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extacy
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.
First Evaluation and Summary of The Veterans on Anticancer Medications in Rural and Community Settings Support (VA CARES) Program: Pharmacist-Driven Medication Management for Veterans Receiving Oral Antineoplastic Therapies Through the MISSION/ CHOICE Act
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.
Evidence-Based Project and Quality Initiative Towards Improving Decision Making and Outcomes in Prostate Cancer Bone Health at Salt Lake City VA
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.
Evaluation of Outcomes With Immune Checkpoint Inhibitor Therapy and Concurrent Antibiotic Usage
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.
Effective Pain Control With Very Low Dose Palliative Radiotherapy for Multiple Myeloma Patients With Osseous 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: 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.
Cerebral Venous Thrombosis, an Extremely Rare Complication of Iron Deficiency Anemia
INTRODUCTION: Cerebral venous thrombosis (CVT) is a rare type of stroke and can be challenging to diagnose. It is seen in most commonly young females and has been linked to thrombophilia, pregnancy, and contraceptive pills. Here we present a rare case of CVT in a young female with iron deficiency anemia.
CASE REPORT: A 19-year-old female patient presented with severe headache, CT scan of the head on admission showed acute superior sagittal sinus thrombosis which was confirmed with CT venogram and MRI of the brain. The patient had intact neurologic exam upon admission. She was started on heparin and admitted for monitoring. Later on she developed expressive aphasia and right sided weakness. She ultimately underwent catheter directed thrombolysis. Follow up CT and MRI scans showed significant decrease in clot burden, and the patient’s neurologic function started to improve.
Her initial labs were significant for thrombocytosis with platelet count 840,000/μL, and microcytic anemia with hemoglobin 9.6 g/dL and MCV 79 fL. She had low serum ferritin and iron levels with high total iron binding capacity consistent with iron deficiency anemia. An extensive hypercoagulable work up was done including antithrombin, protein C and S, factor V Leiden mutation, prothrombin gene mutation, hyperhomocysteinemia, antiphospholipid antibodies, anti-nuclear antibodies which all came back negative. Given her high platelet count, a myeloproliferative disorder was entertained however testing of mutations JAK2V617F, CALR, MPL, and BCR-ABL was negative. She also had a bone marrow biopsy that revealed normal bone marrow. The patient had no prior personal or family history of venous thrombosis, she was not taking any hormonal mediation and pregnancy test was negative. She did report menorrhagia for couple of months prior to admission.
CONCLUSION: After ruling out genetic prothrombotic states, autoimmune disease, and bone marrow disorders. We determined this was a case of cerebral venous thrombosis secondary to reactive thrombocytosis in setting of untreated iron deficiency and menorrhagia. The patient was started on iron supplements with improvement in her iron and hemoglobin levels, and subsequent decrease in her platelet count to normal values. She continued anticoagulation with rivaroxaban for 3-6 months period.
INTRODUCTION: Cerebral venous thrombosis (CVT) is a rare type of stroke and can be challenging to diagnose. It is seen in most commonly young females and has been linked to thrombophilia, pregnancy, and contraceptive pills. Here we present a rare case of CVT in a young female with iron deficiency anemia.
CASE REPORT: A 19-year-old female patient presented with severe headache, CT scan of the head on admission showed acute superior sagittal sinus thrombosis which was confirmed with CT venogram and MRI of the brain. The patient had intact neurologic exam upon admission. She was started on heparin and admitted for monitoring. Later on she developed expressive aphasia and right sided weakness. She ultimately underwent catheter directed thrombolysis. Follow up CT and MRI scans showed significant decrease in clot burden, and the patient’s neurologic function started to improve.
Her initial labs were significant for thrombocytosis with platelet count 840,000/μL, and microcytic anemia with hemoglobin 9.6 g/dL and MCV 79 fL. She had low serum ferritin and iron levels with high total iron binding capacity consistent with iron deficiency anemia. An extensive hypercoagulable work up was done including antithrombin, protein C and S, factor V Leiden mutation, prothrombin gene mutation, hyperhomocysteinemia, antiphospholipid antibodies, anti-nuclear antibodies which all came back negative. Given her high platelet count, a myeloproliferative disorder was entertained however testing of mutations JAK2V617F, CALR, MPL, and BCR-ABL was negative. She also had a bone marrow biopsy that revealed normal bone marrow. The patient had no prior personal or family history of venous thrombosis, she was not taking any hormonal mediation and pregnancy test was negative. She did report menorrhagia for couple of months prior to admission.
