bluuebunny/crossref_metadata_2025 huggingface dataset:
Early case ascertainment and prospective multidisciplinary review for management of new melanoma diagnoses within an integrated healthcare system: The Kaiser Permanente Northern California experience.
Authors: Truong Thach-Giao , Chohan Kirun , Price Angeles , Fevrier Helene B , Peng Peter D , Kavanagh Maihgan A , Jones Maris S , Soni Alpana X , Price Mark A , Rasgon Barry M , Adad Basil , Martin Paul A , Rangel Javier , Kavecansky Juraj , Reddy Mala N. , Wang Stephen E. , Herrinton Lisa J. , Kolevska Tatjana , Morris James P , Chang Ching-Kuo
Published: May 2019

6523

Background: Appropriate surgical treatment of early-stage melanoma yields a high cure rate, but this management can be nuanced. In particular, surgical management, including sentinel lymph node biopsy (SLNB), of thin melanoma (≤1.0mm) is not well-defined. Methods: Biopsies with new melanoma diagnoses were identified electronically and manually reviewed. In a community oncology setting, we organized a review panel of physicians specialized in melanoma from dermatology, medical oncology, nuclear medicine, radiation oncology, and surgical subspecialties (oncology, plastics, head and neck). Patients were assigned to care pathways based on NCCN and ASCO guidelines, including guidance on SLNB for thin melanomas with high-risk features like lymphovascular invasion, high mitotic rate, positive deep margin, and ulceration. These recommendations were documented in the chart and communicated directly to the patients care team. Results: From 11/2016 through 10/2018, our multidisciplinary committee reviewed 3626 patients with new melanoma from 22 sites in our integrated, regional hospital system. Median age was 66 (range 19-99); 60% were male. cT2N0 tumors comprised 7%, cT3 3%, and cT4 2%. Thin melanomas ≤1.0mm represented 71% of cases, of which 34% were ≤0.5mm. SLNB was performed in 9.8% of thin melanomas, and 18% were positive, much higher than historical positive rates of 3-4%. Conclusions: Early case ascertainment and prospective multidisciplinary review in a community oncology setting resulted in increased identification of high-risk thin melanoma, and consequently increased identification of nodal disease through SLNB. Positive SLNB triggers important clinical decision-making regarding need for node dissection versus clinical surveillance, and need for adjuvant therapy, which have been shown to improve survival. This clinical practice structure improved risk-stratification and adherence to national guidelines. We plan to further study the impact of these improvements to melanoma care on disease-free survival and overall survival.
Effect of exercise during adjuvant chemotherapy for breast cancer.
Authors: Haas Barbara K , Osborne Cynthia R. C. , Vukelja Svetislava J. , Selman Jennifer , Davis Trevor , Kimmel Gary T. ,   Texas Oncology-Tyler and Texas Oncology-Baylor Charles A. Sammons Cancer Center
Published: May 2019

6524

Background: In 2018, an estimated 266,120 women faced the challenge of living with breast cancer and approximately 40,920 died from their disease. Nearly 100% of these women experienced significant treatment related side effects that negatively impact quality of life (QOL). Exercise has repeatedly demonstrated to alleviate many of the side effects, improve QOL, and decrease cancer recurrence and mortality. In spite of this evidence, women do not maintain exercise during treatment for breast cancer. The purpose of this randomized controlled trial was to determine the effectiveness of exercising the day chemotherapy is administered on 1) the persistence with an exercise program, 2) side effects, and 3) QOL. Methods: Eligible women were randomly assigned to a control or experimental group. As part of their treatment plan, all participants were referred to one of 14 community-based exercise centers to exercise. Experimental group also exercised at one of two cancer centers each day chemotherapy was administered. Outcome measures include exercise retention and chemotherapy, completion; cancer-related fatigue, nausea/vomiting, peripheral neuropathy, weight gain, and QOL. Outcome measures were assessed prior to every second course of chemotherapy and 3- and 6-months post-chemotherapy. Results: 273 women with Stage I-III breast cancer receiving chemotherapy were enrolled in the study. The number of participants who withdrew from exercise was higher among those in the control group (n= 16; 12.4%) compared with those in the experimental group (n = 10; 6.9%). At cycle 5, those in the experimental group reported less motor peripheral neuropathy than those in the control group (p = .018) and higher physical well-being scores than those in the control group (p = .047). Conclusions: The highest impact of the intervention was on attrition from exercise. Since participants in both the control and experimental groups exercised throughout chemotherapy, it is not surprising that the groups performed comparably with regard to side effects and QOL. Given the positive effects exercise has demonstrated on persons receiving cancer treatment in numerous studies, having patients exercise in the cancer center on the day of chemotherapy is a significant step toward engaging persons receiving chemotherapy in an exercise program.
Clinical outcomes and cost-effectiveness of breast cancer screening for childhood cancer survivors treated with chest radiation: A comparative modeling study.
Authors: Yeh Jennifer , Lowry Kathryn P. , Schechter Clyde B. , Diller Lisa , Alagoz Oguzhan , Armstrong Gregory T. , Hampton John M. , Leisenring Wendy , Liu Qi , Mandelblatt Jeanne S. , Miglioretti Diana L , Moskowitz Chaya S. , Oeffinger Kevin C. , Trentham-Dietz Amy , Stout Natasha K.
Published: May 2019

