bluuebunny/crossref_metadata_2025_split huggingface dataset:
A single institution retrospective analysis of basosquamous carcinoma of the head and neck
Authors: Clement P. , Verheezen J. , Nuyts S. , Vanderpoorten V. , Sciot R. 
Published: March 2020

15530 Background: Basosquamous Cell Carcinoma (BSCC) of the larynx, hypopharynx and base of tongue represents 1% of all head and neck tumours. It is considered a more aggressive disease than squamous cell carcinoma, based on higher incidence of advanced stage disease (60% lymph node-involvement and 40% metastases at diagnosis). Therefore, a treatment regimen including chemotherapy is often recommended in addition to surgery and/or radiotherapy in the literature. Methods: We retrospectively analyzed the data of all patients diagnosed with BSCC of the head and neck at the University Hospital of Leuven between 1993 and 2003, and report here the stage at diagnosis, treatment modality, disease evolution, progression free and overall survival. Results: Seven patients where diagnosed with BSCC in the head and neck region. Six patients were male. Three of the tumours were localised in the larynx, two at the base of tongue, and two in the oral cavity. The AJCC stages of disease ranged from I to IVa. Three patients had lymph node involvement at diagnosis. Six patients were treated with surgery in combination with radiotherapy. One patient was treated with cryotherapy before brachytherapy was applied. Five patients have no evidence of disease with a follow up of 4, 5, 6, 10 and 11 years, respectively. One patient died of an unknown cause 18 months after treatment. Only one of the seven patients, developed metastases during follow up. This patient had BSCC of the base of tongue, and was diagnosed with lungmetastases 16 months after surgery and radiotherapy. He was treated with the combination of Doxorubicine, Cisplatin and Fluorouracil. A partial response was confirmed after six cycles. Eight months after the last treatment cycle, there is still no evidence of disease progression. Conclusions: BSCC is a rare tumour of the head and neck. Seven patients were treated at the University hospital of Leuven in the period between 1993 and 2003 with a median progression free and overall survival of more than 5 years. Only one patient developed metastases, and was consequently treated with chemotherapy, inducing a continuing partial remission 8 months after treatment. In contrast to what is reported in the literature we do not confirm a high incidence of metastases at diagnosis nor a high mortality rate. No significant financial relationships to disclose.
Phase II trial of Gliadel plus O6-benzylguanine (O6-BG) for patients with recurrent glioblastoma multiforme
Authors: Quinn J. A. , Vredenburgh J. J. , Rich J. N. , Reardon D. A. , Desjardins A. , Gururangan S. , Friedman A. H. , Lavin K. , Sathornsumetee S. , Threatt S. , Friedman H. S. 
Published: March 2020

1568 Background. The major mechanism of resistance to alkylnitrosourea therapy involves the DNA repair protein O6-alkylguanine-DNA alkyltransferase (AGT) which removes chloroethylation or methylation damage from the O6-position of guanine. O6-BG is an AGT substrate that inhibits AGT by suicide inactivation. A previous phase III randomized, placebo-controlled trial has shown that Gliadel wafer significantly prolongs 6-month survival (55.5% for Gliadel vs. 35.6% for placebo) and median survival (28 weeks for Gliadel vs. 20 weeks for placebo) in patients with recurrent glioblastoma multiforme (GBM) (Brem et al 1995). Despite the success of Gliadel in prolonging survival we may be able to improve on this success by depleting AGT. Methods. Thus, we have designed a phase 2 trial where we define the activity and the toxicity of Gliadel in combination with a 5-day infusion of O6-BG in patients with recurrent GBM. In a prior study the O6-BG dose found to be effective in depleting tumor AGT activity at 48 hours was an IV bolus of 120 mg/m2 over 1 hour followed by a continuous infusion of 30 mg/m2/d for 48 hours. In order to guarantee depletion of tumor AGT activity for at least 5 days after Gliadel placement, this O6-BG bolus was repeated on days 3 and 5 while continuing the infusion. Results. To date, 24 patients have been enrolled out of a planned accrual of 50 patients. Seventeen of these patients received prior nitrosourea therapy. The 6-month survival is 68% and the median survival is 36 weeks. The adverse events include the following: 2 episodes of CSF leak (8%), 4 episodes of wound infection at craniotomy site (16%), 5 episodes of grade ≥ 3 seizures (21%) and 3 episodes of hyponatremia (12%). These adverse events were similar in frequency to those seen in patients receiving Gliadel in prior placebo-controlled Gliadel trials. Conclusions. Thus far, this data demonstrates an increase in the efficacy of Gliadel when combined with O6-BG. Twenty-six additional patients will be enrolled for a total accrual of 50 patients. [Table: see text]
Ultrafractionated radiation therapy (3x per day) for glioblastoma: Preliminary results of a phase II study
Authors: Beauchesne P. D. , Taillandier L. , Bernier V. , Djabri M. , Michel X. , Maire J. , Martin L. , Verrelle P. , Verrelle P. , Pedeux R. 
Published: March 2020

