bluuebunny/crossref_metadata_2025_split huggingface dataset:
Phase II clinical trial of axitinib in metastatic pheochromocytomas and paraganlgiomas (P/PG): Preliminary results.
Authors: Burotto Pichun Mauricio Emmanuel , Edgerly Maureen , Velarde Margarita , Bates Susan Elaine , Daerr Roland , Adams Karen , Pacak Karel , Fojo Tito 
Published: February 2017

457 Background: Malignant pheochromocytoma/paraganglioma (P/PG) is a rare malignancy. Management of metastatic disease includes surgery, external radiation, 131I-MIBG and systemic chemotherapy. CVD (cyclophosphamide, vincristine and dacarbazine) is the only chemotherapy commonly used to treat metastatic disease. Putative anti-angiogenic agents such as the tyrosine kinase inhibitor (TKI) axitinib target a well-recognized pathway thought to be active in many tumors. Methods: Patients with histologically confirmed P/PG previously treated or naive to treatment received axitinib at initial dose of 5 mg BID. Primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival, response rate and safety. Results: Between January and September 2014 nine patients have been enrolled. The median age was 54.7 years, (range 42.5 – 70.5); median number of previous systemic treatments was one (range 0 – 3). Three of the nine patients achieved a partial response. An additional 5 patients have had tumor shrinkage insufficient to qualify as a partial response with only one patient response scored as progression. Tumor shrinkage has been observed in lymph node, soft tissue and lung metastases; and has been associated with reductions in circulating cathecholamines. Median time to progression has not been reached. A total of 50 cycles have been administered. Toxicity has led to a reduction of the dose of axitinib from a starting dose of 5 mg BID to 3 mg BID in six and 2 mg BID in two patients. The axitinib dose could be increased to 7 mg BID in only one patient Principal grade 3-4 toxicities included hypertension (6 patients), fatigue (4 patients), diarrhea (1 patient) and mucositis (1 patient). Conclusions: Preliminary data shows axitinib can result in tumor shrinkage in patients with a diagnosis of malignant P/PG. The high rate of dose reduction related to toxicity may reflect a different pharmacokinetic profile of the drug in these patients a possibility now under investigation. Clinical trial information: NCT01967576.
Can Gleason 7 prostate cancer ever be low-risk? Results from the Shared Equal Access Regional Cancer Hospital (SEARCH) database.
Authors: McGinley Kathleen F. , Sun Xizi , Howard Lauren E. , Aronson William J. , Terris Martha K. , Kane Christopher J. , Amling Christopher L. , Cooperberg Matthew R. , Freedland Stephen J. 
Published: February 2017

57 Background: Overtreatment of low-risk prostate cancer (PC) is a major issue. Increasing use of active surveillance (AS) will ease this burden. Limited data are available on including men with intermediate risk PC (i.e. Gleason 7) into AS protocols. We examined if a subset of men with Gleason 7 (3+4) PC could be reasonable AS candidates. Methods: We used SEARCH to identify men who had radical prostatectomy from 2001-13 with >8 cores on biopsy and complete data. We compared men who fulfilled low-risk disease criteria (cT1c/T2a; biopsy Gleason ≤6; PSA ≤10 ng/mL) with the exception of biopsy Gleason 7 (3+4) vs. men who met all 3 low-risk criteria. Logistic regression models were used to test the association between biopsy Gleason 3+4 vs. ≤6 and pathological features. Biochemical recurrence (BCR) was examined using multivariable Cox hazards analysis adjusted for clinical and demographic features. To examine if there was a subset of men with low-volume Gleason 7 who would have comparable outcomes to low-risk men, we repeated all analyses limiting the percent positive cores to ≤ 33% and positive cores to ≤ 4, ≤ 3, or ≤ 2. Results: 885 men met inclusion criteria: 505 had low-risk PC and 380 had Gleason 7 low-risk PC. Overall, the Gleason 7 low-risk men had increased risk of pathological Gleason ≥4+3 (p<0.001), positive margins (p=0.069), extracapsular extension (p<0.001), and seminal vesicle invasion (p<0.001) on univariable analysis. Men in the Gleason 7 low-risk group had significantly higher BCR risk (HR 1.65, p=0.004). Analyses were repeated using increasingly strict definitions of low-volume PC. With the exception of higher pathological Gleason score (p<0.001), at ≤3 positive cores, there was no difference in adverse pathological features between groups (all p>0.1). Among men with ≤3 positive cores who met the other low-risk criteria (cT1c/T2a; PSA ≤10 ng/mL), BCR risk was similar in men with Gleason 6 or Gleason 7 (3+4) (HR 1.30; p=0.347) PC. Conclusions: Among men with PSA≤10 ng/mL and stage cT1c/T2a, those with Gleason 7 (3+4) PC in ≤3 positive cores have similar rates of adverse pathology and BCR as men with Gleason ≤6 PC. This finding may expand inclusion criteria of AS protocols to reduce PC overtreatment.
Impact of CCP test on personalizing treatment decisions: Results from a prospective registry of newly diagnosed prostate cancer patients.
Authors: Shore Neal D. , Boczko Judd , Kella Naveen , Moran Brian Joseph , Crawford E. David , Hamilton Stephanie A. , Kaldate Rajesh R. , Roundy Kirstin M , Brawer Michael K. , Gonzalgo Mark L. 
Published: February 2017

