bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of bolus versus continuous infusion of doxorubicin (DOX) on cardiotoxicity in patients with breast cancer (BC) and sarcomas: Analysis of real-world data.
Authors: Cranmer Lee D. , Hess Lisa M. , Sugihara Tomoko , Zhu Yajun Emily
Published: May 2020

e19123

Background: Doxorubicin continues to play a central role in management of breast cancer and sarcomas. Dose-dependent cardiomyopathy is a challenge in its use. Strategies have been proposed to mitigate this, including administration by continuous intravenous (CIV) infusion as an alternative to bolus (BOL) administration. This study used real world data to explore the impact of DOX administration mode on cardiotoxicity, duration of DOX and time to treatment failure (TTF). Methods: This study used IBM MarketScan claims to identify patients age ≥ 18 who received at least 2 DOX administrations after cancer diagnosis. Patients with history of cardiac events/toxicities were excluded. Cardiac events were compared for BOL versus CIV overall, by tumor site and by regimen during three follow-up periods, early (within 1 year), middle (>1 to 5 years) and late (>5 years), from DOX initiation using Fisher’s exact test. Duration of DOX and TTF, defined as time from initiation of DOX to subsequent systemic therapy, hospice or death, were evaluated using Kaplan-Meier method and unadjusted Cox proportional hazards models. Results: 62,597 patients were eligible, including 38,961 with BC and 1,772 with sarcoma. Most patients had codes for both modes; 1,941 and 7,094 patients had exclusive BOL and CIV codes, respectively. For these patients, mean duration of DOX was longer for BOL vs. CIV (83.9 vs. 65.4 days, p<0.001). Cardiac events for BOL vs. CIV were 6.5% vs. 5.6% (p=0.098) during the early period, 4% vs. 5.1% (p=0.046) middle period, and 0.5% vs. 0.9% (p=0.068) late period. This pattern was consistent for BC and sarcoma and among those who were pre-treated. There were no differences in cardiac events for BOL vs. CIV for the chemotherapy naïve or DOX monotherapy groups (all periods p>0.10) but statistically different for the breast during the middle period, sarcoma at any time, and pretreated subgroup middle period (all p<0.05). TTF favored CIV over BOL among patients with BC (p<0.0001) but BOL over CIV in sarcoma (p=0.002). TTF was not significantly different between BOL and CIV for BC monotherapy (p=0.067) but was significant for sarcoma monotherapy favoring BOL administration (hazard ratio 0.72, 95% confidence interval 0.54-0.95, p=0.02). Conclusions: These data suggest that cardiac events may occur at a similar rate irrespective of mode of DOX administration. Further analyses are needed to understand how these relationships are impacted by other potential risk covariates (eg, age, gender) and by protective factors (eg, dexrazoxane).
Annual lung cancer screening by chest X ray to avoid further examinations.
Authors: Kimura Tatsuo , Fukumoto Shinya , Fujii Hideki , Nakano Akemi , Nadatani Yuji , Tauchi Yukie , Suzumura Tomohiro , Ogawa Koichi , Kawaguchi Tomoya , Kawada Norifumi
Published: May 2020

e19124

Background: Chest X ray (CXR) has been the most common screen procedure for detection of lung cancer. However, if patients had old inflammatory shadows such as tuberculosis, calcification and fibrotic changes, it would become increasingly difficult to detect the lung cancer. In that case, a comparative review of the CXR to the previous one helps the detection of new shadows. We examined whether the repeat participants (pts) who received the medical checkup annually, may have a profit for the lung cancer detection screening. Methods: Our clinic “MedCity21” is a university outpatient clinic to undergo a complete medical checkup in private health screening program. The pts with abnormalities detected in CXR were announced by call request and invited to our specialty clinic for chest CT scan as further examination. We examined the varieties of abnormal shadows by CXR and CT scans, and compared the differences between the repeat and the first-time pts using the chi-square tests, in 2018 and 2019 respectively. Results: In 2018, a total of 12540 with repeat / first-time pts of 6898/5642 pts (55/45%) were enrolled. The CXR abnormalities requiring further examinations were a total of 335 (2.6%) with those of 138/188 pts (p < 0.01). After the call requests, a total of 239 (71.3%) with those of 109/130 pts in 2018 received chest CT scan in our specialty clinic. In 2019, a total of 13690 pts with those of 7748/5942 (56.6/43.4%) were enrolled. The CXR abnormalities requiring further examinations were a total of 323 (2.4%) with those of 137/186 pts (p < 0.01). After the call requests, a total of 224 (69.3%) pts with those of 104/120 pts received chest CT scan in our specialty clinic. The varieties of abnormal shadows by CT scans showed that 8.3/20.8% (p < 0.01) in 2018 and 11.5/21.7% (p = 0.04) in 2019 of old inflammatory shadows, 11.0/6.9% (p = 0.27) in 2018 and 14.4/1.7% (p < 0.01) in 2019 of acute inflammatory shadows, respectively. The nodule was detected in 11.9/11.5% in 2018 and 8.7/10.8% in 2019 with no significant differences. Lung cancer was detected in 3/3 pts in 2018, and 1/3 pts in 2019. Conclusions: The repeat pts in each year, had significantly lower rate of CXR abnormalities detection, and had lower rate of the detection of old inflammatory changes as significant. In private health screening program, the repeat pts may have higher profits for the avoidance of further examination for lung cancer detection than the first-time pts.
Factors associated with oral chemotherapy adherence in specialty pharmacies.
Authors: Monestime Shanada , Page Ray D. , Jordan William M. , Aryal Subhash , Rasu Rafia
Published: May 2020

