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Real-World Evidence of Safety Trends Using Rituximab-PVVR in Clinic Infusions
BACKGROUND
The safety and efficacy of biosimilars are carefully reviewed by the Food and Drug Administration (FDA) to ensure the biosimilar meets the high standards for approval. However, safety concerns from infusion nursing staff prompted a review of rituximab-PVVR and rituximab for any new trends in National VA, primary literature, and facility adverse events.
METHODS
Utilizing the VA ADERS (Veteran’s Affairs Adverse Drug Event Reporting System), data was analyzed from 01/01/21 thru 04/01/23. No clear trends were identified to support an increased reaction rate for Rituximab-PVVR or Rituximab. A total of 104 Rituximab product (both parent and biosimilar products) adverse reactions were reported nationally. Of those reported, about half 56 ADEs (54%) were specifically to Rituximab-PVVR.
RESULTS
Reviewing our facility specific VA ADERS data, Birmingham VA reported 7 ADEs. Similarly other sites reported a range of 0 to 13 Rituximab product ADEs. The total number of unique patients to receive a rituximab product in the Birmingham VA since 2021 is 106, resulting in an overall incidence rate of 6.6%.
DISCUSSION
Based on the recent publication, Safety of switching between rituximab biosimilars in onco-hematology “adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of biosimilars.” This prospective clinical trial published in 2021, reported grade 1 rituximab related infusion events in 7.1% of patients (n=83) which correlates closely to the reported incidence at our facility referenced above (6.6%). Our current pre-medications include acetaminophen, an antihistamine, and steroid 30 minutes prior to infusion. Although our interdisciplinary team deemed this appropriate, to improve and minimize infusion reaction symptoms, the following interventions were instituted including changing ORAL Diphenhydramine to intravenous Diphenhydramine 25mg IV and providing education to infusion nursing staff on the safety and efficacy of the rituximab and biosimilar products.
CONCLUSIONS
Following the intervention (04/07/23), 36 total unique patients received rituximab products with zero incidents reported. Although the results are limited, the data may suggest IV diphenhydramine reduces the severity of ADEs which may alter reporting or show a potential “nocebo” effect could be a factor with any rituximab infusion needing further evaluation.
BACKGROUND
The safety and efficacy of biosimilars are carefully reviewed by the Food and Drug Administration (FDA) to ensure the biosimilar meets the high standards for approval. However, safety concerns from infusion nursing staff prompted a review of rituximab-PVVR and rituximab for any new trends in National VA, primary literature, and facility adverse events.
METHODS
Utilizing the VA ADERS (Veteran’s Affairs Adverse Drug Event Reporting System), data was analyzed from 01/01/21 thru 04/01/23. No clear trends were identified to support an increased reaction rate for Rituximab-PVVR or Rituximab. A total of 104 Rituximab product (both parent and biosimilar products) adverse reactions were reported nationally. Of those reported, about half 56 ADEs (54%) were specifically to Rituximab-PVVR.
RESULTS
Reviewing our facility specific VA ADERS data, Birmingham VA reported 7 ADEs. Similarly other sites reported a range of 0 to 13 Rituximab product ADEs. The total number of unique patients to receive a rituximab product in the Birmingham VA since 2021 is 106, resulting in an overall incidence rate of 6.6%.
DISCUSSION
Based on the recent publication, Safety of switching between rituximab biosimilars in onco-hematology “adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of biosimilars.” This prospective clinical trial published in 2021, reported grade 1 rituximab related infusion events in 7.1% of patients (n=83) which correlates closely to the reported incidence at our facility referenced above (6.6%). Our current pre-medications include acetaminophen, an antihistamine, and steroid 30 minutes prior to infusion. Although our interdisciplinary team deemed this appropriate, to improve and minimize infusion reaction symptoms, the following interventions were instituted including changing ORAL Diphenhydramine to intravenous Diphenhydramine 25mg IV and providing education to infusion nursing staff on the safety and efficacy of the rituximab and biosimilar products.
CONCLUSIONS
Following the intervention (04/07/23), 36 total unique patients received rituximab products with zero incidents reported. Although the results are limited, the data may suggest IV diphenhydramine reduces the severity of ADEs which may alter reporting or show a potential “nocebo” effect could be a factor with any rituximab infusion needing further evaluation.
BACKGROUND
The safety and efficacy of biosimilars are carefully reviewed by the Food and Drug Administration (FDA) to ensure the biosimilar meets the high standards for approval. However, safety concerns from infusion nursing staff prompted a review of rituximab-PVVR and rituximab for any new trends in National VA, primary literature, and facility adverse events.
METHODS
Utilizing the VA ADERS (Veteran’s Affairs Adverse Drug Event Reporting System), data was analyzed from 01/01/21 thru 04/01/23. No clear trends were identified to support an increased reaction rate for Rituximab-PVVR or Rituximab. A total of 104 Rituximab product (both parent and biosimilar products) adverse reactions were reported nationally. Of those reported, about half 56 ADEs (54%) were specifically to Rituximab-PVVR.
RESULTS
Reviewing our facility specific VA ADERS data, Birmingham VA reported 7 ADEs. Similarly other sites reported a range of 0 to 13 Rituximab product ADEs. The total number of unique patients to receive a rituximab product in the Birmingham VA since 2021 is 106, resulting in an overall incidence rate of 6.6%.
DISCUSSION
Based on the recent publication, Safety of switching between rituximab biosimilars in onco-hematology “adverse events were similar, in terms of seriousness and frequency, to those described in the literature, providing further support to the clinical safety of biosimilars.” This prospective clinical trial published in 2021, reported grade 1 rituximab related infusion events in 7.1% of patients (n=83) which correlates closely to the reported incidence at our facility referenced above (6.6%). Our current pre-medications include acetaminophen, an antihistamine, and steroid 30 minutes prior to infusion. Although our interdisciplinary team deemed this appropriate, to improve and minimize infusion reaction symptoms, the following interventions were instituted including changing ORAL Diphenhydramine to intravenous Diphenhydramine 25mg IV and providing education to infusion nursing staff on the safety and efficacy of the rituximab and biosimilar products.
CONCLUSIONS
Following the intervention (04/07/23), 36 total unique patients received rituximab products with zero incidents reported. Although the results are limited, the data may suggest IV diphenhydramine reduces the severity of ADEs which may alter reporting or show a potential “nocebo” effect could be a factor with any rituximab infusion needing further evaluation.
Detection of Prostate Cancer in the Transitional Zone by Using a UroNav Biopsy
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
OBJECTIVE
Transitional zone cancers are not accounted for when using standard prostate biopsy techniques. Using MRI/Transrectal ultrasound fusion biopsy (UroNav) can more accurately diagnose transitional zone prostate cancer. The goal of this study is to evaluate 375 patients with transitional zone only cancer found on a UroNav biopsy MRI/Transrectal ultrasound fusion biopsy over a three-year period to evaluate the clinical significance of their cancer.
