Toxicity
neutropenia, intestinal obstruction, fatigue, toxicity, anemia, dehydration, vomiting, small, nausea,, Toxicity, deaths, TEAE, hypokalemia
PULMONARY EMBOLISM, NEUTROPENIA, THROMBOCYTOPENIA, ANEMIA, DEHYDRATION, ADVERSE EVENT, URINARY TRACT INFECTION
Safety profiles consistent with those observed in prior clinical studies with GC. There were no deaths on study or within 60 days of the last dose of study drug. In the sensitive study 12 patients (29%) experienced a serious treatment fmergent adverse event (SAEs), and the most common were neutropenia and thrombocytopenia, 5 (12%) SAEs were considered related to study drug (thrombocytopenia (2 pts), neutropenia, urinary tract infection, and pulmonary embolism). In the resistant study 22 patients (49%) experienced a SAE and in 9 patients (26%) the SAEs were considered related to study drug (thrombocytopenia (2 pts), anemia, nausea, vomiting, small intestinal obstruction, fatigue, dehydration, and hypokalemia), and in 4 (9%) this lead to discontinuation of treatment. Toxicity is shown in Toxicity.Toxicity, TEAE (treatment emergent adverse event) occurring in 15%.Dose reductions or delays due to an AE were common and almost all due to hematologic toxicity (89% for platinum sensitive and 91% for platinum resistant). Dose reductions and delays 81% and 32%, respectively, for platinum sensitive; 85% and 27% for platinum resistant patients. The majority of patients in the platinum sensitive group received >6 cycles: 22 (54%) of the patients received 7-12 cycles, two (5%) 10-18 cycles, and one >18 cycles of therapy. Thirty of the platinum sensitive patients (73%) received G-CSF whereas this was only required in 27% of the platinum resistant patients.