bluuebunny/crossref_metadata_2025_split huggingface dataset:
Renal function among cancer patients with bone metastases treated with zoledronic acid in a real world setting
Authors: Nordstrom B. L. , Langer C. , Hussain A. , Barghout V. , Modi D. , Lacerna L. , Gralow J. R. 
Published: March 2020

19540 Background: Zoledronic acid (ZA) is a bisphosphonate that reduces skeletal related events (SREs) in cancer patients (pts) with bone metastases but can impact renal function in some pts. This retrospective study examined serum creatinine (sCr) elevations and subsequent treatment changes among pts receiving ZA in community based medical practices. Methods: Data were obtained from the Varian Medical Oncology database of electronic medical records from 17 US oncology practices. Cancer pts with bone metastases and at least one ZA infusion in 2002–06 were followed; all available sCr levels were examined. SCr measurements ≤4 weeks after a ZA infusion were considered levels while on ZA. Elevated sCr was defined as an increase over baseline of ≥0.5 mg/dL or a doubling from baseline for pts with baseline levels <1.4 mg/dL (or ≥1.0 mg/dL for higher baseline levels). Pts with a sCr elevation on ZA were followed to observe changes in ZA dosing and sCr. Results: The study included 875 pts (318 with breast cancer, 131 lung, 154 prostate, 23 multiple myeloma, and 249 other or unknown cancer) with ≥1 sCr level during baseline and ≥1 (median 6) while on ZA. Median age was 66, 41% were male, and 90% had baseline sCr under 1.4 mg/dL. Pts received a median of 6 ZA infusions. SCr elevations occurred in 87 pts (10%), at a median of 19 weeks (range 0.6–126) after the start of ZA. Pts with baseline sCr over 2.0 mg/dL were more likely to experience an elevation (11 pts, 33%). Following the elevated sCr, 37 pts (43%) discontinued ZA; dose reductions and delays were infrequent. Among 49 pts who remained on ZA after elevated sCr and had further sCr while on ZA, 20 (41%) returned to within 10% of baseline, at a median of 7 weeks (range 0.3–31) after the first measured elevation. The proportion returning to normal is a conservative estimate given limited follow-up sCr data. Conclusions: The observed incidence of elevated sCr of 10% in this community based study is similar to clinical trials. Most pts either discontinued ZA or returned to baseline levels despite continued ZA treatment. Few practitioners adhered to recommendations to withhold ZA until levels return to within 10% of baseline. No significant financial relationships to disclose.
Erythropoietin stimulating agent dose and use patterns in cancer patients
Authors: Daniel G. W. , Hurley D. L. , Whyte J. L. , Grochulski W. D. , Willey V. J. , Kallich J. D. 
Published: March 2020

19547 Background: Patients with cancer who develop anemia are often treated with erythropoietin-stimulating agents (ESAs), such as darbepoetin alfa (DA) or epoetin alfa (EA). This study compared baseline characteristics, patterns of ESA use, and dosing among cancer patients as observed in a large managed care claims database. Methods: Medical and pharmacy claims from a U.S. managed care database were used to identify 15,007 unique episodes of care (7,238 with DA, 7,769 with EA) among cancer patients between January 2004 and January 2006. Episodes were defined as the time over which consecutive ESA claims occurred with =42 day gap between claims, plus a duration of clinical benefit (DCB) based on the median days between consecutive doses for each product. Six sensitivity analyses were performed that examined the robustness of findings to study methods and assumptions. Results: The mean (± SD) number of administrations per episode was 3.7 (± 4.1) for DA and 5.3 (± 6.4) for EA. The mean ESA episode duration was 55.5 (± 64.7) days for DA and 59.2 (± 59.2) days for EA and median times between consecutive claims was 15 and 8 days, respectively. The estimated mean weekly dose, including the DCB, was 105 (± 56) mcg for DA and 34,242 (± 28,174) U for EA. Average weekly doses were found to be sensitive to the inclusion/exclusion of the duration of clinical benefit (dose ratio 1:326 vs 1:237, respectively). Compared to EA episodes, DA episodes were associated with younger age (75% <65 years, for DA vs. 69% <65 for EA), more platinum containing chemotherapy (31.9% DA vs. 28.4% EA (p<.001), more classes of chemotherapy used (77% with one or more classes (DA) vs. 65% with one or more classes (EA) (p<.001)) and higher comorbidity burden, as measured by the Deyo-Charlson index (54.3% with a score =8 (DA) vs. 46.6% (EA) (p<.001). Conclusions: Patterns of ESA use differed significantly between DA and EA. Additionally, patients receiving DA differed significantly in baseline characteristics compared to patients receiving EA. Adjustments for patterns of use are necessary to appropriately compare the use of the two ESA’s. [Table: see text]
The value of FACT-G in screening cancer patients for depression
Authors: Jang S. , Ackler J. , Braitman L. , Tester W. 
Published: March 2020

