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Table 1 Criteria for dose suspension or reduction

From: Gemcitabine and docetaxel combination chemotherapy for advanced bone and soft tissue sarcomas: protocol for an open-label, non-randomised, Phase 2 study

Toxicity

Grade

Resumption plan

Neutrophil count (with preventive treatment by G-CSFa)

Grade 4 (lasting for 5 days or more)

Preventive treatment by G-CSF.

Neutrophil count (without preventive treatment by G-CSF)

Grade 4 (lasting for 5 days or more)

Reduced dose of 720 mg/m2 of GEMa and 55mg/m2 of DTXa (first occurrence), then 570 mg/m2 of GEM and 44mg/m2 of DTX (second occurrence).

Diarrhea

Grade 3

Mucositis oral

Grade 3

Infection

Grade 3

Pneumonitis

Grade 1

Grade 2

Discontinue protocol treatment.

Neuropathy

Grade 2

Reduced dose of 720 mg/m2 of GEM and 55mg/m2 of DTX (first occurrence), then 570 mg/m2 of GEM and 44mg/m2 of DTX (second occurrence).

Grade 3

Discontinue protocol treatment.

Creatinine

Grade 2-4

Supraventricular tachycardia

Grade 2 (two times), Grade 3

Atrial arrhythmia

Grade 2 (two times), Grade 3

Left ventriclar contractile dysfunction

Grade 2 (two times), Grade 3

Vertigo/Dizziness

Grade 2-3

Depressed level of consciousness

Grade 2-3

Seizure

Grade 2-3

Leukoencephalopathy

Grade 2-3

Non-hematological toxicity

Grade 4

Any adverse events which occurred with dose of 570 mg/m2 of GEM and 44mg/m2 of DTX.

  1. aG-CSF Granulocyte colony stimulating factor, GEM Gemcitabine, DTX Docetaxel