bluuebunny/crossref_metadata_2025_split huggingface dataset:
Costs and outcomes associated with febrile neutropenia-related hospitalizations across patients with varying cancer types: A retrospective analysis
Authors: Schilling M. B. , Parks C. , Deeter R. G. 
Published: August 2020

e20560 Background: Neutropenia, the major dose-limiting toxicity of chemotherapy, is a frequent, often serious, and sometimes fatal complication of myelosuppressive chemotherapy. Its economic and clinical impact is often under-appreciated, and thus this study evaluates the contribution of febrile neutropenia (FN) by tumor type as related to healthcare cost and mortality. Methods: FN patients in this study were identified as having cancer (ICD-9-CM: 140.xx - 208.xx), neutropenia (288.0x) and either opportunistic infections (110 total codes) or fever of unknown origin (780.6) who were hospitalized between 1/05 and 6/08 in a retrospective cohort study from the Aspen US healthcare database (∼11 million pts, >342 inpatient facilities, and >300 million charge-detail records). Unadjusted mean healthcare cost of hospitalization, length of hospital stay (LOS), and mortality rates were calculated, stratifying by cancer type (breast, metastatic breast, and lung cancers, non-Hodgkin lymphoma (NHL), or other hematologic tumors). Results: Among 598 hospitalized patients (mean age 63 years; 53% female) with cancer experiencing FN, the mean cost of hospitalization, LOS and mortality varied significantly by tumor type ( Table ). Conclusions: FN hospitalizations are costly and may be associated with significant mortality. Considerable variations exist across cancer types for hospitalization costs, LOS and mortality. The tumor type is important in assessing the economic and clinical impact of FN hospitalizations. [Table: see text] [Table: see text]
Vitamin D levels during and after high-dose vitamin D supplementation in women with early-stage breast cancer
Authors: Khan Q. J. , Kimler B. F. , Sharma P. , Reddy P. S. , Baxa S. , Klemp J. R. , Fabian C. J. 
Published: August 2020

e20561 Background: Experts define vitamin D deficiency as a 25-hydroxyvitamin D (25OHD) level of < 20 ng/ml; a level < 32 ng/ml is considered insufficient for bone health and > 40 ng/ml may be associated with optimum musculoskeletal function and reduced risk for breast cancer. We conducted a study to determine the effect of high dose vitamin D3 at 50,000 IU/wk (HD vitD) on musculoskeletal symptoms from adjuvant letrozole in breast cancer patients. We present here the effectiveness of HD vitD in achieving optimum 25OHD levels and the rate of decline of 25OHD levels after 12 weeks of HD vitD. Methods: The cohort included post-menopausal women with early stage hormone receptor positive breast cancer initiating letrozole treatment. Women with baseline 25OHD levels < 40 ng/ml received 12 weeks of HD vitD. 25OHD levels were assessed at 6 and 12 weeks during HD vitD supplementation and at 3 and 6 months after completing HD vitD but while taking maintenance dose of 600–1000 IU of vitamin D3 daily. Results: 40 women that received HD vitD completed the follow-up phase of the study and are included in this analysis. At entry on study, median 25OHD level was 23 ng/ml; 38% of the women had vitD deficiency, 75% had insufficiency, and 93% had 25OHD levels < 40 ng/ml. Six weeks of HD vitD increased median 25OHD level to 60 ng/ml and another 6 weeks increased it further to 66 ng/ml. With only 6 weeks of HD vitD supplementation, 98% of the women achieved a 25OHD level of > 40 ng/ml. Median 25OHD levels 3 and 6 months after completion of HD vitD were 49 and 40 ng/ml, respectively. The median rate of decrease in vitD levels per month was 6.8% of the level at completion of supplementation. Using linear regression analysis, projected changes in 25OHD levels were calculated for each subject. Median extrapolated time to drop to a 25OHD level of < 40 ng/ml was 6.0 months, to <32 ng/ml was 7.8 months, and to <20 ng /ml was 10.6 months. Conclusions: Supplementation with vitD3 at 50,000 IU/week for 6 weeks is sufficient to achieve a 25OHD level of >40 ng/ml in 98% of postmenopausal women with breast cancer on an AI. After 12 weeks of HD vitD, there is a steady decline in 25OHD levels at a rate of about 7% per month despite continuing on 600 to 1000 IU of D3 daily. Thus, standard doses of D3 are not adequate to maintain 25OHD levels achieved by HD vitD. No significant financial relationships to disclose.
The effects of surgery type on pretreatment distress and negative expectations in women scheduled for gynecologic surgery
Authors: Higgins S. C. , Schnur J. B. , Montgomery G. H. , Zakashansky K. , Bovbjerg D. H. , Dottino P. 
Published: August 2020

