bluuebunny/crossref_metadata_2025_split huggingface dataset:
Determining issues of importance for patients with breast cancer: Results of a web-based study in 1,072 patients to enhance the content validity for the development of a new health-related quality of life (QL) instrument, the Breast Cancer Symptom Scale (BCSS)
Authors: Horigan J. L. , Gralla R. J. , Davis B. J. , Hollen P. J. , Petersen J. A. , Burg K. , Belland A. , Carleton J. 
Published: August 2020

e20615 Background: Identifying key issues for patients with malignancy is central to assessing QL and patient reported outcomes during all points of the illness trajectory. The involvement of patients in establishing content validity is crucial for instrument development. The conceptual model for the BCSS focuses on areas of importance for patients (Hollen, Supp Care Ca 1994). Methods: We used the established patient base of the web-based NexCura information resource to survey registered patients with breast cancer. Demographic stratifications included disease stage, age, menopausal status, time since diagnosis, prior/current treatment with surgery, RT, chemotherapy, hormonal, targeted, and CAM approaches. 1072 patients (median age 53, 65% stage I, 43% > 2 years since diagnosis) completed the anonymous web-conducted survey. Patients ranked 21 issues on a 5-point scale, assessing the importance of each item. Issues included general, physical, functional, psychosocial and summative items. Results: The 9 highest ranked items are seen below. Results are described by the percent of patients choosing the top category (very important) and the top 2 importance categories. The five lowest ranked items dealt with appetite, breast-specific issues, hot flashes and sexuality. Ratings by breast cancer subsets (newly diagnosed, on treatment, NED, hormonal or non-hormonal treatment, metastatic disease, survivors) showed some differences compared with the whole group. Conclusions: These results represent one of the largest surveys of concerns expressed by patients with breast cancer and support using computer-assisted technology to assess such information for rapid input of large patient samples. This study gives strong support for content validity for the BCSS and provides data on which to base separate QL instruments for specific breast cancer settings. [Table: see text] [Table: see text]
Vitamins B6 and B12 supplementation to prevent chemotherapy-induced neuropathy (CiN): Interim analysis of the taxane cohort
Authors: Verschraegen C. F. , Royce M. , Lee S. J. , Movva S. , Susan L. , Michael G. 
Published: August 2020

e20621 Background: Chemotherapy-induced neuropathy (CiN) is common with heavy metals, taxanes, and vinca alcaloids. Pyridoxine (Vit B6) is used for diabetic neuropathy and cyanocobalamine (Vit B12) is required for synthesis of myelin and maintenance of the integrity of neuronal tissue. We hypothesized that supplementing patients (pts) with these 2 vitamins will prevent CiN. There were 3 pt cohorts depending on the chemotherapy regimen. Pts receiving any taxane enrolled in the taxane cohort (N=46), pts receiving vincristine or vinblastine enrolled in the vinca cohort (N=7), and all other pts receiving a platinum enrolled in the heavy metal cohort (N=25). The taxane cohort is reported here. Methods: Pts starting treatment with a taxane were randomized to a 1/6 of 100% of the daily recommended dose of a multivitamin/day (placebo) versus the same plus Vit B6, 50 mg tid, and Vit B12, 1 mg q 3–4 weeks (MV+Vit), during 4 cycles of chemotherapy. No other supplements were allowed. Taxane Fact G and a formal neurologic examination were performed prior to, and after 2 & 4 cycles of chemotherapy. Statistical methods were based on least squared means with ANCOVA and t-test (Cella, JCO, 2008). Results: To date, 46 pts treated with taxanes were randomized; 22 to placebo and 24 to MV+Vit. 13 and 16 pts completed 2 cycles and 8 and 6 pts completed 4 cycles, respectively. On the neuro examination, the only significant difference between placebo and MV+Vit was in the cold sensation (p=0.0097). The physical well being and the neuro modules of the Taxane Fact G significantly worsened after 4 cycles of chemotherapy in the placebo group (p=0.0289 and 0.0173, respectively), but this significant trend was not observed in the MV+Vit group (p=0.8318 and p=0.0866). The study will accrue 76 pts per cohort. Conclusions: The preliminary trends in this study suggest that vitamin supplementation with Vit B6 and B12 may reduce CiN during taxane-based chemotherapy. No significant financial relationships to disclose.
Retrospective study of phase I clinical trials participation in patients at least 65 years of age at Karmanos Cancer Institute (KCI), Wayne State University, Detroit, Michigan
Authors: Vishnu P. , Jasti P. , Ding L. , Heilbrun L. K. , Venkatramanamoorthy R. , LoRusso P. M. , Heath E. I. 
Published: August 2020