e19137

Background: Specialty pharmacies are expanding in the oncology setting and often favored by payors because of economic and operational benefits. However, challenges exist in coordination of care, patient safety, cost/reimbursement, and operational efficiency. While in-house specialty pharmacies mitigate these challenges due to close proximity of health care providers, these challenges can impact medication adherence. To date, limited data are available on adherence rates and factors associated with oral chemotherapy (OC) adherence in specialty pharmacy settings. Methods: Adult cancer patients who received their first OC between Aug.-Oct. 2018 were analyzed. Pharmacies were contacted to obtain OC pick-up dates over 6 months or until treatment completion. Patients were adherent if the proportion of days covered (PDC) was ≥90%. Descriptive and bivariate logistic regression models were performed to examine demographics, specialty pharmacy type (external vs. internal), distance from pharmacy to home, and chronic comorbidities. Results: Of the 80 patients analyzed, the mean age was 63.59 (SD ±11.8), 51.21% were female, 68.75% were white, 61.25% were married, 82.50% were smokers, 53.75% were on government insurance, 73.75% were using an internal pharmacy, and the mean distance traveled to pharmacy was 17.06 miles (SD±22.66). Thirty-five patients (43.75%) were adherent (mean PDC = 78%, range, 17-100%). Patients who went to an internal pharmacy were 1.81 times likely to be adherent than those who went to an external pharmacy [OR: 1.81, 95% CI (0.64- 5.11)]. We found that males were 1.21 times more likely to be adherent than females [OR: 1.21, 95% CI (0.50- 2.93)] and smokers were 2.21 times more likely to be adherent than non-smokers [OR: 2.21, 95% CI (0.63-7.78)]. Multiple chronic conditions were significantly associated with a decrease in OC adherence, even after controlling for covariates [OR: 0.66, 95% CI (0.66- 0.95); p = 0.02]. Conclusions: Patients with fewer comorbidities receiving OC from specialty pharmacies were significantly more adherent than those with multiple comorbidities. Further studies examining the impact financial toxicity has on adherence for patients with chronic conditions are warranted.
Would patients benefit from a decision aid for surgical decision making for rectal cancer? A qualitative analysis.
Authors: Goldwag Jenaya , Saunders Catherine , Read Jackson , Durand Marie-Anne , Elwyn Glyn , Ivatury Srinivas J
Published: May 2020

e19139

Background: Rectal cancer surgery drastically changes the lives of patients. Decision aids available to guide patients on this decision are limited and of poor quality. We aimed to identify the content and delivery preferences of rectal cancer survivors who have faced this surgical decision and colorectal surgeons to guide future decision aid creation. Methods: We performed semi-structured interviews of survivors and their caregivers, as well as colorectal surgeons from April through August 2019. We purposively sampled patients treated surgically for rectal cancer and colorectal surgeons to include different demographics, surgical experiences, and practice types. We achieved thematic saturation in both groups. We performed dual coding and inductive thematic analysis. Results: A total of 30 participants were interviewed, 15 patients with 5 caregivers, and 10 colorectal surgeons. Patient demographics demonstrated an equal distribution of sex, age categories, and operative type. Physician demographics demonstrated a mean of 10±7 years in practice with 70% academic and 30% private practice. Main themes for both groups stated that a massive patient educational need exists throughout the continuum of disease into survivorship. Participants emphasized the need for a comprehensive educational tool to address these needs rather than a decision aid. Both wanted a tool that was personalized, simple, understandable, visually appealing, interactive, and delivered in a combination of modalities to capture the broadest audience. Patients also desired specific features like care timelines and resources. Surgeons felt than an educational tool would enhance patient/provider interaction by reinforcing material covered in clinic. Conclusions: A surgical decision aid for rectal cancer is not enough. Patients and surgeons acknowledged the need for a comprehensive tool to address the educational gap that exists through the continuum of rectal cancer care.
Emerging trends and utilization of patient-reported outcomes (PROs) in clinical trials of chimeric antigen receptor (CAR) T-cell therapies.
Authors: Messina Anthony John , Andrianov Vasily , Mazzolenis Daniel , Vidal-Fisher Liat
Published: May 2020

e19142

Background: Patient-reported outcomes (PROs) are an important tool to assess the impact of new therapies on health-related quality of life (HRQoL). This study aimed to describe if and what PRO instruments are currently being utilized in CAR-T cell therapy studies in solid and hematological malignancies while assessing the patterns of inclusion and trends of HRQoL data reporting. Methods: We used Citeline to search for clinical trials between Jan 2008 - Jan 2020, excluding planned or terminated studies, non-oncology, non-treatment, and duplicates. Reviewers extracted various parameters for included trials, then cross-matched data with EU Clinical Trials Register, Clinical trials.gov, trial protocols (when available), and Google. The reporting of PRO data was then assessed for those Closed/Completed trials that included a PRO via PubMed/MEDLINE, Sponsor, and Google. Results: A sample of 664 CAR-T trials was identified. PROs were included in only 6.17% (41/664) studies. Of the 41 trials that included a PRO, 63.41% (26/41) utilized more than one PRO, with the generic EORTC QLQ-C30 and the EQ-5D being used predominately. Median HRQoL follow-up was 5-years on most trials. No studies used PROs as primary endpoints. The majority of PROs were observed to be utilized in early phase trials (phase I, 12; Phase I/II, 17). PROs were first incorporated in CAR-T trials beginning in 2014, and the utilization rate has increased steadily, except for 2019. PROs were included in 3 first line trials, 22 second line, 5 third line, and 11 fourth line or greater. PRO utilization between solid tumor trials and hematologic malignancies was comparable (6.04% [9/149], and 6.26% [32/511]). Of the completed/closed trials, 28.57% (3/14) published PRO data and met at least eight of the CONSORT-PRO quality indicators. Conclusions: The utilization of PROs in CAR-T trials (6.17%) is under the industry average of 27%, despite the growing importance of HRQoL and its impact on value-based care. The findings from this review reflect the overall increased attention to CAR-T as a new therapeutic entity and the continued deficiency of including and reporting of PROs in trial designs.
NGS testing use and results: A survey of U.S. oncologists.
Authors: Smith Mary Lou , Railey Elda , White Carol B. , Dieterich Julianne S , Garrett-Mayer Elizabeth , Bruinooge Suanna S. , Freedman Andrew N. , De Moor Janet , Gray Stacy W.
Published: May 2020

