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Table 3 Toxicity and treatment holds

From: A phase 2 study of combined chemo-immunotherapy with cisplatin-pembrolizumab and radiation for unresectable vulvar squamous cell carcinoma

 

Management/next dose for cisplatin

Management/next dose for pembrolizumab

Nausea/vomiting

 ≤ Grade 1

No change in dose

No change in dose

 Grade 2

No change in dose

No change in dose

 Grade 3

Holda until < Grade 2. Resume at one dose level lower, if indicated.

No change in doseb,c

 Grade 4

Holda until < Grade 2. Resume at two dose levels lower.

No change in doseb,c

Diarrhea

 ≤ Grade 1

No change in dose

No change in dose

 Grade 2

No change in dose

No change in dose

 Grade 3

Holda until < Grade 2. Resume at one dose level lower, if indicated

No change in doseb,c

 Grade 4

Holda until < Grade 2. Resume at two dose levels lower

No change in doseb,c

Neutropenia

 ≤ Grade 1

No change in dose

No change in dose

 Grade 2

No change in dose

No change in dose

 Grade 3

No change in dose

No change in dose

 Grade 4

Holdd until < Grade 3. Resume at current dose.

Hold until ≤ Grade 2

Thrombocytopenia

 ≤ Grade 1

No change in dose

No change in dose

 Grade 2

No change in dose

No change in dose

 Grade 3

Holdd until < Grade 2. Resume at same dose level

No change in dose

 Grade 4

Holdd until < Grade 2. Resume at same dose level

Hold until ≤ Grade 2

  1. aParticipants requiring a delay of > 2 weeks should go off protocol therapy
  2. bPlease see pembrolizumab adverse event management in Table 4
  3. cAs long as AE is unrelated to Pembrolizumab
  4. dParticipants requiring a delay of > 4 weeks should go off protocol therapy