e20626 Background: It is important to increase our understanding of recruitment barriers in the elderly population to improve their participation in clinical trials. The primary objective of this study was to describe the demographics, treatment, toxicity, and overall survival (OS) of all patients ≥ 65 years who presented to the Phase I clinical trials service at KCI between 1995–2005. Methods: Patient demographics, co-morbidities, tumor type, reason not enrolled on a Phase 1 clinical trial, toxicities, and OS were obtained by retrospective chart reviews. The patients were divided into 3 mutually exclusive groups: patients considered but not enrolled (PC), enrolled but not treated (PE), and treated (PT). OS was compared across these three groups. Results: 216 patients met the study criteria. Of these, there were 114 PC, 7 PE, and 95 PT. Lack of enrollment was due to ineligibility (30%), loss to follow-up (12%), refusal (8%), or no trial available (2%). Median age was 71 years, 63% were males and 87% were Caucasian. 59% had performance status (PS) 1; 16% had PS 2. 66% of patients had a history of cardiovascular disease but renal, liver, hematological diseases were found in less than 7% of patients at baseline. Colorectal (27%), lung (15%) and prostate (8%) were the 3 most common cancers. 54% received a cytotoxic agent, 62% a biologic agent, and 17% combination therapy. The 3 most common Grade 3–4 toxicities were: 15% leucopenia, 11% electrolyte abnormalities, and 4% anemia. The median OS for PC, PE, and PT was 3.9 mos, 2.2 mos, and 8.4 mos, respectively (p < 0.001 between any pair). However, PS 0–1 patients comprised 47%, 75%, and 73% of those 3 patient subgroups, respectively. Conclusions: More than half of the elderly patients initially considered for Phase 1 clinical trials at KCI were not enrolled due to ineligibility, refusal, or lost to follow up. Phase I chemotherapy appears feasible in patients age ≥ 65 years old. OS was significantly longer for patients treated on Phase I trials compared to those who were not, although that may be confounded by PS differences. More detailed OS comparisons will be presented. No significant financial relationships to disclose.
Epidermal growth factor receptor (EGFR) inhibitor–related skin toxicity: Review of interim data from a phase II study (20060314) of panitumumab (pmab) with FOLFIRI in the first-line treatment of metastatic colorectal cancer (mCRC)
Authors: Karthaus M. , Hofheinz R. , Mineur L. , Letocha H. , Greil R. , Thaler J. , Gamelin E. , Wright L. , Köhne C. ,   20060314 Study Group and Cancer Center Munich South, Study Team Klinikum Neuperlach
Published: August 2020

e20634 Background: Skin toxicity that can impact quality of life as well as treatment adherence is commonly associated with EGFR therapy. Despite their particular importance in terms of making decisions regarding supportive care, time to onset and maximum grade of skin toxicity are seldom reported. Pmab is a fully human monoclonal antibody directed against the EGFR with demonstrated monotherapy activity in patients (pts) with wild-type KRAS expressing, chemotherapy refractory, mCRC. Methods: In this single-arm study, first-line pts with histologically confirmed mCRC were enrolled to receive pmab (6mg/kg) and FOLFIRI every 2 weeks. This trial is ongoing to evaluate the primary endpoint of objective response rate and secondary endpoints including disease control rate, duration of response, time to response, progression-free survival, time to progression and other safety aspects. The focus of this abstract is skin toxicity. Results: Cutoff for the initial interim analysis was 27 June 2008. Of the 154 pts enrolled, 68% are male; median age is 64 years (range 21–84) and 95% of pts had ECOG PS 0–1. A total of 97% of pts had experienced at least one adverse event (any grade) and 55% of pts had experienced a grade 3/4 event. Grade 3/4 skin and subcutaneous toxicities were observed in 20% of pts ( Table ). Median time to first cutaneous toxicity and median time to most severe toxicity were 9 (95%CI, 7–13) and 14 (95%CI, 13–16) days, respectively. The most severe toxicity was grade 4 in one pt. Conclusions: Combining pmab with FOLFIRI in the first-line setting is a well-tolerated regimen. Skin toxicity was observed in 92% of patients; onset, incidence, and severity of which appears to be comparable to published data. Management of skin toxicities will be presented. [Table: see text] [Table: see text]
Sudden onset fatigue (SOF) in patients with breast cancer: Characteristics and symptomatology
Authors: Nahleh Z. A. , Wu H. , Galvin E. , Leedy D. 
Published: August 2020

