bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patterns of care according to treatment intent for metastatic colorectal cancer (mCRC): A 2.5-year review of routine practice.
Authors: Field Kathryn Maree , Desai Jayesh , Tie Jeanne , Kosmider Suzanne , Bae Susie , McKendrick Joseph James , Harold Michael , Gibbs Peter 
Published: March 2020

e16516 Background: Cure is potentially achievable in select patients with mCRC with limited metastatic disease to liver and/or lung. To date the peri-operative strategies undertaken by oncologists in routine practice for such pts have not been well documented. Methods: A clinical database recording information on all pts diagnosed with mCRC since July 2009 from 5 hospitals was analysed. Management strategies where a curative-intent resection had occurred; was planned; or was a potential option were compared with those managed with palliative intent. Results: Status at the time of first review regarding systemic chemotherapy (CT) was documented for 354 pts. 15 (4.2%) had undergone curative-intent resection; 37 (10.5%) had a resection planned; 36 (10.2%) were considered potentially resectable if response to treatment was good; and 266 (75.1%) were treated with palliative intent. Only one patient (1.9%) already resected or planned for resection was >ECOG1, compared with 8% (3/36) potentially resectable and 20% (53/266) palliative pts. CT was delivered in 12 (80%) already-resected, 29 (78%) planned for resection, 33 (92%) potentially-resectable and 202 (76%) palliative-intent pts. Combination CT was the dominant strategy, although 5 of 12 (42%) resected pts received single agent treatment. 17% (n=2) resected pts received bevacizumab with CT, compared with 29% (n=18) of planned or potentially-curative pts and 55% (n=112) of those treated with palliative intent. At the time of analysis 17 pts (46%) with a planned resection and 7 (20%) considered potentially curative have had surgery, while 6 (2.3%) where treatment was initially considered palliative have had curative-intent surgery. Conclusions: Treatment strategies for pts with mCRC differ significantly based on the treatment intent, and may be affected by surgical preference and referral pattern. Bevacizumab was less likely to be used for already-resected pts and the use of single agent therapy in this group was also not uncommon. Many pts initially considered resectable do not ultimately undergo resection, whereas occasional ‘palliative’ pts may become resectable, confirming the importance of continued consideration of this option.
Representation of minorities in randomized lung cancer trials in the United States.
Authors: Mandadi Mounika , Kloecker Goetz H. 
Published: March 2020

e16517 Background: The SEER data base shows a higher rate of lung cancer mortality for African Americans and a lower lung cancer mortality rate of Hispanics compared to Caucasians in the US. It is not clear if this is due to socioeconomic or biological factors. This study reviews the representation of Caucasians, African Americans (AA), Hispanics, and Asians in recent randomized trials published in the US. Methods: A systematic review was done of randomized trials in lung cancer published in the NEJM, JAMA, JCO. The percentage of patients of each race in the individual trials was listed. An average percentage with mean standard error for Caucasian, African-American, Hispanic and Asian race was obtained. The percentage for each group is compared to the racial distribution in the US Census data. Results: 30 randomized clinical trials were analyzed for racial distribution. A total of 227,411 patients were enrolled in the trials. Conclusions: African Americans and Hispanics have been significantly underrepresented in randomized trials published in the US. This affects the external validity of the trial results when generalizing the results to these minorities. Strategies to ensure accrual of people of all races are required to ameliorate the disparities clinical trial enrollment. [Table: see text]
Cost-effectiveness analysis of eribulin (E) versus treatment of physician’s choice (TPC) in patients (pts) with pretreated metastatic breast cancer (MBC).
Authors: Montero Alberto J. , Avancha Kiran Kumar Venkata Raja , Gluck Stefan , Lopes Gilberto de Lima 
Published: March 2020

