The Effect of Treatment Facility and Race on Survival for Signet Ring Cell Carcinoma of the Esophagus: An Analysis of the National Cancer Database

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BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

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BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

BACKGROUND: Signet ring cell carcinoma of the esophagus (SRCCE) is an aggressive tumor that represents approximately 3.5-5.0% of all esophageal cancers. Prior studies have shown a strong correlation between treating facility and survival for different cancers, but this has not been studied in SRCCE. The goal of this study is to assess differences in survival based on the type of treatment facility.

METHODS: There were 1,442 patients with SRCCE identified using the histology 8490 and topography codes C15.0-C15.9 in the National Cancer Database (NCDB). Descriptive analysis, Kaplan-Meier curves, and a multivariable Cox hazard regression analysis were all utilized to determine the significance and impact of treatment facility type, race, age, sex, tumor stage, use of adjuvant or neoadjuvant radiation, and surgical margins on survival.

RESULTS: The cohort was mostly male (86.6%) and Non-Hispanic Caucasian (96.3%) with 52.7% receiving treatment at academic centers followed by 35.9% at community programs and 11.4% at integrated cancer programs. As age increased, mortality also increased (HR = 1.02; 95% CI: 1.01-1.02, p < 0.001). Both Hispanic Caucasians (HR = 2.09; 95% CI: 1.21-3.62, = 0.009) and Africans Americans (HR = 1.69; 95% CI: 1.04-2.75, = 0.036) had an increased risk of mortality when compared to Non-Hispanic Caucasians. Patients at academic facilities demonstrated a decreased risk of mortality when compared to community programs (HR = 0.73; 95% CI: 0.63-0.86, p < 0.001) and integrated cancer programs (HR = 0.74; 95% CI: 0.60- 0.93, = 0.008).

CONCLUSION: For patients diagnosed with SRCCE, receiving treatment at academic centers resulted in better survival probabilities compared to nonacademic facilities. Older patients, African Americans and Hispanic Caucasians, increasing tumor stage, positive surgical margins, and comorbidities with Charlson- Deyo scores of 1 and 2+ were all associated with an increased risk of mortality from SRCCE.

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Short Story Clubs to Decrease Burnout

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Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

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Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

Burnout is common in hematology/oncology practice where work pressure is high, patients are complex, and outcomes are variable. We hypothesized that a short story club could be helpful to improve community, humanism, and transcendence; and thereby to decrease burnout. Most of the potential participants indicated little time for preparation and we, therefore, chose short stories rather than books as reading material. The meetings began in April 2019 and continued until April 2020 when they were suspended for the COVID-19 epidemic. Participants included oncologists (6), oncology fellows (2), psychologist (1), social workers (2), research writer (1) and, student (1). Of these, 7 were females and 6 were males; 4 in senior and 9 in junior positions. Country of origin of participants was USA (6), India (3), Syria (2), Pakistan (1) and, Poland (1). Meetings were held every two months, each time with different stories, focus, themes, and points of view. Readings included classical stories, modern stories, and personal essays, from the eyes of other oncologists, country doctor, patients, nurses, or students. Stories included “The Doctor” by Chekhov, “The Country Doctor” by Kafka, “Three Questions” by Tolstoy, “Elephant Hills” and “Indian Camp” each by Hemingway, “Interpreter of Maladies” by Lahiri, “Get your Own Fatal Disease” by Yalom, “Caves of Lascaux” by Karmel, “The Plagiarist” by Seamon and three essays on “undying,” end-of-life and love. Themes included falling in love with a patient, empathy, loneliness, burnout, communication, helplessness, and end-of-life issues. Discussions lasted two hours and promoted a sense of belonging and community; sharing of feelings and concerns; and transcendence of everyday burdens. Attendance was more than 80% at each meeting and all participants indicated an interest in continuing the club for the foreseeable future. Short story clubs may be one way to overcome or prevent burnout in oncology. Further quantitative and qualitative studies are needed.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Hemolytic Anemia Secondary to Methylene Blue Administration in a G6PD Sufficient Patient

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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.

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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.

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Effective Pain Control With Very Low Dose Palliative Radiotherapy for Multiple Myeloma Patients With Osseous Lesions

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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.

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Correspondence: Jeremy Price ([email protected])

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.

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Central Texas Veterans Health Care System’s Experiences With Hematology Oncology Clinical Trials

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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.

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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.

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Bridging the Gap: Transforming Oncology Care Through Use of Virtual Tumor Boards

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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.

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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.

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Analysis of Oncology Telehealth Services in Veterans Health Administration

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BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

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BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

BACKGROUND: The purpose of this work is to assess the current utilization patterns of telehealth for oncology care and identify opportunities for increased utilization for underserved regions. In order to accurately and efficiently obtain this information a national data extraction and analysis was required to better understand the current needs. Approximately 33% of veterans are considered to live in rural America. A significant proportion of cancer patients must travel long distances to access cutting-edge VA cancer care. Some VAMCs provide academic subspecialized oncology care including next generation sequencing (NGS), genetic counseling, opportunities to enroll in clinical trials, and world-renowned clinical expert consultation. These services are not conveniently accessible for veterans therefore requiring a program which supports access to all.

METHODS: Baseline assessment measurements were identified to understand resource supply, demand, and telehealth utilization needs. Data were extracted from VA’s CDW and VSSCs Service Analysis Services cubes. 15 data measures from 8 data sources were pulled for 141 VAMCs spanning in time period from FY18 to March FY20.

