bluuebunny/crossref_metadata_2025_split huggingface dataset:
Survival improvement by systemic chemotherapy in adult patients with recurrent glioblastoma multiforme treated with two courses of radiotherapy
Authors: Nieder C. , Grosu A. L. , Astner S. , Andratschke N. , Molls M. 
Published: March 2020

1578 Background: We evaluated the added value of systemic chemotherapy (CTx) in adult patients with recurrent supratentorial glioblastoma multiforme (GBM) selected to receive local re-treatment (administered as a 2nd course of radiotherapy, RTx). Methods: Retrospective comparison of two patient cohorts treated subsequently during different time periods. All patients had histologically confirmed recurrent GBM. Minimum recurrence-free interval was 4 months. The first cohort (n=26) had surgical resection and standard postoperative external beam RTx followed by a second course of external beam RTx for recurrence (median cumulative dose 102 Gy). None of these patients ever received CTx during the whole course of disease. The more recently treated cohort (after 1999) of 19 patients also had surgical resection and 2 courses of external beam RTx (median cumulative dose 90 Gy). After primary local treatment, 9 of these patients had adjuvant nitrosourea-based CTx. At recurrence, all 19 patients received temozolomide 150–200 mg/m2/day for five days every 4 weeks in addition to RTx. Results: The cohort without CTx had less favorable baseline characteristics, because of their significantly lower median KPS at recurrence (70 vs. 90%, p<0.01) and shorter interval between primary diagnosis and recurrence (12 vs. 16 months, p<0.05). However, these patients were non-significantly younger (median age 44 vs. 50 years, p>0.05). The percentage of patients with secondary GBM was similar (21 vs. 23%, p>0.5). Median survival from re-irradiation was significantly better in the RTx plus CTx group, 9 vs. 5 months (p<0.05). In multivariate analysis, prognosis was significantly improved by CTx. Importantly, there was also an advantage when overall survival from first diagnosis was evaluated, median 24 vs. 19 months (p<0.05). Conclusion: The current data suggest that re-irradiation plus temozolomide is better than re-irradiation alone. CTx led to a prolongation of overall survival from first diagnosis by 5 months. The most intensively treated, prognostically favourable de-novo GBM patients had surgical resection, 2 courses of RTx and 2 different systemic CTx regimens. [Table: see text]
The cost of treating pancreatic cancer: A pilot study
Authors: Ogdie A. R. , Lee B. C. , Li J. , Maglaris D. , Siddiqi A. , Marshall J. 
Published: March 2020

16004 Background: The treatment of pancreatic cancer (PC) is rapidly changing with the approval of new anti-cancer agents. A pilot analysis of twenty five patients treated for PC was performed to determine the cost of PC treatment. Methods: Twenty-five PC patients were selected from 1998–2004 to represent a variety of treatments, both standard and experimental. Charts were reviewed for hospitalizations, clinic visits, and medications greater than $10 in cost. Costs were determined using pharmacy and hospital billing services. Average costs per month were calculated for all 25 patients in the twelve months preceding death. Results: Mean time from diagnosis to death was 13.6 months and mean duration of treatment was 12.6 months. During the period of treatment, mean monthly anti-cancer treatment and additional pharmacotherapy costs were $3,771 and $3,196 respectively. Mean monthly cost of hospitalizations and clinic visits were $2,258 and $213. In the last twelve months of life, months -3, -5, and -2 (death = 0) were most expensive with average spending of $65,557, $58,820, $47,727 respectively. Breakdown of costs in the three most expensive months was: anti-cancer agents (82%), hospitalization (15%), additional pharmacotherapy (3.0%), and clinic visits (0.5%). Conclusions: In this pilot study, we compiled major contributors to the cost of treating PC and then focused on the twelve months preceding death. Anti-cancer agents were determined to be the largest expenditure overall, and were a greater proportion of the cost in the most expensive months before death. This remains an underestimate as surgery, radiation, and indirect costs are not included. As newer agents become incorporated into standard treatment for PC, costs are expected to rise further. This data is being used in designing a larger study comparing costs, quality of life, and survival using newer combination chemotherapy. No significant financial relationships to disclose.
The development of an outpatient chemotherapy medication safety program
Authors: Hoverman J. R. , Richardson D. , Hansen K. , Dugger P. C. , Shuey K. M. 
Published: March 2020

