bluuebunny/crossref_metadata_2025_split huggingface dataset:
Influence of pregnancy on breast cancer tumor characteristics and mortality in Iowa women
Authors: Scott-Conner C. E. , Romitti P. A. , Lynch C. F. , Wilkinson N. , Lal G. , Zhou L. , Smith B. J. 
Published: March 2020

584 Background: Hormonal factors such as pregnancy influence development and course of breast cancer. We identified women who became pregnant during the preclinical phase or shortly after diagnosis of breast cancer, compared them with similar women who had not been pregnant in that time period, and studied tumor characteristics and mortality. Methods: Birth and fetal death certificates were linked with Iowa Cancer Registry information for 10,624 women ≤50 years of age diagnosed with breast cancer as a first invasive primary between January 1, 1975 and December 31, 2002. Women who were pregnant two years before (n=160) or after diagnosis of breast cancer (n=53)and those who had not been pregnant (NP) (n=5008) were identified using probabilistic computer matching with manual review confirmation. Clinical, pathological and 10-year survival data were compared between these groups. Preliminary analysis revealed similarities between women who were pregnant before and after diagnosis. These were combined for analysis (P). Results: The study subjects distributed themselves across two SEER stages of disease: 1) localized, and 2) locally advanced or regional nodal disease (LABC). SEER stage (50% LABC vs. 39% LABC) and grade (75% high grade vs. 56% high grade) were higher in P than in NP cases. Ten-year survival for localized disease was 0.766 (95% CI 0.649–0.848) for P and 0.874 (95% CI 0.858–0.888) for NP (log rank test p= 0.0178). Ten-year survival for LABC was 0.520 (95% CI 0.373–0.649) for P and 0.629 (95% CI 0.601–0.655) for NP (log rank test p= 0.0234). Multivariate analysis ( table below) showed an adverse effect of pregnancy status on survival, independent of stage, grade, age or progesterone receptor (PR) status. Conclusions: Women who are pregnant within two years of diagnosis of breast cancer have higher grade, more locally-advanced tumors and experience a higher mortality than similar women who are never pregnant. Pregnancy persists as a significant adverse survival variable after adjustment for age, grade, stage, and PR status. [Table: see text] No significant financial relationships to disclose.
Should attribution be considered when interpreting adverse event data: A North Central Cancer Treatment Group (NCCTG) evaluation of a phase III placebo controlled trial
Authors: Hillman S. L. , Mandrekar S. J. , Bot B. M. , Perez E. A. , Kugler J. W. , Adjei A. A. , Buckner J. C. , Sargent D. J. 
Published: March 2020

6006 Background: In March 1998, the Common Toxicity Criteria version 2.0 was implemented and introduced the collection and reporting of attribution of adverse events to study treatment. Collection and reporting of attribution adds time and cost to the clinical trial process, and its use while reporting adverse events (AE) in the literature has varied. We investigate whether attribution adds value to the interpretation of AE data. Methods: Patients on the placebo arm of trial 97–24–51 (CAI vs. Placebo) were chosen since the true relationship of the event to the study treatment is known (“unrelated”). Attribution was collected per CTCv2.0 and categorized as “not related” (not related or unlikely) and “related” (possible, probable, or definite). All reported AEs and the maximum severity for a given AE were evaluated. Patterns were evaluated using generalized estimating equations adjusting for multiple events per patient. Changes in attribution over time for the same event were computed. Results: 84 patients on the placebo arm experienced a total of 1013 AEs. 47% of AEs were reported as “related” with 36% reported as possibly related. Known CAI AEs were more likely to be reported as “related” (p = 0.005). Pulmonary AEs were more likely to be reported as “not related” (p = 0.0006). No patterns were observed by gender, age, PS, severity or treatment cycle of AE. When the same event was reported on the same patient in multiple cycles, the attribution category changed at least once 36% of the time with 25% changing from “related” to “unrelated” or vice versa. Conclusion: Almost 50% of events on a placebo arm of a phase III trial were reported as being attributed to study treatment and 25% of the time the same event was not consistently attributed. These data suggest that attribution is difficult to determine, unreliable, and thus its value in large phase III trials is questionable. [Table: see text] No significant financial relationships to disclose.
Altered fractionated radiotherapy is cost-effective in the treatment of locally advanced head and neck cancer: An economic analysis of Radiation Therapy Oncology Group (RTOG) 90–03
Authors: Konski A. A. , Bhargavan M. , Owen J. , Paulus R. , Cooper J. , Fu K. , Ang K. , Watkins-Bruner D. 
Published: March 2020

