. , Vaidya Riha , Albain Kathy S. , LeBlanc Michael Leo , Minasian Lori M. , Gotay Carolyn , Henry Norah Lynn , Fisch Michael Jordan , Ramsey Scott David , Blanke Charles David , Lyman Gary H. , Hershman Dawn L. 
Published: March 2020

11588 Background: Women have more adverse events (AEs) from chemotherapy than men, but few studies have explored sex differences in biologic/immunotherapies (BIs) or targeted therapies. We examined subjective (symptomatic) and objective AEs by sex across different treatments. Methods: We analyzed drug-related severe (grade 3) or worse AEs by sex in SWOG phase II and III clinical trials conducted between 1980-2018, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events (CTCAE). Subjective or symptomatic toxicities were defined as those aligned with the NCI’s new Patient-Reported Outcome (PRO) CTCAE; lab-based or physician-determined AEs were designated as objective. Multivariable logistic regression was used, adjusting for age, race, and disease prognosis. Thirteen symptomatic and 19 objective AE categories were examined. Results: In total, 36,397 patients (women, 13,907 [38.2%]; men, 22,490 [61.8%]) experiencing 522,835 AEs on 297 trials with 385 treatment arms were analyzed. Overall, 29.1% (n = 10.860) had severe or worse toxicity. Women experienced an increased risk of severe symptomatic AEs for BIs (OR = 1.53, 95% CI: 1.32-1.78, p < .0001), chemotherapy (OR = 1.31, 95% CI: 1.24-1.39, p < .0001), and targeted therapies (OR = 1.23, 95% CI: 1.06-1.43, p = .008). Women also had an increased risk of severe objective AEs for BIs (OR = 1.53, 95% CI: 1.32-1.78, p < .0001), chemotherapy (OR = 1.35, 95% CI: 1.28-1.43, p < .0001), but not targeted therapies (OR = 1.08, 95% CI: 0.94-1.25, p = .28). Across all treatments, sex differences were greater for hematologic (OR = 1.29, 95% CI: 1.24-1.35, p < .0001) v. non-hematologic (OR = 1.13, 95% CI: 1.08-1.18, p < .0001) objective AEs. Conclusions: The greater severity of both symptomatic and objective – especially hematologic – AEs in women across multiple treatment paradigms indicates broad-based sex-differences exist. This could be due to AE reporting, pharmacogenomics of drug metabolism and disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving BIs, suggesting studying AEs from these agents is a priority.
The effect of structured exercise during chemotherapy on chemotherapy-induced peripheral neuropathy (CIPN): A role for interoceptive brain circuitry.
Authors: Kleckner Ian , Gewandter Jennifer S. , Heckler Charles E. , Staples Susan , Colasurdo Ann , Lin Po-Ju , Shayne Michelle , Huston Alissa , Magnuson Allison , Tejani Mohamedtaki Abdulaziz , Dunne Richard Francis , Fung Chunkit , Lipe Brea , Passero Frank Charles , Mohile Nimish , Morrow Gary R. , Janelsins Michelle Christine , Mustian Karen Michelle 
Published: March 2020

11590 Background: Over half of patients receiving “neurotoxic” taxane, platinum, or bortezomib chemotherapy experience CIPN—a dose-limiting toxicity involving numbness and pain in the extremities. There are no FDA-approved drugs for CIPN, but exercise may help. This randomized pilot study explored whether structured exercise during chemotherapy ameliorates CIPN symptoms and whether improvements involve changes in the brain’s sensory processing (interoceptive) circuitry. Methods: Nineteen patients scheduled to receive taxane, platinum, or bortezomib were randomized to exercise (home-based, low-moderate intensity, walking and resistance training; EXCAP) or nutrition education (control) for 12 weeks starting at their first infusion. At 0, 6, and 12 weeks, we assessed CIPN symptoms using the CIPN-20 questionnaire (sensory scale, ranges 9-36, higher is worse) and a finger tactile sensitivity task. We assessed resting functional connectivity between the insula and thalamus via fMRI at 0 and 12 weeks. We used linear regression to model each outcome, tested for an effect of exercise, and controlled for baseline value and age because controls were older. Given the pilot nature of this study we present effect sizes, not p-values. Results: The 19 patients were 65±11 years old, 52% women, with cancer: 42% breast, 32% gastrointestinal, 16% myeloma, and 10% genitourinary. Exercise mitigated CIPN symptoms per the CIPN-20 sensory scale. At 6 weeks, exercisers increased from 11.0 to 12.5 whereas controls increased from 11.0 to 15.5 (+1.5 vs. +4.5; ES = 0.81). At 12 weeks, exercisers increased from 11.0 to 14.8 whereas controls increased from 11.0 to 16.2 (+3.8 vs. +5.2, ES = 0.46). The finger-touching test corroborated results at 6 and 12 weeks (ES = 1.03 and 0.07). Exercisers showed better (reduced) insula-thalamus connectivity vs. controls (ES = 0.41). Reductions in connectivity were correlated with smaller increases in CIPN symptoms (r = 0.74). Conclusions: Exercise during neurotoxic chemotherapy mitigated CIPN symptoms, perhaps via improvements in interoceptive brain circuitry. Future work should test for replication with a larger sample. Clinical trial information: NCT03021174.
Physician concordance with update to ASCO guidelines for antiemetic use with carboplatin AUC ≥ 4.
Authors: Navari Rudolph M. , Ruddy Kathryn Jean , LeBlanc Thomas William , Clark-Snow Rebecca Anne , Wickham Rita S. , Binder Gary , Coberly Tammy Bratton , Potluri Ravi C. , Schmerold Luke M. , Roeland Eric 
Published: March 2020