16005 Background: Through Institute of Medicine publications (To Err is Human) and through the public experience of a major cancer center, chemotherapy safety has been of concern. US Oncology, Inc. (USON) is the nations largest oncology management company, associated with over 900 medical, radiation, gynecologic and pediatric oncologists. In 2004 USON undertook a quality initiative with a principal objective a system-wide approach to medication safety. Methods: Medication safety was identified as a principal concern by a combined clinical/management committee. A questionnaire was prepared for each practice site to differentiate high performing practices in regards to variances from lower performing practices. 8 high performing practices and 8 lower performing practices were physically evaluated by team members. Neither the questionnaire nor onsite evaluation reliably differentiated quality processes. Three issues became apparent: no uniform reporting mechanism, multiple “double-check” interpretations and variable inclusion of medication safety into practice operations. The safety team undertook these first two issues. An online reporting tool was developed. “Double-check” was defined and processes mapped. Results: The team chose 1st hour of chemotherapy as the denominator for medication occurrence reporting. An online reporting tool was developed with now 1 year of experience. 83% of practice sites are reporting, accounting for 445,148 1st hours of chemotherapy. The occurrence rate is 0.66%. Of the total 0.13% is adverse drug reaction, 0.10% is near miss, 0.08% is miscalculation of dose, 0.05% is the wrong dose. Injury to a patient is a very rare event. Conclusions: The development of a culture of quality in an organization with affiliations of national scope is a formidable undertaking. These initial numbers have no comparative measure, as this is self-reporting using a novel denominator. However, there are within the network similar groups for comparison. The challenge continues to be developing a culture of reporting with systematic integration of those reports and quality processes into the fabric of the practice. [Table: see text]
Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies (D.O.S.E.) Registry: Analysis of outcomes and costs of epoetin alfa (EPO) and darbepoetin alfa (DARB) treatment in cancer patients
Authors: Memisoglu A. , Peake C. , Buscaino E. , McKenzie R. S. , Forlenza J. B. , Piech C. T. 
Published: March 2020

16009 Background: NCCN anemia treatment guidelines recommend hemoglobin (Hb) levels be maintained between 11 and12 g/dL. To understand erythropoiesis-stimulating therapy (EST) dosing, outcomes and costs in cancer patients, data were analyzed from an ongoing prospective, observational registry (D.O.S.E. Registry) collecting real-world data on cancer patients treated for anemia in U.S. oncology clinics. Methods: Data were collected from participating hospital- and community-based outpatient oncology practices between 1/2004 and 11/2005. This analysis included adult patients who had received ≥2 doses of either EPO or DARB. Outcomes assessed included Hb values at weeks 4, 8, 12, and 16 following EST initiation. Drug cost was based on EST utilization and 2005 wholesale acquisition cost. Results: 652 patients (235 EPO, 417 DARB) from 32 sites were identified. Baseline characteristics of age, gender, Hb, tumor type and ferritin level were similar between treatment groups. The proportion of patients with iron supplementation at baseline was significantly higher in the DARB-treated group (EPO 18% v. DARB 31%, p < 0.001). EPO-treated patients were maintained between 11 and 12 g/dL throughout the therapeutic duration ( Table ). Mean cumulative administered dose of EPO was 393,047 Units and DARB 1205 mcg, corresponding to an overall drug cost of $4,783 for EPO and $5253 for DARB (p = 0.001). Conclusions: These results demonstrate that EPO-treated patients maintained target Hb levels consistent with NCCN guidelines, which was not observed in the DARB-treated patients. Drug cost was significantly higher in the DARB group compared to the EPO group without considering the costs of iron supplementation. [Table: see text] [Table: see text]
Demographics and disease processes of patients seeking second medical hematology/oncology opinions at a tertiary care center in the United States
Authors: Curtis K. K. , Northfelt D. W. 
Published: March 2020