6525

Background: Survivors of childhood cancer previously treated with chest radiation face elevated breast cancer risk similar to BRCA1 carriers. Children’s Oncology Group (COG) guidelines recommend annual mammography with breast MRI, yet the benefits and costs of various screening strategies are uncertain. Methods: We used two breast cancer simulation models (Model 1 and 2) from the Cancer Intervention and Surveillance Modeling Network (CISNET) and data from the Childhood Cancer Survivor Study to reflect high breast cancer and competing mortality risks among survivors. We simulated 3 screening strategies: annual mammography with MRI starting at age 25 (COG25), annual MRI starting at 25 (MRI25), and biennial mammography starting at 50 (Mammo50). Performance of mammography+/-MRI was based on published studies in BRCA1/2 carriers who have similar cancer risk. Costs and quality of life weights were based on US averages and published studies. Results: Among a simulated cohort of 25-year-old survivors treated with chest radiation, the lifetime breast cancer mortality risk in the absence of screening was 10-11% across models. Compared to no screening, Mammo50, MRI25, and COG25 screening avert approximately 23-25%, 56-62% and 56-71% of deaths, respectively; averted deaths for COG25 compared to MRI25 were higher in Model 1 than Model 2 (9% vs. <1%). In Model 1, both MRI25 and COG25 were cost-effective; in Model 2, MRI25 was preferable (more effective, less costly than COG25). Conclusions: Compared to no screening, initiating annual screening at younger ages for at-risk survivors averts >50% of breast cancer deaths and is cost-effective. Additional data on test performance are needed to inform recommendations on screening modality. [Table: see text]
Use, attitudes, and perceptions of tumor genomic testing: Survey of TAPUR physicians.
Authors: Bruinooge Suanna S. , Dueck Amylou C. , Gray Stacy W. , Butler Nicole L. , White Carol B. , Smith Mary Lou , Mangat Pam K. , Kurian Allison W. , Railey Elda , Hawley Sarah T. , Schilsky Richard L.
Published: May 2019

6531

Background: This survey of Targeted Agent and Profiling Utilization Registry (TAPUR) Study physicians examined use, attitudes, and perception of tumor genomic testing (TGT), defined as any DNA test performed on tumor specimen/plasma. TAPUR is a multibasket study of marketed agents targeting tumor genomics. Methods: 333 physicians at 54 TAPUR sites were surveyed (2016-2017). Survey domains included use of TGT, barriers to ordering TGT, and genomic confidence. Surveys included 3 scenarios for TGT ordering 1) pretreated advanced cancer patients (pts) without options, 2) newly diagnosed, untreated, metastatic pts and 3) early stage/potentially curable pts with standard options. Data were analyzed with descriptive statistics. Results: 112 physicians responded (33%). The table displays demographics and genomic confidence. Respondents reported a median of 25% of their pts had TGT in past 12 months for trials/routine care (range 0-85%). Barriers to testing included access to tumor specimen (86%), insurance coverage (67%), concerns that results will not be actionable (55%), and test issues (wait time, unsure which test/lab to use, test accuracy) (54%). TGT was ordered most often for scenario 1 (96%) and 2 pts (70%). Few respondents (32%) would order testing in scenario 3. Of those who reported testing for scenarios 1 & 2, most told pts that results could inform treatment/prognosis/trials (97%) or may be uninformative (84%). In all scenarios, pt expectations of TGT results were discussed prior to testing. A minority reported frequently telling pts in advance that results could inform heritable cancer susceptibility (37%). Conclusions: Confidence in using TGT was high. TGT was performed most for pts with advanced cancer and few options. Availability of specimens was largest barrier reported, indicating the importance of blood-based tests. Few respondents discussed implications of germline findings in advance, despite growing evidence of germline findings in somatic testing. [Table: see text]
A prospective blinded study of 1000 cases analyzing the role of artificial intelligence: Watson for oncology and change in decision making of a Multidisciplinary Tumor Board (MDT) from a tertiary care cancer center.
Authors: Somashekhar S.P. , Sepúlveda Martín-J. , Shortliffe Edward H , C Rohit Kumar , Rauthan Amit , Patil Poonam , Yethadka Ramya
Published: May 2019

6533

Background: Artificial intelligence is being used to provide support for information-intensive decision making. In this report, we present our experience in explaining how artificial intelligence adds value to MDT’s decision making ability & paves way for personalized therapy. Methods: 1000 cases involving breast, lung, and colorectal cancer were evaluated by a multidisciplinary tumor board at a major cancer center in India between 2016 and 2018. After the tumor board decision was made, MDT was presented with the Watsons recommendations contemporaneously. MDT reviewed their decision after going through Watson’s recommendations and also the evidences that it put forth supporting its decision. Cases in which decision was changed, objective assessment was done by asking MDT to quote the reasons for reviewing and changing their decision. Results: Of 1000 cases, breast, lung, colon & rectal cancers were 620, 130,126 & 124 respectively. There were 712 non-metastatic & 288 metastatic cases. Mean age of the patients was 54.3 ± 12.2. Treatment concordance was observed in 92% for all cancers combined, 93% for rectal cancer, 92% for breast cancer, 89% for lung cancer, and 81% for colon cancer.MDT changed their decision in 136 cases (13.6%). The reasons for tumour board to change their decision was, Watson provided recent evidences for newer treatment in 55%, better personalized alternative in 30% & new insights from genotypic and phenotypic data and evolving clinical experiences in 15% of time. Conclusions: The study suggest that cognitive computing decision support system holds substantial promise to reduce the cognitive burden on oncologists by providing expert, updated, recent evidence-based insights for treatment-related decision-making. The 13.6 % incremental advantage over and above in a tertiary cancer centre with functioning MDT speaks in itself the value of having a learned colleague like Watson for oncology at our disposal. It will certainly add more value in settings lacking ready access to high quality cancer expertise and information. These systems can be valuable adjuncts to strong patient-clinician relationships in the delivery of high quality cancer care.
Leveraging a conversational agent to support adherence to oral anticancer agents: A usability study.
Authors: Mooney Berges Bethany , Cambareri Christine , Takvorian Samuel U , Serpa Mike , Shulman Lawrence N. , Bekelman Justin E. , Rendle Katharine A. , Argon Jesse , Rosin Roy
Published: May 2019

