bluuebunny/crossref_metadata_2025 huggingface dataset:
Comparison of preoperative serum VEGF in leiomyosarcoma and uterus myomatosus patients: A proof of concept study.
Authors: De Gregorio Amelie , Bekes Inga , de Gregorio Nikolaus , Andres Sophia , Hoffmeister Diego , Swerev Tatjana , Friedl Thomas W. P. , Janni Wolfgang , Ebner Florian
Published: May 2019

e17117

Background: The preoperative differentiation of a uterine fibroid from a sarcoma is still a pending clinical problem. Currently with the suspicion of a sarcoma (LMS) the more invasive open surgical approach is recommended to minimise the risk of LMS fragmentation and distribution. In a minority of cases, a malignancy is indicated by clinical suspicion, pre-surgical imaging or routine serum blood samples (SBS). Our hypothesis postulates higher VEGF levels in LMS compared to fibroid patients in the pre-surgical SBS. To assess this hypothesis, SBS were taken from patients with the clinical suspicion of LMS after informed consent and analysed after histology confirmed the diagnosis. Methods: Case series of patients with suspected LMS over a 4year time period. Analysis was performed via SBS collected from LMS- and fibroid patients before surgery. Serum VEGF protein was measured by ELISA. The final tumor histology was obtained from the report of the institutional pathologist. VEGF-serum levels were then compared between fibroid and LMS patients using the non-parametric Mann-Whitney U test. Results: 25 patient SBS were collected prior to surgery. In 9 cases the histopathology confirmed a LMS, with heterogeneous pTNM classifications. On average, VEGF serum levels were higher in the LMS patients as compared to the fibroid patients (628,96 pg/ml vs 351,91 pg/ml; further statistics see Table 1); however, the difference was not statistically significant (Mann-Whitney-U Test, p = 0.141). Conclusions: This proof-of-concept study with a small sample size of pre-surgical SBS indicates that VEGF serum levels may be increased in patients with histologically confirmed LMS; however, larger sample sizes are needed to validate our findings. If additional studies confirm a pronounced increase in pre-surgical serum VEGF levels in LMS patients, serum VEGF levels might routinely be used to assess the risk for a LMS in patients presenting with clinical uterine fibroids. [Table: see text]
Mutational landscape of endometrial cancer identified by prospective clinical sequencing in a nationwide cancer network.
Authors: Schink Julian C. , Alvarez Ricardo H. , Elvin Julia Andrea , Moran Amber , Rollins Rebecca , Geisler John P. , McIntosh David , Godbee Natalie , Tan Bradford A. , Markman Maurie
Published: May 2019

e17123

Background: Tumor genomic profiling is a critical component of precision oncology allowing the detection of genomic alterations (GA) that have the potential to be targeted therapeutically. We present an analysis of comprehensive genomic profiling (CGP) of a large series of endometrial cancer (EC) patients assayed in a nationwide cancer network. Methods: 278 Pts with advanced EC underwent CGP with hybrid capture of up to 406 cancer-related genes on tumor tissue or for 62 genes on circulating tumor DNA ordered during clinical care for treatment decision-making between 01-2013 to 05-2018. Clinically relevant genomic alterations (CRGA) were defined as associated with targeted therapies or mechanism-driven clinical trials. The treatment histories for these patients were obtained with IRB-approved retrospective review. Results: Median age was 59 years (range, 37-85), 58% were Caucasian. GA were identified in 97% (271/278) of EC, of which 218 (80%) had a clinically relevant genomic alteration (CRGA). PI3K/AKT/mTOR pathway ( PIK3CA, AKT1/2/3, PIK3R1, PTEN, MTOR, STK11, FBXW7) CRGA were most common, present in 63.8% of EC. CRGA in other targetable pathways were identified: 28.4% in MEK ( KRAS, NRAS, HRAS, BRAF, RAF1, GNAS, NF1, NF2) , 12.5% in HRD (BRCA1/2, ATM, PALB2, BRIP1 ) and 9.9% in ERBB ( ERBB2, ERBB3, ERBB4, EGFR). 26 patients are MSI-high 9.5% (26/271) and 21 patients are TMB-high 7.7% (21/271). 29.8% (65/218) of EC patients were ordered a genomically-matched treatment, and 61 of these patients received the treatment. 69.2% (45/65) were agents that were FDA approved in a different tumor type, and 24.6% (16/65) through referral to a matched mechanism driven clinical trial. With access to the clinical trial TAPUR, the frequency of matched treatment through clinical trials increased over time from 2013 to 2018. The median PFS for non-clinical trial study patients was 9 weeks, and the median OS was 27 weeks. Conclusions: In a large series of Endometrial and Uterine cancer patients assayed with CGP, 27.9% (61/218) of pts received matched treatment, which was predominantly targeted therapy. The comprehensive sensitive and unbiased nature of CGP, coupled with a multidisciplinary molecular tumor board and staff dedicated to genomic interpretation, assisted in achieving a high frequency of patients’ participation in clinical trials and gene-directed treatment.
The incidence of microscopic adnexal metastatic disease in women with presumed early stage endometrial cancer.
Authors: Khadraoui Wafa , Tierney Christina , Chung Sophie , Azodi Masoud , Ratner Elena , Menderes Gulden
Published: May 2019

