bluuebunny/crossref_metadata_2025_split huggingface dataset:
Common AEs associated with CDK4/6 inhibitors in patients with hormone receptor–positive advanced breast cancer.
Authors: Yardley Denise A. 
Published: November 2017

239 Background: Cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors combined with letrozole or fulvestrant substantially prolong progression-free survival (PFS) with a well-tolerated, predictable safety profile. Understanding the safety profile of selective CDK4/6 inhibitors can inform adverse event (AE) management and can extend and maintain time on treatment. Here, we report common AEs associated with CDK4/6 inhibitors and perspectives on monitoring as well as managing these AEs. Methods: We reviewed 5 published Phase II/III trials of ≥50 patients with advanced breast cancer (ABC) treated with CDK4/6 inhibitors in combination with endocrine therapy with respect to commonly reported AEs, defined as AEs reported in ≥15% (any grade) or ≥5% (Grade 3/4) of patients in ≥4 of 5 trials. Results: The most common AEs consisted of hematologic, gastrointestinal, and general well-being AEs (Table). Nonhematologic AEs were mostly Grade ≤2 and easily managed with dose modification. Uncomplicated neutropenia was the most common hematologic AE and was noncumulative, with the lowest neutrophil counts typically reached within a month of initiating treatment, and did not require intervention. Median time to resolution of Grade 3 neutropenia was 7–15 days. Febrile neutropenia was rare (<2%). Conclusions: CDK4/6 inhibitors are characterized by early, predictable, easily managed, transient AEs that do not require intervention. Awareness of and patient support for these AEs can enable patients with ABC to remain on CDK4/6 treatment and achieve associated PFS benefits. [Table: see text]
Stereotactic body radiation therapy for palliative treatment of bone metastases: Practice patterns and survival outcomes.
Authors: Kinchen Catherine Lee , Taylor Trent N , Johnstone Candice Aitken , Robbins Jared R. 
Published: November 2017

242 Background: Stereotactic body radiation therapy (SBRT) is an emerging modality of treatment designed to deliver high radiation doses in few fractions. We examine practice trends in the use of SBRT for managing bone metastases in patients with breast, kidney, non-small-cell lung, melanoma, or prostate cancer. Methods: We selected patients from the National Cancer Database (2004-2013) diagnosed with bone metastases from breast, kidney, non-small-cell lung, melanoma, or prostate cancer. SBRT fractionation regimens were defined as 12-45 Gy in 1 fraction, 14-50 Gy in 2 fractions, 21-50 Gy in 3 fractions, 28-50 Gy in 4 fractions, and 30-60 Gy in 5 fractions. Standard palliative radiation fractionation regimens were defined as all other cases with 2-40 Gy in 20 fractions or fewer. Results: Patients receiving SBRT regimens made up 1454 of 57,556 total palliative cases. Bone metastases treated with SBRT primarily at the spine (65.5%), hip/pelvis (12.3%), and shoulder/extremity (11.4%). SBRT palliation regimens were used for only 2.5% of patients. Though standard palliative radiation fractionation regimens comprised the majority of treatments (97.5%), SBRT utilization is increasing, with a majority (68.4%) of SBRT cases occurring from 2009-2013. Treatment at an academic center and lack of comorbidities were positively associated with receiving SBRT regimens. Mean survival outcomes were higher for patients receiving SBRT (24.3 months) than patients receiving standard regimens (16.9 months). Conclusions: Though the vast majority of bone metastases were treated with standard palliative radiation fractionation, SBRT utilization increased from 2004-2013, with the greatest portion of SBRT cases occurring at academic institutions. Patients receiving SBRT exhibit better survival outcomes, likely as a result of patient selection practices.
Scrambler therapy for the treatment of chronic central pain due to cavernous hemangioma in the midbrain: A model for treating central cancer pain.
Authors: Smith Thomas J. , Mealy Maureen A , Erdek Michael A. , D'Amato Steven , Kozachik Sharon 
Published: November 2017

