Table 2 Dose adaption of study medication
Neuropathy | Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental activities of daily living, ADL) | Reduction of dose level to 1.0 mg/m2 BSA |
Grade 2 with pain or Grade 3 (severe symptoms; limiting self-care ADL) | Suspension of treatment; if resolved, continuation with reduced dose (one dose level below prior treatment dose); if suspension persists for > 2 weeks, study treatment has to be discontinued. | |
Grade 4 (life-threatening consequences; urgent intervention indicated) | Discontinuation of study treatment | |
Bilirubin | > 1.5× upper limit of normal (ULN) | Reduction of dose level to 0.7 mg/m2 BSA; if additional treatment cycle: depending on tolerability increase of dose level to 1.0 mg/m2 BSA or further reduction to 0.5 mg/m2 BSA |
Thrombopenia/neutropenia | Thrombopenia with < 25.000/μl | Suspension of treatment until resolved If suspension persists for > 2 weeks, study treatment has to be discontinued. |
Neutropenia with fever | ||
Neutropenia with < 750/μl |