e17128

Background: The standard surgical staging for endometrial cancer has been established as a total laparoscopic hysterectomy,bilateral salpingo-oopherectomy and lymphadenectomies. However, ovarian removal can have significant consequences in pre- and peri-menopausal women, which comprise 25% newly diagnosed endometrial cancer. The potential ramifications of premature surgical menopause are clinically important. The goal of this study is to determine the incidence of microscopic adnexal metastatic disease in younger patients with presumed early stage endometrial cancer. Methods: From January 2005 through December 2010, 57 women who were 52 years old or younger with presumed early stage endometrial cancer were identified from our institutional database. Inclusion criteria included (1) FIGO grade 1 endometrioid endometrial cancer on endometrial biopsy, or (2) FIGO grade 1 endometrioid endometrial cancer on frozen section specimen with < 50% myometrial invasion, no evidence of metastatic disease on pre-operative imaging, and no grossly visible metastatic disease in the peritoneal cavity during the staging surgery. Results: Of these 57 patients, four (7%) had lymphovascular space invasion, 20 (35%) had lower uterine segment involvement, 26 (45%) had superficial myometrial invasion or no residual carcinoma, while three (5%) unexpectedly had 50% or greater myometrial invasion on final pathology. Half of our patient population (50%) received vaginal brachytherapy. Of the 57 patients, one (1.8%) had microscopic adnexal involvement in a fallopian tube which upstaged her to stage IIIA disease. Pathological risk factors for advanced stage included LVI, lower uterine segment disease, and 50% myometrial invasion. Conclusions: After a thorough pre-operative evaluation and intra-operative exploration, preservation of the ovaries appears to be a safe and viable option for younger women who are diagnosed with presumed early stage disease. We suggest that ovarian preservation should be discussed on an individual basis in pre- peri-menopausal patients who meet the above-mentioned strict eligibility criteria.
Non-opioid analgesics: New opportunities in early rehabilitation of patients with gynecological cancer.
Authors: Tumanyan Sergey V. , Kit Oleg I. , Frantsiyants Elena M. , Moiseenko Tatiana I. , Oros Oksana V. , Sugak Elizaveta Yu.
Published: May 2019

e17129

Background: An important principle of analgesia is its effect on each component of the pain formation. The purpose of the study was to improve analgesia in the perioperative period in patients with gynecological cancer. Methods: This prospective randomized study of the quality and effectiveness of various analgesics included 97 patients aged 22-67 years receiving surgery for gynecological cancer. The patients were divided into two groups. Group 1 (n = 47): patient-controlled analgesia with trimeperidine and nonsteroidal anti-inflammatory drugs (NSAIDs); group 2 (n = 50): preemptive analgesia based on lidocaine, magnesium sulphate, nefopam and NSAIDs. Results and pain syndrome were assessed by levels of glucose, cortisol, insulin, lactate, C-reactive protein (CRP), Kerdo autonomic index, visual analogue scale (VAS), levels of personal and reactive anxiety and depression. Results: Analgesic effect of trimeperidine was obtained in 83.3% (p < 0.05). However, the effect was less pronounced, compared to non-opioid analgesics, and did not reduce the psychosomatic component of pain after surgical treatment. In group 2, non-opioid analgesia limited the increase of cortisol, glucose, insulin, CRP and lactate (p < 0.05) providing effective pain relief in the perioperative period. Non-opioid analgesics promoted an optimal analgesic effect, did not cause residual sedation, anxiety, depressive effects and cognitive impairments, which showed their obvious advantage over opioids. Opioid-sparing effect was 96.3% (p < 0.05). Reducing the consumption of narcotic analgesics without worsening the quality of postoperative analgesia and the patient's well-being is an important advantage which allows minimizing the negative effects of opioids, facilitating the early rehabilitation of patients. Conclusions: Non-opioid analgesics can significantly limit endocrine and metabolic changes without worsening the quality of analgesia in the perioperative period.
Which role plays specialized palliative care in patients with relapsed and/or metastatic head and neck cancer? A retrospective analysis in Southern Switzerland.
Authors: Espeli Vittoria G. , Gamondi Claudia , Fusi-Schmidhauser Tanja
Published: May 2019

e17503

Background: early palliative care (PC) for patients with advanced cancer improves quality of life, promotes home deaths and can improve survival. Limited data are available regarding PC in advanced head and neck cancer (HNC) patients. To investigate the effect of introducing specialized PC in patients with relapsed and/or metastatic head and neck cancer. Methods: between October 2010 and December 2018, the medical charts of all patients treated in the Oncology Institute of Southern Switzerland with relapsed and/or metastatic HNC were reviewed. Site, status of disease (metastatic at diagnosis, locally or metastatic relapsed), type and lines of treatment, treatment response and referral to specialist palliative care (yes or no) were documented. Comparisons were made between patients referred and non-referred to PC. Results: sixty-two patients with relapsed/metastatic HNC were identified, 32 (51.6%) of which were referred to specialized PC. Patients were mainly men (47, 75.8%), with a median age of 66 years (range 43 – 86). Forty-two patients (67.7%) had a metastatic disease and the most common site of tumor was the oropharynx (35.5%), followed by oral cavity (32.3%), larynx (16.1%), hypopharynx (12.9%), and unknown primary (3.2%). Forty-eight patients (77.4%) were treated with systemic treatment (75% in the PC group and 80% in the non-PC group, p = 0.638). The median overall survival was 8.1 months for all patients, 8 months for the PC group and 8.7 months for the non-PC group, without significant difference (p = 0.440). Of the deceased patients, 70% of the PC group and 73.3% of the non-PC group received chemotherapy in the last three months of life. A greater percentage of patients in the PC group died at home, but without significant difference (39.2% vs. 19%, p = 0.134). Conclusions: only half of the patient had access to specialized PC. Whereas it did not seem to affect overall survival nor influence chemotherapy prescription, it seemed to favor home deaths. Further studies investigating the impact of early PC in recurrent and/or metastatic HNC are needed to improve access to PC and maximize benefits.
Effect of early nutrition intervention on advanced nasopharyngeal carcinoma patients receiving chemoradiotherapy.
Authors: Meng Lingbin , Xu Xiaochun , Jiang Xin , Mekhail Tarek
Published: May 2019