e19145

Background: Scientific advances in genomics have ushered in new cancer tests and therapies. Many researchers, clinicians and advocates wonder how breakthroughs are implemented in practice. Methods: We examined Next Generation Sequencing (NGS) use, results, actions and outcomes among US oncologists (oncs) in treatment of their patients (pts) with advanced cancer (AC). 178 physician members of ASCO who used NGS for AC pts in past 3 months completed an online survey (response rate=30%). Results: Table shows NGS use, outcomes, and perceptions of treatment response among oncs who treat AC pts. Results from questions that were NOT asked by cancer type: 19% of respondents reported that NGS results guided treatment recommendations to a great extent, and 37% to a moderate extent, 65% reported tests often provided no actionable information; among oncs reporting NGS results provided actionable information, 31% reported they sometimes/often tried but couldn’t obtain the FDA-approved drug; respondents used many approaches to “decide what to do” with results. 83% explored trials, 68% reviewed scientific literature, 64% explored feasibility of FDA-indicated drug, 52% used NGS report recommendations, 47% talked with colleague, and 23% accessed molecular tumor board most (>60%) of the time. Conclusions: Oncologists reported high use of NGS results to guide treatment decisions for pts with select ACs and an associated benefit in some pts. Two-thirds of oncs often experienced lack of actionable information across a broad range of tumor types. Even when NGS yielded actionable information, it was common for oncs to experience problems obtaining FDA-approved drugs. The large number of approaches oncs used to make treatment decisions may suggest an important opportunity to improve decision-making efficiency in healthcare delivery. [Table: see text]
Real-world adoption of PD-L1 testing in metastatic urothelial carcinoma.
Authors: Gupta Shilpa , Maculaitis Martine C , Bernstein Andrew , Boudoures Anna , Tesic-Schnell Marija , Seal Brian S. , Mulvihill Emily , Doleh Yunes
Published: May 2020

e19184

Background: The role of PD-L1 testing in locally advanced (LA) or metastatic urothelial carcinoma (mUC) is not currently well-defined, except in cisplatin-ineligible patients (pts). IMVigor130 trial data are the first to suggest cisplatin-eligible PD-L1 positive pts may also benefit from immunotherapy (IO) (ESMO LBA14_PR, 2019). As clinical data accumulate on the influence of PD-L1 expression on LA/mUC pt outcomes with IO, we assessed medical oncologists’ (ONCs) PD-L1 testing perceptions and practices. Methods: ONCs completed a longitudinal, online self-report survey fielded from August 22 to September 23, 2019, prior to release of IMVigor130 data. Baseline results are reported. Descriptive statistics and bivariate comparisons by practice setting were conducted. Results: ONCs (N = 203) had a mean of 15 years in practice; a majority (64%) practice in the community. ONCs tested most LA/mUC pts, but initiated treatment for about a third before receiving results (Table). Half believe PD-L1 testing in LA/mUC will increase over time; this view was more common for ONCs who do not (n = 55) vs. do (n = 148) order PD-L1 testing as standard for LA/mUC pts (55% vs. 49%). Most ONCs reported that pts in an IO + chemotherapy trial arm should be stratified by PD-L1 status (74%), but not platinum agent (69%). Common barriers to more LA/mUC pts (n = 92) getting a PD-L1 test were limited biopsy sample (54%), lack of influence on treatment decisions (54%), and treatment initiation urgency (30%). ONCs varied little by practice setting. Conclusions: PD-L1 testing has been adopted by ONCs for most of their LA/mUC pts. However, ONCs report limited biopsy sample and lack of influence on treatment decisions as barriers to testing more LA/mUC pts, supporting their initiation of therapy prior to receipt of results and desire for trial data to be stratified by PD-L1 status. Results suggest PD-L1 expression is not yet a key driver in treatment decisions. Given the variability in self-reported responses, results should be interpreted with this limitation in mind. [Table: see text]
Implementing a genomic oncology program in an integrated health care network with large scale genomic Next Generation Sequencing (NGS) testing of advanced cancers in a community setting.
Authors: Suga Jennifer Marie , Thomas Sachdev P. , Truong Thach-Giao , Sundaresan Tilak Kumar , Pan Minggui , Kim Won , Hoodfar Elizabeth , Cheng Lirong , Chung Elaine , Tse Pamela , Achacoso Ninah , Jiang Chen , Goldstein Desiree , Habel Laurel A.
Published: May 2020