METHOD
We retrospectively analyzed 1500 patients that underwent a UroNav biopsy over a 3 year period. 375 of these patients had transitional zone only cancers. The patients with transitional and peripheral zone cancer were analyzed. The PIRAD scores were evaluated and the percent cancer determined for each zone. Clinically significant cancer for each zone was also determined.
RESULTS
Of the 1500 patients with a PIRAD lesion, 25% were located in the transitional zone, 36% in the peripheral zone and 39% in both transitional and peripheral zone. Cancer was detected in 40% of transitional zone only lesions, 44% of peripheral zone only lesions and 38% combined zone lesion. Clinically significant cancer was noted in 26%, 27% and 20%, respectively, for the TZ, PZ and combined zones. Kaplan- Meier, Cox Proportional Hazards test, ANOVA and Chi- Square tests were performed. Data was analyzed using IBM SPSS version 27 and statistical significance was set at α=0.05. PIRAD breakdown for transitional zone only cancers are as follows, PIRAD 3 (52% of patients): 24% cancer, 10% clinically significant PIRAD 4 (34% of patients): 43% cancer, 30% clinically significant PIRAD 5 (14% of patients): 75% cancer, 60% clinically significant
CONCLUSIONS
The use of a UroNav biopsy has been instrumental in detecting clinically significant cancers in the transitional zone that otherwise would have been missed on a standard mapping biopsy.
Differential Overall Survival and Treatment in Patients With Small Intestine Adenocarcinoma Based on Insurance Status: A National Perspective
BACKGROUND
The incidence of adenocarcinoma, the most common type of small intestine cancer, is increasing. Prior studies found a 5-year survival of about 25% even with surgical resection and lymph node dissection. A recent study found higher survival in insured versus uninsured patients, yet differential outcomes and treatments between private insurance and Medicare, along with Medicaid and no insurance, are unknown. This study aims to determine differential survival and treatment of patients with small intestine adenocarcinoma based on insurance status.
METHODS
The National Cancer Database was used to identify patients diagnosed with small intestine adenocarcinoma from 2004-2019 using the histology code 8140 as assigned by the Commission on Cancer Accreditation program. Kaplan-Meier, Chi-Square, ANOVA, and Cox Proportional Hazards tests were performed. Data was analyzed using IBM SPSS version 28 and statistical significance was set at α=0.05.
RESULTS
Of the 20,933 patients included, 7,629 (32.4%) had private insurance and 13,075 (55.5%) had Medicare. Patients with private insurance had a longer median survival (28.8 months) than patients with Medicare, Medicaid, and no insurance (p<.001), while patients with Medicare had a shorter median survival (12.2 months) than other insurance statuses (p<.001). No median survival difference existed between those with Medicaid (18.9 months) and no insurance (18.0 months) (p=.882). After controlling for age, co-morbidity score, grade, tumor size, low-income, academic facility, surgery of primary site, palliative care, and days between diagnosis and treatment, private insurance was associated with an independent decrease in hazard (HR=.874; p<.001). Patients with private insurance received more surgery (67.8%) than those with Medicaid (58.6%), no insurance (54.4%), and Medicare (52.9%) (p<.001). Patients with Medicare received more adjuvant radiation, but patients with private insurance received more adjuvant chemoradiation (p<.001). While patients with Medicare presented with greater co-morbidities and age, patients with private insurance presented with fewer co-morbidities, smaller sized tumors, and shorter time between diagnosis and treatment (p<.001).
CONCLUSIONS
Since patients with private insurance received the most surgery and displayed the highest overall survival, while patients with Medicare displayed the lowest survival, future research should explore ways to alleviate this disparity in surgical resections.
BACKGROUND
The incidence of adenocarcinoma, the most common type of small intestine cancer, is increasing. Prior studies found a 5-year survival of about 25% even with surgical resection and lymph node dissection. A recent study found higher survival in insured versus uninsured patients, yet differential outcomes and treatments between private insurance and Medicare, along with Medicaid and no insurance, are unknown. This study aims to determine differential survival and treatment of patients with small intestine adenocarcinoma based on insurance status.
METHODS
The National Cancer Database was used to identify patients diagnosed with small intestine adenocarcinoma from 2004-2019 using the histology code 8140 as assigned by the Commission on Cancer Accreditation program. Kaplan-Meier, Chi-Square, ANOVA, and Cox Proportional Hazards tests were performed. Data was analyzed using IBM SPSS version 28 and statistical significance was set at α=0.05.
RESULTS
Of the 20,933 patients included, 7,629 (32.4%) had private insurance and 13,075 (55.5%) had Medicare. Patients with private insurance had a longer median survival (28.8 months) than patients with Medicare, Medicaid, and no insurance (p<.001), while patients with Medicare had a shorter median survival (12.2 months) than other insurance statuses (p<.001). No median survival difference existed between those with Medicaid (18.9 months) and no insurance (18.0 months) (p=.882). After controlling for age, co-morbidity score, grade, tumor size, low-income, academic facility, surgery of primary site, palliative care, and days between diagnosis and treatment, private insurance was associated with an independent decrease in hazard (HR=.874; p<.001). Patients with private insurance received more surgery (67.8%) than those with Medicaid (58.6%), no insurance (54.4%), and Medicare (52.9%) (p<.001). Patients with Medicare received more adjuvant radiation, but patients with private insurance received more adjuvant chemoradiation (p<.001). While patients with Medicare presented with greater co-morbidities and age, patients with private insurance presented with fewer co-morbidities, smaller sized tumors, and shorter time between diagnosis and treatment (p<.001).
CONCLUSIONS
Since patients with private insurance received the most surgery and displayed the highest overall survival, while patients with Medicare displayed the lowest survival, future research should explore ways to alleviate this disparity in surgical resections.
BACKGROUND
The incidence of adenocarcinoma, the most common type of small intestine cancer, is increasing. Prior studies found a 5-year survival of about 25% even with surgical resection and lymph node dissection. A recent study found higher survival in insured versus uninsured patients, yet differential outcomes and treatments between private insurance and Medicare, along with Medicaid and no insurance, are unknown. This study aims to determine differential survival and treatment of patients with small intestine adenocarcinoma based on insurance status.
METHODS
The National Cancer Database was used to identify patients diagnosed with small intestine adenocarcinoma from 2004-2019 using the histology code 8140 as assigned by the Commission on Cancer Accreditation program. Kaplan-Meier, Chi-Square, ANOVA, and Cox Proportional Hazards tests were performed. Data was analyzed using IBM SPSS version 28 and statistical significance was set at α=0.05.
