bluuebunny/crossref_metadata_2025_split huggingface dataset:
High prevalence of vitamin D deficiency in premenopausal women with early-stage breast cancer
Authors: Hershman D. L. , McMahon D. , Irani D. , Cucchiara G. , Crew K. , Raptis G. , Shane E. 
Published: April 2020

8568 Background: The use of bisphosphonates in the treatment of breast cancer is increasing for patients with metastatic and early-stage disease. Vitamin D deficiency may be a risk factor for breast cancer development and is very common in the northeastern US. Vitamin D deficiency appears to increase the risk of hypocalcemia following IV bisphosphonate therapy. The purpose of this study is to evaluate the prevalence of vitamin D deficiency following the initial diagnosis of breast cancer. Methods: We analyzed fasting morning blood from premenopausal women, from the northeastern US, diagnosed with stage I/II breast cancer. Bloods were obtained following curative surgery, and prior to initiating therapy. Serum was archived, stored at -70o and analyzed in batches in a research laboratory for 25-hydroxyvitamin D (25-OHD; Diasorin RIA), albumin-corrected calcium, phosphate, parathyroid hormone (PTH), markers of bone turnover, FSH, LH, estradiol and sex hormone binding globulin (SHBG). Information on demographic, clinical and tumor characteristics were collected and bone mineral density (BMD) was measured (Hologic 4500). Data were analyzed using SAS version 9. Results: We analyzed sera from 36 premenopausal women, none of whom were taking calcium or vitamin D supplements. The mean age was 42 (range 27–54). The mean serum 25-OHD was 22.6 ng/dl, (SD 7.4) and similar among all racial/ethnic groups. Only 4 patients met contemporary criteria for optimal levels (>30 mg/ml); 18 patients had levels between 20–30 mg/ml, 14patients had “insufficient” levels (<20 mg/ml), and 3 patients had “deficient” levels (<12). Serum 25-OHD was inversely associated with serum PTH and free estradiol, and directly associated with SHBG. There were no associations between serum 25-OHD and serum calcium, phosphate, bone turnover markers, or BMD. Conclusions: Suboptimal vitamin D levels are surprisingly common among premenopausal women with early stage breast cancer. The associations between serum 25-OHD, SHBG and free estradiol, suggest that serum levels of vitamin D binding protein may be influencing 25-OHD measurements. Serum 25-OHD should be measured and low levels supplemented before initiating adjuvant bisphosphonate therapy, as vitamin D deficiency may increase the risk of hypocalcemia. No significant financial relationships to disclose.
Direct decompressive surgery with post-operative radiotherapy (S + RT) versus radiotherapy (RT) alone for the treatment of metastatic epidural spinal cord compression (MESCC): A cost-utility analysis using Ontario health economic data
Authors: Chan K. K. , Furlan J. , Guillermo S. , Lam K. , Klinger C. , Fehlings M. G. , Patchell R. A. , Laporte A. 
Published: April 2020

8570 Background: For selected patients with MESCC, S + RT has recently been shown to improve patients’ ability to ambulate and reduce opioid and corticosteroid use when compared with RT alone, with a trend towards survival benefit. (Patchell et al Lancet 2005) The economic impact of adopting this intervention has not been assessed previously. Methods: An analytic decision model was constructed based on the results from Patchell et al. (2005) The perspective of the public health care insurer of Ontario was adopted for the analysis. Costing was performed by using Ontario data for the following items: surgery, radiotherapy, hospitalization, home care services, palliative hospice, and medications. Utilities were obtained from the Harvard University Catalogue of preference score (HUC) and the Health Outcomes Data Repository Data - Health Utility list (HODaR). The primary analysis is a cost-utility analysis comparing surgery and radiotherapy (S+RT) with radiotherapy alone (RT). A probabilistic sensitivity analysis with Monte-Carlo simulation was performed. Results: When comparing S+ RT with RT alone, the incremental cost-effectiveness ratio (ICER) is CAD$ 43,796 per QALY gained. The cost-utility of S + RT is CAD$ 509,084 per QALY and that of RT alone is CAD$ 2,381,246 per QALY. S + RT costs approximately CAD$ 33 more when compared with RT alone per ambulatory day gained. The cost of surgery is partially offset by the decreased cost of hospice palliative care since more patients remain ambulatory and stay at home. Monte-Carlo simulation showed that there is a 25% chance that S + RT may dominate RT alone. The results are sensitive but generally robust to changes in assumptions about the costs of surgery, home care and palliative hospice care. Conclusions: S+RT is likely cost-effective when compared with RT alone for the treatment of MESCC in selected patients, and should be considered by health care policy makers. No significant financial relationships to disclose.
Symptom prevalence of cancer patients dying with and without palliative sedation at a specialized unit for palliative care in a cancer center
Authors: Van Zuylen L. , Van der Wijk L. , Van Veluw H. , Van der Heide A. , Van der Rijt C. C. 
Published: April 2020