e19185

Background: The importance of NGS testing to help guide oncologic therapy decisions has grown over time, presenting a unique challenge for community oncologists to properly translate the NGS test results to treatment (Tx) recommendations for patients. Kaiser Permanente Northern California (KPNC) is a large, integrated health care system providing comprehensive primary and specialty care to 4.4 million members, with over 4000 patients (pts) diagnosed with advanced cancer each year. NGS testing at KPNC is performed in a collaboration with Strata Oncology, that provides systematized comprehensive NGS testing (StrataNGS) paired with a portfolio of genomically guided clinical trials. Methods: KPNC has established workflows for upfront empiric review of all NGS results by our KPNC Genomic Oncology Committee (GOC), that includes representatives from medical oncology subspecialists, genetics, pathology, and clinical trials. KPNC GOC reviews all StrataNGS test results in our KPNC network to identify patients that might benefit from either a clinical trial, appropriate on or off-label drug options and/or genetic counseling. In addition, GOC conducts an in-depth case review per request of the treating oncologist. A study nurse pre-screens all pts whose results match to a trial for eligibility. Results: The numbers of pts tested with StrataNGS has increased over time with around 300 pts tested monthly and 4,977 NGS tests performed since Nov 2017. Median age was 65.2 (Range 18.5-96.0). About 42.4% of Pts were non-white. Approximately, 39% of Pts had an actionable mutation including 21.7% eligible for a promising in or out of network trial. 1.6% and 10.9% pts were potentially eligible for off- or on-label approved drugs, respectively. 4.9% were recommended to receive genetic counseling. The 3 most frequently sequenced cancers were: lung, colon and breast. Conclusions: KPNC is providing systematic subspecialty review and management of NGS results for pts in a community setting. Our approach has allowed for greater adoption of routine NGS testing, especially for rare cancer types with less effective standard Tx options available. This model also helps accrual to genomic-based drug trials that have been a challenge for the field. Workflows to streamline automated centralized acquisition of prior Tx history and analysis of response to therapy are in development.
Pharmacist assistance for patients on oral oncologic therapy: Impact on adherence and costs.
Authors: Murad Junior Munir , Pegnolato Suellen , Lodi Luiz Adelmo , Marcolino Milena , Fonseca Roberto Porto
Published: May 2020

e19198

Background: Oral cancer treatment has becoming progressively more frequent and its costs are rising. To implement strategies that monitor adverse effects, adherence and manage financial resources is of utmost importance. Our goal is to develop an intervention based on pharmaceutical monitoring that promotes the correct use of medication through the early identification of adverse events, as well as to describe an economic analysis of this intervention. Methods: Quasi-experimental study, which included consecutive patients from a private oncologic clinic in Belo Horizonte, Southeast Brazil, who were taking oral medications for the treatment of cancer. Patients had regular consultations with pharmacists, at the beginning of each treatment cycle. The consultation consisted of the assessment of adherence (if they took at least 80% of the pills on a specific period of time) and adverse effects. The number of pills dispensed in the new cycle was adjusted by the number of pills remaining in the previous cycle. Prices were calculated using Brasindice and the dollar price of Feb/2020. Follow-up period was from Oct/2018 to Nov/2019. Results: Throughout the study, 1224 patients were included: 86% female, mean age 63 years, 37% had at least 7 years education. Breast cancer accounted for 77% and prostate cancer for 6% of the patients, and 23% of all patients were treating stage IV cancer. The most used treatments were tamoxifen (44%) anastrazole (34%) and capecitabine (3%). In total, 10.640 pharmacists consultations were performed, which corresponds, on average, 887 consultations per month and 8.7 per patient. On average, 88.6% were adherent to the medication. In 50% of those consultations, patients reported adverse effects (hot flashes 42%, musculoskeletal syndrome 22%, fatigue 14%, cramps 7%). In that scenario, pharmaceutical care has resulted in total savings of 4067 pills or $ 136,854.89 (Table). Conclusions: Pharmaceutical care was responsible for high rates of adherence, despite the high frequency of adverse effects, and also promoted cost savings. [Table: see text]
Barriers to goals of care discussion and early palliative care referral in patients with advanced cancer: A community oncology clinic survey.
Authors: Maradana Sandhya , Kate Yugandhara , Pandey Deepali , Syed Masood Pasha , Velamala Pruthvi Raj , Patil Shekhar , Siddiqui Ahmad Daniyal
Published: May 2020

e19199

Background: Earlier discussion of end-of-life (EOL) preferences in patients with advanced cancer is associated with less aggressive EOL care. Most terminally-ill patients have not discussed their goals of care (GOC) with their healthcare providers before becoming acutely ill. Identifying various barriers in the outpatient setting might help improve GOC discussion and EOL experience for patients with advanced cancer. Methods: This cross sectional survey was designed after a thorough literature review and distributed to internal medicine residents, oncologists and oncology nurses involved in patient care in an outpatient cancer center at a community hospital. Barriers to GOC discussions and early palliative care (PC) referral were assessed on a 7-point Likert scale (1 = extremely unimportant; 7 = extremely important). Most important barrier was defined by people ranking it as very important or extremely important (6 or 7). A total of 33 health care providers were included in the final analysis. Trends were reported using descriptive statistics. Results: Patient/family related barriers were ranked the highest overall. 88% of respondents perceived patient’s difficulty in accepting prognosis as most important, followed by lack of agreement among family members (82%) and patient wanting to be 'aggressive' (82%). Among groups, 100% (6 of 6) oncologists perceived patient wanting to be ‘aggressive’ as the most important barrier, whereas disagreement among family members and patient’s difficulty in accepting poor prognosis was perceived as most important by 88% (7 of 8) nurses and 84% (16 of 19) residents respectively. Nurses also ranked patient's difficulty in understanding limitations of life sustaining treatments high. 67% of respondents, especially nurses and residents, perceived lack of training to have GOC conversations as the most important health care provider related barrier. Patient’s refusal for PC services was rated as the most important barrier for early PC referral by 61% of respondents, however, oncologists (100%) ranked lack of outpatient PC services the highest. Conclusions: These results emphasize the need for better resources to improve communication between health care providers and cancer patients in an outpatient setting. Initiatives such as formal training and targeted education in communication about GOC to health care providers can be instrumental in addressing these barriers. Integration of outpatient palliative care services into community-based oncology can be beneficial.
Evaluation of high-dose methotrexate serum concentration requirement for discharge.
Authors: Yellala Amulya , Dhakal Prajwal , Deason Brooke , Liewer Susanne , Kallam Avyakta , Lunning Matthew Alexander , Bierman Philip Jay , Vose Julie , Bociek Gregory
Published: May 2020

