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Prostate-Specific Antigen Decline >50% After 4 Weeks of Treatment Is an Indicator of Better Progression Free and Overall Survival Both With Abiraterone and Enzalutamide in Metastatic Castrate Resistant Prostate Cancer

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BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

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BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

BACKGROUND: Abiraterone (ABI) and Enzalutamide (ENZA) are the most common medications used for metastatic castrate resistant prostate cancer (mCRPC). Post treatment prostate specific antigen (PSA) changes correlate with prognosis (1). Early PSA decline defined as PSA decline by >50 % at 4 weeks after starting treatment compared to baseline has been demonstrated to corresponds with improved PSA progression-free survival (PSA PFS) and overall survival (OS) (2). Based on our literature review, this relation has not been elucidated previously in the Veteran population.

METHODS: A retrospective chart review was conducted in subjects with mCRPC who had received ABI and ENZA from 2011 to 2019 at VA Fresno. Subjects must have received at least 3 months of each drug. The primary outcomes were to document PSAPFS and OS between patients with >50% and <50% decline in PSA at 4 weeks after starting treatment with either ABI or ENZA.

RESULTS: 50 patients were identified who were treated with Abiraterone. 30 (60%) patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks after starting was associated with a better PSA PFS (15 vs 5 months) and better median OS (20.5 vs 12 months). 20 patients were identified treated with Enzalutamide. 13(65%) of patients had a PSA decrease of 50% or greater in the first 4 weeks. A 50% or greater decrease in PSA at 4 weeks was associated with a better PSA PFS (14.5 vs 5 months) and better median OS (20 vs 12 months). 50% of patients in the whole group were diagnosed with metastatic disease at initial diagnosis while the rest were previously treated for localized prostate cancer before being diagnosed as metastatic disease. Most baseline characteristics including, baseline PSA, the modality of initial localized treatment, Gleason score, previous treatment with chemotherapy were similar between the two comparison cohorts (>50% and <50% decrease in PSA after starting treatment with ABI or ENZA).

CONCLUSIONS: Early decrease in PSA is an independent marker for the efficacy of antiandrogen treatment with enzalutamide and abiraterone in metastatic hormone- resistant prostate cancer in the veteran population.

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Prostate Cancer in a Transgender Woman

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INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

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INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

INTRODUCTION: As a neoplasm specific to male reproductive anatomy, prostate cancer represents a complex disease experience for transgender women. We present a patient who initiated her male-to-female (MTF) transition amidst a new prostate cancer diagnosis.

CASE REPORT: A 58-year-old male presented with urinary retention and a PSA of 21.53 ng/ml. Prostate biopsy showed a Gleason 4+5 adenocarcinoma with no evidence of metastasis on imaging. The patient underwent radical prostatectomy, which showed seminal vesicle invasion. After surgery, the PSA nadired to 2.5 ng/ml. Salvage radiation and androgen deprivation therapy (ADT) with leuprolide was initiated. ADT-induced physical feminization prompted the patient to begin discussing lifelong gender dysphoria in group therapy. After completing radiation therapy, she opted for bilateral orchiectomy. Shortly thereafter, she started an estradiol patch. Five months later, the PSA level began to rise. Estradiol-induced carcinogenesis due to tumor estrogen receptor (ER) expression versus natural tumor progression was considered, so she underwent a 6-week trial without estradiol. PSA levels continued increasing, and the tumor was found to be ER-negative. Furthermore, the patient suffered psychological and physical side effects from pausing hormonal therapy, so estradiol was restarted. Abiraterone and prednisone were initiated with PSA response (<0.01 ng/ml).

DISCUSSION: To date, there have been ten reported cases of prostate cancer in MTF transgender patients. Prostate cancer management in this population carries unique considerations, such as the possible carcinogenic effect of estrogen. Estradiol, a commonly used hormone in trans female patients, is a ligand for ER-alpha and ER-beta, both of which are implicated in oncogenesis and progression of prostate cancer. ER-alpha expression is associated with higher Gleason score, more advanced disease, and shorter survival. Orchiectomy as an alternative to long-term ADT should be discussed. These patients may also face significant psycho-social challenges such as exacerbation of gender dysphoria by prostate cancer, difficulty engaging with health care providers, and issues with changing gender status in electronic health record. Mental health support, sensitivity to transgender pronouns, and goals-of-care discussions are critical. As gender fluidity becomes more prevalent, physicians need to tailor biopsychosocial cancer care for transgender patients.

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Primitive Neuroectodermal Tumor of the Pancreas in Adults; A Rare and Aggressive Malignancy

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INTRODUCTION: Primitive neuroectodermal tumors (PNET) are highly aggressive malignancies composed of small round cells that are neuroectodermal in origin similar to Ewings Sarcoma. PNET of the pancreas is extremely rare with around 20 cases reported in literature.

CASE REPORT: A 60-year-old male experienced abdominal pain, appetite loss and weight loss of around 40 pounds for several months. Abdominal CT revealed a pancreatic head mass with a pseudocyst causing gastric outlet obstruction. He underwent an endoscopic ultrasound guided FNA which did not show any evidence of malignancy. An attempted endoscopic drainage of the pseudocyst was unsuccessful. An exploratory laparotomy with en bloc resection of multiple abdominal organs did not provide much benefit as the pseudocyt recurred, leading way for a second limited laparotomy. Pathology was consistent with PNET demonstrating Immunohistochemistry (IHI) positivity for FL1, CD99, Vimentin and synaptophysin and a Ki 67 index of 90%. 6 months into his course, he was hospitalized with sepsis which was believed to be secondary to peritonitis. CT abdomen showed multiple hepatic masses and extensive omental carcinomatosis with free fluid in the abdomen. The infection failed to improve with antibiotics and supportive care. His poor performance status meant systemic therapy or repeat surgery was not an option. It was believed that his worsening clinical status was due to his enormous intra-abdominal tumor burden. He eventually decided to become comfort care and proceed with hospice.

DISCUSSION: Histopathology, IHI and genetic analysis are essential in the diagnosis of PNET of the pancreas, as other pancreatic mesenchymal and neuroendocrine tumors, pancreatoblastomas and lymphomas are differentials. PNET generally express the MIC2 protein (CD99), vimentin and 85-95% of the times, have the translocation resulting in the EWS-FLI1 fusion product. Abdominal pain, jaundice, dyspepsia and vomiting are the usual presenting symptoms with the head of the pancreas being the most common location. Multi-agent regimes like cyclophosphamide, adriamycin, and vincristine or neoadjuvant vincristine, dactinomycin, adriamycin, cyclophosphamide, ifosfamide and etoposide have been used with limited success This can be combined with surgery and radiation, but the prognosis remains to be poor. Thus, more research is needed to better manage this morbid malignancy.