1570 Background: Ultrafractionation radiation therapy consists in irradiating cells or tumors several times daily, delivering low doses at which hyperradiosensitivity occur. We recently reported the high efficiency of ultrafractionation radiotherapy in glioma cell lines and xenografts, and are now conducting a phase II clinical trial to determine the effect of an ultrafractionation regimen for glioblastoma patients. Methods: A prospective, multicenter, phase II study has opened for accrual in September 2003. Patients over 18 years of age who are able to give informed consent and have histologically proven, newly diagnosed and unresectable, supratentorial glioblastoma (WHO grade IV) are eligible. Three doses of 0.75 Gy spaced by at least four hours are delivered daily, five days a week for six consecutive weeks for a total of 67.5 Gy. Conformal irradiation includes the tumor bulk including a margin of 2.5 cm. Tolerance and toxicity are the primary endpoints; survival and progression-free survival are secondary endpoints. Results: To date 25 patients have been enrolled in this study, 19 currently evalualbe: 11 men and 8 women, median age 58 (range 37 to 76), median Karnofsky performance status (80 range from 70 to 100). The median time between histological diagnosis and the start of treatment is 7 weeks. The ultrafractionated radiation therapy has been well tolerated; no acute grade 3 and/or 4 CNS toxicity has been observed. Minor responses at the end of irradiation were seen in 5 patients. Median survival from initial diagnosis was 13.5 months, nine patients remain alive. Conclusions: Ultrafractionated radiation therapy is safe and well tolerated. No acute CNS toxicitiy has been observed. Overall survival of over 13 months for patients without prior debulking surgery compares favorably with other reports. Updated definitive results will be presented. No significant financial relationships to disclose.
A phase I trial of imatinib, hydroxyurea and RAD001 for patients with recurrent malignant glioma
Authors: Reardon D. , Quinn J. A. , Rich J. N. , Vredenburgh J. J. , Desjardins A. , Sathornsumetee S. , Gururangan S. , Egorin M. J. , Salvado A. , Friedman H. S. 
Published: March 2020

1580 Background: This study attempts to extend the anti-glioma activity of imatinib mesylate (Gleevec, IM) plus hydroxyurea (H), by adding RAD001 (R), an orally bioavailable inhibitor of mTOR, a critical intracellular mediator of signal transduction and metabolism. Methods: We employ a “3+3” dose escalation design to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of IM + H + R administered daily among adult recurrent malignant glioma patients s with ≤ 3 prior recurrences, KPS > 60% and adequate organ function. Patients are stratified based on concurrent enzyme-inducing anticonvulsant use (EIAC), and both strata are independently escalated. Initial dose level for each stratum: IM - 400 mg/day; H - 500 mg bid; R - 2.5 mg/day. Each treatment cycle is 28 days. Response is evaluated every other cycle. Pharmacokinetic (PK) studies are performed on days 1 and 28 of cycle 1. Results: Twenty-two recurrent GBM patients have enrolled. The median age is 53 (range 37 to 75), 41% are male, and 45% are on EIAC. Two DLTs (grade 4 hypercholesterolemia and thrombocytopenia) occurred among 5 patients on dose level one (non-EIAC stratum). No other DLTs have occurred. The dose escalation schema has been amended to include alternate day R dosing. IM PK were consistent with those previously reported for patients on IM and HU. IM clearance on day 1 was 492 ± 247 ml/min in the EIAC stratum and 231 ± 100 ml/min in the non-EIAC stratum. On day 28, IM clearance was decreased in both strata (243 ± 93 ml/min in the EIAC stratum and 116 ± 47 ml/min in the non-EIAC stratum) PK results for HU and R are pending. Nine patients continue on study having received 2–8 cycles of therapy. Four partial responses have been observed and accrual is ongoing. Conclusions: Further accrual is warranted. An update of outcome, toxicity and pharmacokinetic analyses will be presented. [Table: see text]
Imatinib plus hydroxyurea in pretreated non-progressive glioblastoma (GBM)—A single center phase II study
Authors: Dresemann G. , Hosius C. , Nikolova Z. , Letvak L. 
Published: March 2020