e19204

Background: Methotrexate (MTX) is used in high doses for the treatment of ALL, lymphoma, and metastatic breast cancer with CNS involvement. To avoid drug accumulation and mitigate toxicities caused by delayed clearance, patients (pts) are usually admitted to the hospital and standard supportive care with IV hydration, urinary alkalization, and leucovorin is provided and adjusted based on daily levels. Historically, a serum methotrexate level ≤ 0.05 µmol/L has been used to declare clearance and an ideal level for discharge based on studies conducted in the 1970s. We conducted a retrospective review in 2018 to identify frequency of supportive dose escalations required with MTX levels > 0.05 µmol/L. In 69 pts, 4 patients demonstrated delayed renal clearance and required supportive care escalations but all occurred at MTX levels > 0.3 µmol/L. This led to a proposed pilot discharge process once MTX was < 0.3 µmol/L to confirm the safety of earlier discharge. Methods: A retrospective chart review of pts with baseline CrCl ≥60 who received HD MTX between 07/2018 – 08/2019. Data collection included diagnosis, MTX discharge level, supportive care at discharge including PO Leucovorin and PO sodium bicarbonate and number of days supply, post-discharge complications (AKI, mucositis, fever, others). Primary outcome was the number of patients who required inpatient or outpatient supportive care for acute complications after being discharged with a methotrexate level ≥ 0.1 µmol/L. Descriptive statistics were used. Results: A total of 41 pts were included. Median age was 55 yrs (32-78), 25% were male. 73% were treated for DLBCL, median dose of MTX was 3500 mg/m2. Median MTX level at the time of discharge was 0.16 µmol/L (0.1-0.3 µmol/L). 12 pts were discharged with PO Leucovorin and 15 pts were discharged with both Leucovorin and PO Sodium bicarbonate with an average of 2 day’s supply. 1 acute complication of neutropenic fever requiring admission for inpatient antibiotics occurred which was felt to be unrelated to MTX level at discharge. Conclusions: This pilot suggests that pts can be safely discharged with MTX levels upto 0.3 µmol/L without acute complications. Results of this study will be used to a develop a standardized protocol outlining criteria for early discharge in select pts with MTX levels < 0.3 µmol/L to reduce length of stay, cost of hospitalization and improve patient satisfaction. [Table: see text]
Selection of a set of quality indicators (QIs) for oncological clinical pathway with patient associations and healthcare professionals.
Authors: Di Palma Mario , Fourcade Aude , Ferrua Marie , Chirrane Mariem , Daouphars Mikaël , Berger Virginie , Clairaz-Mahiou Béatrice , Bezie Yvonnick , Garibbo Audrey , Giacchetti Sylvie , Tournigand Christophe , Minvielle Etienne
Published: May 2020

e19221

Background: Clinical pathways in oncology are increasingly complex and involve many healthcare professionals inside and outside the hospital. The available QIs focus on hospital care, few of them describe the entire clinical pathway. Our objective is to select a set of QIs for oncological clinical pathway by involving hospital professionnals, patient associations and non-hospital professionals (GPs, pharmacists and private nurses). The step described concerns the research conducted with hospital professionals and 11 patient associations. Methods: A review of available QIs assessing the clinical pathway was conducted from the gray literature and literature reviews. Selection criteria were applied to extract oncological clinical pathway indicators. The list of identified QIs was submitted to two working groups: hospital professionals (26 oncologists, pharmacists and SRNs of various hospitals in France) and patient associations. Two meetings in each group were necessary. The first one to select by consensus (nominal group) the QIs on the basis of their rating on relevance and feasibility. The second, to describe precisely the QIs selected. Results: 5731 QIs were identified in the initiatives, 131 QIs related to oncological clinical pathway were presented. 10 QIs were selected by hospital professionals: outcome (2), process (3) and structure (5). 10 QIs were retained by patient associations: process (4), structure (2) and outcome (4). Both groups selected QIs on symptom assessment, adherence to treatment, access to palliative care and management of patients receiving oral therapy. They also emphasized the need to gather information directly from patients by selecting PREMS on patients’ experience and PROMS on quality of life, emotional state, symptoms and toxicity. Conclusions: The QIs selected responds to a real need for oncological clinical pathway in France. The next step will be to carry out the same work with non hospital professionals to have a representative set of all actors. The QIs will then be collected from the hospitals experts in France and in Europe to validate their metrological qualities.
Assessing patient satisfaction after comprehensive medication review including oral chemotherapy adherence with an oncology pharmacist at the Southcoast Centers for Cancer Care (SCCC).
Authors: Skeffington Patrick John , Haynes Laura , Raymond Donna , McCarthy Heather
Published: May 2020