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INTRODUCTION: Primitive neuroectodermal tumors (PNET) are highly aggressive malignancies composed of small round cells that are neuroectodermal in origin similar to Ewings Sarcoma. PNET of the pancreas is extremely rare with around 20 cases reported in literature.

CASE REPORT: A 60-year-old male experienced abdominal pain, appetite loss and weight loss of around 40 pounds for several months. Abdominal CT revealed a pancreatic head mass with a pseudocyst causing gastric outlet obstruction. He underwent an endoscopic ultrasound guided FNA which did not show any evidence of malignancy. An attempted endoscopic drainage of the pseudocyst was unsuccessful. An exploratory laparotomy with en bloc resection of multiple abdominal organs did not provide much benefit as the pseudocyt recurred, leading way for a second limited laparotomy. Pathology was consistent with PNET demonstrating Immunohistochemistry (IHI) positivity for FL1, CD99, Vimentin and synaptophysin and a Ki 67 index of 90%. 6 months into his course, he was hospitalized with sepsis which was believed to be secondary to peritonitis. CT abdomen showed multiple hepatic masses and extensive omental carcinomatosis with free fluid in the abdomen. The infection failed to improve with antibiotics and supportive care. His poor performance status meant systemic therapy or repeat surgery was not an option. It was believed that his worsening clinical status was due to his enormous intra-abdominal tumor burden. He eventually decided to become comfort care and proceed with hospice.

DISCUSSION: Histopathology, IHI and genetic analysis are essential in the diagnosis of PNET of the pancreas, as other pancreatic mesenchymal and neuroendocrine tumors, pancreatoblastomas and lymphomas are differentials. PNET generally express the MIC2 protein (CD99), vimentin and 85-95% of the times, have the translocation resulting in the EWS-FLI1 fusion product. Abdominal pain, jaundice, dyspepsia and vomiting are the usual presenting symptoms with the head of the pancreas being the most common location. Multi-agent regimes like cyclophosphamide, adriamycin, and vincristine or neoadjuvant vincristine, dactinomycin, adriamycin, cyclophosphamide, ifosfamide and etoposide have been used with limited success This can be combined with surgery and radiation, but the prognosis remains to be poor. Thus, more research is needed to better manage this morbid malignancy.

INTRODUCTION: Primitive neuroectodermal tumors (PNET) are highly aggressive malignancies composed of small round cells that are neuroectodermal in origin similar to Ewings Sarcoma. PNET of the pancreas is extremely rare with around 20 cases reported in literature.

CASE REPORT: A 60-year-old male experienced abdominal pain, appetite loss and weight loss of around 40 pounds for several months. Abdominal CT revealed a pancreatic head mass with a pseudocyst causing gastric outlet obstruction. He underwent an endoscopic ultrasound guided FNA which did not show any evidence of malignancy. An attempted endoscopic drainage of the pseudocyst was unsuccessful. An exploratory laparotomy with en bloc resection of multiple abdominal organs did not provide much benefit as the pseudocyt recurred, leading way for a second limited laparotomy. Pathology was consistent with PNET demonstrating Immunohistochemistry (IHI) positivity for FL1, CD99, Vimentin and synaptophysin and a Ki 67 index of 90%. 6 months into his course, he was hospitalized with sepsis which was believed to be secondary to peritonitis. CT abdomen showed multiple hepatic masses and extensive omental carcinomatosis with free fluid in the abdomen. The infection failed to improve with antibiotics and supportive care. His poor performance status meant systemic therapy or repeat surgery was not an option. It was believed that his worsening clinical status was due to his enormous intra-abdominal tumor burden. He eventually decided to become comfort care and proceed with hospice.

DISCUSSION: Histopathology, IHI and genetic analysis are essential in the diagnosis of PNET of the pancreas, as other pancreatic mesenchymal and neuroendocrine tumors, pancreatoblastomas and lymphomas are differentials. PNET generally express the MIC2 protein (CD99), vimentin and 85-95% of the times, have the translocation resulting in the EWS-FLI1 fusion product. Abdominal pain, jaundice, dyspepsia and vomiting are the usual presenting symptoms with the head of the pancreas being the most common location. Multi-agent regimes like cyclophosphamide, adriamycin, and vincristine or neoadjuvant vincristine, dactinomycin, adriamycin, cyclophosphamide, ifosfamide and etoposide have been used with limited success This can be combined with surgery and radiation, but the prognosis remains to be poor. Thus, more research is needed to better manage this morbid malignancy.

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Primary Hepatic Neuroendocrine Neoplasm: A SEER Population-Based Study

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BACKGROUND: Neuroendocrine neoplasms (NENs) are relatively rare, accounting for 1-2% of all gastrointestinal (GI) tumors. The liver is the most common site of secondary NEN metastases; however, hepatic neuroendocrine neoplasm (PHNEN) arising as a primary tumor is very rare. In the literature, fewer than 150 cases have been reported. We sought a populationbased registry to identify and describe the incidence, management, and survival of PHNEN.

METHODS: Patients were identified from the Surveillance, Epidemiology, and End Results (SEER) database from 2010 to 2017 using SEER*Stat software. A chi-squared test was used to compare the clinicopathological characteristics. Kaplan–Meier analysis and log-rank tests were used for survival comparisons. A Cox proportional model was implemented for multivariate analyses of the patient population and hazard ratios (HR) and corresponding confidence intervals (CI) were generated.

RESULTS: Among 71,893 GI NEN patients identified, 416 patients (0.6%) were diagnosed with PHNEN. Most of them were older than 60 years of age (63%), female (52.3%), and non-Hispanic whites (65.4%). About one-third of patients had localized disease at presentation and 56.4% had histology consistent with neuroendocrine carcinoma (NEC). In a multivariate analysis, patients with grade III (poorly differentiated) or IV (undifferentiated/anaplastic) disease, vs. grade I (well differentiated), were associated with decreased cause specific survival (CSS) and overall survival (OS). Patients with neuroendocrine tumor histology were associated with a better CSS (HR 0.36, CI 0.21-0.65) and OS (HR 0.46, CI 0.28-0.75) than NEC histology. Patients who underwent surgical resection were also associated with better CSS (HR 0.19, CI 0.11-0.36) and OS (HR 0.19, CI 0.11-0.33) when compared to those that did not undergo surgery.

