Granisetron plus or minus alprazolam for emesis prevention in chemotherapyof lymphomas: a randomized multicenter trial

Anxiety can increase the risk of chemotherapy related emesis, We have studi ed the role of a benzodiazepine (alprazolam: A) in addition to granisetron for controlling emesis in patients treated with moderately emetogenic chemo therapy for malignant lymphomas according to an anxiety scale (Covi score). Two hundred twenty-five patients receiving at least 3 cycles of chemothera py including adriamycin and/or cyclophosphamide and/or epirubicin and/or da carbazine were randomized. Patients in arm G (n=111) received 3 mg IV grani setron 10 min before chemotherapy at cycles (C) 1, 2 and 3 while in arm G+A (n=114), alprazolam (A) was added per os 1 mg 1 hour before chemotherapy ( H-l) and 0.5 mg at H+6 for C-1, At C-2 and C-3, A Was given 0.75 or 1.5 mg at H-48, H-24, H-1 and 0.5 mg at H+6. Patient characteristics were comparab le between the 2 arms. Complete response rates (i.e. no emesis or at least slight nausea) were similar in both arms: G: 83, 94 and 93% versus G+A: 89, 93 and 97% in C-1, C-2 and C-3 respectively. Nevertheless, the Covi score of the population was low rendering difficult the study of the factor << an xiety >>. Somnolence was significantly more frequent in the G+A arm (p < 0. 0001).