e20562 Background: Most women with gynecologic cancer must undergo surgery as part of their treatment. Research suggests that laparoscopic surgery may lead to fewer side effects and faster recovery than laparotomy. Clinically, however, it is unclear if these benefits have led to decreased levels of emotional distress in patients prior to the procedure and/or to reduced expectations of negative side effects. The purpose of the present study was to assess and compare levels of emotional distress and expectations for postoperative discomfort and pain in women scheduled for either laparoscopic gynecological procedures, or laparotomy. Methods: Fifty-nine women scheduled for gynecologic surgery (mean age = 52.0 years) were recruited to this study. The dependent variables, pretreatment emotional distress and expectations of postoperative pain and discomfort, were assessed in the clinic with a numeric rating scales (0–10) prior to surgery. The independent variable, surgery type, was categorized into: minor laparoscopic, major laparoscopic, and laparotomy. Results: Univariate analyses revealed that mean distress levels between minor laparoscopic (x = 3.4), major laparoscopic (x = 4.2) and laparotomy (x = 3.8) did not differ (p>.1), nor did expectations of pain or discomfort (p's>.1). Demographic variables (age, race, education, marital status) did not show bivariate relationships with pre-surgical distress or expectations and therefore were not controlled for in the models. Conclusions: Based on the present results, the benefits of laparoscopic gynecologic surgery do not appear to affect patients’ levels of pretreatment distress or expectations of negative outcomes. The results suggest that women undergoing even minor gynecologic surgery may benefit from interventions to reduce preoperative distress, which has been shown to be a risk factor for increased postoperative side effects. No significant financial relationships to disclose.
Evaluation of psycho-social distress in patients treated in a community-based oncology group practice in Germany
Authors: Mergenthaler U. , Heymanns J. , Köppler H. , Thomalla J. , van Roye C. , Weide R. 
Published: August 2020

e20577 Background: Systematic evaluation of psycho-social distress in oncology outpatients is an important issue. Therefore we assessed feasibility and benefit of standardized routine screening using the Distress Thermometer (DT) and the Problem List (PL) in daily practice. Methods: All patients attending the practice between July and September 2008 were administered the DT and the PL. Patients were classified into the disease groups solid tumors, hematological neoplasms, benign hematological diseases and other non-malignant diseases. The individual treatment phase was evaluated additionally. Participants in a mammography screening programme were assessed as a control group. 500 randomly selected patients were sent a feedback-form to describe how they experienced the DT's influence on the doctor-patient-communication. Results: The 1,446 patients reported an average distress level of 4.7 with 37% indicating a distress level > 5. Patients with other non-malignant diseases (81% autoimmune diseases or hereditary hemochromatosis) showed the highest average distress level of 5.2. Regarding the treatment phases, the most distressed patients were patients who just learned about their diagnosis of relapsed or metastatic disease (6.4), patients receiving Best Supportive Care (5.4) and patients receiving adjuvant anti-hormonal therapy (5.4). The most frequently indicated problems causing distress were exhaustion/fatigue (49%), pain (44%), impaired mobility (41%) and sleep disorders (39%) respectively. Breast cancer patients stated a distress level of 5.2. The average distress level in 474 mammography screening participants was 3.3. 37% of 190 patients who returned the feedback-form indicated that the DT and PL were useful tools to speak to their doctor about their distress more precisely. 38% felt better than usual after this conversation. Conclusions: The study shows that cancer patients do not necessarily show higher distress than patients with severe non-malignant diseases. The problems patients most frequently indicate as distressing are somatic disorders. DT and PL are applicable for routine screening in an outpatient setting. Physicians as well as patients stated that the use of the DT improved the quality of their communication. No significant financial relationships to disclose.
Hypofractionated radiotherapy and hormonal therapy in elderly breast cancer patients
Authors: Minea L. N. , Anghel R. , Isacu I. , Bacinschi X. , Tarlea A. , Georgescu T. , Georgescu T. 
Published: August 2020

