AVAHO

INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

INTRODUCTION: Methylene blue (MB) has recently gained traction as an adjunctive therapy in the management of vasoplegia. Due to risk of inducing oxidative hemolysis its use should be avoided in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency Although rare, drug induced oxidative hemolysis can still occur in patients without G6PD deficiency. In this report, we describe a case of severe oxidative hemolysis in a G6PD sufficient adult following administration of a large dose of MB.

CASE REPORT: A 78-year-old male with a history of coronary artery disease was admitted for coronary artery bypass graft surgery. Patient underwent surgery without any major complications. Post operatively however he developed severe shock refractory to multiple vasopressors and inotropes. A presumptive diagnosis of vasoplegia was made for which the patient was given multiple boluses of MB. Hemodynamics improved thus the patient was started on a MB infusion. Approximately 24 hours later the patient was noted to have an acute drop in his hemoglobin from 9.9 to 8.0 g/dl. He was transfused multiple units of blood with only transient improvements in his hemoglobin. Physical exam and imaging revealed no evidence of bleeding. Additional workup was notable for an LDH of 7222 U/L and an elevated bilirubin raising concern for hemolytic anemia.

Review of his peripheral smear was notable for the presence of numerous bite cells. A diagnosis of oxidative hemolytic anemia secondary to MB administration was made. MB infusion was discontinued and within 48 hours the patient’s LDH normalized and hemoglobin had stabilized. A quantitative G6PD test ordered during the acute hemolytic period and was reported as normal. Due to the possibility of a falsely normal result in the setting of active hemolysis, G6PD testing was repeated two months following discharge and was also normal.

CONCLUSIONS: Methylene blue can be a lifesaving medication in the setting of severe vasoplegia. However, clinicians should be aware of the possibility of inducing severe oxidative hemolytic anemia even in G6PD sufficient patients when giving this agent in large doses. Management of oxidative hemolysis secondary to MB is supportive care with prompt discontinuation resulting in resolution of hemolysis.

BACKGROUND: Oral antineoplastic therapy (OAT) use among Veterans is rising significantly. Through the MISSION/CHOICE Act, Veterans can receive Veterans Affairs (VA)-funded hematology/oncology care from non-VA community providers. These providers can prescribe high-risk, high-cost OATs which the VA then dispenses. However, Veterans receiving hematology/ oncology treatment in rural and community settings often lack access to comprehensive medication management, increasing their risk for suboptimal care.

SYNTHESIS OF RELEVANT LITERATURE: A survey performed within VISN 19 revealed Veterans on OATs prescribed by community providers receive inadequate monitoring and follow-up. Clinical pharmacist- driven medication management programs are established in a variety of clinical settings, including for patients taking OATs for hematologic and oncologic malignancies. Additionally, the American Society of Clinical Oncology (ASCO) considers medically integrated dispensing of OATs, often through hematology/ oncology pharmacist-driven medication management programs, a quality standard.

INTERVENTION(S) PROVIDED: The VA CARES program provides a dedicated clinical pharmacy specialist (CPS) for all phases of OAT treatment prescribed by community providers. During the OAT initiation phase, the CPS ensures appropriate indication and dosing, reviews baseline laboratory results, and performs a thorough drug-drug interaction analysis. The CPS also performs baseline patient assessment and education through a telephone encounter. During the OAT maintenance phase, the CPS ensures necessary monitoring occurs (e.g., labs are drawn and results are within appropriate limits), and schedules regular follow-up encounters with the patient to assess knowledge, adherence, toxicities, and need for OAT refills.

OUTCOME OF THE INTERVENTION/SITUATION: In the first three months, VA CARES enrolled sixteen patients with a total of nineteen community care prescriptions (sixteen for OATs, three for broad-spectrum antifungals). The CPS performed thirty-eight encounters and twenty-nine interventions. The majority of interventions included detection and/or prevention of drug-drug interactions (n=15), followed by prevention of adverse events (n=5). Other interventions included drug not indicated (n=3), alternative therapy suggested (n=2), limited-quantity dispensed (n=1), and unnecessary consultation prevented (n=1). Total cost avoidance and savings in three months were estimated at $52,013.

IMPLICATIONS: A CPS-driven medication management program for Veterans receiving OATs through the MISSION/CHOICE Act is associated with clinical and economic benefits.