11595 Background: In 2017, NCCN (2/2017) and ASCO (8/2017) each amended antiemetic guidelines to classify carboplatin AUC ≥4 as highly emetogenic chemotherapy (HEC), recommending upfront triple prophylaxis with an NK1 receptor antagonist (RA) + 5HT3 RA + dexamethasone. Physician concordance with the new recommendations, and the consequences for avoidable post-chemotherapy acute care, merit study. Methods: In a large electronic health record database (IBM Explorys), we identified carboplatin courses of therapy (≥14-day cycles as a proxy for AUC ≥4) and courses with ≥7-day cycles of other HEC and non-HEC therapy from 4Q 2012 through August 2018. Guideline concordance, defined as triple prophylaxis at HEC initiation, was evaluated. We also assessed 30-day post-chemotherapy acute care (inpatient or emergency department) associated with nausea or vomiting (NV) or eight other toxicities deemed avoidable in the US Centers for Medicare & Medicaid’s new oncology outcome measure OP-35. Results: 11,554 carboplatin courses were identified. Before the guideline change, rates of upfront triple prophylaxis grew from 14% in 2013 to 16% in mid-2017. Rates then rose to 26% by 1Q 2018 before dropping to 21% by 3Q 2018; quarterly rates averaged 20% (range 15%-26%) following the guideline change. In 31% of carboplatin courses we noted 30-day acute care use, of which 75% involved ≥1 of the ten OP-35 toxicities. NV (with or without acute care use) was reported in 24% of courses, and 27% of total OP-35 acute care events involved NV. Rates for NV, and for OP-35-related and NV-related acute care after carboplatin, were similar to rates after other HEC chemotherapy, and higher than rates after other non-HEC IV chemotherapy or oral HEC/MEC agents. Conclusions: Use of upfront triple antiemetic prophylaxis has increased only marginally for carboplatin AUC ≥ 4 since its 2017 re-classification as HEC in national guidelines, perhaps due to low awareness of the change. Patients receiving carboplatin had similar rates of NV and related 30-day acute care events as seen for other HEC, confirming that the new HEC definition fits clinical experience. More triple prophylaxis use is needed to reduce NV and NV-related avoidable acute care seen with carboplatin AUC ≥ 4.
Effect of whey protein isolate supplementation on body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy.
Authors: Pedrazzoli Paolo , Cereda Emanuele , Cappello Silvia , Arcaini Luca , Borioli Valeria , Ferraris Elisa , Chiellino Silvia , Stella Giulia , Benazzo Marco , Ferrari Alessandra , Klersy Catherine , Caccialanza Riccardo 
Published: March 2020