6534

Background: Identifying effective, scalable strategies to ensure patient adherence to oral anticancer agents (OACAs) is a major challenge. Previous studies have shown widely variable rates of adherence, and suboptimal adherence is associated with decreased effectiveness and higher costs. A small but growing literature supports digital health behavioral interventions across a variety of chronic illnesses, including in cancer. In particular, conversational agents—or technologies that mimic human conversation using text or spoken language—have shown early promise in supporting behavior change, but have yet to be rigorously tested in the context of OACAs. Methods: A rapid cycle prototyping approach led to the development of ‘Penny’ – a bidirectional, conversational agent that engages patients via text messaging, and leverages natural language processing and machine learning to learn from clinical interactions. Core functionalities include: (1) real-time dosing instructions, (2) motivational reminders, and (3) symptom monitoring with self-management support. We conducted a four-month usability study between December 24, 2017 and May 1, 2018 in a large academic cancer center. At monthly intervals for the first 12 weeks of follow-up, research staff conducted qualitative interviews with participants to evaluate usability and acceptance. Results: 11 patients with gastrointestinal neuroendocrine cancer on capecitabine and temozolomide were approached regarding the study. Of these, 10 agreed to participate (ages 45 to 71). Overall, participant satisfaction was high with a Net Promoter Score of 100. Reliability of Penny’s algorithmic branching to provide accurate dosing information and symptom triage was also high: symptoms were accurately graded 100% of the time, and there was appropriate self-management advice or provider triage 100% of the time. Average daily adherence (based on self-report) was 98%. Participants reported that 3 emergency room visits were avoided during the study period. Conclusions: In preliminary testing, a mobile phone-based conversational agent was a usable and acceptable means of supporting OACA adherence. Expanded study testing patient safety and efficacy is underway.
Risk stratification and daily symptom monitoring for oncology patients.
Authors: Daly Robert Michael , Perry Claire , Chiu Yeneat O. , Katzen Lauren L. , Rozenshteyn Margarita , Kuperman Gilad , Dhami Amandeep K , Salvaggio Rori , Baldwin Abigail , Holland Jessie C. , Chow Kimberly , Dang Chau T. , Grisham Rachel N. , Veach Stephen R. , Zervoudakis Alice , Wagner Isaac , Simon Brett A , Reidy Diane Lauren , Perchick Wendy
Published: May 2019

6535

Background: Monitoring and managing patient reported outcomes (PROs) has been recommended for oncology patients on active treatment but can be time and resource intensive. Identifying patients likely to benefit and the optimal frequency of PRO capture is still under investigation. We tested the feasibility of monitoring patients who are high-risk risk for acute care with daily PROs. Methods: Using data from our institution, we developed a model that employs over 400 clinical variables to calculate a patient’s risk of an emergency room visit within 6 months following the onset of treatment. From October 15, 2018 to January 23, 2019, we enrolled patients identified as high risk through a technology-enabled program to monitor and manage those patients’ symptoms. Enrolled patients entered PRO assessments daily via an online portal. Symptoms were monitored and managed by a centralized clinical team. Tiered notifications informed the team of concerning or escalating symptoms. We assessed how frequently patients completed symptom assessments and the frequency of symptom notifications. Results: During the pilot, 28 patients were identified as high risk and enrolled in the program (median age 65; 64% percent female). Disease types were: 15 (54%) thoracic, 7 (25%) gynecologic, 6 (21%) gastrointestinal. Median time in the program was 50 (6-98) days. Patients completed 840 of 1,350 assessments (62%). There were 328 assessments that triggered moderate alerts (39%) and 220 that triggered severe alerts (26%). The table describes the prevalence of symptoms at the patient-level. Conclusions: A model can be employed to identify high-risk patients in collaboration with clinicians. Our adherence rate with a daily symptom assessment was similar to those found in studies of less frequent PRO capture. Future work will expand to a larger patient population with other cancer types, evaluate impact on outcomes, and assess optimal frequency for PRO collection and alert thresholds. [Table: see text]
Capacity to provide specialized care for older adults in community oncology practices: Results of the NCI Community Oncology Research Program (NCORP) Landscape survey.
Authors: Williams Grant Richard , Weaver Kathryn E. , Lesser Glenn Jay , Dressler Emily Van Meter , Winkfield Karen Marie , Neuman Heather B. , Kazak Anne , Carlos Ruth , Gansauer Lucy Jean , Kamen Charles Stewart , Unger Joseph M. , Mohile Supriya Gupta , Klepin Heidi D.
Published: May 2019