8576 Background: Palliative sedation (PS) may be needed in dying cancer patients to achieve acceptable symptom control. Little is known about the differences between sedated and non-sedated patients. To determine characteristics of sedated and non-sedated patients, we performed a retrospective study in patients who died during admission to the palliative care unit (PCU) of the cancer center. Methods: From October 2001 until October 2005, 157 out of 753 admitted patients died at the PCU. The medical and nursing records were studied with respect to patient characteristics and the symptom profile at admission and during the last 72 hrs of life. Results: Of all deceased patients, 68 (43%) were sedated prior to death. The median duration of the sedation was 19 hrs (range 0.7–125). No differences between sedated and non-sedated patients were found in age (median 58 years, range 25–89) and time between admission and death (7 days, 1–38). The primary tumor sites were mostly lung (22.1%), GI tract (20.6%), and breast (16.2%) in the sedated patients, and breast (24.7%), lung (13.5%) and urogenital tract (11.2%) in the non-sedated patients. The symptoms at admission were mainly pain (82%), constipation (43%) and dyspnea (31%) and did not differ between both groups. Prior to the start of PS, sedated patients more often had delirium and dyspnea as compared to non-sedated patients at similar times before death. Conclusions: PS was needed to control symptoms for somewhat less than half of the patients dying at the PCU. Pain was a main reason for admission in both groups, but dyspnea and delirium were more common in sedated patients during admission. [Table: see text] No significant financial relationships to disclose.
Validation of single item Linear Analogue Scale Assessments (LASAs) for assessing quality of life (QOL) in patients with newly diagnosed high-grade gliomas
Authors: Decker P. A. , Ballman K. V. , Locke D. E. , Brown P. D. , Jaeckle K. A. , Buckner J. C. , Rummans T. A. , Clark M. M. , Sloan J. A. 
Published: April 2020

8583 Background: Patient QOL assessment requires balancing the detail provided by multi-item assessments with the reduced burden of single-item assessments. We investigated the psychometric properties of single-item LASA assessments used in 3 North Central Cancer Treatment Group (NCCTG) phase II trials for patients with newly diagnosed high-grade gliomas. Methods: Measures included QOL LASAs (overall, physical, emotional, spiritual, intellectual), Symptom Distress Scale (SDS), Profile of Mood States (POMS), and Functional Assessment for Cancer Therapy (FACT; overall, physical, emotional). Association of LASA measures with SDS, POMS, and FACT domains and with ECOG performance score (PS) and MMSE was assessed with Spearman’s correlation. Repeated measures ANOVA models compared the change over time of LASAs and SDS, POMS, and FACT. Cox regression modeled the association of baseline QOL and survival. Results: 205 patients completed the QOL assessments across 3 time points. LASA mean scores ranged from 60–78; SDS, POMS, and FACT ranged from 68–81. No significant changes across time for overall and emotional scores were observed. FACT physical decreased over time (p<0.001) as did LASA physical (p=0.08). LASA scales were strongly associated with corresponding scales on SDS, POMS, and FACT (0.44<rho<0.65; p<0.001). LASA was negatively associated with PS and positively with MMSE. Baseline scores for overall FACT (p=0.005) and LASA physical (p=0.015) were associated with better survival. Conclusions: The single-item LASA assessments have comparable psychometric properties as longer assessments for the same constructs. Correlations with PS and MMSE were as expected (convergent/concurrent validity). The discriminant validity and prognostic ability of LASA items were similar to the multi-item instruments. Collectively, the data suggest that the single item LASA scales are valid for assessing QOL in patients with newly diagnosed high grade gliomas and are an appropriate alternative when a shorter instrument is warranted. No significant financial relationships to disclose.
L-carnitine supplementation improves fatigue, mood and sleep in cancer patients with fatigue and carnitine deficiency
Authors: Cruciani R. A. , Dvorkin E. , Homel P. , Culliney B. , Malamud S. , Shaiova L. , Lapin J. , Blum R. H. , Lesage P. , Portenoy R. K. , Esteban-Cruciani N. V. 
Published: April 2020