RESULTS
Of the 20,933 patients included, 7,629 (32.4%) had private insurance and 13,075 (55.5%) had Medicare. Patients with private insurance had a longer median survival (28.8 months) than patients with Medicare, Medicaid, and no insurance (p<.001), while patients with Medicare had a shorter median survival (12.2 months) than other insurance statuses (p<.001). No median survival difference existed between those with Medicaid (18.9 months) and no insurance (18.0 months) (p=.882). After controlling for age, co-morbidity score, grade, tumor size, low-income, academic facility, surgery of primary site, palliative care, and days between diagnosis and treatment, private insurance was associated with an independent decrease in hazard (HR=.874; p<.001). Patients with private insurance received more surgery (67.8%) than those with Medicaid (58.6%), no insurance (54.4%), and Medicare (52.9%) (p<.001). Patients with Medicare received more adjuvant radiation, but patients with private insurance received more adjuvant chemoradiation (p<.001). While patients with Medicare presented with greater co-morbidities and age, patients with private insurance presented with fewer co-morbidities, smaller sized tumors, and shorter time between diagnosis and treatment (p<.001).
CONCLUSIONS
Since patients with private insurance received the most surgery and displayed the highest overall survival, while patients with Medicare displayed the lowest survival, future research should explore ways to alleviate this disparity in surgical resections.
Survival and Treatment in Older Patients With Ewing Sarcoma
BACKGROUND
Ewing sarcoma (EWS) is a malignancy which primarily arises in adolescence and has been studied extensively in this population. Much less is www.mdedge.com/fedprac/avaho SEPTEMBER 2023 • S23 known about the rare patient cohort over the age of 40 at diagnosis. In this study, we describe the survival outcomes and clinical characteristics of this population.
METHODS
This retrospective cohort study utilized the National Cancer Database (NCDB) to identify 4600 patients diagnosed between 2004 through 2019. Of these patients, 4058 were under the age of 40 and 542 were over 40. Multivariate Cox regression models and Kaplan- Meier curves were used to estimate survival from diagnosis to death between age groups. Chi-square tests were used to compare demographic and socioeconomic patient characteristics. IBM SPSS version 27.0 was used. p<0.05 was used to indicate statistical significance.
RESULTS
EWS patients older than 40 experienced worse survival outcomes compared to patients under the age of 40. 5-year survival was 43.5% for older patients vs. 64.5% for younger patients (p<0.05). A multivariate Cox proportional hazards model showed that age was independently associated with inferior survival. (HR 2.23; p<0.05). EWS patients over the age of 40 were more likely to have tumors originating from the vertebral column (16.2% vs. 9.6%; p<0.05), cranium (5.5% vs. 4.7%; p<0.05), and had a higher rate of axial tumors (43.3% vs. 32.4%; p<0.05) compared to patients under 40. Additionally, patients older than 40 experienced a significantly longer delay between the date of diagnosis and initiation of systemic treatment (29.85 days vs. 19.37 days; p<0.05). Despite presenting with larger tumors , older patients were less likely to undergo a surgical procedure of the primary site (47.6% vs. 52.2%; p<0.05) and had higher rates of micro- and macroscopic residual tumor following surgical resection.
CONCLUSIONS
An age over 40 is associated with decreased survival for patients with EWS. Due to the rarity of EWS in this cohort, the optimal role of systemic treatment remains unknown and has yet to be clearly elucidated. Consequently, our findings suggest that older patients receive disparities in treatment which may be contributing to decreased survival rates.
BACKGROUND
Ewing sarcoma (EWS) is a malignancy which primarily arises in adolescence and has been studied extensively in this population. Much less is www.mdedge.com/fedprac/avaho SEPTEMBER 2023 • S23 known about the rare patient cohort over the age of 40 at diagnosis. In this study, we describe the survival outcomes and clinical characteristics of this population.
METHODS
This retrospective cohort study utilized the National Cancer Database (NCDB) to identify 4600 patients diagnosed between 2004 through 2019. Of these patients, 4058 were under the age of 40 and 542 were over 40. Multivariate Cox regression models and Kaplan- Meier curves were used to estimate survival from diagnosis to death between age groups. Chi-square tests were used to compare demographic and socioeconomic patient characteristics. IBM SPSS version 27.0 was used. p<0.05 was used to indicate statistical significance.
RESULTS
EWS patients older than 40 experienced worse survival outcomes compared to patients under the age of 40. 5-year survival was 43.5% for older patients vs. 64.5% for younger patients (p<0.05). A multivariate Cox proportional hazards model showed that age was independently associated with inferior survival. (HR 2.23; p<0.05). EWS patients over the age of 40 were more likely to have tumors originating from the vertebral column (16.2% vs. 9.6%; p<0.05), cranium (5.5% vs. 4.7%; p<0.05), and had a higher rate of axial tumors (43.3% vs. 32.4%; p<0.05) compared to patients under 40. Additionally, patients older than 40 experienced a significantly longer delay between the date of diagnosis and initiation of systemic treatment (29.85 days vs. 19.37 days; p<0.05). Despite presenting with larger tumors , older patients were less likely to undergo a surgical procedure of the primary site (47.6% vs. 52.2%; p<0.05) and had higher rates of micro- and macroscopic residual tumor following surgical resection.
CONCLUSIONS
An age over 40 is associated with decreased survival for patients with EWS. Due to the rarity of EWS in this cohort, the optimal role of systemic treatment remains unknown and has yet to be clearly elucidated. Consequently, our findings suggest that older patients receive disparities in treatment which may be contributing to decreased survival rates.
BACKGROUND
Ewing sarcoma (EWS) is a malignancy which primarily arises in adolescence and has been studied extensively in this population. Much less is www.mdedge.com/fedprac/avaho SEPTEMBER 2023 • S23 known about the rare patient cohort over the age of 40 at diagnosis. In this study, we describe the survival outcomes and clinical characteristics of this population.
METHODS
This retrospective cohort study utilized the National Cancer Database (NCDB) to identify 4600 patients diagnosed between 2004 through 2019. Of these patients, 4058 were under the age of 40 and 542 were over 40. Multivariate Cox regression models and Kaplan- Meier curves were used to estimate survival from diagnosis to death between age groups. Chi-square tests were used to compare demographic and socioeconomic patient characteristics. IBM SPSS version 27.0 was used. p<0.05 was used to indicate statistical significance.
RESULTS
EWS patients older than 40 experienced worse survival outcomes compared to patients under the age of 40. 5-year survival was 43.5% for older patients vs. 64.5% for younger patients (p<0.05). A multivariate Cox proportional hazards model showed that age was independently associated with inferior survival. (HR 2.23; p<0.05). EWS patients over the age of 40 were more likely to have tumors originating from the vertebral column (16.2% vs. 9.6%; p<0.05), cranium (5.5% vs. 4.7%; p<0.05), and had a higher rate of axial tumors (43.3% vs. 32.4%; p<0.05) compared to patients under 40. Additionally, patients older than 40 experienced a significantly longer delay between the date of diagnosis and initiation of systemic treatment (29.85 days vs. 19.37 days; p<0.05). Despite presenting with larger tumors , older patients were less likely to undergo a surgical procedure of the primary site (47.6% vs. 52.2%; p<0.05) and had higher rates of micro- and macroscopic residual tumor following surgical resection.