e16525 Background: Eribulin was FDA approved in 2010 for pts previously receiving >2 prior chemotherapeutic regimens for MBC. This approval was based on the phase 3 trial (EMBRACE) which demonstrated that E significantly improved median overall survival (OS) relative to different TPC by 2.5 months [HR 0.81; p=0.041]. Methods: The aim of this study was to assess the cost-effectiveness of E versus the 3 most commonly selected TPC in EMBRACE. We also evaluated the cost effectiveness of E compared to other approved drugs for MBC. We created a decision-analytical model using clinical data from the EMBRACE trial. Health utilities were derived from the published literature. Costs for drug acquisition, physician visits, and laboratory tests were obtained from Medicare Services Drug Payment Table and Physician Fee Schedule and are represented in 2011 USD. Life-years saved (LY), Quality-adjusted life years (QALY), and Incremental Cost Effectiveness Ratio (ICER) were calculated using the EMBRACE median OS data. TPC cost was calculated with 3 most commonly used drugs: vinorelbine (V), gemcitabine (G), and capecitabine (X), comprising 60% of pts in the TPC arm. Other drugs analyzed included liposomal doxorubicin (D), nab-paclitaxel (A), and ixabepilone (I). Greater GCSF use with E vs. TPF was also accounted for in our model. Results: E added 0.208 LY and 0.119 QALY with an incremental cost over TPC of $24,035; and therefore a cost of $115,369/LY and an ICER of $201,790/QALY. The main drivers of the model were drug acquisition cost, OS, and health utility values. The results of the model were robust in sensitivity analyses. Because of the very low cost of V and G, we looked at the cost-effectiveness of E relative to several other drugs commonly used in this setting, but used in fewer pts in the pivotal trial. Relative to ixabepilone, liposomal doxorubicin, nab-paclitaxel, and capecitabine the ICER for E was $85,130, $98,538, $119,029, and $154,591, respectively. Conclusions: Using commonly accepted willingness-to-pay thresholds, E appears to be cost effective in the treatment of MBC relative to D, A, X, and I; with marginal cost effectiveness for less expensive drugs such as V and G.
Health state preferences associated with subcutaneous injections and intravenous infusions for treatment of bone metastases.
Authors: Matza Louis S. , Cong Ze , Chung Karen , Stopeck Alison , Tonkin Katia Sonia , Brown Janet Elizabeth , Braun Ada H. , Van Brunt Kate , McDaniel Kelly 
Published: March 2020

e16528 Background: Although cost utility models are often used to estimate the value of treatments for metastatic cancer, limited information is available on the utility of common treatment modalities. Bisphosphonate treatment for bone metastases (BM) is frequently administered via intravenous (IV) infusion, while a recently approved treatment to prevent skeletal-related events (SREs) of BM is administered as a subcutaneous (SC) injection. This study estimated the impact of these treatment modalities on health state (HS) preference. Methods: Participants from the UK general population completed time trade-off interviews to assess the utility of HS vignettes. Respondents first rated a HS representing cancer with BM. Subsequent HSs added descriptions of treatment modalities (ie, injection or infusion) to this basic HS. To represent a range of possible treatment experiences, the two treatment modalities were presented with and without chemotherapy (chemotx), and infusion characteristics were varied by duration (30 minutes or 2 hours) and renal monitoring. Results: A total of 121 participants completed the interviews (47.9% male, 76.9% white). Cancer with BM had a mean utility of 0.40 on a standard utility scale (1 = full health; 0 = death). Adding an injection resulted in a mean utility decrease (ie, disutility) of -0.004. The 30 minute and 2 hour infusions had mean disutilities of -0.02 and -0.04, respectively. Mean disutility of the 30 minute infusion was greater with renal monitoring (-0.05 with same-day blood draw; -0.07 with blood draw 2 days prior). Chemotx was associated with substantial disutility (-0.17). For the HS of BM with chemotx, the mean disutilities of injection, 30 minute infusion, and 2 hour infusion, were -0.02, -0.03, and -0.04, respectively. Disutility associated with injection was significantly smaller than the disutility of both the 30 minute and 2 hour infusions (p < 0.05), regardless of chemotx status. Conclusions: Respondents perceived an inconvenience with each type of BM treatment, but injections were preferred over infusions. The resulting utilities may be used in cost utility models examining the value of treatments for the prevention of SREs in patients with BM.
Comparing prognosis estimates of patients with cancer and their oncologists.
Authors: Gentzler Ryan D. , Kraft Walter K , Leiby Benjamin E , Filicko-O'Hara Joanne E. 
Published: March 2020