16018 Background: Second opinions (SO) are common in medical practice. Aside from case series, little evidence exists to demonstrate a clinical benefit associated with SO. Lack of relevant data limits knowledge of numbers of patients, diseases, and motivations of SO seekers. Within the field of medical hematology/oncology (H/O), no specific demographic data are available to characterize patients seeking SO in the United States. Methods: To typify such patients at Mayo Clinic in Arizona (MCA), we recorded demographic and disease-related information for patients seeking these evaluations over a six month period from 1/1 through 6/30/05. Results: A total of 683 patients contacted MCA for medical H/O SO over the 6 month study period. A complete set of demographic and disease-related information was obtained from 655 patients; the remainder were excluded from the data set. Demographically, the majority of patients were female (53%), married (66%), and lived nearby (i.e., from Arizona-58%, or bordering state-22%). Average age was 62.3 years. Among oncologic diagnoses, the majority of patients (60% of 374 reported oncologic diagnoses) stated a diagnosis of breast, lung, colorectal, pancreatic or prostate cancer. Approximately 1/3 of patients had metastatic disease at the time they sought evaluation at MCA. There were 278 patients seeking evaluation for hematologic abnormalities, with the majority (160 patients, 58%) seeking evaluation for non-malignant conditions. Of those with malignancies, lymphoma (including Hodgkin and non-Hodgkin) was the most common (45%), followed by multiple myeloma (21%) and chronic lymphocytic leukemia (15%). Conclusions: This study provides insight into demographics and disease processes of patients seeking medical H/O SO at a tertiary care center in the United States. Although no definite conclusions can be drawn about motivations for seeking H/O SO, future research should examine patient motivation to better understand factors leading to this behavior. Given a lack of evidence for clinical benefit associated with SO seeking, and its potential costliness, better knowledge of demographic and motivational factors may allow for a more constructive approach to be taken toward the needs of SO seekers. No significant financial relationships to disclose.
Health state utility and toxicities in metastatic lung and breast cancer: A qualitative study
Authors: Bhalla S. , Nafees B. , Stafford M. , Watkins J. 
Published: March 2020

16021 Background: In metastatic lung cancer, it is expected that quality of life is impacted both by the efficacy and toxicity. Previous research has reported health states either based on response to therapy or on toxicity, but not in combination. Using methodology applied in breast cancer (Narewska 2005), we developed health state descriptions for advanced non-small cell lung cancer (NSCLC) for use in cost-utility analyses. Methods: An interview discussion and content validation guide was produced based on literature review and clinical input. Response to therapy was described as responding disease, stable disease, or progressive disease. The most common toxicities were selected based on randomized clinical trials. Descriptions of health states were reviewed by clinical specialists. Final health states will be piloted and then used in a societal-based valuation study using standard gamble technique. The contributory effect of disease state and toxicity will be estimated using a mixed model analysis and compared with the data from the previous breast cancer utility study. Results: Eight toxicities were identified: alopecia and grade 3/4 neutropenia, febrile neutropenia, hand-foot syndrome, gastrointestinal (diarrhea/vomiting), rash, stomatitis and fatigue. These were combined with response to therapy to yield 19 health states: 9 responding disease (one with each toxicity plus one with no toxicity), 9 stable disease (one with each toxicity plus one with no toxicity) and one progressive disease (toxicity not included). These health states were reviewed by 6 pulmonary oncologists and 3 specialist nurses. Conclusion: Development of health states that combine both efficacy and toxicity will be useful in evaluating the relative value of therapies for advanced NSCLC and comparison with other diseases. Input by clinical experts has provided validation for the proposed health states. Evaluation of these health states by members of society will provide appropriate perspective for economic evaluations. [Table: see text]
A report on treatment with rasburicase in 18 adult patients
Authors: Severson D. M. , Wills S. M. , Nguyen M. , Margolis J. H. 
Published: March 2020

