bluuebunny/crossref_metadata_2025 huggingface dataset:
Malignant ascites as a manifestation of advanced papillary renal cell cancer (pRCC).
Authors: Friend Julia C. , Su Daniel , Thimmapuram Rashmi , Peterson James , Hawks Geri , Ninos Martha , Linehan W. Marston , Srinivasan Ramaprasad
Published: February 2017

465

Background: Peritoneal carcinomatosis and ascites are frequent and clinically challenging complications associated with several malignancies such as ovarian cancer. Although ascites is rarely reported in patients with advanced renal cell carcinoma (RCC), its true incidence, particularly in non-clear cell variants, remains poorly defined. Here, we describe the incidence of and clinical characteristics associated with ascites in patients with pRCC. Methods: Patients with metastatic renal cell carcinoma (RCC) seen at the NCI Urologic Oncology Branch were identified in a review of our clinical database. The incidence of radiologically and/or cytologically evident ascites, relevant associated clinical characteristics, and survival were evaluated as was the incidence of ascites in a contemporaneous clear cell RCC (ccRCC) cohort. Results: 241 patients with metastatic RCC were seen between 2002 and 2014, including 109 with pRCC and 125 with ccRCC. Seventeen patients with metastatic pRCC (17/109,15.5%) had evidence of malignant ascites, while only 1/125 pts (0.8%) with ccRCC developed this complication. Median age of PRCC patients with ascites was 45.8 years (range: 26.1 to 76.6 years). Ascites was seen in both patients with type 1 (15.6%, 10/64) and those with type 2 pRCC (15.5%, 7/45). Median time to development of ascites from initial diagnosis of metastatic disease was 16 months (95% CI 7-23 months). Median survival from diagnosis of metastatic disease was 25 months (95% CI 13-41months) in patients with ascites, compared to 20 (95% CI 14-31 months) in those without this complication. (p = 0.59). Conclusions: To our knowledge, this is the largest series evaluating the incidence of and outcome associated with ascites in RCC. Although rare in ccRCC, malignant ascites is a fairly common manifestation of metastatic pRCC. In our cohort, patients with ascites appeared to have outcomes comparable to patients with metastatic pRCC without ascites.
The impact of renal cell carcinoma histopathological subtype on disease prognosis: A Canadian multi-institutional analysis.
Authors: Bjazevic Jennifer , Nayak Jasmir G. , Patel Premal , Kapoor Anil , Tanguay Simon , Finelli Antonio , Rendon Ricardo A. , Black Peter C. , Moore Ronald Brian , Breau Rodney H. , Kawakami Jun , Lacombe Louis , Klotz Laurence , Pautler Stephen E. , Drachenberg Darrel E
Published: February 2017

480

Background: Renal cell carcinoma (RCC) is divided into several histopathological subtypes, each with significantly different clinical features. However, current data regarding the prognostic value of histological subtype is limited and conflicted. We examined the impact of RCC histology on disease prognosis in a large, multi-institutional Canadian analysis. Methods: The Canadian Kidney Cancer Information System (CKCis), a prospective database from 14 Canadian institutions, was utilized for the study. 1284 patients with non-metastatic RCC, who underwent surgical intervention with curative intent, were included in the study. Patients were stratified according to their primary histology and the Chi-squared test was used to determine associations between histopathology and clinical features. The impact of histology of disease-free survival (DFS) was determined with a multivariate analysis adjusted for age, gender, tumor size, tumor grade, and pathological stage. Results: Clear cell RCC was the most prevalent histological subtype found in 80.5% of patients. Histopathology was significantly associated with patient age, tumor grade, and pathological stage. Advanced stage disease (>T3) was associated with clear cell and papillary type II RCC (p<0.05). 90.7%, 86.7%, 78.5%, and 78.8% of patients with chromophobe, papillary type I, papillary type II, and clear cell RCC respectively, were free of disease after a median follow-up of 1.2 years. On multivariate analysis, histological subtype was a significant predictor of disease-free survival (DFS). When compared to clear cell histology, chromophobe RCC had a significantly higher DFS (HR=0.38, 95% CI 0.15-0.95, p<0.05), and papillary type I RCC had a trend towards a lower rate of disease progression (HR=0.31, 95% CI 0.08-1.28, p=0.05). Conclusions: This study demonstrates that histological subtype impacts disease progression. Histological subtype was independently associated with DFS in surgically treated RCC, specifically chromophobe RCC was shown to have the highest DFS. This may be used to help individualize patient treatment and follow-up based on primary tumor histology.
Prognostic biomarker exploration for patients with metastatic renal cell carcinoma receiving VEGFR TKI.
Authors: Park Inkeun , Cho Yong Mee , Lee Jae-Lyun , Ahn Jin-Hee , Lee Dae Ho , You Dalsan , Jeong In Gab , Song Cheryn , Hong Bum-Sik , Hong Jun Hyuck , Ahn Hanjong
Published: February 2017

