Gordon S

Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

Background: Nivolumab (Opdivo) was initially FDAapproved at a dose of 3mg/kg by intravenous infusion over 60 minutes every 2 weeks. In September 2016, nivolumab’s FDA approved dosing was changed from 3mg/kg to a 240mg flat dose. In January 2018, nivolumab’s FDA approved dosing was updated to reflect a decreased infusion time of 30 minutes. In March 2018, nivolumab’s FDA approved dosing was again modified from 240mg every 2 weeks to 480mg every 4 weeks. The VA Northeast Ohio Healthcare System (VANEOHS) adopted the 480mg every 4 weeks regimen in March 2018. The increased nivolumab dose and shortened infusion time raised some concern regarding immune-mediated toxicities which was the rationale behind this medication use evaluation (MUE).

Methods: This retrospective chart review was completed to compare the incidence of toxicity between the every 2 week and the every 4 week dosing schedules and evaluate the adoption of every 4 week dosing regimen by VANEOHS prescribers. Patients newly initiated on nivolumab between 10/1/17 and 9/30/18 were reviewed for the occurrence of immune-mediated adverse events (AEs) within the first 3 months of treatment.

Results: Sixty-five patients were included in the MUE, with 21 (46%) initiated on 240mg every 2 weeks and 25 (54%) initiated on 480mg every 4 weeks. All patients initiated on 240mg every 2 weeks were either converted to 480mg every 4 weeks, or nivolumab therapy was discontinued prior to VANEOHS adoption of the 4 week dosing regimen. Immune-mediated AEs potentially related to nivolumab therapy were documented in 8 (32%) patients receiving 480mg, and 4 (36%) patients receiving 240mg. Of patients who switched from nivolumab 240mg to 480mg, 3 (30%) experienced an AE while receiving 240mg, and 1 (10%) while receiving 480mg.

Conclusion: The nivolumab 480mg every 4 week dosing regimen was readily adopted by oncology providers at VANEOHS and the rate of patients experiencing AEs with nivolumab 480mg every 4 weeks compared to 240mg every 2 weeks, was similar between treatment groups. The results of this MUE support continued prescribing of the nivolumab 480mg every 4 week dosing regimen with close monitoring for adverse reactions.

Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).

Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.

Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.

Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.

Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.

Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).

Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.

Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.

Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.

Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.

Purpose: The purpose of this study is to evaluate the use and dosing strategies of programmed death protein (PD-1) inhibitors and selected immune-mediated adverse effects within the Veteran’s Health Administration (VHA).

Background: The PD-1 inhibitors, nivolumab and pembrolizumab, are two agents used in the treatment of a number of solid tumors. Their dosing varied in clinical trials supporting a change in FDA approved labeling from weight-based to standardized dosing. While these agents have demonstrated efficacy, immune-mediated adverse-effects (IrAEs) have been associated with their use.

Methods: This is a retrospective review of veterans receiving nivolumab or pembrolizumab for the treatment of solid tumors within the VHA between January 2015 and July 2017. Data were collected from the VA Corporate Data Warehouse through the VA Informatics and Computing Infrastructure. The dosing strategy for PD-1 inhibitor was categorized into weight-based versus fixeddosing, where possible, and used to identify actual and potential cost-savings opportunities. The incidence of prespecified IrAEs thyroid dysfunction, pneumonitis, and colitis, was quantified and their management was described. Descriptive statistics will be used for the primary and secondary outcomes.

Results: Nivolumab was the primary PD-1 inhibitor utilized for solid tumor treatment. Both nivolumab and pembrolizumab were primarily dosed based on patient weight. For nivolumab orders there was a total of $8,514,300 estimated actual cost savings with $5,591,250 estimated remaining cost-savings potential identified. Of patients who received nivolumab, 514 (15.8%) developed primary hypothyroidism and 299 (9.2%) developed primary hyperthyroidism. At our local institution, one (1.7%) patient developed pneumonitis and one (1.7%) patient developed colitis which was determined to be related to nivolumab therapy.

Conclusions: Nivolumab was the primary PD-1 inhibitor used, with the primary dosing strategy being weightbased. Pembrolizumab dosing was primarily fixed dosing, which may be due to the available vial size(s). There were substantial actual and potential cost-savings opportunities identified. The incidence of the prespecified IrAEs was similar to the incidence currently available in published literature. This supports the recommendation for continued thyroid laboratory monitoring and recognition of signs and symptoms of IrAEs by all health care providers.