6007 Background: RTOG 9003 compared altered fractionated radiotherapy (AIFX) to standard radiotherapy (SFX). Overall and disease-free survival was improved in the AIFX schedules but with increased toxicity. The specific aim of this study was to compare the cost-effectiveness of AIFX to SFX. Methods: Costs data included Medicare Part A and Part B costs from all providers—inpatient, outpatient, skilled nursing facility, home health, hospice, and physicians and other Part B providers were obtained from the Centers for Medicare & Medicaid Services (CMS) for patients treated on RTOG 9003 from 1992–1996. Claims were restricted to those with a diagnosis of head and neck cancer. We calculated 56-month expected discounted costs for each arm of the trial in 1996 dollars, with Kaplan-Meier sampling average estimates of survival probabilities for each month and mean monthly costs. Costs were discounted back to the time of entry onto the trial, using an annual discount rate of 3% and indexed to 1996 dollars using the Consumer Price Index. The analysis was performed from a payer’s perspective. Incremental cost-effective ratios were calculated comparing AIFX schedules to SFX. Results: Of the 1,130 patients entered, 1,073 patients were analyzable for outcomes and Medicare cost data and clinical outcomes were available for 130 patients. The expected mean 56-month cost and incremental cost-effectiveness ratios (ICER) compared to SFX are presented in the table . Sensitivity analysis and 95% confidence ellipses will be presented. Conclusions: Although more toxic altered fractionated radiotherapy schedules were found to be cost-effective using a willingness to pay of $50,000/life year in patients >65 years old. These results need to be confirmed in a cohort of younger patients. [Table: see text] No significant financial relationships to disclose.
Has demand outpaced supply for clinical trial participants?
Authors: Tam J. T. , Hauser R. , Gura D. , Paraghamian A. , Thomas H. , Lichtman S. 
Published: March 2020

6016 Background: Current estimates are less than 5% of adult cancer patients participate in clinical trials. Initiatives to address barriers to accrual (such as age, physician bias, etc) are ongoing. However, with more drugs in the pipeline and more clinical trials being conducted, demand for trial participants may be outpacing the current “supply”. Methods: The ClinicalTrials.gov database, maintained by National Institutes of Health was selected for review on the basis that it is proposed to be the mandated repository for clinical trials information. Over a 2 month period, the database was mined for all active, US recruiting, phase I, I/II, II, and III trials in breast, lung, and prostate cancers. Results: There were 290 breast, 212 lung, and 177 prostate cancer trials with the prespecified criteria. The number of patients needed to complete these trials is 151,311 (breast), 33,498 (lung), and 53,181 (prostate). These represent 19.4% to 71.6% of the American Cancer Society incidence estimates of the studied tumors. NCI, industry, and academia sponsored, either solely or in collaborations, 42.1%, 26.5%, and 45.6% of trials, respectively. Majority of studies were phase II (51%), with 11.5% phase I, and 15.6% phase III. Remaining studies were either combined phase I/II studies or not specified. Significant percentage of trials involved pts with advanced/metastatic disease (54% breast, 51.4% lung, and 44.6% prostate). Conclusions: Although many studies have anticipated enrollment period over several years, the number of trial participants needed to complete these studies is quite daunting. Our results are likely under-estimates as not all studies currently enrolling patients may be included in this registry, and not all studies in the database specified the recruitment goal. Although not all trial participants are drawn from the incidence numbers, it is clear that given the current trial participation rate, demand has outpaced the supply. The medical community has the ethical responsibility to ensure sufficient patient enrollment for clinical trials. In addition to addressing accrual barriers, the authors encourage the establishment of a task force including academia, government, and industry to systematically evaluate and prioritize the types of trials being conducted. No significant financial relationships to disclose.
21-gene RT-PCR assay in lymph node negative (LN-), estrogen receptor positive (ER+) breast cancer: An economic analysis including prognostic and predictive information
Authors: Cosler L. E. , Kuderer N. M. , Hornberger J. , Lyman G. H. 
Published: March 2020