CONCLUSIONS: We describe a large series of cases with PHNEN, identified from the US population-based registry, that helps better characterize this uncommon disease. We found tumor grade, not SEER historical stage (local, regional, or distant), is an independent prognostic factor. Despite its rarity, PHNENs that are well-differentiated NETs can still have improved survival when surgical resection is considered.

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BACKGROUND: Neuroendocrine neoplasms (NENs) are relatively rare, accounting for 1-2% of all gastrointestinal (GI) tumors. The liver is the most common site of secondary NEN metastases; however, hepatic neuroendocrine neoplasm (PHNEN) arising as a primary tumor is very rare. In the literature, fewer than 150 cases have been reported. We sought a populationbased registry to identify and describe the incidence, management, and survival of PHNEN.

METHODS: Patients were identified from the Surveillance, Epidemiology, and End Results (SEER) database from 2010 to 2017 using SEER*Stat software. A chi-squared test was used to compare the clinicopathological characteristics. Kaplan–Meier analysis and log-rank tests were used for survival comparisons. A Cox proportional model was implemented for multivariate analyses of the patient population and hazard ratios (HR) and corresponding confidence intervals (CI) were generated.

RESULTS: Among 71,893 GI NEN patients identified, 416 patients (0.6%) were diagnosed with PHNEN. Most of them were older than 60 years of age (63%), female (52.3%), and non-Hispanic whites (65.4%). About one-third of patients had localized disease at presentation and 56.4% had histology consistent with neuroendocrine carcinoma (NEC). In a multivariate analysis, patients with grade III (poorly differentiated) or IV (undifferentiated/anaplastic) disease, vs. grade I (well differentiated), were associated with decreased cause specific survival (CSS) and overall survival (OS). Patients with neuroendocrine tumor histology were associated with a better CSS (HR 0.36, CI 0.21-0.65) and OS (HR 0.46, CI 0.28-0.75) than NEC histology. Patients who underwent surgical resection were also associated with better CSS (HR 0.19, CI 0.11-0.36) and OS (HR 0.19, CI 0.11-0.33) when compared to those that did not undergo surgery.

CONCLUSIONS: We describe a large series of cases with PHNEN, identified from the US population-based registry, that helps better characterize this uncommon disease. We found tumor grade, not SEER historical stage (local, regional, or distant), is an independent prognostic factor. Despite its rarity, PHNENs that are well-differentiated NETs can still have improved survival when surgical resection is considered.

BACKGROUND: Neuroendocrine neoplasms (NENs) are relatively rare, accounting for 1-2% of all gastrointestinal (GI) tumors. The liver is the most common site of secondary NEN metastases; however, hepatic neuroendocrine neoplasm (PHNEN) arising as a primary tumor is very rare. In the literature, fewer than 150 cases have been reported. We sought a populationbased registry to identify and describe the incidence, management, and survival of PHNEN.

METHODS: Patients were identified from the Surveillance, Epidemiology, and End Results (SEER) database from 2010 to 2017 using SEER*Stat software. A chi-squared test was used to compare the clinicopathological characteristics. Kaplan–Meier analysis and log-rank tests were used for survival comparisons. A Cox proportional model was implemented for multivariate analyses of the patient population and hazard ratios (HR) and corresponding confidence intervals (CI) were generated.

RESULTS: Among 71,893 GI NEN patients identified, 416 patients (0.6%) were diagnosed with PHNEN. Most of them were older than 60 years of age (63%), female (52.3%), and non-Hispanic whites (65.4%). About one-third of patients had localized disease at presentation and 56.4% had histology consistent with neuroendocrine carcinoma (NEC). In a multivariate analysis, patients with grade III (poorly differentiated) or IV (undifferentiated/anaplastic) disease, vs. grade I (well differentiated), were associated with decreased cause specific survival (CSS) and overall survival (OS). Patients with neuroendocrine tumor histology were associated with a better CSS (HR 0.36, CI 0.21-0.65) and OS (HR 0.46, CI 0.28-0.75) than NEC histology. Patients who underwent surgical resection were also associated with better CSS (HR 0.19, CI 0.11-0.36) and OS (HR 0.19, CI 0.11-0.33) when compared to those that did not undergo surgery.

CONCLUSIONS: We describe a large series of cases with PHNEN, identified from the US population-based registry, that helps better characterize this uncommon disease. We found tumor grade, not SEER historical stage (local, regional, or distant), is an independent prognostic factor. Despite its rarity, PHNENs that are well-differentiated NETs can still have improved survival when surgical resection is considered.

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Patient-Centered Cancer Care: A Streamline Practice to MyHealtheVet Usage

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BACKGROUND: Cancer care is often fragmented for the patient undergoing complex care. Cancer treatments such as chemotherapy and radiation require coordination with medical services and infusion centers. Past practices utilizing telephone communication limited care coordination. Before advances in technology, patients were restricted to obtain their health care information through conversation. Care coordination paired with patient-centered technology enables collaboration among the health care team and creates structure through visual displays of essential information.

OBJECTIVE: Our goals were to introduce technology and maximize enrollment for the patient by: (1) Establishing MyHealtheVet within the Hematology- Oncology department for increased patient support to memorialize communication. (2) Create access to care to better manage treatment of health-related issues. (3) Empower the patient to participate in managing their care.

METHODS: In October of 2017 the NF/SGVA began implementing MyHealtheVet . The Hematology-Oncology department had no formal process. By the Fall of 2019 the infusion room process was to enroll each patient or upgrade the patients’ account to premium status at the time of their first encounter with nursing during chemotherapy education.

RESULTS: MyHealtheVet usage and chemotherapy education appointments within the Hematology-Oncology department were surveyed. Over a two-year period, use in the Hematology-Oncology department at the NF/SGVA showed steady escalation of secure messaging as more oncology patients enrolled. When COVID19 arose in February 2020, the Hematology- Oncology department was already poised to handle care coordination for their patients during this crisis. With our established practices, coordination of care for patients in treatment well prepared to receive care and communication electronically through MyHealtheVet .