e16548 Background: Authors have reported a discrepancy between patient (pt) and physician survival estimates in pts with advanced malignancies. Methods: Oncology pts receiving chemotherapy at Thomas Jefferson University Hospital were assessed for their prognosis estimates. Matched surveys were given to their oncologists. The primary outcome was the level of agreement between pt and physician survival estimates. Prognosis estimates were obtained by three categorical responses: < 1 year, 1–5 years, or > 5 years. Pt prognosis estimates were categorized as pessimistic, concordant, or optimistic in relation to physician estimates, and differences between pt and physician estimates were evaluated using a two-sided Stuart-Maxwell test. Secondary outcomes assessed pt perceptions related to prognosis. Results: 51 pts completed surveys, and 29 of 51 matching physician responses were obtained for the primary analysis. 1 pt was deemed ineligible. 14 (48.2%) pts were optimistic, 14 (48.2%) were concordant, and only 1 (3.4%) was pessimistic. These results demonstrate asymmetric responses for the categorical variables, and pts were more likely to be optimistic when compared to physicians’ estimates (p=0.006). Of the 50 pts completing the survey, only 44% (22) based their survival estimate on information received from their oncologist, while others listed themselves (18%, 9) or hope (6%, 3) as the source of information. The majority of pts (86%, 43) use the internet to learn about their cancer, but only 8% (4) identified the internet as their information source for choosing a prognosis estimate. A discrepancy between pts’ beliefs about curability also exists. 5 of the 20 (25%) pts who believed their disease is curable had metastatic lung, breast, or neuroendocrine pancreatic cancer. Conclusions: The findings of this study demonstrate that pts estimate longer survival when compared to physician estimates. Other results of the survey also shed light on where pts obtain information pertaining to their cancer diagnosis and pts’ beliefs about the curability of their disease. This data highlights a need for a multicenter survey to validate these conclusions and the creation of teaching tools to help pts better understand their disease and prognosis.
Delivery of adjuvant chemotherapy (AC) to veterans with resected colon cancer.
Authors: Riggs Heather Dawn , Lane Kathleen A. , Loehrer Patrick J. , Hui Siu , Rawl Susan , Ormerod Anne , Weiner Michael 
Published: March 2020

e16557 Background: Patients (pts) with incomplete administration of AC for colon cancer (CC) likely experience inferior survival while oxaliplatin- and capecitabine-containing AC may not improve survival for older pts. The influence on AC completion of age, other baseline patient characteristics, or regimen characteristics is unknown. We evaluated the association of baseline characteristics and planned AC regimen with AC delivery in resected CC pts. Methods: This retrospective cohort study identified stage II and III resected CC pts from our local VA Medical Center tumor registry who initiated AC between 2004 and 2010. AC delivery was measured as percentage of planned cumulative dose (PCD) of 5-fluorouracil or capecitabine delivered. Baseline characteristics were demographics, CC stage, travel distance to the treatment site (TD), Adult Comorbidity Evaluation-27 score, and labs. We classified AC as fluoropyrimidine (oral or IV)-based and as oxaliplatin-containing. Linear regression tested each association with PCD. We recorded occurrence of toxicity and death. Cox regression models were used for survival analysis. Results: Fifty pts (98% male, median age 63) initiated AC for stage II (n=6) or III (n=44) disease with median interval from resection to AC of 7.4 weeks. The median PCD was 75%; median treatment duration was 5 months. Lower PCD was associated with older age (p=0.05), lower GFR (p=0.05), higher TD (p=0.02), lower baseline hemoglobin (p=0.10), and receipt of capecitabine (p<0.01). Receipt of capecitabine (p=0.008) and TD (p=0.04) remained significantly associated with PCD in a multiple linear regression model. Toxicity was noted for 78%, and PCD tended to be lower for reported cardiac events (p=0.07). Pts older than 63 had inferior survival (HR=4.17, p=0.03). Pts receiving less than 80% PCD tended toward inferior survival (HR=4.31, p=0.07). Conclusions: Capecitabine-based AC and travel distance were associated with lower PCD, which may negatively impact survival. Efficacy of shorter courses of oxaliplatin-based chemotherapy is being evaluated elsewhere. Close attention to quality prescribing and monitoring practices for capecitabine are recommended. These findings should be confirmed in a larger cohort.
Cost-utility analysis of maintenance therapy with either gemcitabine or erlotinib versus observation with predefined second-line treatment after cisplatin-gemcitabine induction chemotherapy in advanced NSCLC: IFCT-GFPC 0502-eco phase III study.
Authors: Borget Isabelle , Perol Maurice , Perol David , Lavole Armelle , Greillier Laurent , Bizieux-Thaminy Acya , Westeel Virginie , Berard Henri , Auliac Jean Baptiste , Zalcman Gerard , Dujon Cecile , Robinet Gilles , Fournel Pierre , Thomas Pascal , Margery Jacques , Oster Jean-Philippe , Chabaud Sylvie , Vergnenegre Alain , Chouaid Christos 
Published: March 2020