e20637 Background: Cancer-related fatigue is underrecognized and poorly managed. Unpredictability and rapid onset in fatigue is stressed by cancer patients but seldom addressed by health care professionals. Although sudden onset of cancer-related fatigue is anecdotally documented across qualitative studies, the symptom has never been systematically investigated. Our purpose is to describe the symptom and clinical characteristics of SOF in breast cancer patients receiving chemotherapy. Methods: This is a cross-sectional descriptive study enrolling female breast cancer outpatients undergoing chemotherapy in an urban cancer center. A brief questionnaire assessing the symptom characteristics of SOF was completed by subjects. Comprehensive metabolic panel and complete blood counts, were obtained. Descriptive statistics described the symptom characteristics of SOF. Mann-Whitney tests examined the differences between those who did and did not experience SOF. Results: Thirty patients have been enrolled. Median age 53 years (31 to 65; SD=7.7), 60% were Black. 80% (n=24) experienced SOF in the past 7 days with a median of 4 days a week and 2.5 episodes per day. SOF was most likely (75%) to occur in the afternoon while patients were engaging in activities. Levels of fatigue before, during, and after a specific episode of SOF were 5, 9, and 5, respectively, on 0–10 (highest) rating scale. Weakness, sweating, or pain sometimes accompanied SOF. When SOF occurred, individuals immediately needed to stop activities to rest until it went away. Those who experienced SOF had significantly lower levels of calcium (Median=8.9 vs. 9.4), albumin (Median=3.7 vs. 7.1), and hematocrit (Median=32.1 vs. 36) (p<0.05). Those who experienced SOF also had higher levels of GPT (Median=25.5 vs. 17), lower levels of total protein (Median=6.7 vs. 7.1), WBC (Median=4.9 vs. 8.9), RBC (Median=3.4 vs. 3.9), and hemoglobin (Median=10.7 vs. 11.4). Conclusions: Our ongoing study is one of the first to identify the characteristics of patients at high risk of SOF. SOF needs to be recognized and managed when patients undergo chemotherapy. Associated conditions should be identified and addressed. The ultimate goal is to minimize the distress and improve the quality of life of patients receiving chemotherapy. No significant financial relationships to disclose.
Effect of nutritional status and support on survival in esophageal cancer patients undergoing combined modality therapy
Authors: Plastaras J. P. , Haynes J. C. , Mick R. , Hertan L. M. , Urdaneta A. I. , Metz J. M. 
Published: August 2020

e20641 Background: Baseline nutritional status is associated with clinical outcomes in esophageal cancer. Moreover, nutritional support during chemoradiation has been shown to improve outcomes in other disease sites. This retrospective study evaluated the impact of nutritional interventions and baseline nutritional status on outcomes in patients (pts) with locally advanced esophageal cancer. Methods: A retrospective review was performed of 132 pts treated with curative intent using radiation (RT) between 1986 and 2007 at the Hospital of the University of Pennsylvania. The median age of the population was 60 years (range: 33–86). Esophagectomy was performed in 70%, with adjuvant RT in 60% and neoadjuvant RT in 40%. Concurrent chemotherapy was given to 85% of the group. Nutritional counseling was provided to 83% of pts. During RT, oral or enteral nutritional supplements were provided to 77% of pts and intravenous fluids (IVF) were given to 38%. Median follow-up was 14.1 months. Results: Median survival from end of radiation was 1.5 yrs. Median absolute and percentage weight loss during RT were 6.2 lbs and 3.8%, respectively. Median percentage decrease in hemoglobin and albumin were 5.7% and 9.1%, respectively. Univariable Cox regression analysis demonstrated a statistically significant association between weight loss of ≥5 lbs during RT and worse survival (HR 1.74, 95% CI 1.09 - 2.79, p=0.02). Decrease in hemoglobin of 5% or more (HR 1.22, 95% CI 0.59 - 2.54) and decrease in albumin of 10% or more (HR 1.09, 95% CI 0.48 - 2.48) were not associated with survival. Patients who received only nutritional supplements during RT survived significantly longer (p=0.03) than pts who received IVF regardless of nutritional supplementation (HR 2.12, 95% CI 1.12 - 4.01) or pts who received neither nutritional supplements nor IVF (HR 1.8, 95% CI 1.03 - 3.14). Conclusions: Weight loss during RT predicted for worse survival. Nutritional factors before and during RT may be important in outcomes in patients with esophageal cancer and may be modifiable. The use of IVF may be a potential indicator of worse prognosis. Future prospective studies should consider these factors in trial design. No significant financial relationships to disclose.
CNTO328 (Anti-IL-6 mAb) treatment and hemoglobin (Hb) levels in renal cell cancer
Authors: Schipperus M. , Cornfeld M. , Rijnbeek B. , Berns B. , Rossi J. 
Published: August 2020