19557 Background: The prevalence of depression in cancer patients varies greatly, reported in the range of 5–50% depending upon the population studied. Several tools have been used to screen for depression, but it remains uncertain which tool is most valuable. The Zung self-rating depression scale (ZSDS) is one of the commonly used screening tools for depression. Using a cutoff value of ≥ 40, one study reported sensitivity of 100% and specificity of 55% in diagnosing depression. This study was designed (1) to investigate the prevalence of major depression in our population of outpatients receiving chemotherapy, (2) to determine the correlation between the ZSDS score and Functional Assessment of Cancer Therapy - General version (FACT-G) score and (3) to examine whether statements from the FACT-G can be used as a screening tool for major depression. Methods: Sixty-two chemotherapy patients completed both ZSDS and FACT-G. Median age was 62 years (range 22–81); 55% were female. Patients with ZSDS scores ≥ 40 were interviewed, using standard DSM-IV criteria to evaluate for major depression. Pearson’s correlation was used to examine the correlation between ZSDS and FACT-G scores. We then analyzed responses to FACT-G statements to evaluate if certain questions from the FACT-G could be used as a screening tool for major depression. Results: Thirty patients had ZSDS score < 40, and were considered to not have major depression. Among the 32 patients with ZSDS score = 40, 30 underwent clinical interviews. Seven of these 30 were diagnosed with major depression. The prevalence of major depression was 7/60, or 12% (95% CI: 5% - 23%). The ZSDS score and FACT-G score had strong correlation (R= -0.75). If the total score (range 0–24) of six statements from FACT-G were ≤12, then these six FACT-G statements had sensitivity of 100% and specificity of 81% in predicting major depression. Conclusions: The prevalence of major depression was 12% in our population of chemotherapy patients. The ZSDS and FACT-G scores showed strong correlation. Patient responses to six selected statements from the FACT-G appear to be useful as a screening tool for depression. A confirmatory study with larger numbers of patients is planned. No significant financial relationships to disclose.
High-dose bolus interleukin-2 in elderly patients (>60 years old) with metastatic melanoma or renal cell cancer
Authors: Homsi J. , Kim L. C. , Goetz D. , Chen D. , Fishman M. , Daud A. 
Published: March 2020

19559 Background: Although durable complete responses have been reported from using high-dose bolus interleukin-2 (HDB IL-2) in a small number of patients with metastatic melanoma and renal cell cancer (RCC), IL-2 toxicity limits its use especially in the elderly. Methods: the medical records of patients older than 60 years old with melanoma or renal cell carcinoma who received HDB IL-2 at the Moffitt Cancer Center between 2000–2005 were reviewed. The effect of increased age, primary diagnosis, and the HDB IL-2 regimen used on the side effects, number of administered doses, and survival was analyzed. Results: 55 cycles were administered to 35 patients (23 RCC, 12 melanoma, 26 men). Median age was 67 years old (range: 61–77). 17 patients received a traditional regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 14 doses repeated in 2 weeks, maximum of 28 doses) and 18 received a clinical trial regimen (one cycle: 600,000 IU/Kg intravenously every 8 hours for 5 doses repeated weekly, maximum of 20 doses). Median number of administered cycles was 1 (range 1–4) and median number of total doses was 24 (range 3–79). Increased age was not related to total number of administered doses. Median percentage of IL-2 administered in a cycle was 75% of planned (range 11%-100%). Reasons to discontinue therapy were: oliguria (35%), hypotension (25%), and arrhythmia (15%). Side effects in all cycles were: hypotension (71%), oliguria (67%), Arrhythmia (18%), Myocardial infarction (7%), pulmonary edema (7%), hypothyroidism (4%), confusion (4%), seizures (2%) and stroke (2%). Pressors were used in 58% of all cycles. 20 patients died within a year from starting treatment and 5 lived more than 2 years (4 had RCC). Conclusions: 1) HDB IL-2 has multiple and life-threatening side effects in the elderly and caution is needed when selecting these patients to such therapy 2) the number of doses administered is comparable to that general population 3) more studies are needed to identify the population that would mostly benefit from HDB IL2. [Table: see text] No significant financial relationships to disclose.
A case-control study examining the role of recent chemotherapy in causing Clostridium difficile infection among cancer patients
Authors: Thapaliya P. , Donato A. , Curl K. 
Published: March 2020