e19241

Background: Use of oral chemotherapy has increased dramatically over the past few years. Patient often are required to obtain their oral chemotherapy from a third party specialty pharmacy while continuing to receive their other medications from other pharmacies. Many community pharmacists lack knowledge about oral chemotherapy, safe practices, or effective counseling of these medications. Objective: To assess patient perception and satisfaction of a pharmacist 1 on 1 appointment when starting oral chemotherapy. Methods: A program was designed at SCCC whereby all patients starting oral chemotherapy are scheduled for an appointment with a clinical oncology pharmacist to update medication lists, evaluate adherence, and conduct a "brown bag" visit where patients are allowed to voice concerns and ask questions. After each appointment patients were asked to fill out a short survey, The Patient Satisfaction with Pharmacist Services Questionnaire (PSPSQ 2.0). Results: PSPSQ 2.0 uses a Likert scale ranging from 1 to 4. From October 2016 to June 2019, 174 patients had appointments and 55 returned their surveys yielding a 30% response rate. Average scores hovered around 1 (strongly agree) for each question except question 11 (the only negatively worded question). Question 11 averaged 3.1; Disagree. Conclusions: Patients who were seen by an oncology clinical pharmacist to evaluate adherence, participate in a "brown bag" clinic and open discussion, found the appointment worthy of their time.
Physician burnout: An innovative way to find “sanity out of madness” in the infusion center of a cancer institute.
Authors: Sewaralthahab Sarah , Thorne Shaunika , King Linda , Goswami Debolina , Gallagher Christopher , Kaufman Laura , Veytsman Irina
Published: May 2020

e19246

Background: Physician burnout is affecting over 50% of physicians in the US alone and is related to the high workload, loss of anonymity and a sense of powerlessness in the face of multiple bureaucratic hurdles. The result is physical exhaustion, moral distress, high turnover and increased rates of suicide. Methods: The faculty and staff at Washington Cancer Institute (WCI) were surveyed using AMA/ASCO burnout questionnaire to identify burnout rates. A brainstorming session with staff captured the perceived causes of burnout in a fishbone diagram, and the most prominent cause was noted to be pertaining to delays in the infusion center (IC) related to chemotherapy orders. We tracked causes of delay in starting chemotherapy from 7/23/19 to 8/7/19, and utilizing a Pareto Chart identified that over 80% of the delays were due to missing chemotherapy orders on the day of IC appointment. Process flow charts were developed for all provider teams at WCI noting variations that may be leading to delays. The aim was to decrease the number of missing chemotherapy orders for patients coming to the IC by 50%, decreasing the resultant stress on providers and IC nurses. Results: By retrospective chart review, 6/21/2019 to 8/30/ 2019, an average of 13.18% of patients scheduled to receive chemotherapy at WCI IC had missing orders on the day of the infusion, which resulted in up to a 111-minute delay in starting chemotherapy. This, in turn, resulted in stress/burnout among 42.1% of providers and 55.6% of supportive staff. To remedy the problem, we implemented 4 interventions over two plan-do-study-act (PDSA) cycles. In the first PDSA cycle the process was standardized to obtain necessary labs 48 hours prior to IC appointment and review and sign orders by 2 pm the day prior to IC appointment. Email notifications were also sent to all providers and nurse navigators regarding missing orders 48 hours prior to IC appointment. In the second PDSA cycle we continued with the previous interventions in addition to addressing pharmacy related delays in releasing premedication if dose adjustments of chemotherapy are needed. In the time period of 10/2/2019 to 11/11/2019, two PDSA cycles were implemented and resulted in a decrease in the average number of missing orders on the day of IC appointment to 7% achieving our aim. Conclusions: Using a systems approach to standardize the process promotes a more effective environment in the work place and decreases burnout on physicians and staff.
Incorporating molecular markers in standard prognostic models for DLBCL patients using real-world data.
Authors: Mathura Shivam , Fung Vicki Kay , Dilwali Keshava , Lakshmanan Ashwin Subramanian
Published: May 2020

e19251

Background: NCCN-IPI is a prognostic scoring system that outperforms other risk classification mechanisms in diffuse large B-cell lymphoma (DLBCL) but does not consider the molecular profile of patients. We evaluated the predictive value of NCCN-IPI and clinically relevant molecular markers on the overall survival (OS) of patients with diagnosed DLBCL in real-world data (RWD). Methods: Patients diagnosed with DLBCL were identified in the COTA RWD population, and then subset to those with sufficient attributes to calculate NCCN-IPI at diagnosis (age, stage, LDH ratio, performance status, extranodal disease) and those who received a monoclonal antibody targeting CD20 (n = 383). This population was further filtered to patients tested for BCL-2, BCL-6, and C-MYC (n = 176). Disease characteristics were summarized using descriptive statistics and chi-square tests of independence were performed to assess the relationship between NCCN-IPI Risk-Group and molecular marker results. A Cox proportional hazard model was used to identify prognostic features of OS. Results: There were statistically significant relationships between NCCN-IPI Risk-Group and both BCL-2 (p = 0.007) and C-MYC (p < 0.001) after Bonferroni correction for the number of molecular markers tested. A Cox proportional hazard model with the three molecular markers as covariates revealed a statistically significant correlation between the presence of C-MYC alteration and decreased OS (HR = 2.02, CI: 1.24-3.32, p = 0.005). However, when NCCN-IPI Risk-Group was added as a covariate, the relationship between C-MYC and OS was no longer significant. The hazard ratios associated with high-intermediate and high risk groups were larger than that of the low-intermediate group. All three of these risk groups were statistically significant in the model (p < 0.038). Conclusions: The inclusion of molecular markers to the NCCN-IPI prognostic model did not increase predictive power in this RWD cohort. We validated the NCCN-IPI model and found it to be a robust tool for classifying risk and estimating OS in patients who have received a CD20 monoclonal antibody. A larger sample size would increase power to further explore the impact of molecular markers on overall survival. [Table: see text]
The role of non-oncology specialties in the real world longitudinal journey of prostate cancer patients.
Authors: Carnegie Daniel , Argentinis Elenee , Mazumder Dibyajyoti , Dhangar Indu
Published: May 2020