491

Background: To verify the prognostic importance of selected tumor tissue biomarkers in metastatic renal cell carcinoma (mRCC) patients (pts), we performed immunohistochemical (IHC) staining in tumor sample and statistical analyses. Methods: The clinicopathological features, treatment, and outcome of mRCC pts treated with vascular endothelial growth factor tyrosine kinase inhibitor (VEGFR TKI) between July 2006 and March 2011 at our center were reviewed. IHC staining for FGF base, FGFR1, 2, 3, and 4, HGF, PTEN, CAIX, pS6, HIF-1a, HIF-2a, IL-8, mTOR was done, and each specimen was scored based on the staining intensity and the percentage of positive cells. We performed univariate and multivariable analyses to verify prognostic factors for overall survival (OS). Results: We found 123 pts who met inclusion criteria. Most pts had clear cell carcinoma (107 pts, 87.0%). Fuhrman’s nuclear grade (NG) was 2 in 21 (17.1%), 3 in 49 (39.8%), and 4 in 52 (42.3%), respectively. Sarcomatoid change and coagulative necrosis were found in 51 pts and 58 pts. Using Heng’s criteria, 20 pts (16.3%), 87 (70.7%), and 16 (13.0%) belonged to favorable, intermediate, and poor risk group, respectively. First-line VEGFR TKIs prescribed were sunitinib (97 pts, 78.9%), sorafenib (23 pts, 18.7%), and pazopanib (3 pts, 2.4%). In univariate analysis, CAIX (less than 47.5% vs 47.5% or more, p=0.001), mTOR (20% or less vs more than 20%, p=0.0032), Heng risk group (good vs intermediate vs poor, p<0.001), sarcomatoid change (40% or less vs more than 40%, p<0.001), coagulative necrosis (20% or less vs more than 20%, p<0.001), Furhman NG (2 vs 3 vs 4, p=0.037) were statistically significant. In multivariable analysis, CAIX, Heng risk group, sarcomatoid change, and hyaline necrosis were identified as independent prognostic factors (Table). Conclusions: All investigated biomarkers but CAIX did not show prognostic importance for mRCC pts receiving VEGFR TKI. [Table: see text]
The predictive value of ARv7 expression in localized prostate caner treated with abiraterone, degarelix, and bicalutamide.
Authors: Corcoran Niall , Hovens Christopher , Howard Nicholas , Bugeja Patricia , Kerger Michael , Peters Justin , Clarke David , Grummet Jeremy , Dundee Phillip , Pedersen John , Ryan Andrew , Costello Anthony , Ruljancich Paul , Parente Phillip
Published: February 2017

71

Background: Androgen receptor splice variants (ARvs) are upregulated in response to castration, and can activate transcription in the absence of ligand. Recent evidence indicates that CTC ARv7 expression is an accurate predictor of absence of response to abiraterone and enzalutamide, providing strong clinical support for ARv7 upregulation as potential overarching mechanism of castration resistance. There is however limited data regarding the expression of ARv7 in clinically localized prostate cancer (CaP), and it is unknown if expression in the primary tumor is similarly predictive. We were therefore interested to determine the expression of ARv7 in high-risk disease, and correlate this with response to an abiraterone-containing castrating regimen. Methods: We performed an open label non-randomized Phase II neoadjuvant study of ‘supercastration’ in men with high-risk clinically localized CaP using an optimal 2-stage design (ACTRN12612000772842). Treatment consisted of degarelix 240/80mg q 1/12, abiraterone 1000mg OD, bicalutamide 50mg OD and prednisolone 5mg OD for 24 weeks. The primary endpoints were safety/tolerability and pT0 response rate. ARv7 expression was determined by immunohistochemistry and qRT-PCR in both pre- and post treatment tumor specimens, and correlated with pathological response. Fresh specimens from resistant tumors are currently being profiled by RNA-seq. Results: 17 patients were recruited to the study. The combination treatment was well tolerated, with hot flushes and fatigue being the most commonly reported side effects, and all patients completed six months of treatment. Six patients with asymptomatic elevation of liver transaminases required Abiraterone dose reductions, and there were no unexpected toxicities. 16 patients proceeded to prostatectomy, and a pT0 response observed in one patient, with minimal residual disease present in a further three patients. ARv7 expression was uniformly present in all pre-treatment specimens, and neither level nor localization of expression predicted tumor response. Conclusions: ARv7 expression in primary CaP does not predict response to abiraterone-based castration. Clinical trial information: ACTRN12612000772842.
Clinical performance of PCA3 and TMPRSS2:ERG urinary biomarkers for African American men undergoing prostate biopsy.
Authors: Feibus Allison H. , Sartor Oliver , Thomas Raju , Maddox Michael M. , Lee Benjamin , Levy Justin , Stewart Carrie A. , Wang Julie , Moparty Krishnarao , Silberstein Jonathan L.
Published: February 2017

