| . | CTCAE/NCCN Guidelines Definition . | Work-up . | Management . | Therapy . | |
|---|---|---|---|---|---|
| Pancreatic enzymes elevation | Grade 1 | amylase/lipase > ULN−1.5xULN | Assess for signs/symptoms of pancreatitis | If no evidence of pancreatitis continue ICI therapy. Consider other causes. | No treatment If evidence of pancreatitis, manage according to pancreatitis algorithm. |
| Mild Form | amylase/lipase ≥ 3xULN | ||||
| Grade 2 | amylase/lipase > 1.5-2xULN or >2.0–5.0 xULN and asymptomatic; | As Grade 1 and consider abdominal CECT or MRCP | As Grade 1 and evaluate if continue ICI therapy | ||
| Grade 3 | amylase/lipase > 2.0–5.0 xULN with signs or symptoms or >5.0 x ULN and asymptomatic | ||||
| Moderate Form | amylase/lipase > 3.0–5.0xULN | ||||
| Grade 4 | amylase/lipase > 5.0 xULN with signs or symptoms | ||||
| Severe Form | amylase/lipase > 5.0xULN | ||||
| Pancreatitis | Grade 2 | enzyme elevation or radiologic findings only | Assess for signs/symptoms of pancreatitis Provide basic medical support (hospitalization, aggressive fluid resuscitation, pain control) | As Grade 1 of “pancreatic enzymes elevation”. Evaluate gastroenterological counseling. | No treatment |
| Mild Form | at least one among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis | ||||
| Grade 3 | severe pain, vomiting, medical intervention indicated | Hold ICI therapy | Prednisone/Methylprednisolone treatment | ||
| Moderate Form | two or three among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis (i.e., abdominal pain or vomiting) | ||||
| Grade 4 | life-threatening consequences, urgent intervention indicated | Permanently discontinue ICI therapy | Higher doses of prednisone/methylprednisolone treatment | ||
| Severe Form | elevation of amylase/lipase > 3 xULN±radiological findings on CT ± severe clinical findings and hemodynamically unstable | ||||
| . | CTCAE/NCCN Guidelines Definition . | Work-up . | Management . | Therapy . | |
|---|---|---|---|---|---|
| Pancreatic enzymes elevation | Grade 1 | amylase/lipase > ULN−1.5xULN | Assess for signs/symptoms of pancreatitis | If no evidence of pancreatitis continue ICI therapy. Consider other causes. | No treatment If evidence of pancreatitis, manage according to pancreatitis algorithm. |
| Mild Form | amylase/lipase ≥ 3xULN | ||||
| Grade 2 | amylase/lipase > 1.5-2xULN or >2.0–5.0 xULN and asymptomatic; | As Grade 1 and consider abdominal CECT or MRCP | As Grade 1 and evaluate if continue ICI therapy | ||
| Grade 3 | amylase/lipase > 2.0–5.0 xULN with signs or symptoms or >5.0 x ULN and asymptomatic | ||||
| Moderate Form | amylase/lipase > 3.0–5.0xULN | ||||
| Grade 4 | amylase/lipase > 5.0 xULN with signs or symptoms | ||||
| Severe Form | amylase/lipase > 5.0xULN | ||||
| Pancreatitis | Grade 2 | enzyme elevation or radiologic findings only | Assess for signs/symptoms of pancreatitis Provide basic medical support (hospitalization, aggressive fluid resuscitation, pain control) | As Grade 1 of “pancreatic enzymes elevation”. Evaluate gastroenterological counseling. | No treatment |
| Mild Form | at least one among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis | ||||
| Grade 3 | severe pain, vomiting, medical intervention indicated | Hold ICI therapy | Prednisone/Methylprednisolone treatment | ||
| Moderate Form | two or three among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis (i.e., abdominal pain or vomiting) | ||||
| Grade 4 | life-threatening consequences, urgent intervention indicated | Permanently discontinue ICI therapy | Higher doses of prednisone/methylprednisolone treatment | ||
| Severe Form | elevation of amylase/lipase > 3 xULN±radiological findings on CT ± severe clinical findings and hemodynamically unstable | ||||
CTCAE: common terminology criteria for adverse events; NCCN: National Comprehensive Cancer Network; ULN: upper limit of normal.