CONCLUSIONS: Personal health networks (PHN) have evolved and have become a novel solution to address challenges of the cancer care continuum. MyHealtheVet serves as a voice for the VA for navigating patient care coordination needs. My- HealtheVet is a clinical tool that functions locally using administrative features to involve, engage, and educate the patient with an array of resources. This enrollment process allowed us to remain patient- centered and well equipped to face COVID19 related access challenges as they quickly evolved in the spring of 2020. Pharmacy functions and Secure Messaging emerge as the strongest tools in our communication toolbox.

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BACKGROUND: Cancer care is often fragmented for the patient undergoing complex care. Cancer treatments such as chemotherapy and radiation require coordination with medical services and infusion centers. Past practices utilizing telephone communication limited care coordination. Before advances in technology, patients were restricted to obtain their health care information through conversation. Care coordination paired with patient-centered technology enables collaboration among the health care team and creates structure through visual displays of essential information.

OBJECTIVE: Our goals were to introduce technology and maximize enrollment for the patient by: (1) Establishing MyHealtheVet within the Hematology- Oncology department for increased patient support to memorialize communication. (2) Create access to care to better manage treatment of health-related issues. (3) Empower the patient to participate in managing their care.

METHODS: In October of 2017 the NF/SGVA began implementing MyHealtheVet . The Hematology-Oncology department had no formal process. By the Fall of 2019 the infusion room process was to enroll each patient or upgrade the patients’ account to premium status at the time of their first encounter with nursing during chemotherapy education.

RESULTS: MyHealtheVet usage and chemotherapy education appointments within the Hematology-Oncology department were surveyed. Over a two-year period, use in the Hematology-Oncology department at the NF/SGVA showed steady escalation of secure messaging as more oncology patients enrolled. When COVID19 arose in February 2020, the Hematology- Oncology department was already poised to handle care coordination for their patients during this crisis. With our established practices, coordination of care for patients in treatment well prepared to receive care and communication electronically through MyHealtheVet .

CONCLUSIONS: Personal health networks (PHN) have evolved and have become a novel solution to address challenges of the cancer care continuum. MyHealtheVet serves as a voice for the VA for navigating patient care coordination needs. My- HealtheVet is a clinical tool that functions locally using administrative features to involve, engage, and educate the patient with an array of resources. This enrollment process allowed us to remain patient- centered and well equipped to face COVID19 related access challenges as they quickly evolved in the spring of 2020. Pharmacy functions and Secure Messaging emerge as the strongest tools in our communication toolbox.

BACKGROUND: Cancer care is often fragmented for the patient undergoing complex care. Cancer treatments such as chemotherapy and radiation require coordination with medical services and infusion centers. Past practices utilizing telephone communication limited care coordination. Before advances in technology, patients were restricted to obtain their health care information through conversation. Care coordination paired with patient-centered technology enables collaboration among the health care team and creates structure through visual displays of essential information.

OBJECTIVE: Our goals were to introduce technology and maximize enrollment for the patient by: (1) Establishing MyHealtheVet within the Hematology- Oncology department for increased patient support to memorialize communication. (2) Create access to care to better manage treatment of health-related issues. (3) Empower the patient to participate in managing their care.

METHODS: In October of 2017 the NF/SGVA began implementing MyHealtheVet . The Hematology-Oncology department had no formal process. By the Fall of 2019 the infusion room process was to enroll each patient or upgrade the patients’ account to premium status at the time of their first encounter with nursing during chemotherapy education.

RESULTS: MyHealtheVet usage and chemotherapy education appointments within the Hematology-Oncology department were surveyed. Over a two-year period, use in the Hematology-Oncology department at the NF/SGVA showed steady escalation of secure messaging as more oncology patients enrolled. When COVID19 arose in February 2020, the Hematology- Oncology department was already poised to handle care coordination for their patients during this crisis. With our established practices, coordination of care for patients in treatment well prepared to receive care and communication electronically through MyHealtheVet .

CONCLUSIONS: Personal health networks (PHN) have evolved and have become a novel solution to address challenges of the cancer care continuum. MyHealtheVet serves as a voice for the VA for navigating patient care coordination needs. My- HealtheVet is a clinical tool that functions locally using administrative features to involve, engage, and educate the patient with an array of resources. This enrollment process allowed us to remain patient- centered and well equipped to face COVID19 related access challenges as they quickly evolved in the spring of 2020. Pharmacy functions and Secure Messaging emerge as the strongest tools in our communication toolbox.

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Oncology-Palliative Care Collaboration: Impact on Hospice Accession and End-of-Life Care

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BACKGROUND: Timely hospice care in oncology improves end-of-life care, decreases hospitalizations, improves quality of life and satisfaction. However, collaborative practice of palliative care and oncology remains inconsistent, resulting in absent or delayed hospice services. Short hospice length of service is a marker of poor quality of care and end-user dissatisfaction. Most Americans desire end-of-life care in their homes; however, most of them receive their end-of-life care in hospitals.

HYPOTHESIS: A collaborative oncology-palliative care clinic model improves access to hospice care.

INTERVENTION: In January 2015, we implemented an integrated oncology-palliative care clinic model with the following elements:
(1) Pre-clinic “huddle” among palliative care and oncology staff to identify palliative care needs for patients;
(2) Shared palliative care and oncology clinic appointments;
(3) Introduction of palliative care for every new oncology clinic patient, for advance care planning;
(4) Concurrent oncology and palliative care follow-up for all high-risk patients (aggressive histology, progressing disease, etc.) for goals of care discussions and symptom management;
(5) Palliative care and oncology staff co-managing oncology patients enrolled in hospice care.

MEASUREMENTS: In December 2019, we conducted a retrospective review of all Veterans seen in oncologypalliative care clinic during FY2018-FY2019 with specific attention to community hospice referrals, hospice length of stay, and location of Veterans’ death.

RESULTS: Of a total of 189 Veterans seen in this clinic in FY18-FY19, at the time of review.
(1) 68 (36%) Veterans accessed hospice care.
(2) Of 71 deceased Veterans, 59 (83%) died on hospice (Medicare data: 50%).
(3) Average length of stay on hospice was 64 days (other studies: 48 days).
(4) Compared to other studies, our longer hospice stay was consistent across various cancers: lung (75 vs. 40 days), prostate (69 vs. 48 days), pancreas (40 vs. 32 days), colorectal (140 vs. 46 days).
(5) Of Veterans who died on hospice care, 30 (51%) died at home (other studies: 25%).