e17504

Background: Patients with nasopharyngeal carcinoma (NPC) frequently developed the problem of malnutrition at the time of diagnosis. Chemoradiotherapy (CRT) can even worsen the situation. Therefore, nutritional intervention should be applied to prevent CRT-associated weight loss and interruption of CRT. However, it is still controversial if early nutritional intervention is beneficial to NPC patients with CRT. This study is to investigate the influence of early nutritional intervention on advanced NPC patients with CRT by evaluating the nutritional status and CRT treatment tolerance. Methods: A cohort of 78 stage III-IV nasopharyngeal carcinoma patients was divided into early (n = 46) and late (n = 32) nutrition intervention groups. The early group of patients received nutritional support at the beginning of CRT, whereas the late group received such a support until development of the side effects, like 50% required oral dietary intake or > 10% weight loss. The data were collected and statistically analyzed. Results: There was no significant difference in baseline clinical characteristics between these two groups, suggesting that no selection bias occurred. Both groups of patients had weight loss at the end of CRT and 3 months thereafter. However, at the later time point, the early group started to regain their weight, while the late group continued to lose weight. At both time points, the early group had a lower percentage of weight loss than the late group. Similar results were also obtained for BMI, albumin, and pre-albumin levels (All p< 0.05). Besides, the early group showed a lower rate of advanced mucositis, a lower percentage of patients with more than 3 days RT breaks, fewer days of RT delayed for toxicity, and a lower percentage of patients with unplanned hospitalizations (All p< 0.05). A linear correlation was also found between the percentage of weight loss and the number of days of RT delayed. Conclusions: Early nutritional intervention provides beneficial outcomes to NPC patients by maintaining their nutritional status and enhancing CRT treatment tolerance. Our results also indicated early nutrition intervention may reduce the hospital cost and improve patients’ life quality.
Long-term toxicity following radiation therapy for head and neck squamous cell carcinoma: A retrospective study analyzing the effect of concurrent chemotherapy and advanced t-stage on late treatment-induced toxicities.
Authors: Barrett William , Cassidy Christine
Published: May 2019

e17560

Background: There are approximately 436,000 survivors of head and neck squamous cell carcinoma (HNSCC) in the U.S. Toxicities related to definitive chemoradiation or radiation therapy can persist for many years, with some toxicities not presenting clinically until five or more years after definitive treatment. Long-term management of late radiotherapy effects is thus warranted. Methods: This retrospective chart review has three aims: (1) comprehensively assess overall late effects of definitive radiation and chemoradiation; (2) compare treatment-related toxicities between definitive radiation and chemoradiation; and (3) compare treatment-related toxicities between patients with TNM stage T1/T2 tumors to T3/T4 tumors. Late term effects were assessed using 17 toxicity categories including xerostomia, dysphagia, and neck fibrosis. HNSCC patients included in the study were those seen by a single practitioner for follow-up of definitive radiation or chemoradiation, without a history of surgical intervention to the primary site, between June 2017 and June 2018 (N = 49). Results: The median time from the end of treatment to the most recent follow-up was 8.53 years (1.17-24.08 years). In the total cohort, the most common late effect was xerostomia (78%, N = 38), followed by dysphagia (43%, N = 21), and neck fibrosis (27%, N = 13). For the majority of toxicity categories (11 of 17), the cohort that received definitive chemoradiation had higher rates of toxicity than the cohort that received definitive radiation alone. Additionally, for the majority of toxicity categories (10 of 17), the cohort of T3/T4 tumors had higher rates of long-term toxicity than the cohort of T1/T2 tumors. Conclusions: Although the patient population in this study has excellent locoregional control after definitive radiation or chemoradiation, the majority of patients suffer from long-term treatment-related toxicities. Long-term follow up care is needed to manage the late effects of radiotherapy that can develop and persist for years after treatment completion.
Characteristics of the course of squamous cell carcinoma of the oral cavity depending on the HPV status.
Authors: Svetitskiy Pavel V. , Zykova Tatiana A. , Volkova Viktoriya L. , Aedinova Irina V.
Published: May 2019