19563 Background: Clostridium difficle infection is a major cause of morbidity and mortality in hospitalized patients. The recent use of cancer chemotherapy agents is a frequently cited risk factor but there is a paucity of evidence to this regard. Objective: To determine if an association exists between C. difficile infection requiring hospitalization and recent chemotherapy in patients with cancer. Design: A retrospective case control study. Setting: Community Teaching Hospital Participants: 357 cancer patients admitted with diarrhea or developed diarrhea during their hospital stay that were tested for C. difficile diarrhea via toxin assay over a 2 year period. Outcome Measurements: C. difficile infection using tests for toxin A and or B in stool. Results: Eighty-nine cases had stool positive for C. difficile toxin whereas 267 controls were negative. 30/89 (33%) cases and 90/268 (33%) controls were found to have chemotherapy in the six weeks before collection of stool for toxin assay (Odds Ratio (OR) 1.09, p=1.0 using Pearson Chi square). Factors associated with infection on logistic regression analysis included recent antibiotic usage (OR 1.99, 95% CI 1.01- 3.93),hospitalization in preceding 2 wks with OR 4.1 (95%CI 2.39–7.05) and institutionalization with OR 2.13 (95 % CI 1.03–4.39). Conclusions: C .difficile infection in cancer patients is more likely in recently institutionalized or hospitalized patients who have received recent antibiotics, but not patients with recent chemotherapy. No significant financial relationships to disclose.
Prediction of short-term outcome in terminally ill cancer patients
Authors: Durand J. , Pourchet S. , Goldwasser F. 
Published: March 2020

19572 Background: Oncologists tend to overestimate survival of advanced cancer patients (pts) emphasizing the need for objective prognostic models to prevent futility. Methods: From January 2004 to May 2006, a prospective unicenter study was done in terminally ill cancer pts referred to a palliative care unit. Evaluation at admission included physical examination and the following routine blood tests : total blood count, hemostasis (Prothrombin Time (PT), activated Partial Thromboplastin Time (aPTT)), inflammatory and nutritional proteins (fibrinogen, ferritin, PINI = [alpha-1 acid glycoprotein x C-reactive protein (CRP)] / [albumin x prealbumin]), serum lipids (total and HDL cholesterol), biochemistry (urea, serum creatinine, calcium, total bilirubin, B12 vitamin) and liver enzymes (AST, ALT, LDH). Fatal outcome within the first 48 hours and lack of blood tests were exclusion criteria. A multivariate analysis according to a logistic regression was used to estimate the probability of fatal outcome within 2 weeks (wks) based on baseline patients characteristics. Results: 285 consecutive pts were hospitalized; 246 were evaluable : 133 men and 113 women (median age : 64 years; range: 18–94). Primary tumor was gynecological (18.3%), gastro-intestinal (16.3%), pulmonary (13.4%), hepatic or biliary (13.8%), urological (11.8%), head and neck (9.3%), haematological (3.3%) or others (13.8%). In univariate analysis, survival ≤ 2 wks correlated with male gender (p<0.001), Karnofsky Index (KI) (p<0.001), leucocytes (WBC) (p<0.001), aPTT (p=0.04), Urea (p=0.011), Total bilirubin (p=0.004), AST (p<0.001), LDH (p=0.008), albumin (p=0.042), prealbumin (p=0.004), CRP (p=0.028), ferritin (p=0.007), B12 vitamin (p=0.042) and PINI (p=0.001). In multivariate analysis, male gender (p=0.034), cutaneous metastases (p=0.012), KI ≤ 20% (p=0.002), WBC > 7.5G/l (p=0.012), fibrinogen > 6.5 g/l (p=0.021), LDH > 2N (p=0.035) and PINI > 20 (p=0.007) were predictive. A mathematical model was built to estimate the probability of fatal outcome within 2 wks. Conclusions: We created a tool which may help physicians to better estimate survival of terminally ill cancer pts and to prevent unnecessary overtreatment. Our score needs prospective validation in a multicenter study. No significant financial relationships to disclose.
Efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of malignant pleural effusions
Authors: Goodwin R. A. , Reaume M. , Gallant V. , MacArtney G. , Maziak D. , Matzinger F. , Gertler S. 
Published: March 2020