1583 Background: GBM is a highly malignant tumor with a median survival of less than 15 months. Dysregulated signalling of platelet derived growth factor receptors (PDGF-Rs) is implicated in pathogenesis. Imatinib (I) plus Hydroxyurea (HU) is effective in patients (pts) with recurrent progressing GBM. In a pilot series of 30 pts with recurrent GBM progression free survival (PFS) at 6 and 24 months was 32 % and 16 % respectively. 37 % of pts achieved disease stabilisation (SD). Despite the aggressive course of GBM, short periods without progression after primary treatment or effective treatment of relapse is common. The current Phase II study is designed to analyse the efficacy of I plus HU treatment in GBM pts with SD as sequential treatment. Methods: From Dec 2003 up to June 2005 30 pts were included. No enzyme-inducing anticonvulsive drugs were allowed. I at the dose of 600 mg and 1000 mg of HU were given as a continuous daily treatment, follow up included blood cell count weekly and magnetic resonance imaging (MRI) every 6 weeks. The primary endpoint is 12 months PFS. Results: All pts are eligible for safety and 28 pts of them for 6 months PFS and 6 months overall survival (OS) so far; 25 pts were male, 5 pts female, median age was 44 years (32 to 71). All 30 pts had prior irradiation, 21 pts had temozolomid containing and 9 pts non-temozolomid containing regimens. Eight pts were free from relapse, 17 pts after first and 5 pts after second relapse. 25 pts had measurable disease in MRI scan, 5 pts had no evidance of disease. The median follow up was 14 months. The best response was partial remission in 4 pts. SD for more than 3 months in 20 pts. 6 months PFS was 64% (18/28) and 6 months OS was 93 % (26/28). Hematotoxicity grade 2 and 3 occurred in 11 out of 30 pts (anemia grade 3: 2 pt; anemia grade 2: 4 pts; leucopenia grade 3:2 pts; grade 2: 7 pts; thrombopenia grade 2: 4 pts) and required dose reduction of HU in 8 pts, dose reduction of I in 1 patient and G-CSF subcutaniously in 8 pts. Conclusions: I (600 mg/d) and HU (1000 mg/d) showed significant efficacy as sequential treatment. Hematotoxicity was higher compared to I (400 mg/d) and HU (1000mg/d). Six months PFS and OS data are promising so far. Complete analysis according to the primary endpoint will be presented at the 2006 ASCO meeting. [Table: see text]
The effect of changes in the treatment paradigm for chronic lymphocytic leukemia: A tumor registry study
Authors: Waheed S. , McClune B. , Buadi F. , Wright K. , Przepiorka D. 
Published: March 2020