BACKGROUND: Oral antineoplastic therapy (OAT) use among Veterans is rising significantly. Through the MISSION/CHOICE Act, Veterans can receive Veterans Affairs (VA)-funded hematology/oncology care from non-VA community providers. These providers can prescribe high-risk, high-cost OATs which the VA then dispenses. However, Veterans receiving hematology/ oncology treatment in rural and community settings often lack access to comprehensive medication management, increasing their risk for suboptimal care.

SYNTHESIS OF RELEVANT LITERATURE: A survey performed within VISN 19 revealed Veterans on OATs prescribed by community providers receive inadequate monitoring and follow-up. Clinical pharmacist- driven medication management programs are established in a variety of clinical settings, including for patients taking OATs for hematologic and oncologic malignancies. Additionally, the American Society of Clinical Oncology (ASCO) considers medically integrated dispensing of OATs, often through hematology/ oncology pharmacist-driven medication management programs, a quality standard.

INTERVENTION(S) PROVIDED: The VA CARES program provides a dedicated clinical pharmacy specialist (CPS) for all phases of OAT treatment prescribed by community providers. During the OAT initiation phase, the CPS ensures appropriate indication and dosing, reviews baseline laboratory results, and performs a thorough drug-drug interaction analysis. The CPS also performs baseline patient assessment and education through a telephone encounter. During the OAT maintenance phase, the CPS ensures necessary monitoring occurs (e.g., labs are drawn and results are within appropriate limits), and schedules regular follow-up encounters with the patient to assess knowledge, adherence, toxicities, and need for OAT refills.

OUTCOME OF THE INTERVENTION/SITUATION: In the first three months, VA CARES enrolled sixteen patients with a total of nineteen community care prescriptions (sixteen for OATs, three for broad-spectrum antifungals). The CPS performed thirty-eight encounters and twenty-nine interventions. The majority of interventions included detection and/or prevention of drug-drug interactions (n=15), followed by prevention of adverse events (n=5). Other interventions included drug not indicated (n=3), alternative therapy suggested (n=2), limited-quantity dispensed (n=1), and unnecessary consultation prevented (n=1). Total cost avoidance and savings in three months were estimated at $52,013.

IMPLICATIONS: A CPS-driven medication management program for Veterans receiving OATs through the MISSION/CHOICE Act is associated with clinical and economic benefits.

BACKGROUND: Oral antineoplastic therapy (OAT) use among Veterans is rising significantly. Through the MISSION/CHOICE Act, Veterans can receive Veterans Affairs (VA)-funded hematology/oncology care from non-VA community providers. These providers can prescribe high-risk, high-cost OATs which the VA then dispenses. However, Veterans receiving hematology/ oncology treatment in rural and community settings often lack access to comprehensive medication management, increasing their risk for suboptimal care.

SYNTHESIS OF RELEVANT LITERATURE: A survey performed within VISN 19 revealed Veterans on OATs prescribed by community providers receive inadequate monitoring and follow-up. Clinical pharmacist- driven medication management programs are established in a variety of clinical settings, including for patients taking OATs for hematologic and oncologic malignancies. Additionally, the American Society of Clinical Oncology (ASCO) considers medically integrated dispensing of OATs, often through hematology/ oncology pharmacist-driven medication management programs, a quality standard.

INTERVENTION(S) PROVIDED: The VA CARES program provides a dedicated clinical pharmacy specialist (CPS) for all phases of OAT treatment prescribed by community providers. During the OAT initiation phase, the CPS ensures appropriate indication and dosing, reviews baseline laboratory results, and performs a thorough drug-drug interaction analysis. The CPS also performs baseline patient assessment and education through a telephone encounter. During the OAT maintenance phase, the CPS ensures necessary monitoring occurs (e.g., labs are drawn and results are within appropriate limits), and schedules regular follow-up encounters with the patient to assess knowledge, adherence, toxicities, and need for OAT refills.

OUTCOME OF THE INTERVENTION/SITUATION: In the first three months, VA CARES enrolled sixteen patients with a total of nineteen community care prescriptions (sixteen for OATs, three for broad-spectrum antifungals). The CPS performed thirty-eight encounters and twenty-nine interventions. The majority of interventions included detection and/or prevention of drug-drug interactions (n=15), followed by prevention of adverse events (n=5). Other interventions included drug not indicated (n=3), alternative therapy suggested (n=2), limited-quantity dispensed (n=1), and unnecessary consultation prevented (n=1). Total cost avoidance and savings in three months were estimated at $52,013.

