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Primary Site and Other Prognostic Factors Affecting Myxoid Liposarcoma Survivorship
Background: Myxoid liposarcomas (MLS) are intermediate to high grade liposarcomas, which are the most common type of soft tissue sarcoma. Although MLS most frequently develops in the legs, it can arise in any of the body’s soft tissue adipose. Previous studies of MLS survival have been limited in terms of geography, cohort size, variety of treatment settings, and assessment of primary site role. We retrospectively studied survival data for a nationwide cohort of MLS patients to identify prognostic factors and assess their effects on survival.
Methods: Using the National Cancer Database, we obtained data on 4636 patients diagnosed with MLS (ICD-O-3 8852) between 2004 and 2016. 5- and 10-year survival curves were estimated with Kaplan-Meier analysis and compared with log-rank analysis. Cox hazard regression was also used to compare multiple variables’ effects on survival.
Results: Approximately 59.2% of the cohort was male with a median age of presentation of 49 years. The most common site of metastasis was the bone followed by lung, liver, and brain. The majority (46.8%) of patients were stage I at time of diagnosis, followed by stage II with 18.1%, stage III with 13.1%, and stage IV at 5.3%. Overall 5- and 10-year survival probabilities for the cohort were 76.1% and 62.0%. Female patients (5-year: 79.6% and 10-year: 65.5%) had better survivals than male patients (5-year: 73.8% and 10-years: 59.6%). As stage increased, overall survival decreased with stage IV patients having 5- and 10-year survival probabilities of 21.2% and 9.4%, respectively. Patients with tumors localized to the extremities (5-year: 81.2%) had the best overall survival followed by tumors in the head or neck (5-year: 79.9%), pelvis (5-year: 77.3%), pelvis (5-year: 78.0%), thorax or trunk (5-year: 66.5%), and the retroperitoneum or abdomen (5-year: 53.1%). Finally, adjuvant radiation treatment correlated with decreased mortality to surgical resection of primary tumor alone (HR: 0.847; 95% CI: 0.726-0.989), whereas adjuvant chemotherapy correlated with increased mortality (HR: 2.769; 95% CI: 1.995-3.841).
Conclusion: Primary anatomical site was determined to be a major prognostic factor along with treatment facility type, sex, stage, and surgical margins for patients with myxoid liposarcoma.
Background: Myxoid liposarcomas (MLS) are intermediate to high grade liposarcomas, which are the most common type of soft tissue sarcoma. Although MLS most frequently develops in the legs, it can arise in any of the body’s soft tissue adipose. Previous studies of MLS survival have been limited in terms of geography, cohort size, variety of treatment settings, and assessment of primary site role. We retrospectively studied survival data for a nationwide cohort of MLS patients to identify prognostic factors and assess their effects on survival.
Methods: Using the National Cancer Database, we obtained data on 4636 patients diagnosed with MLS (ICD-O-3 8852) between 2004 and 2016. 5- and 10-year survival curves were estimated with Kaplan-Meier analysis and compared with log-rank analysis. Cox hazard regression was also used to compare multiple variables’ effects on survival.
Results: Approximately 59.2% of the cohort was male with a median age of presentation of 49 years. The most common site of metastasis was the bone followed by lung, liver, and brain. The majority (46.8%) of patients were stage I at time of diagnosis, followed by stage II with 18.1%, stage III with 13.1%, and stage IV at 5.3%. Overall 5- and 10-year survival probabilities for the cohort were 76.1% and 62.0%. Female patients (5-year: 79.6% and 10-year: 65.5%) had better survivals than male patients (5-year: 73.8% and 10-years: 59.6%). As stage increased, overall survival decreased with stage IV patients having 5- and 10-year survival probabilities of 21.2% and 9.4%, respectively. Patients with tumors localized to the extremities (5-year: 81.2%) had the best overall survival followed by tumors in the head or neck (5-year: 79.9%), pelvis (5-year: 77.3%), pelvis (5-year: 78.0%), thorax or trunk (5-year: 66.5%), and the retroperitoneum or abdomen (5-year: 53.1%). Finally, adjuvant radiation treatment correlated with decreased mortality to surgical resection of primary tumor alone (HR: 0.847; 95% CI: 0.726-0.989), whereas adjuvant chemotherapy correlated with increased mortality (HR: 2.769; 95% CI: 1.995-3.841).
