title: Granisetron plus or minus alprazolam for emesis prevention in chemotherapy of lymphomas: a randomized multicenter trial. Granisetron Trialists Group.
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 and/or dacarbazine were randomized. Patients in arm G (n = 111) received 3 mg i.v. 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. Patients 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).
authors.affiliation: Service des Maladies du Sang et Chimiothérapie, Centre Hospitalier de la Côte Basque, Bayonne, France.
authors.forename: F
authors.initials: F
authors.lastname: Bauduer
authors.forename: B
authors.initials: B
authors.lastname: Coiffier
authors.forename: B
authors.initials: B
authors.lastname: Desablens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000525:Alprazolam / Q000627:therapeutic use*; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D003520:Cyclophosphamide / Q000627:therapeutic use; D003606:Dacarbazine / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D015251:Epirubicin / Q000627:therapeutic use; D005260:Female; D017829:Granisetron / Q000627:therapeutic use*; D006801:Humans; D008223:Lymphoma / Q000150:complications* / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000627:therapeutic use; D014839:Vomiting / Q000150:complications / Q000517:prevention & control*
chemical_list: D000525:Alprazolam; D014151:Anti-Anxiety Agents; D000932:Antiemetics; D000970:Antineoplastic Agents; D003520:Cyclophosphamide; D003606:Dacarbazine; D004317:Doxorubicin; D015251:Epirubicin; D017829:Granisetron; D011241:Prednisone