bluuebunny/crossref_metadata_2025 huggingface dataset:
Assessing simple measures of patient-reported (PR) fatigue for oncology clinical trials: A pooled analysis of 3,915 patients
Authors: Liu H. , Sloan J. A. , Sargent D. J. , Satele D. V. , Schaefer P. L. , Halyard M. Y. , Grothey A. , Garces Y. I. , Brown P. D. , Buckner J. C.
Published: August 2020

9563

Background: Fatigue is a prevalent and debilitating symptom reported by cancer patients (pts) which compromises a pt's quality of life (QOL). This study examined the relationship between PR fatigue and QOL as well as cancer-related symptoms (CRS) in 43 North Central Cancer Treatment Group and Mayo Clinic Cancer Center clinical trials. Methods: 3,915 pts from 43 oncology clinical trials provided baseline fatigue data on a single-item 0–100 point scale. Pts' QOL assessment included a single-item overall QOL and associated QOL domains measured by numerical analogues, the Profile of Mood States (POMS), and PR symptom assessment measures. Associations between fatigue and QOL domains were assessed by Spearman correlation coefficients. Wilcoxon rank sum test compared QOL scores between pts with clinically deficient fatigue(CDF, score ≤50) vs. no clinically deficient fatigue (nCDF, score>50). Changes from baseline in fatigue and QOL were compared by Wilcoxon rank sum test with a 20-point change defined as clinically meaningful. Results: 38% of pts reported CDF at baseline and 45% of pts reported CDF at last assessment. Fatigue was only moderately correlated at best with overall QOL, pain, POMS, social and physical function (Spearman rho's of .27,.40, .56, .38 and .38 respectively). Pts with CDF averaged over 10 points lower overall QOL, pain, POMS, social, and physical function (see table below, all p<.0001) as well as worsening CRS including sleepiness, nausea, headache, abnormal sweating, trouble sleeping, dry mouth, and sexual dysfunction (all p<.001). Pts with 20+ points worsening in fatigue declined in overall QOL, physical function, pain and POMS (all p<.0001). Conclusions: Patients with CDF suffer greater deficits in QOL and CRS. Patients report fatigue as distinctly different from overall QOL, pain, physical, social, mood status and CRS. Fatigue appears with a broad spectrum of CRS clusters. Routine measurement and management of fatigue could impact QOL and treatment-related symptoms.

[Table: see text]

No significant financial relationships to disclose.
Determinants of functional disability in stage IV breast cancer
Authors: Cheville A. L. , Basford J. , Troxel A. , Kornblith A.
Published: August 2020

9567

Background: Functional disability degrades cancer patients' quality of life, exhausts caregivers and incurs significant expense yet little is know of the factors that contribute to disablement or whether the impact of these factors differs across functional domains. Better understanding of the influence that symptoms, physical impairments, and disease characteristics exert on disablement is needed in order to develop service delivery models that preserve function. Methods: To identify factors that influence functional performance in community dwelling people with stage IV breast cancer we conducted a cross-sectional study in a tertiary medical center outpatient cancer clinic. A consecutive sample of 163 community-dwelling patients with stage IV breast cancer were administered self- and clinician-rated functional metrics covering multiple domains including overall functioning, mobility, and self care. Self report measures included the Medical Outcomes Study Physical Function Subscale (PF-10) and the Older Americans Resource Study (OARS) Activities of Daily Living (ADL) and Instrumental ADL (IADL) subscales, and clinician report measures included the Karnofsky Performance Scale (KPS) and the Functional Independence Measure (FIM) Total and Mobility scores. Pain and mental health were assessed through administration of the Brief Pain Inventory (BPI) and Mental Health Inventory-17 (MHI-17), respectively. Electronic medical record review provided cancer-related and demographic information. The presence of physical impairments was determined through a comprehensive musculoskeletal and neurological physical examination including the 6 minute walk test. Linear and ordinal logistic regression models were constructed with function metrics as dependent variables. Results: Total number of physical impairments, BPI scores, and the presence of pleural effusions were highly significant in all models (p<0.01). Exertional intolerance and age were associated with PF-10 and OARS-ADL scores (p<0.01), while the presence of a pre-morbid disability was associated compromised mobility. Conclusions: Potentially remediable factors; pain intensity, cumulative impairment burden and pleural effusions, degrade all functional domains in patients with stage IV breast cancer.

No significant financial relationships to disclose.
Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) to characterize cachexia in newly diagnosed advanced cancer patients
Authors: Vigano A. , Trutschnigg B. , Morais J. A. , Chaudhury P. , Lucar E. , Metrakos P. , Hassanain M. , Molla H. , Hornby L. , Kilgour R. D.
Published: August 2020