16024 Background: Tumor lysis syndrome (TLS) is a life threatening complication occurring in highly proliferative malignancies. Chemotherapy often causes rapid tumor breakdown resulting in metabolic derangement, abnormal electrolytes and hyperuricemia. Untreated TLS can lead to renal failure and death. Rasburicase (recombinant urate oxidase) is a novel agent that reduces serum uric acid (SUA) levels in pediatric patients. Here we report on 18 adult patients treated with Rasburicase with highly proliferative malignancies. Methods: We retrospectively identified all adult TLS patients treated with Rasburicase at William Beaumont Hospital, Royal Oak, Michigan. We evaluated pre and post treatment SUA, electrolytes and renal function to determine the effect of a single dose of Rasburicase. Results: Twelve men and 6 women (mean age 56.5 years) received Rasburicase between July 2004 and November 2005. Thirteen patients had a diagnosis of TLS prior to treatment, 5 were treated prophylactically and did not develop TLS, 1 patient died of sepsis within 48 h of treatment and 1 patient died from cerebral hemorrhage within 72 h of treatment. Of the 12 assessable patients with TLS, the mean pretreatment SUA was 11.2 mg/dL and the mean 48 h post treatment SUA was 0.68 mg/dL. All SUA levels returned to normal (2.5–8 mg/dL) within 48 h. Ten patients had elevated pretreatment serum creatinine (Scr) levels (mean 2.5 mg/dL) and 2 patients had normal (0.7–1.5 mg/dL) levels. Within 72 h of treatment 7 of the 10 assessable patients showed improvement (mean reduction 0.6 mg/dL) in Scr. Conclusions: It is notable that while almost all patients had hematologic malignancies, 1 patient was diagnosed with an ovarian malignancy and showed great improvement in both SUA and Scr. Rasburicase reduced SUA levels in this patient group. Further studies on larger adult populations in or at high risk for TLS are necessary to determine statistical significance. No significant financial relationships to disclose.
A prospective study evaluating the relationship between fatigue and patient satisfaction in advanced cancer
Authors: Levin R. D. , Daehler M. , Lis C. G. , Gupta D. , Wodek T. , Grutsch J. F. , Granick J. , Williams S. , Citrin D. L. , Neelam R. 
Published: March 2020

16025 Background: Fatigue is the most common and disabling symptoms experienced by cancer patients. No study has prospectively quantified the relationship between fatigue and patient satisfaction (PS) in advanced cancer. We therefore assessed this relationship before the start of chemotherapy and at 3 and 6 months after treatment at our integrative cancer treatment center. Methods: 294 cancer patients treated at Cancer Treatment Centers of America between 04/01 and 11/04. Of 954 patients at baseline, only 294 were available for follow-up at 6 months. Fatigue was measured using the EORTC QLQ-C30 3-item fatigue subscale. Scores ranged from 0–100, higher scores indicating more fatigue. PS was measured using Ferrans & Powers Quality of Life Index (QLI). Scores ranged from 0–30, higher scores indicating better QoL. The mean fatigue scores were compared using ANOVA across the 3 time periods at baseline, 3 and 6 months. The relationship between fatigue and QLI was evaluated using multiple linear regression at all 3 time points. Results: Of 294 patients, 106 were males and 188 females. 91 had breast ca, 52 colorectal, 43 lung, 25 pancreas, 13 prostate, and 70 had other cancers. 112 were newly diagnosed and 182 had received prior treatment elsewhere. The mean fatigue scores at baseline, 3 and 6 months were 43.6, 37.3, and 41.8 respectively; the scores at baseline and 3 months were significantly different (p = .009). At baseline, after controlling for age, gender, prior treatment history, and tumor stage at diagnosis, every 10 unit increase in fatigue was significantly associated with 1.3 units decrease in QLI health subscale. Similarly at 3 and 6 months after treatment, every 10 unit increase in fatigue was significantly associated with 1.2 and 1.4 units decrease in QLI health subscale. Conclusions: In our study, we found that fatigue is a strong correlate of PS independent of the effects of age, gender, prior treatment history and tumor stage at diagnosis during the first 6 months of treatment. Interestingly, fatigue showed a significant improvement after 3 months of treatment and returned back to baseline levels at 6 months. This finding needs to be investigated further to evaluate the impact of integrative cancer care services on PS. No significant financial relationships to disclose.
Multiple primary cancer in adults (MPCA)
Authors: Ares S. L. , Polo S. , Ezcurdia L. , Tognelli F. , Mussini S. , Gercovich N. , Rivarola E. , Morgenfeld E. , Gil Deza E. , Gercovich F. G. 
Published: March 2020