CONCLUSION: Our intervention improved access to hospice care in cancer care.

FUTURE IMPLICATIONS: (1) Impact of this intervention of cost of end-of-life care.
(2) Future innovative clinic models for delivery of collaborative comprehensive care for complex nee

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BACKGROUND: Timely hospice care in oncology improves end-of-life care, decreases hospitalizations, improves quality of life and satisfaction. However, collaborative practice of palliative care and oncology remains inconsistent, resulting in absent or delayed hospice services. Short hospice length of service is a marker of poor quality of care and end-user dissatisfaction. Most Americans desire end-of-life care in their homes; however, most of them receive their end-of-life care in hospitals.

HYPOTHESIS: A collaborative oncology-palliative care clinic model improves access to hospice care.

INTERVENTION: In January 2015, we implemented an integrated oncology-palliative care clinic model with the following elements:
(1) Pre-clinic “huddle” among palliative care and oncology staff to identify palliative care needs for patients;
(2) Shared palliative care and oncology clinic appointments;
(3) Introduction of palliative care for every new oncology clinic patient, for advance care planning;
(4) Concurrent oncology and palliative care follow-up for all high-risk patients (aggressive histology, progressing disease, etc.) for goals of care discussions and symptom management;
(5) Palliative care and oncology staff co-managing oncology patients enrolled in hospice care.

MEASUREMENTS: In December 2019, we conducted a retrospective review of all Veterans seen in oncologypalliative care clinic during FY2018-FY2019 with specific attention to community hospice referrals, hospice length of stay, and location of Veterans’ death.

RESULTS: Of a total of 189 Veterans seen in this clinic in FY18-FY19, at the time of review.
(1) 68 (36%) Veterans accessed hospice care.
(2) Of 71 deceased Veterans, 59 (83%) died on hospice (Medicare data: 50%).
(3) Average length of stay on hospice was 64 days (other studies: 48 days).
(4) Compared to other studies, our longer hospice stay was consistent across various cancers: lung (75 vs. 40 days), prostate (69 vs. 48 days), pancreas (40 vs. 32 days), colorectal (140 vs. 46 days).
(5) Of Veterans who died on hospice care, 30 (51%) died at home (other studies: 25%).

CONCLUSION: Our intervention improved access to hospice care in cancer care.

FUTURE IMPLICATIONS: (1) Impact of this intervention of cost of end-of-life care.
(2) Future innovative clinic models for delivery of collaborative comprehensive care for complex nee

BACKGROUND: Timely hospice care in oncology improves end-of-life care, decreases hospitalizations, improves quality of life and satisfaction. However, collaborative practice of palliative care and oncology remains inconsistent, resulting in absent or delayed hospice services. Short hospice length of service is a marker of poor quality of care and end-user dissatisfaction. Most Americans desire end-of-life care in their homes; however, most of them receive their end-of-life care in hospitals.

HYPOTHESIS: A collaborative oncology-palliative care clinic model improves access to hospice care.

INTERVENTION: In January 2015, we implemented an integrated oncology-palliative care clinic model with the following elements:
(1) Pre-clinic “huddle” among palliative care and oncology staff to identify palliative care needs for patients;
(2) Shared palliative care and oncology clinic appointments;
(3) Introduction of palliative care for every new oncology clinic patient, for advance care planning;
(4) Concurrent oncology and palliative care follow-up for all high-risk patients (aggressive histology, progressing disease, etc.) for goals of care discussions and symptom management;
(5) Palliative care and oncology staff co-managing oncology patients enrolled in hospice care.

MEASUREMENTS: In December 2019, we conducted a retrospective review of all Veterans seen in oncologypalliative care clinic during FY2018-FY2019 with specific attention to community hospice referrals, hospice length of stay, and location of Veterans’ death.

RESULTS: Of a total of 189 Veterans seen in this clinic in FY18-FY19, at the time of review.
(1) 68 (36%) Veterans accessed hospice care.
(2) Of 71 deceased Veterans, 59 (83%) died on hospice (Medicare data: 50%).
(3) Average length of stay on hospice was 64 days (other studies: 48 days).
(4) Compared to other studies, our longer hospice stay was consistent across various cancers: lung (75 vs. 40 days), prostate (69 vs. 48 days), pancreas (40 vs. 32 days), colorectal (140 vs. 46 days).
(5) Of Veterans who died on hospice care, 30 (51%) died at home (other studies: 25%).

CONCLUSION: Our intervention improved access to hospice care in cancer care.

FUTURE IMPLICATIONS: (1) Impact of this intervention of cost of end-of-life care.
(2) Future innovative clinic models for delivery of collaborative comprehensive care for complex nee

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Novel Combination Therapy Rises When Occam’s Razor Falls

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A 70-year-old veteran followed in clinic for metastatic castration-resistant prostate cancer (mCRPC) was found to have a new left axillary lymph node conglomerate on routine imaging, despite stable PSA on Enzalutamide therapy. Biopsy of the axillary mass showed metastatic neuroendocrine carcinoma, with a differential diagnosis of small cell carcinoma of unknown primary vs. Merkel Cell Carcinoma (MCC). Given his prostate cancer diagnosis and the rarity of MCC, small cell differentiation of prostate cancer was initially favored. However, the patient appeared well and subsequent PET/CT only showed two subcutaneous hypermetabolic lesions. These findings would be unusual with small cell differentiation of prostate cancer. A second biopsy of a subcutaneous lesion was most consistent with MCC, confirming our diagnosis.

At time of diagnosis, staging MRI Brain revealed 3 parenchymal brain lesions, presumed to be metastatic MCC. As per a landmark trial by Nghiem et al, the patient was started on Pembrolizumab 2 mg/kg every three weeks for treatment of metastatic MCC. Brain lesions were locally treated with stereotactic radiosurgery (SRS).

Although his mCRPC was under good control with Enzalutamide, this drug is associated with increased risk of seizures in clinical trial and is not recommended for those with predisposing seizure risk. In light of MCC brain metastases, we decided to switch mCRPC therapy to Darolutamide, an androgen receptor antagonist that has lower penetration of the blood-brain barrier and less incidence of seizures. He tolerated the combination of Darolutamide with Pembrolizumab well, with only a grade 1 acneiform rash.