e17579

Background: HPV infection has a positive prognostic value in the treatment of patients with oropharyngeal squamous cell carcinoma. The purpose of the study was to evaluate the effect of HPV status on the course of oral cavity cancer. Methods: Formalin-fixed paraffin-embedded tumor tissues were studied in 34 patients with cancer of the floor of the mouth aged 47-85 years, 3 (8.8%) women and 31 (91.2%) men. All patients had histologically verified squamous cell carcinoma: stage (st) I in 1 (2.9%), II st - 8 (23.5%), III st - 12 (35.3%), IV st - 13 (38.3%); G1 in 15 (44.1%), G2 - 19 (55.9%). HPV DNAs were detected by Real-time PCR. Results: HPV DNAs were found in 12 (35.3%) samples of tumor tissues, including type 6 in 1 (2.9%), 11 in 3 (8.8%), 16 in 6 (17.6%), 35 in 1 (2.9%), 16+35 in 1 (2.9%). HPV+ tumors were more often in women (66.7% vs 32.3% in men), but high-risk HPV types were detected in men only - 8 (25.8%). Among patients aged 47-55 years, HPV+ tumor status was detected in 4 (33.3%), 56-65 years in 7 (53.8%), 66 years and older - in 1 (11.1%). In st I, no HPV+ tumors were observed; st II - 3 (37.5%) HPV+ tumors, low-risk in all; st III - 3 (25%) HPV+ patients, including high-risk in 2 (16.7%); st IV - 6 (46.2%) HPV+ samples, high-risk in all. G1 tumors: HPV+ in 7 (46.7%), HPV- in 8 (53.3%) patients; G2 tumors: HPV+ in 5 (26.3%), HPV- in 14 (73.7%) patients. Among patients with HPV+ tumors, metastases were observed in 5 (41.7%), no metastases - in 7 (58.3%); for patients with HPV- tumors, the values were 12 (54.5%) and 10 (45.5%) respectively. 4 (33.3%) patients with HPV+ tumors died, while 8 (66.7%) survived; for patients with HPV- tumors, the values were 12 (54.5%) and 10 (45.5%) respectively. Conclusions: The development of squamous cell carcinoma of the oral cavity was multidirectional and depended on the HPV status. HPV+ tumors, especially high-risk ones, were more often registered in stages III and IV. HPV+ tumors were more often lower-grade ones and less often metastasized; the mortality rate among patients with HPV+ tumors was lower than with HPV- ones.
Anaplastic thyroid cancer: A report of six consecutive cases treated successfully with nab-paclitaxel.
Authors: Travers Nicholas , Cronin Eleanor , Marinova Mira , Smith Peter , Dean Andrew Peter
Published: May 2019

e17586

Background: Advanced anaplastic thyroid cancer is a disease with very few treatment options. Poor response rates have been reported with cisplatin / doxorubicin and modest response noted in a single phase 2 trial with 24 hour paclitaxel infusion. The 50% response rate has not been reproduced by other investigators but raises questions about the possible utility of taxanes. Although paclitaxel is not approved for this indication in Australia, nab-Paclitaxel is available on a compassionate access scheme. We report 6 consecutive cases treated with nab-paclitaxel (as an alternative to paclitaxel infusion) who all exhibited a response to treatment. Methods: 6 consecutive patients with histologically proven advanced anaplastic thyroid cancer were assessed and imaged to document extent of disease. They were all treated with nab-paclitaxel 100mg/M2 given weekly either continuously or for 3 weeks out of every 4. Clinical and radiological response to treatment was documented. Results: The number of cycles given ranged from 3 to 8. Two patients required dose reductions due to neuropathy. Of the 6 patients; 5 had measurable metastatic disease and 5 had measurable local disease. Four patients showed clinical response to treatment with shrinkage of measurable local disease. One patient showed response to treatment with shrinkage of the primary tumour. Three patients with stridor developed considerable relief from this distressing symptom. Three patients with inoperable disease subsequently became operable and were resected to obtain local disease control. One patient with no evaluable disease after resection (Stage 4B) who received adjuvant nab-paclitaxel remains free of recurrence at 4 years. Conclusions: Anaplastic thyroid cancer is generally regarded as malignancy untreatable by chemotherapy. Our pilot series suggests nab-Paclitaxel warrants further evaluation and should be considered as a chemotherapy backline for combination with targeted agents.
Potential length of stay reduction with outpatient management of low risk febrile neutropenia in a regional cancer centre.
Authors: Nguyen Mike , Jacobson Tate , Tamjid Babak , Torres Javier , Sahu Arvind , Wann Alysson
Published: May 2019

