bluuebunny/crossref_metadata_2025_split huggingface dataset:
Identifying potential barriers to sperm cryopreservation among Pakistani male cancer patients.
Authors: Latif Nida , Ali Natasha 
Published: September 2018

e18223 Background: Cancer survivor rates have increased over the past few decades leading to a growing interest in research related to quality of life. The American society of clinical oncology’s updated guidelines of 2013 recommend that health care providers discuss the possibility of infertility with patients and present fertility preservation options to those who express interest. We attempted to explore the unique barriers that might prevent adult male cancer patients from accessing sperm cryopreservation in Pakistan Methods: We conducted semi-structured interviews of male cancer patients aged 18-45 years, diagnosed with cancer of any stage or type. The interviews were audio-recorded in Urdu and translated to English, following which they were transcribed ad verbatim. The topics included quality of information received regarding the risk of infertility following chemotherapy, future reproductive choices and barriers to sperm cryopreservation Results: Out of the 25 patients interviewed, there were n = 10 cases of Leukemia, n = 3 of Lymphoma, n = 2 cases each of colorectal carcinoma and Multiple Myeloma, n = 1 case each of Neuroblastoma and Osteosarcoma, and solitary cases involving the lung, breast, thymus, brain, jaw and testis. Only n = 4 patients knew about the potential for infertility due to cancer chemotherapy, all of whom were also aware of the option of sperm cryopreservation. Two patients had their sperm preserved prior to the initiation of chemotherapy. Perceived treatment related expenses appeared to be the biggest barrier to sperm cryopreservation for n = 9 patients (36%). This was followed by lack of information which was cited by n = 8 patients (32%) and religious reasons (n = 2 patients, 8.3%). Other barriers were identified as family wishes, female gender of the doctor and patient’s preferences. Four patients stated there are no barriers. Conclusions: There is a significant lack of awareness among male cancer patients regarding threat to fertility following cancer treatment. It is imperative that physicians inform them of this and discuss treatment options, along with addressing potential barriers.
Institutional scientific review of cancer clinical research protocols: Impact of requirement on activation timelines.
Authors: Dietrich Martin Frederik , Ning Ning , Yan Jingsheng , Xie Xian-Jin , Gerber David E. 
Published: September 2018

e18224 Background: The National Cancer Institute (NCI) requirement that clinical trials at NCI-designated cancer centers undergo institutional scientific review in addition to Institutional Review Board review is unique among medical specialties. We evaluated the impact of this process on protocol activation timelines. Methods: We analyzed oncology clinical trials that underwent full board review by the Harold C. Simmons Comprehensive Cancer Center Protocol Review and Monitoring Committee (PRMC) from January 1, 2009, through June 30, 2013. We analyzed associations between trial characteristics, PRMC decisions, protocol modifications, and process timelines using Chi-square test, Fisher’s exact test, Wilcoxon rank-sum test, Kruskal-Wallis test, and logistic regression. Results: A total of 226 trials were analyzed. Of these, 77% were industry-sponsored and 23% were investigator-initiated. While only 40% of trials were approved initially, 97% of trials were eventually approved after a mean of 0.6 protocol changes were requested and a mean of 0.5 protocol changes were implemented. Protocol changes were more likely to be requested ( P< 0.001) and implemented ( P= 0.008) for investigator-initiated trials. Median time from submission to PRMC approval was 55 days. The longest component interval was from submission initiation to completion of required documents by the study team (median 29 days). Total process duration depended on approval timing: median 35 days for first review, 68 days (2nd review), and 116 days (3rd review) ( P< 0.001). Similarly, process duration was also associated with the number of changes/clarifications requested: median 39 days for none, 64 days for 1-3, and 73 days for ≥4) ( P< 0.001). Requested changes/clarifications had greater impact on timelines for industry-sponsored trials than for investigator-initiated trials. Conclusions: NCI-mandated institutional scientific review of cancer clinical trials contributes substantially to protocol activation timelines. Further evaluation of this process and the value added to research quality is warranted.
Cancer patients with undiagnosed and poorly managed diabetes mellitus.
Authors: Kim Sooha , Garg Anukul , Raja Fharat 
Published: September 2018

