bluuebunny/crossref_metadata_2025_split huggingface dataset:
Cost of febrile neutropenia management in cancer patients in Spain
Authors: Mayordomo J. I. , López A. , Viñolas N. , Castellanos J. , Pernas S. , Alonso J. D. , Frau A. , Layola M. , Gasquet J. A. , Sánchez J. 
Published: March 2020

6089 Background: Febrile neutropenia (FN), a dose-limiting event for many myelosuppressive chemotherapy (CT) regimens, often causes subsequent CT dose delays (DD) and reductions (DR), lengthens hospital stay and increases monitoring, diagnostic and treatment costs. No studies are known to date on economic costs of FN in common clinical practice in Spain. Methods: This is a multicentre, retrospective, observational chart review of adult patients with breast cancer, lung cancer or non-Hodgkin’s lymphoma (NHL) who suffered from at least one FN episode related to cytotoxic CT from 16 Spanish hospitals. Resource use and subsequent costs including days of hospitalization, number of RBC transfusions, number and type of complementary tests, use of colony-stimulating factors (CSF), antibiotics and other drugs to manage FN were assessed. Potential impact of FN on planned CT dose and/or schedule was also analysed. P-value was obtained by one-way ANOVA using the Bonferroni correction. Results: A total of 194 medical charts including 238 documented FN episodes were reviewed. Women, 59.8%; age > 60 yrs, 49.5%; breast cancer, 43% (83% treated with taxane or anthracycline-based CT); lung cancer, 22% (95.5% treated with platinum-based CT); NHL, 35% (58.2% treated with CHOP-like CT). Hospitalization due to FN lasted a median of 7 days. During the episode, 32.3% of pts needed 1 or more RBC transfusions, 97.9% required a blood test and 87% a blood culture. CSFs were used in 67.6% of pts. All pts were treated with antibiotics and 78.2% with other drugs. 58.4% of FN episodes had an impact on planned CT dose and/or schedule: DR was observed in 34.9% of cases, DD in 28% and CT withdrawal in 14.7%. Conclusions: Main drivers of cost of FN are hospitalization and antibiotic treatment. FN is more costly in NHL pts than breast or lung pts (statistically significant in lung pts). FN episodes have a relevant impact on planned CT dose and/or schedule. In each row statistically significant differences ( p<0.05) were obtained between values with the same letter. [Table: see text] [Table: see text]
Metastatic breast cancer: A regional audit of HER2 testing and trastuzumab access
Authors: Scullin P. , Drake A. T. , Coyle V. M. , McAleer J. J. 
Published: March 2020

6097 Background: Clinical trials have clearly established that patients receiving taxane-based chemotherapy for metastatic breast cancer (MBC) should be treated with trastuzumab if their tumour is shown to overexpress the human epidermal growth factor receptor 2 (HER2) receptor. This is based on median survival gains for patients with HER2 positive tumours treated with trastuzumab plus taxane chemotherapy compared to taxane alone. Methods: Patients commencing chemotherapy for MBC in Northern Ireland in 2004 were identified from pharmacy records. Their case notes were retrospectively reviewed to determine whether patients in routine clinical practice had HER2 testing and trastuzumab treatment if indicated. Results: One hundred and fifty six patients commenced chemotherapy, of whom 145(93%) had HER2 testing. In 69(44%) patients the HER2 result was already available at the time of this relapse. In the remaining 76(49%) patients the result became available in a median of 41.5 (range 0–368) days. Of those tested, 48 patients (33%) were HER2 positive (immuno-histochemistry 3+ or fluorescence in situ hybridization positive). Thirty eight of these patients were treated with trastuzumab, either as a single agent or in combination with chemotherapy. There were valid reasons for trastuzumab omission in 7 of 10 patients not given trastuzumab (4 given first line anthracycline-based regimen, 1 had cardiac dysfunction, 1 had extensive lung metastastes and 1 was unfit for treatment). The data were examined for variations in chemotherapy and trastuzumab use across the 4 health boards which comprise the region. The number of patients commencing chemotherapy ranged from 6.9 to 11.4 patients per 100,000 population indicating a significantly different utilisation (p<0.001). Conclusions: In our region 145 of 156 patients who received chemotherapy for MBC were tested for overexpression of the HER2 receptor (93%). Of those patients who were eligible to receive trastuzumab 31 out of 34 (91%) received trastuzumab. There were inequalities in the region regarding chemotherapy for MBC and the time required to obtain a HER2 result averaged 41.5 days. Testing of HER2 status at time of original diagnosis would streamline management of metastatic disease. No significant financial relationships to disclose.
Delays in diagnosis and initiating treatment for patients with lung cancer
Authors: Vandermeer R. L. , Dimitry S. J. , Arnold A. , Ellis P. M. 
Published: March 2020