19575 Background: Small-bore chest tubes are now recognized as a safe and effective alternative to large-bore catheter chest tubes for the treatment of malignant pleural effusions (MPEs). The Ottawa Hospital (TOH) developed protocols for insertion and pleurodesis to maximize efficiency and minimize complications. Objective: To evaluate the efficacy and compliance of small-bore chest tube insertion and pleurodesis protocols for the treatment of MPEs. Methods: Retrospective chart review of TOH medical oncology inpatients treated for a MPE using our small-bore chest tube insertion and pleurodesis protocols from February 2003 to May 2004. Outcomes reviewed included deviations from protocol (major and minor), proportion of patients proceeding to pleurodesis and efficacy at six weeks, complications, as well as length of hospital stay. Results: One-hundred and fourteen potential cases were identified, of those 78 small-bore chest tubes were inserted into 72 patients. Major deviations from the chest tube protocol occurred in 21 patients (27%) who lacked microbiological analysis of their pleural fluid. Major complications of tube insertion occurred in ten patients (13%) who developed pulmonary infections and two patients (2.5%) who developed a significant pneumothorax. Of the 78 tube insertions, 24 cases went on to pleurodesis. Major deviations from our pleurodesis protocol occurred in five patients (2.1%) who failed to have a chest xray twenty-four hours prior to pleurodesis. The most common complication post pleurodesis was pain with seven of 24 patients (29%) rating their pain as severe. Fifteen of the 24 patients (63%) had fluid reaccumulation within six-weeks post pleurodesis. Median length of stay for patients without pleurodesis versus those with pleurodesis was 14.5 and 16.0 days, respectively. Conclusions: Our preliminary data suggests that chest tube insertion and pleurodesis protocols have good compliance rates with low rates of complications. Only a minority of patients were able to proceed to pleurodesis and long term control of effusion occurs in less than half of patients in this subgroup. As well, pain control at the time of pleurodesis was not adequate in one third of patients with the current protocol. No significant financial relationships to disclose.
Efficacy and safety of echoguided catheterisation approach in oncological and hematological patients. Report on 843 consecutive patients
Authors: Lazzaro A. , Vallisa D. , Moroni C. F. , Bertè R. , Bernuzzi P. , Anselmi E. , Arcari A. , Bosi C. , Mordenti P. , Trabacchi E. , Cavanna L. 
Published: March 2020

19581 Background: A central venous catheter (CVC) represents the most frequently adopted intravenous line for patients undergoing infusional chemotherapy, bone marrow transplantation (BMT) and parenteral nutrition. The aim of this study was to explore the feasibility and safety of CVC insertion under ultrasound (US) control. US offers the advantage of real-time, multiplanar imaging as well as Doppler analysis. Methods: The echoguided approach allowed us to insert CVC in right supraclavicular site nearby the clavicular head of sternocleidomastoid muscle. Using a 7.5-MHz probe we were able to perform a real time control of the hip of the needle while it was inserted in the last side of internal jugular vein. At the end of the procedure chest Rx was executed to evaluate CVC position and to detect pneumotorax. Mainly Sekalon Seldy, Becketon Dickinson was employed. For PBSC collection, 14-gauge Arrow double lumen revealed to be highly efficacious (46 PBSC collections, no one failure). Results: From November 1999 to December 2006 the echoguided CVC insertion method was applied 1003 times in 843 patients. The procedure was applied 288 times in haematological malignancies, in 698 solid tumors, in 3 neurological autoimmune diseases. Among solid tumors colon carcinoma was the first indication, while gastric carcinoma the second. Among haematological patients: non-Hodgkin lymphoma was the first indication, then acute leukemia. Ten patients underwent allogenic BMT and 92 autologous BMT. Nine in 1003 procedures failed (1%). Failures were caused by: arterial puncture in 3, CVC dislocation in 1, vein collapse in 3 and no efficacious “eco window” in 2. No pneumotorax was registered. The safety of this procedure was confirmed by 35 catheterisations obtained with platelets under 20000/μl, by 7 procedure with prothrombin activity under 50%. In 44 patients catheter was inserted with neutrophil count below 100/μl and in 66 below 500/μl without any increase in infections. Mean time of catheter permanence was 151 days with 1,7 infectious events every 1000 days of permanence. Symptomatic deep veins thrombotic complications were 9 (1%). Conclusions: This procedure is safe, cheap with high accuracy and success rate, and above all US-guidance avoids pneumothorax. No significant financial relationships to disclose.
Additional binding mechanism of palonosetron to the 5-HT3 receptor versus first generation 5-HT3 receptor antagonists
Authors: Rojas C. , Stathis M. , Alt J. , Rubenstein E. , Cantoreggi S. , Sebastiani S. , Slusher B. 
Published: March 2020

