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Corticosteroid use for immune-mediated adverse events often does not match guidelines

FORT WORTH, Texas — An evaluation of physician prescribing practices showed utilization of corticosteroids for management of immune-mediated adverse events among patients with cancer who received immune checkpoint inhibitors often was not based on national guidelines, according to study results presented at HOPA Ahead 2019.

However, Adrian Tsui, PharmD, PGY2 oncology pharmacy resident at Allegheny General Hospital, and colleagues reported a high rate of immune-mediated adverse event symptom resolution, and a number of patients re-initiated therapy with immune checkpoint inhibitors.

Immune checkpoint inhibitors have become a key component of cancer treatment. ASCO and National Comprehensive Cancer Network recently issued guidelines for management of immune-mediated adverse events can occur. Before that, however, management recommendations were guided by clinical trial protocols, which vary for each immune checkpoint inhibitor and could create discrepancies between recommendations and clinical practice, according to study background.

Tsui and colleagues conducted a retrospective chart review to evaluate physician prescribing practices for immune-mediated adverse event management within their hospital health network. They also compared prescribing practices with guideline recommendations, and they evaluated incidence of symptom resolution, incidence of immune checkpoint inhibitor re-initiation and immune-mediated adverse event recurrence upon treatment re-initiation.

The analysis included 81 adults (median age, 62.4 years; range, 29-73) with cancer who had a documented immune-mediated adverse event secondary to immune checkpoint inhibitor therapy and received corticosteroids between February 2016 and July 2018. The most common malignancies were melanoma (33%), non-small cell lung cancer (23%) and renal cell carcinoma (19%).

Immune-mediated adverse events occurred after a median 11 treatment cycles (range, 1-62).

The most common immune-mediated adverse events were colitis (28%), pneumonitis (27%), skin reactions (12%), hepatitis (10%) and nephritis (7%).

Median starting corticosteroid dose was 0.76 mg/kg daily (range, 0.04-1.5).

Researchers reported 100% resolution rates for patients who developed colitis (median time to resolution, 25 days; range, 4-91), skin reactions (median time to resolution, 10 days; range, 2-20) and nephritis (median time to resolution, 11 days, range, 11-16). They reported resolution rates of 96% for those who developed pneumonitis (median time to resolution, 10 days; range, 4-42) and 88% for those who developed hepatitis (median time to resolution, 21 days; range, 6-50).

“The big problem that we saw was physicians were not starting patients on a high-dose steroid — 1 mg/kg — when they identified an adverse event,” Tsui told HemOnc Today. “However, we saw a good number of patients have resolution of their adverse event despite not aggressively starting steroid treatment on the appropriate dose.”

Overall guideline-recommended management occurred in 38% of cases. Reasons for guideline-discordant management included use of a condensed steroid taper (74%), inappropriate starting dose for immune-mediated adverse event severity (64%) and initiation of steroid taper prior to the adverse event reaching grade 1 or lower (38%).

Rates of immune checkpoint inhibitor re-initiation were 57% of patients who developed colitis, 38% of those who developed pneumonitis, 80% of those who had skin reactions, 29% of those who developed hepatitis and 83% of those who had nephritis.

Adverse event recurrence after re-initiation were 54% for those who had colitis, 25% for those who had pneumonitis, 25% for those who had skin reactions, 50% for those who had hepatitis and 60% for those who had nephritis.

“We did see a number of patients develop recurrence, and that may have been attributed to the condensed taper or not using the appropriate starting dose of steroid therapy,” Tsui told HemOnc Today. “Moving forward, it may be important to have a protocol across the system for these patients and to educate physicians about overall management of adverse events.” – by Mark Leiser

 

Reference: Tsui A, et al. Evaluation of the use of corticosteroids for management of immune-mediated adverse events in cancer patients who received immune checkpoint inhibitors. Presented at: HOPA Ahead 2019; April 3-6, 2019; Fort Worth, Texas.

