bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparison of drug approval between health Canada (HC) and the U.S. Food and Drug Administration (FDA).
Authors: Ezeife Doreen Anuli , Tang Patricia , Heng Daniel Yick Chin , Welch Stephen 
Published: March 2020

6082 Background: Differences in drug approval processes between countries can impact patient access to new therapies. In Canada, patients can freely access a new treatment after regulatory approval by Health Canada (HC) followed by funding approval from the provincial government. The aims of this study were to delineate the Canadian drug approval timeline and to compare the time to drug approval between HC and the US FDA. Methods: Cancer drugs approved by the FDA from 1989 to 2011 were reviewed. For each drug, the following endpoints were determined: publication date of phase I and pivotal phase III trial, date of FDA and HC approval, HC submission date, and funding approval in Alberta (AB). Time intervals between the aforementioned endpoints were calculated. Results: Of 55 FDA-approved drugs, 51 drugs are approved by HC with 40 of these drugs funded in AB. HC approval occurs an average of 14.4 months post FDA approval (95% CI -36.9 to 66.1, sign rank test p<0.0001). However, there was no significant difference between the mean time from Phase I to FDA approval (48.5 months; 95% CI 21.2 to 75.8) and Phase I to HC approval (61.5 months; 95% CI 32.4 to 90.5). Most drugs (74%) were approved by the FDA prior to publication of the phase III trial. There was a trend towards faster drug approval from Phase III to FDA approval compared to HC (-14.97 versus 0.1 months, p = 0.05). HC submission occurs before FDA drug approval 77% of the time (mean 3.0 months prior; 95%CI: -59.1 to 43.4, p = 0.0206). HC approval occurs on average 17 months post HC submission. AB funding approval occurs on average 22 months after HC approval. The time interval from Phase I to AB funding approval was significantly shorter for targeted compared to cytotoxic agents (mean time 58 vs. 120 months; p = 0.039). Conclusions: HC drug approval lags behind FDA approval by about 14 months. Time from Phase III to drug approval tends to be shorter for the FDA compared to HC. This is the first documentation, to our knowledge, of the time required to bring a drug from phase I trial to provincial funding approval.
Chemotherapy in the oldest old: The feasibility of cytotoxic therapy in the 80+ population.
Authors: Sud Shelly , Lai Pamela , Balchin Katelyn , Clemons Mark , Wheatley-Price Paul 
Published: March 2020

6083 Background: The incidence of most common malignancies increases with age. As life expectancy improves globally, more elderly cancer patients will be candidates for systemic therapy. There is little data investigating chemotherapy (CT) in those over 80 – the “oldest old”. Our hypothesis is that CT in the 80+ population may be associated with significant toxicities and is therefore not feasible for many patients. Methods: A retrospective chart review was undertaken to report outcomes of patients ≥80 years old who initiated CT for solid tumors at the Ottawa Hospital Cancer Center between Nov. 2005 and Jan. 2010. Baseline data on patient demographics, cancer type and CT were collected. Primary endpoints included: rates of CT dose reduction, omission, delay and discontinuation due to toxicity, hospitalization and blood transfusion rates. Results: CT was initiated on 212 occasions (32% lung, 31% GU, 24% GI, 13% other cancer). Median age was 83 (range 80-92) and 60% of patients were male. Where data were available, 60% had a good performance score (ECOG 0-1) and 63% were current or ex-smokers. 82% had Charlson risk index scores of ≥5, 37% had ≥6 baseline medications, 18% lived alone independently. At baseline, 11% were anemic, 12% had leukocytosis, and 45% had impaired renal function (eGFR<60). Most patients had stage 4 disease (76%), were treated with palliative intent (75%) and were receiving first line CT (77%). Initial dose was adjusted in 34% of cases. Therapy was discontinued due to toxicity in 30% of cases, and 53% of patients required dose reduction, omission or delay. In 38% of cases, patients were hospitalized during their course of therapy or within 30 days thereof. Blood transfusions were required in 24%. Factors associated with risk of hospitalization included baseline number of medications ≥6 (OR 1.96, 95% CI 1.1-3.5) and baseline anemia (OR 2.55, 95% CI 1.07-6.05). Initial dose reduction at cycle 1 did not significantly affect rates of hospitalization, transfusion or CT discontinuation. Conclusions: CT in the 80+ population is associated with a significant risk of hospitalization, transfusion and discontinuation due to toxicity, even when doses are adjusted from the outset. We plan to prospectively validate these findings.
Physical activity (PA) and physical function (PF) in adult cancer survivors (CS).
Authors: Birks Peter Crawford , Tashakkor Amir Yashar , Moghaddamjou Ali , Cheung Winson Y. 
Published: March 2020