6102 Background: Many patients with lung cancer report delays in the diagnosis of their disease. This situation may contribute to advanced stage at diagnosis and poor long term survival. This study explores the delays experienced by patients referred to a regional cancer centre with lung cancer. Methods: A prospective cohort of patients referred to a regional cancer centre with newly diagnosed lung cancer were surveyed over a 3 month period. Surgically resected patients were not included as they were treated at another site. Patients were asked when they first experienced symptoms, when they saw their doctor, what tests were done, when they saw a specialist and when they started treatment. A medical record review was employed to validate the data patients provided. Descriptive statistics were used to summarize the different time intervals. Results: 56 of 73 patients consented (RR 77%). However, only 52 patients (30M, 22F) were interviewed as two expired before being interviewed and two could not be contacted. The mean age was 68 yrs. Stage distribution was as follows: IB/IIA 10%, IIIA 20%, IIIB/IV 70%. The initial treatment was as follows: 10% of patients supportive care alone, 19% chemotherapy, 44% radiation and 27% had combined chemoradiation. Patients waited a median of 21 days (IQR 7–51d) before seeing a doctor and a further 22d (IQR 0–38d) to complete any investigations. The median time from presentation to specialist referral was 27d (IQR 12–49d) and a further 63d (IQR 44–102d) to complete investigations. The median wait time to start treatment once patients were seen at the cancer centre was 10d (IRQ 2–28d). The overall time from development of first symptoms to starting treatment was 139d (IQR 100–174d). Conclusions: Lung cancer patients experience substantial delays from development of symptoms to first initiating treatment. There is a need to develop and evaluate rapid assessment clinics for patients with suspected lung cancers. No significant financial relationships to disclose.
Providing practitioner-specific outcomes is associated with higher patient satisfaction with information about prostate cancer treatment
Authors: Gilbert S. M. , Sanda M. G. , Dunn R. L. , Greenfield T. , Hembroff L. , Klein E. , Saigal C. , Michalski J. , Sandler H. , Litwin M. S. , Wei J. T. 
Published: March 2020

6106 Background: After being diagnosed with prostate cancer, patients must assimilate abundant cancer related information. Satisfaction with Information (SWI) is a patient’s cognitive evaluation of information sources used to understand and select therapy. We sought to describe sources of information used by prostate cancer patients and to identify factors associated with SWI. Methods: 1,072 men with newly diagnosed prostate cancer have enrolled in the prospective, multi-center PRostate cancer Outcomes and Satisfaction with Treatment Quality Assessment (PROST-QA) study. Reports of source(s) of information were documented prior to treatment (radical prostatectomy, external radiation, brachytherapy or combination). The validated SWI domain of the Service Satisfaction Scale-Cancer (SSS-Ca) was completed by patients 2 months following treatment. Relationships between socio-economic factors, demographics, cancer severity, and types of information sources and satisfaction (SWI) were evaluated with multivariate regression. Results: Sources of information endorsed by patients varied by race ( Table ), education, and study site. The most helpful sources of information were description of treatment by a physician (32.8%), books and internet (18.3% each), family/friends (16.6%) and pamphlets/brochures (11.4%). In bivariate analysis internet use was negatively associated with SWI (p=0.025). In multivariable models patient age (p=0.005) and information provided by the physician regarding their own outcomes (p=0.01) were independently associated with SWI. Conclusions: Although a variety of informational sources were endorsed by patients, only printed results for physician’s own patients was associated with SWI. Because SWI is a function of both experiences and expectations, providing patients with a treating physician’s results may improve satisfaction by enhancing concordance of expectations and outcomes. [Table: see text] [Table: see text]
Potential clinical and economic impact of switching U.S. women to exemestane following 2–3 years of therapy with tamoxifen for early breast cancer
Authors: Thompson D. , Taylor D. C. , Montoya E. L. , Jones S. E. , Weinstein M. C. 
Published: March 2020