CONCLUSION: After ruling out genetic prothrombotic states, autoimmune disease, and bone marrow disorders. We determined this was a case of cerebral venous thrombosis secondary to reactive thrombocytosis in setting of untreated iron deficiency and menorrhagia. The patient was started on iron supplements with improvement in her iron and hemoglobin levels, and subsequent decrease in her platelet count to normal values. She continued anticoagulation with rivaroxaban for 3-6 months period.
INTRODUCTION: Cerebral venous thrombosis (CVT) is a rare type of stroke and can be challenging to diagnose. It is seen in most commonly young females and has been linked to thrombophilia, pregnancy, and contraceptive pills. Here we present a rare case of CVT in a young female with iron deficiency anemia.
CASE REPORT: A 19-year-old female patient presented with severe headache, CT scan of the head on admission showed acute superior sagittal sinus thrombosis which was confirmed with CT venogram and MRI of the brain. The patient had intact neurologic exam upon admission. She was started on heparin and admitted for monitoring. Later on she developed expressive aphasia and right sided weakness. She ultimately underwent catheter directed thrombolysis. Follow up CT and MRI scans showed significant decrease in clot burden, and the patient’s neurologic function started to improve.
Her initial labs were significant for thrombocytosis with platelet count 840,000/μL, and microcytic anemia with hemoglobin 9.6 g/dL and MCV 79 fL. She had low serum ferritin and iron levels with high total iron binding capacity consistent with iron deficiency anemia. An extensive hypercoagulable work up was done including antithrombin, protein C and S, factor V Leiden mutation, prothrombin gene mutation, hyperhomocysteinemia, antiphospholipid antibodies, anti-nuclear antibodies which all came back negative. Given her high platelet count, a myeloproliferative disorder was entertained however testing of mutations JAK2V617F, CALR, MPL, and BCR-ABL was negative. She also had a bone marrow biopsy that revealed normal bone marrow. The patient had no prior personal or family history of venous thrombosis, she was not taking any hormonal mediation and pregnancy test was negative. She did report menorrhagia for couple of months prior to admission.
CONCLUSION: After ruling out genetic prothrombotic states, autoimmune disease, and bone marrow disorders. We determined this was a case of cerebral venous thrombosis secondary to reactive thrombocytosis in setting of untreated iron deficiency and menorrhagia. The patient was started on iron supplements with improvement in her iron and hemoglobin levels, and subsequent decrease in her platelet count to normal values. She continued anticoagulation with rivaroxaban for 3-6 months period.
Central Texas Veterans Health Care System’s Experiences With Hematology Oncology Clinical Trials
BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.
METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.
RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.
BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.
METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.
RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.
BACKGROUND: Availability of clinical trials for veterans is limited and more clinical trials are needed. Central Texas Veterans Health Care System (CTVHCS) has been actively involved with hematologic oncologic clinical trials over the last 10 years. This poster describes the number and types of hematology/oncology clinical trials that are either active or completed, and the processes of opening clinical trials, identifying patients, and trial management.
METHODS: Locating clinical trials is key to veteran enrollment into active trials and is accomplished through networking at medical meetings and VA work groups. Developing a clinical trial program requires working closely with the research department/foundations and becoming comfortable with the IRB oversight process. Conduct of a clinical trial is a team effort, with individual members having delegated responsibilities of patient care, data collection, and adverse effect reporting to the sponsors and IRB. The CTVHCS Oncology Section has been active in recruiting and enrolling veterans in clinical trials for treatment of many hematologic malignancies and solid tumors.
RESULTS: At the time of this presentation, 49 veterans have been successfully enrolled in 1 of 9 hematology/ oncology clinical trials ranging from phase Ib to phase III from 2011-2020. Advantages to opening clinical trials include academic scholarship, authorship in publications, generating revenue and most importantly to provide state of the art treatment for our cancer patients. We have been able to effectively accrue/enroll patients into clinical trials through a collaborative effort between the research department and our oncology department by identifying open clinical trials that fit our unique patient population and having a team of providers aiding in the management and care of these enrolled veterans.
Bridging the Gap: Transforming Oncology Care Through Use of Virtual Tumor Boards
PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.
BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.
METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.
RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.
CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.
PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.
BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.
METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.
RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.
CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.
PURPOSE: A quality improvement pilot study was conducted to assess the feasibility of implementing virtual tumor boards (VTBs) to address barriers in cancer care for Veterans at the VA North TexasHealth Care System (VANTHCS) located in Dallas, Texas.