6085 Background: The longevity of CS is increasing, underscoring the importance of lifestyle modifications and preventive care, consisting of regular PA and maintenance of PF. Our aims were to 1) compare PA and PF among short-term CS, long-term CS and non-cancer controls (NCC) and 2) identify other clinical factors associated with decreased PA and PF. Methods: We identified CS and NCC from the US National Health and Nutrition Examination Survey (NHANES). CS were categorized into </=5 (short-term) and >5 years (long-term) based on date of diagnosis. Multivariate weighted regression models were constructed to examine for differences in 28 and 26 measures of PA and PF, respectively, while controlling for age, gender, ethnicity, education, income, and other confounders. We explored specific and general PA domains such as aerobic activity and decline from past activity level as well as PF areas including ADLs, IADLs and mobility. Results: In total, 26,185 subjects were identified: 968 short-term CS, 1,367 long-term CS, and 23,832 NCC. For the entire cohort, the mean age was 50 years, 52% were men, and 50% were white. Comparing across the 3 patient groups, CS were generally older than NCC (60 vs 45 years, p<0.01). In terms of PA, short-term CS reported less general activity compared to 1 year ago (OR 0.58, 95%, CI 0.46-0.73, p<0.01) than long-term CS and NCC. In comparison to NCC, both groups of CS also described less current activity than their baseline from 10 years ago (OR 0.63, 95% CI 0.48-0.82, P=0.001 and OR 0.67, 95% CI 0.55-0.83, P=<0.01). There were significant differences among patient groups in several areas of PF (Table). Other factors that were associated with lower PA and PF included advanced age, low education, and low income. Conclusions: PA between CS and NCC were similar, although current activity as compared to that of the preceding year or past decade appears lower in CS, which may reflect their older age. Impairments in several measures of PF were observed among CS, which could impact their quality and quantity of life. [Table: see text]
The NCI Community Cancer Centers Program (NCCCP): A model for reducing cancer health care disparities.
Authors: O'Brien Donna M. , Bright Mary Anne , Clauser Steven B. , Fennell Mary , Harness Jay K. , Hood Deborah D. , Johnson Maureen , Katurakes Nora C. , McCaskill-Stevens Worta , Zapka Jane , Adjei Brenda A. , Castro Kathleen M. , Dimond Eileen P. , St. Germain Diane C. , Springfield Sanya 
Published: March 2020

6086 Background: In 2007, NCI launched the NCCCP, a public-private partnership with 16 community hospital cancer centers in 14 states, to explore methods to improve patient access to advanced cancer care in the community. With 40% of its NCI funding directed to reduce disparities across the cancer continuum, the NCCCP aims to: 1) Enhance access to care; 2) Improve quality of care; and 3) Increase clinical trials accrual. This approach supports priorities in the 2009 ASCO Policy Statement: Disparities in Cancer Care. Methods: A disparities workplan was developed to support the three aims. NCI and the sites worked as a learning collaborative to develop strategies and metrics for: race and ethnicity data tracking; near real-time reporting of adherence to Commission on Cancer (CoC) treatment quality measures; community outreach and patient navigation to increase cancer screening; and improved clinical trial underserved accrual. The tools and resources supporting these efforts will be discussed. ( http://ncccp.cancer.gov/About/Progress.htm ). Results: Evaluation of the 3 year pilot shows improvement for underserved populations: Concordance with CoC treatment quality measures for radiation therapy for breast conserving surgery among Medicaid patients improved from 59.5 percent to 84.8 percent (p<.05). Increased community screening events (from 992 to 1,585) and community partnerships focused on underserved populations (from 78 to 195). Increased accrual to NCI trials (minority accrual from 82 to 151 and elderly from 200 to 641). Conclusions: To be effective in reducing healthcare disparities, a multi-level approach is needed. This includes having: organizations which demonstrate a strong community-oriented mission; commitment by hospital management; engagement of private practice physicians; targeted training of staff; use of standardized data collection and metrics; involvement of strategic partners with aligned goals at the national and local level; support by relevant NCI experts; and sharing best practices across a learning collaborative. The NCCCP disparities model was used in a variety of community settings targeting different underserved populations and has demonstrated effect in care in the respective communities.
Unanticipated hospital admissions in patients undergoing radiotherapy with or without concurrent chemotherapy: Incidence and predictive factors.
Authors: Arastu Nabeel H. , Chen Ronald C. , Jackson Marianne , Green Rebecca L. , Qaqish Bahjat F. , Camporeale Jayne , Xu Zijie S. , Collichio Frances A. , Marks Lawrence Bruce 
Published: March 2020