CONCLUSIONS
An age over 40 is associated with decreased survival for patients with EWS. Due to the rarity of EWS in this cohort, the optimal role of systemic treatment remains unknown and has yet to be clearly elucidated. Consequently, our findings suggest that older patients receive disparities in treatment which may be contributing to decreased survival rates.
Adherence to Lung Cancer Screening in a Veterans Population Using Centralized and Decentralized Approaches
BACKGROUND
Implementation of lung cancer screening (LCS) in high-risk individuals reduces the risk of dying from lung cancer. The mortality benefit of LCS, however, can only be fully actualized in patients who adhere to follow-up screening examinations. Question: Does a centralized program offer better adherence to lung cancer screening compared with a decentralized approach?
METHODS
A retrospective analysis of a large Veterans Affairs medical center LCS program was conducted to compare adherence to follow-up screening in veterans established through the consult-based (centralized) program with those screened by primary care providers (decentralized). In addition, imaging referral rates from the centralized program were longitudinally reviewed and compared. The cohort included patients completing an LCS imaging examination between 10/2020 and 1/2022. Annual adherence was assessed in patients with a baseline Lung CT Screening Reporting and Data System (Lung-RADS) score of 1 or 2 and was defined as returning for follow-up imaging within 15 months. Outcomes among patients undergoing screening using a centralized and decentralized approach were compared using a two-proportion z-test.
RESULTS
A total of 1,114 patients with a baseline Lung-RADS score of 1 or 2 were included. The amount of low-dose CT (LDCT) imaging ordered for LCS increased exponentially from 2021 to 2023; however, a higher percentage of LDCT examinations were ordered via the decentralized approach, with no significant change observed over time (76%, 71%, and 74% in 2021, 2022, and 2023, respectively). Overall adherence was 42%. Within the centralized program, adherence was 74% compared to 34% using a decentralized approach (p <0.001).
IMPLICATIONS
Adherence to annual screening among eligible veterans is greater within a centralized program. Future research aimed at identifying barriers and maximizing adherence to LCS is needed.
BACKGROUND
Implementation of lung cancer screening (LCS) in high-risk individuals reduces the risk of dying from lung cancer. The mortality benefit of LCS, however, can only be fully actualized in patients who adhere to follow-up screening examinations. Question: Does a centralized program offer better adherence to lung cancer screening compared with a decentralized approach?
METHODS
A retrospective analysis of a large Veterans Affairs medical center LCS program was conducted to compare adherence to follow-up screening in veterans established through the consult-based (centralized) program with those screened by primary care providers (decentralized). In addition, imaging referral rates from the centralized program were longitudinally reviewed and compared. The cohort included patients completing an LCS imaging examination between 10/2020 and 1/2022. Annual adherence was assessed in patients with a baseline Lung CT Screening Reporting and Data System (Lung-RADS) score of 1 or 2 and was defined as returning for follow-up imaging within 15 months. Outcomes among patients undergoing screening using a centralized and decentralized approach were compared using a two-proportion z-test.
RESULTS
A total of 1,114 patients with a baseline Lung-RADS score of 1 or 2 were included. The amount of low-dose CT (LDCT) imaging ordered for LCS increased exponentially from 2021 to 2023; however, a higher percentage of LDCT examinations were ordered via the decentralized approach, with no significant change observed over time (76%, 71%, and 74% in 2021, 2022, and 2023, respectively). Overall adherence was 42%. Within the centralized program, adherence was 74% compared to 34% using a decentralized approach (p <0.001).
IMPLICATIONS
Adherence to annual screening among eligible veterans is greater within a centralized program. Future research aimed at identifying barriers and maximizing adherence to LCS is needed.
BACKGROUND
Implementation of lung cancer screening (LCS) in high-risk individuals reduces the risk of dying from lung cancer. The mortality benefit of LCS, however, can only be fully actualized in patients who adhere to follow-up screening examinations. Question: Does a centralized program offer better adherence to lung cancer screening compared with a decentralized approach?
METHODS
A retrospective analysis of a large Veterans Affairs medical center LCS program was conducted to compare adherence to follow-up screening in veterans established through the consult-based (centralized) program with those screened by primary care providers (decentralized). In addition, imaging referral rates from the centralized program were longitudinally reviewed and compared. The cohort included patients completing an LCS imaging examination between 10/2020 and 1/2022. Annual adherence was assessed in patients with a baseline Lung CT Screening Reporting and Data System (Lung-RADS) score of 1 or 2 and was defined as returning for follow-up imaging within 15 months. Outcomes among patients undergoing screening using a centralized and decentralized approach were compared using a two-proportion z-test.
RESULTS
A total of 1,114 patients with a baseline Lung-RADS score of 1 or 2 were included. The amount of low-dose CT (LDCT) imaging ordered for LCS increased exponentially from 2021 to 2023; however, a higher percentage of LDCT examinations were ordered via the decentralized approach, with no significant change observed over time (76%, 71%, and 74% in 2021, 2022, and 2023, respectively). Overall adherence was 42%. Within the centralized program, adherence was 74% compared to 34% using a decentralized approach (p <0.001).
IMPLICATIONS
Adherence to annual screening among eligible veterans is greater within a centralized program. Future research aimed at identifying barriers and maximizing adherence to LCS is needed.
Disparities Affecting Survival Outcomes of Small Intestine Leiomyosarcoma, an NCDB Analysis
BACKGROUND
Leiomyosarcoma is a rare neoplasm of smooth muscle that can originate from various organ systems. Of the gastrointestinal tract, the rarity and the difficulty of diagnosing small intestine leiomyosarcoma affect its poor prognosis. With an average age of diagnosis of 64 years and a median life expectancy of 45 months, there exists a lack of information on the disparities that exist in these patients and how patient demographics contribute to differences in survival outcomes.
METHODS
We used the National Cancer Database to identify patients diagnosed with small intestine leiomyosarcoma (ICD-O-3 histology code 8890) between 2004-2019 (N=406). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p<0.05.
RESULTS
When analyzing race, patients diagnosed with small intestine leiomyosarcoma were predominantly White (81.8%) and African American (14.3%); however, White patients had statistically worse survival outcomes than African Americans (67 vs 97 months) (p=0.004). Patients with private insurance had statistically better outcomes when compared to Medicare (p<0.001). When compared to White patients, African Americans had a higher proportion of private insurance (53.4% vs 37.2%) and lower proportion of Medicare coverage (5.2% and 48.2%), a lower average age of diagnosis (60.5 vs 64.7 years), shorter travel distances (14.7 vs 31.1 miles) and fewer days between staging procedure and surgical diagnostics from initial diagnosis (4.54 vs 12.5 days). Patients who received surgical intervention had a statistically significant improved survival outcome than those who did not (78 vs 15 months) (p<0.001) with the majority of these procedures being partial gastrectomies (53.6%). More patients of the cohort were treated at comprehensive community cancer programs (36.2%), followed by academic research programs (32.0%), integrated network cancer programs (18.5%) and community cancer programs (8.6%).