6109 Background: Switching postmenopausal women with early breast cancer to exemestane after 2–3 years of tamoxifen therapy has been reported to increase disease-free survival. However, the potential impact of this management strategy on the U.S. health-care system is unknown. The objective of this study was to estimate the 10-year clinical and economic consequences that would accrue if all eligible U.S. patients in 2006 were switched from tamoxifen to exemestane. Methods: A Markov model with a 10-year time horizon was used to predict patients’ transitions across various health states based on treatment strategy (continuing tamoxifen versus switching to exemestane), breast cancer status (no recurrence, local or distant recurrence, contralateral breast cancer), and other related health events (osteoporosis, endometrial cancer, death). Disease- and treatment-related events were estimated using data from the Intergroup Exemestane Study (IES); survival and medical-care costs by type of recurrence were estimated using SEER-Medicare data and published literature. The switch-eligible cohort was defined to be consistent with IES selection criteria and its size in 2006 estimated based on SEER-Medicare and market research data. Costs incurred in future years were discounted at 3% annually. Results: We estimate that 71,800 U.S. women would be eligible to switch from tamoxifen to exemestane in 2006. Doing so would be expected to prevent 3,000 cases of recurrence (21,100 vs 24,100) and 2,000 breast cancer deaths (12,800 vs 14,800) over 10 years. The net budgetary impact over 10 years is projected to be $320M ($992M vs $672M), reflecting a $336M increase in costs of adjuvant hormonal therapy ($500M vs $164M), a $32.1M increase in costs of monitoring and treatment of adverse events ($73.7M vs. $41.6M), and a $47.4M reduction in recurrence-related treatment costs ($419M vs $466M). Conclusion: Switching all eligible U.S. breast cancer patients from tamoxifen to exemestane in 2006 would increase medical-care costs by $4,460 per patient but reduce breast cancer recurrences by 12% and breast cancer deaths by 14% over 10 years. [Table: see text]
Separate DCIS progression pathways derived from breast disease heterogeneity data
Authors: Maskery S. M. , Hu H. , Mural R. , Hooke J. , Shriver C. D. , Liebman M. N. 
Published: March 2020

612 Background: Observation of heterogeneity in breast pathology has been a consistent theme but one that has had little detailed analysis and/or interpretation. Typically, this research has been limited due to variation in pathology description by different pathologists. We have utilized a unique breast disease tissue and data repository to infer multiple pathways from breast disease to breast cancer. Methods: Breast pathology diagnoses are drawn from 1029 standardized and highly expanded pathology reports. A single pathologist records the occurrence of any and all pathologies seen in a patient’s breast biopsy. This co-occurrence data is analyzed using a Bayesian network learning algorithm that links data observations in a probabilistic order of events. The resultant Bayesian network is a visualization of how breast disease diagnoses can predict the presence or absence of other diagnoses. For example, a connection between ductal carcinoma in situ (DCIS) and invasive ductal carcinoma (IDC) visualizes the statement: the presence of DCIS alters the likelihood of the presence of IDC. Results: Separate progression pathways are implicated for DCIS comedo to IDC and DCIS non-comedo to IDC. Multiple breast lesions predict DCIS non-comedo occurrence. One pathway inferred from these predictive lesions is: columnar cell hyperplasia-florid ductal hyperplasia-atypical ductal hyperplasia-DCIS non-comedo-IDC. In contrast, no hyperplasia or atypical lesion can predict DCIS comedo occurrence. That DCIS comedo and DCIS non-comedo have very different progression pathways implies these two pathologies may be two separate diseases. Parallel genomic studies at our institute provide strong evidence that DCIS non-comedo and DCIS comedo are two separate genomic entities. Conclusions: Bayesian network analysis provides a mechanism for the use of heterogeneity in breast disease pathology to predict multiple breast disease progression pathways. Using novel bioinformatic techniques and traditional genomic analysis methods we have gathered compelling evidence that DCIS progression follows two separate pathways. No significant financial relationships to disclose.
Survival trends for advanced colorectal cancer (CRC): Are improvements only for patients in clinical trials?
Authors: Price T. J. , Roder D. , Pittman K. , Patterson K. , Rieger N. , Hewett P. , Rodda D. , Colbeck M. , Maddern G. , Luke C. 
Published: March 2020