9574

Background: Our objective was to evaluate whether the scored PGSGA questionnaire in advanced cancer patients (ACP) might relate better then weight loss (WL) alone to the nutritional, functional, biological and quality of life features of cachexia (C) and to some complications related to this syndrome. Methods: 214 newly diagnosed ACP with non-small cell lung and gastrointestinal primaries were categorized according to PG-SGA triage intervals of 0–1, 2–8 and ≥9 and also according to WL ≤5% or >5%. Baseline assessments included: hand-grip strenght, body composition by DXA, selective measures of symptom and quality of life (QoL), CBC and differential counts, albumin and CRP. Survival hospitalization rates and data on chemotherapy tolerability were recorded during patient follow-up. Beta coefficients (β), odds ratios (OR), and hazard ratios (HR) were estimated to compare patients with >5% WL to those with ≤5% WL and to compare patients with PGSGA of 0–1 to those with 2–8 and ≥9 scores. All analyses were controlled for gender, age, diagnosis (lung/GI), treatment (radio/chemo), survival (at 8 weeks), and medications. Results: PGSGA was better than the simple recording of WL in defining a population of patients that differed for WBC 109/L(>5% WL β: 0.25 vs. 2–8 PGSGA β: 0.57 and ≥9 PGSGA β: 1.72), CRP mg/L (4.12 vs. 2.16 and 17.49), albumin g/L(-0.63 vs -2.60 and -4.45); weakness 0–10 (1.57 vs.1.56 and 3.32), anorexia 0–10 (2.36 vs. 2.36 and 5.17); Brief Fatigue Inventory 0–90 (17.75 vs. 9.89 and 25.15); McGill QoL 10–0 (-0.95 vs. -0.64 and -2.29); grip strength lbs.(-4.04 vs. -8.82 and -8.06); body fat kg. ( -8.74 vs. -5.94 and -11.72). PGSGA was able to better identify patients with higher rates of both hospitalization (2.6 vs. 1.62 and 9.46) and dose reduction of chemotherapy (1.2 vs. 0.58 and 1.74). Finally, PGSGA was able to better characterize patient survival as compared to WL alone (>5% WL HR: 1.85; 2–8 PGSGA HR: 1.6 and ≥9 PGSGA HR 3.35). Conversely, WL alone was associated with higher probability of a sarcopenia diagnosis by DXA (>5% WL OR: 1.56)Conclusions: Our data support the use of the PGSGA versus the simple recording of WL for identifying C, monitoring its clinical course and predicting possible complications of this syndrome in ACP.

No significant financial relationships to disclose.
Code status documentation in the outpatient electronic medical records of patients with metastatic cancer
Authors: Greer J. , Temel J. , Admane S. , Solis J. , Lynch T. , Pirl W.
Published: August 2020

9576

Background: Advanced care planning is an essential component of cancer care for patients with incurable malignancies. However, the extent to which clinicians clearly document end-of-life care discussions and code status preferences in ambulatory medical records is unknown. The goal of the study was to investigate the rate of code status documentation in the electronic longitudinal medical record (LMR) of patients with metastatic cancers. Methods: We conducted a retrospective review of outpatient medical records of 2498 patients with metastatic solid tumors seen at an academic cancer center from 10/1/06 through 2/29/08. An electronic database was used to gather information on patient demographics, cancer type, and visits to the cancer center. The sample consisted of patients with metastatic breast, colorectal, non-colorectal gastrointestinal (GI), bladder/kidney, ovarian, prostate, and lung cancers. For the study endpoints, we queried the LMR to determine completion and designation of code status, which could be documented as follows: full code, do not resuscitate (DNR)/do not intubate (DNI), or DNR/DNI with specific resuscitation requests. Multiple logistic regression was used to identify independent predictors of code status completion and resuscitation preference. Results: Among the 2498 patients, 508 (20.3%) had a documented code status. Code status was documented more frequently in patients with metastatic non-colorectal GI (193/609, 31.7%) and lung (179/583, 30.7%) cancers compared to patients with genitourinary malignancies (bladder/kidney [4/89, 4.5%], ovarian [4/93, 4.3%] and prostate [7/365, 1.9%] cancers). Independent predictors of having documented code status included cancer type and a greater number of visits to the cancer center. Younger patients and black patients were less likely to be designated as DNR/DNI. Conclusions: Despite the incurable nature of metastatic cancers, a minority of patients had a code status documented in the outpatient medical record. Given the importance of advanced care planning for those with terminal illness, interventions are needed to encourage discussion and documentation of end-of-life care preferences in patients with advanced cancer.

No significant financial relationships to disclose.
J-HOPE study: Evaluation of end-of-life cancer care in Japan from the perspective of bereaved family members
Authors: Miyashita M. , Morita T. , Sato K. , Tsuneto S. , Shima Y.
Published: August 2020

9577

Background: The Japan Hospice and Palliative Care Evaluation (J-HOPE) study was conducted in 2007 and 2008. The aim of the study was to evaluate the quality of end-of-life care at regional cancer centers (CCs), inpatient palliative care units (PCUs), and home hospices (HHs) in Japan from the perspective of bereaved family members. Methods: A nationwide cross-sectional mail survey was conducted in 2007 and 2008. The survey was sent to bereaved families 6–18 months after the death of a patient at 56 CCs, 100 PCUs, or 14 HHs. Outcome measures were the good death inventory, the care evaluation scale, and overall satisfaction with care. The protocol of this study was approved by the institutional review boards of each participating institution. Results: Of the 13,181 bereaved family members that received the survey, 8,163 (62%) participants returned their responses. Among bereaved family members, significantly fewer responded that patients were free from physical distress at CCs (50%) than PCUs (80%) and HHs (73%) (P<0.0001). Significantly fewer patients trusted the physicians at CCs (79%) when compared with PCUs (83%) and HHs (88%) (P<0.0001). Significantly fewer patients were valued as people at CCs (83%) than PCUs (93%) and HHs (95%) (P<0.0001). In addition, significantly fewer participants felt physicians should have worked to improve the patients' symptoms more quickly at CCs (55%) when compared with PCUs (78%) and HHs (77%) (P<0.0001). Significantly fewer participants felt nurse should improve their knowledge and skills regarding end-of-life care at CCs (51%) when compared with PCUs (76%) and HHs (78%) (P<0.0001). A total of 51% of participants reported that nurses should improve their knowledge and skills regarding end-of-life care. Finally, significantly fewer participants were satisfied with the end-of-life care provided by CCs (80%) when compared with PCUs (93%) and HHs (94%) (P<0.0001). Conclusions: Overall, the bereaved family members appreciated the end-of-life care provided by CCs, PCUs, and HHs in Japan. However, in some situations, the quality of end-of-life care provided by CCs was lower than that provided by PCUs and HHs.