e19255

Background: Electronic health records (EHRs) are increasingly being recognized by regulators and researchers as reliable sources of evidence. It is therefore critical that real world evidence databases accurately reflect all diagnostics and interventions that could affect patient outcomes. Some of the commercially available datasets source data solely from oncology clinics, which may not reflect patients’ full care journey. This analysis assessed the contribution of non-oncology specialties to prostate cancer care. Methods: Newly diagnosed prostate cancer patients with encounters between Jan 2014 to Dec 2017 were analyzed from the deidentified Optum Electronic Health Record Data Repository. Diagnostic procedures 6 months prior to the index date (first diagnosis date within the study period) and 1 year post index date were identified. Attending physician specialties were identified. All treatment related encounters up to 1 year post the index dates were mapped by specialty. Codes were verified by certified medical professional. Results: A total of 186,299 prostate cancer patients were identified between Jan 2014 to Dec 2017. In the 6 months prior to index date, biopsy was most commonly ordered by urologists (70%), followed by surgical specialists (14%). Biomarker tests were ordered mostly by general practitioners (40%) followed by urologists (18%). The trend was similar for 1 year post biopsy and other histology procedures. Interestingly, a large portion of treatment encounters was observed outside oncology: 48% of surgical management by urologists (48%), chemotherapy was prescribed by both oncologists (27%) and urologists (31%) in a similar ratio, while radiotherapy was performed predominantly by radiation oncologists (81%). Conclusions: In prostate cancer, a large proportion of care encounters occur outside oncology specialties, with urology conducting a significant proportion of diagnostic testing and early treatment. Restricting source data to oncology specialties may omit key factors affecting patients’ outcomes, therefore data for such studies should reflect the entire care continuum.
Hepatic failure in malignancy: A nationwide analysis.
Authors: Baral Binav , Vohra Ishaan , Attar Bashar , Katiyar Vatsala , Lingamaneni Prasanth , Moturi Krishna Rekha , Banskota Shristi Upadhyay , Malapati Sindhu Janarthanam , Singh Sunny R K , Farooq Muhammad Zain , Ba Aqeel Sheeba Habeeb , Gupta Shweta
Published: May 2020

e19257

Background: Hepatic failure (HeF) accounts for 6% of all liver-related mortality and 7% liver transplants (LT) in the US. Epidemiologically, while viral hepatitis, acetaminophen and drug injuries are common; malignancy-related HeF remains relatively unexplored. Methods: We performed a retrospective study using nationwide inpatient database (NIS) 2016, which is the largest US inpatient database. HeF admissions were identified as primary diagnosis (through ICD-10 codes) and stratified into two major groups with and without cancer. The cancer group was subdivided into solid (excluding hepato-cellular cancer (HCC)) and non-solid malignancies. Primary outcome was inpatient mortality while secondary outcomes included Length of stay (LOS), Total charge (TCHG), LT and respiratory failure requiring ventilation (MV). Results: 71,000 inpatients met inclusion criteria for HeF, of which 7,715(10.87%) had an underlying malignancy. 39.4%( n = 3,045) had solid malignancies (excluding HCC), 8.4%( n = 650) had non-solid malignancies and 56%( n = 4,020) had HCC. Mean LOS was 5.4 days (95% CI 5.4-5.6, p = 0.23) and mean TCHG was 63,240$(95% CI 57,258$-69,222$, p = 0.03). African Americans (61.2 % vs 53.6%, p = 0.001) and males (12.05% vs 8.71%, p = 0.001) were preponderant in the cancer group. Inpatient mortality was higher in the cancer group (15.3% vs 5.5% p = 0.000), among which solid cancer (20.39%) predominated over non-solids (13.85%) and HCC (11.71%). LT was higher in cancer group (3.7 % vs 2%), whereas no difference in MV was found. Multivariable analysis results are summarized in the table below. Conclusions: HeF patients with underlying malignancy have higher mortality, LOS, TCHG and LT rates. Furthermore, high median income, large center admissions, HCC and Charlson index < = 3 among others were associated with higher odds of undergoing LT in HeF. This study sheds light on the epidemiology and impact of HeF in cancers, as well as disparities in LT among GI cancer patients with HeF. [Table: see text]
Safety of immunotherapy in Peruvian patients with diverse type of malignancies: Experience at a private center.
Authors: Aguilar Alfredo , Mariñas Michelle , Bravo Leny , Zavaleta Jenny , Pinto Joseph , Ruiz Rossana , Schwarz Luis
Published: May 2020