e16560 Background: The IFCT–GFPC 0502 phase III study reported a prolongation of progression-free survival with maintenance with either gemcitabine or erlotinib versus observation after cisplatin-gemcitabine induction chemotherapy in advanced NSCLC. The aim of this analysis is to assess the incremental cost-effectiveness ratio (ICER) of these strategies in the global population and in pre specified sub-groups. Methods: A cost-utility analysis was performed to evaluate ICER of maintenance therapy with either gemcitabine or erlotinib, compared to observation, from randomization until end of follow up. Direct medical costs (including drugs costs, hospitalization, follow-up examinations, second-line treatment and palliative costs) were prospectively collected per patient alongside the trial, until death, from the third party payer perspective. Utility data were extracted from literature. Sensitivity analyses were performed. Results: The ICER for maintenance therapy with gemcitabine and erlotinib were respectively 84,011 and 183,261 euros per quality-adjusted life years (QALY). Gemcitabine maintenance therapy had a favourable ICER in patients with PS = 0 (51,168 €/Qaly), in responders to induction chemotherapy (65,554€/Qaly) and in patients with squamous cell carcinoma (44,884€/Qaly); erlotinib had a favourable ICER in patients with PS = 0 (162,371 €/Qaly) and objective response to induction (101,569 €/Qaly ). Conclusions: Gemcitabine and erlotinib maintenance therapy have acceptable ICER but with a wide variation function of histology, PS and response to the first line chemotherapy.
Overcoming the barriers to early-phase clinical trials (EPCT): Increasing EPCT minority accrual.
Authors: Weitman Steven D. , Ramirez Amelie G. , Chalela Patricia , Munoz Edgar , Pollock Brad H. 
Published: March 2020

e16566 Background: Increasing minority accrual is critical to the development of novel cancer therapeutics. Without adequate minority representation in EPCT, researchers cannot assess differential effects among groups nor ensure the generalizability of trial results. Little is known about cultural factors that impact the decision to participate in EPCT among Hispanics. Methods: The goals of this research were to identify cultural, economic and environmental barriers to EPCT accrual and potential interventions to reduce these barriers. Two surveys were conducted. One survey was with 114 oncologists and one with 100 cancer patients (50 who were enrolled in an EPCT and 50 who never participated). Results: The top four logistical barriers stated by oncologists were all related to the extra work and time of recruiting and referring patients: referring patients is extra work (63%), too much paperwork (57%), too complex of procedures (57%) and excessive details of protocols (50%). Significant differences between clinical trial and non-clinical trial participants were found for two barriers in the decision-making process [lack of knowledge about available trials (88% and 94%), and lack of understanding about trial processes and purpose due to medical jargon (82% and 90%)]. Non-clinical trial participants gave higher importance to four barriers related to attitudes and beliefs [fear of being a guinea pig (80%), fear that the experiment is more important than the patient (76%), distrust in the medical system (72%), and fear of sacrificing QoL (72%)]. Non-participants in EPCT tended to have less education, lower income, and were Hispanic. In addition, two-thirds (68%) of non-participants considered language as a major barrier. Conclusions: Oncologists would be more likely to refer patients for EPCT if they are aware of the studies, feel confident with their patients, trust the research team, see benefit for their patients, and have an easy way to refer patients. The results of this study may have implications in terms of message development for groups traditionally underrepresented, which may require language appropriate materials, more visual materials with lower reading levels, and with more precise economic information.
Quality Oncology Practice Initiative (QOPI): Preliminary results from a Brazilian academic public oncology service.
Authors: Cubero Daniel Iracema , Cruz Felipe Melo , Martins Suelen Patricia dos Santos , Glasberg Joao , Rivelli Thomas Giollo , Campos Arinilda Silva , Matos Leandro Luongo , Del Giglio Auro 
Published: March 2020