e18000

Background: Febrile neutropenia is a serious complication of chemotherapy. The Multinational Association for Supportive Care in Cancer (MASCC) risk index score can reliably identify patients with febrile neutropenia at low risk of serious complications. Outpatient management programs utilising protocol based risk stratification, daily ambulatory nursing visits, telephone follow up and early outpatient review have been successfully piloted in other Australian cancer treatment centres. Methods: We performed a retrospective review of medical records for all patients admitted at our institution with febrile neutropenia between January 1 2016 and December 31 2018. We collected information regarding patient characteristics, cancer diagnosis and treatment, determined the MASCC risk index score, and if low risk, we determined the potential eligibility for outpatient care and potential reduction in length of stay. Results: A total of 98 hospital admissions with febrile neutropenia were analysed. Of these, 66 were determined to have a MASCC low risk index score. 58 patients met the eligibility criteria for outpatient management. The median age was 67 years. 71% were female. The most common tumour type was breast cancer. 52% were treated with palliative intent. The median length of stay was 3 days. The median potential reduction in length of stay for each admission was 2 days. The total potential reduction in length of stay was 198 days. No admission resulted in serious complications indicating the safety of outpatient care. Conclusions: Febrile neutropenia is a common complication of chemotherapy and a leading cause of hospital admission. This review demonstrates a significant number of hospital admission days can be avoided with outpatient care. We intend to conduct a prospective pilot study at our centre to institute an outpatient febrile neutropenia program for such low risk groups with potential reduction in hospital bed length of stay. This has significant implications on health resource usage, service provision planning and patient quality of life.
Patient attendance at molecular tumor board: A new means of shared decision making?
Authors: Cannon Timothy Lewis , Trump Donald L. , Knopp Laura , Wang Hongkun , DeMarco Tiffani , Jessup John Milburn
Published: May 2019

e18001

Background: Patient engagement in medical decision-making improves patient related outcomes through compliance and patient satisfaction. The Inova Schar Cancer Institute (ISCI) has a weekly molecular tumor board (MTB) to match comprehensive genomic sequencing results with targeted therapies for patients. The ISCI MTB invites patients to attend and engage in the MTB discussion. We performed a pilot study to investigate the feasibility and satisfaction in patients who attended MTB. Methods: During the time of this study, August 2017 through October 2018, 139 patients were presented and all 20 who were able to attend MTB completed pre-and post- MTB surveys. Patients who did not attend were either not invited by their primary oncologist, unable to attend, or chose not to attend. The survey included six questions related to comprehension, engagement, and satisfaction with the treatment team. Results: There was a statistically significant change for the question “I am satisfied with how well informed I am about targeted therapy” with p = 0.016. All 20 patients answered positively that it was beneficial for them to attend. Many patients expressed concerns about their difficulty understanding the technical aspects of the meeting. Conclusions: Patients who attended MTB reported a higher level of satisfaction after MTB attendance as compared to before MTB. This may reflect a sense of engagement in shared decision making rather than comprehension of genomic information. A more holistic method of studying this practice would include sampling a larger patient population and a formal evaluation of the physicians’ experience with patients attending. Supported by philanthropic funds from the Inova Schar Cancer Institute.
Patient factors that drive unplanned acute care utilization in oncology care.
Authors: Kaufmann Tara L. , Aakhus Erin , Bilger Andrea , Gabriel Peter Edward , Nimgaonkar Vivek , Rendle Katharine A. , Shah Arnav , Trotta Rebecca , Bekelman Justin E. , Barg Frances
Published: May 2019

e18011

Background: There is a critical need to develop oncology care delivery models that help cancer patients avoid preventable acute hospital care. We are conducting a mixed methods study to assess patient- provider- and system-level factors that drive unplanned acute care utilization in order to implement evidence-based practices (EBPs) at a large health system. Here we present data from patient perspectives on the factors that influence their decision to seek acute care. Methods: We used a purposive sampling approach to identify cancer patients with solid tumors on active treatment with unplanned acute care events at an academic cancer center or its two affiliated community practices from August 2018-January 2019. We conducted semi-structured interviews designed to elicit patient factors that drive unplanned acute care utilization and to understand strategies patients use to manage unexpected symptoms at home. Interviews were analyzed using the constant comparative method to identify key themes. Results: Forty-three patients participated in this study. We identify several patient factors that intersect with the decision to seek care: self-management behaviors, guilt, negative ED perception, safety concerns, and trust. Patients attempt self-management prior to contacting their oncology team, which introduces variability in the duration and severity of reported symptoms. Delay is related to patients’ sense of guilt for burdening their oncology team and to differences in provider accessibility. Patients describe a high symptom threshold to seek care that is often coupled with a negative perception of the ED. However, due to safety concerns, patients do prefer in-person evaluation for new and distressing symptoms. They also express a high level of trust in the oncology team and relative distrust of non-oncology providers. Conclusions: Our data suggest a conceptual model for patient factors that drive unplanned acute care and identify the following targets for implementation of EBPs: 1) symptom management 2) provider accessibility 3) alternate triage pathways for in-person evaluation. Strategies to target these needs should address patients’ emotional concerns and be well integrated within the oncology team.
Barriers to accessing healthcare services: A multidisciplinary approach towards improving pancreatic cancer survival in a Canadian province.
Authors: Faour Elizabeth , Colwell Bruce , Lamond Nathan William Dana , Snow Stephanie Leann , Jeyakumar Alwin S. , Patil Nikhilesh Gajanan , Costa Andreu F. , Walsh Mark , Gala-Lopez Boris , Livingstone Scott M , Peltekian Kevork , Stueck Ashley , Huang Weei-Yuarn , Arnason Thomas , Ramjeesingh Ravi
Published: May 2019