After just 1 cycle of Pembrolizumab, the patient’s clinically-evident MCC drastically regressed. After 8 months of treatment, his MCC continues to respond clinically and radiographically. This case emphasizes the importance of not relying on “Occam’s razor” – that one should assume a single diagnosis for multiple findings. The simplest explanation of the patient’s left axillary mass biopsy would have been small cell differentiation of prostate cancer; however, this has proved to be a synchronous MCC, which portends a much more favorable prognosis with immunotherapy treatment. We also demonstrate a successful approach to concurrent treatment of metastatic MCC and mCRPC.

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A 70-year-old veteran followed in clinic for metastatic castration-resistant prostate cancer (mCRPC) was found to have a new left axillary lymph node conglomerate on routine imaging, despite stable PSA on Enzalutamide therapy. Biopsy of the axillary mass showed metastatic neuroendocrine carcinoma, with a differential diagnosis of small cell carcinoma of unknown primary vs. Merkel Cell Carcinoma (MCC). Given his prostate cancer diagnosis and the rarity of MCC, small cell differentiation of prostate cancer was initially favored. However, the patient appeared well and subsequent PET/CT only showed two subcutaneous hypermetabolic lesions. These findings would be unusual with small cell differentiation of prostate cancer. A second biopsy of a subcutaneous lesion was most consistent with MCC, confirming our diagnosis.

At time of diagnosis, staging MRI Brain revealed 3 parenchymal brain lesions, presumed to be metastatic MCC. As per a landmark trial by Nghiem et al, the patient was started on Pembrolizumab 2 mg/kg every three weeks for treatment of metastatic MCC. Brain lesions were locally treated with stereotactic radiosurgery (SRS).

Although his mCRPC was under good control with Enzalutamide, this drug is associated with increased risk of seizures in clinical trial and is not recommended for those with predisposing seizure risk. In light of MCC brain metastases, we decided to switch mCRPC therapy to Darolutamide, an androgen receptor antagonist that has lower penetration of the blood-brain barrier and less incidence of seizures. He tolerated the combination of Darolutamide with Pembrolizumab well, with only a grade 1 acneiform rash.

After just 1 cycle of Pembrolizumab, the patient’s clinically-evident MCC drastically regressed. After 8 months of treatment, his MCC continues to respond clinically and radiographically. This case emphasizes the importance of not relying on “Occam’s razor” – that one should assume a single diagnosis for multiple findings. The simplest explanation of the patient’s left axillary mass biopsy would have been small cell differentiation of prostate cancer; however, this has proved to be a synchronous MCC, which portends a much more favorable prognosis with immunotherapy treatment. We also demonstrate a successful approach to concurrent treatment of metastatic MCC and mCRPC.

A 70-year-old veteran followed in clinic for metastatic castration-resistant prostate cancer (mCRPC) was found to have a new left axillary lymph node conglomerate on routine imaging, despite stable PSA on Enzalutamide therapy. Biopsy of the axillary mass showed metastatic neuroendocrine carcinoma, with a differential diagnosis of small cell carcinoma of unknown primary vs. Merkel Cell Carcinoma (MCC). Given his prostate cancer diagnosis and the rarity of MCC, small cell differentiation of prostate cancer was initially favored. However, the patient appeared well and subsequent PET/CT only showed two subcutaneous hypermetabolic lesions. These findings would be unusual with small cell differentiation of prostate cancer. A second biopsy of a subcutaneous lesion was most consistent with MCC, confirming our diagnosis.

At time of diagnosis, staging MRI Brain revealed 3 parenchymal brain lesions, presumed to be metastatic MCC. As per a landmark trial by Nghiem et al, the patient was started on Pembrolizumab 2 mg/kg every three weeks for treatment of metastatic MCC. Brain lesions were locally treated with stereotactic radiosurgery (SRS).

Although his mCRPC was under good control with Enzalutamide, this drug is associated with increased risk of seizures in clinical trial and is not recommended for those with predisposing seizure risk. In light of MCC brain metastases, we decided to switch mCRPC therapy to Darolutamide, an androgen receptor antagonist that has lower penetration of the blood-brain barrier and less incidence of seizures. He tolerated the combination of Darolutamide with Pembrolizumab well, with only a grade 1 acneiform rash.

After just 1 cycle of Pembrolizumab, the patient’s clinically-evident MCC drastically regressed. After 8 months of treatment, his MCC continues to respond clinically and radiographically. This case emphasizes the importance of not relying on “Occam’s razor” – that one should assume a single diagnosis for multiple findings. The simplest explanation of the patient’s left axillary mass biopsy would have been small cell differentiation of prostate cancer; however, this has proved to be a synchronous MCC, which portends a much more favorable prognosis with immunotherapy treatment. We also demonstrate a successful approach to concurrent treatment of metastatic MCC and mCRPC.

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Initiation of Schwartz Rounds at VA Connecticut to Engage Providers and Improve Communication

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PURPOSE: Analysis of data from nearly 150 VA medical centers over a three-year period in 2019 by the Partnership for Public Service and the Boston Consulting Group showed a statistically significant link between employee engagement and patient satisfaction. Schwartz Rounds, sponsored by the national Schwartz Center for Compassionate Healthcare, offer a way to engage providers in an interdisciplinary dialogue and improve communication (the Joint Commission lists Schwartz Rounds as a recommended resource for this purpose). Schwartz Rounds are currently held at a number of VA medical centers, but there is limited data on their effectiveness in the VA. The purpose of this initiative was to establish Schwartz Rounds at VA Connecticut and assess its effectiveness in engaging providers and improving communication.

BACKGROUND: Schwartz Rounds provide an opportunity to discuss the social and emotional issues providers face in caring for patients and families. In contrast to traditional medical rounds, the focus is on the human dimension of medicine. Providers have an opportunity to share their experiences, thoughts and feelings on diverse topics, often drawn from patient cases. Schwartz Rounds have been shown to enhance providers’ teamwork, decrease their perceived stress and improve their ability to cope with the psychosocial demands of care (Lown, 2010).

RESULTS: We initiated quarterly Schwartz Rounds at VA Connecticut in early 2020. They are based in our Cancer Center but coordinated through Hospital Education and open to all employees, and CME is available. We have held two sessions to date, the second via Webex due to COVID-19. We collected detailed survey data from participants after each session. Feedback was positive with 79% and 65% of respondents rating the sessions as excellent, 95% and 90% reporting feeling less isolated, and 100% at both sessions reporting feeling better prepared to understand the experiences of and communicate with colleagues.