IMPLICATIONS: A CPS-driven medication management program for Veterans receiving OATs through the MISSION/CHOICE Act is associated with clinical and economic benefits.

PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

PURPOSE/BACKGROUND: Long term androgen deprivation therapy (ADT) forms the backbone of treatment of locally advanced and metastatic prostate cancer. Bone modifying agents, such as bisphosphonates and denosumab, may be indicated in osteoporosis dosing in the castration-sensitive setting, and more intense dosing for bone metastases in the castration-resistant setting only. Dental evaluation and care prior to bone modifying agent use in osteoporosis or bone metastases has safety benefit. Historical lack of clinical practice guidelines for bone health in men with prostate cancer have limited evidence-based practice. A retrospective review of patients on active bone remodeling therapies for prostate cancer, Revealed that several patients with castration-sensitive disease received treatment at dosing supported only in the setting of castration resistance with bone metastases. Some patients had not completed dental evaluation prior to initiation of bone modifying agents.

METHODS: Following evidence-based expert consensus recommendations from multiple sources regarding bone health in prostate cancer, we created an algorithm- based clinical practice tool. This decision tool is activated within the electronic medical record order set when starting therapy with a bone remodeling agent in patients with prostate cancer. The tool supports treatment with appropriate dosing for the indication, and ensures pretreatment supportive care, such as dental evaluation, is performed.

DATA ANALYSIS/RESULTS: Since implementation of the algorithm-based decision tool, 0/10 (0%) patients were placed on inappropriate bone modifying agent dosing and dental care was addressed on every patient 10/10 (100%) initiating treatment. When evaluating the effect of the decision tool on the desired outcomes, we note that the fraction of patients getting overly intensive treatment before and after implementation of the tool was 24/41 vs 0/10 (p = 0.0008); lack of pretreatment dental assessment before and after implementation of the tool was noted to be 12/41 vs 0/10): ( =0.09). Fisher’s Exact Test was used for both comparisons.

IMPLICATIONS: Through implementation of an evidence- based algorithm and clinical practice tool while prescribing bone remodeling agents to patients with prostate cancer, we were able to improve our institutional practice to a high quality evidenced-based approach to prostate cancer bone health care.

PURPOSE: Immune checkpoint inhibitor (ICI) therapy has become a mainstay in cancer treatment and even has first-line indications for malignancies such as melanoma, non-small cell lung cancer, and many others. Recent data has demonstrated that patients who received either antimicrobial therapy prior to or within the first 60 days of ICI initiation tend to have worse outcomes as measured by time to progression and overall survival. It has been theorized that this may be caused by the influence of the antibiotics on the intestinal microbiota. This study evaluates the effect of antimicrobial therapy on outcomes in veteran patients initiated on ICI therapy.

METHODS: A retrospective chart review was conducted on all patients initiated on ICIs from 1/1/2015 through 12/31/2017. Patients were evaluated as to whether they received any antibiotics within 30 days of ICI initiation or 60 days after ICI initiation or if they received no antibiotics during this time. Data was gathered using the Veterans Health Administration electronic health record. Primary endpoints evaluated were progression free survival (PFS) and overall survival (OS), using Wilcoxon signed-rank test. Descriptive statistics were utilized for patient demographics and antibiotic characteristic comparisons.

RESULTS: A total of 55 patients were identified as having been initiated on an ICI. Twenty-two patients (40%) had received antibiotic treatment prior to or concurrently with their ICI therapy and 33 patients (60%) did not. Median overall survival was numerically longer in patients who did not receive antibiotics at 10 months (95% confidence interval [CI], 4-17 mo.) versus 4 months in patients who received antibiotics (95% CI, 2-9 mo.). However, no significant benefit was observed in median PFS among patients who did not receive antibiotics compared to those who received antibiotics (5 mo. versus 11 mo.).

CONCLUSIONS: No association was observed between antibiotic use and ICI patient outcomes. Although this correlation has been suggested by several recent publications, the cause is not fully understood. This study has several limitations, which could explain why this association was not reproduced. Future investigation and monitoring will be helpful to elucidate any true relationship between ICI and antimicrobial therapies.