91

Background: Urinary assaysfor PCA3 and TMPRSS2:ERG (T2:ERG) fusion are established biomarkers for the detection of prostate cancer (PCa). However few African Americans (AA) have been included in previous studies. We sought to determine the performance characteristics of these assays in a racially diverse group of men who elected to undergo prostate biopsy. Methods: Following IRB approval, from 12/2013-10/2014, post digital rectal exam urine was collected in 152 patients without a diagnosis of PCa, prior to biopsy. PCA3 and T2:ERG RNA copies were quantified using transcription-mediated amplification assays and normalized to PSA mRNA copies. Results: Of the 152 patients who met study inclusion, 93 (61%) were AA, 59 were non-AA (39%); 72(47%) were diagnosed with PCa (55% AA, 36% non-AA). Both PCA3 and T2:ERG scores were greater in men with biopsy-proven PCa, those with ≥3 PCa cores, ≥33.3% PCa cores, >50% PCa involvement of greatest biopsy core and Epstein significant PCa (all p-values ≤ 0.02). PCA3 but not T2:ERG scores were greater in men with Gleason grade ≥7 (p = 0.0003). ROC analyses for prediction of biopsy outcome resulted in AUCs of 0.7, 0.61 and 0.59 for PCA3, T2:ERG and serum PSA. For the subgroup of AA, PCA3 and T2:ERG scores were greater in men with biopsy-proven PCa, those with ≥3 PCa cores, ≥33.3% PCa cores, >50% PCa involvement of greatest biopsy core and Epstein significant PCa (all p-values ≤0.01). Both PCA3 and T2:ERG scores were greater in men with Gleason grade ≥7 (p ≤ 0.03). ROC analyses for prediction of biopsy outcome for AA only resulted in AUCs of 0.66, 0.66 and 0.58 for PCA3, T2:ERG and serum PSA. For the non-AA cohort, PCA3 scores were greater in men with biopsy-proven PCa, those with ≥3 PCa cores, ≥33.3% PCa cores, >50% PCa involvement of greatest biopsy core, Epstein significant PCa and Gleason grade ≥7 (all p-values ≤ 0.03). T2:ERG did not reach significance for any of these variables. In this subgroup, ROC analyses for prediction of biopsy outcome resulted in AUCs of 0.73, 0.54 and 0.56 for PCA3, T2:ERG and serum PSA. Conclusions: In AA men undergoing prostate biopsy, both PCA3 and T2:ERG urinary assays demonstrate clinical utility in predicting biopsy outcome and PCa disease characteristics.
Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of Onartuzumab Plus Bevacizumab Versus Placebo Plus Bevacizumab in Patients With Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O
6
-Methylguanine–DNA Methyltransferase Biomarker Analyses
Authors: Cloughesy Timothy , Finocchiaro Gaetano , Belda-Iniesta Cristóbal , Recht Lawrence , Brandes Alba A. , Pineda Estela , Mikkelsen Tom , Chinot Olivier L. , Balana Carmen , Macdonald David R. , Westphal Manfred , Hopkins Kirsten , Weller Michael , Bais Carlos , Sandmann Thomas , Bruey Jean-Marie , Koeppen Hartmut , Liu Bo , Verret Wendy , Phan See-Chun , Shames David S.
Published: February 2017

Purpose

Bevacizumab regimens are approved for the treatment of recurrent glioblastoma in many countries. Aberrant MET expression has been reported in glioblastoma and may contribute to bevacizumab resistance. The phase II study GO27819 investigated the monovalent MET inhibitor onartuzumab plus bevacizumab (Ona + Bev) versus placebo plus bevacizumab (Pla + Bev) in recurrent glioblastoma.

Methods

At first recurrence after chemoradiation, bevacizumab-naïve patients with glioblastoma were randomly assigned 1:1 to receive Ona (15 mg/kg, once every 3 weeks) + Bev (15 mg/kg, once every 3 weeks) or Pla + Bev until disease progression. The primary end point was progression-free survival by response assessment in neuro-oncology criteria. Secondary end points were overall survival, objective response rate, duration of response, and safety. Exploratory biomarker analyses correlated efficacy with expression levels of MET ligand hepatocyte growth factor, O
6
-methylguanine–DNA methyltransferase promoter methylation, and glioblastoma subtype.

Results

Among 129 patients enrolled (Ona + Bev, n = 64; Pla + Bev, n = 65), baseline characteristics were balanced. The median progression-free survival was 3.9 months for Ona + Bev versus 2.9 months for Pla + Bev (hazard ratio, 1.06; 95% CI, 0.72 to 1.56;
P
= .7444). The median overall survival was 8.8 months for Ona + Bev and 12.6 months for Pla + Bev (hazard ratio, 1.45; 95% CI, 0.88 to 2.37;
P
= .1389). Grade ≥ 3 adverse events were reported in 38.5% of patients who received Ona + Bev and 35.9% of patients who received Pla + Bev. Exploratory biomarker analyses suggested that patients with high expression of hepatocyte growth factor or unmethylated O
6
-methylguanine–DNA methyltransferase may benefit from Ona + Bev.

Conclusion

There was no evidence of further clinical benefit with the addition of onartuzumab to bevacizumab compared with bevacizumab plus placebo in unselected patients with recurrent glioblastoma in this phase II study; however, further investigation into biomarker subgroups is warranted.
Randomized trial of early integrated palliative and oncology care.
Authors: Greer Joseph A. , El-Jawahri Areej , Pirl William F. , Jackson Vicki A. , Park Elyse R. , Back Anthony , Muzikansky Alona , Kamdar Mihir , Rinaldi Simone , Jacobsen Juliet , Gallagher Emily R. , Fishbein Joel , Eusebio Justin , VanDusen Harry , Temel Jennifer S.
Published: February 2017

104

Background: Early palliative care (PC) improves outcomes in patients with newly diagnosed metastatic non-small cell lung cancer (NSCLC) and in patients identified by clinicians as having poor prognosis, advanced cancer. We evaluated the impact of early, integrated palliative and oncology care in patients with newly diagnosed lung and gastrointestinal (GI) cancer. Methods: Between 5/2/11 and 7/20/15, we randomly assigned patients with newly diagnosed incurable lung (NSCLC, small cell, mesothelioma) or GI (pancreas, hepatobiliary, gastric, esophageal) cancer to PC integrated with oncology care (monthly visits with PC) or usual oncology care. We used the Functional Assessment of Cancer Therapy-General (FACT-G) to assess quality of life (QOL) and the Patient Health Questionniare-9 (PHQ-9) for mood at baseline, weeks 12 and 24. We also assessed patients’ coping styles (Brief COPE), perceptions of likelihood of cure and communication about end-of-life (EOL) preferences. To evaluate intervention effects on patient-reported outcomes, we performed chi square tests and linear regression, controlling for baseline values and clinical factors. Results: We randomized 350 patients (175 per group), including 191 lung and 159 GI cancer patients. Patients assigned to early PC had higher QOL (B = 5.36, 95% CI: 2.04 to 8.69, p = 0.002) and less depression on the PHQ-9 (B = -1.17, 95% CI: -2.33 to -0.01, p = 0.048) at 24 weeks, but not at 12 weeks. Also at 24 weeks, the intervention group was significantly more likely to report using active and engaged coping styles compared to the usual care group (B = 1.09, 95% CI: 0.23 to 1.96, p = 0.013). Similar proportions of patients at 24 weeks reported that their cancer was unlikely to be cured (36/105 [33.6%] in PC and 43/115 [37.4%] in usual care) but more patients assigned to early PC reported they discussed their EOL preferences (35/116 [30.2%] versus 17/117 [14.5%], p = 0.004). Change in QOL over time differed between the lung and GI cancer cohorts. Conclusions: Early PC improved QOL, mood, coping, and the frequency of EOL discussions in patients with newly diagnosed lung and GI cancer. The benefits of the integrated care model extend to other populations with advanced disease and include improved communication about EOL care. Clinical trial information: NCT01401907.
Advance care planning and palliative care consultation for stem cell transplant patients.
Authors: Wang Winnie S , Ma Joseph D. , Nelson Sandahl H , Revta Carolyn , Buckholz Gary T , Mulroney Carolyn M. , Roeland Eric
Published: February 2017