6124 Background: Significant improvements in the outcome for patients with advanced CRC have been achieved. We have reviewed the prospective CRC database at our institution from 1992 to 2004 to explore whether the availability of new chemotherapy drugs (irinotecan & oxaliplatin) and surgical advances has impacted on survival in the normal population. Earlier results had suggested a trend to improved survival (1). Methods: In Australia the first of these drugs became available at the end of 1997 thus we have taken this as the time point to compare outcomes pre and post. Disease-specific survivals were analysed from the date of diagnosis for stage D, and from the date of distant recurrence for stages A, B and C, with a date of censoring of live cases at December 31st, 2004. The Kaplan-Meier product-limit estimate was used for univariate analyses and Cox proportional hazards regression for multivariable analyses. Results: The current analysis is of 744 patients; 92–97 n=313, 98–04 n=431. Survival for the respective time periods were 47.6% and 54.9% 12 mths; 28.0% and 34.8% 24 mths; 18.9% and 23.0% 36 mths; 12.6% and 17.2% 48 mths; and 10.4% and 14.9% 60 mths. Cox proportional hazards regression indicated a lower risk of case fatality for 1998–2004 than 1992–1997 cases (p=0.048) after adjusting for age measured in years. The key predictors of case fatality in a multivariate analysis were found to be period (i.e., 1992–97/1998–04), age, and stage of disease at time of initial diagnosis. While an upward trend in survival was recorded for all ages, it was most pronounced for 70–79 year olds (n=272), where the increase in 24 mth survival was from 21.1% for 1992–97 to 36.1% for 1998–2004 (p=0.015). For patients aged 80 years and over (1992–97 n=40 & 1998–2004 n=67) the 24mth survivals were 18.6% (6.7%) and 26.4% (6.9%) respectively (p>0.200). Conclusions: Clinical trials have shown improvements in survival for highly selected patients. This current analysis confirms an improvement in survival over time for advanced CRC and this is seen in unselected patients including the elderly. Preliminary data has suggested that a number of factors have contributed to the trend of improved survival. Final analysis, including updated chemotherapy trends, will be presented at the meeting. (1) Proc ASCO 2004, #3707 No significant financial relationships to disclose.
Drug interactions in ambulatory cancer patients receiving cancer-directed therapy
Authors: Riechelmann R. P. , Wang L. , Tannock I. F. , Krzyzanowska M. K. 
Published: March 2020

