Table 1.

Criteria for dose reduction and discontinuation, with action plans and reduced dose level

Criteria	Action	Dose reduction
ANC <500/μL PLT <50 000/μL ECOG PS ≥2§ Grade 3 non‐hematological toxicity§	Withhold PEG IFN‐α‐2b. When all criteria below are met, resume treatment reducing the dose: ANC ≥500/μL PLT ≥50 000/μL ECOG PS 0–1 Non‐hematological toxicity resolves to grade 1 or baseline.	Induction phase (weeks 1–8) 6 μg/kg per week	First reduction: 3 μg/kg per week Second reduction: 2 μg/kg per week Third reduction: 1 μg/kg per week Discontinue if did not tolerate at 1 μg/kg per week
		Maintenance phase (weeks 9–260) 3 μg/kg per week†	First reduction: 2 μg/kg per week Second reduction: 1 μg/kg per week Discontinue if did not tolerate at 1 μg/kg per week
Grade 4 non‐hematological toxicity Not tolerated at 1 μg/kg per week. New retinopathy	Discontinue PEG IFN‐α‐2b.

^§Except transient ECOG PS ≥2 and the following grade 3 events: (i) influenza‐like symptoms such as fever, chill, myalgia, arthralgia, fatigue or headache; (ii) manageable toxicity by adequate supportive care or non‐prohibited therapies (e.g. nausea, vomiting); and (iii) laboratory events that may have no clinical significance (e.g. transient decreased lymphocyte, transient electrolytes abnormality, increased liver γ‐glutamyltransferase or alkaline phosphatase). ^†If the dose was reduced to ≤3 μg/kg per week in the induction phase, the following maintenance phase started with the last dose in the induction. ANC, absolute neutrophil count; ECOG PS, Eastern Cooperative Oncology Group Performance Status; PEG IFN, pegylated interferon; PLT, platelet count.