244 Background: Central pain syndromes are caused by damage to the sensory pathways of the central nervous system (CNS) within the brain or spinal cord, and are estimated to affect several million people worldwide. This can occur with malignant or benign brain tumors, or after surgery or radiation. The pain impulse is generated centrally but the pain is felt peripherally. Treatment is unsatisfactory with no universally accepted method of relief. Methods: A 52 year old woman had central pain manifest as burning pain from her left foot to the knee for 12 years. This happened after suboccipital craniectomy and C1 hemilaminectomy for a medullary cavernoma diagnosed after a right-sided brainstem bleeding episode due to a mulberry hemangioma, in 2004. The pain was minimally responsive to multiple neuropathic pain agents. Results: In early 2017, she underwent ten daily Scrambler (Calmare) Therapy treatments with reduction in her pain from 9-10/10 to 0-0.5/10 and was able to discontinue all her pain medications. Her pain recurred after a month but was again controlled to 1-2/10 with just two additional daily treatments, and remains controlled at three months. Her function and quality of life is much better. She has had no side effects. Conclusions: Scrambler (Calmare) Therapy may be an effective, safe, and non-invasive way to treat central pain from benign and malignant brain tumors, and/or their treatment, and deserves further study.
Standardizing opioid prescribing practices for cancer-related pain via a novel interactive documentation template at a public hospital.
Authors: Nusrat Maliha , Parkes Amanda Marie , Hu Bei , Farhat Dalia , Rieber Alyssa G. , Ma Hilary Y. 
Published: November 2017

253 Background: Aberrant opioid use during treatment of cancer related pain poses serious risks for patients and society. Identifying and monitoring those at risk is challenging and time consuming. We aimed to standardize the process of managing opioids at a public hospital oncology clinic in compliance with Texas (TX) state regulations to improve patient safety. Methods: We gauged the current practices of assessing and documenting opioid efficacy, toxicity and misuse via provider survey and chart review. A process flowchart was then created and streamlined in the light of: published literature, TX Administrative Code on pain management, and practices of palliative care specialists at MD Anderson Cancer Center, TX. We made an interactive documentation template (SmartPhrase) in electronic medical record system (EPIC) to implement the standardized process. Results: Pre-intervention data showedhigh inter-provider variability in opioid misuse screening, safety monitoring and documentation. Of the 22 providers surveyed, 6 (22%) had a TX PMP Aware login; 8 (36%) ever checked the website; and 19 (86%) stated the need of a standardized process for prescribing opioids. Hence, we instituted baseline screening for aberrant behavior based on substance abuse history, TX PMP Aware query and urine drug screen; increased monitoring of high risk patients; universal screening for chemical coping at each visit; and timely referral of such patients to palliative care. We created a SmartPhrase that prompts providers to risk stratify and monitor for opioid misuse as above; assess analgesic efficacy; evaluate and manage uncontrolled pain and toxicities; and specify a refill plan. This SmartPhrase allows quick selection of options pertinent to a given patient from pre-populated lists before the encounter can be closed. Conclusions: We created a systematic approach to prescribing and monitoring opioid analgesics so as to ensure safe and judicious use of opioids to treat cancer related pain. We generated an interactive SmartPhrase for efficient documentation compliant with TX state regulations. Post-implementation review of efficacy and use of this intervention is ongoing to further refine it.
A qualitative exploration of companion involvement in the presurgical consent visit for patients undergoing major surgery for advanced cancer.
Authors: Isenberg Sarina , Roter Debra , Wolff Jennifer L , Smith Thomas J. , Smith Katherine Clegg , Aslakson Rebecca 
Published: November 2017