No significant financial relationships to disclose.
Effect of adherence to monthly zoledronic acid treatment on risk and frequency of skeletal complications and follow-up duration in breast cancer patients
Authors: Hatoum H. T. , Lin S. , Smith M. R. , Lipton A.
Published: August 2020

9593

Background: Bone is the most common site of metastasis in breast cancer patients (pts). Clinical trials and outcome studies have demonstrated benefit of zoledronic acid (ZA) in reducing risk of skeletal complications (SC). This study explored relationships between persistency on ZA and the intended treatment (TX) outcomes. Methods: Female breast cancer pts with first bone metastasis (BM) diagnosed between Jan 03 to Oct 06 were identified from PharMetrics database. Persistency was defined as duration from initiating ZA TX to date of first TX gap of >45 days. Pts were divided into short (≤90 days, 230 pts), medium (91–180, 171 pts) and long (>180, 313 pts) persistency groups. TX selection bias was handled by calculating propensity scores using year of first BM diagnosis, having other metastases or >1 BM claim, use of opioids and oral bisphoshonate before BM. Propensity scores, age and Charlson's Comorbidity Index (CCI) were included in multiple regressions to investigate impact of ZA persistency on follow-up duration, risk and rate of SC. Results: 2394 pts were enrolled, with 714 (29.72%) ZA treated. Three persistency groups had similar age. Short group had higher CCI than long group (mean 8.53 vs 8.34, p<0.05). Frequency of ZA TX decreased over time in all groups. For short, medium and long persistency groups, means of follow-up durations were 9.8 (median, 7.0), 13.0 (9.0), 19.3 (18.1) months, and means of time to first SC after BM were 249 (median: 167), 323 (217), 418 (365) days. Means of SC rates were 0.27, 0.21, and 0.12 per month for patients who experienced at least 1 SC among the three groups. Medium and long persistency groups had 41% and 139% longer follow-up than short group (p<0.05). Long group had lower risk of SC than short group (HR=0.576, p<0.05). In patients who developed at least 1 SC, long group experienced 39% less SCs (p<0.005) than short group. Conclusions: TX with zoledronic acid in breast cancer pts with BM positively impacts the risk, frequency of SC and follow-up duration. Also, longer persistency on ZA TX is associated with significantly longer follow-up and lower risk of SC.

[Table: see text]
Plasma cytokine concentrations and quality of life in patients with non-small cell lung cancer in a phase II trial of first-line treatment with carboplatin-paclitaxel and/or vandetanib
Authors: Hanrahan E. O. , Kim F. , Lin H. Y. , Tran H. T. , Ryan A. J. , Krebs A. D. , Lee J. J. , Johnson B. E. , Heymach J. V. , Kim E. S.
Published: August 2020

9596

Background: A randomized phase II trial (JCO 26:5407–15, 2008) compared carboplatin-paclitaxel (CP) with vandetanib (VEGFR-EGFR inhibitor) monotherapy (V) and V plus CP (VCP) 1st-line for advanced NSCLC (N=181). PFS was superior for VCP vs CP (HR 0.76). We performed analyses of quality of life (QOL) and its correlations with plasma concentrations of cytokines and angiogenic factors (CAF) among the participants in this trial. Methods: QOL was serially measured by Functional Assessment of Cancer Therapy-Lung (FACT-L) and Trial Outcome Index (TOI) scores. Concentrations of 35 plasma CAFs were measured at baseline and multiple timepoints during treatment with multiplexed bead suspension arrays and ELISAs. We performed exploratory analyses for the following associations: (1) QOL with plasma CAF levels at baseline; (2) changes in QOL with changes in plasma CAF levels. Spearman correlation coefficient, log-rank test and mixed linear models were applied in the analyses. P-value < 0.05 was considered significant. Results: Baseline QOL and plasma samples were both available for 120 patients. Lower baseline FACT-L scores (inferior QOL) were associated with higher pre-treatment plasma levels of INF-γ, IL-1RA, IL-6, IL-12, IL-15, TNF-α, RANTES, MIG, MIP-1β, MMP-9, bFGF, VEGF and sVEGFR-2 (all P<0.05). Lower baseline TOI scores (inferior QOL) were also associated with higher pre-treatment plasma levels of multiple CAFs, including GCSF, HGF, INF-α, INF-γ, IL-2, IL-6, IL-8, IL-12, IL-15, TNF-α, bFGF, sVEGFR-2 and VEGF (all P<0.05). Among all patients, decreasing TOI scores post cycle 2 (HR=2.57 [1.28,5.17], P=0.008) and cycle 4 (HR=2.58 [1.01,6.56], P=0.049) were associated with increased progression risk. Trends for FACT-L were similar, but did not reach statistical significance. Rises in GCSF, HGF, IL-2, IL-8, IL-15, MCP-1, MIP-1β, and VEGF from baseline to post cycle 2 were associated with decreased FACT-L and/or TOI scores (all P<0.05). Conclusions: High plasma concentrations of multiple CAFs pre-treatment in patients with NSCLC correlated with inferior QOL, and rises in these factors during treatment were associated with worsening QOL. This work was funded in part by grant from ACS (FK).

