Comparison of the efficacy and safety of tropisetron, metoclopramide, and chlorpromazine in the treatment of emesis associated with far advanced cancer.
BACKGROUND
A single institution, prospective, randomized trial was performed in terminal cancer patients to compare tropisetron (TRO), metoclopramide (MET), and chlorpromazine (CHL) in the management of nausea and emesis. Patients had far advanced cancer, were far removed from chemotherapy or radiotherapy, and their nausea and emesis was not due to bowel obstruction, drug intake, or cranial, electrolytic, or metabolic causes. The effects of antiemetic treatments were evaluated from Days 1-15.


METHODS
Two hundred and eighty patients were randomized to receive 1) MET+ dexamethasone (DEX) (10 mg*4 and 2 mg*1, respectively, orally), 2) TRO (5 mg*1, orally), 3) TRO + MET (5 mg*1 and 10 mg*2, respectively, orally), 4) TRO + MET + DEX (5 mg*1, 10 mg*2, and 2 mg*1, respectively, orally), 5) CHL + DEX (25 mg*2 and 2 mg*1, respectively, orally), 6) TRO + CHL (5 mg*1 and 12.5 mg*2, respectively, orally), or 7) TRO + CHL + DEX (5 mg*1, 12.5 mg*2, and 2 mg*1, respectively, orally). Total control was defined as no nausea or emesis.


RESULTS
By the end of the 15th day, total control of emesis was obtained in 23.6% (9 of 38) of MET + DEX patients, 78.9% (30 of 38) of TRO patients, 84.2% (32 of 38) of TRO + MET patients, 92.3% (36 of 39) of TRO + MET + DEX patients, 33.3 (13 of 39) of CHL + DEX patients, 84.6% (33 of 39) of TRO + CHL patients, and 92.5% (37 of 40) of TRO + CHL + DEX patients. Total control of nausea was achieved in 18.4% (7 of 38) of MET + DEX patients, 65.7% (25 of 38) of TRO patients, 73.6% (28 of 38) of TRO + MET patients, 87.1% (34 of 39) of TRO + MET + DEX patients, 17.9% (7 of 39) of CHL + DEX patients, 74.3% (29 of 39) of TRO + CHL patients, and 85% (34 of 40) of TRO + CHL + DEX patients. When comparing MET + DEX versus TRO; MET + DEX versus TRO + MET; MET + DEX versus TRO + MET + DEX; MET + DEX versus TRO + CHL; MET + DEX versus TRO + CHL + DEX; CHL + DEX versus TRO; CHL + DEX versus TRO + MET; CHL + DEX versus TRO + MET + DEX; CHL + DEX versus TRO + CHL; and CHL + DEX versus TRO + CHL + DEX, significant differences were noted. All antiemetic drugs were well tolerated with no severe side effects observed in any treatment arm.


CONCLUSIONS
These data suggest that 5-HT3 receptor antagonists such as tropisetron clinically are more effective in the control of emesis of patients with far advanced cancer than previously used agents. This study raises important issues when attempting to decide which antiemetic therapy to choose for an individual patient with far advanced disease.
Mystakidou
K
K
Pain Relief and Palliative Care Unit, Areteion Hospital, University of Athens, Greece.
Befon
S
S
Liossi
C
C
Vlachos
L
L
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D002746:Chlorpromazine / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008787:Metoclopramide / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D009325:Nausea / Q000188:drug therapy* / Q000209:etiology; D009369:Neoplasms / Q000150:complications*; D011446:Prospective Studies; D000077526:Tropisetron; D014839:Vomiting / Q000188:drug therapy* / Q000209:etiology
D000932:Antiemetics; D007211:Indoles; D000077526:Tropisetron; D003907:Dexamethasone; D008787:Metoclopramide; D002746:Chlorpromazine