63 Background: The cell cycle progression (CCP) test is a validated molecular assay that assesses risk of prostate cancer−specific disease progression and mortality when combined with standard clinicopathologic parameters. PROCEDE−1000 is the largest prospective registry to evaluate CCP test impact on personalizing prostate cancer treatment. Results of an interim analysis are presented. Methods: Untreated patients with newly diagnosed (≤6 months), clinically localized prostate adenocarcinoma were enrolled (n=816). The physician’s initial therapy recommendation (pre−CCP) was recorded on the first questionnaire. The CCP test was then conducted on prostate biopsy tissue. Three post−CCP questionnaires recorded the physician’s revised treatment recommendation, physician/patient treatment decision, and actual treatment administered. Changes in treatments between the pre-CCP and post−CCP questionnaires demonstrated the impact of CCP testing on treatment decisions at each stage. Results: Visual analog scale measurements indicated a significant increase (p=0.0125) in the physician’s likelihood of recommending non−interventional treatment post−CCP test; there was an increase in active surveillance from the initial interventional therapy recommendation. From pre−CCP therapy recommendation, the CCP score caused a change in actual treatment administered in 44% of patients; 72% of changes were reductions in treatment. Reductions occurred in radical prostatectomy (27%), radiation therapy (44% primary; 56% adjuvant), brachytherapy (46% interstitial; 66% HDR) and hormonal therapy (33% neoadjuvant; 68% concurrent) treatments. While 35.9% of patients were recommended for conservative management pre−CCP testing, there was a 6.5% increase in non−interventional treatments during actual follow−up. Overall, there was a significant reduction in the number of treatment options at each successive evaluation (p<0.0001). Conclusions: The CCP risk assessment score has a significant impact in helping physicians and patients reach consensus on an appropriate personalized treatment decision, often with major reductions in interventional treatment burden. Clinical trial information: NCT01954004.
Sector analysis to provide additional spatial information on the permanent prostate brachytherapy learning curve.
Authors: Mohamed Yoosuf Ahamed Badusha , Jonnada Sai , Napier Eoin , Byrne Monica M. , Flynn Margaret A. , Workman Geraldine , Mitchell Darren M. , Jain Suneil 
Published: February 2017

93 Background: To evaluate the spatial pattern of permanent prostate brachytherapy (PBT) learning curve using post-implant multi-sector dosimetric analysis. Methods: Two hundred patients treated with I-125 PBT at a single institution were assessed. A 12 sector analysis of post-implant CT was created for each case by dividing the prostate base, mid gland and apex into 4 sectors each. Dosimetric analysis was evaluated for whole prostate and individual sectors assessing: minimum dose to 90% of prostate (D90) and dose to 0.1 cm3 of the rectum (D0.1cc). Linear regression analysis and Pearson’s correlation co-efficient were used to investigate changes in D90with case number. Results: Global prostate analysis demonstrated a post-implant learning curve with significant improvement in D90 (p<0.01) in the last 50 cases (157.0 Gy ± 9.7) when compared to the initial 50 (141.6 Gy ± 14.5). Linear regression confirmed a significant improvement in global D90 with case number (r2=0.19, p=0.0001) at a rate of 0.11 Gy/case. Sector analysis demonstrated greatest improvement in base sectors with increasing case number with an improvement of 0.16 Gy/case (Table; p=0.049 when compared to global D90). Further, D90 in posterior mid-gland reduced with case number and correlated with reduced rectal D0.1cc. Conclusions: Sector analysis demonstrated increased spatial information on the PBT learning curve which may enable on-going improvements in implant quality. [Table: see text]
Complications of intrathecal pump therapy in malignancy-related pain.
Authors: Noreika Danielle M , Del Fabbro Egidio 
Published: February 2017

