Abstract
This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin- containing chemotherapy (≤75 mg/m 2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high- dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. Of the 62 patients enrolled in the study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consistently experienced a greater degree of antiemetic control than those who received 0.6 mg/kg. Complete responses were achieved by 55% of patients who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher complete/major response rate than the 0.6-mg/kg group (77% vs 55%, respectively) and a significantly (p = 0.004) longer time to the first emetic episode (>24 h vs 13.5 h, respectively). More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high- dose cisplatin for the first time and should be evaluated further in clinical trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 619-623 |
| Number of pages | 5 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 19 |
| Issue number | 6 |
| DOIs | |
| State | Published - 1996 |
| Externally published | Yes |
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Keywords
- 5- HT
- antagonist
- Antiemetic
- Chemotherapy-induced emesis
- Cisplatin
- Clinical trial
- Dolasetron
- Emesis
- Nausea
ASJC Scopus subject areas
- Oncology
- Cancer Research
Cite this
Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy. / Yeilding, Allen; Bertoli, Luigi; Eisenberg, Peter; Plezia, Patricia; Modiano, Manuel R.; Alberts, David S; Khojasteh, Ali; Cramer, Michael B.; Hahne, William F.
In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 19, No. 6, 1996, p. 619-623.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Antiemetic efficacy of two different single intravenous doses of dolasetron in patients receiving high-dose cisplatin-containing chemotherapy
AU - Yeilding, Allen
AU - Bertoli, Luigi
AU - Eisenberg, Peter
AU - Plezia, Patricia
AU - Modiano, Manuel R.
AU - Alberts, David S
AU - Khojasteh, Ali
AU - Cramer, Michael B.
AU - Hahne, William F.
PY - 1996
Y1 - 1996
N2 - This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin- containing chemotherapy (≤75 mg/m 2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high- dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. Of the 62 patients enrolled in the study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consistently experienced a greater degree of antiemetic control than those who received 0.6 mg/kg. Complete responses were achieved by 55% of patients who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher complete/major response rate than the 0.6-mg/kg group (77% vs 55%, respectively) and a significantly (p = 0.004) longer time to the first emetic episode (>24 h vs 13.5 h, respectively). More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high- dose cisplatin for the first time and should be evaluated further in clinical trials.
AB - This randomized, double-blind, parallel-group, multicenter study compared the antiemetic effectiveness, safety, and tolerability of two different intravenous (i.v.) doses of dolasetron mesylate (0.6 and 1.8 mg/kg) in cancer patients receiving their first course of high-dose cisplatin- containing chemotherapy (≤75 mg/m 2). Efficacy was assessed by recording the timing, number, and severity of emetic episodes in the 24 h following high- dose cisplatin. Safety was evaluated by monitoring adverse events, vital signs, clinical laboratory parameters, and electrocardiograms. Of the 62 patients enrolled in the study, 29 received 0.6 mg/kg of dolasetron mesylate and 33 received 1.8 mg/kg. Patients who received dolasetron mesylate 1.8 mg/kg consistently experienced a greater degree of antiemetic control than those who received 0.6 mg/kg. Complete responses were achieved by 55% of patients who received 1.8 mg/kg compared with 31% for the 0.6-mg/kg group. The 1.8-mg/kg group achieved a significantly (p = 0.039) higher complete/major response rate than the 0.6-mg/kg group (77% vs 55%, respectively) and a significantly (p = 0.004) longer time to the first emetic episode (>24 h vs 13.5 h, respectively). More than 80% of patients were either satisfied or very satisfied with dolasetron treatment. The most common adverse events were mild to moderate in intensity, consistent with other studies, and included headache (24.1% of patients) and diarrhea (4.8%). These results demonstrated that a single 1.8-mg/kg i.v. dose of dolasetron mesylate provided effective antiemetic activity in a majority of patients given high- dose cisplatin for the first time and should be evaluated further in clinical trials.
KW - 5- HT
KW - antagonist
KW - Antiemetic
KW - Chemotherapy-induced emesis
KW - Cisplatin
KW - Clinical trial
KW - Dolasetron
KW - Emesis
KW - Nausea
UR - http://www.scopus.com/inward/record.url?scp=0029852564&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0029852564&partnerID=8YFLogxK
U2 - 10.1097/00000421-199612000-00018
DO - 10.1097/00000421-199612000-00018
M3 - Article
C2 - 8931684
AN - SCOPUS:0029852564
VL - 19
SP - 619
EP - 623
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 6
ER -