Conclusion: Primary anatomical site was determined to be a major prognostic factor along with treatment facility type, sex, stage, and surgical margins for patients with myxoid liposarcoma.
Background: Myxoid liposarcomas (MLS) are intermediate to high grade liposarcomas, which are the most common type of soft tissue sarcoma. Although MLS most frequently develops in the legs, it can arise in any of the body’s soft tissue adipose. Previous studies of MLS survival have been limited in terms of geography, cohort size, variety of treatment settings, and assessment of primary site role. We retrospectively studied survival data for a nationwide cohort of MLS patients to identify prognostic factors and assess their effects on survival.
Methods: Using the National Cancer Database, we obtained data on 4636 patients diagnosed with MLS (ICD-O-3 8852) between 2004 and 2016. 5- and 10-year survival curves were estimated with Kaplan-Meier analysis and compared with log-rank analysis. Cox hazard regression was also used to compare multiple variables’ effects on survival.
Results: Approximately 59.2% of the cohort was male with a median age of presentation of 49 years. The most common site of metastasis was the bone followed by lung, liver, and brain. The majority (46.8%) of patients were stage I at time of diagnosis, followed by stage II with 18.1%, stage III with 13.1%, and stage IV at 5.3%. Overall 5- and 10-year survival probabilities for the cohort were 76.1% and 62.0%. Female patients (5-year: 79.6% and 10-year: 65.5%) had better survivals than male patients (5-year: 73.8% and 10-years: 59.6%). As stage increased, overall survival decreased with stage IV patients having 5- and 10-year survival probabilities of 21.2% and 9.4%, respectively. Patients with tumors localized to the extremities (5-year: 81.2%) had the best overall survival followed by tumors in the head or neck (5-year: 79.9%), pelvis (5-year: 77.3%), pelvis (5-year: 78.0%), thorax or trunk (5-year: 66.5%), and the retroperitoneum or abdomen (5-year: 53.1%). Finally, adjuvant radiation treatment correlated with decreased mortality to surgical resection of primary tumor alone (HR: 0.847; 95% CI: 0.726-0.989), whereas adjuvant chemotherapy correlated with increased mortality (HR: 2.769; 95% CI: 1.995-3.841).
Conclusion: Primary anatomical site was determined to be a major prognostic factor along with treatment facility type, sex, stage, and surgical margins for patients with myxoid liposarcoma.
Primary Anatomical Site as a Prognostic Factor for Pleomorphic Liposarcoma
Background: Pleomorphic liposarcomas is an aggressive, high grade subtype of soft tissue sarcoma representing < 15% of liposarcomas. It most commonly arises in the retroperitoneum and proximal upper extremities. Current prognostic factors are centered around staging, which accounts for the grade, size, and location of the tumor in relation to the superficial fascia.
Methods: A total of 1778 patients diagnosed with pleomorphic liposarcoma were identified in the National Cancer Database and stratified by primary anatomical site: head/neck, upper limb, lower limb/hip, thorax/lung, pelvis, and retroperitoneum/abdomen. Kaplan-Meier survival tables were produced to estimate 1-, 5-, and 10-year overall survival. Log-rank tests with a Bonferroni correction for multiple comparisons and a multivariable Cox proportional hazards analysis were utilized to compare the primary site groups; P < 0.05 was considered significant.