113

Background: Advance care planning (ACP) in stem cell transplantation (SCT) is particularly challenging given the potential for cure for patients with blood cancers despite an increased risk of suffering and even death. Data regarding ACP and palliative care (PC) integration in SCT is limited. Methods: A retrospective chart review was conducted of patients with hematologic malignancies who underwent SCT at UCSD from January 2011 to December 2015. The primary objective was to determine the medical discipline of the initial and last code status documentation. Secondary objectives included evaluation of AD and/or POLST completion, PC consultation, hospice enrollment, and location of death. Data were compiled from a single electronic medical record and descriptive statistical analyses performed. Results: A total of 633 SCT were performed from 2011 to 2015 including 39% (n = 245) allogeneic and 61% (n = 388) autologous transplants (n = 29 patients had 2 transplants). Mean age of SCT patients was 55 years (±13). All but one (n = 632) had code status documentation, and 0.8% (n = 5) were initially DNR. The initial code status was documented outpatient for 3% (n = 17), and by the primary SCT physician for 1 patient. The final code status was documented outpatient for 22% (n = 14), and by the primary SCT physician for 0.9% (n = 6). Nearly half (44%, n = 279) had an AD and/or POLST completed. PC consultation occurred for 19% (n = 121) with the majority (83%, n = 101) completed inpatient. PC consultation requests were made by the primary SCT physician (18%, n = 22), inpatient SCT team (68%, n = 82), critical care (8%, n = 10), or other (5%, n = 6).The most common reason for consultation was symptom management (80%, n = 94). As of January 2016, 20% (n = 127) of SCT patients died with a mean time from transplant of 312 days (± 317). Of those that died, the majority (83%, n = 106) died in the hospital, 15% (n = 19) were full code, 48% (n = 62) had an AD and/or POLST, and 14% (n = 18) were enrolled in hospice. Conclusions: These single center data suggest ACP and PC integration in SCT is limited. Opportunities exist to expand integration to the outpatient setting and earlier in the course of illness.
Equity in patient-provider communication regarding treatment-related symptoms and health-related quality of life (HRQOL) among breast cancer survivors.
Authors: Samuel Cleo A. , Schaal Jennifer , Robertson Linda , Eng Eugenia , Kollie Jemeia G , Yongue Christina , Foley Karen , Smith Beth , Yee Mellissa K , Black Kristin , Ellis Katrina , Hoffman Lucretia , Lightfoot Alexandra , Morse Claire , Padilla Neda , Cykert Sam
Published: February 2017

127

Background: Compared with white breast cancer patients, black patients more often report inadequate symptom control and decrements in health-related quality of life (HRQOL). Racial differences in patient-provider communication (PPC) are well-documented and linked to worse health outcomes for minorities; however, less is known about inequities in symptom and HRQOL discussions among cancer patients and providers. As part of an NCI-funded systems change intervention to improve racial equity in treatment completion among Black and White cancer patients, we assessed racial differences in PPC regarding treatment-related symptoms, HRQOL issues (e.g., physical, psychosocial, financial, and spiritual well-being), and symptom management among breast cancer survivors (BCS). Methods: We conducted 6 focus groups (FGs) and semi-structured interviews with 22 stage 1-3 BCS (3 black FGs; 3 white FGs) from 2 cancer centers. Guided by a community-based participatory research approach, our diverse community-academic-medical team facilitated FGs and conducted qualitative analyses. Results: Although both black and white BCS reported multiple treatment-related symptoms and changes in HRQOL, perspectives on PPC differed. Some black and white BCS described positive aspects of PPC, including providers’ thorough explanations of treatment side effects and responsiveness to symptom concerns. However, white BCS expressed greater satisfaction with PPC, while black BCS more often described concerns regarding providers’ verbal (e.g., nondisclosure, dismissiveness) and non-verbal communication (e.g., unapproachability, poor eye contact) skills in the context of symptom management. Most BCS, regardless of race, indicated that providers typically discussed physical symptoms/HRQOL issues, but often failed to mention non-physical side effects of treatment (e.g., social isolation, financial toxicity). Conclusions: Racial differences in PPC exist among BCS and may contribute to inequities in symptom management and HRQOL. Inadequate communication regarding non-physical symptoms likely represents a critical missed opportunity for improving the quality and equity of palliative care.
Evaluation of an advanced practice radiation therapist role in palliative radiation therapy.
Authors: Job Mary , Holt Tanya
Published: February 2017