e18018

Background: Pancreatic cancer (PC) is associated with the highest death rate among common malignancies and is the fourth leading cause of cancer-related death in North America. Despite similar access to treatment options across Canada, the province of Nova Scotia (NS) has the lowest 5-year survival rate for PC. To investigate reasons behind the poor PC outcomes in NS, a multidisciplinary team was created to investigate barriers to care and streamline patient flow. In 2016, initial data informed the reorganization of the hepatopancreaticobiliary (HPB) multidisciplinary team towards the goal of identifying and reducing barriers to care and, ultimately, improving survival. Methods: This quality improvement project included a retrospective chart review of PC patient data from a single institution (The NS Cancer Center), where over 80% of PC patients from this province are seen. A review of PC diagnosis, referrals patterns, and wait time data was undertaken. Results: Data was extracted on 365 patients with a diagnosis of PC between 2011 and 2014. During that period, only 40.4% of patients diagnosed with PC had a tissue diagnosis and just over 71% had a baseline CA19-9. Referral rate to Medical Oncology (MO) was 53%, mean wait time to see MO was 37.2 days and only 23% of patients received systemic treatment. Initiatives to improve access to care included standardization of diagnostic procedures, early triaging of referrals, transfer of port-a-cath (PAC) insertions from interventional radiology to the HPB surgeons, and the creation of provincial guidelines, which were implemented in 2016. Positive Improvements were observed in all identified barriers to care. Conclusions: Barriers to accessing care for PC patients in NS were identified, and a multidisciplinary team proposed provincial guidelines were implemented to expedite care. Preliminary results show improvement in all aspects of healthcare delivery. Survival data will be available in late 2019. [Table: see text]
Oncology leadership development using decentralization, task shifting, techno-mentoring and creation of alternate oncology workforce.
Authors: Pendharkar Dinesh
Published: May 2019

e18043

Background: Access to cancer care remains the greatest challenge world over. One of the solutions include task shifting , decentralization and empowerment of alternate oncology workforce, with health system strengthening. “Pendharkar model “ of cancer care delivery is widely being followed across four states in India and is expanding to two more. It has sustainably created alternate oncology workforce with community oncology leaders. Methods: The model involved creating nodal cancer units in government run district hospitals and creating a physician point of contact for cancer in every unit. The method involved training these general physicians over one month and giving them techno-mentoring backup over every cancer patient they see. They were supposed to play multiple roles including early diagnosis, patient care including chemotherapy, palliative care. One of their role being advocacy and public education. Results: The model led to training of more than 140 physicians and starting of cancer units in about 125 hospitals, with population coverage of more than 200 million population across five states of India. Through their training and mentorship backup they were encouraged to take leading role in the society s cancer advocates, besides care of the cancer patients. In 2018 alone thousands of patients benefited from the services including thousands of courses of chemotherapy. They took up the role of community leaders in oncology. The list of activities performed by them varied from-oncology education and training of the paramedical staff, education of the physicians, cancer counselling camps, designing educational material, public educational meeting, rallies , leaflet distributions, multiple press and TV – mass media presentations on cancer, organizing cancer related painting exhibitions, slogan campaigns and so on. World cancer activities were simultaneously observed in more than 100 districts in last two consecutive years. Conclusions: The model as by product led to the creation of an huge army oncology leaders in the community. The general physicians from periphery turned in to powerful cancer advocates.
Social media for oncology clinical trial recruitment: Oncologists’ attitudes and perceptions.
Authors: Sedrak Mina S. , Hurria Arti , Sun Virginia , Li Daneng , Liu Jennifer , George Kevin , Wong Andrew R. , Padam Simran , Katheria Vani , Mohile Supriya Gupta , Waisman James Ross , Dale William , Mortimer Joanne E. , Dizon Don S.
Published: May 2019

e18066

Background: Social media may be an effective strategy to improve public awareness of oncology clinical trials and increase accrual. How oncologists perceive the role of social media in clinical trials now and in the future remains unknown. We explored oncologists’ attitudes and perceptions related to social media and clinical trial recruitment. Methods: Semi-structured interviews were conducted with 44 medical oncologists at City of Hope from March to June 2018. Primary measures were oncologists’ self-reported benefits, concerns, and future interventions to leverage social media for trial recruitment. Secondary measures were facilitators and barriers to social media use for professional purposes. Responses were recorded digitally, transcribed, and de-identified. Data was managed using NVivo v12. Two analysts coded interview data using thematic content analysis (kappa = 0.7). Results: Of the 44 participants, 55% were academic and 45% were community oncologists, 36% were women, and 68% had > 10 years of experience. The most commonly cited benefit was increased awareness and visibility (63%). The most commonly cited concerns were: lack of time or support (31%), misinformation or oversimplification (31%), and lack of guidance (regulatory/ethical oversight) (28%). Oncologists reported a desire for an institutional-level intervention (e.g., personnel support with social media expertise) to facilitate trial recruitment using social media (50%). Oncologists’ perceptions of the facilitators to social media use for professional purposes were centered on networking (40%) and staying up to date in the field (33%). Perceived barriers were clustered around lack of comfort, training, time (38%), and lack of evidence of benefit (25%). No differences were identified between academic and community oncologists. Conclusions: Oncologists are hopeful that social media can increase awareness and visibility of cancer clinical trials. However, they have numerous concerns about the application of social media in clinical trials due to lack of time, support, and risk of misinformation. Further research is needed to examine whether social media can facilitate recruitment to oncology clinical trials.
Deriving real-world oral antineoplastic treatment endpoints: A comparison of automated data extraction versus manual chart abstraction.
Authors: Chen James Lin , Shadra Chhaya , Cho-Phan Cheryl D. , Ghosh Aradhana , Hirsch Jonathan
Published: May 2019