Results: The most common primary anatomical site was the lower limb/hip. The head/neck primary anatomical site demonstrated the highest 10-year overall survival probability, while retroperitoneum/abdomen had the lowest (50% and 18.4%, respectively). Median survival was 9.19 years for the head/neck group, and 3.08 years for the retroperitoneum/abdomen group. Significant overall survival differences were found between the retroperitoneum/abdomen group and each of the following groups: head/neck (P=0.001), upper limb (P<0.001), lower limb/hip (P<0.001), and pelvis (P=0.001). After adjusting for age, biological sex, race and ethnicity, Charlson-Deyo comorbidity index, and AJCC pathologic stage, a 48.4% increased risk of death was found for retroperitoneum/abdomen vs. lower limb/hip primary site (95% CI: 14.6% to 92.1%; P=0.003). Thorax/lung vs. lower limb/hip was also associated with a 55.1% increased risk of death (95% CI: 8.4% to 121.9%; P=0.016).
Conclusion: The current prognostic modality for pleomorphic liposarcoma is limited. There are statistically significant differences in survival based on primary anatomical sites, which may serve as a useful prognostic indicator. Tumors manifesting in the retroperitoneum/abdomen demonstrated the lowest survival.
Background: Pleomorphic liposarcomas is an aggressive, high grade subtype of soft tissue sarcoma representing < 15% of liposarcomas. It most commonly arises in the retroperitoneum and proximal upper extremities. Current prognostic factors are centered around staging, which accounts for the grade, size, and location of the tumor in relation to the superficial fascia.
Methods: A total of 1778 patients diagnosed with pleomorphic liposarcoma were identified in the National Cancer Database and stratified by primary anatomical site: head/neck, upper limb, lower limb/hip, thorax/lung, pelvis, and retroperitoneum/abdomen. Kaplan-Meier survival tables were produced to estimate 1-, 5-, and 10-year overall survival. Log-rank tests with a Bonferroni correction for multiple comparisons and a multivariable Cox proportional hazards analysis were utilized to compare the primary site groups; P < 0.05 was considered significant.
Results: The most common primary anatomical site was the lower limb/hip. The head/neck primary anatomical site demonstrated the highest 10-year overall survival probability, while retroperitoneum/abdomen had the lowest (50% and 18.4%, respectively). Median survival was 9.19 years for the head/neck group, and 3.08 years for the retroperitoneum/abdomen group. Significant overall survival differences were found between the retroperitoneum/abdomen group and each of the following groups: head/neck (P=0.001), upper limb (P<0.001), lower limb/hip (P<0.001), and pelvis (P=0.001). After adjusting for age, biological sex, race and ethnicity, Charlson-Deyo comorbidity index, and AJCC pathologic stage, a 48.4% increased risk of death was found for retroperitoneum/abdomen vs. lower limb/hip primary site (95% CI: 14.6% to 92.1%; P=0.003). Thorax/lung vs. lower limb/hip was also associated with a 55.1% increased risk of death (95% CI: 8.4% to 121.9%; P=0.016).
Conclusion: The current prognostic modality for pleomorphic liposarcoma is limited. There are statistically significant differences in survival based on primary anatomical sites, which may serve as a useful prognostic indicator. Tumors manifesting in the retroperitoneum/abdomen demonstrated the lowest survival.
Background: Pleomorphic liposarcomas is an aggressive, high grade subtype of soft tissue sarcoma representing < 15% of liposarcomas. It most commonly arises in the retroperitoneum and proximal upper extremities. Current prognostic factors are centered around staging, which accounts for the grade, size, and location of the tumor in relation to the superficial fascia.
Methods: A total of 1778 patients diagnosed with pleomorphic liposarcoma were identified in the National Cancer Database and stratified by primary anatomical site: head/neck, upper limb, lower limb/hip, thorax/lung, pelvis, and retroperitoneum/abdomen. Kaplan-Meier survival tables were produced to estimate 1-, 5-, and 10-year overall survival. Log-rank tests with a Bonferroni correction for multiple comparisons and a multivariable Cox proportional hazards analysis were utilized to compare the primary site groups; P < 0.05 was considered significant.