e18232 Background: Cancer patients are at increased risk of developing diabetes mellitus (DM) or having worsening control of their pre-existent DM. The causes of this are multifactorial but the use of steroids, either in the palliative setting or short-term whilst on chemotherapy, is a significant contributor. An audit carried out at a district general hospital demonstrated that 5% of all oncology admissions were secondary to DM complications. A study was conducted to evaluate the prevalence of impaired blood glucose (BG) control and to assess the value of routine HbA1c testing in this population. Methods: Patients having routine chemotherapy blood tests were also tested for HbA1c over a 10 day period in December 2016. HbA1c diagnostic criteria was used as per NICE guidelines. Information on previous diabetic status, primary tumour type, chemotherapy status (number of cycles and treatment intent) was recorded. Results: 134 patients were tested for HbA1c; 28 (21%) had a HbA1c diagnostic of DM and 32 (24%) were at high risk of DM. The mean HbA1c of those in the DM group was 67.3 mmol/mol (range 48-120). Of the 28 with a HbA1C diagnostic of DM, 13 (46%) were already known to have DM with 15 (54%) being newly diagnosed from this study. 11 (73%) of those with a new diagnosis of DM were receiving a short course of steroids with chemotherapy. 12 patients in the DM group were having chemotherapy with curative intent; 6 of whom were newly diagnosed. Conclusions: 11% of the study cohort met criteria for a new diagnosis of DM with 73% of this group receiving steroids. NICE advises on monitoring of BG for all diabetics receiving steroids. Monitoring of BG and using anti-diabetic medications could prevent DM related complications. This highlights the need to involve local diabetic services and primary care providers for diabetic management. 43% of patients in DM group were receiving chemotherapy with curative intent. This has large implications on cancer survivorship and it is vital that these patients receive appropriate DM treatment. This will not only improve quality of care and patient satisfaction but also lead to significant cost savings from reduced admissions and length of stay in hospital. We therefore recommend a routine HbA1c test for all cancer patients having chemotherapy.
Delays in treatment for colorectal cancer patients in an NCI-designated cancer center serving a Hispanic majority community.
Authors: Wangjam Tamna , Rauenzahn Sherri L. , Iruku Praveena , Lindauer Stephanie Purkat , Butler Matthew James , Hung Annie , Yarta Kinan , Jones Jessica Trevino , Konkel Brandon , McCracken Andrew , Arora Sukeshi Patel 
Published: September 2018

e18233 Background: Timeliness of cancer treatment is an important aspect of health care quality. Colorectal cancer (CRC) care requires the coordinated multidisciplinary effort of various aspects of the health care system, which can lead to delays between initial diagnoses to definitive therapy. Little is known about the time from diagnosis to cancer-directed treatment, neither about the factors that cause delays or its effect on patient outcomes. Delays to curative surgery beyond 12 weeks are associated with increased mortality in CRC. Longer time to adjuvant chemotherapy is associated with worse survival among patients with resected CRC. The objective of our study is to identify delays in initiation of CRC treatment and its causative factors. Methods: We retrospectively reviewed the medical records of CRC patients who were either initially diagnosed or had initial surgical resection at University Hospital and had further treatment at Cancer Therapy and Research Center, between 7/1/2010 and 12/22/2014. Data were collected on patient and disease characteristics, treatment timelines and outcomes, till pre-specified data cut-off date of 8/1/16. Results: Of 256 patients treated for CRC, majority were males (59 %), Hispanic (59 % ) and uninsured (34 %). Most had non-metastatic disease (70%). 72 % were still alive at the time of data cut-off. The median time from diagnosis to treatment (TDT) was 21 days, with most of te patients getting first treatment between 0-30 days of diagnosis (60 %). Median time from first treatment to first progression or recurrence was 12 months (range 0.9- 42 mos.). Median overall survival (OS) was 17 months (0.1- 51 months). There were no statistically significant difference between the progression or recurrence free survival and OS in patients with TDT < 30 days, 30-89 days and > 90 days. Compared to non-Hispanics, Hispanic patients were more likely to have a TDT of 31-89 days (31% vs 37%, p = 0.0003) and > / = 90 days (3% vs 7%, p = 0.0001). Conclusions: Hispanic patients were more likely to have a longer time from diagnosis to treatment compared to non-Hispanic patients. The factors for such disparities in health care quality and their effect on survival needs to be explored further.
Early integration of palliative care in Ontario cancer settings.
Authors: Wright Frances Catriona 
Published: September 2018