PURPOSE: Immune checkpoint inhibitor (ICI) therapy has become a mainstay in cancer treatment and even has first-line indications for malignancies such as melanoma, non-small cell lung cancer, and many others. Recent data has demonstrated that patients who received either antimicrobial therapy prior to or within the first 60 days of ICI initiation tend to have worse outcomes as measured by time to progression and overall survival. It has been theorized that this may be caused by the influence of the antibiotics on the intestinal microbiota. This study evaluates the effect of antimicrobial therapy on outcomes in veteran patients initiated on ICI therapy.

METHODS: A retrospective chart review was conducted on all patients initiated on ICIs from 1/1/2015 through 12/31/2017. Patients were evaluated as to whether they received any antibiotics within 30 days of ICI initiation or 60 days after ICI initiation or if they received no antibiotics during this time. Data was gathered using the Veterans Health Administration electronic health record. Primary endpoints evaluated were progression free survival (PFS) and overall survival (OS), using Wilcoxon signed-rank test. Descriptive statistics were utilized for patient demographics and antibiotic characteristic comparisons.

RESULTS: A total of 55 patients were identified as having been initiated on an ICI. Twenty-two patients (40%) had received antibiotic treatment prior to or concurrently with their ICI therapy and 33 patients (60%) did not. Median overall survival was numerically longer in patients who did not receive antibiotics at 10 months (95% confidence interval [CI], 4-17 mo.) versus 4 months in patients who received antibiotics (95% CI, 2-9 mo.). However, no significant benefit was observed in median PFS among patients who did not receive antibiotics compared to those who received antibiotics (5 mo. versus 11 mo.).

CONCLUSIONS: No association was observed between antibiotic use and ICI patient outcomes. Although this correlation has been suggested by several recent publications, the cause is not fully understood. This study has several limitations, which could explain why this association was not reproduced. Future investigation and monitoring will be helpful to elucidate any true relationship between ICI and antimicrobial therapies.

PURPOSE: Immune checkpoint inhibitor (ICI) therapy has become a mainstay in cancer treatment and even has first-line indications for malignancies such as melanoma, non-small cell lung cancer, and many others. Recent data has demonstrated that patients who received either antimicrobial therapy prior to or within the first 60 days of ICI initiation tend to have worse outcomes as measured by time to progression and overall survival. It has been theorized that this may be caused by the influence of the antibiotics on the intestinal microbiota. This study evaluates the effect of antimicrobial therapy on outcomes in veteran patients initiated on ICI therapy.

METHODS: A retrospective chart review was conducted on all patients initiated on ICIs from 1/1/2015 through 12/31/2017. Patients were evaluated as to whether they received any antibiotics within 30 days of ICI initiation or 60 days after ICI initiation or if they received no antibiotics during this time. Data was gathered using the Veterans Health Administration electronic health record. Primary endpoints evaluated were progression free survival (PFS) and overall survival (OS), using Wilcoxon signed-rank test. Descriptive statistics were utilized for patient demographics and antibiotic characteristic comparisons.

RESULTS: A total of 55 patients were identified as having been initiated on an ICI. Twenty-two patients (40%) had received antibiotic treatment prior to or concurrently with their ICI therapy and 33 patients (60%) did not. Median overall survival was numerically longer in patients who did not receive antibiotics at 10 months (95% confidence interval [CI], 4-17 mo.) versus 4 months in patients who received antibiotics (95% CI, 2-9 mo.). However, no significant benefit was observed in median PFS among patients who did not receive antibiotics compared to those who received antibiotics (5 mo. versus 11 mo.).

CONCLUSIONS: No association was observed between antibiotic use and ICI patient outcomes. Although this correlation has been suggested by several recent publications, the cause is not fully understood. This study has several limitations, which could explain why this association was not reproduced. Future investigation and monitoring will be helpful to elucidate any true relationship between ICI and antimicrobial therapies.

BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ² P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ² P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

BACKGROUND: Osteolytic lesions are present in 75% of multiple myeloma (MM) patients and frequently require palliation with radiation therapy (RT). Case series of MM patients with bone pain undergoing palliative RT suggest doses > 12 Gy (EQD2) provide excellent bone pain relief. However, recent advances in novel biologic agents have significantly improved overall survival and quality of life for MM patients. We hypothesized that lower-dose RT (LDRT, EQD2 < 12 Gy) offers an effective alternative to higher-dose RT (HDRT, EQD2 > 12 Gy) for palliation of painful MM bone lesions.