e20584 Background: Life expectancy increased in female population and we are facing higher incidence of breast cancer in patients over 80 years old. Considering age related comorbidities they are usually frail population which often can not receive chemotherapy or radical surgery. We evaluated once-a-week hypofractionated radiotherapy together with hormonal therapy for these patients in terms of local control, side effects and progression-free survival. Methods: Between January 2002 - December 2006 in the Oncological Institute of Bucharest Radiotherapy Department 59 patients with the age over 80 have been treated with once weekly hypofractionated radiotherapy associated with hormonal therapy. The clinical stage distribution was: stage I 9 patients, stage II 28 patients, stage III 22 patients. Radiation therapy was delivered once a week, dose=6.5 Gy, to a total dose of 32.5 Gy in 5 fractions for tumor site and lymph nodes. All patients received post irradiation hormonal therapy: Tamoxifen intended for 5 years. Results: 45 patients supporting the entire treatment (77%). 8 patients received less than 32.5 Gy (13%). 6 patients received less than 2 years hormonal therapy (10%). Radiotherapy led to: CR in 13 patients, PR in 31 patients, SD in 10 patients and PD in 5 patients. Toxicities after radiation therapy have been: grade 1–2 nausea in 6 patients, radiodermitis in 43 patients (grade 1–2 - 36 patients and grade 3–4 - 7 patients) and grade 1–2 leucopenia in 18 patients. Late toxicities of all grade occurred in 49.15% of patients: skin reaction - 19 patients, lung fibrosis - 8 patients (2 symptomatic and 6 asymptomatic) and cardiac failure - 2 patients. After one year 12 patients were free of disease and 38 patients were free of progression. 9 patients progressed; 4 of them died, 2 from their cancer. After two years 10 patients were free of disease and 35 free of progression. 14 patients dead and 4 death were cancer-related. Progression-free survival rate at 2 years was 76.27%. Conclusions: Definitive hypofractionated radiotherapy allows a good local control with acceptable toxicity and good progression free survival rate. This schedule associated with hormonal therapy is a good alternative to conventional multimodality treatment and to standard fractionation for patients over 80 years old. No significant financial relationships to disclose.
Life-threatening dermatologic toxicities to cancer drug therapy: An assessment of the published peer-reviewed literature
Authors: Sorrell J. , West D. P. , Bennett C. L. , Raisch D. W. , Lacouture M. E. 
Published: August 2020

e20592 Background: Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) lie on opposite ends of a clinical spectrum characterized by skin detachment, mucosal involvement and bullous skin lesions. Currently, reporting is in the range of 1–7 cases of SJS and 0.4–1.2 of TEN/million persons/year, with mortality as high as 35%. The association of cancer drug therapy with SJS/TEN has been uncommonly addressed. Methods: We searched Ovid (incl.1950 through Nov 2008), PubMed (incl.1948 to present) and Litt's Drug Eruption Reference Manual (incl.1980 through Oct 2007) using search terms and combination of terms relevant for SJS/TEN and cancer drug therapy. Only primary case reports were included. Histology reporting was not required for inclusion. Results: Of 448 results, there were 20 reports of SJS associated with 12 FDA-approved drugs and 22 reports of TEN associated with 16 FDA-approved drugs. In addition, all cases (cancer therapy and non-cancer therapy) were obtained from Medwatch (through Mar 2008). ( Table ) Conclusions: Whereas mild-moderate dermatologic toxicities including alopecia, nail abnormalities or rashes are frequent with cancer drug therapies, it is essential for the oncologist to be familiar with life-threatening dermatologic toxicities such as SJS and TEN, and the agents that have been associated with such reactions. [Table: see text] [Table: see text]
Effect of PHY906 on capecitabine (CAP)-induced diarrhea in patients with GI malignancies
Authors: Hoimes C. J. , Lamb L. , Lok W. , Elligers K. , Carbone R. , Keley K. , Lansigan F. , Liu S. H. , Cheng Y. C. , Saif M. W. 
Published: August 2020