6093 Background: Unanticipated admissions are burdensome for patients and the healthcare system. An improved understanding of their frequency and predictive factors can inform initiatives to prevent such admissions and mitigate their associated human and financial costs. Methods: Electronic medical records of 500 patients undergoing external beam radiotherapy (RT) at our center in 2010 were reviewed. Unanticipated admission within 90 days of initiating RT, and associated clinical factors, were recorded. Chi-squared and uni- and multivariate logistic regression was used to examine factors associated with admission. Results: Unanticipated admissions occurred in 20% (101/500) of patients, mean length of stay was 4 days (range 1-16), and the mean interval between the start of RT and admission was 32 days (0-86 days). The most common indications for admissions were pain (19% of admissions), respiratory distress (15%), and neurologic symptoms (13%). On univariable analysis, 33% of patients treated for palliative intent were admitted (vs. 16% of curative intent patients, p<0.001), as were 26% of patients receiving concurrent chemotherapy (vs. 17% receiving RT alone, p=0.02). Multivariable analysis showed treatment intent, chemotherapy, and marital status to be associated with unplanned admissions (Table). A highly variable rate of unanticipated admission per diagnosis was observed (e.g. 4% for breast, 19% for GI/GU/GYN/ENT, and 37% for metastatic sites). Conclusions: Rates of unanticipated admissions are ≈20% in patients undergoing RT. Approximately 1/3 of patients receiving palliative RT, and more than 1/4 receiving concurrent chemoradiation, experienced an unplanned admission. Prophylactic measures should be studied in these high-risk patients to reduce admission rates, as unplanned admission may be an important quality of care indicator in oncology. [Table: see text]
Differential receipt of sentinel lymph node biopsy within practice-based research networks.
Authors: Meyer Anne-Marie , Reeder-Hayes Katherine Elizabeth , Liu Huan , Wheeler Stephanie B. , Penn Dolly , Weiner Bryan , Carpenter William Ruffin , Stitzenberg Karyn Beth 
Published: March 2020

6104 Background: Sentinel lymph node biopsy (SLNB) for breast cancer was introduced into clinical practice in the late 1990s as an alternative to axillary lymph node dissection (ALND). Provider-based research networks (PBRNs) are believed to promote diffusion of innovations like SLNB into clinical practice; however, evidence of this association is limited. This study examines the diffusion of SLNB for early-stage breast cancer through the Community Clinical Oncology Program (CCOP), a community-based PBRN. Methods: We identified women undergoing breast conserving surgery with axillary staging for stage I or II breast cancer between January 2000 and December 2003 using Surveillance Epidemiology and End Results-Medicare data (n=6,226). The primary outcome was receipt of SLNB vs. ALND, and exposure was care received from CCOP physicians or institutions between diagnosis and surgery. Exposure was quantified as both a binary measure of ever seeing a CCOP, and as a proportion of all their claims associated with a CCOP. Covariates included race, age, marital status, education, Medicaid eligibility, comorbidity, tumor grade, stage, estrogen receptor status, year of diagnosis, SEER region, and other institutional characteristics such as NCI center designation, cooperative group, and medical school affiliation. Multivariable generalized linear modeling with generalized estimating equations was used to measure association between CCOP exposure and receipt of SLNB. Results: Women who received a higher proportion of their care from a CCOP-affiliated physician or hospital were more likely to receive SLNB. A 10% increase in the proportion of CCOP-affiliated claims was associated with a greater odds of receiving SLNB (OR 1.14; 95% CI 1.08, 1.20), after controlling for covariates. Similarly, sensitivity analysis of the binary indicator of CCOP exposure also showed greater odds of receiving SLNB (OR 1.32; 95%CI 1.01, 1.74). Conclusions: The quality of cancer care delivered in community settings can be influenced by provider-based research networks. Our findings contribute to the growing body of evidence that community-based PBRNs can facilitate adoption of cancer innovations outside of academic medical centers.
Frequency of cognitive impairment (CI) in elderly patients (pts) suffering from malignancies and impact on therapeutic decision.
Authors: De La Motte Rouge Thibault , Chaïbi Pascal , Vignot Stéphane , Boussion Helene , Cabel Luc , Geiss Romain , Delgado Francois-Michel , Khayat David , Chebib Amale , Spano Jean-Philippe 
Published: March 2020