136

Background: To evaluate the impact a new Advanced Practice Palliative Radiation Therapist (APRT) role had on patients treated with palliative intent, with respect to reducing time from referral to treatment. To evaluate the technical ability of the APRT to delineate palliative field borders on digitally reconstructed radiographs (DRR) compared to the treating Radiation Oncologist (RO). Methods: The time in working days from referral to treatment and referral to planning was recorded for all palliative patients having 10 fractions or less. The patients were classified into two groups. Patients from G1 were referred to one of four selected ROs or directly to the APRT. All clinical and technical elements of their radiotherapy treatment were managed by the APRT. Patients from G2 were referred to one of the remaining four ROs in the department and had their radiation therapy treatment managed through the standard pathway. The APRT delineated field borders on all patients in G1, blinded to the ROs field delineation. The RO then deemed the APRTs field placement acceptable or unacceptable. If unacceptable the RO documented the reasons for rejection. Results: Over 5 months, data was collected on 150 palliative patients. The APRT managed 94 patients. The remaining 56 patients were processed through the standard pathway. The APRT delineated 90 palliative fields on patients blinded to the RO. Of these, 89% were deemed acceptable by the RO. Conclusions: There has been a positive impact with respect to reducing time from referral to treatment for patients receiving palliative radiotherapy with the introduction of the APRT role in palliative radiotherapy.[Table: see text]
Integration of palliative care for patients with solid tumors on phase I clinical trials.
Authors: Ferrell Betty R. , Chung Vincent M. , Koczywas Marianna , Williams Anna Cathy , Hurria Arti , Borneman Tami R. , Cooper Rhonda , Knight Louise , Fischer Patricia , Gallagher Denise , Smith Thomas J.
Published: February 2017

138

Background: Cancer patients receiving Phase I clinical trials are a population with advanced disease, high symptom burden, and with multiple QOL concerns including use of advance directives. Methods: An NCI funded R01 is currently in progress (2014-2019) as a randomized clinical trial to test a palliative care intervention (PCI) in this population. The PCI includes comprehensive patient assessment, goals of care communication, interdisciplinary care planning and patient teaching. Aims and hypotheses test the impact of the PCI on symptoms, QOL, resource use, spirituality and distress. Outcomes for the study (N = 400) will be conducted at the conclusion of the RCT. This paper reports preliminary baseline data of the first 100 subjects accrued. Results: Subjects mean age was 59 years and 59% were female, similar to prior trials. Forty eight percent (48%) were ethnic minorities, higher than prior trials (3% non-white, Finlay E, 2014; 9%, Parsons JA, et al. PLoS One 2012) with colon (22%) and lung (21%) cancers as dominant. Patients had a mean of 2 comorbidities (range 0-8) and 40% of the patients are > 65 years of age. The most common symptoms reported by PRO-CTCAE (1 = least to 5 = most concern) were sexuality (4.2), fatigue (2.9), pain (2.6) and anxiety (2.5). Psychological Distress Thermometer, (0 - least to 10 = most distress) mean score was 4. FACIT spiritual concerns (1 = least to 5 = most concerning) identified greatest concerns of illness strengthening faith (2.0), strength from faith (2.0) and sense of harmony (2.6). There was limited use of supportive care services, PC consultation, or advanced directives. Conclusions: The population of Phase I trial patients is an important group for palliative care integration with major unmet needs in symptom management and advance care planning.
Multidisciplinary tumor board for improvement of oncology collaboration in advanced cancer patients.
Authors: Chang Sanders , Doshi Amish , Smith Cardinale B. , Scarborough Bethann , Serban Stelian , Ciccone Jeffrey , Dharmarajan Kavita Vyas
Published: February 2017

175

Background: The Palliative and Supportive Oncology Tumor Board was developed in 2015 to provide an interdisciplinary forum for discussion and management of patients with complex or refractory symptoms from advanced cancer. The board meets monthly and consists of medical, surgical, and radiation oncologists, interventional radiologists, pain management, palliative care specialists, residents, and fellows. Here, we assess the impact of the tumor board on the care of these patients. Methods: Electronic records of advanced cancer patients discussed at the tumor board from January 2015 to December 2015 were analyzed. We extracted data regarding sociodemographics, primary cancer site, pain interventions delivered, palliative care services utilized, and readmissions. Results: Thirty-two patients were presented at the tumor board over twelve months. The median age was 60 years (range 26-89); 47% were male. Primary cancer site included multiple myeloma (n = 11), gastrointestinal (n = 9), genitourinary (n = 5), breast (n = 2), lung (n = 2), skin (n = 1), and unknown origin (n = 2). At the time of discussion, 16 patients were hospitalized and 18 were in the ambulatory setting. Recommendations from the tumor board included altering medication regimen (n = 4), discussing eligibility to receive an anesthetic block (n = 7), undergoing vertebroplasty (n = 9), and planning palliative radiation treatment (n = 19). Patients were seen by specialists from pain (n = 21), interventional radiology (n = 14), neurosurgery (n = 9), palliative care (n = 20), radiation oncology (n = 21), or medical oncology (n= 32) within one day of their case presentation at the tumor board. Seven patients were transferred to the inpatient palliative care unit within a day of their tumor board discussion. Five patients were readmitted to the hospital within 30 days due to uncontrolled pain or other symptoms. Conclusions: The palliative and supportive oncology tumor board was well received by clinicians overall. It fostered interdisciplinary collaboration and supported comprehensive management of pain and other symptoms, as evidenced by the mix of cases discussed and the short time within which patients were seen after presentation by the participating specialists.
Provider perceptions of burnout while engaging in end-of-life care conversations: A pilot study using the Serious Illness Conversation Guide.
Authors: Beck Anna Catherine , Miraglia Allison , Rajeev Deepthi , Hanover Rita , Steenstra Joshua , Talebreza Shaida , Martinez Holli , Looney Emily
Published: February 2017

