Use of granisetron in patients refractory to previous treatment with antiemetics.

A multicenter, open-label, compassionate-use trial studied the antiemetic efficacy and tolerability of granisetron in patients who had failed other antiemetic therapies in previous cycles of cytostatic chemotherapy. The antiemetics that had been used previously included metoclopramide, dexamethasone and ondansetron. A total of 517 patients, 456 of whom had failed other antiemetics, were treated in up to 15 successive cycles of chemotherapy. The numbers of patients treated in the first six of these cycles were large enough to allow the drawing of meaningful conclusions from the results. During that period, a complete response was achieved in 53-60% of patients. In addition, antiemetic efficacy was sustained throughout these six repeated treatment cycles. Granisetron was less effective against high-dose cisplatin chemotherapy than against other cytostatic regimens. The treatment was well tolerated--the main adverse events reported were headache and constipation; no serious adverse events were considered to be attributable to the drug. It is concluded that granisetron treatment was effective and well tolerated in patients who had previously failed other antiemetic therapies, including treatment with 5-hydroxytryptamine3 antagonists.