Grade 1, Grade 2, Grade 3, and Grade 4: according to the last version (version 5) of CTCAE.15
Mild form, moderate form, and severe form: according to NCCN guidelines.23
| . | CTCAE/NCCN Guidelines Definition . | Work-up . | Management . | Therapy . | |
|---|---|---|---|---|---|
| Pancreatic enzymes elevation | Grade 1 | amylase/lipase > ULN−1.5xULN | Assess for signs/symptoms of pancreatitis | If no evidence of pancreatitis continue ICI therapy. Consider other causes. | No treatment If evidence of pancreatitis, manage according to pancreatitis algorithm. |
| Mild Form | amylase/lipase ≥ 3xULN | ||||
| Grade 2 | amylase/lipase > 1.5-2xULN or >2.0–5.0 xULN and asymptomatic; | As Grade 1 and consider abdominal CECT or MRCP | As Grade 1 and evaluate if continue ICI therapy | ||
| Grade 3 | amylase/lipase > 2.0–5.0 xULN with signs or symptoms or >5.0 x ULN and asymptomatic | ||||
| Moderate Form | amylase/lipase > 3.0–5.0xULN | ||||
| Grade 4 | amylase/lipase > 5.0 xULN with signs or symptoms | ||||
| Severe Form | amylase/lipase > 5.0xULN | ||||
| Pancreatitis | Grade 2 | enzyme elevation or radiologic findings only | Assess for signs/symptoms of pancreatitis Provide basic medical support (hospitalization, aggressive fluid resuscitation, pain control) | As Grade 1 of “pancreatic enzymes elevation”. Evaluate gastroenterological counseling. | No treatment |
| Mild Form | at least one among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis | ||||
| Grade 3 | severe pain, vomiting, medical intervention indicated | Hold ICI therapy | Prednisone/Methylprednisolone treatment | ||
| Moderate Form | two or three among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis (i.e., abdominal pain or vomiting) | ||||
| Grade 4 | life-threatening consequences, urgent intervention indicated | Permanently discontinue ICI therapy | Higher doses of prednisone/methylprednisolone treatment | ||
| Severe Form | elevation of amylase/lipase > 3 xULN±radiological findings on CT ± severe clinical findings and hemodynamically unstable | ||||
| . | CTCAE/NCCN Guidelines Definition . | Work-up . | Management . | Therapy . | |
|---|---|---|---|---|---|
| Pancreatic enzymes elevation | Grade 1 | amylase/lipase > ULN−1.5xULN | Assess for signs/symptoms of pancreatitis | If no evidence of pancreatitis continue ICI therapy. Consider other causes. | No treatment If evidence of pancreatitis, manage according to pancreatitis algorithm. |
| Mild Form | amylase/lipase ≥ 3xULN | ||||
| Grade 2 | amylase/lipase > 1.5-2xULN or >2.0–5.0 xULN and asymptomatic; | As Grade 1 and consider abdominal CECT or MRCP | As Grade 1 and evaluate if continue ICI therapy | ||
| Grade 3 | amylase/lipase > 2.0–5.0 xULN with signs or symptoms or >5.0 x ULN and asymptomatic | ||||
| Moderate Form | amylase/lipase > 3.0–5.0xULN | ||||
| Grade 4 | amylase/lipase > 5.0 xULN with signs or symptoms | ||||
| Severe Form | amylase/lipase > 5.0xULN | ||||
| Pancreatitis | Grade 2 | enzyme elevation or radiologic findings only | Assess for signs/symptoms of pancreatitis Provide basic medical support (hospitalization, aggressive fluid resuscitation, pain control) | As Grade 1 of “pancreatic enzymes elevation”. Evaluate gastroenterological counseling. | No treatment |
| Mild Form | at least one among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis | ||||
| Grade 3 | severe pain, vomiting, medical intervention indicated | Hold ICI therapy | Prednisone/Methylprednisolone treatment | ||
| Moderate Form | two or three among elevation of amylase/lipase > 3 xULN±radiological findings on CT ± clinical findings concerning for pancreatitis (i.e., abdominal pain or vomiting) | ||||
| Grade 4 | life-threatening consequences, urgent intervention indicated | Permanently discontinue ICI therapy | Higher doses of prednisone/methylprednisolone treatment | ||
| Severe Form | elevation of amylase/lipase > 3 xULN±radiological findings on CT ± severe clinical findings and hemodynamically unstable | ||||
CTCAE: common terminology criteria for adverse events; NCCN: National Comprehensive Cancer Network; ULN: upper limit of normal.
Grade 1, Grade 2, Grade 3, and Grade 4: according to the last version (version 5) of CTCAE.15
Mild form, moderate form, and severe form: according to NCCN guidelines.23
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