e18234 Background: Introducing palliative care early in the cancer journey results in a better life quality, less aggressive care and possibly longer survival compared to patients receiving standard care. The INTEGRATE project aimed to identify and manage patients who may benefit from palliative care earlier in their cancer treatment. This pilot project assessed whether multidisciplinary forums (Multidisciplinary Cancer Conferences, Clinics and Diagnostic Assessment Programs ) could be used to identify patients using the UK Gold Standards Framework Surprise Question (SQ) “Would you be surprised if this person died within the next year?” Methods: Cancer centres volunteered to pilot test the efficacy of the SQ at multidisciplinary forums and implement a palliative model of care. A survey was completed at 3 different points during the project to measure provider comfort in providing palliative care. All sites received primary level palliative care education. Patient and caregiver experience were assessed using interviews and a validated survey. Identified patients received Advance Care Planning (ACP), symptom management, referrals and standardized reporting to primary care. Patient level data was collected. Results: 3 academic and 1 non-academic cancer centres used the SQ in multidisciplinary forums to identify patients in the Lung, Gastrointestinal and Central Nervous System disease sites between February '15-August '16. A baseline survey showed over 50% of providers had no palliative care training. 157 providers received education and at the end of the project providers had increased comfort & confidence in delivering palliative care. Analyses show that 933 patients were identified using the SQ, from which 78% had ACP initiated and 83% are receiving community palliative care services Conclusions: Multidisciplinary forums appear to be excellent for identifying patients who may benefit from a palliative approach to care. Inter-professional provider education and organized approaches to linking patients to community resources, had a positive impact on provider willingness to address end-of-life and palliative issues. Patients & caregivers report positive experiences of care, but different levels of ‘readiness’ to have the ACP discussions.
Kidney cancer mobile application: Comparison of treatment choice of online and offline medical oncologists.
Authors: Tsimafeyeu Ilya , Vetluzhskiy Andrey 
Published: September 2018

e18240 Background: There are online tools aimed at helping professionals assess the risks of getting therapy after surgery . Our kidney cancer mobile application (KCMA) has been designed for oncologists to help them decide on the ideal course of treatment of metastatic renal cell carcinoma (mRCC). Here, we present results of comparison of treatment choice of oncologists used KCMA and oncologists made choice based on their knowledge. Methods: KCMA has been developed in 2016. It is strictly built on NCCN guidelines (ver. 3.2016). In our study 122 medical oncologists participated at the RCC meetings were involved. Three clinical cases were proposed. First clinical case described non-treated mRCC patient with favorable MSKCC prognosis (0 unfavorable factors) and clear-cell RCC. Second case described non-treated mRCC patient with poor prognosis (3 factors) and non-clear-cell RCC. Third case characterized patient treated with sunitinib in first-line with progression. 60 and 62 oncologists made treatment choice with (online) or without (offline) mobile application, respectively. Results: Comparison of choice is listed in Table. 100% oncologists used KCMA recommended sunitinib, pazopanib, bevacizumab+IFN or temsirolimus in first-line treatment. 6%, 6% and 12% of offline doctors chose sorafenib, everolimus and axitinib in first-line treatment of clear-cell mRCC. 98.3% of oncologists correctly used application for administration of second-line. 21 of 62 (34%) offline doctors recommended axitinib or everolimus as second-line and 66% prescribed bevacizumab+IFN (31%), sorafenib (15%), pazopanib (4%), temsirolimus (8%) or even continued sunitinib (8%) in patient with disease progression on sunitinib. Conclusions: Online tools based on guidelines could educate and support oncologists to score prognosis and to select best systemic therapy in daily practice. [Table: see text]
Predicting the failure of randomized clinical trials in radiation oncology: What can we learn?
Authors: Nguyen Timothy K. , Nguyen Eric K , Warner Andrew , Louie Alexander V. , Palma David A. 
Published: September 2018