CONCLUSIONS: Schwartz Rounds at VA Connecticut have been well received and effective in engaging providers. Preliminary data suggests a positive impact on well-being and relationships with colleagues. This forum may help VA medical centers improve multidisciplinary employee engagement and communication, goals that have become even more important during the recent pandemic.

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PURPOSE: Analysis of data from nearly 150 VA medical centers over a three-year period in 2019 by the Partnership for Public Service and the Boston Consulting Group showed a statistically significant link between employee engagement and patient satisfaction. Schwartz Rounds, sponsored by the national Schwartz Center for Compassionate Healthcare, offer a way to engage providers in an interdisciplinary dialogue and improve communication (the Joint Commission lists Schwartz Rounds as a recommended resource for this purpose). Schwartz Rounds are currently held at a number of VA medical centers, but there is limited data on their effectiveness in the VA. The purpose of this initiative was to establish Schwartz Rounds at VA Connecticut and assess its effectiveness in engaging providers and improving communication.

BACKGROUND: Schwartz Rounds provide an opportunity to discuss the social and emotional issues providers face in caring for patients and families. In contrast to traditional medical rounds, the focus is on the human dimension of medicine. Providers have an opportunity to share their experiences, thoughts and feelings on diverse topics, often drawn from patient cases. Schwartz Rounds have been shown to enhance providers’ teamwork, decrease their perceived stress and improve their ability to cope with the psychosocial demands of care (Lown, 2010).

RESULTS: We initiated quarterly Schwartz Rounds at VA Connecticut in early 2020. They are based in our Cancer Center but coordinated through Hospital Education and open to all employees, and CME is available. We have held two sessions to date, the second via Webex due to COVID-19. We collected detailed survey data from participants after each session. Feedback was positive with 79% and 65% of respondents rating the sessions as excellent, 95% and 90% reporting feeling less isolated, and 100% at both sessions reporting feeling better prepared to understand the experiences of and communicate with colleagues.

CONCLUSIONS: Schwartz Rounds at VA Connecticut have been well received and effective in engaging providers. Preliminary data suggests a positive impact on well-being and relationships with colleagues. This forum may help VA medical centers improve multidisciplinary employee engagement and communication, goals that have become even more important during the recent pandemic.

PURPOSE: Analysis of data from nearly 150 VA medical centers over a three-year period in 2019 by the Partnership for Public Service and the Boston Consulting Group showed a statistically significant link between employee engagement and patient satisfaction. Schwartz Rounds, sponsored by the national Schwartz Center for Compassionate Healthcare, offer a way to engage providers in an interdisciplinary dialogue and improve communication (the Joint Commission lists Schwartz Rounds as a recommended resource for this purpose). Schwartz Rounds are currently held at a number of VA medical centers, but there is limited data on their effectiveness in the VA. The purpose of this initiative was to establish Schwartz Rounds at VA Connecticut and assess its effectiveness in engaging providers and improving communication.

BACKGROUND: Schwartz Rounds provide an opportunity to discuss the social and emotional issues providers face in caring for patients and families. In contrast to traditional medical rounds, the focus is on the human dimension of medicine. Providers have an opportunity to share their experiences, thoughts and feelings on diverse topics, often drawn from patient cases. Schwartz Rounds have been shown to enhance providers’ teamwork, decrease their perceived stress and improve their ability to cope with the psychosocial demands of care (Lown, 2010).

RESULTS: We initiated quarterly Schwartz Rounds at VA Connecticut in early 2020. They are based in our Cancer Center but coordinated through Hospital Education and open to all employees, and CME is available. We have held two sessions to date, the second via Webex due to COVID-19. We collected detailed survey data from participants after each session. Feedback was positive with 79% and 65% of respondents rating the sessions as excellent, 95% and 90% reporting feeling less isolated, and 100% at both sessions reporting feeling better prepared to understand the experiences of and communicate with colleagues.

CONCLUSIONS: Schwartz Rounds at VA Connecticut have been well received and effective in engaging providers. Preliminary data suggests a positive impact on well-being and relationships with colleagues. This forum may help VA medical centers improve multidisciplinary employee engagement and communication, goals that have become even more important during the recent pandemic.

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In-Depth Look at a Community- Based Population of Multiple Myeloma (MM) Patients Undergoing an in-Class Transition (iCT) from Parenteral Bortezomib to Oral Ixazomib in the United States (US) MM-6 Study

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BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

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BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

BACKGROUND: Randomized clinical trials (RCTs) typically enroll highly selected populations. Oncology RCTs have an average of 16 eligibility criteria (Unger JNCI 2014). Registry analyses indicate that up to ~40% of ‘real-world’ MM patients are ineligible for RCTs based on common criteria (Shah CLML 2017).

PURPOSE: US MM-6 (NCT03173092) is evaluating iCT from parenteral bortezomib-based induction to all-oral ixazomib-lenalidomide-dexamethasone (ixazomib-Rd) in MM patients treated at US community oncology centers. Eligibility criteria are less stringent than RCTs, to enroll patients more representative of the real-world MM population.

METHODS: Non-transplant-eligible newly-diagnosed MM patients with stable disease or better after 3 cycles of bortezomib-based induction are being enrolled at 22 US community sites (including three Veterans Affairs hospitals) to receive ixazomib-Rd for up to 39 28- day cycles or until progression/toxicity.

DATA ANALYSIS: We reviewed 84 consecutively enrolled patients using standard RCT eligibility criteria. Initially, six criteria were explored to determine the proportion of patients who might have been RCT-ineligible: renal dysfunction, congestive heart failure (CHF), stroke, prior malignancies, chronic obstructive pulmonary disease (COPD), and memory loss. Dosing information was evaluated to determine any correlation between dose modifications and eligibility status.

RESULTS: Based on six criteria, 24/84 patients (29%) may have been RCT-ineligible: 12% (n=10) had renal dysfunction, 7% (n=6) CHF, 6% (n=5) stroke, 5% (n=4) each other prior malignancies and COPD, and 2% (n=2) memory loss; 6% (n=5) had >1 criterion. Among the 24 RCT-ineligible patients, 75% (n=18), 42% (n=10), and 54% (n=13) received the highest starting doses of ixazomib (4mg), lenalidomide (25mg), and dexamethasone (40mg), respectively. Ixazomib, lenalidomide, and dexamethasone dose reductions were required in 29% (n=7), 25% (n=6), and 21% (n=5), respectively (due to adverse events [AEs]: 21% [n=5], 21% [n=5], 4% [n=1]). 50% (n=12) discontinued treatment (consent withdrawal/patient decision, n=7; disease progression, n=2; sufficient response, AE, death, each n=1); n=3/2/2 discontinued ixazomib/lenalidomide/ dexamethasone due to AEs.

