Granisetron Plus or Minus Alprazolam for Emesis Prevention in Chemotherapy of Lymphomas: A Randomized Multicenter Trial

Abstract

Anxiety can increase the risk of chemotherapy related emesis. We have studied the role of a benzodiazepine (alprazolam: A) in addition to granisetron for controlling emesis in patients treated with moderately emetogenic chemotherapy for malignant lymphomas according to an anxiety scale (Covi score). Two hundred twenty-five patients receiving at least 3 cycles of chemotherapy including adriamycin and/or cyclophosphamide and/or epirubicin andlor dacarbazine were randomized. Patients in arm G (n=111) received 3 mg IV granisetron 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-1) and 0.5 mg at H+6 for C₁. At C₂ and C₃, 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 comparable 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 C₁, C₂ and C₃ respectively. Nevertheless, the Covi score of the population was low rendering difficult the study of the factor anxiety. Somnolence was significantly more frequent in the G+A arm (p < 0.0001).

Key Words:

• 5 HT₃ receptor antagonist
• granisetron
• antiemetics
• chemotherapy induced emesis
• lymphomas