Results: The most common primary anatomical site was the lower limb/hip. The head/neck primary anatomical site demonstrated the highest 10-year overall survival probability, while retroperitoneum/abdomen had the lowest (50% and 18.4%, respectively). Median survival was 9.19 years for the head/neck group, and 3.08 years for the retroperitoneum/abdomen group. Significant overall survival differences were found between the retroperitoneum/abdomen group and each of the following groups: head/neck (P=0.001), upper limb (P<0.001), lower limb/hip (P<0.001), and pelvis (P=0.001). After adjusting for age, biological sex, race and ethnicity, Charlson-Deyo comorbidity index, and AJCC pathologic stage, a 48.4% increased risk of death was found for retroperitoneum/abdomen vs. lower limb/hip primary site (95% CI: 14.6% to 92.1%; P=0.003). Thorax/lung vs. lower limb/hip was also associated with a 55.1% increased risk of death (95% CI: 8.4% to 121.9%; P=0.016).
Conclusion: The current prognostic modality for pleomorphic liposarcoma is limited. There are statistically significant differences in survival based on primary anatomical sites, which may serve as a useful prognostic indicator. Tumors manifesting in the retroperitoneum/abdomen demonstrated the lowest survival.
Prescribing Practices Based on Recommendations of the Veterans Health Administration’s National Precision Oncology Program
Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.
Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.
Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.
Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.
Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.
Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.
Background: Next-generation sequencing (NGS) of cancer gene panels is now standard-of-care for patients with advanced solid tumors. In July 2016, the Veterans Health Administration (VHA) launched the National Precision Oncology Program (NPOP) to increase access to NGS testing to VHA cancer patients across the country. A review of the prescription patterns among patients with highly actionable mutations is warranted to measure the impact of NPOP.
Purpose: The objective of this study is to assess the use of targeted therapies among patients with advanced solid tumors who received a Level 1, 2A, or R1 recommendation based on NGS results. For cases in which patients failed to receive targeted agents, underlying reasons will be identified. Study results will be used to improve outcomes of veterans undergoing NGS testing and the cost-benefit of NPOP.
Methods: This study will be conducted as a retrospective analysis of veterans who received oncologic care through the VHA and underwent NGS testing. From program inception in July 2016 until January 2019, the tumor samples of 5,897 patients have undergone NGS testing through NPOP. NGS results were categorized by Watson for Genomics (WfG), an artificial intelligence decision-support system. Among these, 608 (10.3%) samples noted to have at least one genetic variant with Level 1 or 2A actionability. The NPOP database will be queried to identify these patients who had a recommendation to receive a targeted agent. Prescribed and dispensed drugs will be identified from the Corporate Data Warehouse to indicate patients who have received targeted agents through VHA and compute the percentage of those who were not prescribed therapy through VHA. The medical records of patients who did not receive a corresponding targeted drug will be reviewed to identify non-VA drug use and code reasons if no record of drug administration is recorded. These codes will be examined for association with patients and tumor characteristics, sites of treating oncologists, and types of cancers. The most frequent coded reasons will be recorded, and assessment of this data will be performed to identify potential interventions to improve the utility of NGS testing for veterans.
Identifying VA Cancer Patients for Clinical Trials: Use of an Umbrella Pre-Screening Protocol to Improve Enrollment in Oncology/Hematology Clinical Trials Within the VA Healthcare System
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
A Focus on Implementation and Impact of a Pharmacy Driven Oral Chemotherapy Clinic
Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).
To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.
Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.
Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.
Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).
Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.
Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).
To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.
Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.
Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.
Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).
Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.
Background: The utilization of oral chemotherapy agents is becoming increasingly widespread due to expanding indications in the oncology world. This change represents a shift in managing patients with cancer from intermittent intravenous therapy to self-administered chronic oral therapy which presents unique issues regarding patient safety. A previous study conducted in Toronto, Canada showed that the formation of a multidisciplinary oral chemotherapy clinic helped improve patient outcomes (Disperati et al, 2017).