METHODS: We retrospectively identified MM patients treated with RT for painful bone lesions and stratified by EQD2 < 12Gy versus ≥12Gy. Clinical pain response (CPR) rates, acute and late toxicity, pain response duration, and retreatment rates between LDRT and HDRT groups were analyzed. RESULTS: Thirty-five patients with 71 treated lesions were included: 24 patients (49 lesions) treated with HDRT and 11 patients (22 lesions) with LDRT. Median follow up was 16.8 months. The median dose of HDRT treatment was 20 Gy (range 8-30 Gy, EQD2 12- 32.5 Gy) versus 4 Gy in the LDRT group (range = 4-8 Gy, EQD2 4.67-9.3 Gy). The CPR rate was 98% for HDRT and 95% for LDRT. There was no significant difference in any grade acute toxicity between the HDRT cohort and LDRT cohort (24.5% vs. 9.1%, χ² P=0.20). Pain recurred in 10% of lesions (12% HDRT versus 9.5% LDRT). Median duration of pain response did not significantly differ between cohorts (p=0.91). Five lesions were retreated, 2 (9.5%) in the LDRT cohort and 3 (6.3%) in the HDRT cohort.

CONCLUSIONS: In this study, LDRT effectively palliated painful MM bony lesions with acceptable CPR and duration of palliation. These data support prospective comparisons of LDRT versus HDRT for palliation of painful MM bony lesions.

BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

BACKGROUND: PARP inhibitors (PARPi’s) were recently approved for the treatment of metastatic prostate cancer among patients harboring mutations in an array of genes responsible for DNA repair. We sought to identify whether a subset of these genes correlates with response to treatment more frequently than others. Consequently, an evaluation of the specific DNA repair genotypes associated with durable clinical benefit (DCB) using real-world patient data was undertaken.

METHODS: The U.S. Department of Veterans Affairs (VA) National Precision Oncology Program’s (NPOP) database and Corporate Data Warehouse (CDW) were reviewed to select patients who (1) carried a diagnosis of prostate cancer, (2) successfully underwent tumor DNA sequencing through NPOP, (3) were prescribed olaparib, rucaparib, nirapib, and/or talazaporib for their prostate cancer between July 2016 and February 2020, and (4) and achieved DCB, defined as no progression in prostate-specific antigen (PSA) for at least 6 months following PARPi initiation without concurrent systemic or non-systemic therapies other than androgen-deprivation. The DNA repair gene variants and orders placed for NPOP consultative support were reviewed.

RESULTS: Of the 44 prostate cancer patients treated with a PARPi, 6 (13.6%) had tumor DNA sequencing through NPOP and had achieved DCB. Five patients were treated with olaparib and 1 with rucaparib. The median PSA progression-free survival was 8.9 (interquartile range = 8.5 – 11.2) months among these selected patients. Regarding gene variants, 5 patients had 7 BRCA2 mutations, including 4 frameshift, 1 nonsense, 1 single nucleotide variant, and 1 splice site. One patient had frameshift and missense ATM mutations. Referrals to the NPOP consult service were ordered for 2 out of the 5 patients with BRCA2 mutations achieving DCB.

CONCLUSIONS: Within the VA’s NPOP, the presence of BRCA2 gene variants was the most common finding from tumor DNA sequencing among patients with prostate cancer achieving DCB with a PARPi. Further analysis of the genotypes of all patients treated with PARPi in NPOP to assess the differential impact of BRCA2 mutations is needed to confirm the clinical implication of this finding.

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.

CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.

CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.

CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.

CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.

BACKGROUND: Primary central nervous system lymphoma (PCNSL) is a rare and aggressive malignancy of predominantly B-cell origins. Where tolerated, strong sensitivity is seen with induction regimens containing high-dose methotrexate and rituximab. However, little is known regarding ideal therapy for T-cell variants, especially anaplastic large cell lymphoma.