11598 Background: Malnutrition is frequent in cancer pts, particularly in advanced disease, which requires appropriate multidisciplinary interventions. We evaluated the benefit of whey protein isolate (WPI) supplementation in addition to nutritional counseling in malnourished cancer pts undergoing chemotherapy (CT). Methods: In a single-center, randomized, pragmatic, parallel-group controlled trial (ClinicalTrials.gov: NCT02065726), 166 malnourished advanced cancer pts undergoing CT were randomly assigned to receive nutritional counseling with (N=82) or without (N=84) WPI supplementation (20 grams/daily) for 3 months. Primary endpoint was the change in phase angle (PhA). Secondary endpoints included changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, quality of life and CT toxicity. Results: In pts with the primary endpoint assessed (modified intention-to-treat population), counseling plus WPI (N=66) resulted in improved PhA compared to nutritional counseling alone (N=69): mean difference, 0.48° [95%CI, 0.05 to 0.90] (P=0.027). Imputation of missing outcomes yielded consistent findings. WPI supplementation resulted also in improved SPA (P=0.021), FFMI (P=0.041), body weight (P=0.023), muscle strength (P<0.001) and in reduced risk of CT toxicity, particularly of severe (grade ≥3) events (Table). Conclusions: In malnourished advanced cancer patients undergoing CT and receiving nutritional counseling, 3-month supplementation with WPI resulted in improved body composition, muscle strength, body weight and reduced CT toxicity. Further trials in newly diagnosed specific cancer types are warranted. Clinical trial information: NCT02065726. [Table: see text]
Interim analyses of the efficacy of a collaborative care intervention for patients diagnosed with comorbid cancer and depression.
Authors: Steel Jennifer Lynne , Miceli Jessica , Hecht Carol Lynn , Tsung Allan , Marsh Wallis , Antoni Michael , Vodovotz Yoram , Peddada Shaymal , Spring Michael , Jackson Heather , Vanegas Yanet , Olejniczak Donna , Chen Qi , Geller David A. 
Published: March 2020

11599 Background: There is an urgent need for evidence-based and scalable interventions to reduce depression, pain, and fatigue and improve quality of life in patients diagnosed with cancer. The aims of this study were to share the interim analyses of testing the efficacy of a stepped collaborative care intervention for patients diagnosed with cancers affecting the hepatobiliary and pancreatic system. Methods: Patients were screened for clinical levels of depression, pain, or fatigue and were enrolled in the study if they screened positive for depression, pain, and/or fatigue. After completing a baseline battery of instruments, patients were randomized to the stepped collaborative care intervention or the screening and referral arm. Post-treatment data was collected at 6 months and 12 months to assess efficacy and maintenance of change in depressive symptoms. Results: A total of 100 patients have completed the post-treatment assessment. Interim data analyses revealed that the mean age of patients was 64.0 years (SD = 10.3) and the majority of patient were male (51%), Caucasian (89%), diagnosed with liver cancer (47%) and stage III and IV (60%). Patients randomized to the stepped collaborative care intervention reported significant reductions in depressive symptoms (F(1,92) = 6.22, p = 0.014) and improvements in quality of life (F(1,92) = 7.36, p = 0.008) with moderate effect sizes (Cohen’s d = 0.547 and 0.652, respectively) at 6-months. The mean change in depressive symptoms from randomization to 6-month post- treatment was -4.3 (SD = 9.7) for the patients randomized to the collaborative care intervention and +0.71 (SD = 9.4) for the patients randomized to the screening and referral arm of the study. The mean change in quality of life from randomization to 6-month post-treatment was +4.5 (SD = 16.2) for the patients randomized to the collaborative care intervention and -4.4 (SD = 15.2) for the patients randomized to the screening and referral arm of the study. Conclusions: This promising evidence-based, scalable intervention to treat comorbid cancer and depression was shown to be effective in reducing depressive symptoms and improving quality of life in patients with cancer. Clinical trial information: NCT02939755.
Progress and trends in the utilization and adoption of palliative care in patients with terminal gynecologic cancer in the United States: A study of 4,264 women.
Authors: Milki Anthony , Mann Amandeep Kaur , Kapp Daniel Stuart , Chan John K. 
Published: March 2020