6024 Background: The prognostic accuracy of a 21-gene RT-PCR assay has undergone validation in 668 evaluable LN-, ER+ early stage breast cancer patients receiving tamoxifen on NSABP B-14 (Paik, NEJM 2004) and its economic evaluation (Hornberger, Am J Man Care 2005). Assay predictive accuracy for response to chemotherapy or tamoxifen has also undergone recent validation in 651 patients on NSABP B-20 and 645 patients on NSABP B-14 (Paik, SABCS 2004). Methods: Based on the model recurrence score (RS), women with LN−, ER+ breast cancer with and without adjuvant chemotherapy (C) or tamoxifen (T) were classified as high (RS ≥31), intermediate (RS 18–30) or low (RS <18) risk of distant recurrence at 10 years. Incremental costs ($), life-years (LYs), quality-adjusted LYs (QALYs) and cost-effectiveness (C/E; cost per LY gained) were estimated for: RS-guided treatment (RSGT) with T for low and intermediate risk patients and C+T for high-risk patients, compared to either T alone or C+T for all patients. Results: Under base case assumptions, no significant difference in life expectancy at 10 years is estimated between the RSGT and C+T strategies whereas RSGT is associated with a gain in individual life expectancy of 2.7 LYs compared to T alone. RSGT is estimated to yield a net cost savings of $4,502 compared to C+T with an incremental C/E of $1,059 per LY saved compared to T alone. At a utility of 90% associated with adjuvant chemotherapy, RSGT is associated with a gain in individual QALYs of 1.82 compared to T alone at a cost utility of $1,573/QALY and a gain in 3.21 QALYs compared to C+T. RSGT is associated with lower expected cost than C+T for total chemotherapy costs above $3,998. The gain in LYs with RSGT compared to T alone increases with healthy age-specific life expectancy (years) while the cost per LY gained decreases. Conclusions: Treatment based on the RSGT compared to T alone is associated with acceptable C/E ratios and substantially lower toxicity and cost compared to C+T. [Table: see text] [Table: see text]
Timely access to care for colorectal cancer (CRC): A description and analysis of associated factors
Authors: Porter G. A. , Inglis K. M. , Murdoch J. L. , Veugelers P. J. 
Published: March 2020

6028 Background: There are multiple points in the presentation, diagnosis and treatment of CRC where access to physicians and/or medical services may affect the timeliness of appropriate care. A single interval, such as time from diagnosis to surgery, may incompletely reflect the timeliness of care in CRC. We describe the various components of access to care for resectable CRC, and identify factors associated with variation in such components. Methods: From 02/15/2002 to 02/15/2004, all patients undergoing surgery for primary CRC within a single health district were enrolled in a prospective consecutive cohort study. A comprehensive, standardized method of ascertaining specific time intervals, including a patient interview, was used to quantify the timeliness of presentation, diagnosis and surgery. Differences in these time intervals according to demographic and clinical factors were examined using multivariate linear regression. Results: Among the 455 patients in the study cohort, the median time intervals (interquartile range) for the various components of access to care were as follows: symptoms to first physician visit - 36 days (12–79); first physician visit to diagnosis - 51 days (15–127); diagnosis to surgery - 23 days (10–39). On multivariate analysis, the interval from initial symptoms to first physician visit was 96% longer for patients < 50 years (p = 0.02) and 144% longer for rectal lesions (p < 0.001). The interval from first physician visit to diagnosis was 190% longer for patients < 50 years (p < 0.001), and was positively correlated with gross household income (p = 0.02). The interval from diagnosis to surgery was 33% longer in females (p = 0.003) and 70% longer for rectal lesions (p < 0.001). None of these intervals were found to vary significantly according to geographic residence, education level, body mass index, number of years with family doctor, smoking history, or previous use of CRC screening. Conclusions: The timeliness of access to care for CRC involves several defined components; the longest interval is from initial physician visit to diagnosis. Although associated factors vary somewhat according to the specific interval, interventions aimed at improving the timeliness of access to care in CRC should address younger patients and those with rectal cancer. No significant financial relationships to disclose.
Effect of race/ethnicity and treatment delay on breast cancer survival
Authors: Sheinfeld Gorin S. , Heck J. E. , Cheng B. , Smith S. 
Published: March 2020