6539

Background: American Society of Clinical Oncology guidelines recommend that patients ≥65 years of age starting chemotherapy undergo a geriatric assessment (GA) to inform and guide management; however, little is known about resources available in community oncology practices to facilitate geriatric specialty care and implement these guidelines. Methods: Community oncology practices were electronically surveyed in 2017 regarding the availability of various providers, supportive services, and practice characteristics, as part of a larger survey of cancer care delivery research (CCDR) capacity at NCORP sites. Designated CCDR leads provided information about their site. Descriptive statistics were used to report prevalence of resources available at each community practice. Results: Of the 925 NCORP practice locations, 504 (54%) responded to the survey, representing 227 practice groups. Of respondents, 58% included a free-standing clinic or private/group practice and 82% included inpatient services. The median number of new cancer cases per year ≥65 years of age was 443 (Interquartile range [IQR] 220-903). The median number of medical oncology providers was 5 (IQR 3-11). Only 1.8% of practices had a dual fellowship trained geriatric oncologist on staff. Geriatricians were available for consultation or co-management for 34% of sites, but only 13% of those had availability within the oncology clinic. Among those with access to geriatricians, consultations were primarily outpatient (90%) versus inpatient (54%). Ancillary services that could support GA were variably available onsite: social work (83%), nurse navigators (78%), pharmacist (77%), dietician (69%), supportive caregiver services (62%), rehabilitative medicine (57%), psychologist (41%), and psychiatrist (39%). Most sites utilized electronic health record systems (84%) and patient portals (89%). Conclusions: Availability of geriatric-trained providers is limited in community oncology practices. Use of primarily self-administered GA tools that direct referrals to available ancillary services may be an effective implementation strategy for guideline-based care.
Using real-world cohorts to assess the generalizability and relevance of randomized clinical trials (RCTs).
Authors: Bennette Caroline Savage , Nussbaum Nathan Coleman , Curtis Melissa D. , Meropol Neal J.
Published: May 2019

6540

Background: RCTs are the gold standard for understanding the efficacy of new treatments, however, patients (pts) in RCTs often differ from those treated in the real-world. Further, selecting a standard of care (SOC) arm is challenging as treatment options may evolve during the course of a RCT. Our objective was to assess the generalizability and relevance of RCTs supporting recent FDA approvals of anticancer therapies. Methods: RCTs were identified that supported FDA approvals of anticancer therapies (1/1/2016 - 4/30/2018). Relevant pts were selected from the Flatiron Health longitudinal, EHR-derived database, where available. Two metrics were calculated: 1) a trial’s pt generalizability score (% of real-world pts receiving treatment consistent with the control arm therapy for the relevant indication who actually met the trial's eligibility criteria) and 2) a trial’s SOC relevance score (% of real-world pts with the relevant indication and meeting the trial's eligibility criteria who actually received treatment consistent with the control arm therapy). All analyses excluded real-world pts treated after the relevant trial’s enrollment ended. Results: 14 RCTs across 5 cancer types (metastatic breast, advanced non-small cell lung cancer, metastatic renal cell carcinoma, multiple myeloma, and advanced urothelial) were included. There was wide variation in the SOC relevance and pt generalizability scores. The median pt generalizability score was 63% (range 35% - 88%), indicating that most real-world pts would have met the RCT eligibility criteria. The median SOC relevance score was 37% (range 15% - 74%), indicating that most RCT control arms did not reflect the way trial-eligible real-world pts in the US were actually treated. Conclusions: There is great variability across recent RCTs in terms of pt generalizability and relevance of SOC arms. Real-world data can be used to inform selection of control arms, predict impact of inclusion/exclusion criteria, and also assess the generalizability of the results of completed trials. Incorporating real-world data in planning and interpretation of prospective clinical trials could improve accrual and enhance relevance of RCT outcomes.
Prospective comparative effectiveness trial of multidisciplinary lung cancer (LC) care.
Authors: Osarogiagbon Raymond U. , Faris Nicholas Ryan , Smeltzer Matthew , Ray Meredith , Ward Kenneth Daniel , Rugless Fedoria , Jackson Bianca Michelle , Meadows Meghan Brooke , Berryman Courtney , Fehnel Carrie , Houston-Harris Cheryl , McHugh Laura , Klesges Lisa , Robbins Edward T
Published: May 2019