To address these concerns at our facility, an oral chemotherapy clinic was implemented to provide closer monitoring of patients on oral chemotherapeutic agents. The pharmacy driven oral chemotherapy clinic includes a multidisciplinary team of an oncology pharmacist, oncology physicians, and support staff. The oncology pharmacist provides counseling on proper medication administration, ensures medication adherence, and manages adverse drug events.
Physicians collaborate with the oncology pharmacist to enroll patients into the clinic by placing an intrafacility consult. Referred patients may be newly starting oral chemotherapy or continuing an oral chemotherapy regimen. Patients are not eligible if partial care is provided by a community oncologist. Pharmacist appointments may be face to face or telephone and are in addition to routine physician provider visits.
Results: After the first 4 months of initiating the oral chemotherapy clinic, there were 10 patients enrolled. There were 22 documented interventions, 16 pharmacist interventions and 6 physician interventions. The most common pharmacist interventions included medication adjustments and initiation of supplemental medications to treat adverse events. Patients engaged in 49 encounters, including 17 traditional visits, 21 oral chemotherapy clinic visits, 8 scheduled telehealth visits, and 3 unscheduled telehealth visits with only 1 emergency department visit. Notably, no emergency visits were due to a patient’s oral chemotherapy regimen.
Additional outcomes were analyzed showing 100% patient compliance, 100% proper renal/hepatic dosing and the oral chemo clinic achieved 84% appropriate lab monitoring (improved from 36% in the control group).
Implications: A multidisciplinary approach and integrating the pharmacist run oral chemotherapy clinic improved patient monitoring, drug compliance and patient access to care. With these positive results, we hope to expand the program and incorporate a fulltime pharmacist.
Demographic Factors of Patients with Oligodendroglioma: A NCDB Analysis
Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.
Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.
Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.
Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.
Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.
Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.
Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.
Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.
Background: Oligodendrogliomas represent about 12% of all brain tumors. Our goal was to compare the demographic factors of patients diagnosed with oligodendroglioma from 2004-2014 identified in the National Cancer Database (NCDB). We also examined the survival of patients based off of the number of their comorbidities.
Methods: We identified 7525 patients diagnosed with oligodendroglioma in the NCDB diagnosed between 2004-2014. Many demographic factors were examined such as age, gender, race, facility treated at, comorbidities, and surgery type. Between-insurance survival differences were estimated by the Kaplan-Meier method and associated log-rank tests; Tukey-Kramer adjusted P < .05 indicated statistical significance.
Results: More men were diagnosed with the tumor than females (55% vs 45%). Average age of patients at diagnosis was 43.5 years old. 66% of patients had private insurance, while 7% of patients were uninsured. 88.9% of patients were white, while 5.5% of patients were black. Patients that were treated at an academic/ research program were 32% of the sample size. 17% of the sample size were treated at a comprehensive community cancer program. Those with no comorbidities had the highest mean survival time of 111 months, those with one comorbidity had a mean survival time of 97 months, and those with two comorbidities had the lowest mean survival time of 75 months. 12.8% of patients had radical, total gross resection of tumor, lesion, or mass in their brain and 10% of patients had less than half of the lobe involved with the tumor resection. 20.1% of patients had systemic therapy after surgery. 59% of patients had no systemic therapy or surgery.
Conclusion: Our study shows men were affected more than women and that the mean age at diagnosis was 44 years old. The greater number of comorbidities a patient had, the lower the mean survival time was. Majority of patients were treated at an academic/research program. This is one of the largest studies to examine the demographics of patients with oligodendroglioma. Understanding who and how patients are affected can allow us to provide better resources and treatment.
Characterization of Adverse Reactions to ‘4-week’ Nivolumab Dosing
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Background: Nivolumab was recently approved for a new flat-dose schedule 480 mg IV every 4 weeks (“480 Q4w”) using data from pharmacokinetics simulations without being first tested directly in humans. We noted several unusual adverse drug reactions (ADRs) using the new dosing and hypothesized that this new dose schedule might generate more ADRs than prior dosing schedules.