29 Background: The decision to undergo non-emergent cancer surgery is complicated by risk of mortality and diminished quality of life weighed against potential benefits of extended life and symptom management. Sometimes, unanticipated clinical information or quality of life considerations (“disruptions”) arise during these pre-surgical visits, which can lead to to the surgery’s reconsideration, postponement, or cancelation. Little is known about disruptions. This paper explores case studies of how patients, companions, and surgeons negotiate surgical plan disruptions. Methods: This study is based on secondary analysis of pre-surgical recordings with 61 patients and nine surgeons. Patients were recruited at nine surgical oncology clinics at an academic tertiary care hospital from July 2015-September 2016. Qualitative analysis incorporated existing theory and inductively developed codes. Results: Four of the 61 pre-surgical visits were identified as having a disruption. Each case study explores the presentation of the disruption, patient reaction to the disruption, companion involvement and role in the encounter, and resolution of the disruption. While each disruption involves a nuanced approach to decision making, there are cross cutting themes across the cases. Specifically, analysis of these visits explored companion roles, including: patient autonomy-enhancing behaviors and patient autonomy-detracting behaviors. This analysis also addressed variation and similarities in surgeons’ behaviors, including examples of collaborative, facilitative, and informative behaviors. Conclusions: As more high risk surgeries are performed on sicker and older patients, decision making regarding whether to pursue surgery may become increasingly complex, and lend itself more frequently to disruptions. Disruption reflects the engagement and mutual influence of multi-party participants in treatment decision making. By enhancing our understanding of disruptions, we hope to assist in the delicate communication and shared decision making needed for a patient and family centered resolution. Clinical trial information: NCT02489799.
Innovative pilot to reimburse nurse and social work-led advance care planning.
Authors: Kalisiak Angela , Hansen Lisa Kathryn , Newell Jamie , Mills Lydia 
Published: November 2017

3 Background: Research has shown that advance care planning (ACP) leads to better patient care and outcomes. The Oregon Health Leadership Council (OHLC) identified ACP as an opportunity to improve care and offset costs. In 2014, the OHLC commissioned a workgroup to pilot a payment model to promote broader adoption of ACP. A community oncology provider and 4 health plans implemented the pilot for nurses (RNs) and licensed clinical social workers (LCSWs) to conduct ACP in an effort to elicit and honor patient preferences at end of life (EOL). Methods: Five RNs and 2 LCSWs underwent specific ACP training (by academic EOL educator or VitalTalk). They conducted one or more substantive ACP conversations (minimum 20 minutes) with 149 patients (89 female, 60 male; median age 64; range 24-92) between 12/5/14 and 5/9/16. Most patients had recurrent and/or metastatic cancer. Charts were reviewed in April 2017 for goals of care (GOC) discussion, ACP documents, preferences for EOL care, hospice enrollment, date of death, and death location. Results: Among all 149 patients, GOC discussion was documented for 126 (85%). Advance directives were in the chart for 34 (23%) and POLST for 53 (36%) patients. Among the 69 patients who died, 80% were on hospice (median days = 14; 15% on hospice < 3 days); 87% preferred comfort care at time of death. Three patients (4%) requested life-prolonging treatment until death. Conclusions: This pilot demonstrated that RNs and LCSWs can provide substantive ACP within robust team-based care. Hospice enrollment, POLST completion, and EOL care consistent with preferences were high. Cost data was inadequate to draw conclusions. While physician management, patient values, disease and treatment factors may also impact EOL choices, pilot data indicates that expanding ACP through trained RNs and LCSWs serves to normalize ACP as an integral component of quality care and promote outcomes congruent with GOC. [Table: see text]
Oncology care model: Early palliative care experiences and outcomes.
Authors: Spain Pamela , West Nathan , Teixeira-Poit Stephanie , Schaefer Elizabeth , Ketler Kerry 
Published: November 2017