8588 Background: Carnitine is a natural aminoacid derivative that plays a crucial role in cellular energy metabolism. To determine the dose and tolerability we conducted a phase II study with increasing doses of L-carnitine supplementation. In a preliminary analysis, we reported that L-carnitine could improve fatigue, mood and sleep. (Cruciani et al., 2004). Analysis of the full dataset has confirmed and extended these findings. Methods: Patients had active cancer, fatigue and a Karnofsky ≥50. Carnitine deficiency was defined as free carnitine <35 μm]/L for males and <25 for females (normal range 35–67 and 25–55 respectively), or a ratio of acyl/free carnitine >0.4. We utilized a standard maximum tolerated dose (MTD) design, with 3 patients assigned to each successive dose group, starting at 250 mg/day and increasing in each group by 500 mg/day to a maximum dose target of 3000 mg/day. Fatigue (measured by the BFI), depressed mood (CES-D), quality of sleep (ESS), and performance status (Karnofsky), as well as carnitine serum levels were assessed at baseline and after one week of L-carnitine supplementation. Results: Seven groups of three patients each received L-carnitine supplementation for a week with 250, 750, 1,250, 1,750, 2,250, 2,750 or 3,000 mg/day. Of the 27 patients accrued 21 completed the study. Of these, 17 (mean (SD) age = 63.0 (18), females=8) showed an increase in serum L-carnitine levels. The median (min, max) total carnitine increased from 31 (21, 68) to 51 (29, 111) (p < 0.001) and the free carnitine increased from 25.0 (17, 48) to 39 (25, 82) (p < 0.001). The median (min, max) BFI score at baseline was 63 (36, 81) versus 39 (8, 82) after one week (p<0.001). There was also a significant dose response for BFI (r = -0.61, p = 0.01). Median (min, max) CES-D at baseline was 31. (4, 48) and 18.0 (0, 40) after one-week (p = 0.001). Median (min, max) ESS at baseline was 13.7 (2, 22) and 10.3 (1, 18) after one week (p=0.003). Median Karnofsky score did not change (pre and post = 70). Side effects were not observed in any of the groups. Conclusions: This study suggests that L-carnitine is safe up to 3,000 mg/day. Supplementation was associated with improvements in fatigue and depression scores. Fatigue improved in a dose dependent manner. [Table: see text]
Development of the functional capacity screening tool (FCST): A brief instrument to identify functional capacity deficits in anemic cancer patients
Authors: Cella D. , Viswanathan H. , Hays R. D. , Mendoza T. , Stein K. , Pasta D. , Potter L. , Vadhan-Raj S. , Kallich J. 
Published: April 2020

8593 Background: Existing fatigue measures are long and often difficult to incorporate in practice. The objective of this study was to develop a short tool (Functional Capacity Screening Tool [FCST]) to identify functional capacity deficits related to fatigue in anemic cancer patients (pts) using self-report and performance-based measures of functional capacity. Methods: Data were obtained from a multicenter, open-label, single-arm study of darbepoetin alfa therapy (3.0 μg/kg every 2 weeks) in cancer pts (n=1558) who were ≥ 18 years of age with nonmyeloid malignancies receiving cyclic chemotherapy and anemia (hemoglobin [Hb] ≤ 11 g/dL). The Modified Harvard Step Test (MHST) was used as a performance-based measure of functional capacity to assess adjusted VO2max. Pts who contributed data for the development of FCST completed the following: MHST, baseline and ≥ 1 follow-up Hb measurement, baseline and ≥ 1 follow-up Functional Assessment of Cancer Therapy-Fatigue (FACT-F), and fatigue assessed within 3 days of MHST. Items from FACT-F, Brief Fatigue Inventory (BFI), Fatigue Symptom Inventory (FSI) and Medical Outcomes Study physical functioning scale were tested for inclusion in the FCST. Individual item scores were transformed to a 100-point scale. Item selection was based on identifying best predictors of adjusted VO2max, Hb, and global FACT-F scores using linear regression and the r-square selection method. FCST scores were calculated by summating item scores and dividing by number of items. Results: Data from401 pts contributed to the development of the FCST. Eight items were identified for the FCST with a Cronbach’s coefficient alpha of 0.92. Construct validity was supported by correlations of FCST with FSI (r = 0.80, P < .0001) and BFI (r = 0.86, P < .0001). Correlations between FCST and energy (r = 0.75, P < .0001), productivity (r = 0.72, P < .0001), and Hb (r = 0.24, P < .0001) further supported construct validity. Conclusions: FCST holds promise as a short screening tool for identifying functional capacity deficits in cancer pts. This new instrument was reliable, easy to score, and completed quickly by pts, making it suitable for incorporation in clinical practice. Further validation is required in different cancer populations. [Table: see text]
A population-based study on the quality of life for cancer patients as reported in a tumor registry follow-up
Authors: Novotny P. J. , Sloan J. A. , Frost M. , Harris M. , Huntington J. , Chute C. , Clement-Brown K. 
Published: April 2020