6129 Background: Cancer patients (pts) are susceptible to drug interactions (DI) because they receive multiple medications. Here we evaluate the epidemiology of potential DI in cancer patients. Methods: Ambulatory, adult pts with solid malignancies who were receiving antineoplastic treatment completed a questionnaire about drugs taken in the previous month. Drug Interactions Facts software was used to screen for potential DI and to classify them in terms of severity (major, moderate and minor, where major is a life-threatening interaction) and level of scientific evidence (1 to 5, with 1 being the highest level). Summary statistics and logistic regression were used to describe the results. Results: Between Sept -Dec 2005, 183 pts completed the questionnaire: median age was 61 (range 26–88), and 114 (62%) were women. Cancer sites included breast 63 (35%), gastrointestinal 45 (25%), and genitourinary 36 (20%). Treatment intent was palliative in 139 (60%). Most pts (76%) were receiving chemotherapy; 111 (66%) had at least one co-morbid condition, and 72 (47%) had abnormal liver and/or renal function. The median number of drugs per pt was 5 (range 0–16). Among the 183 pts, 131 potential DI were identified of which 65 (50%) were due to pharmacokinetic interactions. Sixteen (12%) of all potential DI were major, 94 (72%) were moderate, and 21 (16%) were minor. Fourteen (11%), 54 (41%), 5 (4%), 42 (32%), and 16 (12%) were supported by levels 1,2,3,4,5 of evidence respectively. Most potential DI involved non-chemotherapy agents such as warfarin, antihypertensives, and anti-inflammatory drugs. In multivariate analyses, number of comorbidities (p= .0001), number of drugs (p= .005), and cancer type (p= .03) were significant risk factors for DI. Conclusion: PotentialDI are common in oncology, and usually involve non-chemotherapeutic drugs. Risk factors for potential DI include comorbid illness, number of medications and type of cancer. Oncologists should be aware of such an important issue. No significant financial relationships to disclose.
Prophylactic oophorectomy in premenopausal women with non-metastatic colon cancer: A decision analysis
Authors: Mourton S. M. , Hollenberg J. P. , Abu-Rustum N. R. , Chi D. S. , Wong W. D. , Temple L. K. 
Published: March 2020

6130 Background: There is data to suggest that prophylactic oophorectomy (PO) in premenopausal women with colon cancer may improve survival. However, the potential for improved survival must be balanced against the trade-off of premature menopause and its affect on quality of life (QOL). The objective of this study was to determine the value of PO in premenopausal women undergoing surgical excision of colon cancer. Methods: We constructed a decision-analytic model comparing PO versus no PO for premenopausal women undergoing resection of stage I-III colon cancer. The model included detection of ovarian micrometastases (OMM), adjuvant chemotherapy, development of metachronous ovarian metastases, subsequent risk of ovarian cancer and QOL. Probabilities and utilities were estimated from published data. Life expectancy (LE) and quality adjusted LE (QALE) were calculated using the Declining Exponential Approximation of Life Expectancy. Results: With a baseline OMM incidence of 8%, a 5 yr survival of OMM removed (19%) vs OMM left in situ (11%), there was a gain in LE of 2.8 months with PO. With QOL adjustments for menopause (utility 0.77) and colon cancer (utility 0.37–0.85 ), QALE was 1.7 months less with PO. One-way sensitivity analysis (SA) demonstrated that the utility of menopause had the greatest effect on QALE differences, with a threshold value of 0.86 at which QALE was greater with PO. With increasing OMM incidence and 5-year survival with removed OMM, QALE became greater in the PO cohort. All 1, 2, and 3 way SAs demonstrated that the model was robust through the probable range of variables. Conclusions: Our model demonstrated the significant effect of menopause QOL on overall QALE. Although PO may lead to a small gain in LE, the trade-off of premature menopause must be considered when counseling patients. No significant financial relationships to disclose.
Temporal trends in oncology product approvals in the United States, 1986–2005
Authors: Ross D. B. , Weiss K. D. , Keegan P. , Justice R. , Pazdur R. 
Published: March 2020

6131 Background: No systematic examination of temporal trends in oncology approvals in the United States (US) has been conducted. Methods: Internal databases at the US Food and Drug Administration (FDA) were queried to determine the number of first-time approvals for New Molecular Entities (NMEs) (both traditional drugs and therapeutic biologics) for oncology indications between the years 1986 and 2005, inclusive; 1986 was the first year for which database records were available for both drugs and biologics. Correlation analysis was used to analyze the data for time-dependent changes in approvals and approval rates. Results: During the period examined, 70 NMEs received first-time approval for an oncology indication ( Table ); 52 (74%) were drugs and 18 were biologics. The median annual number of approvals was 3 (range, 1 to 7); the maximum number of approvals during the period examined occurred in 2004. Statistical analysis showed a weak positive correlation between the number of oncology approvals and time, and between the proportion of applications approved as a percentage of all oncology product applications and time. Conclusions: Available data suggest that the number and rate of oncology product approvals has remained stable in the US over the last two decades. [Table: see text] No significant financial relationships to disclose.