e20648 Background: CNTO328 is a chimeric monoclonal antibody against the inflammatory cytokine, IL-6, which is currently being studied in hematologic and solid malignancies. IL-6 is a potent inducer of hepatic production of hepcidin, which is the key regulator of iron homeostasis and causes anemia by blocking iron export from enterocytes and macrophages. Hepcidin is an important factor in the pathogenesis of ‘anemia of chronic disease‘. CNTO328 treatment has previously been shown to produce profound Hb increases in Castleman's disease, a disorder caused by deregulated IL-6 production. We subsequently conducted this retrospective review to assess whether CNTO328 treatment is associated with an increase in Hb level in renal cell cancer patients (pts). Methods: All laboratory results for pts with metastatic renal cell carcinoma in this open label phase 2 study were reviewed. Pts were treated with CNTO328 (6 mg/kg) IV infusions Q2 weeks and were evaluated for tumor response and markers of pharmacodynamic effect. The difference in Hb levels from baseline to end of study was calculated. Results: Twenty pts (19 males) with a median age of 62 yrs (range 50–77) were studied. The median number of infusions was 6 (1–13). Of 18 pts evaluable for tumor response, 11 (61%) had SD and 7 (39%) had PD. The median baseline Hb was 13.6 g/dL (10.8–17.1). Nineteen pts were evaluable for Hb response. No pts received ESAs or transfusions. Treatment with CNTO328 resulted in a sustained Hb increase in 16 of the 19 pts (84%), with 13 (68%) achieving a max Hb increase of ≥ 1 g/dL (median 1.9; range 1.0–3.5). Hb responses were early (by day 8) and independent of tumor response. No Hb overshoot or thromboembolic events were observed. A trend toward decreased platelet and neutrophil counts was observed. Conclusions: Though pts were not anemic at baseline, our results suggest that CNTO328 leads to sustained increase in Hb levels, not correlated with tumor response. This increase in Hb is presumably due to the reduction of hepcidin via IL-6 blockade and targeting the hepcidin pathway may lead to new therapies for anemia of cancer. This hypothesis warrants further evaluation with prospective mechanistic studies. [Table: see text]
The importance of fertility preservation in women with early breast cancer
Authors: Agbarya A. , Linn S. 
Published: August 2020

e20663 Background: Young women with breast cancer often seek advice regarding treatment effects on their fertility. The purpose of this study was to gain a better understanding of women's attitudes to fertility and how these concerns affect decision-making. Methods: A survey on fertility issues was developed for young women with a history of early-stage breast cancer. The survey was completed by direct interviews with the patients. Results: Eighty-four eligible respondents completed the survey. Mean age at breast cancer diagnosis was 34.7 years. Fifty-seven percent of the women were Jewish and 43% were Arabic; 71% were married; 75% had more than 12 years of education. Stages at diagnosis were: I - 51%; II - 38%; III - 11%. Seventy-seven percent of the women were within six months of diagnosis and 49% reported substantial concern about becoming infertile with treatment. In multivariate logistic regression, a greater concern about infertility was associated with a wish for children (p=0.0008), number of children less than three (p=0.001), more than 12 years of education (p=0.004), and a moderate or high level of fear of treatment (p=0.004). Seventy-nine percent of patients reported discussing fertility concerns with their doctors, and 14% underwent a medical procedure for fertility preservation. Only five patients stated that infertility concerns influenced their treatment decisions. Conclusions: 1. Fertility after treatment is a major concern for young breast cancer patients undergoing chemotherapy. 2. This statement was not affected by ethnicity. 3. There is a need to communicate with and educate young patients regarding fertility issues and large scale future research directed at preserving fertility for young breast cancer survivors is warranted. No significant financial relationships to disclose.
Ovarian function after high-dose chemotherapy in childhood: Risk factors for developing partial ovarian failure and how to identify them early
Authors: Frey M. , Brugières L. , Bougnères P. , Bouvattier C. , Thomas-Teinturier C. , Calmanti S. , Goma G. , Oberlin O. , Hartmann O. 
Published: August 2020

