bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II study of the combination of thalidomide and irinotecan in patients with recurrent anaplastic gliomas not on enzyme inducing anticonvulsants
Authors: Puduvalli V. K. , Giglio P. , Groves M. D. , Hess K. R. , Gilbert M. , Mahankali S. , Hsu S. , Colman H. , Conrad C. , Levin V. A. , Alfred Yung W. K. 
Published: March 2020

1564 Background: Patients with recurrent anaplastic glioma (AG) have few treatment options after initial alkylating agent therapy. In this study, the efficacy of thalidomide and irinotecan against recurrent AG was tested to assess if synergistic activity of cytotoxic and antiangiogenic agents could affect clinical outcome. Methods: Patients with recurrent AG with a KPS≥70 not on enzyme inducing anticonvulsants and with fewer than three relapses after radiation therapy and chemotherapies were eligible; the total planned enrollment is 39 patients. Irinotecan is administered at 125 mg/m2 weekly for 4 weeks followed by 2 weeks rest; thalidomide is initiated at 100 mg daily and escalated weekly up to 400 mg daily. Warfarin (1 mg) is given for prevention of venous thromboembolism (VTE). Patients undergo clinical and radiologic evaluations every 6-weeks. The primary endpoint is progression free survival at 6 months (PFS-6). To determine possible radiologic correlates to treatment effects, DCE- MR perfusion-imaging studies are obtained at baseline and subsequent follow up visits. Results: 17 are evaluable for response; the remainder were inevaluable. All evaluable patients had previously failed temozolomide and 9 had also failed nitrosourea therapy. The median age is 44 yrs and median KPS is 90. Four patients are alive and progression free at 6-months whereas 9 have progressed; the median progression free survival is 23 weeks and the PFS-6 is 34%. The best response was a CR in one patient, PR in 2 and stable disease in 9. Two patients have died of unspecified causes probably related to treatment. Median overall survival has not been reached; the 12-month and 18 month survivals by Kaplan Meier analysis are 73% and 26% respectively. Grade 3 and 4 toxicities included fatigue (29%), leukopenia (29%), nausea/vomitting (24%), and diarrhea (18%) requiring dose reductions. Two patients had VTE. Conclusions: The preliminary results of this ongoing study suggest that the combination of irinotecan and thalidomide has activity in patients with recurrent anaplastic gliomas; the ongoing assessment of this combination in patients with AG will more definitively define whether the combination can be an effective second line therapy for this population. [Table: see text]
Use of modified PCV chemotherapy as principal therapy for adults with incompletely resected or recurrent low-grade glioma: A retrospective review
Authors: Arenson E. B. , Bank J. , Pierick M. , Greenwald C. , McVicker J. , Elliott J. P. , Day J. D. , Fullagar T. M. 
Published: March 2020

1571 Background: In order to assess outcomes of patients treated with chemotherapy versus a more standard approach of radiotherapy (RT), we reviewed 48 patients with newly diagnosed, partially resected or recurrent low-grade glioma (LGG) treated between 1996 and the present. Methods: Patients were divisible into three groups: those treated with chemotherapy ± RT before (Group A, 28 patients) or after (Group B, 13 patients) radiographic progression, and those with recurrences after treatment with RT (Group C, 7 patients). Diagnoses included astrocytoma (23%), oligodendroglioma (48%) and mixed glioma (29%). 39 patients were treated with chemotherapy alone and 9 received post-chemotherapy RT. Chemotherapy consisted of PCV in one case; all other patients received modified PCV (MPCV) which variably included addition of carboplatin (200–360 mg/m2) and etoposide (150 mg/m2) and substitution of temozolomide (150 mg/m2 × 5 doses) for procarbazine. The intent was to treat monthly for one year. Results: Patients received a mean of 10 courses of MPCV; 481 cycles were given. There were no deaths or admissions during chemotherapy. Grade III/IV toxicities occurred in 108 cycles (25 patients), 107 hem. and 1 GI. Late events included 1 case of MDS and 1 AML. There were no cases of disease progression during chemotherapy. Two patients stopped MPCV early, one because of worsening seizures (2 cycles) and one by personal preference (1 cycle); both died of disease. With median follow-up of 46 months (range 4–120) from initiation of chemotherapy, overall survival and progression-free survival were 89% and 79% for Group A, 91% and 83% for Group B, and 100% and 86% for Group C. Of 7 patients (15%) who recurred after completing chemotherapy, 2 have died; both had received post-chemotherapy RT and had clinical features of GBM. Four patients are either lost to follow-up (2) or alive with stable disease (2) following additional treatment. Conclusions: 1. MPCV is a tolerable regimen which can be given more aggressively than standard PCV. 2. There is minimal risk of early disease progression with MPCV. 3. Results support a prospective trial comparing MPCV to RT in patients with progressive unresectable LGG, and use of MPCV as salvage therapy for patients who fail RT. No significant financial relationships to disclose.
An analysis of adjuvant temozolomide plus radiotherapy vs radiotherapy alone in a single academic institution
Authors: Hopkins S. , Gertler S. , Nicholas G. 
Published: March 2020