6549

Background: LC is common and lethal; care-delivery is complex, varies in quality and outcomes, stimulating calls for multidisciplinary treatment planning (MTP) involving key specialists. This much-advocated model lacks rigorous evaluation. We conducted a prospective cohort study of MTP v Serial Care (SC) in a community healthcare system. Methods: Newly-diagnosed LC patients with performance status (PS) 0-2, and their caregivers, were enrolled from a LC multispecialty group clinic (MGC) or single-specialty general oncology clinics. A subset of general oncology clinic patients were discussed in a Multidisciplinary Thoracic Oncology Conference (MTOC), others were not (Serial Care [SC]). In this analysis, we compare MGC and MTOC patients (MTP recipients) to SC patients. Primary endpoint was overall survival (OS); secondary endpoints were measures of quality: staging practices, guideline-concordant treatment, timeliness of care, patient and caregiver satisfaction. We adjusted proportional hazards and logistic models for age, sex, histology, stage, PS, insurance, and race. Results: 254 patients received MTP v 272 SC. After a median 30 months’ follow up, there was no difference in OS (adjusted hazard ratio 1.10 [CI 0.87-1.40], p = .43). Stage-confirmatory biopsy was done in 61% MTP v 45% SC patients (adjusted odds ratio [aOR] 2.59, CI 1.74-3.86, p < .0001); 81% MTP v 68% SC patients received guideline-concordant treatment (aOR 2.04, CI 1.31-3.19, p < .002). Although the time from lesion detection to diagnostic biopsy (25 v 15 days, p = .004) or staging biopsy (29 v 20 days, p = .007) was higher with MTP, there was no difference in time to definitive treatment (60 v 57 days, p = .06). MTP patients and their caregivers reported greater satisfaction with the combined quality of care received from all team members (p < .0001) at baseline, 3 and 6 months. Conclusions: MTP for LC significantly improved the quality of care including the thoroughness of staging, use of guideline-concordant care, and patient satisfaction. Contrary to reports from retrospective analyses, timeliness of care was worse with MTP. Patient and caregiver satisfaction was superior with MTP. Despite improved quality, MTP was not associated with improved LC survival. Clinical trial information: NCT02123797.
Minimizing drug wastage (DW) and cost of cabazitaxel used to treat metastatic castrate-resistant prostate cancer (mCRPC).
Authors: Jiang Di Maria , Fallah-Rad Nazanin , Lee Roy , Ng Pamela , Smith Alan D. , Hansen Aaron Richard , Joshua Anthony M. , Sridhar Srikala S.
Published: May 2019

6550

Background: Cabazitaxel is indicated for mCRPC, but is associated with substantial DW and financial strain on hospital budgets. It is only available in single-dose 60mg vials and has short reconstituted drug stability of < 24 hours. We aimed to determine feasibility and cost savings of an aggressive batching strategy to facilitate vial sharing of Cabazitaxel. Methods: Our mitigation strategy was to administer Cabazitaxel 20mg/m2 q3-weekly (without prophylactic G-CSF) on a single weekday whenever possible. Drug was prepared after patient (pt) arrival. Remaining amount from each vial was saved for subsequent pts on the same day. Amount administered, discarded and number of (#) vials used were obtained from pharmacy records. We estimated drug cost without batching by assigning 1 vial/treatment, and drug cost with batching from the actual # vials used. Cost of DW was determined from the amount discarded. All cost calculations were based on market price ($96.7CAD/mg) accounting for Sanofi’s discount incentive (5 vials for the price of 4), allowing a real-world cost assessment. Results: Between 09/2015 and 09/2018, 74 pts received 404 Cabazitaxel treatments on 164 days using 319 vials. Multiple pts were batched on 68% treatment days. Every 3 pts batched saved 1 vial. Average dose/treatment was 37mg (20-45mg). Among 10 treatment cancellations, prepared drug was administered for subsequent pts in 9 cases. Drug and DW costs over the 3-year period with and without batching are shown in Table. Conclusions: Batching ≥3 pts on a single weekday was feasible and significantly lowered drug cost of Cabazitaxel by reducing wastage. This strategy could help mitigate costs associated with wastage for other oncology drugs. [Table: see text]
Trends in the use of proton beam therapy among newly diagnosed cancer patients in the United States.
Authors: Nogueira Leticia Maciel , Efstathiou Jason A. , Sineshaw Helmneh M. , Yabroff K Robin , Jemal Ahmedin
Published: May 2019

6551

Background: Proton Beam Therapy (PBT) is a potentially superior radiotherapy technology for tumors with complex anatomy surrounded by sensitive tissues and for childhood cancers where sparing surrounding normal tissue is better achieved than with photon radiotherapy. The first conditions for payment of PBT claims went into effect in 2009. In 2014, the American Society of Radiation Oncology categorized PBT clinical indications into Group 1, for which health insurance coverage is recommended, and Group 2, for which coverage is recommended only if additional requirements are met. Methods: We evaluated 21,920 newly diagnosed patients in the National Cancer Database (NCDB) who received PBT between 2004 and 2016. Joinpoint analyses were used to evaluate the Annual Percent Change (APC) in the number and characteristics of patients treated with PBT. Results: The number of patients treated with PBT in NCDB facilities increased from 1,114 in 2004 to 3,173 in 2016 (APC = 8.78, p < .001), due mainly to increases in Group 1 cancers after 2010 (from 271 patients in 2010 to 1,124 in 2016, APC = 26.4, p < .001). The number of Group 2 patients treated with PBT increased slower (from 937 in 2004 to 2,049 in 2016, APC = 6.1, p < .05). Breast and prostate cancers were most common, although trends varied substantially by cancer site. Between 2010 and 2016, receipt of PBT increased for breast cancer patients from 40 in 2010 to 405 in 2016 (APC = 48.5, p < .001), but decreased for prostate cancer patients from 1,205 in 2011 to 680 in 2016 (APC = -14.06, p < .001). While most of Group 1 patients had private insurance coverage (59.3% of patients treated in 2016), Medicare was the most common primary insurance type among Group 2 patients (50% of patients treated in 2016). Conclusions: The number of newly diagnosed cancer patients treated with PBT has increased between 2004 to 2016 in the US, with a sharp increase for cancers with clinical indications for health insurance coverage since 2010. While most of these patients have private insurance coverage, the steady increase in the number of patients being treated with PBT for cancers with additional requirements for health insurance coverage is primarily in those with Medicare coverage.
Development of an artificial intelligence model to predict survival at specific time intervals for lung cancer patients.
Authors: Agrawal Smita , Vaidya Vivek , Chandrashekaraiah Prajwal , Kulkarni Hemant , Chen Li , Rudeen Karl , Narayanan Babu , Inbar Orr , Hyde Brigham
Published: May 2019