37 Background: Through the Oncology Care Model (OCM), the Center for Medicare & Medicaid Innovation at the Centers for Medicare & Medicaid Services aims to improve the effectiveness and efficiency of cancer care. OCM practices have committed to provide enhanced services to Medicare beneficiaries, including palliative care designed to optimize quality of life. This study examines if OCM practices engaging in early palliative care discussions have timely hospice referrals as well a lower aggressive end-of-life care and Medicare costs. Methods: During site visits to 30 OCM practices, we asked was How and when is palliative care introduced to patients? We used Medicare claims data to stratify the 30 practices into high or low performers based on 3 end-of-life quality measures scores. Next, we examined their scores on Cancer CAHPS shared decision making and Medicare expenditures, as well as what staff reported about the use of palliative care during site visits. Claims and CAHPS data encompass the first 6 months of OCM, July-December 2016. Site visits were conducted February - May 2017. Results: Patient risk scores were equal among practice groups. High Performers said: “Palliative care is introduced right off the bat. We provide information on hospice and palliative care so it’s not a word they find with end of life only. It’s a difficult conversation but you have to put it out there. As part of patient education, we say the differences between palliative care and hospice. Low Performers said: “Palliative care is introduced on a case by case basis. To transfer to an inpatient hospice, now you have to be on your last breath. Programs that get cut because they are not integral to the patients’ acute issues include palliative care. If hospice comes up, I pull palliative care at that point.” Conclusions: Early OCM results support growing evidence that palliative care shared decision making discussions are most beneficial near the time of cancer diagnosis. [Table: see text]
Utilizing advance care planning videos to empower perioperative cancer patients and families: Results from a randomized controlled trial.
Authors: Aslakson Rebecca , Isenberg Sarina , Crossnohere Norah L. , Conca-Cheng Alison M. , Moore Madeleine , Bhamidipati Akshay , Mora Silvia , Miller Judith , Singh Sarabdeep , Larson Susan , Swoboda Sandy , Pawlik Timothy M. , Weiss Matthew J. , Volandes Angelo E. , Smith Thomas J. , Bridges John F.P. , Roter Debra 
Published: November 2017

5 Background: The feasibility and impact of integrating advance care planning (ACP) in surgical oncologic populations is unknown. We hypothesized that an ACP video could be integrated into surgical oncologic care and that patients who preoperatively viewed the video would engage in more ACP and patient-centered communication with their surgeon. Methods: Randomized controlled, phase II trial with two study arms: intervention ACP video and control (no ACP) video; and four data collection periods: enrollment, presurgical consent, postoperative one week, and postoperative one month. Participants included patients undergoing major cancer surgery recruited from nine surgical oncology clinics at a single, academic, inner city, tertiary care hospital. Main Outcomes and Measures: Primary Outcome - Content of ACP and patient-centeredness during the presurgical consent visit as measured through the Roter Interaction Analysis System (RIAS). Secondary patient outcomes – mood; goals of care; and video helpfulness. Results: Ninety-two patients (target enrollment of ninety) were enrolled over 15 months. The ACP video was successfully integrated into the intervention arm and no study-related harms were noted. Patient-centeredness was unchanged between the study arms (IRR=1.06, CI [0.87,1.3], p=0.545) and there was a trend of increased ACP content in the intervention arm (23% intervention vs. 10% control, p=0.182). There were no differences in secondary outcomes other than patients found the intervention video more “helpful” (p=0.007). There was a statistically significant increase in mood symptoms in both groups one week post-operative as compared to enrollment (p=0.01). Patients in both groups most frequently noted cure-related goals of care. Conclusions: The ACP video was integrated successfully into surgical care, well-tolerated, and thought helpful by patients, but did not significantly change the nature or ACP content in patient-surgeon pre-operative conversation. Future studies could increase the “dose” of ACP through modifying video content and/or how or who presents that content prior to surgery. Clinical trial information: NCT02489799.
Integration of end-of-life care in clinical trials for advanced malignancies.
Authors: Klil-Drori Adi Joseph , Silva Karine , Regimbald Tracy , Assouline Sarit E. 
Published: November 2017