1575 Background: The NCIC CE.3/EORTC 22981/26981 was open during the time period of August 2000 to March 2002. When the study closed, there existed a gap in care that did not address the ongoing management of patients (pts) with glioblastoma multiforme (GBM) that had been surgically excised. As a result of this gap, it was decided that the adjuvant use of temozolomide (TMZ) was to become the standard of care at our centre due to its lack of perceived toxicities and early evidence for its activity. Methods: An analysis was performed of all pts with GBM that were seen at the centre from 1998 to the summer of 2005. In total, 240 pts were identified across multiple medical and radiation oncologists. 75 pts were treated with radiotherapy (RAD) alone post surgery, 86 pts were treated with RAD + TMZ post surgery, 18 pts only had surgery and the remaining pts were unresectable. Average age was 59.7 years for pts treated only with RAD, and 54.6 years for those treated with TMZ + RAD (p = 0.028). 59% of pts treated with RAD were male, while 62% treated with RAD + TMZ were male. Median follow-up was 11.3 months for RAD and 15.7 months for TMZ + RAD (p = 0.0001816). Preliminary survival analysis demonstrates a 56% reduction in the risk of death for pts treated with TMZ + RAD when compared to RAD (log rank p = 9.6 × 10−6). Median survival was 12.7 months for pts treated with RAD and 27 months for pts treated with TMZ + RAD (see table ). A further analysis including recursive partitioning analysis (RPA) and duration of therapy post RAD will be attempted to confirm the similarities between the two groups. Conclusion: Adjuvant TMZ + RAD has increased overall survival by 14.3 months in our institution. Further analysis is necessary to determine the impact on duration of therapy of TMZ. [Table: see text] [Table: see text]
Are trends in recruitment of older patients in clinical trials (CT) changing?
Authors: Garcia M. , Perez X. , Saldaña J. , Cardenal F. , Germà J. R. 
Published: March 2020

16007 Background: It has been widely reported that older patients are underrepresented in CT. This barrier has been extensively studied and some efforts have been made to increase older patient participation. This study was performed to characterize and evaluate the enrolment of elderly patients in CT in a cancer centre (Barcelona, Spain). Methods: A database-based analysis of patients entered in CT of any cancer type in a single institution between 1998 and 2005 was performed. (1) During the first 6-month period in 2005 we selected opened age-unspecified trials (AUT). Rates of patients of 74 Y entered in those trials (between 2001–2005) were analysed and compared with the corresponding rates on target population (new patients seen in Oncology Department in the first 6-month period in 2005). (2) Averages of age of CT patients in two periods of time: 1998–1999 and 2004–2005 were compared. Chi-squared and T-student analyses were used. Results: 2029 patients were entered in CT between 1998–2005. There were 1006 FTSP patients during the first 6-month period of 2005. The number of patients entered in AUT (19 trials among 71 opened [27%]) between 2001–2005 was 277. Table 1 summarizes the data by age groups. Statistically significant differences were found only between >74 y patients in CT and FTSP populations. Average age was 57.4 during 1998–1999, and 60.5 during 2004–2005 (p: 0.004). Conclusions: The number of patients >74 Y accrued in CT in a single cancer centre has clearly increased over time, maybe due to the rise of life expectancy, better patient care and the efforts in improving recruitment rates. In spite of the increase, this patient population remains underrepresented in general cancer CT. [Table: see text] No significant financial relationships to disclose.
Development of an information technology system to assist oncologists in daily clinical practice
Authors: Fasola G. , Puglisi F. , Aprile G. , Belvedere O. , Follador A. , Pattitoni C. , Russo S. , Sacco C. , Zanier L. , Mansutti M. 
Published: March 2020