[Table: see text]
Longitudinal course of suicidal ideation in patients with newly diagnosed thoracic cancers
Authors: Pirl W. F. , Solis J. , Temel J. S. , Admane S. , Rosovsky R. , Prigerson H. G. , Greer J.
Published: August 2020

9606

Background: While cancer itself is associated with elevated suicide rates, thoracic cancers have the highest rates. Previous studies of suicidal ideation (SI) in cancer patients have all been cross-sectional. This study investigates the longitudinal course of SI in newly diagnosed thoracic cancer patients. Methods: Between 8/7/07–9/16/08, a prospective cohort was recruited from consecutive new patients at a thoracic oncology clinic in an academic cancer center. At initial visit and approximately every two months afterward, participants completed the Patient Health Questionnaire depression and anxiety modules, which include one item measuring SI over the prior two weeks. Participants were assessed at points of care; those not returning within follow up periods were not assessed. Factors bivariately associated with SI at initial visit were entered into multiple logistic regression models to identify independent predictors. Linear mixed effects models investigated change in SI level over time within individuals. Results: 373 participants enrolled. At initial visit, 254 (68.1%) had known lung cancers, 38 (10.2%) had esophageal cancer. 127 (34.1%) had advanced cancer. Mean age was 63.71 (11.50) and 200 (53.6%) were women. 368 completed initial assessment. At initial visit, 21 (5.7%) expressed SI and 111 (30.16%) met criteria for depressive or anxiety disorders. While ECOG performance status was associated with SI in bivariate analyses, only depression and anxiety remained independent predictors, both p=.01. Cancer type and stage were not significantly associated. Controlling for performance status, SI was more likely in those with any depressive or anxiety disorders (OR=7.14, 95% CI 2.48–20.55). Levels of SI within individuals decreased over time (p=.02). Only 2.2% (3/135) had SI at two months and none at four and six months. One participant (4.8%) with SI at initial visit had a known suicide attempt during the study period. Conclusions: Newly diagnosed thoracic cancer patients had a 6% SI rate at initial visit, slightly lower than other reports with mixed cancers. SI appears to decrease over time, with highest risk early after diagnosis. Given previous data that suicide rates are highest with thoracic cancers, our findings may suggest greater likelihood to act on SI.

[Table: see text]
The predictive accuracy of survival between patient-reported versus clinician-reported pain in a cohort of 1,214 patients with metastatic cancer
Authors: Quinten C. , Martinelli F. , Coens C. , Cleeland C. S. , Flechtner H. , Gotay C. , Greimel E. , Taphoorn M. J. , Weis J. , Bottomley A.
Published: August 2020

9607

Background: Accurate assessment of pain involves cooperation between clinician and patient. However, in patients with metastatic disease agreement between clinician and patient ratings is known to be poor. The objectives of this meta-analysis are to investigate the degree of agreement between clinician- versus patient- reported cancer pain at entry in a cohort of patients with metastatic cancer and whether their ratings were associated with a difference in survival. Methods: Eight European Organisation for Research and Treatment of Cancer (EORTC) Randomized Controlled Trials (RCT), across different cancer sites, were eligible for this study. Pain was scored at baseline by the clinician [Common Toxicity Criteria (CTC)] and the patient (EORTC QLQ-C30). The Wilcoxon rank sign test was applied to investigate scoring differences between patient- versus clinician- reported pain and logistic regression to model whether clinical parameters, i.e., performance status, gender, age or cancer site, affected scoring differences. The model accuracy of both scorings was investigated with the Harrell's discrimination c-index (c) after correction for the clinical parameters. Results: 1214 patients provided valid patient- and clinician- reported pain data at entry. Cancer pain was specified as bone metastasis by 643 (53%) patients and not specified otherwise. The overall mean pain as scored by the clinician was 2.25 (standard deviation (SD) 1.1) and by the patient was 2.28 (SD=0.95) on a 1 to 4 scale. Scoring differences were found to be statistically significant for colorectal (p<.01), lung (p<.01), prostate (p<.01), and breast (p=0.03, but not for pancreatic cancer (p=0.49). Clinical parameters did not significantly affect the scoring differences. Pain as reported by patients (vs clinicians) showed similar predictive accuracy (c =0.62 vs 0.61, p=0.59). Conclusions: Our results provide further evidence that significant differences exist in pain reporting between clinicians and patients. Such results provide a rationale to include patient self reported pain assessment in future cancer RCTs to better assess disease status and survival prognosis.

No significant financial relationships to disclose.
Quality of life in advanced non-small cell lung cancer patients receiving first-line gefitinib monotherapy
Authors: Shao Y. , Lin Z. , Hu F. , Yu C. , Shih J. , Hu W. , Chang Y. , Cheng A. , Yang P. , Yang C.
Published: August 2020

9614

Background: Gefitinib is a potential first-line treatment option for patients with advanced non-small cell lung cancer (NSCLC), especially for patients with activating mutations in the EGFR gene. However, little is known about patient-reported health-related quality of life (HRQOL) in this patient population. The aims of this study were to explore the prognostic values of baseline HRQOL for time-to-treatment failure (TTF), as well as the predictors of repeatedly measured posttreatment HRQOL, in advanced NSCLC patients receiving first-line gefitinib. Methods: A total of 106 chemonaive patients with advanced NSCLC were enrolled in a phase II trial. Gefitinib was given at a dose of 250 mg/d. HRQOL was assessed monthly with the EuroQoL instrument (EQ-5D) and the Lung Cancer Symptom Scale (LCSS) questionnaire. Baseline HRQOL and clinical/molecular predictors of TTF were jointly examined by multiple Cox's proportional hazards model. The associations between the clinical/molecular factors and repeatedly measured posttreatment HRQOL were analyzed by fitting marginal linear regression model using the generalized estimating equations (GEE) method. Results: In this prospective study, HRQOL data were obtained from 94 patients. Baseline EQ-5D index (estimated hazard ratio = 0.286, 95% C.I.: 0.135–0.603, p = 0.001) and the presence of L858R EGFR mutation in adenocarcinoma (estimated hazard ratio = 0.520, 95% C.I.: 0.307–0.880, p = 0.015) were retained as independent prognostic factors in the final multiple Cox's proportional hazards model for TTF. According to preliminary GEE analysis of repeatedly measured posttreatment HRQOL, the patients with wild-type EGFR consistently had worse HRQOL in EQ-5D index (p < 0.0001), EQ-5D VAS score (p = 0.0002), and LCSS global score (p < 0.0001), respectively. Conclusions: In advanced NSCLC patients receiving first-line gefitinib, better baseline EQ-5D index and L858R EGFR mutation in adenocarcinoma predict longer TTF. In addition, patients with wild-type EGFR had worse posttreatment HRQOL.