CONCLUSIONS
Factors associated with increased survival outcomes include race, average age of diagnosis, travel distance, fewer days between diagnostic procedure and initial diagnosis, insurance status and surgical treatment. These findings make a valuable contribution to the ongoing research on disparities affecting survival in patients with small intestine leiomyosarcoma.
BACKGROUND
Leiomyosarcoma is a rare neoplasm of smooth muscle that can originate from various organ systems. Of the gastrointestinal tract, the rarity and the difficulty of diagnosing small intestine leiomyosarcoma affect its poor prognosis. With an average age of diagnosis of 64 years and a median life expectancy of 45 months, there exists a lack of information on the disparities that exist in these patients and how patient demographics contribute to differences in survival outcomes.
METHODS
We used the National Cancer Database to identify patients diagnosed with small intestine leiomyosarcoma (ICD-O-3 histology code 8890) between 2004-2019 (N=406). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p<0.05.
RESULTS
When analyzing race, patients diagnosed with small intestine leiomyosarcoma were predominantly White (81.8%) and African American (14.3%); however, White patients had statistically worse survival outcomes than African Americans (67 vs 97 months) (p=0.004). Patients with private insurance had statistically better outcomes when compared to Medicare (p<0.001). When compared to White patients, African Americans had a higher proportion of private insurance (53.4% vs 37.2%) and lower proportion of Medicare coverage (5.2% and 48.2%), a lower average age of diagnosis (60.5 vs 64.7 years), shorter travel distances (14.7 vs 31.1 miles) and fewer days between staging procedure and surgical diagnostics from initial diagnosis (4.54 vs 12.5 days). Patients who received surgical intervention had a statistically significant improved survival outcome than those who did not (78 vs 15 months) (p<0.001) with the majority of these procedures being partial gastrectomies (53.6%). More patients of the cohort were treated at comprehensive community cancer programs (36.2%), followed by academic research programs (32.0%), integrated network cancer programs (18.5%) and community cancer programs (8.6%).
CONCLUSIONS
Factors associated with increased survival outcomes include race, average age of diagnosis, travel distance, fewer days between diagnostic procedure and initial diagnosis, insurance status and surgical treatment. These findings make a valuable contribution to the ongoing research on disparities affecting survival in patients with small intestine leiomyosarcoma.
BACKGROUND
Leiomyosarcoma is a rare neoplasm of smooth muscle that can originate from various organ systems. Of the gastrointestinal tract, the rarity and the difficulty of diagnosing small intestine leiomyosarcoma affect its poor prognosis. With an average age of diagnosis of 64 years and a median life expectancy of 45 months, there exists a lack of information on the disparities that exist in these patients and how patient demographics contribute to differences in survival outcomes.
METHODS
We used the National Cancer Database to identify patients diagnosed with small intestine leiomyosarcoma (ICD-O-3 histology code 8890) between 2004-2019 (N=406). General patient characteristics were assessed using descriptive statistics. Survival was evaluated using Kaplan-Meier curves and log-rank tests. Significance was set at p<0.05.
RESULTS
When analyzing race, patients diagnosed with small intestine leiomyosarcoma were predominantly White (81.8%) and African American (14.3%); however, White patients had statistically worse survival outcomes than African Americans (67 vs 97 months) (p=0.004). Patients with private insurance had statistically better outcomes when compared to Medicare (p<0.001). When compared to White patients, African Americans had a higher proportion of private insurance (53.4% vs 37.2%) and lower proportion of Medicare coverage (5.2% and 48.2%), a lower average age of diagnosis (60.5 vs 64.7 years), shorter travel distances (14.7 vs 31.1 miles) and fewer days between staging procedure and surgical diagnostics from initial diagnosis (4.54 vs 12.5 days). Patients who received surgical intervention had a statistically significant improved survival outcome than those who did not (78 vs 15 months) (p<0.001) with the majority of these procedures being partial gastrectomies (53.6%). More patients of the cohort were treated at comprehensive community cancer programs (36.2%), followed by academic research programs (32.0%), integrated network cancer programs (18.5%) and community cancer programs (8.6%).
CONCLUSIONS
Factors associated with increased survival outcomes include race, average age of diagnosis, travel distance, fewer days between diagnostic procedure and initial diagnosis, insurance status and surgical treatment. These findings make a valuable contribution to the ongoing research on disparities affecting survival in patients with small intestine leiomyosarcoma.
Comparison of Intravenous Low Molecular Weight Iron Dextran and Intravenous Iron Sucrose to Treat Iron Deficiency Anemia: A Single Center Experience
PURPOSE
To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.
BACKGROUND
In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.
METHODS
We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.
RESULTS
We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.
CONCLUSIONS
In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.
PURPOSE
To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.
BACKGROUND
In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.
METHODS
We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.
RESULTS
We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.
CONCLUSIONS
In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.
PURPOSE
To evaluate if low molecular weight iron dextran (LMWID) is a safe and effective alternative to iron sucrose for intravenous iron administration.
BACKGROUND
In recent years, intravenous iron administration has increased due to clinical indications and rapid iron repletion. Early IV iron formulations had safety concerns that precluded widespread use. High molecular weight iron dextran was removed from the US market in 2009 due to safety concerns. Since then, several new IV formulations including LMWID and iron sucrose have been approved with a favorable benefit risk profile. While recent evidence and guidelines indicate that LMWID and other iron formulations have comparable safety profiles, no head-to-head comparisons exist. Both iron sucrose and LMWID are used for the treatment of IDA in Veterans Affairs hospitals. Iron sucrose is given 200 mg weekly for 5 weeks, while LMWID is given as a single 1-gram dose over 3 hours. We conducted a retrospective crosssectional analysis to compare the safety and efficacy of IV LMWID to IV iron sucrose.
METHODS
We identified 129 patients (LMWID: n=29, iron sucrose: n=100) who received intravenous iron from 01/01/2022 to 03/03/2023. To match the sample size, we selected every 3rd patient from the iron sucrose group (n=33). We captured data on infusion-related reactions, history of asthma/inflammatory bowel disease/> 2 drug allergies, overall and ≥ 2 g/dL hemoglobin increase, and treatment cost. Descriptive statistics were used to describe the safety and efficacy parameters. An unpaired t-test was used to calculate statistical significance of the cost.
RESULTS
We found that 82.7% of the patients who received LMWID had an increase in hemoglobin vs. 60.6% in the iron sucrose group. 48.3% of patients in LMWID had ≥ 2 hemoglobin increases vs. 27.3% in the iron sucrose group. The cost for LMWID administration was $2016.10, compared to $2315.40 for administration of IV iron sucrose cost. Two-tailed p value < 0.0001 indicating the observed difference to be statistically significant. No infusion reactions were observed in both groups.
CONCLUSIONS
In this single center analysis, IV LMWID administered provided comparable safety, and improved effectiveness, and cost-effectiveness to iron sucrose.