6110 Background: Therapeutic decision remains complex when a cancer is diagnosed in elderly pts. Our aim was to evaluate the frequency of CI in this population and its impact on therapeutic decision. Methods: An oncogeriatric evaluation including Comprehensive Geriatric Assessment (CGA) is systematically performed for all elderly cancer pts referred in our unit. We reviewed data of all pts assessed by geriatric oncologist at our institution from January 2009 to June 2011. Results: 378 pts were identified, among them a CI was noted in 87. Median age was 84 years (range 71 –94), 70 % ≥ 80 years. Most of the pts (78/87) were referred at the time of diagnosis. Metastatic disease was diagnosed in 32 pts (52%) and Diffuse Large B Cell Lymphoma stage III or IV in 21 pts (81 %). In 41 pts, CI was already diagnosed: Alzheimer disease (AD) (n=38) and Vascular Dementia (n=3). CGA help to identify CI in 46 additional pts: AD (n=36); Vascular Dementia (n=2) and Mild Cognitive Impairment (n=8). 45/87 pts (52 %) were dependant for at least one activity of daily living (ADL). As a result of CGA and benefit/risk oncologic assessment, best supportive care was recommended in 12 pts. Among them, only 4 pts presented with advanced metastatic disease (main reason for palliative care). Pts in whom “best supportive care” decision (n=12) was recommended were more dependants than those who received specific anticancer therapy (n=75): dependence for at least 2 ADL: 10/12 pts (83%) versus 16/75 (21%); and presented more AD already diagnosed (11/12 versus 30/75). In the remaining 75 pts, specific cancer therapy was proposed, including chemotherapy (n=67), surgery (n=5), radiotherapy (n=3) and hormonotherapy (n=9). Treatment was initiated as recommended in all but 4 pts (best supportive care decision taken following discussion with pts and relatives). During the follow-up, only 11/75 pts needed to be placed in nursing home because of loss of autonomy. A survival ≥ 1 year was observed in 27/75 (36%) pts. An update of cognitive performance will be presented. Conclusions: Our data support that even if CI is frequent in elderly pts with malignancies, specific anticancer therapy remains feasible and should be considered in most elderly pts with CI.
An integrated analysis of comprehensive geriatric assessment (CGA) in elderly patients with non-small cell lung cancer (NSCLC) (JCOG1115-A).
Authors: Katayama Hiroshi , Takeda Koji , Fukuda Haruhiko , Nakamura Shinichiro , Nakamura Kenichi , Mizusawa Junki , Saijo Nagahiro , Yokoyama Akira , Ohe Yuichiro , Shinkai Tetsu , Nakagawa Kazuhiko , Abe Tetsuya , Mitsuoka Shigeki , Ichinose Yukito , Okamoto Hiroaki , Yamamoto Nobuyuki , Yoshioka Hiroshige , Ando Masahiko , Tamura Tomohide 
Published: March 2020

6112 Background: The number of elderly NSCLC patients is increasing all over the world. Actual age and ECOG PS is not always efficient to select "fit-elderly" for chemotherapy. We integrated the data from two phase III trial (JCOG0207, JCOG0803/WJOG4307L) and evaluated 4 CGA items as well as age and PS to determine whether they would predict survival, response and toxicities. Methods: Eligibility criteria of both trials included histologically or cytologically proven NSCLC; stage III/IV; age 70 or more; ECOG PS of 0-1; unfit for bolus cisplatin; no prior treatment; adequate organ function. Patients were randomized to receive either weekly docetaxel (D) or D plus cisplatin (DP) in J0207, and either 3-weekly D or DP in J0803/W4307L. This study included all eligible pts for whom all of 4 CGA items (Activity of Daily Living [ADL], Instrumental Activity of Daily Living [IADL], Mini-Mental State Examination [MMSE], Geriatric Depression Scale [GDS-15]) were assessed before treatment. Primary endpoint was overall survival (OS). Survival curves are estimated by Kaplan-Meier method and multivariate analysis for OS adjusting baseline factors were performed by using stratified Cox regression model. Results: This analysis included 331 pts (J0207/J0803-W4307L: 105/226) in total. The result of multivariate analysis for OS was shown in the table. After adjusting baseline factors, MMSE as well as sex and PS was significantly associated with OS. None of the CGA items were associated with response and toxicities. Conclusions: It is not actual age but MMSE and PS that is useful for predicting prognosis of elderly pts. MMSE should be taken into consideration to determine the indication of chemotherapy for elderly pts. [Table: see text]
Loss to follow-up of cancer patients in the poorest district of the United States.
Authors: Mangardich Antranik , Mamorska-Dyga Aleksandra , Paul Doru , Khan Ghulam , Vassel Svetlana , Gerber Linda , Guset Valentin , Segni Jessica 
Published: March 2020