11606 Background: To determine the factors associated with the utilization of palliative care (PC) in patients with metastatic gynecologic cancer who died while hospitalized. Methods: Data were extracted from the National Inpatient Sample (NIS) database for patients with cervical, uterine, and ovarian cancers from 2005 to 2011. Chi-squared and logistic regression models were employed for statistical analyses. Results: Of 4264 women with gynecologic cancer, 983 (23.0%) utilized PC (median age: 66 years). 2633 (61.8%), 1034 (24.3%), and 597 (14.0%) patients had ovarian, uterine, and cervical cancer, respectively. The majority were white (57.9%), and the remainder were black (12.6%), Hispanic (7.8%), and Asian (3.1%). 24.9, 23.9, 23.6, and 25.2% were low, low-middle, middle-high, and high with respect to median income. Medicare, Medicaid, and private insurance was found in 46.7, 10.8, and 37.6% of patients. 36.9, 21.0, 18.0, and 24.1% of patients were treated in hospitals in the South, West, Midwest, and Northeast. 11.3, 23.9, and 64.2% of patients were treated in small, medium, and large hospitals, designated as teaching (53.1%) and nonteaching (46.3%) institutions. The utilization of PC increased from 5.2% in 2005 to 30.4% in 2011. Older age (OR: 1.34; 95% CI: 1.10-1.64; P = 0.01), high SES (OR: 1.37; 95% CI: 1.09-1.72; P = 0.01), privately insured (OR: 1.81; 95% CI: 1.46-2.24; P < 0.001), treatment at Western (OR: 1.94; 95% CI: 1.56-2.41; P < 0.001) and Midwestern hospitals (OR: 1.43; 95% CI: 1.15-1.77; P = 0.001), and depression (OR: 1.34; 95% CI: 1.00-1.80; P = 0.05) were associated with higher PC use. However, race, cancer type, hospital teaching status, and hospital location were not associated with PC use. Conclusions: The use of inpatient palliative care has increased significantly over the study period. The lower utilization of palliative care for terminal illness associated with younger, lower socioeconomic status, Southern and smaller volume hospitals warrants further attention.
The individualized Goals of Care Discussion Guide: A simple tool to empower patients with metastatic breast cancer.
Authors: Peppercorn Jeffrey M. , Lei Yvonne Y. , Horick Nora , Quain Katharine M. , Dizon Don S. , Jimenez Rachel , Shin Jennifer Adrienne , Sepucha Karen , Perez Giselle Katiria 
Published: March 2020

11622 Background: Individualized treatment planning is a critical part of quality cancer care, but how best to achieve this for patients with metastatic breast cancer (MBC) is unclear. We evaluated the feasibility, acceptability and impact of using a simple and scalable “Individualized Goals of Care Discussion Guide” (IGCDG) to facilitate patient-provider communication at the time of treatment decisions. Methods: We developed the IGCDG based on structured interviews with MBC patients and input from experts in cancer care, decision sciences, psychology and palliative care. We then conducted a single arm feasibility trial among patients with newly diagnosed or progressive MBC. Prior to clinic, patients received the IGCDG, an 8-page MBC informational brochure and 1-page questionnaire regarding treatment preferences, personal goals and priorities for care planning. The completed questionnaire was provided to the oncology team at the patient’s visit. Pre and post assessment included the Distress Thermometer (DT), Patient Satisfaction with Cancer Care Scale and the Control Preferences Scale. Feasibility was defined as: 1) accrual of > 50%, 2) attrition rate < 32%, and 3) < 50% of patients experiencing increased distress following the intervention. Results: Among 60 eligible patients, 42 participated (70% accrual), 40 completed all surveys (2% attrition), and only 7 (18%) reported increased distress. Mean age was 57 (range 31 – 79), 85% were white, 7% black, 5% Hispanic, 66% were college graduates, and 40% reported high baseline distress (DT > 4). Patient priorities for discussion included cancer directed therapy (70%), symptom management (70%), and prognosis/planning ahead (60%). At 2-month follow-up, 53% reported decreased distress compared to baseline. Satisfaction with cancer care was high at baseline and follow-up. Most patients preferred shared decision making (77%), and 79% reported decision roles concordant with preferences. Overall, 72% of participants found the IGCDG helpful, 93% found the questionnaire easy to complete, and 44% felt it improved communication with their doctor (49% unsure). Conclusions: Administration of the Individualized Goals of Care Discussion Guide is feasible and provides patients with MBC an opportunity to define their goals of care and priorities for discussion in clinic. Clinical trial information: NCT03375827.
Effectiveness of psychological distress reduction with cognitive behavioral therapy for oncological patients: A one-year follow-up study.
Authors: Rossi Alessandro , Marconi Maria , Mannarini Stefania , Minelli India , Anderboni Monica , Rossini Chiara , Di Lucca Giuseppe , Verusio Claudio 
Published: March 2020