BACKGROUND: The VANTHCS is the second largest VA health care system in the country, serving more than 129,000 veterans with 1.4 million outpatient episodes of care in the FY2017. Cancer is one of the leading causes of these episodes of care. This specific population faces unique needs due to the complexity of cancer care. Multidisciplinary tumor boards (MTBs) can serve as facilitators in augmenting quality cancer care for veterans. Specifically, MTBs have been shown to support diagnostic decision-making, adherence to evidence-based guidelines, as well as enhance collaboration and care coordination. The VANTHCS Cancer Program hosts seven accredited disease-site specific MTBs that meet in a face-to-face conference. However, the COVID-19 pandemic created a gap in continuity cancer care through use of MTBs. Prior to the initiation of this study, no VTBs had previously been implemented.
METHODS: In March 2020, key stakeholders within the cancer program formulated a plan to continue MTBs during the pandemic. A multidisciplinary cancer conference coordinator (MCCC) lead this task utilizing a web-based platform in addition to Biomedical Engineering assistance ensuring appropriate applications were correctly interfaced on all VA Computers to properly support imaging. A Plan-Do-Study-Act was conducted to assess for any changes.
RESULTS: Data were collected and analyzed from January 2, 2020 until July 2, 2020, utilizing a cancer conference tracking tool conducted by the MCCC. A total of 72 MTBs were completed as well as 446 prospective cases were presented. After implementation of VTBs, data showed a 26.8% increase in interdisciplinary attendance rate for MTBs.
CONCLUSION: This innovative pilot study provided a unique approach to meet the demands of the COVID- 19 pandemic as well as showed the feasibility in enhancing quality cancer care. Virtual tumors boards provide an effective tool in improving accessibility through increased participation at MTBs. This may have future implications in which further research is needed including cancer survival and patient satisfaction rates.
Atypical Cardiac Metastasis From a Typical Rectal Cancer
BACKGROUND: The heart is an unusual site of metastasis from any malignancy. The pericardium is the most frequently involved site of cardiac metastasis. Myocardial metastasis is rare and metastasis only to heart without evidence of spread anywhere else is extremely rare. Here we present a case of rectal cancer with metastasis only to heart.
CASE REPORT: A 64-year-old man was found to have a large ulcerated mass in the upper rectum, 15cm above the anal verge during colonoscopy. Biopsy of the mass revealed poorly differentiated invasive adenocarcinoma. After 5 weeks of neo adjuvant capecitabine with concurrent radiation, he underwent robotic low anterior resection (LAR) with coloanal anastomosis with loop ileostomy. Pathology revealed 5cm poorly differentiated adenocarcinoma of rectum invading through muscularis propria with 7/17 lymph nodes and margins involved with adenocarcinoma. He was staged as ypT3pN2bM0 (Stage IIIC, AJCC 8th edition, 2017). Adjuvant therapy was delayed until 12 weeks from surgery due to wound dehiscence/infection. After 5 cycles of adjuvant capecitabine and oxaliplatin, a follow up contrast CT chest/abdomen/pelvis revealed 2.3cm mass extending from pericardium to myocardium. Transesophageal echocardiogram(TEE) and cardiac MRI revealed 2 separate masses(1cm and 2cm) in the right ventricle (RV) free wall projecting into RV cavity concerning for free wall metastases. After 3 weeks, he presented to ED with shortness of breath. Transthoracic echocardiogram(TTE) showed large pericardial effusion with cardiac tamponade. 1250ml of pericardial fluid was removed by pericardiocentesis and cytology revealed metastatic colorectal adenocarcinoma. CT chest/abdomen/pelvis with IV contrast did not show any other site of metastasis. He was started on systemic chemotherapy with Fluorouracil and Irinotecan (FOLFIRI). He has tolerated FOLFIRI for a year without recurrence of pericardial effusion.
CONCLUSION: Most cardiac metastases are associated with widely metastatic disease, but this case is unique in having only cardiac metastasis from a previously resected rectal adenocarcinoma. Although often clinically silent, cardiac metastases should be considered in any patient with cancer and new cardiac symptoms. TTE is the initial imaging test but TEE, Cardiac CT and Cardiac MRI may help further characterize and delineate the extent of cardiac disease. A multidisciplinary team to evaluate and manage the patient with cardiac metastasis is recommended.
BACKGROUND: The heart is an unusual site of metastasis from any malignancy. The pericardium is the most frequently involved site of cardiac metastasis. Myocardial metastasis is rare and metastasis only to heart without evidence of spread anywhere else is extremely rare. Here we present a case of rectal cancer with metastasis only to heart.