6063 Background: Several papers have examined the relationship between treatment delay and survival among patients who are diagnosed with cancer. None has yet relied on a large, population-based dataset to systematically examine survival among women within different ethnic/racial groups who delay breast cancer treatment. Methods: Subjects were 49,865 female Medicare enrollees age 65 and older who were diagnosed with breast cancer between 1992 and 1999 and identified by the Surveillance, Epidemiology, and End Results (SEER) program. Dates of their health care visits were identified through the linkage of SEER with Medicare claims data. Mortality from breast cancer was assessed through linkage with death certificates. Propensity score analyses that compared patients matched according to their propensity to receive treatment were used to balance patient characteristics between treatment groups, as would occur in a randomized clinical trial. Results: A propensity score analysis and a Cox proportional hazards model of survival (with adjustments for ER/PR status, treatment type, race/ethnicity, stage, age, comorbidities, marital status, poverty status, geographic location, and average number of service contacts) revealed that subjects with 1-month delay in the start of treatment had a reduced likelihood of survival (adjusted HR=1.17, 95% CI, 1.06–1.30) relative to those with less delay. Blacks had significantly lessened survival than women in other races/ethnicities (adjusted HR=1.23, 95% CI, 1.00–1.52). Receipt of radiation (adjusted HR=1.45, 95% CI, 1.24–1.69), chemotherapy (adjusted HR=1.73, 95% CI, 1.51–1.99), stage three diagnosis (adjusted HR=1.35, 95% CI, 1.08–1.70), being age 70 or older (adjusted HR=1.24, 95% CI, 1.09–1.41), or having 2 or more comorbidities (adjusted HR=1.47, 95% CI, 1.12–1.92) also predicted reduced survival from breast cancer. Conclusions: One month delay in accessing breast cancer treatment has a clear relationship to reduced survival, particularly among older, later-stage, comorbid black women who receive chemotherapy or radiation. Mechanisms for rapid access to treatment, using both provider- and system-based strategies, are recommended for these women who are at increased risk for breast cancer-related mortality. No significant financial relationships to disclose.
Routine use of sentinel lymph node surgery in patients undergoing prophylactic mastectomy: A decision analysis model
Authors: Boughey J. C. , Cormier J. N. , Xing Y. , Meric-Bernstam F. , Ross M. I. , Babiera G. V. , Ames F. C. , Hunt K. K. , Bedrosian I. 
Published: March 2020

607 Background: Patients with invasive carcinoma identified following prophylactic mastectomy (PM) require axillary lymph node dissection (ALND) for nodal staging as standard surgical treatment. Since most patients will be node negative, sentinel lymph node (SLN) surgery has been advocated to avoid the sequelae of unnecessary axillary surgery. However, since SLN surgery is not without complications and the incidence of invasive cancer in PM is extremely low, we sought to compare surgical strategies using a decision analysis model in order to define the true risks and benefits of routine SLN surgery versus standard surgical treatment (ALND). Methods: Model estimates were derived by systematic review of the literature. The outcomes examined were: (1) the number of SLN procedures that would need to be performed to avoid one ALND in a pathologically node negative patient; and (2) the probability of long-term axillary complications with each strategy. Occult breast cancer was defined as invasive cancer in the PM specimen and/or SLN metastases. Results: The following weighted averages were used to inform the model: i) incidence of invasive cancer in PM of 1%, ii) incidence of nodal disease of 25% in the presence of invasive breast cancer and 1% in the absence of invasive cancer in the breast, and iii) incidence of complications after ALND of 30% and after SLN surgery of 6%. Routine use of SLN surgery doubled the sensitivity for detection of carcinoma compared to ALND. However, 133 SLN procedures were required to avoid one ALND in a node negative PM patient. Additionally, the probability of complications per breast cancer detected was 10-fold greater with the SLN strategy. When the risk of breast cancer was projected at 10%, 13 SLN procedures were required to avoid one negative ALND and the complication rate per cancer detected was 2-fold greater in the SLN arm. Conclusions: The benefit of adding SLN surgery in patients undergoing PM depends on the probability of detecting invasive cancer. Routine SLN surgery in PM is not warranted given the large number of procedures required to benefit one patient and the complications associated with performing SLN surgery in all patients. However, the SLN strategy may be appropriate for subgroups of patients at higher risk of occult carcinoma. No significant financial relationships to disclose.
Poor access to clinical trials among community cancer patients requiring chemotherapy for recurrent or progressive disease: Limitations of current cancer cooperative groups
Authors: Meyer L. A. , Lee J. A. , Mathiason M. A. , Frisby K. A. , Bruden K. C. , Meyer C. M. , Keller J. K. , Go R. S. 
Published: March 2020