e18070

Background: Real world data (RWD) is increasingly being used to generate evidence that informs clinical care. Calculating outcomes measures using RWD, such as time-on-treatment (ToT), requires accurate medication start/end dates. Whereas intravenously administered medication dates are typically available, dates for oral antineoplastics (OANs) are challenging as they are filled by specialty pharmacies and documented separately. To determine the feasibility of automated ToT extraction, we used the Syapse Learning Health Network to compare the utility of automated chart extraction (ACE) and of manual chart abstraction (MCA) from the electronic health record (EHR) in providing high-quality OAN data. Methods: We selected cancer patients (pts) from two histologies for whom OANs were prescribed. For these pts, ACE was compared to MCA. ACE data were derived from EHR structured medication lists through existing interoperability pipelines. MCA was performed by 4 trained data abstractors who reviewed the corresponding progress notes per pt. Expected date of OAN start/end, and actual medication start/end, were recorded as available. Chi-square and descriptive statistics were used for analysis. Results: 61 cancer pts (31 lung, 30 breast; mean age 62y [27-90]; 20% male) who received OAN from 3 multi-hospital medical systems were evaluated. ACE detected a greater number of expected start/end dates as compared to MCA (Table, P < 0.001). In contrast, for actual start/end dates, the converse was true; ACE was inferior to MCA (P < 0.001). Noteworthy, only 26% of pts had actual start/end dates using manual chart abstraction only. There was no concordance between the actual ACE and MCA dates. We evaluated if ACE expected ToT dates could be used as a surrogate for actual MCA ToT dates. Of the 12 pts satisfying this criteria, mean discordance in ToT was 19 days (1-71 days). Conclusions: MCA only captured actual ToT in a small minority of pts. ACE expected dates were a poor surrogate for ToT and highly discordant to over 2 months. Neither MCA nor ACE from EHR data were adequate for the majority of pts. Alternative mechanisms such as integration with additional data sources like specialty pharmacy dispensing records are essential. [Table: see text]
Toward early diagnosis decision support for breast cancer: Ontology-based semantic interoperability.
Authors: Gong Mengchun , Wang Zhi , Liu Yefu , Zhou Hong , Wang Fang , Wang Yishang , Hong Na
Published: May 2019

e18072

Background: Breast cancer is ranked as the most common cancer among women in China, cases in China account for about 300,000 of all newly diagnosed breast cancers each year. Developing Clinical Decision Supporting System (CDSS) to assist early diagnosis breast cancer is valuable, however, lack of semantic interoperability in CDSS has been identified as the main obstacle for broad adoption of CDSS. Ontology is considered to be one of the effective approaches to bridge the terminology gap between various clinical systems and data sources. In this study, we describe our efforts in transforming breast cancer clinical knowledge into computable ontology to support breast cancer early diagnosis. Methods: We have built a breast cancer ontology (BCO) to support our CDSS pipeline. A number of NCCN clinical practice guidelines in Oncology for Breast Cancer and the breast cancer diagnosis and treatment guidelines of China are the main knowledge sources of the BCO. BCO is a manually curated resource that contains concepts and relations of breast cancer clinical findings, demographics, laboratory tests, imaging results, treatments, pathologies, cancer stages, body structure and follow-up information. These curated knowledges are annotated through interoperable standard vocabulary SNOMED CT. Two physicians reviewed and evaluated the BCO. Results: Concepts in BCO currently contains 79 clinical findings, 8 demographics, 42 laboratory tests, 105 imaging results, 332 treatments, 141 pathology and cancer stages, 30 body structures and 3 follow-ups. Relations are defined such as finding site, associated with, etc. The concepts hierarchies and relationships were built by using Protégé to support OWL representation. As an initial evaluation results, most of concepts could be mapped to SNOMED CT, but there are some concepts could not be exactly mapped to SNOMED CT. We created local Chinese Vocabularies for these local terms. Conclusions: Based on interoperable BCO, a group of computable rules are developed by adding statements according to early diagnosis criteria of breast cancer. Diagnosis assistance around complex patients is supported though connecting the Electronic Health Record (EHR). This is an ongoing development that the BCO is continuingly enriched with standard concepts, relations and integrate with individual instances to support broader adoptability.
Patient-reported outcomes during hospitalization for patients with late discharge after an open surgery for GYN tumors.
Authors: Wang Xin Shelley , Shi Qiuling , Cleeland Charles S. , Chen Ting-Yu , Garcia-Gonzalez Araceli , Iniesta-Donate Maria , Chen Tsun Hsuan , Griffin Donna , Meyer Larissa
Published: May 2019

