bluuebunny/crossref_metadata_2025_split huggingface dataset:
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.