Repeated use of granisetron in patients receiving cytostatic agents.

BACKGROUND: Granisetron was shown to be a safe and effective antiemetic agent when given with initial cytostatic therapy. This study was undertaken to investigate the efficacy and safety of the continued use of granisetron.
METHODS: Ninety-one patients were given 438 cycles of granisetron during subsequent courses of cytostatic treatment. In 56 patients, 40 micrograms/kg i.v. was given in 159 cycles, and in 42 patients, 3 mg i.v. was given in 279 cycles. In patients having breakthrough symptoms, as many as two rescue doses were given to re-establish control.
RESULTS: Overall objective control of nausea and vomiting was observed in 88.6% of the 40 micrograms/kg-cycles and in 90.32% of the 3-mg cycles. In the 438 cycles given, complete control was achieved in 105 of 159 (66%) of the 40-micrograms/kg cycles and in 217 of 279 (77.78%) of the 3-mg cycles. Thirty-three patients received 97 cycles of cisplatin-based regimens. The objective control rate was 82.47% (80 of 97 cycles) in these patients. The control rate in patients receiving regimens not containing cisplatin was 94.4% (322 of 341 cycles). Rescue doses improved or resolved symptoms in 53 of 61 (86.9%) cycles. No statistically significant difference in nausea and vomiting control was seen between men and women or between the different age groups. The only toxicities encountered were headache in 14 of 438 (3.2%) cycles and mild constipation in 8 of 438 (1.8%) cycles.
CONCLUSION: Granisetron is safe and well tolerated, maintains its antiemetic efficacy after repeated cycles of therapy, and is effective as an interventional treatment for nausea and vomiting.