e18078

Background: Using patient-reported outcomes (PRO) in perioperative care is increasingly common in patients undergoing major surgery. Few reports relate the patient’s symptomatic status using validated PROs during hospitalization with other outcomes, such as length of stay (LOS). Methods: Patients with GYN tumors scheduled for open surgery at MD Anderson Cancer Center were recruited prospectively. The MD Anderson Symptom Inventory gynecology perioperative care module (MDASI-PeriOp-GYN) was used to assess symptoms daily during hospitalization. Longitudinal analysis compared patient’s PROs between groups who were discharged within and beyond the median LOS. Results: From Feb 2018–Dec 2018, 83 patients were evaluable. The median LOS was 3 days. 70% of patients were discharged within 3 days, and 30% were hospitalized longer (defined as late discharge group, range 4-10 days). The median LOS for the two groups was 5.64 vs. 2.41 days, P < .0001. Compared to patients who were discharged within 3 days, late discharge patients had longer surgical time (310 min vs. 209 min, P < .0001), and greater operative blood loss (668mL vs. 289 mL, P < .001). Additionally, more patients in the late discharge group had a worse performance status (ECOG PS 2-3: 24% vs. 3.5%, P < .05), and higher comorbidity (Charlson comorbidity Index > 1: 92% vs. 69%, P < .05), and more used opioids within 6 month pre-surgery (16% vs. 1.7%, P < .05). For all patients, the 5 worst symptoms during the first 3 hospital days were pain, fatigue, drowsiness, dry mouth, bloating. Late discharge patients reported significant more severe pain, distress, dry mouth, and interference with walking during the first 3 days post-surgery (all P < .05). Conclusions: Despite all patients undergoing standardized perioperative care on an Enhanced Recovery pathway, this study demonstrates how baseline and intraoperative factors are associated with longer LOS and more severe symptom burden, especially pain and interference with walking.
Quantifying interoperability: An analysis of oncology practice electronic health record data variability.
Authors: Bernstam Elmer Victor , Warner Jeremy Lyle , Krauss John C. , Ambinder Edward P. , Rubinstein Wendy S. , Komatsoulis George Anthony , Miller Robert S. , Chen James Lin
Published: May 2019

e18080

Background: Implementation of electronic health records (EHRs) has engendered a large quantity of machine-readable data. However, different practices choose different EHR vendors and the same vendor product may be implemented differently at each practice. Motivated by the desire to facilitate appropriate integration of data, our goal was to describe and quantify the consistency and variation of structured data within EHRs. Methods: De-identified and aggregated CancerLinQ data from 47 practices regarding the standards and variability of structured data including race, diagnoses, encounters, cancer staging, selected cancer-relevant medications, lab values and biomarkers were analyzed. EHR represented included ARIA, MOSAIQ, Allscripts, Centricity, Epic, Intellidose, NextGen, and OncoEMR. Results: De-identified EHR implementations included 23 A, 12 B, C and 5 other vendors. Only 6 practices (13%) used non-standard race representation. All practices used ICD-9/10 for diagnoses. There was variability in coding of encounters. Sixteen practices always used CPT, 5 practices always used SNOMED CT and 26 practices used multiple standards. Multiple staging systems were used. An average of 48% (range 11%-; including patients staged more than once) of patient records included coded staging information. Only one practice used a standard (LOINC) for laboratory data. No standards were used for medications ordered/administered or biomarkers. The table shows the number of distinct names for selected lab tests, medications and biomarkers across systems. Conclusions: In this cross-sectional sample, standards are used consistently for diagnoses and encounter data, often for race and rarely for medications, laboratory tests or biomarkers.[Table: see text]
RDI as a method for reviewer performance monitoring in BICR setup for improving data quality.
Authors: Sharma Manish , Bohnsack Oliver , O'Connor Michael , Shao Yibin , Enus Nicholas , Karve Sayali , Fotinos-Hoyer A. Kassel
Published: May 2019

e18082

Background: Double read with adjudication is a preferred independent review model of regulatory authorities for blinded independent central review (BICR) in order to minimize reviewer bias in clinical trials. Adjudication rate (AR) and adjudication agreement rate (AAR) are commonly used indicators for monitoring independent reviewer performance quality. We will present data on Reader Disagreement Index (RDI), an innovative indicator for accurately monitoring reviewer performance and triggering timely intervention when applicable. Methods: A detailed review of BICR adjudication data was performed for 12 oncology clinical trials, with a total of 5,369 subjects (ranging from 119 to 894 per individual study) with 27,056 time points using RECIST, the Lugano classification or iwCLL assessment criteria. RDI for each reviewer was calculated as RDI = (# of cases where adjudicator disagreed with given reviewer ÷ Total # of all cases read) × 100, with high RDI indicating high % disagreement. RDI was used to identify the discordant reader (i.e. reviewer with the highest level of cases disagreed with by the adjudicator) when approximately 10% of the total reads were completed for each study. RDI was also calculated and compared with AR and AAR on an ongoing basis throughout the study. Mean RDI + standard deviation (SD) were used to identify outlier readers. Results: RDI reliably identified the most discordant reader consistently across all 12 studies, while AR & AAR did not. The results confirm the advantage of RDI as a lagging and leading indicator for independent reviewer performance across indications and criteria using double read with adjudication review model. RDI, when calculated as early as at the 10% of total reviewed cases benchmark, demonstrated a positive predictive value of 91% and negative predictive value of 93% (Sensitivity 71%; Specificity 98%). Conclusions: Early identification of an outlier reviewer as per RDI (i.e. after reviews completed for ~ 10% study visits), followed by detailed analysis and corrective measures, such as retraining of the reviewer can serve as timely intervention to improve review quality. Thus, RDI proves to be a better indicator for not just monitoring reviewer performance, but also as an excellent tool for triggering timely corrective intervention. [Table: see text]