16000 Background: In the early 1990s, several new agents became available for treatment of chronic lymphocytic leukemia (CLL), leading to a shift in the treatment paradigm with the hope of improving long-term survival. To determine if that outcome has been achieved, we performed a retrospective analysis of survival of patients in our community. Methods: The hospital tumor registry was queried to identify patients with CLL diagnosed 1980 to 2004. Zip code at diagnosis was used to assign a median household income based on census data. Survival was estimated by the method of Kaplan and Meier. Comparisons between the two groups were made by chi square. Hazard ratios for mortality were calculated in a Cox proportional hazard model using a backward stepping procedure retaining factors having a p-value < 0.1. Results: There were 192 patients with a diagnosis of CLL for analysis. The study cohort was comprised of 58% males and 42% females of median age 67 years (range, 39–96 years) at diagnosis. Fifty-three (28%) were <60 years of age, 29% were 60–69 years old, 26% were 70–79 years old, and 18% were >79 years at diagnosis. The group was 71% caucasian and 29% African American. Seventy-five (39%) patients had a household income greater than the median for the state, and the remainder had lesser incomes. There was a significant increase in the proportion of African Americans diagnosed >1990 compared to those diagnosed ≤1990 (40% vs 19%, p = 0.002), but there were no differences between time periods in gender, age, age category or income category. On multivariate analysis, factors predicting mortality differed between time periods as shown in the table. Median survival was 4.0 years for all patients, 3.9 years for the early group and 4.1 years for the later group (p = NS). Conclusion: We conclude that with changes in the treatment paradigm for CLL, gender and race are no longer prognostic for mortality, and the relative hazard for death is less amongst those 60–69 years and >79 years old, but there is no difference in survival for patients overall. [Table: see text] No significant financial relationships to disclose.
Survey of the sociodemographic and motivational profile of volunteers in oncology
Authors: Nanni O. , Serra P. , Tison C. , De Castro M. , Ridolfi R. , Falcini F. , Amadori D. , Erroi V. , Meggiolaro E. 
Published: March 2020

16011 Background: The volunteer sector developed rapidly in Italy throughout the 1980s, especially in the areas of cancer and palliative care. Istituto Oncologico Romagnolo (IOR), a non profit organization based in Forlì, actively supports the public health sector in the fight against cancer by funding scientific research, organizing voluntary work, promoting education campaigns, and setting up prevention and screening programs. The aim of the present work is to trace a sociodemographic and motivational profile of IOR volunteers. Methods: In May 2005, all IOR volunteers were invited to complete an anonymous questionnaire composed of 12 structured questions designed to collect sociodemographic data, information on type of voluntary work done and the reasoning behind such a choice. Results: Of IOR’s 1043 volunteers, 471 completed the questionnaire, of whom 70% were female and about one-third over 65 years of age. The majority of professions were represented, even though about two-thirds of men and half of the female volunteers were retired. About 40% of the group had been doing voluntary work for more than 10 years. Although fund-raising proved to be the most frequent activity (80%), there is a growing number of volunteers, especially those of a younger age group, involved in home- and hospital-based care. Various reasons were given for becoming a IOR volunteer: ethical considerations (35 % males and 28% females), personal experiences (24% and 38%, respectively), high regard held for IOR and its work (31 and 26%, respectively), and involvement directly through other volunteers (29 and 36%, respectively). Conclusions: The major involvement in fund-raising and perseverance over time of volunteers indicate a favorable social perception of medical research. It also emerged that the decision to start voluntary work was often closely linked to a previous personal experience of loss or disease, especially in female volunteers, who tend to react more constructively and develop a more active and concrete solidarity than men. We can therefore conclude that volunteers in the area of cancer act out of a sense of responsibility and awareness rather than out of pity or a desire for self-gratification. No significant financial relationships to disclose.
Regional differences in the use of trastuzumab in Sweden
Authors: Wilking U. , Bergh J. , Wilking N. , Jönsson B. 
Published: March 2020

16019 Background: The number of deaths due to metastatic breast cancer (MBC) in Sweden is around 1.500 patients/year. It is important that patients have access to new drugs that may delay disease progression and potentially improve survival. HER2 over expression (H+) is used to identify patients eligible for trastuzumab treatment (T). Between 15–30% of patients with MBC have H+ disease. Methods: This study uses sales data from the retail supplier in Sweden, as well as breast cancer mortality data from the National Board of Health and Welfare. Date of marketing approval for trastuzumab in Sweden is Oct 2000. The median treatment time used in this study, as reflected in the pivotal trials, has been set to 38 weeks. This study examines the variation of use in the six health care regions of Sweden (total population 9 millions). Results: The per capita use of T in patients with H+ MBC varies significantly across Sweden. In 2000 minor regional differences in usage were observed. These differences increased and in Q4 2004 usage (measured in sales) varied between 12.500 USD and 37000 USD per 100,000 inhabitants (regions with the lowest/highest sales). Only half (approx. 1100 patients) based on the estiamted prevalent 2200 patients (based on 25% H+ MBC patients) have received T. The first year after marketing authorization 9% of the prevalent population received T. Four years later 93% of the incident population received T. Conclusions: Access of T to patients with H+ MBC in Sweden varies significantly across the 6 Health Regions. Uptake has been slow and not all eligeble patients receive T, even 5 years after marketing authorization. [Table: see text]
The use of innovative oncology drugs in Europe
Authors: Wilking N. E. , Svedman C. , Jönsson B. , Zethraeus N. 
Published: March 2020