e18241 Background: Although randomizedcontrolled trials (RCTs) are essential to evidence-based medicine, a significant proportion of cancer RCTs fail to complete. As RCT failure is not well understood in the field of radiation oncology, we sought to review radiotherapy RCTs to identify predictors of RCT failure. Methods: We undertook a review of the trial registry ClinicalTrials.gov to assess factors influencing the completion of RCTs involving radiotherapy. Eligible trials were registered in ClinicalTrials.gov between 09/27/2007 to 12/31/2010, included radiation (brachytherapy or external beam radiotherapy) in at least one study arm, and were closed due to either successful completion or failure to complete. Data was abstracted by two independent investigators, with discrepancies settled through consensus. Univariable and multivariable logistic regression analyses were performed to determine factors predictive of RCT failure. Results: The initial search yielded 460studies. After reviewing protocol details, 138 studies met inclusion criteria, of which 41 (30%) failed to complete. Most common reasons for RCT incompletion were: lack of accrual (59%), inadequate funding (15%), drug unavailability (7%) and interim data monitoring report recommendations (7%). The highest proportion of RCT failure was observed in the most recent era (p = 0.009), with rates increasing from 11% (1987-2006) to 39% (2009-2012). On univariable analysis, independent predictors of failure included RCTs with a surgical comparator (odds ratio [OR] of failure 6.45; p = 0.010), government sponsorship (OR 3.68; p = 0.024), inclusion of a safety endpoint (OR 3.03; p = 0.014) and study start year (OR 1.18; p = 0.030). On multivariate analysis, surgical RCTs were strongly predictive of failure (OR 7.90; p = 0.015), while behavioral RCTs were less likely to fail (OR 0.14; p = 0.047). Conclusions: Rates of RCT failure in radiation oncology are high. Trials with a surgical comparator are highly prone to failure, whereas behavioral trials are more likely to succeed. These factors can help to inform the design of future RCTs, and develop strategies to mitigate the risk of failure in future radiation RCTs that include a surgical comparator.
Patterns of futile care for comorbidities in colorectal cancer patients near the end of life.
Authors: Sam Davis , Lee-Ying Richard M. , Lau Sally C , Cheung Winson Y. 
Published: September 2018

e18242 Background: Futile care includes interventions that no longer provide benefit, may cause significant harm, and/or lack sufficient utility to justify the required resources. Cancer care such as chemotherapy use has been shown to be overly aggressive near the end of life. We hypothesized that futile care for non-cancer comorbidities in terminal colorectal cancer (CRC) patients may also be prevalent and associated with specific clinical factors. Methods: We constructed a large retrospective cohort of decedents aged ≥18 years who were diagnosed with CRC during 2008-2012 and who died by the end of 2013. We analyzed population-based data through linked provincial files with information on cancer management, pharmacy records, hospital discharges, and vital statistics. We defined endpoints for futile care as ≥1 hospitalization and/or ≥1 prescription for statins, dihydropyridine calcium channel blockers (CCBs), or acid suppressants within 2 months preceding death. Different time points were used in sensitivity analyses. Results: We included 2,530 patients. Median age at CRC diagnosis and death was 70 (IQR 61-79) and 72 (IQR 62-80) years, respectively. Among them, 59% were men, 66% had colon cancer, and 87% were diagnosed with advance disease. Median time from diagnosis to death was 452 (IQR 201-800) days. In terms of futile care, 4.7% had hospitalizations, 8.7% received statins, 6.8% received CCBs, and 38.2% received acid suppressants within 2 months prior to death. In multivariate analyses, there were no clear associations between demographics and hospitalizations. With respect to medication use, advanced age was correlated with increased use of statins (OR 2.235, 95%CI 1.469-3.401, p < 0.001) and CCBs (OR 2.039, 95%CI 1.304-3.190, p = 0.002), but inversely associated with use of acid suppressants (OR 0.750, 95%CI 0.598-0.941, p = 0.013). Men were also more likely to receive statins (OR 1.653, 1.099-2.488, p = 0.016), but less likely to receive acid suppressants (OR 0.764, 0.608-0.960, p = 0.021). Conclusions: Even near death, a fair number of decedents with CRC continued to receive medications for comorbidities that were unlikely to provide clinically meaningful benefits. Futile care was more prevalent in men and in the elderly.
Impact of multidisciplinary discussion on therapeutic decision in cancer patients: a prospective observational study.
Authors: Amaro Carla Pires , Gomes Larissa , Almeida Daniel , Reiner Kelly , Almeida Gustavo Fernandes Godoy , Cruz Marcelo Rocha S 
Published: September 2018

