The authors retrospectively studied the incidence and severity of adverse events in 16 in-patients with locally advanced and/ or metastatic transitional cell carcinoma of the urothelium who had received GC [gemcitabine (1000 mg/m2) on day 1, 8, and 15 and cisplatin (70 mg/m2) on day 2 of every 28-day cycle] chemotherapy at Iwate Prefectural ISAWA Hospital.
Regarding hematotoxicity, the most common causes for postponement and dose adjustment on day 8 and 15 were leucopenia, neutropenia, and thrombocytopenia. The percentages of postponed administration and the average number of days of postponement were 31.3% and 14.8 days for day 8 and 36.4% and 6.5 days for day 15 during the first course. Rates for dosage reduction during the second course and the third course were 28.6% and 8.3% for GEM and 21.4% and 8.3% for CDDP. Very few of the patients were able to receive the chemotherapy on an outpatient basis on day 8 (7.1%) or 15 (14.3%). For patients with hematopenia, a positive correlation was observed between pre-treatment nadir levels and the lowest nadir levels.
Regarding non-hematotoxicity, the frequencies of the subjective symptoms of anorexia (75.0%), nausea (43.8%), diarrhea (37.5%), and constipation (25.0%) of Grade 1 or 2 as defined in Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v.4.0) were high during the first course. Frequencies of abnormal liver and renal function were also relatively high.
These results suggest that the adverse events for this GC chemotherapy regimen are not mild by any means, and great caution should be exercised to monitor for hematotoxicity and non - hematotoxicity that may occur during it.