6123 Background: Loss to follow-up (LFU) of cancer patients is a serious dilemma, and has only been narrowly studied. Lincoln Medical and Mental Health Center (LMMHC) serves South Bronx (SB), the poorest district in the nation. The purpose of this study was to assess rates of LFU and correlate it with age, sex, ethnicity, race, cancer types, and stage at diagnosis. Methods: We collected data from 1,552 patients diagnosed with invasive cancer in LMMHC between 2006-2010. The data collected were age, sex, ethnicity, race, type of cancer, stage, LFU, treatment, and vital status. Results: From the 1,552 patients, roughly 25 % were LFU, with 50% receiving some initial form of treatment. The remaining percentages are shown below (Table). A higher rate of LFU was with patients younger than 65 (OR: 1.38, 95% CI: 1.08-1.76). There was no correlation between sex and LFU. Non-Hispanics were more likely to be LFU compared to Hispanics (OR: 1.39, 95% CI: 1.07 – 1.8). Blacks were more likely to be LFU compared to non-Blacks (OR: 1.43, 95% CI: 1.12–1.82). There was no significance between LFU and stage at diagnosis. Looking at cancer specific data, colon cancer (C) and head and neck cancers (HN) had the highest percentage of LFU (30% each). There was higher LFU rate for C compared to breast cancer (B) (OR: 1.7, 95% CI: 1.03-2.8), prostate cancer (P) (OR: 1.88, 95% CI: 1.18-3.02), and lung cancer (L) (OR: 1.64 95% CI: 0.94- 2.8). HN patients were more likely LFU compared to B (OR: 2.4, 95% CI: 1.13-5.2), P (OR: 2.69, 95 % CI: 1.28-5.68), and L (OR: 2.3, 95% CI: 1.05-5.19) patients. There was no significant difference between C and HN patients in respect to LFU. Conclusions: In the SB, LFU rates are related to age, ethnicity, race, and type of cancer. Younger patients, blacks, non-Hispanics, and those with C and HN cancers were most likely to be LFU, the latter likely due to the lack of a HN surgeon at LMMHC. We hope that with focus on race, ethnicity, and cancer-specific disparities in LFU rates, we will improve the retention rate of our cancer patients in the future. [Table: see text]
In-hospital mortality of patients admitted through the emergency department of a comprehensive cancer center.
Authors: Elsayem Ahmed F. , Gonzalez Carmen E. , Yeung S. J. , Merriman Kelly W. , Todd Knox H. 
Published: March 2020

6125 Background: Cancer is a common presenting condition for emergency departments (EDs); however, there is limited information on outcomes of ED cancer patients subsequently admitted to the hospital. The purpose of this study is to describe outcomes of patients with hematologic malignancies versus those with solid tumors admitted through the ED of a comprehensive cancer center. Methods: We queried the ED database of The University of Texas MD Anderson Cancer Center for calendar year 2010 and linked it to our institutional data warehouse, including tumor registry data. We classified all leukemia and related disorders, lymphoma, multiple myeloma, and bone marrow transplant patients as hematologic malignancies, and remaining cancers as solid tumors. Descriptive statistics, including chi-square, and t-tests were used in two-sided comparisons. All statistical analyses were performed using SPSS version 15. Results: 20,732 total ED visits were made by 9,320 unique cancer patients. Of these, 5,364 (58%) were admitted to the hospital at least once (range 1-13 admits). ED admissions constituted 39% of total unique patients admitted (N=13,753). The main admission indications for solid tumor patients were infectious complications (particularly pneumonia), intractable pain, or dehydration. For hematologic malignancies, the main indication was neutropenic fever. 211/1656 (13%) of liquid tumor patients were admitted to the Intensive Care Unit (ICU) compared to 484/3708 (13%) of solid tumor patients (P=NS). Of all patients admitted through the ED, 587/5364 (10.9%) died during hospitalization. The hematologic hospital mortality rate was 225/1653 (13.6%) versus 362/3708 (9.8%) for solid tumors (P<0.001). Only 242/8389 (3%) of patients admitted directly from outpatient clinics died during the hospitalization (p<0.001). Conclusions: Patients admitted through the ED, particularly those with hematologic malignancies, have a high hospital mortality rate. ED-based palliative care interventions may be justified to improve quality of life and prevent unnecessary costly interventions and ICU admission. Further research should define predictors of poor outcomes in cancer patients admitted through the ED.