Testing for Associations Between an Environmental Risk Score and Most Significant Colonoscopy Findings Among US Veterans in CSP #380
PURPOSE
To construct a composite score representing modifiable lifestyle and environmental risk (e-score) and test for associations with colonoscopy findings among US Veteran participants of CSP #380.
BACKGROUND
Understanding environmental and genetic risks beyond self-reported family history is a way to develop personalized colorectal cancer (CRC) screening. The Genetics and Epidemiology of Colorectal Cancer Consortium (GECCO) study examined CRC risk stratified by sex and included an e-score along with genetic risk scores, where higher scores indicated higher risk. Both e-scores and genetic risk scores were significantly associated with CRC risk and models that included these were more robust than models that only included family history.
METHODS
CSP #380 is a prospective study of outcomes during colonoscopy screening (1994-97) and follow- up (1994-2009) for 3,121 asymptomatic Veterans aged 50-75. The dichotomous outcome of interest was most significant colonoscopy findings (MSCF) of i) advanced neoplasia (AN: ≥10mm adenomas or advanced histology, or invasive CRC) vs. ii) non-advanced adenomas (<10mm with tubular histology) or no neoplasia. The independent variable, e-score, was weighted according to the GECCO male sample and comprised BMI, height, diabetes, NSAID use, education, alcohol intake, smoking, exercise, and diet.
DATA ANALYSIS
Logistic regression was used to test associations between MSCF and e-scores, controlling for age, family history and number of colonoscopies.
RESULTS
Among 2,846 participants with complete data, 33.3% were aged 50-59 at baseline, 97% were male, and 83.8% were White. Those with AN (n=405, 14.2%) compared to those without AN (n=2,441, 85.8%) had higher median e-scores (29.5, range:0-99.8 vs. 29.0, range:5.2-100), suggesting a difference. The logistic regression models showed older participants (aOR: 1.04, 95% CI: 1.03-1.06) and those with more colonoscopies (aOR: 1.19, 95% CI: 1.06-1.33) had higher odds for AN. However, e-scores and family history were not significantly associated with MCSF.
IMPLICATIONS
E-scores were not significantly associated with MSCF in this preliminary study. Developing escores among a larger, diverse sample (N~381,695) of US veterans in the Million Veterans Program study will allow for stratified models in investigations of environmental and genetic risk for CRC. Outcomes from those analyses will support advances in screening guidelines with tailored programs for long-term CRC prevention.
PURPOSE
To construct a composite score representing modifiable lifestyle and environmental risk (e-score) and test for associations with colonoscopy findings among US Veteran participants of CSP #380.
BACKGROUND
Understanding environmental and genetic risks beyond self-reported family history is a way to develop personalized colorectal cancer (CRC) screening. The Genetics and Epidemiology of Colorectal Cancer Consortium (GECCO) study examined CRC risk stratified by sex and included an e-score along with genetic risk scores, where higher scores indicated higher risk. Both e-scores and genetic risk scores were significantly associated with CRC risk and models that included these were more robust than models that only included family history.
METHODS
CSP #380 is a prospective study of outcomes during colonoscopy screening (1994-97) and follow- up (1994-2009) for 3,121 asymptomatic Veterans aged 50-75. The dichotomous outcome of interest was most significant colonoscopy findings (MSCF) of i) advanced neoplasia (AN: ≥10mm adenomas or advanced histology, or invasive CRC) vs. ii) non-advanced adenomas (<10mm with tubular histology) or no neoplasia. The independent variable, e-score, was weighted according to the GECCO male sample and comprised BMI, height, diabetes, NSAID use, education, alcohol intake, smoking, exercise, and diet.
DATA ANALYSIS
Logistic regression was used to test associations between MSCF and e-scores, controlling for age, family history and number of colonoscopies.
RESULTS
Among 2,846 participants with complete data, 33.3% were aged 50-59 at baseline, 97% were male, and 83.8% were White. Those with AN (n=405, 14.2%) compared to those without AN (n=2,441, 85.8%) had higher median e-scores (29.5, range:0-99.8 vs. 29.0, range:5.2-100), suggesting a difference. The logistic regression models showed older participants (aOR: 1.04, 95% CI: 1.03-1.06) and those with more colonoscopies (aOR: 1.19, 95% CI: 1.06-1.33) had higher odds for AN. However, e-scores and family history were not significantly associated with MCSF.
IMPLICATIONS
E-scores were not significantly associated with MSCF in this preliminary study. Developing escores among a larger, diverse sample (N~381,695) of US veterans in the Million Veterans Program study will allow for stratified models in investigations of environmental and genetic risk for CRC. Outcomes from those analyses will support advances in screening guidelines with tailored programs for long-term CRC prevention.
PURPOSE
To construct a composite score representing modifiable lifestyle and environmental risk (e-score) and test for associations with colonoscopy findings among US Veteran participants of CSP #380.
BACKGROUND
Understanding environmental and genetic risks beyond self-reported family history is a way to develop personalized colorectal cancer (CRC) screening. The Genetics and Epidemiology of Colorectal Cancer Consortium (GECCO) study examined CRC risk stratified by sex and included an e-score along with genetic risk scores, where higher scores indicated higher risk. Both e-scores and genetic risk scores were significantly associated with CRC risk and models that included these were more robust than models that only included family history.
METHODS
CSP #380 is a prospective study of outcomes during colonoscopy screening (1994-97) and follow- up (1994-2009) for 3,121 asymptomatic Veterans aged 50-75. The dichotomous outcome of interest was most significant colonoscopy findings (MSCF) of i) advanced neoplasia (AN: ≥10mm adenomas or advanced histology, or invasive CRC) vs. ii) non-advanced adenomas (<10mm with tubular histology) or no neoplasia. The independent variable, e-score, was weighted according to the GECCO male sample and comprised BMI, height, diabetes, NSAID use, education, alcohol intake, smoking, exercise, and diet.
DATA ANALYSIS
Logistic regression was used to test associations between MSCF and e-scores, controlling for age, family history and number of colonoscopies.
RESULTS
Among 2,846 participants with complete data, 33.3% were aged 50-59 at baseline, 97% were male, and 83.8% were White. Those with AN (n=405, 14.2%) compared to those without AN (n=2,441, 85.8%) had higher median e-scores (29.5, range:0-99.8 vs. 29.0, range:5.2-100), suggesting a difference. The logistic regression models showed older participants (aOR: 1.04, 95% CI: 1.03-1.06) and those with more colonoscopies (aOR: 1.19, 95% CI: 1.06-1.33) had higher odds for AN. However, e-scores and family history were not significantly associated with MCSF.
IMPLICATIONS
E-scores were not significantly associated with MSCF in this preliminary study. Developing escores among a larger, diverse sample (N~381,695) of US veterans in the Million Veterans Program study will allow for stratified models in investigations of environmental and genetic risk for CRC. Outcomes from those analyses will support advances in screening guidelines with tailored programs for long-term CRC prevention.