16028 Background: Daily documentation and maintenance of medical record quality is a crucial issue in oncology. Computerization can offer many advantages, but needs training and motivation of operators and fitting of clinical processes and administrative rules to technological requirements. The electronic medical record (EMR) system, a software application for the entry, retrieval, and display of patients information into a digital database, could quantitatively and qualitatively improve medical recording. Methods: We developed an application system, named G2-clin, including EMR and computerized physician order-entry (CPOE). It was integrated into the hospital information system, for documentation and therapy planning to support physicians in daily clinical practice. G2-clin was developed by internal committee of oncologists, nurses and computer scientists, with an assured information technology during the learning curve and over the years. After training, staff physicians and nurses have routinely used the G2-clin starting on March 2002. Medical records collect all data concerning management of inpatient and outpatient care. Results: To date, 317 chemotherapy protocols are available in the CPOE pick list, including experimental regimens. In 2005, G2-clin registered 1550 new patients, with 7730 chemotherapy courses and was able to provide the following data: drug storage, administration and safety procedures, assessment of adverse events according CTC, specific patient safety policies, monitoring of resources and costs, data analysis for clinical research. Main benefits are improvement of the quality of patient care and safety, practice standardization, decrease in the risk of therapy ordering errors. The main drawbacks are inhibition of patient-physician interaction and visit time extension. Conclusions: According to our pilot experience, G2-clin successfully satisfied requirements of procedures standardization and allowed distribution of accurate data to all operators. Moreover it has been useful in monitoring outcomes of care, effectiveness, efficiency, adherence to clinical practice guidelines, resources and costs. No significant financial relationships to disclose.
The burnout syndrome among Brazilian medical oncologists
Authors: Glasberg J. , Horiuti L. , Novais M. , Canavezzi A. , Miranda V. , Chicoli F. , Gonçalves M. , Bensi C. , Del Giglio A. 
Published: March 2020

16038 Background: The burnout syndrome (BNS) is prevalent among oncologists and is characterized by three components: emotional exhaustion, depersonalization and low personal accomplishment. BNS is associated with depression anxiety and impaired job performance. We aimed at evaluating the prevalence of BNS among brazilian medical oncologists and the variables that correlate with its presence. Methods: We sent three questionnaires (general, Maslach burnout questionnaire and an opinion survey) to the 458 members of the Brazilian Society of Medical Oncology (SBOC) and we attempted to increase the amount of answers by an email recall to all members. In order to evaluate correlations between variables we used Fisher, Chisquare and ANOVA tests, and considered significant only p values lower than 0.05. We used logistical regression to conduct multivariate analysis, having the presence of BNS as a dependent variable. Results: The response rate was 22.3%. When asked if they would choose oncology as a career again, 90 (88.25%) answered affirmatively. According with the criteria proposed by Grunfeld, that considers BNS present when at least one dominion is severely abnormal, the incidence of this syndrome was 68.6% (95% CI: 58,68% to 77.45%). By univariate analysis, we observed a negative significant correlation of BNS with having regular physical activity and/or a hobby, reporting to have a religious affiliation and with willingness to choose oncology as a career again. We found a positive significant correlation of BNS with living together with someone and reporting vacation time as insufficient. By multivariate analysis having a hobby/physical activity, a religious affiliation, living with a companion and rating vacation’s time as sufficient were all correlated significantly and independently with BNS. Conclusions: BNS is prevalent among brazilian medical oncologists, nevertheless most of them would choose medical oncology as a career again. To have a hobby and/or a regular physical activity, enough time of vacations and a religious affiliation correlate negatively with the presence of BNS and are potentially modifiable preventive measures to decrease the frequency of this syndrome. No significant financial relationships to disclose.
A phase 1 trial of a novel organic arsenic S-dimethylarsino-glutathione (ZIO-101) in hematological malignancies
Authors: Kornblau S. M. , Jackson C. E. , Worthing A. , Faderl S. , Beran M. , Fayad L. , Ravandi-Kashani F. , Bothakur G. , Gale R. , Verstovsek S. 
Published: March 2020