6556

Background: Survival prediction models for lung cancer patients could help guide their care and therapy decisions. The objectives of this study were to predict probability of survival beyond 90, 180 and 360 days from any point in a lung cancer patient’s journey. Methods: We developed a Gradient Boosting model (XGBoost) using data from 55k lung cancer patients in the ASCO CancerLinQ database that used 3958 unique variables including Dx and Rx codes, biomarkers, surgeries and lab tests from ≤1 year prior to the prediction point, which was chosen at random for each patient. We used 40% data for training, 25% for hyper-parameter tuning, 20% for testing and 15% for holdout validation. Death date available in the Electronic Health Record was cross checked by linkage to death registries. Results: The model was validated on the holdout set of 8,468 patients. The Area Under the Curve (AUC) for the model was 0.79. The precision and recall for predicting survival beyond the three time points were between 0.7-0.8 and 0.8-0.9 respectively (see table). This compares favourably to other lung cancer survival models created using different machine learning techniques (Jochems 2017, Dekker 2009). A Cox-PH model created using the top 20 variables also had a significantly lower performance (see table). Analysis of input variables yielded distinctive patterns for patient subgroups and time points. Tumor status, medications, lab values and functional status were found to be significant in patient sub cohorts. Conclusions: An AI model to predict survival of lung cancer patients built using a large real world dataset yielded high accuracy. This general model can further be used to predict survival of sub cohorts stratified by variables such as stage or various treatment effects. Such a model could be useful for assessing patient risk and treatment options, evaluating cost and quality of care or determining clinical trial eligibility. [Table: see text]
Access to care and financial burden for patients with breast cancer in Ghana, Kenya, and Nigeria.
Authors: Twahir Majid , Oyesegun Rasaaq Adisa , Yarney Joel , Gachii Andrew , Edusa Clement , Nwogu Chukwumere , Mangutha Gitangu , Anderson Philip , Benjamin Emmanuel , Müller Borna , Ngoh Charles
Published: May 2019

6562

Background: Breast cancer is the most frequently diagnosed malignancy and the most common cause of cancer-related death in women in Ghana, Kenya, and Nigeria. We evaluated healthcare resource use and financial burden for patients treated at tertiary cancer centers in these countries. Methods: Records of breast cancer patients treated at the following government/private tertiary centers were included – Ghana: Korle-Bu Teaching Hospital and Sweden Ghana Medical Centre; Kenya: Kenyatta National Hospital and Aga Khan University Hospital; Nigeria: National Hospital Abuja and Lakeshore Cancer Center. Patients presenting within a prespecified 2-year period were followed until death or loss to follow-up. Results: The study included 299 patient records from Ghana, 314 from Kenya, and 249 from Nigeria. The use of common screening modalities (eg, mammogram, breast ultrasound) was < 45% in all 3 countries. Use of core needle biopsy was 76% in Kenya and Nigeria, but only 50% in Ghana. Across the 3 countries, 91-98% of patients completed blood count/chemistry, whereas only 78-88% completed tests for hormone receptor and human epidermal growth factor receptor 2 (HER2). Most patients underwent surgery: mastectomy (64-67%) or breast-conserving Most patients in Ghana and Nigeria (87-93%) paid for their diagnostic tests entirely out of pocket (OOP) compared with 30-32% in Kenya. Similar to diagnostic testing, the proportion of patients paying OOP only for treatments was high: 72-89% in Nigeria, 45-79% in Ghana, and 8-20% in Kenya. Among those receiving HER2-targeted therapy, average number of cycles was 5 for patients paying OOP only vs 14 for patients with some level of insurance coverage. Conclusions: Patients treated in tertiary facilities in sub-Saharan African countries lack access to common imaging modalities and systemic therapies. Most patients in Ghana and Nigeria bore the full cost of their breast cancer care, suggestive of privileged financial status. Access to screening/diagnosis and appropriate care is likely to be substantively lower for the general population.
Effectiveness of mobile computerized tomographic (CT) lung scanning unit for early diagnosis of lung cancer in under-served populations.
Authors: Raghavan Derek , Doege Darcy L , Wheeler Mellisa S , Doty John D , Oliver James , Kim Edward S. , Mileham Kathryn Finch , Carrizosa Daniel R.
Published: May 2019