e20595 Background: 15.4% of pts with GI cancers treated with CAP alone at 1250mg/m2 BID D1–14 q 3 wks (14/7) develop G3/4 diarrhea (Hoff et al. JCO, 2001). PHY906 composed of 4 herbs, Scutellaria baicalensis Georgi, Glycyrrhiza uralensis Fisch., Ziziphus jujuba Mill., and Paeonia lactiflora Palla, has been used to treat diarrhea since approximately 300AD. Preliminary studies showed synergistic activity of PHY906 with chemotherapeutics and reduction of chemotherapy-induced GI toxicities, especially chemotherapy-induced diarrhea (CID). Methods: We prospectively evaluated 44 pts treated on a clinical study with CAP plus PHY906 for diarrhea (experimental arm) and compared to historical data by Hoff et al., CAP 14/7 alone arm (control arm). Experimental arm consisted of pts with refractory solid tumors in phase I and gemcitabine-refractory advanced pancreatic cancer (APC) in phase II. Ph I pts received PHY906 800mg BID D1–4 with escalating doses of CAP (1000mg/m2→1250mg/m2→1500 mg/m2→1750mg/m2 BID) D1 -7 q 2 wks (7/7), until MTD. Ph II treated pts with APC at 1500 mg/m2 and PHY906 800mg BID D1–4. Toxicity was assessed per NCI-CTCAE-v3.0. In addition, correlative chemokine (IL-2, IL-4, IL-5, etc) levels will be quantified by cytometric bead array. Results: 44 pts (30M/14F; median 64yr) received 209 cycles (median:3, r:<1–14) of PHY906 in the four CAP-7/7 escalation cohorts in Phase I (19 pts), then at the MTD of 1500mg/m2 BID in Phase II (25 pts). Phase I pts had GI malignancies; 15 (63%) had APC and 6 (25%) colorectal. Of all phase I and phase II pts, G3/4 diarrhea was observed in 5 (11.4%) pts, without G3/4 constipation. One pt with APC who received 3 cycles at the 1500mg/m2 dose level was diarrhea-free until he was removed from the study; he continued on single-agent CAP at 1000mg/m2 BID and developed G3 diarrhea. Conclusions: In this study, G3/4 diarrhea was reduced by 19.5% in pts treated with PHY906 (experimental arm) when combined with CAP 7/7 compared to historical controls (control arm). As an underlying mechanism of CID may include cytokine activation, evalation of cytokines is ongoing. [Table: see text]
Budget impact analysis of sargramostim use in patients with chemotherapy-induced neutropenia
Authors: Duh M. , Toy E. L. , Porter C. L. , Books P. L. , Vekeman F. , Barghout V. , Skarin A. T. 
Published: August 2020

e20596 Background: Myeloid growth factors are used to treat and prevent chemotherapy-induced neutropenia (CIN). Filgrastim and its long-acting version pegfilgrastim are granulocyte colony-stimulating factors (G-CSF), whereas sargramostim is a dual granulocyte- macrophage colony-stimulating factor (GM-CSF). This study analyzed the budget impact of substituting GM-CSF for G-CSF in the management of CIN from the perspective of a US health plan. Methods: A spreadsheet model was developed to compute annual and per-member-per-month (PMPM) costs associated with CSFs. Inputs included cancer prevalence, the proportion of patients receiving chemotherapy and G/GM-CSFs, incidence and cost of relevant adverse events (e.g., bone pain), and G/GM-CSF drug acquisition and administration costs. Incidence and cost of infection- and febrile neutropenia-related hospitalizations, based on recent analysis of medical insurance claims data, were also used. Cost savings (2006 USD) were assessed for utilization share switches from G-CSF to GM-CSF. Results: For a health plan with 1 million members, an estimated 976 patients received G/GM-CSF annually. Increasing baseline utilization shares for pegfilgrastim, filgrastim, and sargramostim of 70/30/0%, respectively, to alternative shares of 50/25/25% yielded substantial cost savings (see Table ), primarily related to G/GM-CSF acquisition and administration costs. Savings for patients switching from pegfilgrastim were greater than for patients switching from filgrastim. Results were sensitive to assumptions for drug cost and frequency of administration, but cost savings were observed for most scenarios. Conclusions: This study suggests that health plans can realize substantial cost savings by substituting sargramostim for filgrastim and pegfilgrastim in CIN patients. With 25% of sargramostim substitution, the cost saving could reach ≈$2 million for a health plan with 1 million members, or a saving of 16 cents per member per month. [Table: see text] [Table: see text]
Classification procedure of the German version of the Cancer Fatigue Scale (CFS-D)
Authors: Reif M. , Kröz M. , Schad F. , von Laue H. , Feder G. , Matthes H. , Girke M. 
Published: August 2020