102 Background: Intrathecal pumps (ITP) are used to manage severe malignancy related pain by delivering analgesics directly into the cerebrospinal fluid, in theory allowing for a reduced opioid dose and fewer complications. Although there is literature to support efficacy in patients with cancer, including improved survival, this mode of drug delivery also carries a risk of serious complications. Reports of complications in non-malignant pain suggest the risks and mortality related to ITP may be under-appreciated and that injury and liability occur with both ITP placement and ITP maintenance. Additional burdens to consider in patients with cancer include accurate prognostication to identify appropriate candidates, and the logistics of providing ITP maintenance. Methods: A retrospective chart review of 26 consecutive patients that underwent implantation of a programmable ITP at a National Cancer Institute center between 2008 and 2014 for malignancy related pain. Results: 53% (n = 14) of patients experienced major and minor ITP complications. Major complications occurred in 35% (9) including leg weakness post operatively requiring wheelchair use for months; granuloma formation causing leg weakness and requiring repeat operation; pump infection leading to sepsis and death; intra-abdominal abscess; significant bleeding requiring discontinuation of therapeutic anticoagulation for PE; and neurological complications including delirium and protracted seizures requiring ICU admission. Minor complications occurred in 31% (8) and included wound infections, urinary retention requiring catheterization, foot drop, and spinal headaches related to CSF leaks. 42% (11) died < 90 days after ITP implantation; 19% (5) died < 30 days after ITP implantation. 7 patients (27%) were either lost to follow up, relocated, transitioned to hospice, or had difficulty finding providers to refill the pump. Conclusions: More than a third of patients with cancer receiving an ITP at our institution experienced major complications including death, sepsis, and neurological problems.
A pilot trial of early specialty palliative care for patients with advanced pancreatic cancer: Challenges encountered and lessons learned.
Authors: Schenker Yael , Bahary Nathan , Claxton Rene , Childers Julie , Kavalieratos Dio , King Linda , Lembersky Barry C. , Park Seo Young , Tiver Greer A , Arnold Robert 
Published: February 2017

110 Background: Palliative care trials face implementation barriers. We describe challenges encountered in a pilot trial of early specialty palliative care for patients with pancreatic cancer. Methods: We conducted a mixed-methods pilot randomized controlled trial of early specialty physician-led palliative care in advanced pancreatic cancer. Recently diagnosed patients with borderline, locally-advanced, or metastatic pancreatic cancer and their caregivers (total N=60) were recruited from clinic at a comprehensive cancer center and randomized (2:1) to receive monthly specialty palliative care visits for 3 months in addition to standard oncology care vs. standard oncology care alone. Feasibility assessments included enrollment and intervention completion rates. Acceptability and perceived effectiveness were assessed via drop-out rates and semi-structured participant interviews. Results: The enrollment target was reached after 50 weeks, with a randomized: approached rate of 27%. Mean patient age was 63 (SD 11) and 50% were male. Mean caregiver age was 62 (SD 12), 47% were male, and 80% were the spouse or partner of a patient. 70% of participants in the intervention group completed at least one specialty palliative care visit and 15% completed 3 palliative care visits within the 3-month time period. Two patients and 3 caregivers withdrew, and 4 patients died prior to 3 months. Enrollment barriers included patients not planning to continue receiving care from a participating oncologist and feeling too overwhelmed at the time of diagnosis to consider research participation. In semi-structured interviews, patients and caregivers noted that long travel times to the cancer center, difficulty scheduling palliative care visits at a convenient time, and lengthy study assessments posed burdens. Oncologists and palliative care physicians recommended more in-person communication between clinicians and tailoring palliative care visit content and schedules to match patient needs. Conclusions: Future palliative care intervention trials must consider implementation challenges related to recruitment, retention, intervention fidelity, and participant burden. Clinical trial information: NCT01885884.
Palliative Care Always as a massive open online course (MOOC) to build primary palliative care in a global audience.
Authors: Tribett Erika Lauren , Ramchandran Kavitha , Fronk Joshua , Passaglia Judy , Bugos Kelly , Kogon Manuela , Klein Lori , Brown Ellen , Chan Sandy , Hutton Lynn , Lyo Grace , Sickler Kimberly Frost 
Published: February 2017