CASE REPORT: A 20-year-old male with no past medical history developed progressive positional headaches, nausea, and dizziness over several months. Between several hospital visits, he was found to have enhancing lesions of his right caudate, left cerebellum, and right frontal lobe. A lumbar puncture demonstrated pleocytosis (152 WBC, 97% lymphocytes) and a small population of atypical CD5- T-cells on flow cytometry. Preliminary biopsy of the right caudate lesion was inconclusive, significant only for demyelination and a subset of LGL-like T-cells expressing CD3 and TIA-1. Neurology was consulted and he was given high-dose methylprednisolone with significant improvement in his symptoms. However, several months later he returned to the emergency department with new headaches, vomiting, and bilateral nystagmus. A repeat brian MRI showed lesion progression and evidence of hydrocephalus. He received hypertonic saline prior to external ventricular drain placement. Once stabilized, he underwent an uncomplicated left retrosigmoid craniotomy with resection of his cerebellar lesion. Histopathology demonstrated strong CD30 and ALK1 expression, with atypical mature T-cells on flow cytometry (CD4+, CD8+, CD5-). PET/CT imaging, bone marrow biopsy, and an ophthalmologic slit lamp exam were without evidence of systemic disease. He was given a diagnosis of PCNSL of T-cell origin (ALK+ anaplastic large cell subtype) and discharged on a dexamethasone taper. After surgical recovery he was started on induction chemotherapy with high-dose methotrexate, procarbazine, and vincristine (MPV). Interval MR imaging demonstrated marked decrease in the size of his intracranial lesions. He was subsequently transitioned to consolidation with HiDAC with the intent to undergo autologous hematopoietic cell transplant.

CONCLUSIONS: Incidence of ALK-positive anaplastic large cell PCNSL is extremely rare, and thus consensus data regarding optimal treatment is lacking. For younger patients with good functional status and renal clearance, induction therapy containing high-dose methotrexate (i.e. MPV) can provide an effective bridge to consolidation and autologous hematopoietic cell transplant.

PURPOSE: Determine the feasibility of telehealth as a safe and effective modality for CRC surveillance in the post-COVID era.

BACKGROUND: CRC survivors require routine cancer surveillance for a minimum of five years as directed by NCCN Survivorship guidelines. The onset of COVID inMarch 2020 severely limited the ability to have face to face encounters with New Mexico Veterans. Combining social distancing requirements and generalized fear among Veterans made it difficult to maintain routine face to face surveillance.

METHODS: Thirty CRC survivors in the surveillance phase were evaluated using VA Video Connect (VVC) technology. Established CRC Survivorship surveillance notes were completed during the VVC visit. The documented components included COVID screening, general and CRC focused symptomatology, psychological stress, physical exam, laboratory, and radiology studies. All surveillance questions were completed. Veterans were asked to complete a self-exam with video visualization of non-sensitive anatomical regions. Digital rectal exam was deferred. Lab and radiology studies were ordered to be done at a later time in VA/CBOC. To assist with poor hearing or visual acuity, VVC communication was enhanced by utilizing screen sharing with the Veteran to review the most recent lab/radiology results, as well as PowerPoint presentations to explain anatomy, disease process, and plan for continued surveillance. Veterans were assessed for level of anxiety regarding COVID and inability to seek routine medical care.

RESULTS: Veterans and their families were extremely satisfied with the ability to “see” a provider without incurring the risk of exposure and the cost of traveling with the economic hardship of COVID. As a result, the VA did not incur travel fees for remote Veterans. VVC improved access to Veteran specialty care and decreased overall anxiety and concerns regarding possible delayed diagnosis for cancer recurrence due to missed clinic appointments.

CONCLUSIONS: VVC is a viable option for CRC surveillance, however the Veteran still requires interval physical exam, labs, and imaging. A feasible option is to alternate in-person face to face visits with VVC appointments as a means to meet the expected long-term requirements for social distancing while still providing the vital care and reassurance to our Veterans.

PURPOSE: Determine the feasibility of telehealth as a safe and effective modality for CRC surveillance in the post-COVID era.

BACKGROUND: CRC survivors require routine cancer surveillance for a minimum of five years as directed by NCCN Survivorship guidelines. The onset of COVID inMarch 2020 severely limited the ability to have face to face encounters with New Mexico Veterans. Combining social distancing requirements and generalized fear among Veterans made it difficult to maintain routine face to face surveillance.