16020 Background: A number of new innovative cancer drugs have recently been approved or are in the process of being approved. Rapid patient access to new innovative drugs is important as it may lead to improved survival. Methods: We have analysed the access and uptake of new oncology drugs in 19 European countries over a 15 year period based on sales data provided by IMS Health. In the study we focus on select, “targeted” drugs that have been introduced over the last 10 years: rituximab, trastuzumab and imatinib. We have also analysed data to assess the composition of the drug “arsenal” used in the selected countries based on % of total sales for cancer drugs introduced before 1993; between1993–1998 and after 1999. Results: We see different patterns of uptake in countries studied, both with respect to speed and level of usage, in relation to use per person dying of the specific cancers.. Fast uptake is seen in Austria, Switzerland and Spain, and slow uptake as well as low usage is seen in Poland, Hungary, Norway and the UK. For example, trastuzumab uptake indicates that countries with the fastest uptake treat the majority of HER2 over expressing metastatic breast cancer patients within 2–3 years after introduction while countries with slow uptake still after 5 years seem to have a large proportion of patients not receiving trastuzumab treatment. On the other hand, for a drug like imatinib the uptake has been more rapid and uniform in most countries. The composition of the cancer drug “arsenal” used also differs significantly in between countries. Conclusions: Patient access to innovative cancer drugs varies significantly between European countries. [Table: see text]
Age as a factor influencing patterns of care for women with breast cancer receiving chemotherapy
Authors: Bule W. , Quigley J. M. , Runyon J. 
Published: March 2020

16026 Background: Older patients with breast cancer are underrepresented in clinical trials evaluating chemotherapy agents. Articles recently in JAMA and JCO have stated that older patients with cancer are being under treated. We investigated chemotherapy usage in patients with breast cancer who were greater then 70 years old and under 70 years old. Methods: Physicians capture de-identified data on up to 20 patients per week using a clinically validated, software driven algorithm from a randomized sample of oncologists in the US. Using this validated database with physician entered, de-identified patient data we evaluated all female patient records with breast cancer that were receiving chemotherapy for their disease, from January 2005 through November 2005. All data elements are required fields, allowing for a complete patient record with each entry, including race, age, stage of disease, nodal status, hormone status, her 2 status and chemotherapy treatments. Results: During this 11 month period, 8717 breast cancer records were received for patients receiving chemotherapy. All were included in this analysis. Of the 8717 patient records, age ranges were: 70+ years n = 1332, under 70 years n = 7385. These patients had the following characteristics, the 70+ patients had an avg. age of 76, 23% were her 2+, 66% were ER+, and 25% were node+. The under 70 patients had an avg. age of 53, 32% were her 2+, 59% were ER+ and 36% were node +. The top 3 regimens overall in the 70+ patients were: AC, Xeloda, and CMF. Top 3 regimens overall for the under 70 patients were: AC followed by Taxol (dose dense), AC followed by TH and Herceptin. Segmenting the 70+ patient by adjuvant therapy, the top 3 regimens were AC, AC followed by Taxol (dose dense) and CMF. The adjuvant 70 and under patients top 3 regimens were AC followed by Taxol (dose dense), AC followed by TH, and TAC. Conclusions: The use of anthracyclines, and taxanes is less in the 70+ patients, in the overall population (metastatic and adjuvant) as well as the adjuvant patient population. Further investigation into co-morbid conditions, performance status and segmentation by pathologic grade are warranted. No significant financial relationships to disclose.