123 Background: Primary palliative care (PC) is critical to improve access to PC from the point of diagnosis. Still, barriers exist to providing primary PC worldwide, including a lack of awareness, time, and training. Interactive online learning experiences can help overcome these. This project describes a massive open online course (MOOC)--Palliative Care Always--designed to build primary PC skills in a global audience. Methods: A team of PC providers and online instructional experts developed 12 modules that included: patient scenes, brief lectures, empathy exercises, and Google Hangout discussions. Course objectives included awareness of PC, practicing effective communication skills, basic symptom assessment and management. The target audience included oncology clinicians; secondary audience included patients and families. The MOOC launched January-April 2016. Participant engagement, satisfaction and self-reported knowledge were assessed through pre- and post-surveys. Multiple choice assessments captured knowledge gain. Follow-up assessments will be distributed three months post-MOOC. Results: By April 2016, the course reached 1,300 participants from 91 countries. 54% were from the US, followed by India, Brazil, and Canada. 76% were healthcare professionals, the majority being nurses (40%), physicians (19%) and social workers (13%). The remaining 24% included patient, caregivers, and others interested in PC. Top reasons for enrolling were interest in PC, personal growth and job relevance. On average, 27% of enrollees actively engaged week-over-week. Eighty-six percent of respondents were “very satisfied” with the amount learned, and over 50% cited learning “a great deal” in: communicating difficult news, goals of care, psychosocial and hospice care. 93% cited being “very likely” to recommend the course. Conclusions: Interactive MOOC experiences have the potential to build PC awareness, primary skills and global PC networks. Upcoming iterations will incorporate: accommodations for varying levels of PC knowledge; additional opportunities for interaction between participants, including social networks; blended learning; and evaluation of impact on practice and healthcare outcomes.
Disparities in access to palliative care services among cancer patients in south Texas.
Authors: Rauenzahn Sherri L. , Schmidt Susanne , Aduba Ifeoma , Jones Jessica , Tenner Laura LaNiel 
Published: February 2017

130 Background: Palliative medicine is dedicated to improving quality of life for patients throughout their disease course. The integration of palliative medicine in oncology practice has increased due to growing evidence of benefits for patient. While the collaboration of palliative and oncology care is beneficial, access to palliative services remains an issue for cancer patients. The aim of this project is to evaluate how insurance status impacts palliative care access for cancer patients in South Texas. Methods: During a 5-month study period, 607 patients from medical oncology clinics were evaluated based on their Edmonton Symptom Assessment System (ESAS) scores collected during their clinic visit to determine symptom burden and palliative care need. If providers saw a need, palliative care referrals were made. 27 unique patients received a total of 32 referrals over the study period. We examine time to initial palliative care appointment after the first referral was made. We compare time to consult based on where patients were able to receive palliative services. Location of care was based on type of insurance coverage. Results: During our study period, 13 patients were eligible to receive care through the University of Texas (UT) Medicine System (Group A) and 14 patients qualified for care at University System, which provides services to under-insured and safety net patients (Group B). Of the 27 referred patients, 85% made efforts to seek palliative care (n = 23), of which 78% had a palliative care visit (n = 18). On average, patients seeking care at the safety net facility (Group B) had 29.8 days longer wait times until their first potential visit (p < 0.01) compared to patients eligible for UT Medicine (Group A). Time to actual visit was on average 39.2 days longer for patients in Group B compared to patients in Group A (p = 0.02), averaging at 55.7 days for patients seeking care at the safety net facility. Conclusions: This investigation revealed a 4-fold increase in time to scheduled visit depending on insurance coverage. While this study is limited by a small sample, data suggests that under-insured oncology patients may have significantly different access to palliative care services which may impact the quality of cancer care.
Strength training to enhance early recovery after hematopoietic stem cell transplantation.
Authors: Hacker Eileen Danaher , Collins Eileen , Park Chang , Peters Tara , Rondelli Damiano 
Published: February 2017