8594 Background: Between 1/96 and 3/00, 94,516 SF-36 or SF-12 Quality of Life (QOL) forms were sent to every patient on the Mayo Clinic tumor registry not seen at the clinic in the last year. This study is a descriptive summary of each patient’s first reported QOL score. Method: QOL scores were combined with tumor registry information about age, gender, tumor site, tumor stage, residence, and date of diagnosis. Responder versus non-responder characteristics were compared via Fisher’s exact tests and two-sample t-tests. Means and standard deviations were used to summarize the data. Patient reported scores and SF norms from a healthy population were compared using one sample t-tests. Results: Data were available on 28,166 patients (48,463 forms). Men were more likely to respond. More patients were male (56%) with a mean age of 66 and filled out their first SF form an average of 9 years after their initial diagnosis. Overall, mean physical and mental subscale scores were not clinically different from the age- and sex-adjusted SF normative data (Table). Within tumor sites, mental subscale scores were similar to the general population. Physical subscale scores were also approximately normal within each of the tumor sites. The exceptions were that patients with lung or musculoskeletal cancers tended to report lower physical scores than a healthy population. Conclusions: Patients responding to a tumor registry follow-up program reported QOL scores that were not clinically different from that of a healthy population. QOL deficits observed in patients with lung cancer and musculoskeletal cancers may indicate a need for targeted interventions specific for these cancer patient populations. [Table: see text] No significant financial relationships to disclose.
Pegfilgrastim (N) induced bone pain (NIBP): Incidence, risk factors and management in a community practice
Authors: Kirshner J. J. 
Published: April 2020

8598 Background: In the early clinical trials, the incidence of NIBP was 15–30%, with ‘severe‘ pain in less than 8% of patients (pts). The incidence in clinical practice may be higher and contribute to a significant decrease in quality of life (QOL) for pts undergoing chemotherapy(Ch). Methods: In our large oncology practice (HOACNY), pts were surveyed following their initial injection of N. Pain was graded on a scale of 1–10. Pts were divided into 3 groups: no pain (1), pain 1–5 (2) and pain 6–10(3). Pts recorded the day of onset, duration of pain and its location. Information was obtained as to how the pts treated their pain and how effective the treatment was.Data was collected re: age, sex, disease,and Ch and whether pts were already on analgesics/steroids. All pts received 10–20 mg of IV dexamethasone pre-Ch. N was administered 24–72 h post chemotherapy. Differences among the groups were analyzed using the t-test. Results: To date, surveys have been analyzed from 75 pts, with results tabulated below. Dose dense AC for adjuvant breast ca was the most common Ch (44%). There were no significant differences among the groups when analyzed by pt age, sex, disease, or Ch, although there was a higher % of lung ca pts in Gp 3 (treated with carboplatin/paclitaxel). On average, the onset of pain was within the first 2 days & lasted 2–3 days(Gp2) and an additional day (Gp 3). Gp 2 pts had more localized pain than Gp 3 pts & responded very well to APAP or NSAID’s. Gp 3 pts had more diffuse pain and 50% had minimal or no relief with OTC analgesics. Conclusions: NIBP is a significant problem in clinical practice, interfering with pt QOL. It is unpredictable and often severe & may be refractory to OTC analgesia. It may be more common in lung ca pts treated with carboplatin/paclitaxel. A prospective randomized trial is planned (URCC CCOP Research Base) to further define the problem and determine if daily ‘premedication‘ with NSAIDS could reduce or eliminate NIBP. [Table: see text] [Table: see text]
Eltrombopag, a novel, oral platelet growth factor, increases platelet counts in thrombocytopenic patients and healthy subjects
Authors: Bussel J. , Saleh M. , Provan D. , Stone N. , Hamilton J. M. , Hassani H. , Mayer B. , Uhl J. , Jenkins J. , Glaspy J. 
Published: April 2020