No significant financial relationships to disclose.
Survey of disease and treatment-related symptoms in outpatients with invasive cancer of the breast, prostate, lung, or colon/rectum (E2Z02, the SOAPP study)
Authors: Fisch M. , Lee J. W. , Manola J. , Wagner L. , Chang V. , Gilman P. , Lear K. , Baez L. , Cleeland C.
Published: August 2020

9619

Background: The full spectrum and impact of symptoms experienced by ambulatory patients (pts) in medical oncology clinics throughout their care trajectory is poorly understood. Methods: This large prospective study by the Eastern Cooperative Oncology Group (ECOG) enrolled pts with invasive cancer of the breast, prostate, colon/rectum or lung regardless of phase of care or stage of disease. The study was conducted between 3/06 and 5/08 at multiple academic (n=7) and community (n=32) medical oncology clinics. Pre-defined sampling algorithms were used to reduce selection bias. At baseline and again 4 weeks later, pts completed a 25-item measure of symptoms and functional interference (M.D. Anderson Symptom Inventory-ECOG). Patients’ providers simultaneously prioritized their symptoms. Results: 3124 patients were enrolled (90% from community clinics) and 3077 were analyzable with 1524 breast (50%), 715 colorectal (23%), 518 lung (17%), and 320 prostate (10%) pts. The most prevalent moderate-to-severe symptoms of the full cohort at baseline (B) and follow-up (F) were: fatigue (B34% to F32%), disturbed sleep (B27% to F21%), drowsiness (B22% to F21%), hair loss (B20% to F19%), pain (B19% to F18%), dry mouth (B19% to F15%), and numbness/tingling (B19% to F17%). At baseline, 40% of the cohort had at least 3 moderate-to-severe symptoms and 36% had this attribute at follow-up. Clinician perception of symptoms was strongly correlated with patient symptom survey results regardless of disease site, race, or ethnicity. Of the 849 pts receiving anti-cancer treatment for metastatic disease, half had 2 or more metastatic sites with 75% receiving cytotoxic chemotherapy. Clinicians judged lung cancer patients’ symptoms to be the most difficult to manage (p<0.01). Conclusions: Non-pain symptoms, particularly fatigue and sleep disturbance, are a major source of symptom distress in ambulatory medical oncology practice. Overall, symptom burden remains substantial and difficult to resolve. These data will help guide future interventional studies.

No significant financial relationships to disclose.
Evaluation of reported bone pain in patients (pts) receiving chemotherapy in pegfilgrastim clinical trials
Authors: Sierra J. , Harms R. , Mo M. , Vogel C. L.
Published: August 2020

9621

Background: Bone pain is the most commonly reported treatment-related adverse event (AE) associated with colony-stimulating growth factors. Some authors have suggested that pegfilgrastim-induced bone pain is unpredictable and refractory to analgesics (Kirshner 2007), though that impression may not be uniformly accepted. To better characterize this adverse event we evaluated bone pain across pegfilgrastim clinical trials. Methods: Completed Amgen-sponsored trials that both incorporated pegfilgrastim 6mg administered 24 hours after chemotherapy and utilized MedDRA library coding of AEs were examined. Included were 2 studies comparing pegfilgrastim with placebo (Vogel 2005, Hecht 2007) and 2 studies comparing pegfilgrastim with filgrastim (Sierra 2008, Lopez 2004). The incidence of bone pain was determined by treatment (pegfilgrastim, filgrastim, or placebo), chemotherapy (taxane-containing or not), cycle, severity, age, and body surface area (BSA). Analysis and recoding of studies with preferred AEs coded to nonMedDRA dictionaries is ongoing. Results: 1310 pts (filgrastim=67, pegfilgrastim=665, placebo=578) were analyzed. In studies comparing pegfilgrastim (n=74) and filgrastim (n==7) in pts with AML and NHL, 52% were female, and the mean (SD) age was 50 (15.1) years. Similar proportions (CI) of pts reported bone pain (24.3% [16.1, 35.7] vs 25.4% [15.5, 37.5], respectively), and grade 3/4 bone pain was reported in 3% [0.3, 9] versus 0% [-, -] of pts, respectively. Studies comparing pegfilgrastim (n=591) and placebo (n=578) pts in breast and colorectal cancer are below ( Table ). Conclusions: Bone pain of any grade was commonly reported in all 3 groups (pegfilgrastim, filgrastim, and placebo) and was marginally higher in pts receiving pegfilgrastim compared with placebo. Bone pain was most common in cycle 1. Severe bone pain was infrequently reported. Bone pain was similar in pts receiving pegfilgrastim and filgrastim. Chemotherapy (eg, taxanes) may also contribute to bone pain. [Table: see text]

[Table: see text]
The McGill Cancer Nutrition and Rehabilitation Program
Authors: Chasen M. R. , Eades M. , Jelowicki M. , Amdouni S. , Sharma R.
Published: August 2020