METHODS: Thirty CRC survivors in the surveillance phase were evaluated using VA Video Connect (VVC) technology. Established CRC Survivorship surveillance notes were completed during the VVC visit. The documented components included COVID screening, general and CRC focused symptomatology, psychological stress, physical exam, laboratory, and radiology studies. All surveillance questions were completed. Veterans were asked to complete a self-exam with video visualization of non-sensitive anatomical regions. Digital rectal exam was deferred. Lab and radiology studies were ordered to be done at a later time in VA/CBOC. To assist with poor hearing or visual acuity, VVC communication was enhanced by utilizing screen sharing with the Veteran to review the most recent lab/radiology results, as well as PowerPoint presentations to explain anatomy, disease process, and plan for continued surveillance. Veterans were assessed for level of anxiety regarding COVID and inability to seek routine medical care.

RESULTS: Veterans and their families were extremely satisfied with the ability to “see” a provider without incurring the risk of exposure and the cost of traveling with the economic hardship of COVID. As a result, the VA did not incur travel fees for remote Veterans. VVC improved access to Veteran specialty care and decreased overall anxiety and concerns regarding possible delayed diagnosis for cancer recurrence due to missed clinic appointments.

CONCLUSIONS: VVC is a viable option for CRC surveillance, however the Veteran still requires interval physical exam, labs, and imaging. A feasible option is to alternate in-person face to face visits with VVC appointments as a means to meet the expected long-term requirements for social distancing while still providing the vital care and reassurance to our Veterans.

PURPOSE: Determine the feasibility of telehealth as a safe and effective modality for CRC surveillance in the post-COVID era.

BACKGROUND: CRC survivors require routine cancer surveillance for a minimum of five years as directed by NCCN Survivorship guidelines. The onset of COVID inMarch 2020 severely limited the ability to have face to face encounters with New Mexico Veterans. Combining social distancing requirements and generalized fear among Veterans made it difficult to maintain routine face to face surveillance.

METHODS: Thirty CRC survivors in the surveillance phase were evaluated using VA Video Connect (VVC) technology. Established CRC Survivorship surveillance notes were completed during the VVC visit. The documented components included COVID screening, general and CRC focused symptomatology, psychological stress, physical exam, laboratory, and radiology studies. All surveillance questions were completed. Veterans were asked to complete a self-exam with video visualization of non-sensitive anatomical regions. Digital rectal exam was deferred. Lab and radiology studies were ordered to be done at a later time in VA/CBOC. To assist with poor hearing or visual acuity, VVC communication was enhanced by utilizing screen sharing with the Veteran to review the most recent lab/radiology results, as well as PowerPoint presentations to explain anatomy, disease process, and plan for continued surveillance. Veterans were assessed for level of anxiety regarding COVID and inability to seek routine medical care.

RESULTS: Veterans and their families were extremely satisfied with the ability to “see” a provider without incurring the risk of exposure and the cost of traveling with the economic hardship of COVID. As a result, the VA did not incur travel fees for remote Veterans. VVC improved access to Veteran specialty care and decreased overall anxiety and concerns regarding possible delayed diagnosis for cancer recurrence due to missed clinic appointments.

CONCLUSIONS: VVC is a viable option for CRC surveillance, however the Veteran still requires interval physical exam, labs, and imaging. A feasible option is to alternate in-person face to face visits with VVC appointments as a means to meet the expected long-term requirements for social distancing while still providing the vital care and reassurance to our Veterans.

BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.

METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.

RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.

CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.

BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.

METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.

RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.

CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.

BACKGROUND: Mantle cell lymphoma (MCL) is an incurable B-cell non-Hodgkin lymphoma. There is limited data on MCL burden to US veterans. OBJECTIVE: This retrospective cohort analysis aims to examine the clinical burden, costs and healthcare resource utilization of MCL to veterans.

METHODS: Adults who were newly diagnosed with MCL and initiated treatment were identified in the Veteran Health Administration (VHA) dataset (2014-2018). Treatment regimens are mutually exclusive and categorized as: bendamustine-based (alone or in combination); BTK-based (Bruton’s tyrosine kinase inhibitors: ibrutinib or acalabrutinib, alone or in combination); RCHOP-based; rituximab-monotherapy; and other regimen. Treatment discontinuation is defined as no MCL treatment for 60 days from the last day of supply. Treatment regimens, costs and hospitalizations are examined by 1st, 2nd, and 3rd lines of therapy.

