TY - JOUR
T1 - Granisetron compared with prednisolone plus metopimazine as anti-emetic prophylaxis during multiple cycles of moderately emetogenic chemotherapy
AU - Sigsgaard, T
AU - Herrstedt, J
AU - Andersen, L J
AU - Havsteen, H
AU - Langer, S W
AU - Kjaerbøl, A G
AU - Lund, H
AU - Kjaer, M
AU - Dombernowsky, P
PY - 1999/5
Y1 - 1999/5
N2 - This randomized, double-blind, double-dummy parallel study compared the anti-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D2 antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women with stage I or II breast cancer scheduled to intravenous cyclophosphamide, fluorouracil and methotrexate or cyclophosphamide, epirubicin and fluorouracil every 3 weeks were included. Patients received a single intravenous dose of granisetron 3 mg or a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day. A total of 223 women were enrolled and 218 patients (97.8%) were evaluable for efficacy. Granisetron (n = 109) was superior to prednisolone plus metopimazine (n = 109) in the prophylaxis of acute nausea and vomiting during the first cycle of chemotherapy (P < 0.001) and prednisolone plus metopimazine was superior on days 2-5 (P = 0.002). Overall, granisetron was superior on days 1-5 (P = 0.009). The median number of cycles completed with granisetron was five (95% confidence interval 4-6) compared with two (95% confidence interval 2-2) for prednisolone plus metopimazine (P = 0.0019). Constipation and rash were reported more frequently with granisetron (P < 0.001 and P = 0.043 respectively) and palpitations more frequently with prednisolone plus metopimazine (P = 0.015). In conclusion, the number of cycles completed with granisetron was significantly higher than the number completed with prednisolone plus metopimazine, but the anti-emetic efficacy of both treatments declined during multiple cycles of moderately emetogenic chemotherapy.
AB - This randomized, double-blind, double-dummy parallel study compared the anti-emetic efficacy and tolerability of the serotonin antagonist granisetron with prednisolone plus the dopamine D2 antagonist metopimazine during nine cycles of moderately emetogenic chemotherapy. Chemotherapy naive women with stage I or II breast cancer scheduled to intravenous cyclophosphamide, fluorouracil and methotrexate or cyclophosphamide, epirubicin and fluorouracil every 3 weeks were included. Patients received a single intravenous dose of granisetron 3 mg or a 3-day oral treatment with prednisolone 25 mg once a day plus metopimazine 30 mg four times a day. A total of 223 women were enrolled and 218 patients (97.8%) were evaluable for efficacy. Granisetron (n = 109) was superior to prednisolone plus metopimazine (n = 109) in the prophylaxis of acute nausea and vomiting during the first cycle of chemotherapy (P < 0.001) and prednisolone plus metopimazine was superior on days 2-5 (P = 0.002). Overall, granisetron was superior on days 1-5 (P = 0.009). The median number of cycles completed with granisetron was five (95% confidence interval 4-6) compared with two (95% confidence interval 2-2) for prednisolone plus metopimazine (P = 0.0019). Constipation and rash were reported more frequently with granisetron (P < 0.001 and P = 0.043 respectively) and palpitations more frequently with prednisolone plus metopimazine (P = 0.015). In conclusion, the number of cycles completed with granisetron was significantly higher than the number completed with prednisolone plus metopimazine, but the anti-emetic efficacy of both treatments declined during multiple cycles of moderately emetogenic chemotherapy.
KW - Adult
KW - Aged
KW - Antiemetics/adverse effects
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Breast Neoplasms/complications
KW - Cyclophosphamide/administration & dosage
KW - Dopamine Antagonists/adverse effects
KW - Double-Blind Method
KW - Drug Administration Schedule
KW - Epirubicin/administration & dosage
KW - Female
KW - Fluorouracil/administration & dosage
KW - Glucocorticoids/adverse effects
KW - Granisetron/adverse effects
KW - Humans
KW - Isonipecotic Acids/adverse effects
KW - Methotrexate/administration & dosage
KW - Middle Aged
KW - Nausea/chemically induced
KW - Prednisolone/adverse effects
KW - Serotonin Antagonists/adverse effects
KW - Vomiting/chemically induced
U2 - 10.1038/sj.bjc.6690372
DO - 10.1038/sj.bjc.6690372
M3 - Journal article
C2 - 10408847
SN - 0007-0920
VL - 80
SP - 412
EP - 418
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 3-4
ER -