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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