PERSISTENCE OF EFFICACY OF 3 ANTIEMETIC REGIMENS AND PROGNOSTIC FACTORS IN PATIENTS UNDERGOING MODERATELY EMETOGENIC CHEMOTHERAPY

Purpose: To evaluate antiemetic efficacy and tolerability of granisetr on, dexamethasone, and their combination over repeated courses of mode rately emetogenic chemotherapy, and the influence of the prognostic fa ctors on occurrence of nausea and vomiting. Patients and Methods: Four hundred twenty-eight consecutive cancer patients were entered onto mu lticenter, randomized, double-blind study to compare granisetron 3 mg intravenously, dexamethasone 8 mg intravenously, and 4 mg orally every 6 hours for four doses, or the combination of dexamethasone plus gran isetron al the same doses, administered for three consecutive cycles. Occurrence of nausea, retching, and vomiting was monitored for 24 hour s after chemotherapy administration by a diary card. Results: Three hu ndred ninety-eight patients were assessable for clinical efficacy at t he first cyle, 354 were assessable at the second cycle, and 322 were a ssessable at the third cycle of chemotherapy. Dexamethasone plus grani setron induced significantly greater complete protection from vomiting , nausea, and both nausea and vomiting than granisetron alone in all t hree cycles. With respect to dexamethasone alone, complete protection from vomiting was significantly greater at the first and second cycle, and complete protection from nausea and from both nausea and vomiting only at the first cycle. Complete protection did not differ significa ntly among the three cycles in patients receiving dexamethasone plus g ranisetron or dexamethasone alone, whereas it decreased significantly, at least for vomiting, in patients receiving granisetron alone. Prote ction obtained in the previous cycle of chemotherapy wets the most imp ortant prognostic factor in the occurrence of nausea and vomiting. Con clusion: The combination of dexamethasone plus granisetron offers the best antiemetic protection because of its greater efficacy with respec t to the other two regimens at first cycle, and because its activity i s maintained in the subsequent cycles of chemotherapy. (C) 1995 by Ame rican Society of Clinical Oncology.