e20665 Background: During the last 30 years, polychemotherapies, surgery and radiotherapy have been established as standard therapies for treating pediatric cancers thus leading to a significant improvement in terms of 5-year-overall-survival which is now around 70% among children and adolescents. On the other hand, these treatments cause severe sequelae such as ovarian failure (OF) in young girls leading to a premature menopause and infertility. Methods: 29 patients treated at the Institute Gustave Roussy (Villejuif, France) have been investigated in an attempt to find biological and/or clinical markers, and imaging predictive of a partial ovarian insufficiency leading to an early menopause. Eligibility criteria: age >12 years at time of analysis; peripheral stem cell graft between 2–20 years; high dose chemotherapy. Results: 23/29 were eligible for this analysis (6 withdrawn due to oral contraception). 13/23 patients (56.5%) show no clinical evidence of ovarian treatment-related toxicity with a 13 years median time to transplant. 10/23 (43.5%) have complete ovarian insufficiency, among whom the majority have already received substitution hormone therapy (SHT). Out of 75% of pre-pubescent patients at transplant, only 2 have OF. All patients grafted at puberty (15.3 years) have high-dose chemotherapy-related immediate or definitive OF. Thiotepa >900mg/mq is castrating (odds ratio-10.1; p-0.04). Dosages of anti-müllerian hormone (AMH) collapses in patients with IO (p=0.002). Mensed patients have lower AMH dosages compared to normal population (p=2.10-e9) as for antral follicule count (>2mm). Conclusions: 1) 13/23 patients show no evidence of OF. 2) Main risk factors of OF: age ≥ 12 years; post pubertal status; thiotepa >900 mg/m2 (OR=10.1 and p=0.04). 3) Despite normal menses, many women who underwent high dose chemotherapy exhibit low AMH and Inhibine B levels and low count of follicles at a young age. These are possible markers of ovarian depletion. Cryopreservation of the ovarian cortex should be proposed to patients grafted due to a cancer independently of the age at which they have undergone high-dose chemotherapy. No significant financial relationships to disclose.
Efficacy of orally available selective melanocortin-4 receptor antagonists in a murine model of cancer cachexia
Authors: Dallmann R. , Weyermann P. , Magyar J. P. , Anklin C. , Hufschmid M. , Nordhoff S. , Henneböhle M. , Dubach- Powell J. , Courdier-Fruh I. , Mondadori C. 
Published: August 2020

e20668 Background: Cachexia is among the most debilitating and life-threatening aspects of cancer. It represents a metabolic syndrome affecting essential functional circuits involved in the regulation of homeostasis, and includes anorexia, fat and muscle tissue wasting. The anorexigenic peptide alpha-MSH is believed to be crucially involved in the normal and pathologic regulation of food intake. It was speculated that blockade of its central physiological target, the melanocortin (MC)-4 receptor, might provide a promising anti-cachexia treatment strategy. This idea is supported by the fact that in animal studies, agouti-related protein (AgRP), the endogenous inverse agonist at the MC-4 receptor, was found to affect two hallmark features of cachexia, i.e. to increase food intake and to reduce energy expenditure. Methods: Two recently discovered, non peptidic, chemically unrelated, orally active MC-4 receptor antagonists penetrating the blood brain barrier were studied. Specifically, the influence on food intake in healthy mice, and effects in the murine C26 cancer-cachexia model were investigated. Results: Both compounds were found to distinctly increase food intake in healthy mice. Moreover, in mice subcutaneously implanted with C26 adenocarcinoma cells, repeated oral administration (starting the day after tumor implantation) of each of the two compounds almost completely prevented tumor induced weight loss, and diminished loss of lean body mass and fat mass. Conclusions: In contrast to the previously reported peptidic and small molecule MC-4 antagonists, the compounds described here work by the oral administration route. In the light of patient care, orally active compounds might offer a considerable advantage for the treatment of cancer cachexia. [Table: see text]