19

Background: Studies recommend improved attention to patient end-of-life (EOL) care preferences and there is evidence that effective provider-patient EOL care conversations yield positive patient outcomes and reduce stress, anxiety, and depression for providers. Providers lack training to elicit patients’ EOL care goals and hence are reluctant to initiate EOL conversations. Methods: The Serious Illness Conversation Guide (SICG) was used to train providers and data were collected based on the Maslach Burnout Inventory to assess provider burnout, determine satisfaction of SICG training, and change in confidence/knowledge related to EOL conversations. Results: 18 providers were trained with a median work experience of 15 years. 41% spent 8+ hours/week interacting with seriously ill patients, 50% initiate EOL conversations < twice/month, and 19% reported burnout. 10 providers responded to the post-training evaluation, 80% reported burnout (Table). Conclusions: Providers reported high satisfaction of SICG training and increased knowledge and confidence related to EOL care conversations. However, provider burnout increased, possibly due to their increased awareness of an appropriate way to elicit patients’ EOL care goals. To explore this further, we will be conducting additional training sessions in the future. [Table: see text]
Investigating high-concentration 8% capsaicin patch in chronic cancer-treatment related peripheral neuropathic pain.
Authors: Ramnarine Sabrina , Laird Barry , Williams Linda J , Fallon Marie T
Published: February 2017

208

Background: Cancer-treatment related peripheral neuropathic pain is a challenging clinical problem as current interventions have limited efficacy and significant toxicities. This study aims to examine the analgesic effect of high-concentration 8% capsaicin patch in this cohort of patients. Methods: A single arm study was conducted. Patients with long-term peripheral neuropathic pain received a single application of 8% transdermal capsaicin patch to the affected area (chest wall, hands or feet). Assessments at baseline, 4 weeks and 12 weeks post-treatment included: Brief Pain Inventory (BPI) short form (pain severity and interference with function); Hospital Anxiety and Depression Scale (HADS). The primary efficacy measure was a clinically significant improvement in pain (≥ 30% reduction in total BPI score (responders) from baseline to 4 weeks and 12 weeks). Secondary efficacy measures assessed worst pain, function and associated changes in mood. Results: 19 patients, median age 61.5 all had peripheral neuropathic pain for a median of 2 years (IQR 1-3) following treatment for various types of cancer: gynecological (n = 2), breast (n = 6), colorectal (n = 8), multiple myeloma (n = 2) or other (n = 1). At 4 weeks, 37% (7/19) patients showed a clinically significant improvement in pain (≥ 30%). Of the 7 responders, 5 had > 50% reduction in pain. 16% (3/19) suggested a partial improvement (mean 17%). Of the patients reassessed at 12 weeks, 50% (7/14) were responders with all patients exhibiting a reduction in: worst pain score, -1.3 (95% CI: -2.5, -0.06; p = 0.04), interference with function, -10.9 (95% CI: -21.5, -0.4; p = 0.04) and HADS depression score, -1.7 (95% CI: -3.4, 0.02; p = 0.05). Total HADS score correlated with total BPI at 4 weeks (r = 0.68) and 12 weeks (r = 0.70). HADS depression score also correlated with BPI at 12 weeks (r = 0.73). All correlations were significant (p < 0.01). Conclusions: In patients with chronic, resistant, cancer-treatment related peripheral neuropathic pain, high-concentration 8% capsaicin patch may provide some benefit in pain severity, function and mood with the effect continuing at 12 weeks post-treatment. This may warrant further long-term follow up in a larger cohort.
The elephant in the room: Facilitating conversations about advanced cancer between patients and their spouses.
Authors: Porter Laura S. , FIsh Laura , Uronis Hope Elizabeth , Zafar Yousuf , Steinhauser Karen E.
Published: February 2017

233

Background: Interventions to enhance couples’ communication about cancer-related issues can lead to benefits for patients, spouses, and their relationships. We recently conducted a pilot study testing a couples communication skills training (CCST) intervention targeted to couples in which one partner had advanced GI cancer, a population who may need particular help addressing difficult and emotionally-laden topics related to life-limiting illness. Results of quantitative analyses suggested that the intervention was effective in improving relationship satisfaction for these couples. The objective of the current study was to analyze intervention session conversation content to identify themes that couples addressed spontaneously, with the ultimate goal of determining whether an intervention that more specifically guides couples to discuss issues related to end of life and the life-limiting nature of the patient’s illness would be acceptable. Methods: 12 couples (10 male and 2 female patients and their spouses) completed the 6 session CCST intervention which provided training in communication skills for sharing thoughts and feelings and making decisions, and gave couples the opportunity to use these skills to discuss cancer-related issues of their choosing. We conducted qualitative content analysis of the 72 audio-recorded sessions, and coded common and recurrent topics raised by patients and spouses. In addition to identifying breadth of topics, we used theme frequency as an initial gauge of theme importance and acceptability. Results: The most common themes identified were prognosis, treatment, emotional intimacy, completion, spouse’s life after the death of the patient, roles, communication, sublimating needs, emotional support, and family. These represent themes previously identified as important to patients at end of life, as well as themes unique to dyads in intimate relationships. Conclusions: These findings support the feasibility of conducting an intervention that combines training in communication skills with guidance for using these skills to discuss topics that are potentially most meaningful to couples facing advanced illness.
Inpatient integrated palliative and transplant care to improve family caregiver (FC) outcomes of patients hospitalized for hematopoietic stem cell transplantation (HCT).
Authors: VanDusen Harry , LeBlanc Thomas William , Traeger Lara , Greer Joseph A. , Pirl William F. , Jackson Vicki A. , Telles Jason , Rhodes Alison , Chen Yi-Bin Albert , Temel Jennifer S. , El-Jawahri Areej
Published: February 2017