6567

Background: The National Lung Screening Trial (NLST) demonstrated that screening high-risk patients with low-dose CT (LDCT) of the chest reduces lung cancer mortality compared to screening with chest x-ray. Uninsured and Medicaid patients lack access to this hospital-based screening test due to geographic isolation/socio-economic factors. We hypothesized that a mobile screening unit would improve access and confer benefits demonstrated by the NLST to this under-served group, which is most at risk of lung cancer deaths. Methods: In collaboration with Samsung Inc, we inserted a BodyTom portable 32 slide low-dose CT scanner into a 35-foot coach, reinforced to avoid equipment damage, to function as a mobile lung scanning unit. The unit includes a waiting area, high speed wireless internet connection for rapid image transfer, and electronic tablets to deliver smoking cessation and health education programs and shared decision-making video aids. It has been certified as a lung cancer screening Center of Excellence by Lung Cancer Alliance. We employed the LUNG RADS approach to lesion classification, yielding high sensitivity and specificity in assessment. All films were reviewed by a central panel of oncologists, pulmonologists and radiologists. The protocol was approved by Chesapeake IRB, which oversees all LCI cancer trials. Interim analysis at this time was approved by the Oversight Committee. Results: We screened 470 under-served smokers between 4/2017-1/2019; M:F 1.1:1, mean age 61 years (range 55-64), with average pack year history of 45.7 (30-150) (25% African-American; 3% Hispanic; 65% rural; 100% uninsured, under-insured or Medicaid - NC Medicaid does not cover lung cancer screening). Patients over the age of 64 years were excluded as they are covered by Medicare for lung cancer screening. We found at initial screen 35 subjects with LUNG RADS 4 lesions, 49 subjects with LUNG RADS 3 lesions, 10 lung cancers (2.1%), including 4 at stage I-II. 4 non-lung cancers were identified and treated. Other incidental non-oncologic findings are the subject of another presentation. Conclusions: In this small sample using the first mobile low dose CT lung screening unit in the United States, the initial cancer detection rate is comparable to that reported in the NLST but with marked improvement of screening rates in underserved groups and with better anticipated outcomes at lower cost than if they had first presented with metastatic disease.
Clinical impact of the Mexican healthcare system "Seguro Popular" on breast cancer survival.
Authors: Cancel Luis Antonio , Salazar-Mejía Carlos Eduardo , Vera Badillo Francisco Emilio , Gonzalez Guerrero Juan Francisco , Lara-Campos Jackeline Grace , González-Palau Lorena Itzel , Wimer-Castillo Blanca Otilia , Vidal-Gutiérrez Oscar , Gonzalez Vela Jose Luis , Jaime-Villalon Diego A
Published: May 2019

6569

Background: Breast cancer (BC) is one of the leading issues in public health in low and middle-income countries. In Mexico, access to healthcare is fragmented according to the patient´s employment and not by its needs; IMSS and ISSTE (Social Security) provide access to prepaid medicine to those under the formal sector of the economy, leaving up to 50 million Mexicans without access to a prepaid scheme. In 2003, the Seguro Popular (SP) was created in order to bring universal access to prepaid medicine in Mexico, and in 2007 expanded its coverage for BC. Methods: Retrospective and comparative study. The primary endpoint was to determine the impact on survival of SP on BC. Records were obtained from the electronic database of the Hospital Universitario “Dr. José Eleuterio González”. We included patients with invasive BC stage I-IV. Patients with any other kind of healthcare schemes other than SP, patients who underwent treatment outside our institution, and those with a follow up no greater than 3 months were excluded. 104 patients from the period prior the implementation of the SP (2000-2007) met the criteria for evaluation; thereafter we randomly selected a second cohort with the same size from the period after the implementation of the SP (2008-2013). Results: Median age at diagnosis was 48 and 51 years, respectively, for the periods before and after the implementation of SP. Distribution by clinical stage (Non-SP vs SP): CS I, 4.8 vs 10%, CS II, 31 vs 44%, CS III, 52 vs 38%, and CS IV, 10 vs 6.7%. Molecular subtypes distribution (Non-SP vs SP): Luminal, 61 vs 62%, HER2 Positive (IHC+++/FISH+) 17 vs 22%, TNBC, 21 vs 18%, unknown 6.7 vs 5.7%. Regarding survival, we observed a statistically significant difference on progression-free survival and overall survival favoring the SP cohort; PFS at 5 years, 54 vs 81% (p = < 0.0001) and OS at 5-year, 72 vs 86% (p = 0.01). Conclusions: We present evidence that the Mexican healthcare scheme SP, created to bring medical access to those patients without prepaid health protection, provides a significant clinical benefit on survival (PFS and OS) in women with breast cancer.
Hormone replacement therapy (HRT) and risk of distant recurrence in newly diagnosed ER+, node-negative (N-) breast-cancer (BC) patients: A retrospective population-based matched-cohort study.
Authors: Hammerman Ariel , Feldhamer Ilan , Greenberg-Dotan Sari , Liebermann Nicky , Yerushalmi Rinat
Published: May 2019

6591

Background: Observational studies have shown an increased risk of BC with use of HRT. However, data on the prognosis of BC that develop in HRT users are inconsistent. The association between HRT use and results of the 21-gene Recurrence Score (RS) assay (Oncotype DX, Genomic Health Inc.) has not been investigated. We aimed to analyze this association, and examine the actual rate of distant recurrence or death in this population. Methods: Clalit Health Services (CHS) is the largest health maintenance organization (HMO) in Israel. We identified all CHS newly diagnosed ER+, N- breast-cancer patients, aged 45-60 that performed a RS assay between 01/2006-12/2012 and that were treated for at least three months with HRT during the eight years before BC diagnosis. A 1:4 matched-cohort analysis was performed, with matching made according to age and year of BC diagnosis. Clinical and demographic data were extracted from the CHS centralized registry for all patients. RS assay scores was grouped according to the TAILORX categorization and distribution was compared using Chi-square test. Kaplan-Meier analysis with log-rank test was performed in order to compare time to a combined outcome of distant-recurrence and mortality. Results: A cohort of 259 HRT-treated patients was identified and matched with 1001 controls, not treated with HRT. The proportions of low-risk patients (RS 0-25) and high-risk patients (RS 26-100) were 76.8% and 23.2%, respectively, within HRT-treated patients, and 80.4% and 19.6% within controls. Chi square test was not found significant (χ2= 1.634, p = 0.201). The mean follow-up time was 148.4 months for the cases and 146.9 months for controls, with log-rank test not showing a significant difference between groups. Conclusions: These data did not show significant association between HRT use and higher RS assay scores, and also did not find an association between HRT use and actual distant recurrence or death. Although the proportion of patients with high risk RS appeared to be slightly higher within HRT treated patients, this difference had not reached significance and further studies are required.
Association of sex, age and ECOG performance status with cancer immunotherapy efficacy in randomized controlled trials.
Authors: Yang Fang , Wang Yucai , Nowakowski Grzegorz S. , Wang Michael , Chintakuntlawar Ashish V. , Halfdanarson Thorvardur Ragnar , Pagliaro Lance C. , Wei Jia , Liu Baorui , Molina Julian R. , Markovic Svetomir
Published: May 2019