9623

Background: Cancer rehabilitation is a process that assists the individual with cancer to obtain optimal physical, social, psychological, and vocational functioning within the limits created by the disease and treatment. The McGill Cancer Nutrition and Rehabilitation (CNR) program developed as a result of the ever-increasing demand to address the individual cancer patients and their needs, as well as on achieving optimal tumour-related outcomes. Methods: To assess the effect of an interdisciplinary 8-week rehabilitation program on the functional outcomes of patients with advanced cancer. Sixty-five patients were assessed prior to and following an 8-week interdisciplinary cancer rehabilitation program consisting of medical, nursing, physiotherapy and nutritional interventions. All patients were evaluated with the Edmonton Symptom assessment Score (ESAS), Distress thermometer (DT), Patient Generated Subjective Global Assessment (PG-SGA), Simmonds Functional Assessment Tool and the 6-Minute Walk Test (6MWT). A paired t-test comparing patient’ pre and posttest scores was used. Results: Thirty three male and 32 female participants were enrolled. Their median age was 57 years (25 to 80). Their cancer diagnoses were: gastro-esophageal (20%), hepatobiliary (19%), breast (17%), hematological (12%), lung, ENT and sarcoma (9% each), colorectal (3%) and CNS lymphoma (2%) There was a significant improvement after an 8-week cancer rehabilitation program in strength (p=. 02), appetite (p< 0.001), nausea (p< =0.02), nervousness (p< 0.001) sleepiness (p=0.01), shortness of breath (p=0.02), depression (p< 0.001), DT (p< 0.001), total PG-SGA score (p< 0.001) and 6MWT (p=0.001). Conclusions: Preliminary findings suggest that participation in a cancer rehabilitation program ameliorates symptoms and global distress resulting in an increase in physical activities. We can conclude that participation in the Cancer Rehabilitation Program is beneficial.

No significant financial relationships to disclose.
Analysis of cytokines in ECOG E4Z02: A phase III randomized study of l-carnitine supplementation for fatigue in patients with cancer
Authors: Rich T. A. , Fisch M. J. , Manola J. , Cella D. , Ansari B. , Koc M. , Cruciani R.
Published: August 2020

9635

Background: The purpose of the study was to investigate associations between fatigue, depression and pain and serum levels of proinflammatory cytokines among pts randomized to l-carnitine supplementation or placebo. Methods: 376 cancer pts with normal hemoglobin and fatigue assessed as moderate or severe were randomized to 4 wks of supplementation with oral carnitine (n=189) or placebo (n=187) 1000 mg bid. Serum levels of 10 inflammatory cytokines and growth factors were measured with Luminex bead ELISA at baseline and 4 wks for 98 pts. Wilcoxon rank sum tests were used to compare cytokine levels between arms and between pts with/without symptoms. Multivariable models of fatigue, depression and pain at 4 wks were examined, adjusting for treatment arm, baseline symptoms and baseline cytokine levels. Results: There were no statistically significant differences in cytokine levels between pts with or without severe fatigue, pain, or depression at baseline. Levels of IL-1rα were higher at baseline among pts randomized to placebo (p=0.01) and increased after 4 wks, while levels among pts randomized to l-carnitine declined (p <0.001). Levels of IFN-γ, TGF-α, IL-6, and TNF-α decreased more among pts randomized to placebo (p=0.008, p=0.006, p=0.01, and p=0.05, respectively). Pts with severe pain at 4 wks had greater declines in levels of EGF, IFN-γ, IL-1α, and IL-1rα than pts without (p=0.05, 0.05, 0.02 and 0.03, respectively). Reductions in IL-1α and TGF-α predicted lower pain severity at 4 wks (p=0.02 and p=0.04, respectively). Conclusions: Levels of proinflammatory cytokines or EGFR ligands failed to distinguish between patients with moderate vs. severe fatigue or levels of depression and pain (severe vs. not) prior to treatment intervention. Lower levels of IL-1α and TGF-α appear to be associated with improvement of pain severity but are not associated with treatment. Mechanisms for these findings require exploration.

No significant financial relationships to disclose.
Serum 25-hydroxy vitamin D and nutritional status: Implications for vitamin D assessment and dietary supplementation in oncology
Authors: Trukova K. , Gupta D. , Vashi P. G. , Adams A. , Lambert G. M. , Grutsch J. F. , Lammersfeld C. A.
Published: August 2020

9638

Background: There is emerging evidence in the literature to suggest a protective role of vitamin D in cancer survival. Vitamin D status is not routinely assessed, despite the high prevalence of malnutrition in this population. We hypothesized that malnutrition could contribute to vitamin D deficiency, and therefore expected mean serum 25-hydroxy-vitamin D [25(OH)D] levels to be significantly lower in malnourished oncology patients. Methods: A consecutive case series of 737 cancer patients seen at Cancer Treatment Centers of America between Jan-June 08. Nutritional status was assessed using Subjective Global Assessment (SGA) and serum albumin. SGA categorizes patients into 3 distinct classes of nutritional status; well nourished (SGA-A), moderately malnourished (SGA-B) and severely malnourished (SGA-C). Serum albumin was divided into 2 groups: >=3.6 g/dl and <=3.5 g/dl. Mean serum 25(OH)D was compared across 3 categories of SGA using ANOVA and across 2 categories of serum albumin using 2 sample t test. Results: Of 737 patients, 302 were males and 435 females. The mean age at presentation was 55.7 years (SD = 10.2). The most common cancer types were lung (133, 18%), breast (131, 17.8%), colorectal (97, 13.2%), pancreas (86, 11.7%), prostate (44, 6%) and ovarian (38, 5.2%). The mean serum albumin and serum 25(OH)D was 3.5g/dl (SD = 0.6) and 21.9 ng/ml (SD = 13.5) respectively. There was no significant difference in the mean vitamin D levels across serum albumin (p = 0.76). The mean vitamin D levels across the 3 classes of SGA also showed no statistically significant difference ( Table ). Conclusions: Contrary to what we expected, vitamin D deficiency was found to be prevalent in cancer regardless of nutritional status. No significant differences were found across the 3 classes of SGA. Based on these results, screening for vitamin D deficiency and aggressive vitamin D repletion should be considered for all people with cancer. [Table: see text]

No significant financial relationships to disclose.
Prevalence and predictors of posttraumatic stress disorder in adult survivors of childhood cancer: A report from the Childhood Cancer Survivor Study
Authors: Stuber M. , Meeske K. , Zebrack B. , Krull K. , Stratton K. , Leisenring W. , Robison L. , Zeltzer L.
Published: August 2020

CRA10002

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
National survey of physicians practice patterns: Fertility preservation and cancer patients
Authors: Quinn G. , Vadaparampil S. T. , Jacobsen P. , Lee J. , Lancaster J. , Bepler G. , Keefe D. L. , Albrecht T. L.
Published: August 2020

CRA9508

The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology.