e19258

Background: Immunotherapy has changed the landscape of cancer treatment. The aim of this work was to describe the adverse events related to immunotherapy treatment in diverse type of malignant tumors using real-world data. Methods: This is a retrospective review of patients with diverse type of advanced malignancies treated with immunotherapy at Oncosalud-AUNA (Lima-Peru) during the period 2016-2018. We present a descriptive analysis of the clinicopathological and treatment features of the patients, as well as data of safety of immunotherapeutic agents. Results: In total, 37 patients were included in the study. The median age was 67 years (38 to 84 years); 64.9% of patients were male; 54.1% were smoker/former smoker and 45.9% non-smokers. Regarding to the primary tumor, 75.7% were lung cancers (82.1%, adenocarcinomas and 17.9%, squamous cell carcinomas), 16.2% were melanomas, 5.4, head and neck cancers and 2.7%, were bladder cancers. Central nervous system metastases were present in 29.7% of patients. Immunotherapy was given after a first line in 43.2% of cases, 40.5% after the second line and 16.2%, after the third line of treatment. The types of immunotherapy were prembrolizumab in 54.1%, nivolumab in 40.5%, atezolizumab in 2.7% and avelumab in 2.7%. 27% of cases had combination of immuno with chemotherapy. Finally, regarding to adverse events, 94.6% had any adverse event; 48.6% fatigue and asthenia; 35.1%, nausea; 32.4, pruritus/rash; 27.7%, decreased appetite; 18.9%, hypo/hyperthyroidism; 13.5%, diarrhea/colitis; 10.8%, pneumonitis and 5.4%, infusion-related reactions. Conclusions: During the study period we had a slightly higher incidence of adverse events than reported by other works. It could be probably due to the age of patients and several prior lines of treatment.
Clinical outcomes of pancreas cancer patients with peritoneal spread: Results from the chord consortium.
Authors: Pauls Mehrnoosh , AlJassim AlShareef Abdulaziz , Cheung Winson Y. , Goodwin Rachel Anne , Meyers Brandon M. , Kim Christina , Vickers Michael M.
Published: May 2020

e19268

Background: Prior studies have demonstrated that clonal cells that give rise to pancreatic peritoneal metastases (PM) are geographically and genetically distinct from clonal cells, giving rise to lung and liver metastases. The objective of this study was to assess if there is a distinct difference in prognosis and therapeutic response among patients with pancreatic cancer with (PM compared to the lung/liver. Methods: Using a retrospective cohort design, medical records from adult patients diagnosed with metastatic adenocarcinoma of the pancreas at five Canadian academic cancer centers (2014 - 2019) were reviewed. Prognostic variables including age, Charlson comorbidity index, ECOG, cigarette smoking, nodal status, sites of metastases, and first line chemotherapy were collected. Cox proportional hazards model (MVA) was used to examine the association between peritoneal involvement and survival, adjusted for measured confounders. Analyses were completed using SAS, where alpha of 0.05 was defined as the level of significance. Results: A total of 1161 patients were included. Metastatic sites included peritoneum (n = 170, 14.6%), lung (n = 145, 12.5%) and liver (n = 563, 48.5%). Patients with PM received first-line FOLFIRINOX (FFX, n = 31), Gemcitabine + nab-paclitaxel (G/N, n = 20), Gemcitabine (G, n = 18), and no treatment (n = 97). In univariate analyses, worse ECOG PS was associated with PM (p = 0.002). The majority of patients died (89%), with a median overall survival (OS) of 3 vs 7 months for patients with PM and those without PM (p < 0.001), respectively. The median OS in patient whom receive first-line chemotherapy was 7 months in FFX group (95% CI 1.66-12.33), 6 months in G/N (95% CI 4.54-7.45) and 2 months in G group (95% CI 1.42-2.57). Patients had significantly better OS when treated with FFX or G/N compared to G alone (p = 0.002). Time to treatment failure was significantly shorter among patient treated with G alone compare to patients treated with FFX and G/N (P < 0.005). Conclusions: In the setting of combination chemotherapy for advanced pancreatic cancer, patients with PM continue to have a poor prognosis. This may be due to the impact of PM on PS and the inability to administer palliative chemotherapy. For eligible patients, FFX or G/N results in a higher OS than G monotherapy.
Overall survival (OS) in advanced non-small cell lung cancer (aNSCLC) patients treated with frontline chemotherapy or immunotherapy by comorbidity: A real-world data (RWD) collaboration.
Authors: Rivera Donna R. R , Lasiter Laura , Christian Jennifer , Enewold Lindsey , Espirito Janet L. , Hansen Eric , Henk Henry J. , Kushi Lawrence H. , Lane Daniel , Natanzon Yanina , Pe Benito Ruth , Rasmussen Erik , Robert Nicholas J. , Stewart Mark , Sweetnam Connor , Tymejczyk Olga , Valice Emily , Wagner Joseph , Zander Alia , Allen Jeff
Published: May 2020

e19270

Background: Friends of Cancer Research convened 9 data partners to identify data elements and common definitions for real world (rw) endpoints to evaluate populations typically excluded from clinical trials. Here we report on rwOS by frontline treatment and comorbidities. Methods: A retrospective observational analysis of patients with aNSCLC initiating frontline platinum doublet chemotherapy (chemo) or PD-(L)1-based immuno-oncologic (IO) therapy (monotherapy or chemo combination) between 1 Jan 2011 to 31 Mar 2018 was conducted using administrative claims, EHR, and cancer registry RWD. We evaluated rwOS from frontline therapy initiation using Kaplan-Meier methods, stratified by ECOG status, brain metastases (ICD), history of chronic kidney or liver disease (CKD/ CLD, ICD), and evidence of kidney or liver dysfunction (KD/ LD, lab-based). Results: A total of 33,649 patients were included (N 972-17,454) with 10 to 26% of patients receiving IO as frontline therapy. There was a broad range of comorbidity prevalence across datasets and patients with evidence of comorbidity had comparatively shorter 12-month OS (Table). Conclusions: RWD analyses can generate expanded evidence on patient outcomes for populations routinely excluded from clinical trials and may help inform decision making where sparse data exist on appropriate treatment approaches. Additional understanding of data missingness, sensitivity of definitions, and covariate adjustment are needed to make direct comparisons across regimens and data sources. [Table: see text]