190 Background: Intensive cancer treatment followed by hematopoietic stem cell transplantation (HCT) results in moderate to severe fatigue and physical inactivity leading to diminished functional ability. Methods: This study compared strength training to enhance early recovery (STEER) (n = 33) to attentional control with health education (n = 34) in adult HCT patients on primary outcomes (physical activity and fatigue) and secondary outcome (functional ability) in a single-blind randomized clinical trial. Subjects were randomly stratified by type of transplant (allogeneic or autologous) and age (≤ 60 years of age or > 60 years of age). STEER consisted of a comprehensive program of progressive resistance introduced during hospitalization and continued for six weeks following hospital discharge. Attention control with health education subjects received structured weekly health education post hospitalization. Variables were assessed prior to HCT hospital admission and six weeks following hospital discharge. Using the two-sided alpha level of 0.05, a final sample size of 66 (n = 33 per arm) was planned with 80% statistical power. Data were analyzed using split-plot ANOVAs. Results: Interactions effects were noted for fatigue, p = .04, ηp 2 = .06. The STEER group reported more fatigue at baseline and less fatigue following strength training compared to the health education group. Time, p < .001, ηp 2 = .16, and group effects, p = .05, ηp 2 = .05, were observed for physical activity. Physical activity decreased from baseline to six weeks post hospitalization. The STEER group was more physically active. Group effects were observed for two functional tests (15-foot timed walk, p = .04, ηp 2 = .06; and, timed up and go test, p = .03, ηp 2 = .07). The STEER group completed both tests faster. The timed stair climb, p = .03. ηp 2 = .07, and timed up and go tests, p = .05, ηp 2 = .06, interaction effects. The STEER group completed both tests faster following completion of strength training. Conclusions: Strength training enhances early recovery following HCT with moderate effect sizes. Strength training significantly reduced fatigue while improving physical activity and functional ability six weeks following hospital discharge.
A cluster randomized trial of a patient-centered communication intervention in advanced cancer: The Values and Options In Cancer Care (VOICE) study.
Authors: Fenton Joshua J , Kravitz Richard L , Duberstein Paul , Tancredi Daniel J , Xing Guibo , Epstein Ronald M. 
Published: February 2017

2 Background: Observational studies demonstrate links between patient-centered communication, prognosis discordance, quality of life (QoL) and aggressive treatments near the end of life, yet there are few randomized evaluations of communication interventions in advanced cancer. Methods: We completed a cluster randomized controlled trial in cancer clinics in Western NY and Northern CA with medical oncologists (n = 38 randomized to intervention or control) and their community-dwelling adult patients with advanced non-hematologic cancer (n = 265; 194 with enrolled caregivers). Interventions foroncologists (individualized communication training using Standardized Patient Instructors) and patients/caregivers (individualized coaching using question prompt lists) were directed towards enhancing patient engagement in consultations, oncologists’ response to emotions, and provision of balanced information about prognosis and treatment choices. Oncologists and patients randomized to control received no interventions. Primary outcome was a composite of 4 communication measures coded from audio-recorded oncologist visits shortly after patient coaching (intervention) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QoL, and utilization of aggressive treatments and hospice in the last 30 days of life. Results: In fully-adjusted models, the intervention significantly improved mean composite communication scores [0.34, 95% CI (0.06, 0.62), p = 0.017]. Effects on secondary outcomes were not significant. Conclusions: Oncologist communication training combined with coaching for patients with advanced cancer and available caregivers promoted patient-centered communication. Nevertheless, we did not observe changes in QoL and utilization, suggesting that more intensive, psychologically-oriented or longitudinal interventions may be needed, along with support and incentives for clinicians to participate. Clinical trial information: NCT01485627.