Methods: This study attempts to summarize and characterize the types of ADRs seen on the new 480 Q4w dosing. We conducted a retrospective, descriptive chart review and case series including patients at the San Antonio VA Hematology/Oncology clinic treated with at least one dose of Nivolumab 480 mg between 2/1/18 and 10/1/18. We tracked whether these patients developed ADRs, and if so, the highest CTCAE 4.03 grade of reaction, the number of treatments before the reaction developed, and whether the reaction influenced treatment (hold treatment, stop treatment, dose change).
Results: 18 patients matched this criterion (all male, average age 67.6 years). 6 patients experienced an ADR during treatment with the 480 Q4w dose. Grade 1 toxicities included pruritis, abdominal pain, skin rash, fatigue, fever, cramping, myalgia, and diarrhea. There was a Grade 3 case of encephalopathy and a Grade 2 case of diplopia. Of the 6 patients who experienced an adverse drug reaction, 2 (with only Grade 1 toxicities) continued treatment at their same dose frequency; the others changed to 240 mg Q2w. All 4 patients who experienced an ADR and had their dose changed to 240 mg Q2w experienced resolution or improvement in their symptoms except for 1 patient’s complaint of abdominal pain.
Conclusion: 480 Q4w dosing of Nivolumab may have a different ADR profile from prior dose regimens; further quantitative analysis will be required to answer this question. Dose frequency change may present an opportunity to relieve toxicities while allowing patients to continue treatment.
Atypical Presentation and Management of Refractory Multisystem Checkpoint Inhibitor Toxicities
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
Background: Immunotherapy with checkpoint inhibition represents a significant development in the management of advanced malignancies. Toxicity associated with this therapy, or immune-related adverse events (irAEs), is most frequently seen in the form of colitis, dermatitis, pneumonitis, or hepatitis. Prompt initiation of high-dose corticosteroids in severe cases is essential. Refractory toxicity can be seen and requires a multimodality approach.
Case Report: A 68 year old male with a history of stage IVB squamous cell carcinoma (SCC) and an illdefined left renal mass (4.8 × 4.1 cm2, presumed urothelial carcinoma) was successfully maintained on nivolumab monotherapy for nearly two years. However, after 45 cycles he presented to the emergency department with acute hypoxic respiratory failure. He was admitted and found to have multifocal pulmonary consolidations refractory to empiric antibiotics. Ultimately his symptoms were attributed to nivolumab-induced pneumonitis. He improved on corticosteroids and was discharged with a prednisone taper. One month later he returned with severe lower extremity weakness, an elevated creatinine kinase, grade IV hepatitis, and hematuria. Notwithstanding immediate escalation to intravenous methylprednisolone (2 mg/kg) and a trial of IVIG, his myositis and liver dysfunction worsened. Mycophenolate mofetil was added (1000 mg BID) and successfully reversed his creatinine kinase (from 3633 U/L); however, his hepatitis continued to progress (total bilirubin to 16.4 mg/dL). After further discussion with gastroenterology, tacrolimus was also started (2 mg BID) and caused gradual improvement in his transaminases. Once stabilized, he underwent a left nephrectomy for persistent hematuria; pathology results revealed an unusual focus of metastatic SCC. Unfortunately, he developed post-operative bleeding complications and CMV viremia. He elected to pursue comfort measures and passed 2 weeks later.
Conclusion: Checkpoint inhibitor toxicities can demonstrate delayed presentations despite numerous cycles of successful therapy. In cases where aggressive corticosteroid therapy is unsuccessful, additional immunomodulatory agents are required to curb progression of organ-specific damage. Close surveillance for opportunistic infections must be maintained. Additional studies are needed to assess whether earlier discontinuation of checkpoint inhibition is feasible in patients with sustained responses to minimize late irAEs.