8602 Background: Eltrombopag (SB-497115) is a novel, first in class, orally bioavailable, thrombopoietin receptor agonist that induces differentiation and proliferation of megakaryocyte progenitors and has been shown to increase platelet counts in preclinical and clinical studies. Methods: In two randomized, placebo-controlled trials, eltrombopag was administered as oral tablets, once daily for 10 days to 73 healthy male subjects at doses of 5–75mg in an ascending dose cohort study, and to 103 (64 female/39 male) adult chronic immune thrombocytopenic purpura (ITP) patients, with a platelet count of <30×109/L, once daily for 6 weeks at doses of 30–75mg in a parallel dose cohort study. The primary efficacy endpoint in the Phase II ITP trial was the proportion of subjects with a platelet count >50×109/L after 6 weeks of dosing. Results: In healthy subjects, eltrombopag induced a dose dependent increase in the platelet counts. Mean maximal platelet count increases were 24.1 % at 30mg, 42.9 % at 50mg, and 50.4 % at 75mg. In 95 eligible ITP patients, platelet counts increased from <30 to >50×109/L in 16% (4/25) of subjects on placebo, and in the eltrombopag groups in 28% (7/25, p=ns) on 30mg, 67% (16/24, p<0.001) on 50mg and 86% (18/21, p<0.001) on 75mg eltrombopag. The median platelet counts in each treatment arm after 6 weeks of dosing were 16×109/L on placebo, 29×109/L on 30mg, 132×109L on 50mg, and 202×109/L on 75mg. The dose dependent effect was not significantly affected by the splenectomy status, background immunosuppressant use, or baseline platelet count (greater than or less than 15×109/L). Conclusions: The platelet count data from these clinical studies suggests that eltrombopag could be an effective therapy for the treatment of thrombocytopenia. Eltrombopag is being tested in further studies involving patients with ITP and chronic liver disease, and cancer patients receiving thrombocytopenic chemotherapy. [Table: see text]
Renal insufficiency in cancer patients: Prevalence and implications on anticancer drugs management. Results of the IRMA study
Authors: Launay-Vacher V. , Oudard S. , Janus N. , Le Tourneau C. , Rixe O. , Pourrat X. , Gligorov J. , Beuzeboc P. , Deray G. , Morere J. 
Published: April 2020

8603 Background: Patients with abnormal renal function are at high-risk for drug-induced nephrotoxicity. Furthermore, near half anticancer drugs are predominantly excreted in urine and dosage adjustment in RI is therefore a crucial issue. In 2005, the IRMA study (Insuffisance Rénale et Médicaments Anticancéreux) thus investigated the prevalence of RI in cancer patients and the profile of anticancer drugs prescribed. Methods: Data were collected for cancer patients presenting at one of the 14 IRMA centers in February 1st-15th or October 1st-15th, 2004: type of tumour, sex, age, weight, serum creatinine (SCR), haemoglobinemia, anticancer drugs. Dialysis and myeloma patients were not included. The prevalence of SCR>110 μmol/L was assessed. GFR was estimated with the Cockcroft-Gault (CG) and the abbreviated MDRD (aMDRD) formulae and patients were classified according to their K/DOQI stage of RI (Table). Anticancer drugs necessitating dosage adjustment and those potentially nephrotoxic were identified. Results: 4,684 patients (Breast, 1,898; Colorectal, 573; Lung, 445; Ovarian, 270; Prostate, 222) were included: mean age 58.1 years, weight 65.8 kg, sex-ratio 0.55. The prevalence of elevated SCR was 7.2% and those of GFR <90 ml/min was 57.4% with CG and 52.9% with aMDRD. 53.4% of the 7181 prescriptions needed dosage adjustment and 79.9% of treated patients (n=3823) were receiving at least one drug needing dosage adjustment. 53.3% of prescriptions were potentially nephrotoxic and 80.1% of treated patients received at least one nephrotoxic drug. 46.8% had a serum haemoglobin lower than 12 g/dL and still 25.9% were lower than 11 g/dL. Conclusions: The results of the IRMA study showed that RI is highly frequent in cancer patients and that 80% of the patients receive potentially nephrotoxic drugs and/or for which dosage must be adjusted in RI. Furthermore in IRMA patients, anemia was still highly frequent. [Table: see text] No significant financial relationships to disclose.