Assessment of Smoking and Tobacco Use in Newly Diagnosed Veterans With Cancer: Just ASK and Beyond Just ASK: Assisting and Referring
BACKGROUND
Tobacco use is a known factor in oncologic outcomes in Veterans. Lung cancer is not only the leading cause of cancer death in the U.S., but it is also more prevalent among Veterans. Tobacco use is underassessed and undertreated in healthcare settings. Newly diagnosed cancer patients seen at the Day-Treatment Center of Edward Hines Jr. VA Hospital were not consistently screened for tobacco use or appropriately referred to the hospital-based Tobacco Cessation Program.
PURPOSE
This quality improvement project was created to use existing resources to increase the percentage of newly diagnosed cancer patients screened for tobacco use based off the CoC Just ASK Quality Improvement Project and Clinical Study.
METHODS/DATA ANALYSIS
Using Plan-Do-Study- Act (PDSA) quality improvement methodology, a multidisciplinary team led by Oncology Nursing, Oncologists, Pharmacy, Social Work and Behavioral Health, to standardize processes to increase the percentage of tobacco use screening. The primary intervention was designating nurse educators to standardize the cancer treatment education process to include an assessment for tobacco by using the Just ASK criteria. The primary study goal was to increase tobacco use screening from 54.8% (Baseline Data) to 85% (Target State Goal).
RESULTS
Baseline number of tobacco screening in 2021 was 54.8%. From 1/1/22-6/30/22, 52.8% were screened using the Just ASK criteria. After the first PDSA cycle, from 7/1/22-12/31/22, tobacco screenings increased to 95.1%. PDSA cycle two revealed a 25% increase in Q1 accepting referrals. 62.5% of positive tobacco users agreed to accept care compared to 25% in PDSA cycle one.
CONCLUSIONS/IMPLICATIONS
The quality study met the primary goal of screening newly diagnosed cancer patients. The success of this project supported the use of existing VA hospital-based program resources such as educational materials, supportive medication, and behavioral counseling. Interventions directed at standardization of clinical workflow processes through nursing education and linkage to resources increased tobacco screening among newly diagnosed Veterans with cancer. Planned PDSA cycle two will spread standardized processes in the Rad/Onc Department and build capacity to offer smoking cessation assistance to newly diagnosed cancer patients who report as a current smoker. Annual VHA clinical reminders will be built in and satisfied by using an EMR tobacco screen template.
BACKGROUND
Tobacco use is a known factor in oncologic outcomes in Veterans. Lung cancer is not only the leading cause of cancer death in the U.S., but it is also more prevalent among Veterans. Tobacco use is underassessed and undertreated in healthcare settings. Newly diagnosed cancer patients seen at the Day-Treatment Center of Edward Hines Jr. VA Hospital were not consistently screened for tobacco use or appropriately referred to the hospital-based Tobacco Cessation Program.
PURPOSE
This quality improvement project was created to use existing resources to increase the percentage of newly diagnosed cancer patients screened for tobacco use based off the CoC Just ASK Quality Improvement Project and Clinical Study.
METHODS/DATA ANALYSIS
Using Plan-Do-Study- Act (PDSA) quality improvement methodology, a multidisciplinary team led by Oncology Nursing, Oncologists, Pharmacy, Social Work and Behavioral Health, to standardize processes to increase the percentage of tobacco use screening. The primary intervention was designating nurse educators to standardize the cancer treatment education process to include an assessment for tobacco by using the Just ASK criteria. The primary study goal was to increase tobacco use screening from 54.8% (Baseline Data) to 85% (Target State Goal).
RESULTS
Baseline number of tobacco screening in 2021 was 54.8%. From 1/1/22-6/30/22, 52.8% were screened using the Just ASK criteria. After the first PDSA cycle, from 7/1/22-12/31/22, tobacco screenings increased to 95.1%. PDSA cycle two revealed a 25% increase in Q1 accepting referrals. 62.5% of positive tobacco users agreed to accept care compared to 25% in PDSA cycle one.
CONCLUSIONS/IMPLICATIONS
The quality study met the primary goal of screening newly diagnosed cancer patients. The success of this project supported the use of existing VA hospital-based program resources such as educational materials, supportive medication, and behavioral counseling. Interventions directed at standardization of clinical workflow processes through nursing education and linkage to resources increased tobacco screening among newly diagnosed Veterans with cancer. Planned PDSA cycle two will spread standardized processes in the Rad/Onc Department and build capacity to offer smoking cessation assistance to newly diagnosed cancer patients who report as a current smoker. Annual VHA clinical reminders will be built in and satisfied by using an EMR tobacco screen template.
BACKGROUND
Tobacco use is a known factor in oncologic outcomes in Veterans. Lung cancer is not only the leading cause of cancer death in the U.S., but it is also more prevalent among Veterans. Tobacco use is underassessed and undertreated in healthcare settings. Newly diagnosed cancer patients seen at the Day-Treatment Center of Edward Hines Jr. VA Hospital were not consistently screened for tobacco use or appropriately referred to the hospital-based Tobacco Cessation Program.
PURPOSE
This quality improvement project was created to use existing resources to increase the percentage of newly diagnosed cancer patients screened for tobacco use based off the CoC Just ASK Quality Improvement Project and Clinical Study.
METHODS/DATA ANALYSIS
Using Plan-Do-Study- Act (PDSA) quality improvement methodology, a multidisciplinary team led by Oncology Nursing, Oncologists, Pharmacy, Social Work and Behavioral Health, to standardize processes to increase the percentage of tobacco use screening. The primary intervention was designating nurse educators to standardize the cancer treatment education process to include an assessment for tobacco by using the Just ASK criteria. The primary study goal was to increase tobacco use screening from 54.8% (Baseline Data) to 85% (Target State Goal).
RESULTS
Baseline number of tobacco screening in 2021 was 54.8%. From 1/1/22-6/30/22, 52.8% were screened using the Just ASK criteria. After the first PDSA cycle, from 7/1/22-12/31/22, tobacco screenings increased to 95.1%. PDSA cycle two revealed a 25% increase in Q1 accepting referrals. 62.5% of positive tobacco users agreed to accept care compared to 25% in PDSA cycle one.
CONCLUSIONS/IMPLICATIONS
The quality study met the primary goal of screening newly diagnosed cancer patients. The success of this project supported the use of existing VA hospital-based program resources such as educational materials, supportive medication, and behavioral counseling. Interventions directed at standardization of clinical workflow processes through nursing education and linkage to resources increased tobacco screening among newly diagnosed Veterans with cancer. Planned PDSA cycle two will spread standardized processes in the Rad/Onc Department and build capacity to offer smoking cessation assistance to newly diagnosed cancer patients who report as a current smoker. Annual VHA clinical reminders will be built in and satisfied by using an EMR tobacco screen template.