16503 Background: Inorganic Arsenicals (IA, e.g. AS2O3) kill many human leukemia cell lines and have efficacy in APL. Evaluation of efficacy against other types of leukemia is limited by the substantial toxicity of IA. Organic Arsenicals (OA) are less toxic than IA. ZIO-101 (S-dimethylarsino-glutathione) is an OA with activity against diverse cancers in in vitro tests and animals mediated through mitochondrial damage and apoptosis induction. ZIO-101 may induce apoptosis by different mechanisms than As2O3 and can kill As2O3-resistant cancer cells. Compared to As2O3, the LD50 of ZIO-101 in mice is 50X higher and at equimolar extracellular arsenic concentrations ZIO-101 produces 15× higher intracellular arsenic concentration. These features make ZIO-101 attractive for evaluation in leukemia. Methods: A phase-1 study evaluating the safety and pharmacokinetic (PK) profile of ZIO-101 in subjects with advanced hematological malignancies is underway. 8 patients (PATS) with acute myelogenous leukemia (AML) (median 3 prior treatments) received ZIO-101 at doses of 78, 109 or 153 (n = 4, 3, 1) mg/m2/d IV for 5 d every mo. Results: Therapy with ZIO-101 has been safe and well-tolerated. Toxicities ≥ grade-2 included hyperglycemia (N = 3) and decreased albumin (N = 3) and Ca (N = 3) and 1 subject each had ≥ grade 2 elevations in LFT, or decreases in K, or PO4, febrile neutropenia and rash. Preexisting anemia and thrombocytopenia increased by 1 grade in 4 and 3 PATS each. Grade ≥3 neutropenia occurred in 2 PATS. No significant renal, liver or heart toxicity occurred, 1 patient with prior 10AV block had transient prolongation of QT interval non-recurring on rechallenge. PK studies at 109 mg/m2/d showed a tmax = 1.5 h (SD ± 0.7 h), Cmax = 402 ng/mL (±33 ng/mL), t1/2 = 14.4 h (±2.9 h) and AUC0-∞ = 8.93 μg · min/mL (±1.82 μgzmdmin/mL). 4 PATS progressed after 1 cycle, 3 had stable disease and received a 2nd cycle: 1 progressed and 2 remain on study. 1 patient is too early to evaluate. Blood myeloblasts decreased (9 to 1.1 × 10e9/L at day 13) in 1 subject and completely resolved in 2 (pre-therapy: 100 and 336 × 10e9/L). Bone marrow myeloblasts were unchanged. Conclusions: Administration of ZIO-101 to PATS with advanced AML was safe and dose-escalation continues and a modest antileukemic effect has been observed. [Table: see text]
Evaluation of efficacy of serum and broncho-alveolar lavage Galactomannan estimation by ELISA in high-risk persistent febrile neutropenic patients
Authors: Sengar M. , Kumar L. , Thulkar S. , Kochupillai V. 
Published: March 2020