16027 Background: As a result of the improvement in oncological treatments, MPCA could arise as a more frequent problem in Public Health. The purpose of this retrospective review was to estimate both the incidence and medical features of MPCA pts treated at the Instituto Oncológico Henry Moore (IOHM). Methods: We analyzed 17,100 medical charts from our database since 1987 and identified 378 MPC (2,21%). Then we retrieved data over the last eight years (1997–2005). Those pts with at least two second primary tumors were included in this analysis. They were categorized as synchronous (second tumor diagnosis within the first six months from the first one) and metachronous (all the remaining). Pts with skin cancer different from melanoma were excluded. Results: One hundred and seventy eight (M:73; F:105) out of 8,500 cancer pts (2.09%) had at least two primary cancers. Median age was 59, 64 and 68 yo at the moment of the first, second and third diagnosis, respectively. In 138 (78%) pts, the diagnosis of the second cancer was suspected by clinical findings, while in 40 (22%) pts, it was discovered because of medical screening in an otherwise asymptomatic pt. (See Table below) The most frequent site combination was breast-breast (n = 21). A total of 57 pts (32%) had a family history of oncologic diseases. With a median follow-up of 31 mo (range: 0,57–311) after the second cancer diagnosis, 127 pts are still alive (71,35%) and 51 (28,65%) are dead. Conclusions: In the last eight years, 178 (2.09%) pts had developed MPC, being breast, prostate, colon and lung the most frequent (first and later) localizations, and breast-breast the most frequent site combination. The so-called “screening effect” seems to have a low impact on the studied population. [Table: see text] No significant financial relationships to disclose.
The European Organisation for Research and Treatment of Cancer (EORTC) translation procedure for standardized quality of life questionnaires
Authors: Koller M. , Aaronson N. K. , Blazeby J. , Bottomley A. , Johnson C. , Ramage J. , West K. 
Published: March 2020

16033 Background: The EORTC Quality of Life (QoL) Group has developed a modular approach to QoL measurement for use in clinical trials in cancer. Questionnaires are used in international trials and standardized translation procedures are therefore required. This report summarizes the EORTC translation procedure, its accomplishments and translation problems. Methods: Translations follow a forward-backward procedure, independently carried out by two native-speakers of the target language. Discrepancies are arbitrated by a third consultant, and solutions are reached by consensus. Translated questionnaires undergo pilot-testing. Suggestions (by patients and users) are incorporated into the final questionnaire version. Most translations are performed by professional translators. The translation procedure is managed and supervised by the Translation Committee within the EORTC QoL Group. Results: To date, the core EORTC QoL questionnaire, the QLQ-C30, has been translated and validated into 62 languages, with a further 12 translations in progress. Translations include all major Western languages, East European languages, Asian languages and also remote languages, such as Xhoza (Africa).The validated, condition-specific questionnaire modules have been translated in up to 37 languages. The following major translation problems were encountered: lack of expressions for specific symptoms in various languages, the quest for formal versus informal versions, recent spelling reforms in several European countries, and different weights of social issues between Western and Eastern cultures. The EORTC measurement system is now registered for use in over 9000 clinical studies in 80 countries worldwide. Conclusions: The EORTC provides a strong infrastructure and methodology to produce high quality translations of their QoL questionnaires for use in international clinical trials. Translation problems have been identified and it will be an important topic for future research to specify whether these problems arise out of procedural/methodological shortcomings or are due to subtle cross-cultural differences in concepts of health, illness and QoL. No significant financial relationships to disclose.