Rasburicase Use and Glucose-6-Phosphate Dehydrogenase Testing
BACKGROUND/PURPOSE
Tumor lysis syndrome (TLS) occurs when malignant cells rapidly break down. This may lead to hyperuricemia, hyperkalemia, hyperphosphatemia, and/or hypocalcemia. Rasburicase reduces uric acid in cancer patients undergoing anti-cancer therapy. However, caution is required as rasburicase is contraindicated for patients with glucose- 6-phosphate dehydrogenase (G6PD) deficiency due to the increased risk of hemolysis. G6PD deficiency is more prevalent among African Americans (AA), affecting approximately 12% of this population. The FDA recommends testing for G6PD deficiency in higher risk groups before administering rasburicase.
METHODS
A retrospective analysis was conducted at the Louis Stokes Cleveland VAMC from February 1, 2018, to January 31, 2023 addressing appropriate use of rasburicase and incidence of G6PD deficiency and hemolysis. Appropriate use was defined by: TLS (2 or more: uric acid ≥ 8 or 25% increase; K+ ≥ 6.0 or 25% increase; Phos > 4.5mg/dL, or 25% increase; or calcium < 7, or 25% decrease, from baseline) or at high risk for TLS (CLL: venetoclax use w/lymph node > 10cm or WBC > 25k and elevated uric acid; AML: WBC > 100k; ALL: WBC > 100k and LDH 2x ULN; Burkitt lymphoma: LDH 2x ULN).
RESULTS
50 patients were identified who received rasburicase. 21/50 (42%) did not meet criteria for appropriate use. 44/50 (88%) underwent G6PD testing. The average time from G6PD testing order to obtaining the results was 3.4 days; 18/50 patients (36%) had G6PD resulted prior to rasburicase administration, and 26 patients (52%) received rasburicase prior to G6PD results. Overall, 13/50 (26%) were AA. Of the AA pts, 12/13 (92%) were tested for G6PD. Of these 12, 1/12 was found to be G6PD deficient and this patient experienced G6PD deficiency-induced hemolysis after rasburicase. None of the non-AA pts (0/31) tested were found to be G6PD deficient.
IMPLICATIONS
There was a high (42%) level of inappropriate use of rasburicase. G6PD deficiency was uncommon and only found in the AA population. To reduce inappropriate use, rasburicase orders will be restricted to medical oncology. G6PD testing will be limited to AA pts, with pathology to develop a rapid turnaround time for results prior to rasburicase administration to prevent hemolysis.
BACKGROUND/PURPOSE
Tumor lysis syndrome (TLS) occurs when malignant cells rapidly break down. This may lead to hyperuricemia, hyperkalemia, hyperphosphatemia, and/or hypocalcemia. Rasburicase reduces uric acid in cancer patients undergoing anti-cancer therapy. However, caution is required as rasburicase is contraindicated for patients with glucose- 6-phosphate dehydrogenase (G6PD) deficiency due to the increased risk of hemolysis. G6PD deficiency is more prevalent among African Americans (AA), affecting approximately 12% of this population. The FDA recommends testing for G6PD deficiency in higher risk groups before administering rasburicase.
METHODS
A retrospective analysis was conducted at the Louis Stokes Cleveland VAMC from February 1, 2018, to January 31, 2023 addressing appropriate use of rasburicase and incidence of G6PD deficiency and hemolysis. Appropriate use was defined by: TLS (2 or more: uric acid ≥ 8 or 25% increase; K+ ≥ 6.0 or 25% increase; Phos > 4.5mg/dL, or 25% increase; or calcium < 7, or 25% decrease, from baseline) or at high risk for TLS (CLL: venetoclax use w/lymph node > 10cm or WBC > 25k and elevated uric acid; AML: WBC > 100k; ALL: WBC > 100k and LDH 2x ULN; Burkitt lymphoma: LDH 2x ULN).
RESULTS
50 patients were identified who received rasburicase. 21/50 (42%) did not meet criteria for appropriate use. 44/50 (88%) underwent G6PD testing. The average time from G6PD testing order to obtaining the results was 3.4 days; 18/50 patients (36%) had G6PD resulted prior to rasburicase administration, and 26 patients (52%) received rasburicase prior to G6PD results. Overall, 13/50 (26%) were AA. Of the AA pts, 12/13 (92%) were tested for G6PD. Of these 12, 1/12 was found to be G6PD deficient and this patient experienced G6PD deficiency-induced hemolysis after rasburicase. None of the non-AA pts (0/31) tested were found to be G6PD deficient.
IMPLICATIONS
There was a high (42%) level of inappropriate use of rasburicase. G6PD deficiency was uncommon and only found in the AA population. To reduce inappropriate use, rasburicase orders will be restricted to medical oncology. G6PD testing will be limited to AA pts, with pathology to develop a rapid turnaround time for results prior to rasburicase administration to prevent hemolysis.
BACKGROUND/PURPOSE
Tumor lysis syndrome (TLS) occurs when malignant cells rapidly break down. This may lead to hyperuricemia, hyperkalemia, hyperphosphatemia, and/or hypocalcemia. Rasburicase reduces uric acid in cancer patients undergoing anti-cancer therapy. However, caution is required as rasburicase is contraindicated for patients with glucose- 6-phosphate dehydrogenase (G6PD) deficiency due to the increased risk of hemolysis. G6PD deficiency is more prevalent among African Americans (AA), affecting approximately 12% of this population. The FDA recommends testing for G6PD deficiency in higher risk groups before administering rasburicase.
METHODS
A retrospective analysis was conducted at the Louis Stokes Cleveland VAMC from February 1, 2018, to January 31, 2023 addressing appropriate use of rasburicase and incidence of G6PD deficiency and hemolysis. Appropriate use was defined by: TLS (2 or more: uric acid ≥ 8 or 25% increase; K+ ≥ 6.0 or 25% increase; Phos > 4.5mg/dL, or 25% increase; or calcium < 7, or 25% decrease, from baseline) or at high risk for TLS (CLL: venetoclax use w/lymph node > 10cm or WBC > 25k and elevated uric acid; AML: WBC > 100k; ALL: WBC > 100k and LDH 2x ULN; Burkitt lymphoma: LDH 2x ULN).
RESULTS
50 patients were identified who received rasburicase. 21/50 (42%) did not meet criteria for appropriate use. 44/50 (88%) underwent G6PD testing. The average time from G6PD testing order to obtaining the results was 3.4 days; 18/50 patients (36%) had G6PD resulted prior to rasburicase administration, and 26 patients (52%) received rasburicase prior to G6PD results. Overall, 13/50 (26%) were AA. Of the AA pts, 12/13 (92%) were tested for G6PD. Of these 12, 1/12 was found to be G6PD deficient and this patient experienced G6PD deficiency-induced hemolysis after rasburicase. None of the non-AA pts (0/31) tested were found to be G6PD deficient.
IMPLICATIONS
There was a high (42%) level of inappropriate use of rasburicase. G6PD deficiency was uncommon and only found in the AA population. To reduce inappropriate use, rasburicase orders will be restricted to medical oncology. G6PD testing will be limited to AA pts, with pathology to develop a rapid turnaround time for results prior to rasburicase administration to prevent hemolysis.