11624 Background: Distress has a negative impact on medical treatment (Di Matteo, Lepper & Croghan, 2006) and it is considered one of the most important indexes of psychological suffering in oncological patients (NCCN, 2015). Thus, the purpose of this study was to determine the long term effectiveness of brief Cognitive Behavioral Therapy for patients with cancer (CBT-C) compared with a control group (CG) of oncological patients without any psychotherapy intervention - at one year after a chemotherapy treatment. Methods: Participants ( n = 80; mean age = 63.3, SD = 13.4; 54 female) enrolled at the Oncology Day Hospital at the “Presidio Ospedaliero” of Saronno, ASST Valle Olona, Italy who undertook (CBT-C: n = 40) or non-undertook (CG: n = 40) a psychotherapy intervention. Individual psychotherapy sessions strictly followed the IPOS guidelines (Watson & Kissane, 2017). Participants were tested with the Psychological distress Inventory (PDI) at the baseline (T1; Cronbach α = .88) at the end of the chemotherapy treatment (T2; Cronbach α = .87), at the end of the psychotherapy intervention (T3; Cronbach α = .88), 6-month follow-up (T4; Cronbach α = .85), and 1-year follow-up (T5; Cronbach α = .84). Results: Multilevel growth curve modeling – controlling for age, number of sessions, type and localization of tumor – showed a sharper reduction of distress for CBT-C participants that continue after posttreatment until 1-year follow-up ( p < .001); whereas for CG participants it reduced more gradually from pretreatment to 1-year follow-up ( p < .001). The results revealed a significant difference between the linear slopes for each treatment condition ( p < .001). The overall Hedges’ g comparing the two groups for distress reduction between pretreatment and 1-year follow-up was 2.14 (p < .001) in favor of CBT-C. Conclusions: Given that psychological distress occurs frequently among oncological patients this study is into an important area of study. Results suggest that CBT-C is statistically and clinically effective in treating psychological distress 1 year after the chemotherapy treatment. These findings revealed a kind of long-term effectiveness psychological intervention able both to reduce psychological suffering and improve a better quality of life in oncological settings.
Till death do us part: Existential loneliness (EL), psychosocial distress, and survival of advanced cancer patients (ACPs), and their spousal caregivers (SCs).
Authors: Hlubocky Fay J. , Sher Tamara , Cella David , Ratain Mark J. , Daugherty Christopher 
Published: March 2020

11628 Background: Terminally-ill ACP often experience existential suffering as they near the end-of-life. However, the specific impact of EL on ACP and SC psychosocial wellness and survival has yet to be identified. Methods: A prospective ACP cohort enrolled in phase I trials was assessed at baseline (T1) and at one month (T2) utilizing psychosocial measures: state/trait anxiety (STAI-S/T), depression (CES-D), quality of life/QOL (FACIT-Pal), and global health (SF-36). Semi-structured interviews evaluated the ACP-SC EL experience: cognitive awareness (e.g. death, terminal prognosis); and, emotions (physical isolation; emptiness; abandonment). Results: To date, 160 participants (80 Phase I ACP and 80 SC) have been separately interviewed at T1 and T2. Total population demographics include: median age 62 (28-78y); 50% male; 100% married; 89% Ca; 68% > HS educ; 58% GI dx; ACP median survival 8.3 months (.51-18.9) 55% income < $65,000 yr. At T1, 77% of ACP acknowledged a cognitive awareness of death, 72% reported physical isolation; 54% felt emotional emptiness. For SC at T1, 65% recognized a cognitive awareness of death; 89% felt isolated; and 82% sensed emotional abandonment. Over time, rates of EL remained consistent for ACP-SC with the exception of increased self-reported isolation at 79% and 92% respectively at T2. At T2, ACP with death cognitions had higher STAI-S (32±10 v. 30±11, p = 0.03) and CES-D scores (13±12 v. 11±10, p = 0.02). SC with self-reported abandonment had higher STAI-S anxiety (39±17 v. 35±13, p = 0.03) at T2. Regression analyses revealed ACP with EL death cognitions had poorer FACIT-Pal QOL over time. Moreover, SC with self-reported physical isolation at T2 was negatively associated with SF-36 scores. ACP with EL had shorter overall survival compared to ACP without EL (4.1 v. 6.9 months, p = 0.02). ACP and SC qualitative inquiry re EL exposed unique themes: difficulty articulating EL experience; acceptance of death; finding meaning within crisis. Conclusions: EL is negatively associated with QOL for ACP participating in Phase I trials. Supportive couples-based, dyadic psychological interventions at the end-of-life to assist with coping are warranted.