e18243 Background: Continued and rapid evolution of diagnosis and staging methods along with the development of new treatments has changed decision-making process of cancer patient into a more complex task. We evaluated the impact of multidisciplinary tumor board meetings (MTM) in the final decision of cancer patients approach in comparison to the initial decision based on clinical oncologist’s individual choice. Methods: Between April 2016 and January 2017, data were collected prospectively during the MTM held daily at the Antônio Ermírio de Moraes Cancer Center, Sao Paulo, Brazil. Data were gathered by filling out a questionnaire. The therapeutic plan initialy proposed by the physician was compared to the proposal offered by the multidisciplinary team. We evaluated data from breast, gastrointestinal (GI) and lung cancer MTM. Results: We evaluated 100 questionnaires: 39% GI tumors, 34% lung cancer, 27% breast cancer. The main theme for discussion was selection of systemic therapy (65%). The rate of change in therapy choice was 24.6%. The recommendation suggested by the MTM surgeons and radio-oncologists showed disagreement with the one initially proposed in 21 cases. The majority of discordant cases was related to the choice of therapeutic method (57%) with 42% changes in the chemotherapy protocol. Eight patients were submitted to genetic test and mutations search. Only two cases were recommended for clinical trial enrollment. Conclusions: The rate of therapy plan change after MTM is in accordance with international studies. The largest volume of discussions on systemic therapies reflects the large number of new therapies as well as new treatment strategies. This research highlights the potential of multidisciplinary discussions in changing decision-making in cancer cases, allowing a more comprehensive care with the patient. In addition, a MTM allows the access of more patients to new medications made available through clinical trials and protocols. The small number of patients referred to a clinical study reflects the lack of clinical protocols available in Brazil, a problem that needs to be acknowledged and become a priority for Brazilian medical societies and regulatory agencies.
Tumor flare reaction (TFR) in cancer treatments: A systematic review.
Authors: Taleb Amina B. 
Published: September 2018

e18258 Background: In the last decade, TFR was described as a side-effect associated with immunomodulatory agents IMiDs (thalidomide and lenalidomide), and as a specific condition to chronic lymphocytic leukemia (CLL). However, this phenomenon is seen with the use of new immunotherapy (checkpoints inhibitors) in solid tumors, in addition, cases of TFR were reported in advanced gynecologic, prostate cancer and lymphoid malignancies. TFR is defined as an increase of lesion size related to treatment which simulates disease progression. This phenomenon that occurs after initiating cancer therapy is poorly understood and incidence is under-estimated, since not captured by Recist. It has been suggested that TFR may be the results of immune system activation and may precede tumor shrinkage. TFR is associated with morbidity, severe cases were reported, some of them life-threatening or leading to death. So, early recognition and initial management of patients presenting with TFR, is critical. Methods: From 1985 to 2016, a search was performed in the Pubmed, ASCO and ASH abstracts to identify publications reporting TFR or pseudoprogression. Results: The incidence of all grades of TFR in CLL, ranged from 28% in a study to 58% in another trial. In CLL, painful lymph nodes and/or spleen enlargement were reported with a sudden onset after the first dose. Following initial progression (TFR), tumor response in patients treated beyond progression, was reported inmelanoma trials: 9.7% with ipilimumab, 10% with nivolumab, 6.7% and 12% with pembrolizumab, and in renal cell carcinoma 69% with nivolumab. Even if rare cases of life-threatening or fatal TFR were reported, symptoms are usually mild. While correct diagnosis and adequate management are critical, it is important to better recognize TFR, and avoid an effective treatment discontinuation. Some studies showed that treating patients beyond progression yielded tumor responses, considering TFR as predictive of response. Conclusions: Treatment with immunomodulatory agents is associated with TFR. This is likely to be misinterpreted as progression, hence the need to identify appropriate clinical benefit criteria and the use of immune-related RECIST (irRC) in prospective trials for a better understanding.