6076 Background: Data on clinical trial accrual among cancer patients treated in the community are limited. In a prospective study at our community-based cancer center, we found that the accrual rate was only 4% for newly diagnosed patients and protocol limitations accounted for 68% of non-accrual (Go RS, et al. Cancer 2006). We would like to determine the availability of trials for adult cancer patients with recurrent or progressive disease treated in the community and the accrual rate. Methods: We retrospectively identified this specific group of patients who received chemotherapy at our institution between November 2004 and October 2005 and collected data on the number, types, and sources of trials that were available. Results: We identified a total of 140 patients. There was an equal number of females (52.9%) and males, with a median age of 66 years (range, 38–89) at the time of chemotherapy. Fifty trials were available, with about half for the following cancers: lung (14%), pancreatic (12%), renal (10%), head and neck (8%), prostate (6%), and breast (6%). No trials were available for bladder, colorectal, and gastroesophageal cancers. The proportions of phase I, II, and III trials were 4%, 62%, and 34%, respectively. The sources of trials were: ECOG (56%), Wisconsin Oncology Network (14%), Intergroup (12%), GOG (10%), RTOG (2%), CTSU (2%), our institution (2%), and pharmaceutical companies (2%). Only 69 (49.3%) patients had trials appropriate for their type and stage of cancers. Among those patients with available trials, 24 (34.8%) were eligible to participate and 6 were enrolled, for an overall accrual rate of 4.3%. There were no differences in age and sex among subgroups in terms of trial availability, eligibility, and accrual. Conclusions: At our institution, enrollment of cancer patients with recurrent or progressive disease in clinical trials is as low as for newly diagnosed patients. Over 80% of the patients were denied access to a trial because of protocol unavailability and ineligibility. Current cancer cooperative groups do not provide adequate trials for patients in the community. No significant financial relationships to disclose.
The potential for lost productivity in lung cancer patients
Authors: Zawisza D. , Pepe C. , Mittmann N. , Feld R. , Shepherd F. , Leighl N. 
Published: March 2020

6093 Background: Lung cancer significantly impacts on a patient’s personal and professional life. Little is known about lung cancer patients’ lost productivity, which in turn has an important effect on society. We undertook this descriptive study to learn about lost productivity experienced by lung cancer patients and their caregivers. Methods: 40 consecutive patients attending outpatient lung clinics at a major cancer centre completed questionnaires assessing demographic details, patient and caregiver productivity, and quality of life (EQ5D, FACT-L). Results: 52.5% of respondents were male. Median age was 67 years (range 36 -81). Median disclosed income was $20,000–$39,999; 46.2% had pursued post-secondary training. 70% were ex-smokers, 40% had NSCLC, 27% SCLC, while a third did not know their diagnosis. Treatments received included IV chemotherapy (62.5%), oral therapy (20%), radiation (55%), surgery (42.5%) and 5% no treatment. Over 25% were working full-time prior to diagnosis, 40% were retired. None were able to continue full-time employment; 20% required disability or sick leave. 8 (20%) were able to work part-time. Of those still working, a median of 14 h were missed due to illness in the preceding 3 weeks, with a median of 32 h worked in that period. Patients reported an overall moderate (5/10) impact on their productivity and a significant (6/10) impact on their daily activities attributable to their cancer. Only 8.5% of patients received paid assistance, while 76% had their spouse, relative or friend as an unpaid caregiver. In the preceding 3 weeks, caregivers who assisted patients provided a median 24h of care; 25% of caregivers missed a median 12h of work. Overall, mobility, self-care and anxiety/depression were rated as mildly affected (1/3), while daily activities and pain/discomfort were rated as moderately affected (2/3). Median overall health state rated by the respondents was 60 {scale 0(worst)-100(best)}. Quality of life overall was poor - FACT-L median score was 93.2 (range 50 to 125). Conclusion: Lung cancer negatively impacts work productivity and significantly impairs activity. While many lung cancer patients are retired, there is a significant burden on caregivers, which may result in a substantial burden to society in lost productivity. No significant financial relationships to disclose.