Name | ∗NC/NA | 1 | 2 | 3 | 4 | 5 | All grades |
---|---|---|---|---|---|---|---|
Neutrophil count decreased | 70% | 6% | 8% | 10% | 6% | 0% | 30% |
White blood cell decreased | 50% | 8% | 24% | 12% | 6% | 0% | 50% |
Anemia | 64% | 20% | 14% | 2% | 0% | 0% | 36% |
Platelet count decreased | 80% | 8% | 10% | 0% | 2% | 0% | 20% |
Anorexia | 76% | 16% | 8% | 0% | 0% | 0% | 24% |
Nausea/Vomiting | 90% | 8% | 2% | 0% | 0% | 0% | 10% |
Diarrhea | 82% | 6% | 2% | 10% | 0% | 0% | 18% |
Abdominal distention | 70% | 22% | 8% | 0% | 0% | 0% | 30% |
Neurotoxicity | 94% | 6% | 0% | 0% | 0% | 0% | 6% |
Venous thrombosis | 98% | 0% | 2% | 0% | 0% | 0% | 2% |
Asthenia | 72% | 18% | 8% | 2% | 0% | 0% | 28% |
Abbreviations: NC/NA, no change, no adverse event.
Treatment-related adverse events in all treated patients (n = 50) are shown in Table 3. At the data cutoff, a total of 129 treatment-related AEs of any grade were reported in 42 (84.0%) patients (Table 3), with the common events being leucopenia (50.0%), anemia (36.0%), neutropenia (30.0%), and abdominal distention (30.0%). Grade 3 or 4 treatment-related AEs occurred in 12 (24.0%) patients and included leucopenia (18.0%), neutropenia (16.0%), and anemia (2.0%). However, most grade 3 or 4 treatment-related AEs were reversible by a dose reduction, interruptions, or supportive care. During the study, all deaths (n = 22) occurred due to disease progression; no deaths were deemed to be related to treatment. No treatment-related AEs led to study discontinuation, while 5 (10.0%) patients discontinued the protocol treatment because of AEs, including renal function abnormal (n = 1), diarrhea (n = 2), appetite decrease (n = 1), and neutropenia (n = 1).