IMPLICATIONS: US MM-6 is enrolling real-world, community- based MM patients, including those who may be ineligible for RCTs based on standard inclusion criteria. Our analysis indicates that iCT to ixazomib- Rd appears to be feasible in these RCT-ineligible US MM-6 patients. Further criteria will be analyzed and presented.

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Improving Ototoxicity Monitoring with Cisplatin Therapy at VA Northeast Ohio Healthcare System (VANOHS), An Interdisciplinary Team Approach

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BACKGROUND: Platinum-based chemotherapy is very effective in treating a variety of cancer types however, it has the potential to cause dose limiting ototoxicity that may result in permanent hearing loss. Studies have shown that hearing loss can affect quality of life by interfering with relationships and degrading communication. Early detection of hearing loss assists the oncologist in determining drug dosing and selecting the appropriate treatment regimens. It also allows the audiologist the opportunity for early intervention with rehabilitative measures. At our facility, Veterans starting cisplatin did not consistently have an audiology consult placed or a baseline audiogram completed prior to initiating treatment. A literature review was conducted, and an interdisciplinary team was formed with key stakeholders from medical oncology, audiology, pharmacy, and nursing.

RESULTS: The initial data review from January 1, 2016 to August 8, 2018 (n=85) showed only 17 Veterans (20%) had an audiology consult placed prior to initiating treatment. The target timeframe determined by the audiology department for baseline audiogram completion was eight weeks prior to or up to 24 hours post initial cisplatin administration. Following these guidelines, only seven (8%) of the 17 audiology consults were placed and completed within the recommended timeframe. Our goal was to increase the number of Veterans receiving audiograms prior to cisplatin administration from 8% to 100% by January 1, 2020.

INTERVENTIONS: enhanced provider education for early identification of Veterans starting cisplatin, creation of an email group for increased communication between nursing and audiology, trialing a portable audiometer in the outpatient infusion clinic, and adding a quick order set to the audiology consult on all cisplatin templates. A post-intervention data review from January 1, 2020 to April 30, 2020 (n=17) demonstrated all 17 (100%) Veterans had an audiology consult placed prior to the first dose of cisplatin. The data review also showed that 17 out of 17 Veterans (100%) had an audiogram completed within the target timeframe. This quality improvement project is aimed at maintaining quality of life for our Veterans throughout their cancer journey.

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Correspondence: Alecia Smalheer (alecia.smalheer@va.gov)

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Correspondence: Alecia Smalheer (alecia.smalheer@va.gov)

BACKGROUND: Platinum-based chemotherapy is very effective in treating a variety of cancer types however, it has the potential to cause dose limiting ototoxicity that may result in permanent hearing loss. Studies have shown that hearing loss can affect quality of life by interfering with relationships and degrading communication. Early detection of hearing loss assists the oncologist in determining drug dosing and selecting the appropriate treatment regimens. It also allows the audiologist the opportunity for early intervention with rehabilitative measures. At our facility, Veterans starting cisplatin did not consistently have an audiology consult placed or a baseline audiogram completed prior to initiating treatment. A literature review was conducted, and an interdisciplinary team was formed with key stakeholders from medical oncology, audiology, pharmacy, and nursing.

RESULTS: The initial data review from January 1, 2016 to August 8, 2018 (n=85) showed only 17 Veterans (20%) had an audiology consult placed prior to initiating treatment. The target timeframe determined by the audiology department for baseline audiogram completion was eight weeks prior to or up to 24 hours post initial cisplatin administration. Following these guidelines, only seven (8%) of the 17 audiology consults were placed and completed within the recommended timeframe. Our goal was to increase the number of Veterans receiving audiograms prior to cisplatin administration from 8% to 100% by January 1, 2020.

INTERVENTIONS: enhanced provider education for early identification of Veterans starting cisplatin, creation of an email group for increased communication between nursing and audiology, trialing a portable audiometer in the outpatient infusion clinic, and adding a quick order set to the audiology consult on all cisplatin templates. A post-intervention data review from January 1, 2020 to April 30, 2020 (n=17) demonstrated all 17 (100%) Veterans had an audiology consult placed prior to the first dose of cisplatin. The data review also showed that 17 out of 17 Veterans (100%) had an audiogram completed within the target timeframe. This quality improvement project is aimed at maintaining quality of life for our Veterans throughout their cancer journey.

BACKGROUND: Platinum-based chemotherapy is very effective in treating a variety of cancer types however, it has the potential to cause dose limiting ototoxicity that may result in permanent hearing loss. Studies have shown that hearing loss can affect quality of life by interfering with relationships and degrading communication. Early detection of hearing loss assists the oncologist in determining drug dosing and selecting the appropriate treatment regimens. It also allows the audiologist the opportunity for early intervention with rehabilitative measures. At our facility, Veterans starting cisplatin did not consistently have an audiology consult placed or a baseline audiogram completed prior to initiating treatment. A literature review was conducted, and an interdisciplinary team was formed with key stakeholders from medical oncology, audiology, pharmacy, and nursing.

RESULTS: The initial data review from January 1, 2016 to August 8, 2018 (n=85) showed only 17 Veterans (20%) had an audiology consult placed prior to initiating treatment. The target timeframe determined by the audiology department for baseline audiogram completion was eight weeks prior to or up to 24 hours post initial cisplatin administration. Following these guidelines, only seven (8%) of the 17 audiology consults were placed and completed within the recommended timeframe. Our goal was to increase the number of Veterans receiving audiograms prior to cisplatin administration from 8% to 100% by January 1, 2020.

INTERVENTIONS: enhanced provider education for early identification of Veterans starting cisplatin, creation of an email group for increased communication between nursing and audiology, trialing a portable audiometer in the outpatient infusion clinic, and adding a quick order set to the audiology consult on all cisplatin templates. A post-intervention data review from January 1, 2020 to April 30, 2020 (n=17) demonstrated all 17 (100%) Veterans had an audiology consult placed prior to the first dose of cisplatin. The data review also showed that 17 out of 17 Veterans (100%) had an audiogram completed within the target timeframe. This quality improvement project is aimed at maintaining quality of life for our Veterans throughout their cancer journey.

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