 

Disclosures: The authors report no relevant financial disclosures.

FORT WORTH, Texas — An evaluation of physician prescribing practices showed utilization of corticosteroids for management of immune-mediated adverse events among patients with cancer who received immune checkpoint inhibitors often was not based on national guidelines, according to study results presented at HOPA Ahead 2019.

However, Adrian Tsui, PharmD, PGY2 oncology pharmacy resident at Allegheny General Hospital, and colleagues reported a high rate of immune-mediated adverse event symptom resolution, and a number of patients re-initiated therapy with immune checkpoint inhibitors.

Immune checkpoint inhibitors have become a key component of cancer treatment. ASCO and National Comprehensive Cancer Network recently issued guidelines for management of immune-mediated adverse events can occur. Before that, however, management recommendations were guided by clinical trial protocols, which vary for each immune checkpoint inhibitor and could create discrepancies between recommendations and clinical practice, according to study background.

Tsui and colleagues conducted a retrospective chart review to evaluate physician prescribing practices for immune-mediated adverse event management within their hospital health network. They also compared prescribing practices with guideline recommendations, and they evaluated incidence of symptom resolution, incidence of immune checkpoint inhibitor re-initiation and immune-mediated adverse event recurrence upon treatment re-initiation.

The analysis included 81 adults (median age, 62.4 years; range, 29-73) with cancer who had a documented immune-mediated adverse event secondary to immune checkpoint inhibitor therapy and received corticosteroids between February 2016 and July 2018. The most common malignancies were melanoma (33%), non-small cell lung cancer (23%) and renal cell carcinoma (19%).

Immune-mediated adverse events occurred after a median 11 treatment cycles (range, 1-62).

The most common immune-mediated adverse events were colitis (28%), pneumonitis (27%), skin reactions (12%), hepatitis (10%) and nephritis (7%).

Median starting corticosteroid dose was 0.76 mg/kg daily (range, 0.04-1.5).

Researchers reported 100% resolution rates for patients who developed colitis (median time to resolution, 25 days; range, 4-91), skin reactions (median time to resolution, 10 days; range, 2-20) and nephritis (median time to resolution, 11 days, range, 11-16). They reported resolution rates of 96% for those who developed pneumonitis (median time to resolution, 10 days; range, 4-42) and 88% for those who developed hepatitis (median time to resolution, 21 days; range, 6-50).

“The big problem that we saw was physicians were not starting patients on a high-dose steroid — 1 mg/kg — when they identified an adverse event,” Tsui told HemOnc Today. “However, we saw a good number of patients have resolution of their adverse event despite not aggressively starting steroid treatment on the appropriate dose.”

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Overall guideline-recommended management occurred in 38% of cases. Reasons for guideline-discordant management included use of a condensed steroid taper (74%), inappropriate starting dose for immune-mediated adverse event severity (64%) and initiation of steroid taper prior to the adverse event reaching grade 1 or lower (38%).

Rates of immune checkpoint inhibitor re-initiation were 57% of patients who developed colitis, 38% of those who developed pneumonitis, 80% of those who had skin reactions, 29% of those who developed hepatitis and 83% of those who had nephritis.

Adverse event recurrence after re-initiation were 54% for those who had colitis, 25% for those who had pneumonitis, 25% for those who had skin reactions, 50% for those who had hepatitis and 60% for those who had nephritis.

“We did see a number of patients develop recurrence, and that may have been attributed to the condensed taper or not using the appropriate starting dose of steroid therapy,” Tsui told HemOnc Today. “Moving forward, it may be important to have a protocol across the system for these patients and to educate physicians about overall management of adverse events.” – by Mark Leiser

 

Reference: Tsui A, et al. Evaluation of the use of corticosteroids for management of immune-mediated adverse events in cancer patients who received immune checkpoint inhibitors. Presented at: HOPA Ahead 2019; April 3-6, 2019; Fort Worth, Texas.

 

Disclosures: The authors report no relevant financial disclosures.

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