Safety
death, neutropenia, leukopenia, peripheral sensory neuropathy, nab‐paclitaxel, pneumothorax, ILD, anemia, anorexia
NEUTROPENIA, LEUKOPENIA, PERIPHERAL SENSORY NEUROPATHY, ADVERSE EVENTS, PNEUMOTHORAX, LUNG INFECTION, ANEMIA, HYPERGLYCEMIA, HYPERURICEMIA, TUMOR PROGRESSION, INTERSTITIAL PNEUMONITIS, INTERSTITIAL LUNG DISEASE, ADVERSE DRUG REACTIONS, ANOREXIA
AEs occurred in 87.5% (35/40) of subjects in group A and 80.5% (33/41) in group B. Grade 3 or worse AEs occurred in 57.5% of patients (23 out of 40) in group A and 41.5% of patients (17 out of 41) in group B. Serious side effects developed in 10.0% of patients (4 out of 40) in group A and 4.9% of patients (2 out of 41) in group B (Table Treatment‐related adverse events.
Grade 5 nab‐paclitaxel induced interstitial pneumonitis.Among the AEs that occurred in 10 or more patients in group A were leukopenia in 17 patients (42.5%), neutropenia in 22 patients (55.0%), anemia in 13 patients (32.5%), and anorexia in 10 patients (25.0%). In group B, there was occurrence of leukopenia in 14 patients (34.1%), neutropenia in 11 patients (26.8%), and anemia in 10 patients (24.4%). All grades of peripheral sensory neuropathy occurred in 4 patients (10.0%) in group A and 6 patients (14.6%) in group B. These AEs were considered adverse drug reactions.Serious AEs such as discontinuation of treatment occurred in 10.0% of patients (4 out of 40) in group A and 4.9% (2 out of 41) in group B. In group A, anemia, lung infection, hyperglycemia, and pneumothorax occurred in each of the 4 patients. In group B, interstitial lung disease (ILD) occurred in 2 patients. However, it was difficult to conclude that lung infection, hyperglycemia, and pneumothorax were treatment‐related adverse events. AEs leading to death occurred in 2.5% of patients (1 out of 40) in group A and 2.4% of patients (1 out of 41) in group B. The reason for the death of the group A patient was poor general condition with hyperuricemia, and suspicion of tumor progression. On the contrary, the death in group B was due to severe drug induced ILD.