RESULTS: Prevalence and incidence of MCL among the VHA population ranged from 8-11 cases, and 0.6-2.6 cases per 100,000 persons, respectively. A total of 390 patients (mean age: 70 years, 85% white) received 1st line (mean duration: 243 days), 146 (37%) patients received 2nd line (mean duration: 259 days), and 47 (12%) received 3rd line (mean duration: 154 days) therapy. Bendamustine-based regimen was the most common 1st line MCL treatment (43%), with lower utilization later (2nd line: 18%; 3rd line: 2%). BTK-based regimen was the second most common 1st line MCL treatment (23%), and the most common MCL treatment in later settings (2nd line: 34%, 3rd line 28%). RCHOP-based regimens were seldomly used in any setting (<5%). The overall treatment discontinuation rate was 82%. Approximately 38% of MCL patients had a hospitalization, with mean length-of-stay (LOS) of 5.6 days. The hospitalization rate was 29% (mean LOS: 3.5), 36% (mean LOS: 4.4), and 26% (mean LOS: 3.1) during 1st, 2nd, and 3rd line, respectively. Per-patient-per-month costs were $19,338 overall, and $19,239, $20,064, and $27,663 respectively, during 1st, 2nd, and 3rd line of therapy.

CONCLUSION: This study showed that bendamustine- based and BTK-based regimens were the common frontline treatments among newly diagnosed MCL patients in the VHA population. Future studies are warranted to understand factors associated with treatment selection, discontinuation and clinical benefits among these MCL Veteran patients.

PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.

PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.

PURPOSE: Moderately hypofractionated radiotherapy (MHRT) is a commonly used treatment modality for localized prostate cancer (LPC). In this setting, dosimetric correlations to acute and late toxicities remain poorly defined.

METHODS: Patients with LPC treated with MHRT between September 2008 and April 2018 were retrospectively identified. We excluded those with < 12 months follow up, elective nodal coverage, or additional boost. All patients received either 70Gy/28 fractions or 60Gy/20 fractions. Demographics, clinical outcomes, and toxicity data were obtained. Acute and late (≥3 months following MHRT completion) gastrointestinal (GI) and genitourinary (GU) toxicities were determined per CTCAE 5.0. Univariate and multivariate analyses were performed for acute and late grade 2+ GI/GU toxicity via logistic regression and log rank testing for demographic and dosimetric variables.

RESULTS: A total of 436 patients with LPC were treated with MHRT. Mean age was 64 years (IQR 60-68), median pre-treatment PSA was 8.7 (IQR 5.7-12.2), and T stages included T1a/2a (357), T2b/2c (58), and T3 (21). Acute grade 3 GU and GI toxicities were observed in 16(3.7%) and 3(0.7%) patients respectively, with no acute grade 4 toxicity events. Late grade 3 GU and GI toxicities were observed in 17(3.9%) and 4(0.9%) patients respectively, with two late grade 4 GI (0.05%) events. On multivariate analysis, acute grade 2+ GU toxicity was associated with pre-treatment PSA (odds ratio [OR] 1.02 95% confidence interval [CI] 1.01-1.04, P = 0.011) and pre-radiotherapy AUA SS (OR 1.06 95%CI: 1.03-1.09, P < 0.001); late grade 2+ GU toxicity was associated with pre-treatment AUA (hazard ratio [HR] 1.04 95%CI: 1.02-1.06, P < 0.001), lack of pre-treatment urinary meds (HR 0.65, 95%CI: 0.46-0.92, P = 0.049), and ADT use (HR 1.45, 95%CI: 1.03-2.03, P = 0.034); acute grade 2+ GI toxicity did demonstrate significant correlation; late grade 2+ GI toxicity was associated with ethnicity (Black vs White, HR 0.50, 95% CI: 0.25-0.99, P = 0.008) and pre-treatment PSA (HR 1.02, 95%CI: 1.00- 1.03, P = 0.024).

CONCLUSION: LPC patients completing MHRT experienced low rates of grade 3+ acute and late GU/GI toxicities. No dosimetric variables demonstrated significance on multivariate analysis of acute or late GU/ GI grade 2+ toxicity. Late grade 2+ GU toxicity was associated with ADT use, while late grade 2+ GI toxicity was associated with ethnicity and pre-treatment PSA.