67 Background: ASCO endorses early integration of palliative care in the treatment of patients with advanced cancers and encourages patient education with regards to prognosis and participation in medical decision making. We implemented a uniform process of discussing end of life and advance directives (AD) early in the course of experimental cancer treatment and assessed whether this process is aligned with our patients' perspectives. Methods: This was a pilot study in a research unit conducting early-phase trials for patients with no remaining standard of care. Accrual goal was 15 patients in four months. We identified patients with advanced malignancies who were screened for cancer trials and approached their physicians with a request to fill out an AD form in discussion with their patients. Upon initiation of treatment, we filled out a supportive care checklist for each patient. The patients filled out a structured questionnaire probing their views on end-of-life discussion and awareness to supportive care resources on cycle 2 day 1 (Q1) and on cycle 3 day 1 (Q2). Results: Out of 41 screened, we completed checklists for 36 patients. Of these, 26 filled out Q1 and 11 filled out Q1 + Q2. Response rate to the questionnaires was 100%. The patients were diagnosed with metastatic solid tumor (23) and hematologic malignancies (3) and had 2 (0-5) previous lines of treatment. Females and males were 14 and 12, respectively. AD forms were filled out in most patients (81%), but about half (54%) reported having had AD discussions with their physicians. Most patients (73%) were aware of supportive resources (palliative care, social worker, support groups), and most (62%) actually used them while on study. Agreement in Q1 and Q2 was comparable (Table), with some rise in agreement with the timing of AD discussion. Conclusions: In the context of treatment on clinical trials, a large-scale initiative is feasible. More patients agree with time that early discussion of AD meets their goals while almost half report having had no such discussion with their physicians. [Table: see text]
Using natural language processing to assess palliative care processes in cancer patients receiving venting gastrostomy tube.
Authors: Lindvall Charlotta , Lilley Elizabeth J. , Cooper Zara , Forsyth Alexander W. , Barzilay Regina , Lorenz Karl A. , Walling Anne Margaret , Tulsky James A. 
Published: November 2017

7 Background: Natural Language Processing (NLP) presents a novel method of extracting text-embedded information from the electronic health record (EHR) to improve routine assessment of palliative quality metrics such as timely advance care planning (ACP), palliative care provision (PC), and hospice referral. Methods: We identified cancer patients (ICD-9-CM codes 140-209) who received a gastrostomy tube (ICD-9-CM 43.11, 43.19, 44.32; CPT code 49440) from Jan 1, 2012, to Mar 31, 2016 at an academic medical center. We used NLP to identify palliative indication for gastrostomy tube placement by labeling clinical notes from the EHR containing the key word “venting” near the time of the procedure. Documentation of ACP, PC, and hospice referral was identified by NLP using a validated key term library. The sensitivity and specificity of the NLP method was determined by comparing outcome identification to manual chart abstraction performed by two clinicians. All NLP code was written in the open-source programming language Python. Results: NLP was performed for 75,626 documents. Among 305 cancer patients who underwent gastrostomy, 75 (24.6%) were classified by NLP as having a palliative indication for the procedure compared to 72 patients (23.6%) classified by human coders. Manual chart abstraction took > 2,600 times longer than NLP (28 hrs vs. 38 seconds). NLP identified the correct patients with high precision (0.92) and recall (0.96). ACP was documented during the index admission for 89.3% of patients. PC was documented for 85.7% and hospice referral was documented for 64.3% of these patients with advanced cancer during the index hospitalization. NLP identified ACP, PC and hospice referral with high precision (0.88-1.0) and recall (0.92-1.0) compared to human coders. Median survival was 37 days following gastrostomy tube procedure. Conclusions: NLP can greatly speed the assessment of established palliative quality metrics with an accuracy approaching that of human coders. These methods offer opportunities for facilitate quality improvement in palliative care for patients with advanced cancer.