No significant financial relationships to disclose.
Sentinel lymphadenectomy for the staging of clinical axillary node-negative breast cancer before neoadjuvant chemotherapy
Authors: Menard J. , Extra J. , Jacquemier J. , Buttarelli M. , Lambaudie E. , Bannier M. , Brenot Rossi I. , Houvenaeghel G.
Published: August 2020

e11604

Background: Several authors reported sentinel lymph node biopsy after neoadjuvant chemotherapy. Nevertheless, the ideal time of sentinel lymph node biopsy is still a matter of debate. Methods: We evaluated the feasibility and the accuracy of sentinel lymph node biopsy before neoadjuvant chemotherapy using a combined procedure (blue dye and radio-labelled detection) in a homogeneous cohort study with clinically axillary node-negative breast cancer. Study candidates were patients referred to the Institut Paoli-Calmettes Cancer Center (Marseille, France) for the treatment of invasive breast cancer. Patients were included in the study if they had tumor more than 3 cm in diameter without palpable axillary lymph node for which a neoadjuvant chemotherapy was indicated in order to enhance the likelihood of breast conservation. An axillary lymph node dissection was performed after completion of neoadjuvant chemotherapy. Results: From September 2005 to September 2007, thirty-one women with T2 or T3 invasive breast cancer without palpable axillary lymph node underwent sentinel lymph node biopsy before neoadjuvant chemotherapy and an axillary lymph node dissection after neoadjuvant chemotherapy. Among the 20 women who had metastatic sentinel lymph node biopsy (65%), 4 (20%) had additional metastatic node on axillary lymph node dissection. By contrast, all the 11 women who had no metastatic sentinel lymph node biopsy had no involved nodes in the axillary lymph node dissection. The sentinel lymph node biopsy identification rate before neoadjuvant chemotherapy was 100% with any false negative. Conclusions: Sentinel lymph node biopsy before neoadjuvant chemotherapy is a feasible and an accurate diagnostic tool to predict the pre-therapeutic axilla status. These findings suggest that axillary lymph node dissection may be avoided in patients with a negative sentinel lymph node biopsy performed before neoadjuvant chemotherapy.

No significant financial relationships to disclose.
Impact of FDG-PET scan on follow-up care in nonmetastatic breast cancer
Authors: Almubarak M. , Gadiyaram V. , Osman S. , Hobbs G. , Saad A. , Marano G. , Abraham J.
Published: August 2020

e11611

Background: Fluorine-18-FDG positron emission tomography (FDG-PET) role in the follow up care of non-metastatic breast cancer is not defined. Methods: We retrospectively analyzed 177 patients with stage I-III breast cancer between November 2004 and June 2006. IRB approval was obtained for this study. Patients were divided into two groups. Group A consisted of patients who had one or more FDG-PET scans as part of their clinical follow up (N=68), and Group B consisted of patients who did not (N=109). Clinical, radiological and pathology data were obtained from patients’ records. Results: Median follow-up is 35 months. Mean age 53 years for group A and 57 years for group B. Group A patients were more likely to have had higher stages (29% stage I, 53% stage II, and 18% stage III) compared with group B (64 % stage I, 31% stage II and 4% stage III). The two groups did not differ significantly in ER+ status (69% vs. 78% p=0.21), or Her2neu status (19% vs. 17%; p=0.6). Group A patients had more clinic visits (18 vs. 11; p=0.009), their tumor marker was checked more often (13 vs. 9 times; p=0.0001), had more radiological studies (10 studies vs. 5; p=0.0001), and had more biopsies (0.88 vs. 0.48 biopsy per patient; p=0.05). These differences were significant even after controlling for stage and chemotherapy. 9/68 patients in group A had tumor recurrence compared to 1/109 in group B (p=0.0003). PET scan indications were as follows: 29 (43%) for asymptomatic follow up evaluation [2 recurred]; 18 (26%) concerning symptoms [0 recurred]; 10 (15%) elevated tumor marker [2 recurred]; 7 (10%) other abnormal imaging studies [1 recurred]; 4 (6%) metastatic workup. Conclusions: While FDG-PET might aid in detecting recurrence in some patients with non-metastatic breast cancer, its use was associated with more clinic visits, blood tests, biopsies, and radiological tests.

No significant financial relationships to disclose.
Bisphosphonate therapy requirement during adjuvant aromatase inhibitor therapy in early breast cancer patients according to UK bone health guidelines
Authors: Moe M. , Almatari M. , Ali P. , Willshaw P.
Published: August 2020