6592

Background: Sex, age and ECOG performance status (PS) may affect immune response and the efficacy of cancer immunotherapy with immune checkpoint inhibitors (ICI). We did a meta-analysis to assess the potential sex, age and ECOG PS differences of immunotherapy efficacy in advanced cancer. Methods: PubMed was searched up to January 15, 2019 for randomized controlled trials (RCT) comparing overall survival (OS) in patients with advanced cancer treated with ICI immunotherapy vs control therapy (without ICI). For sex difference analysis, pooled hazard ratio (HR) of death for men and women was calculated separately, and the heterogeneity between the two estimates was assessed using an interaction test by pooling study-specific interaction HR. Age ( < 65 vs ≥65) and ECOG PS (0 vs ≥1) difference was analyzed similarly. Subgroup analysis by cancer type and line of therapy (frontline vs subsequent) was explored. All analyses were done in Comprehensive Meta Analysis (v2) with random effects models. Results: Thirty phase 2/3 RCTs involving 17,728 patients were included. An OS benefit of immunotherapy was found for both men (HR 0.75, 95% confidence interval [CI] 0.69-0.81, P < 0.01) and women (HR 0.79, 95% CI 0.69-0.90, P < 0.01); for both younger ( < 65; HR 0.75, 95% CI 0.68-0.83, P < 0.01) and older (≥65; HR 0.76, 95% CI 0.69-0.83, P < 0.01) patients; and for both ECOG PS 0 (HR 0.78, 95% CI 0.69-0.89, P < 0.01) and PS ≥1 (HR 0.77, 95% CI 0.71-0.84, P < 0.01) patients. No significant difference of relative benefit from immunotherapy over control therapy was found in patients with different sex ( P = 0.283), age ( P = 0.906) or ECOG PS ( P = 0.783). In melanoma RCTs, compared with women (HR 0.77, 95% CI 0.64-0.94, P < 0.01), men (HR 0.56, 95% CI 0.42-0.76, P < 0.01) had more OS benefit from immunotherapy ( P = 0.037). No significant difference was found in other subgroup analyses by cancer types or line of therapy. Conclusions: Overall we found no evidence of association of sex, age, or ECOG PS with cancer immunotherapy efficacy. However, in melanoma, men might benefit more from immunotherapy than women.
Incidence and outcome of interval breast cancer among women participating in the provincial population based screening program in Manitoba, Canada.
Authors: Niraula Saroj , Biswanger Natalie , Decker Kathleen
Published: May 2019

6595

Background: The province of Manitoba, Canada has an organized population based biennial mammographic screening program. Here we report outcomes of women diagnosed with Interval Cancers (IC), defined as cancer diagnosed within 24 months of a normal screening mammogram and before the next screening mammogram, compared to Screen Detected (SD) cancers. Methods: The Manitoba Cancer Registry was used to obtain data about tumor and host characteristics and cause-specific mortality for women 52 to 64 years of age diagnosed with invasive breast cancer from January 2004 to December 2010. Lead time bias in SD cancers was adjusted based on Duffy's correction factor. Competing risk analysis was used to examine the risk of death by cancer detection method. To examine the relationship between breast cancer detection type and personal and tumour characteristics, we performed multinomial logistic regression analysis with age, area-level income quintile, tumour grade, hormone receptor, and HER2 receptor as independent variables. Results: There were 5,884 women diagnosed with invasive breast cancer during the study period of which 1,338 were SD, 362 were IC, and the remainder were diagnosed outside the screening program or were non-compliant to screening. IC were more likely than SD cancers to be high grade [Odds Ratio (OR) 3.8, 95% Confidence Interval (CI): 2.1-6.8], and ER negative [OR 1.7, 95% CI: 1.02-3.12]. At data cut-off date of June 30, 2012, risk of death from breast cancer was significantly higher for IC compared to SD cancers [Hazard Ratio (HR) 4.18, 95% CI: 1.97-8.87)], for sojorn time (period when tumour is asymptomatic but screen detectable) of 2 years adjusting for area-level average income quintile and age. Sensitivity analyses with sojourn times of 1, 3, and 4 years showed similar results. Risk of non-breast cancer death was not increased with IC compared to SD cancers (HR 1.33, 95% CI: 0.43-4.15). Conclusions: Among women who participated in a systematic population-based screening program, IC occurred frequently; breast cancer-related death for IC was 4-times that of SD cancers. These results highlight the discordance between the principles underpinning population based breast cancer screening and natural history of these more lethal breast cancers.