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Table 2 Treatment criteria for the first cycle and subsequent cycles

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

Cycle 1 criteria Subsequent cycles
Absolute neutrophil count ≥ 1500/mcL
Platelets ≥ 100,000/mcL
Hemoglobin ≥ 9 g/dL
Total bilirubin ≤ 1.5 × institutional upper limit of normal
AST (SGOT)/ALT (SGPT) ≤ 2.5 × institutional upper limit of normal
Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min for subjects with creatinine levels above institutional ULN
All toxicities of previous therapy (aside from alopecia) must have resolved to ≤ grade 1
ECOG performance of 0 or 1
No evidence of life-threatening medical problems
Absolute neutrophil count ≥ 500/mcL
Platelets ≥ 50,000/mcL
AST (SGOT)/ALT (SGPT) ≤ 2.5  ×  institutional upper limit of normal
Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min for subjects with creatinine levels above institutional ULN
All toxicities of previous cycles must have resolved to ≤ grade 2
ECOG performance of 0 to 2
No evidence of life-threatening medical problems
  1. ULM upper limit of normal