e11612

Background: Adjuvant aromatase inhibitor (AI) therapy increases bone loss and incidence of bone fracture. Recently published UK bone health guidelines recommend to prescribe bisphosphonate (BPN) during adjuvant AI therapy for T score of -2 or less, or annual loss of bone density >4%, or known vertebral fracture, or patients over the age of 75 with one or more clinical risk factors (previous low-trauma fracture after age 50, previous hip fracture, alcohol intake of >4 units/ day, diseases associated with secondary osteoporosis, prior corticosteroids for >6 months, BMI <22). We evaluated the impact of BPN therapy requirement using UK guidelines on adjuvant AI therapy patients. Methods: Patients who were commencing adjuvant AI therapy for early breast cancer underwent Dual energy X-ray Absorptiometry (DXA) bone density assessment, with a baseline scan and 2 subsequent scans. Results: A total of 91 patients were eligible and included in this study (median age 59). Different AIs included anastrozole(68), exemestane (7) and letrozole (16). Patients received AI therapy in up-front (56), sequential (15) and extended adjuvant (20) therapy settings. Median duration of AI therapy was 35 months, with 85 patients having received therapy for more than 24 months. BPN was prescribed to 35 patients during AI therapy as per local practice. According to WHO classification, 11 patients were found to have osteoporosis at the 1st scan, and 4 & 2 patients were found to develop osteoporosis at 2nd & 3rd scans, respectively. According to UK guidelines, however, BPN therapy would be indicated in 56 patients (62%): after 1st scan 22 patients, after 2nd scan another 26 patients and following the 3rd scan an additional 8 patients. Factors predictive of BPN indication during AI therapy are hyperthyroidism (p = 0.009), previous fracture (p = 0.001) and smoking (p = <0.001). Patients who took tamoxifen for more than one year are less likely to require BPN compared to those who did not take tamoxifen (p = 0.028) Conclusions: Majority of patients (up to 62% in our study) will require BPN during adjuvant AI for breast cancer. Therefore the cost of BPN and potential drug side effects need to be taken into account in the use of adjuvant AI, and it's health economic analysis.

No significant financial relationships to disclose.
Patterns of care and outcomes of locally advanced breast cancer at the Cancer Centre of Southeastern Ontario
Authors: Mates M. , Hopman W. , Madarnas Y.
Published: August 2020

e11614

Background: Preoperative chemotherapy (PCT) is the standard of care for locally advanced breast cancer (LABC). As part of a multicentre provincial initiative we undertook a review of practice patterns and outcomes for women with LABC at our institution. Methods: We reviewed electronic and paper records for M0 pts receiving PCT for LABC between 1995–2007 at our institution, collecting demographic, disease and treatment-related, and outcome variables. Results: Sixty pts with LABC who received PCT were included in this review. Median age was 54y (31–80), 38% premenopausal. Median BMI was 28kg/m2, 78% were overweight or obese. Stage distribution: 10% IIB, 11% IIIA, 77% IIIB and 2% IIIC, of which 45% had inflammatory breast cancer (IBC). At biopsy 90% were invasive ductal carcinoma, 36% were ER and PR(-) and 25% were her2(+). Median time from surgical consultation to PCT was 22d (6–126). PCT was anthracycline-based alone in 85% of pts, 8% received a taxane, 3% also received preop endocrine therapy (ET), no pts received trastuzumab (T) preop. Pts received a median of 6 (3–8) cycles of PCT. Local therapy: mastectomy (M) in 82% of pts and partial M in 11%. Axillary surgery was done in only 92% of pts (axillary node dissection 90%, sentinel node biopsy 1pt) and 7% had no definitive breast or axillary surgery due to local progression (3) or refusal (1). All pts received radiotherapy. Postop systemic therapy: CT in 5% of pts, ET in 65% and T in 10% of pts. Clinical complete response (CR) rate was 28%. At definitive surgery 10% of pts had no residual disease in breast or axilla and 3 pts had only DCIS present, for a pathologic (p)CR rate of 15% using MDACC criteria. Median follow-up was 24mo (1–238). Median 5y DFS was not reached for the entire population and those with a pCR vs. 26mo for pts with IBC; corresponding 5y DFS rates were 58%, 78%, and 41% respectively. Median 5y OS was for the entire population was 52mo vs. 48mo for pts with a pCR and 47mo in the IBC group; corresponding 5y OS rates were 62%, 78% and 44% respectively. Conclusions: Management of LABC in our cohort is fairly uniform and consistent with current guidelines. Local outcomes of LABC managed with PCT are in keeping with the published literature and arguably better since almost half of our cohort is represented by IBC which carries a worse prognosis.

No significant financial relationships to disclose.
Modalities of prescription of aromatase inhibitors (AI) in adjuvant therapy for postmenopausal women with HR+ breast cancer: Analysis of daily practices in France
Authors: Delozier T. , Antoine E. , Franck D. , Namer M. , Spielman M. , Petit T. , Guastalla J.
Published: August 2020

e11619

Background: Aromatase inhibitors (AIs) are widely used as adjuvant therapy for HR+ breast cancer. This survey is an overview of clinical daily practices in France Methods: Multicentric survey conducted in October 2008 by Internet among a sample of 293 physicians specialized in breast cancer management (oncologists, radiotherapists, surgeons) prescribing adjuvant AIs in post-menopausal patients with HR+ breast cancer Results: When started upfront, 87% of physicians expressed that the optimal duration of AIs treatment is 5 years, and 7 % more than 5 years. Nevertheless only, 33% of physicians inform their patients of a total duration of AIs therapy of 5 years, and 66% of a possible adjustment according to the evolution of the scientific knowledge during the five years. AIs are prescribed after the end of chemotherapy by 97% of physicians, after the end of radiotherapy by 83%, and during radiotherapy by 15%. When started after two years of tamoxifen, 71 % of physicians expressed that the optimal duration of AIs treatment is 3 years, 22% 5 years, and 3% more than five years. When started after five years of tamoxifen, 48% of physicians expressed that the optimal duration of AIs treatment is less than three years, 15% 3 years, 15% 5 years, and 2% more than five years. The optimal duration of treatment with aromatase inhibitors is still subject to question for 73% of the physicians interviewed Conclusions: In France, most physicians declared an optimal duration of treatment with aromatase inhibitors in adjuvant setting in HR+ breast cancer in line with guidelines and/or approved indications. However, the optimal duration of treatment is still subject to question for many physicians

No significant financial relationships to disclose.