235

Background: As their loved ones struggle physically and psychologically with transplant toxicities, FCs of patients undergoing HCT experience substantial distress. We assessed the impact of an inpatient palliative care intervention on FC quality of life (QOL) and mood during their loved ones’ HCT hospitalization. Methods: We conducted a randomized trial of inpatient palliative care integrated with transplant care versus transplant care alone for patients hospitalized for HCT and their FCs. Eligible FCs were identified as a relative or a friend with regular in-person contact with the patient and enrolled within 72 hours of the patient’s HCT admission. The intervention entailed at least twice weekly visits between the patient and palliative care during the transplant hospitalization, and FCs were welcome but not required to be present for these visits. We used the CareGiver Oncology QOL Questionnaire (CarGOQOL) to examine QOL, and the Hospital Anxiety and Depression Scale (HADS) to assess FC mood at baseline and week-2 during HCT hospitalization. We used the two-sample t-test to assess changes in QOL and mood from baseline to week-2. Results: We enrolled 160 patients and 94 (58.8%) FCs (control n = 49, intervention n = 45) between 8/2014 and 1/2016. Study groups did not differ significantly in baseline characteristics or overall FC QOL. At 2 weeks, FCs of patients randomized to the intervention reported improvements compared to those receiving transplant care alone in some QOL domains including better coping (0.23 vs. -0.74, p = 0.02) and handling of finances (0.24 vs. -0.46, p = 0.02) and also reported lower depression symptoms (HADS-Depression: 0.25 vs. 1.80, p = 0.03). No other CarGOQOL domains or HADS-anxiety symptoms were significantly different. Conclusions: Involvement of palliative care for patients hospitalized for HCT leads to improvement in FC depression and some aspects of their QOL. These findings demonstrate the positive impact of inpatient integrated palliative and transplant care extends to FCs of patients with hematologic malignancies undergoing HCT. Clinical trial information: NCT02207322.
Effect of red blood cell transfusions on patient-reported outcomes in an ambulatory oncology population.
Authors: Chen Lillian Jo-ann , Moeller Kimberly D , Wagman Lawrence David
Published: February 2017

78

Background: The standard transfusion (Tf) trigger in the hospitalized patient is hemoglobin (Hgb) level driven. Triggers in the ambulatory oncology population are often symptom based. The symptoms of exercise intolerance (EI), fatigue (F), and shortness of breath (SOB) were identified from a hospital quality review. The purpose of this study was to evaluate patient reported symptom (SX) changes following red blood cell (RBC) Tf. Methods: Standardized Tf orders required symptom indication(s) which include EI, F, SOB and Other. After Tf, patients were asked to complete a telephone survey to evaluate symptom changes. Responses were recorded: same, better, or worse. Data collected: # of SX/patient, initial Hgb, days between Tf and survey, cancer diagnosis, # of units Tf, age and gender. Pre and post-Tf changes were calculated. p-values were obtained with binomial distribution, testing that the observed proportion of SX improvement was different from 50%. Results: From 12/2015 to 05/2016, 62 patients had 115 Tf episodes (TfE). M:F 30:32. Avg age: 72, (42-101). Avg Hgb 7.7 (3.4-9.9) Cancer diagnoses: MDS, breast, lung, colon, renal, prostate, gallbladder, rectal, gynecologic, myeloma, lymphoma, leukemia. 106/115 (92%) received 2 units of RBC per TfE. 35/115 (30%) were interviewed on post-TfE day 7 (4-14d). Fatigue (103 of 115, 90%) was the most common SX, Of the 115 TfE : 42/115 (37%) had 1 SX, 30/115 (26%) had 2 SX, 43/115 (37%) had 3 SX. Of the total TfE(155), 82 (71%) resulted in at least 1 SX improvement and in 33 (29%) there was no SX improvement, (p < 0.001). Conclusions: Fatigue, shortness of breath, and total reported symptom changes improved with Tf (statistically significant). The greatest improvement was seen in F followed by SOB. This unique analysis focuses on the ambulatory oncology patient. Reported symptoms can serve as a quality of life endpoint model to develop guidelines for RBC Tf not limited to Hgb levels. [Table: see text]
Prevalence of myofascial pain syndrome in patients with incurable cancer.
Authors: Ishiki Hiroto , Kinkawa Junya , Watanabe Aya , Watanabe Chie , Chiba Tsukuru , Shimada Naoki , Ariyoshi Keisuke , Nojima Masanori , Iwase Satoru , Tojo Arinobu
Published: February 2017