e20608 Background: Fatigue severely reduces quality of life in many cancer patients. Cancer related fatigue (CRF) occurs with anaemia, during and after chemo- or radiotherapy and in advanced tumour states. The Cancer Fatigue Scale (CFS) is a well validated 15-item, 3-dimensional inventory (physical, cognitive, affective). Our classification procedure of its German version aimed at best separation of fatigue in cancer patients from healthy controls. Methods: CFS-D study data was combined from two studies that included CSF-D evaluations: a) 21 breast cancer (BC) and 7 colorectal cancer (CRC) patients (from a group of 57 cancer patients) and all 57 matched-pairs healthy controls (C); b) 41 BC and 25 CRC patients with chemotherapy. Analysing repeated ratings, four groups were found to significantly differ in global CFS-D (N female/male): C 65/27, CRC with (+) viscum album (VA) 27/34, BC + VA 110/0, BC without (-) VA 30/0. In cut-off analyses of sum- and subscales we iteratively categorized the data using moving thresholds and calculated their chi-square (X2) statistics when crossed with the study groups. CFS-D values were chosen as cut-off thresholds that yielded maximum X2 values when tested in 2x2-, 3x4-, and 4x4-tables. We plotted ROC curves to check for congruency of cut-off and ROC values. Results: Global CFS-D median (min.-max.) were: C 18 (2–38), CRC 22 (1–46), BC + VA 27 (0–54), and BC - VA 29.5 (7–48). For global CFS-D, cut-off and ROC analyses indicated ‘unclear’ CRF starting at 23 and ‘probable’ at 30. Subscale results were less definite; maybe with categories ‘unclear’/‘probable’ for dimensions ‘physical’: 9/15, ‘cognitive’: 9/11, ‘affective’: 6/8. Conclusions: The CFS-D is a highly reliable and valid global CRF questionnaire indicating categories ‘probable’ >= 30, ‘unclear’ at 23–29 and ‘none’ < 23. Thresholds for CFS-D subscales are less clear-cut and can not simply be calculated as proportional fractions of the total scale. No significant financial relationships to disclose.
Zoledronic acid for the prevention of bone loss in patients with previously untreated lymphoma undergoing chemotherapy
Authors: Cataldo V. D. , Thompson M. A. , Toth B. B. , Sanjorjo P. , Bourgeois S. J. , Bekele B. N. , Jimenez C. , Murphy W. A. , Byfield S. A. , Hagemeister F. B. 
Published: August 2020

e20611 Background: Treatment of lymphoma with alkylating agents and steroids causes bone loss and increased fracture risk. In addition, over half of all untreated lymphoma patients are osteopenic or osteoporotic at diagnosis. Pamidronate reduces bone loss and risk of vertebral fractures in lymphoma patients undergoing chemotherapy (CT). However, the effects of the more potent bisphosphonate (BP) zoledronic acid (ZA) in this setting are unknown. Therefore, we report on a phase III trial evaluating the effect of ZA on bone mineral density (B) in patients with newly-diagnosed lymphoma undergoing CT. Methods: In total, 72 patients will be randomized to either the control arm [calcium carbonate (1,200 mg orally/day) plus vitamin D (400 IU orally/day)], or the BP arm [calcium carbonate and vitamin D as in the control arm plus ZA (4 mg IV at baseline and at 6 months)]. The primary endpoint is the absolute change in B of the lumbar spine (LS) and femoral neck (FN) at baseline and 12 months. Results: Thus far, 112 patients have been screened for enrollment. Twenty-seven patients (24.1%) failed screening due to periodontal disease, a predetermined exclusion criterion of the study. To date, 14 patients in the control arm and 9 patients in the BP arm have completed the one-year follow up period including baseline and one-year B evaluations. Comparing patients in the control arm to those in the BP arm, the average absolute change in B at the LS was -0.048 g/cm2 vs. 0.0093 g/cm2 (p=0.005), at the left FN was -0.039 g/cm2 vs. 0.0074 g/cm2 (p=0.01), and at the right FN was -0.043 g/cm2 vs. 0.0211 g/cm2 (p<0.001), respectively. There have been no therapy-related serious adverse events or skeletal fractures in either arm. Conclusions: ZA in combination with calcium carbonate and vitamin D improves the B of patients with lymphoma undergoing CT. Given the incidence of below-average pre-treatment B and the known deleterious effects of lymphoma therapy on bone density, baseline B evaluation is warranted in all lymphoma patients. The high rate of periodontal disease in this patient population emphasizes the need for careful dental evaluation prior to BP therapy given the well-described, albeit rare, risk of osteonecrosis of the jaw from ZA. [Table: see text]