CASE REPORT: A 64-year-old man was found to have a large ulcerated mass in the upper rectum, 15cm above the anal verge during colonoscopy. Biopsy of the mass revealed poorly differentiated invasive adenocarcinoma. After 5 weeks of neo adjuvant capecitabine with concurrent radiation, he underwent robotic low anterior resection (LAR) with coloanal anastomosis with loop ileostomy. Pathology revealed 5cm poorly differentiated adenocarcinoma of rectum invading through muscularis propria with 7/17 lymph nodes and margins involved with adenocarcinoma. He was staged as ypT3pN2bM0 (Stage IIIC, AJCC 8th edition, 2017). Adjuvant therapy was delayed until 12 weeks from surgery due to wound dehiscence/infection. After 5 cycles of adjuvant capecitabine and oxaliplatin, a follow up contrast CT chest/abdomen/pelvis revealed 2.3cm mass extending from pericardium to myocardium. Transesophageal echocardiogram(TEE) and cardiac MRI revealed 2 separate masses(1cm and 2cm) in the right ventricle (RV) free wall projecting into RV cavity concerning for free wall metastases. After 3 weeks, he presented to ED with shortness of breath. Transthoracic echocardiogram(TTE) showed large pericardial effusion with cardiac tamponade. 1250ml of pericardial fluid was removed by pericardiocentesis and cytology revealed metastatic colorectal adenocarcinoma. CT chest/abdomen/pelvis with IV contrast did not show any other site of metastasis. He was started on systemic chemotherapy with Fluorouracil and Irinotecan (FOLFIRI). He has tolerated FOLFIRI for a year without recurrence of pericardial effusion.
CONCLUSION: Most cardiac metastases are associated with widely metastatic disease, but this case is unique in having only cardiac metastasis from a previously resected rectal adenocarcinoma. Although often clinically silent, cardiac metastases should be considered in any patient with cancer and new cardiac symptoms. TTE is the initial imaging test but TEE, Cardiac CT and Cardiac MRI may help further characterize and delineate the extent of cardiac disease. A multidisciplinary team to evaluate and manage the patient with cardiac metastasis is recommended.
BACKGROUND: The heart is an unusual site of metastasis from any malignancy. The pericardium is the most frequently involved site of cardiac metastasis. Myocardial metastasis is rare and metastasis only to heart without evidence of spread anywhere else is extremely rare. Here we present a case of rectal cancer with metastasis only to heart.
CASE REPORT: A 64-year-old man was found to have a large ulcerated mass in the upper rectum, 15cm above the anal verge during colonoscopy. Biopsy of the mass revealed poorly differentiated invasive adenocarcinoma. After 5 weeks of neo adjuvant capecitabine with concurrent radiation, he underwent robotic low anterior resection (LAR) with coloanal anastomosis with loop ileostomy. Pathology revealed 5cm poorly differentiated adenocarcinoma of rectum invading through muscularis propria with 7/17 lymph nodes and margins involved with adenocarcinoma. He was staged as ypT3pN2bM0 (Stage IIIC, AJCC 8th edition, 2017). Adjuvant therapy was delayed until 12 weeks from surgery due to wound dehiscence/infection. After 5 cycles of adjuvant capecitabine and oxaliplatin, a follow up contrast CT chest/abdomen/pelvis revealed 2.3cm mass extending from pericardium to myocardium. Transesophageal echocardiogram(TEE) and cardiac MRI revealed 2 separate masses(1cm and 2cm) in the right ventricle (RV) free wall projecting into RV cavity concerning for free wall metastases. After 3 weeks, he presented to ED with shortness of breath. Transthoracic echocardiogram(TTE) showed large pericardial effusion with cardiac tamponade. 1250ml of pericardial fluid was removed by pericardiocentesis and cytology revealed metastatic colorectal adenocarcinoma. CT chest/abdomen/pelvis with IV contrast did not show any other site of metastasis. He was started on systemic chemotherapy with Fluorouracil and Irinotecan (FOLFIRI). He has tolerated FOLFIRI for a year without recurrence of pericardial effusion.
CONCLUSION: Most cardiac metastases are associated with widely metastatic disease, but this case is unique in having only cardiac metastasis from a previously resected rectal adenocarcinoma. Although often clinically silent, cardiac metastases should be considered in any patient with cancer and new cardiac symptoms. TTE is the initial imaging test but TEE, Cardiac CT and Cardiac MRI may help further characterize and delineate the extent of cardiac disease. A multidisciplinary team to evaluate and manage the patient with cardiac metastasis is recommended.
Association of Eosinophilia With Complete Response in Patients With Metastatic Solid Tumors Treated With Immunotherapy
BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.
METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.
RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.
CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.
BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.
METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.
RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.
CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.
BACKGROUND: Immune-related eosinophilia is a new immune related adverse effect associated with anti- PD-1 or anti-PD-L1 treatment (Bernard-Tessier, 2017). It appears to be a rare adverse effect with estimated frequency of 2.9% (Bernard-Tessier, 2017). There is evidence that changes in blood eosinophilia during anti- PD-1 therapy can be a predictor of long-term disease control in metastatic melanoma (Gaba, 2015). At least 3 studies have correlated immune mediated eosinophilia with high overall response rates up to 69% (Bernard- Tessier, 2017; Gaba, 2015; A, 2017). With this interesting observation, we retrospectively reviewed 36 patients in our center who were treated with PD-1 and anti PD-L1 agents. The Objective of our review was to assess the correlation of eosinophilia with the complete response rate.
METHODS: We retrospectively reviewed the medical records of 36 patients from May 2016 -May 2020 who had received anti PD-1 or anti PD-L1 treatment for metastatic solid tumors. Patients who had received consolidation immunotherapy were excluded from the review. Absolute Eosinophil Count (AEC) of over 500 per mm3 was used to define eosinophilia. Incidence rate of eosinophilia was estimated in comparison to the total number of patients who had received the above treatments.
RESULTS: In this small single center cohort of 36 male patients, eosinophilia was observed in 4/36 patients (11.11%). The median time to the absolute eosinophilia was 24 weeks (3 weeks - 52 weeks). Three out of the 4 patients had complete response. Complete response rates in patients with eosinophilia at any point after initiation of immunotherapy was 75% compared with 2.7% in the noneosinophila group. Overall response rate was 75% (3/4) in the eosinophilia group vs 12.5% (4/32) in the noneosinophilia group.
CONCLUSIONS: In our small retrospective cohort of patients, immune-related eosinophilia with anti-PD-1 and anti-PD-L1 treatments appear to be a biomarker and associated with beneficial clinical response. Additional, larger prospective studies are required to validate this. If validated in prospective studies, immune related eosinophilia could serve as a cost effective biomarker to identify responders likely to derive long-term disease control with immune therapies.
Assessing Risk for and Management of Secondary CNS Involvement in Patients With DLBCL Within the Veterans Health Administration (VHA)
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.
INTRODUCTION: In diffuse large B-cell lymphoma (DLBCL), approximately 5-10% of patients develop secondary central nervous system (CNS) involvement. CNS disease is associated with very poor outcomes. Therefore, it is important to identify patients at risk, via the CNS International Prognostic Index (IPI), in order to initiate appropriate interventions. Additional independent risk factors for CNS involvement include HIV-related lymphoma and high-grade B-cell lymphomas. The purpose of this study was to assess for appropriate CNS evaluation and prophylaxis in DLBCL patients within the Veterans Health Administration (VHA).
METHODS: We performed a retrospective chart review of 1,605 randomly selected patients seen in the VHA nationwide who were diagnosed with lymphoma between January 1, 2011 and December 31, 2017. We included patients diagnosed with DLBCL and excluded patients diagnosed or treated outside the VHA. We evaluated CNS IPI score, HIV status, pathology reports to identify high-grade lymphomas, performance of lumbar puncture (LP), and administration of CNS prophylaxis.
RESULTS: A total of 725 patients met our inclusion criteria. Patients were predominantly male (96.8%), white (74.5%), had a median age of 67, and presented with advanced disease (stage III 26.5%, stage IV 40.3%). From the included population, 190 (26.2%) had a highrisk CNS IPI score. Of those with high-risk CNS IPI scores, 64 (33.7%) underwent LP and 46 (24.2%) were treated with CNS prophylaxis. 23 (3.2%) were HIV positive; of those, 14 (60.8%) underwent LP and 4 (17.4%) were treated with CNS prophylaxis. FISH results were available in only 242 (33.4%) of patients and of these, 25 (10.3%) met criteria for high-grade lymphoma. Of those with high-grade lymphoma, 9 (36%) underwent LP and 7 (28%) were treated with CNS prophylaxis.
CONCLUSIONS: The National Comprehensive Cancer Network guidelines recommend that patients at high risk for CNS involvement undergo LP and treatment with CNS prophylaxis. This study found that within the VHA, patients with DLBCL at high risk for CNS involvement are not being evaluated with LPs or treated with CNS prophylaxis as often as indicated, based on CNS IPI, HIV status, and high-grade pathology. We demonstrate a need for improvement in the evaluation and treatment of these patients in order to improve outcomes.