The most common adverse events of any grade (>25% in either group) were alopecia (62·8% [187 of 298] in the intravenous group vs 62·6% [186 of 297] in the subcutaneous group), nausea (48·7% [145 of 298] vs 48·5% [144 of 297]), neutropenia (46·3% [138 of 298] vs 44·1% [131 of 297]), diarrhoea (36·6% [109 of 298] vs 33·7% [100 of 297]), asthenia (25·2% [75 of 298] vs 24·6% [73 of 297]), and fatigue (26·5% [79 of 298] vs 22·6% [67 of 297]). The same proportion of patients (52%) in each group had a severe adverse event ( [Table 4] , [Table 5] ). There were numerically more grade 3 and grade 4 adverse events in the intravenous group than in the subcutaneous group (table 5). The pattern of severe adverse events was comparable between study groups (table 6). Most grade 3 or worse adverse events were haematological toxic effects, followed by gastrointestinal disorders (table 6). The most common severe adverse events were neutropenia, leucopenia, and febrile neutropenia (table 6).
...
No infection was associated with a subcutaneous trastuzumab injection site. Overall, the type of serious adverse event reported was in line with what would be expected of the investigated trial population and study treatment. Four adverse events led to death (one [<1%] of 298 in the intravenous group vs three [1%] of 297 in the subcutaneous group), all of which occurred during the neoadjuvant phase of the study. In the intravenous group, a 66-year-old obese patient with a history of pulmonary fibrosis experienced fatal acute pneumonia. In the subcutaneous group, one 59-year-old obese patient with a history of hypertension and hyperuricaemia died of a myocardial infarction 8 days after the first study drug; one 71-year-old overweight patient with hypertension and diabetes experienced sudden death; and one 77-year-old patient with prior grade 2 and 3 anaemia developed grade 4 febrile neutropenia and thrombocytopenia, leading to fatal septic shock. Two of the deaths in the subcutaneous group—those from septic shock and myocardial infarction—were judged to be treatment related by the investigator.
F Hoffmann-La Roche.
Copyright © 2012 Elsevier Ltd. All rights reserved.
http://www.ncbi.nlm.nih.gov/pubmed/22884505
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