97

Background: Myofascial pain syndrome (MPS) is a condition that involves skeletal muscles. It is caused by overload or disuse of muscles and is characterized by extreme tenderness in the muscles with taut bands. Treatment for MSP is different from that for cancer-related pain. Cancer patients have many factors that cause restriction of body movement and posture. Although cancer patients appear to demonstrate risk factors for MPS, its prevalence has not been reported in patients with incurable cancer. This study was conducted to investigate the prevalence of MPS in patients with incurable cancer. Methods: The data for patients with incurable cancer who received palliative care by our department between September 2015 and March 2016 were retrospectively investigated. We examined the prevalence of MPS. MPS was diagnosed on the basis of the Rivers criteria (RC) and Simons criteria (SC). We also examined the following factors associated with MPS: performance status (PS), use of medical devices (MD), and primary cancer sites. The primary outcome was the prevalence of MPS using the RC. Secondary outcomes included the prevalence of MPS using the SC, and the relationship between MPS and either PS or MD. Results: Thirty-four patients with incurable cancer were identified. The clinical characteristics are as follows: age (median, range): 65 (39-89) years; male/female ratio: 16/18; primary sites: pancreas (n = 8), breast (n = 8), lung (n = 4), colorectal (n = 4), head and neck (n = 2), and other primary sites (n = 8). Seventeen of 34 patients (50%) had a PS 3 or 4. Twenty-two patients (64.7%) complained of pain. MPS using the RC was detected in 10 patients (29%). MPS using the SC was detected in 20 patients (59%). Of 22 patients who complained of pain, MPS using the RC was detected in 10 (45%) patients and MPS using the SC was detected in 20 (90%) of patients. Patients with central venous port (CVP) devices had a significantly higher number of MPS lesions than patients without CVP devices (p = 0.029). Conclusions: A very high prevalence of MPS was detected in our study population. MPS should be considered when patients with incurable cancer complain of pain. A multi-center prospective study will be conducted to confirm our findings.
NRG Oncology RTOG 0415: A randomized phase III non-inferiority study comparing two fractionation schedules in patients with low-risk prostate cancer.
Authors: Lee W. Robert , Dignam James J. , Amin Mahul , Bruner Deborah , Low Daniel , Swanson Gregory P. , Shah Amit , D'Souza David , Michalski Jeff M. , Dayes Ian , Seaward Samantha A. , Hall William Adrian , Nguyen Paul L. , Pisansky Thomas Michael , Faria Sergio , Chen Yuhchyau , Koontz Bridget F. , Paulus Rebecca , Sandler Howard M.
Published: February 2017

1

Background: To determine whether the efficacy of a hypofractionated (H) schedule is no worse than a conventional (C) schedule in men with low-risk prostate cancer. Methods: From April 2006 to December 2009, one thousand one hundred fifteen men with low-risk prostate cancer (clinical stage T1-2a, Gleason ≤ 6, PSA < 10) were randomly assigned 1:1 to a conventional (C) schedule (73.8 Gy in 41 fractions over 8.2 weeks) or to a hypofractionated (H) schedule (70 Gy in 28 fractions over 5.6 weeks). The trial was designed to establish with 90% power and alpha = 0.05 that (H) results in 5-year disease-free survival (DFS) that is not lower than (C) by more than 7% (hazard ratio (HR) < 1.52). Secondary endpoints include freedom from biochemical recurrence (FFBR) and overall survival. At the third planned interim analysis (July 2015), the NRG Oncology Data Monitoring Committee recommended that the results of the trial be reported. Results: One thousand one hundred and one protocol eligible men were randomized: 547 to C and 554 to H. Median follow-up is 5.9 years. Baseline characteristics are not different according to treatment arm. At the time of analysis 185 DFS events have been observed; 99 in the C arm and 86 in the H arm. The estimated 7-year disease-free survival is 75.6% (95% CI 70.3, 80.1) in the C arm and 81.8% (77.5, 85.3) in the H arm. The DFS HR (C/H) is 0.85 (0.64, 1.14). Comparison of biochemical recurrence (HR = 0.77, (0.51, 1.17)) and overall survival (HR = 0.95, (0.65, 1.41)) also met protocol non-inferiority criteria. Grade ≥ 3 GI toxicity is 3.0% (C) vs. 4.6% (H), Relative risk (RR) for H vs. C 1.53, (95% CI 0.86, 2.83); grade ≥ 3 GU toxicity is 4.5% (C) vs. 6.4% (H), RR = 1.43 (0.86,2.37). Conclusions: In men with low-risk prostate cancer, 70 Gy in 28 fractions over 5.6 weeks is non-inferior to 73.8 Gy in 41 fractions over 8.2 weeks. Clinical trial information: NCT00331773.
Histopathologic correlation of PI-RADS V.2 lesions on 3T multiparametric prostate MRI.
Authors: Katz Aaron , Liu Corinne , Kosinski Kaitlin E.
Published: February 2017

10

Background: Prostate Imaging Reporting and Data System (PIRADS) Version 2 was recently issued by The American College of Radiology. Each score, from 1 to 5, corresponds to the likelihood of clinically significant cancer. We aim to evaluate the correlation between a higher PIRADS score and the presence of high grade tumor on histopathology. Methods: 300 consecutive 3T Multiparametric Prostate MRI (MP-MRI) were identified from March 26, 2012, to June 29, 2015. We reviewed patient charts and a total of 102 patients underwent either a transrectal ultrasound guided (TRUS) biopsy or a total prostatectomy after the MP-MRI. Thirty-four patients were excluded due to prior radiation or cryoablation to the prostate, leaving 68 treatment-naive patients (44-84 years). MP-MRIs were re-interpreted utilizing the new PIRADS V.2 scoring system and correlated with pathology findings. Statistical comparisons were made using R (v.3.1.2) and Fisher’s exact test. Results: High grade (Gleason 8-10) tumors were found only in MP-MRI with a PIRADS score of 5 and a higher percentage of tumor is found in MP-MRI with PIRADS scores of 4 and 5 (80%) when compared to PIRADS scores of 2 and 3 (32%). Low grade (Gleason 6-7) tumors were also found in both PIRADS 4 and 5 categories. There was a significant relationship between a higher PIRADS score and a finding of cancer on pathology (p = 0.0003, OR=0.118, 95% CI 0.03-0.41). Conclusions: The PIRADS scoring system is a useful tool in suggesting the likelihood of clinically significant cancer, with high grade tumors found only in MP-MRI with a score of PIRADS 5. However, MP-MRI and PIRADS criteria alone are not sufficient for determining clinically significant prostate cancer since both high grade and low grade tumors were found in PIRADS 5 and 4 categories. Correlation with other clinical parameters and biopsy is required for confirmation. A larger scale study would be helpful for further delineation. [Table: see text]