A randomized, double-blind, cross-over study comparing a levosulpiride-based and a metoclopramide-based combination in the prevention of ProMECE-CytaBOM-induced emesis.
BACKGROUND
To test two different antiemetic regimens for preventing nausea and vomiting in patient with non-Hodgkin's lymphoma (NHL) undergoing systemic chemotherapy (CT) with ProMECE-CytaBOM (P-C).


METHODS
Twenty consecutive untreated adult outpatients with histologically confirmed NHL and scheduled to receive P-C chemotherapy were registered in a randomized, double-blind, cross-over study to compare the antiemetic efficacy of a levosulpiride (LS)-based and metoclopramide (MTC)-based regimen.


RESULTS
Complete protection from vomiting was recorded in 93% (62/67) of courses with the LS-regimen and in 89% (62/70) with the MTC-regimen (p = 0.428). No nausea was observed in 84% (56/67) of courses with the LS-regimen and in 74% (52/70) with the MTC-regimen (p = 0.183). No differences in prevention of emesis were recorded when patients crossed to the other regimen. Both regimens were well tolerated; however, on day 8 of chemotherapy, when both antiemetic regimens were administered at a higher dose, the LS-based combination showed significantly lower toxicity (p = 0.035).


CONCLUSIONS
ProMECE-CytaBOM-induced emesis can be prevented in most cases with appropriate, specifically designed antiemetic therapy. Both the LS- and MTC-based combinations resulted in a high percentage of complete protection from emesis, but the higher incidence of side effects observed with MTC makes the LS-based regimen preferable for patients receiving P-C chemotherapy.
Sabbatini
R
R
Department of Medical, Oncological and Radiological Sciences, University of Modena, Italy.
Federico
M
M
Baldini
L
L
Barbieri
F
F
Maiolo
M T
MT
Silingardi
V
V
D000328:Adult; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D018592:Cross-Over Studies; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D003975:Diazepam / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000150:complications / Q000188:drug therapy*; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects; D008787:Metoclopramide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D011346:Prochlorperazine / Q000008:administration & dosage / Q000627:therapeutic use; D011398:Promethazine / Q000008:administration & dosage / Q000627:therapeutic use; D013469:Sulpiride / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
D000932:Antiemetics; D003561:Cytarabine; D001761:Bleomycin; D015251:Epirubicin; D014750:Vincristine; D005047:Etoposide; D013469:Sulpiride; D003520:Cyclophosphamide; D011398:Promethazine; C078143:levosulpiride; D008787:Metoclopramide; D003975:Diazepam; D011241:Prednisone; D011346:Prochlorperazine; D008727:Methotrexate