Cluster Analysis, k-means clustering method, were used to classify VAMCs into distinct groups to identify facilities with the highest needs for oncology telehealth services. The evolutionary solving method was used to find the minimum sum of squared estimate of errors (SSE) allowing a more diversified approach in cluster assignment. Three cluster analysis were performed which include a combination of three variables specific to oncology staffing, telehealth usage, patient rurality, and community care consults (CCC).

RESULTS: Results show that 30 (21%) VAMCs are categorized as high need for TeleOncology. These facilities have low staff support, high CCC, and low telehealth usage. Of these, 11 (37%) VAMCs have high percent of rural patients. Eleven (8%) of all VAMCs are categorized as having high staff support, low CCC, and high telehealth usage; good hub site candidates for the National TeleOncology Program.

CONCLUSION: VA is expanding the National TeleOncology Program to offer oncology services to underserved VAMCs and Veterans across the United States. Results of this analysis are being applied to determine where to prioritize telehealth services for oncology care and which sites may serve as hubs.

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A Single Center Experience of Immune Related Adverse Events From Immune Checkpoint Inhibitors and an Attempt to Identify Populations at High Risk

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INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.

METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.

RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.

Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.

CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.

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INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.

METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.

RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.

Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.

CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.

INTRODUCTION: American Society of Clinical Oncology (ASCO) has developed guidelines on the management of immune-related adverse events (irAEs) associated with immune checkpoint inhibitors (ICPIs). However, many irAEs are under-reported and the studies to investigate predictive factors are limited with variable results.

METHODS: A total of 66 patients who received ICPIs at Stratton VAMC Albany between January 2015 to December 2018 were studied. Computerized Patient Record System (CPRS) was used to do a retrospective chart review to identify irAEs and related parameters. IRB approval was obtained.

RESULTS: Sixty-three patients received PD-1 inhibitors (62 males). Our study included 39 patients with lung, 10 renal, 6 head and neck, 4 skin (melanoma), and 2 bladder cancers, and 1 metastatic cancer with unknown primary. Median age of patients with irAEs was 69.5 years versus 66.7 years for patients without irAEs. 23 (36.5%) patients experienced 28 irAEs. 45 patients received nivolumab, 18 (40%) of which had 21 irAEs. 17 got pembrolizumab and 5 (35.2%) had 7 irAEs. Majority of the irAEs were grade I (n=10, 35.7%) or grade II (n=11, 39.2%), while 6 (21.4%) grade III and only 1 (3.5%) grade IV irAE was observed. Median time to appearance of irAEs was 2 cycles. Immunotherapy was continued in 12, temporarily held in 7 and permanently discontinued only in 4 patients. No death was attributed to irAEs. Six patients developed diarrhea, 4 hepatitis, 6 skin rash, 5 thyroid issues and 3 pneumonitis. Rare irAEs included cardiac tamponade (grade IV), uveitis (grade II), central adrenal insufficiency and mild neutropenia in one patient each. 2 patients had pre-existing autoimmune conditions (rheumatoid arthritis and chronic dermatitis), both had transient flares though immunotherapy was continued. Of note, only 3 patients received PDL-1 inhibitors and 1 developed grade II polymyalgia rheumatica and hypothyroidism.

Using multivariate logistic regression, we found no significant association between irAEs and age, body mass index, derived neutrophil to lymphocyte ratio, chronic kidney disease or environmental/medical allergies.

CONCLUSIONS: ICPIs were generally well tolerated in our population, though prompt recognition of rare and severe irAEs is essential. Larger studies are needed to investigate the predictive risk factors for irAEs.

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A Multi-Center Retrospective Study Evaluating Palliative Antineoplastic Therapy Administered and Medication De-escalation in Veteran Cancer Patients Toward the End-of-life

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BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.

OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.

METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.

RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.

CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.

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BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.

OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.

METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.

RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.

CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.

BACKGROUND: Metastatic cancer patients near endof- life often continue to receive aggressive cancer treatments and are prescribed many chronic futile medications. The American Society of Clinical Oncology recommends avoiding use of chemotherapy towards end of life in solid tumor patients with poor performance due to potential risk of adverse events.

OBJECTIVES: The objective of this multi-site study was to evaluate the incidence of palliative antineoplastic therapy administration for patients with metastatic cancer as well as the number of patients who received non-essential medications at thirty and fourteen days prior to death.

METHODS: This was a retrospective, multicenter study conducted at 6 Veteran Affairs Medical Centers: Southern Arizona, Lexington, Robley Rex, John D Dingell, San Diego, and Richard L Roudebush. The electronic medical record system identified patients deceased between July 1, 2016 to June 30, 2018 with metastatic lung, colorectal, prostate, pancreatic cancer, or melanoma. Data were analyzed using descriptive analysis.

RESULTS: A total of 651 patients were included in the multicenter study, and the average age of veterans was 71 years with metastatic lung cancer being the most common malignancy at 55%. Within 30 days and 14 days of death, respectively, 24.6% and 13.2% had an antineoplastic agent. Within the last 30 days of life, 45% of patients received systemic chemotherapy, 38% received oral targeted agent, and 17% received immunotherapy. Within last 30 days of life, 50% received a first line treatment, 26.9% received a second line treatment, and 23.2% received ≥ third line of treatment. There was a large proportion of patients hospitalized (n=208) and/ or had ED visits (n=204) due to antineoplastic treatment and/or complications from malignancy. Within the last 30 days of death, 76.3% had ≥ 1 active chronic medication. Palliative care providers were the top recommenders for medication de-escalation.

CONCLUSION: The results of this multi-site retrospective study provides insight into the management of endof- life care for metastatic cancer patients across the VA health care system. Overall the results of this study demonstrate an opportunity for promoting detailed discussions with patients regarding palliative care earlier after diagnosis of metastatic cancer.

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