19583 Background: Palonosetron has a higher binding affinity and longer plasma half-life than first generation 5-HT3 receptor antagonists. Clinical trials have demonstrated that a single intravenous dose of palonosetron 0.25 mg provides better protection from chemotherapy-induced nausea and vomiting than other 5-HT3 receptor antagonists throughout the 5-day post-chemotherapy period. The purpose of this work is to determine differences in the molecular interactions of the antagonists with the receptor that could help explain the clinical efficacy differences. Methods: Molecular ligand-receptor relationships for commonly used 5-HT3 receptor antagonists were investigated. In particular, competitive vs. potential allosteric interactions between ondansetron, granisetron and palonosetron and the 5-HT3 receptor were examined. Binding experiments were carried out using each unlabeled antagonist in competition with [3H]-antagonist. Concentrations of [3H]-antagonists used in these experiments included the equilibrium dissociation constant (Ki) and several-fold Ki values in an effort to represent the probable concentrations of each antagonist at the receptor site in vivo. The inhibitory concentration of unlabeled antagonist needed to observe half maximal binding (IC50) as a function of [3H]-antagonist concentration was plotted for comparisons between ondansetron, granisetron and palonosetron. Results: A plot of the concentration of unlabeled antagonist needed to observe IC50 as a function of [3H]- antagonist concentration was linear when ondansetron and granisetron were in competition. On the other hand, when palonosetron was in competition with either granisetron or ondansetron the plot was curvilinear in each case. Conclusions: These results indicate that palonosetron exhibits both competitive and allosteric interactions with the 5-HT3 receptor, in contrast to ondansetron and granisetron which display strictly competitive antagonism. As allosteric interactions may induce changes in the receptor conformation, we can speculate that palonosetron's dual action on the 5-HT3-receptor could induce amplification of its inhibitory effect at the primary receptor binding site. No significant financial relationships to disclose.
Effectiveness of epoetin beta 30,000 UI once weekly (QW) for treatment of anemia in solid tumor patients under chemotherapy
Authors: Spaeth D. , Hennequin C. , Salles G. , Facon T. , Cure H. , Ferrero J. , Avenin D. , Bergougnoux L. , Bleuzen P. , Jenabian A. 
Published: March 2020

19588 Background: Anemia is the most frequent hematological complication of cancer. Epoetin beta (E), an effective treatment of anemia in patients with solid tumors (ST) was administered three-times weekly. However, the QW regimen used in patients with hematological malignancies would be more convenient and may improve patient compliance. The aim of our study was to evaluate efficacy and safety of E 30 000 IU QW in patients with ST. Methods: This study was an open-label, single-arm, multicenter trial carried out in 87 French centers between December 2003 and August 2005. Eligibility criteria were: informed consent, age =18 yrs, WHO performance status 0–2, malignant ST or non-myeloid hematological malignancy, on-going chemotherapy and anemia: hemoglobin (Hb) <12 g/dl. E 30 000 IU QW was administered SC for up to 16 weeks. Follow-up visits were scheduled after each chemotherapy cycle. Primary endpoint was Hb response defined as an Hb increase of =2 g/dl (whatever the baseline Hb level) and/or an achievement of Hb level of =12 g/dl or 13 g/dl (patients with Hb levels <11 g/dl or >11 g/dl at baseline respectively). Delay of Hb response, transfusion requirement, mood and cognitive functions were also assessed. Here we focus specifically on the subgroup of patients with ST. Results: In total, 365 patients with ST were included. The most frequent cancer sites were: lung (102 pts) and breast (86 pts). Median Hb level at baseline was 10.4 g/dl [7.9–12.3]. At endpoint, median Hb level increased to 12.5 g/dl [8.4–15.0]. Hb response rate (RR) was: 61% (IC95: 55–66%), 50% (IC95: 38–55%) in patients treated with platinum based regimen and 72% (IC95 : 62–76%) in patients treated without platinum. RR was 54% in lung (IC95: 44–64%), 76% in breast (IC95: 67- 85%). E treatment was well tolerated. Thromboembolic events occurred in 7% of patients, a rate consistent with information provided in the current label for E. Conclusion: Epoetin beta 30 000 IU once weekly is effective and well tolerated in anemic patients with solid tumor treated with chemotherapy. Once weekly treatment offers a convenient therapy which will improve patient compliance. [Table: see text]