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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
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Journal of Translational Medicine

ISSN: 1479-5876

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