e16568 Background: The Quality Oncology Practice Initiative (QOPI) is a voluntary program developed by ASCO to aid oncology practices in quality self-assessment and continuous improvement of patient records. It consists of a cyclical, semiannual measurement of the adequacy of several care processes pertaining to some important aspects of patient care. Few academic cancer centers have been QOPI participants in the United States and there aren’t reports to our knowledge of any Latin American Cancer Center adopting this strategy. Methods: This study shows the pilot initiative to implement the QOPI at the ABC School of Medicine, Discipline of Oncology, a large public academic cancer center of Santo André, São Paulo, Brazil. Results: From January 2008 to December 2010, we consecutive selected 37 patients with gastric cancer, 40 with breast cancer, 33 with lung cancer and 40 colorectal cancer. The table below shows the first round of the core QOPI. Conclusions: There are several opportunities for improvement such as assessing and recording of pain and analgesic use, documentation patient consent and of the intent of chemotherapy and providing patients with their chemotherapy summaries. Our current electronic record will be modified to reflect the aforementioned needs in order to improve our results in the following rounds of QOPI program. [Table: see text]
Effect of epigenetic modulation on interleukin-6 (IL-6) gene expression with adjuvant selenomethionine (Se-Met) with imatinib mesylate (IM) in remission of chronic myelogenous leukemia (CML-cp) patients.
Authors: McPherson Eugene 
Published: March 2020

e17022 Background: Histone deacetylase (HDAC) are enzymes involved remodeling chromatin and epigenetic regulation of gene expression. Histone deacetylase inhibitors (HDACI) can reverse aberrant epigenetic changes in CML stem cells. BCR-abl tyrosine kinase inhibitors IM is effective in inducing remission in CML-cp patients but residual leukemia stem cells (LSC) may give rise to resistance and relapse. Pan-HDACI may arrest this with downregulation of IL-6, and NFkb activation when adjuvant Se-Met is combined with IM. Methods: CML-cp , CML-bc cases were presented with evidence of overexpression of BCR-abl fusion protein reported previously in elderly patients. A 91 YOF with CML-cp , subclinical hypothyroidism with elevated IL-6, CRP, sIL-2R, VEGF, NFkb, and IGF-1 was treated for seven years with adjuvant Se-Met, IM and levothyroxine ith normalization, minmal toxicity and extended trending down of IL-6, CRP,sIL-2R. Results: After seven years of adjuvant therapy with Se-Met, IM, and Levothyroxine a significant reduction of IL-6, CRP of 9.8075 down from 30.783 mg/L. Subsequuent normalization of the other pro-inflammatory cytokines were normalized. Conclusions: HDACI activity expressed in synergism of Se-Met with IM and Levothyroxine may lower the apoptotic threshold in CML-cp stem cells decreasing BCR-abl expression and rescuing quiescent progenitor cells that may prolong remission and decrease disease relapse.
Radiochemotherapy for lung cancer with cisplatin and vinorelbine orally and shrinking field radiotherapy: Effectivity and feasibility in a nonselected patient collective.
Authors: Zagel Miriam , Tobermann Anja , Fischer von Weikersthal Ludwig , Fahrig Antje 
Published: March 2020

e17516 Background: To explore the side effects and effectivity of simultaneous radiochemotherapy (sim RCT) with cisplatin (Cis-DDP) and vinorelbine orally (VRBo) in pts. with NSCLC. Methods: From 2009 and 2011, a total of 20 pts. (5 female, 15 male) aged between 46 and 82 yrs. with NSCLC stage IIIA/B were irradiated with a median dose of 66.6 Gy to the primary and 45 Gy to the involved nodes as neoadjuvant or palliative treatment. Treatment volumes were adapted to tumor shrinkage after 19.8, 30.6, 45 and 59.4 Gy. Cis-DDP (20 mg/qm d1-4, d29-32) and VRBo (50 mg/qm d1,8,15,22,36,43) were administered simultaneously. Comorbidity was scored by the Charlson Index and nutritional status was monitored. Results: Toxicity rates: thrombopenia 3° 10%, 4° 0%, leucopenia 3° 15%, 4° 20%, haemoglobin 0% 3°/4°, esophagitis 3° 5%, 4° 0%, pneumonitis 3° 0%, 4° 5%. No reduction of planned RT-dose. Chx reduction was done due to hematologic toxicity in 35%. Response rates: CR 10%, PR 75%, SD 10%, PD 5%. 11pts. (55%) are alive after a median FU of 19 months. Conclusions: Sim RCT with Cis-DDP and VRBo results in good tumor response rates and is feasible with acceptable side effects. Shrinking treatment volumes allow adequate dose escalation without the risk for early locoregional recurrence.