16505 Background: Chest infections constitute 36% of all infections in our acute leukemia patients. Conclusively establishing the diagnosis of invasive fungal aspergillosis (IPA), an important cause pulmonary infiltrates and mortality in high-risk febrile neutropenic patients, however, is difficult. We therefore evaluated the value of ELISA for Galactomannan (Gm) antigen and correlated the results with radiological findings. Methods: Twenty patients with persistent high-risk febrile neutropenia were assessed with chest X-ray, high resolution computed tomography (HRCT) chest and bronchoalveolar lavage (BAL) from the affected segment on day 5 of fever. Microbial cultures of blood, sputum and BAL and Galactomannan estimation in serum and BAL were done. IPA was defined as per the Mycoses Study Group criteria. Sensitivity, specificity and negative and positive predictive value of Galactomannan assay and diagnostic yield of each investigation was determined. Results: Diagnostic yield of CXR was 10%, blood culture, mainly gram negative bacilli, 15%, and BAL 20% (Aspergillus - 10%). Based on microbiology, radiology and cytopathology IPA was diagnosed in 16 cases (proven -1, probable -2, possible -13) and miliary tuberculosis, bacterial pneumonia and nocardiosis constituted the remaining. Nodules and halo sign were the most frequent (60%) CT findings in IPA. Sensitivity, specificity and positive and negative predictive value for serum were 78%, 100%, 100% and 64%, respectively, and for BAL, were 87.5%, 100%, 100% and 75%, respectively. Conclusions: CT-guided BAL and serial serum GM estimations are valuable non-invasive screening tools for IPA in high-risk persistent febrile neutropenic patients. No significant financial relationships to disclose.
Long term follow up after treatment of hairy cell leukemia with 2-CdA
Authors: Ramzi M. , Haghshenas M. 
Published: March 2020

16518 Background: Hairy cell leukemia (HCL) is a chronic B cell disorder that follows an indolent but progressive course. The ability of new purine analogue deoxyadenosine to induce long lasting complete remission in patients with hairy cell leukemia has revolutionized the treatment of this disease. We report the long term outcomes of patients with HCL treated in Shiraz, in south of Iran,with this drug. Methods: Between October 1993 till April 2004, 79 patients with classic symptomatic hairy cell leukemia were treated with 2-cholorodeoxy adenosine (2-CdA) with dose of 0.1 mg/kg of body weight per day by continuous intravenous infusion for 7 days. Results: sixty nine (87%) of patients achieved an initial complete response and 10 (12.6) a partial response with an overall median duration of response follow up of 78 months. Five patients had relapsed at a median of 43 months. All of 5 patients after relapse treated with second courses of 2-CdA, 4 (80%) achieved second complete responses and one (20%) partial response. In our study we had not any case of second malignancy after treatment with 2-CdA with median follow up of 82.5 months. Conclusion: This study confirms single course of 2-CdA induced long lasting complete response in the vast majority of patients. Relapse rate for complete responders were low. Patients who relapse can be successfully retreated with this drug, so we conclude 2-CdA had high efficacy and a favorable acute and long term toxicity profile in our patients in south of Iran, without any increase in risk of second malignancy. No significant financial relationships to disclose.
Staging of small cell lung cancer (SCLC): Comparison of two criteria by survival analysis
Authors: Williams R. , Eskandari N. , Kendall A. 
Published: March 2020

17030 Background: Consistent staging of SCLC is pertinent to the selection and evaluation of treatment regimens. The Veterans Administration Lung Study Group (VALG) defines patients with limited disease (LD) as those with tumor limited to one hemithorax. In contrast, the International Association for the Study of Lung Cancer (IASLC), basically a TNM method, defines limited disease as those with no distant metastases. We assessed the survival of intermediate patients (ID), defined as those who qualified as LD by the IASLC but not the VALG criteria. Methods: A retrospective chart review was done on 252 patients consecutively diagnosed with SCLC between 1990 and 2004 at a Northern California hospital. Kaplan Meier analysis and log-rank tests were used to compare the survival of ID and LD patients. We also compared survival of both ID and LD to patients with extensive disease (ED). Multivariate Cox regression analysis was used to incorporate clinically relevant data. Bonferroni adjustment was made for multiple comparisons. Results: We defined 93 patients as LD, 32 as ID and 127 as ED. Median survival of patients with ID was 12 months (95% CI 9–16 months) and for LD 11 months (95% CI 9–13 months). Median survival for patients with ED was 6 months (95% CI 4–7 months) and significantly shorter (P < .0001) than either ID or LD. Conclusions: The present study questions the inclusiveness of the VALG definition of LD concurs with prior findings from Germany (Lung Cancer 37:271, 2002). SCLC patients should be staged by the IASLC criteria when being evaluated for treatment regimens. No significant financial relationships to disclose.