A Rural VA Utilizing Telehealth Platform to Address Dietary Issues of Veterans With Cancer
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
Background: The Salisbury VA Medical Center (SVA) is a rural VA and some of our veterans with cancer are treated at VA Health Care Center (HCCs) in Kernersville or Charlotte. The VA telehealth platform provides a bridge to address dietary issues for veterans that cannot travel to Salisbury. The SVA offers virtual nutrition counseling sessions conveniently scheduled in conjunction with veterans HCC oncology visit and eliminates the need for additional appointments or having to arrange transportation to SVA.
Dietary counseling for veterans with cancer is an integral part of the SVA cancer care program. This commitment is shown by SVA Medical Centers commitment to a board certified oncology dietician FTE. The oncology dietician staffs the SVA outpatient medical oncology clinic and manages dietary issues that are present at diagnosis or arise during treatment. Annually, the oncology dietician averages a case load of 334 unique veterans and averages 1395 visits with these veterans. Most of these dietary encounters occur at the SVA infusion center while veterans are getting treatment or in the SVA oncology exam room after the veteran visits with their oncologic provider.
Methods: To provide this same dietary service to Kernersville and Charlotte veterans, the dietary oncology telehealth program was established. The program has performed 99 telehealth visits. The telehealth visits accomplish the same objectives as the live clinic appointments.
Common dietary issues that are managed in the clinic involve weight loss in lung cancer veterans, weight gain in prostate cancer veterans, and malabsorption in colorectal cancer veterans. The oncology dietician has competency and resources in managing these nutrition impact symptoms.
Implizations: Ideas for expansion of the Salisbury oncology dietary telehealth program would be to utilize the new Anywhere to Anywhere initiative, to improve access to veterans in the SVA system and to possibly aid other VAs oncology programs that do not have a dedicated oncology dietician.
A Rare Case of Immunotactoid Glomerulopathy and Monoclonal Gammopathy of Renal Significance due to an IgM Kappa Clone at the VA Pittsburgh Healthcare System
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.
Introduction: Monoclonal gammopathy of renal significance (MGRS) is a recently recognized disorder from pathologic M protein causing renal disease and minimal hematologic disease burden. Failure to treat leads to poor outcomes from progression to advanced monoclonal gammopathies and end stage renal disease (ESRD). We present a case of MGRS with immunotactoid glomerulopathy.
Case Report: A 66-year-old female presented in December 2015 with mild granulocytopenia and anemia. Workup revealed serum 0.28 mg/dL IgM kappa monoclonal M-protein and kappa/lambda ratio of 2.23. She underwent surveillance for MGUS. Due to acute kidney injury, peripheral edema and hypertension, nephrology workup was obtained in December 2017. She had nephrotic range proteinuria and hematuria. Urine studies suggested paraproteinemia. Renal biopsy demonstrated immunotactoid glomerulopathy with membranoproliferative glomerulonephritis pattern. Immunofluorescence showed kappa light chain in mesangial and capillary loop, and heavy IgM and moderate C3 staining. Electron microscopy revealed numerous immunotactoid deposits beneath the glomerular basement membrane and mesangium. M-protein burden remained stable. Her bone marrow biopsy was nondiagnostic, however peripheral flow cytometry identified a small CD20+, CD5-, CD10-, CD23-, B-cell population with kappa light chain restriction. Diagnosis was reclassified as MGRS and she was treated with rituximab weekly for four doses. Follow-up demonstrated stability of M-protein and light chains, improvement of AKI and hypertension, but persistent nephrotic range proteinuria. We are planning an additional eight-week course of weekly rituximab. Treatment outcome and further studies are pending.
Discussion: MGRS is a rare monoclonal gammopathy that was formerly subclassified under MGUS. Patients were undertreated due to under-recognition of the disorder and its renal sequalae. Treatment with regimens targeting a plasma cell or B-cell clone can reduce the clone and improve renal outcomes. Our patient experienced a partial response to clone directed therapy with rituximab. Further treatment is pending.
Conclusion: Clinicians should be aware of MGRS. Collaboration with nephrology is key for proper diagnosis and prognosis. Consider treating more aggressively than MGUS to improve renal and hematologic outcomes. Prospective interventional studies are needed.