Table 3. Select Trials in Patients Receiving Chemotherapy
| Study | N | Antiemetic treatments Chemotherapy | Electrocardiogram assessments | Electrocardiographic effects |
|---|---|---|---|---|
| Lifsey 1993 NR (abstract) |
20 | D: 1.8-3 mg/kg IV O: 32 mg IV Cisplatin |
Prior to antiemetic therapy and chemotherapy, and repeated 1-2 h after antiemetic | 1. Small QTc, PR,
and QRS prolongations. 2. No cardiovascular events were associated with these ECG changes |
| Baltzer
1994 NR (abstract) |
45 | D: 2.4 mg/kg IV O: 32 mg IV Cisplatin |
Prior to antiemetic therapy and at 2 h and 24 h after injection | 1. Minor, asymptomatic,
reversible prolongations in PR, QRS, QT and QTc intervals that resolved
by 24 h. 2. Mean changes at 2 h post dose significantly (P < .05) different from baseline for PR, QRS, and QT for both agents. |
| Wantanabe
1995 Open-label, observational |
12 | G:
50 mcg/kg IV over 10 min Methrotrexate, vincristine, cisplatin, pirarubicin, bleomycin, ifosfamide, or actinomycin D |
Continuous ECG monitoring 1 h prior to antiemetic therapy and continuing for 5 days | 1. In 4 patients:
ECG changes: bradycardia, P-wave changes, junctional escape beats, and
atrioventricular block.
2. All ECG changes transient and returned to baseline. 3. All patients exhibited some degree of bradycardia, but HR suppression not statistically significant versus baseline. |
| Jantunen
1996 Open-label, observational |
30 | G:
3 mg IV over 5 min Doxorubicin or epirubicin |
Prior antiemetic dose, immediately after end of granisetron, and following chemotherapy administration | No clinically significant changes in PR interval, QRS duration, or QTc interval. |
| Hesketh 1996 Randomized, double-blind, parallel |
609 | D:
1.8 or 2.4 mg/kg IV O: 32 mg IV Cisplatin |
Before antiemetic and repeated at 1-2 h and at 24 h | 1. Small, transient,
and clinically insignificant changes in PR, QRS, QT, QTc, and JT intervals
for all regimens versus baseline.
2. No increased risk of cardiovascular events with ECG changes. |
| Lofters
1997 Multicenter, randomized, 6-parallel arm |
696 | D:
2.4 mg/kg IV single dose + 200 mg oral x 6 days O: 32 mg IV or 8 mg oral twice daily x 6 days Placebo Doxorubicin, epirubicin, cisplatin, carboplatin, and/or cyclophosphamide |
Prior to antiemetic therapy and at 1-2 h and 8 days | 1. ECG changes with
both agents, but more frequent with D versus O.
2. QTc and QRS interval prolongations the most common ECG changes, but did not result in clinical events or symptoms. |
| Audhuy
1997 Multicenter, randomized, double-blind, double-dummy, 3-arm |
474 | D:
1.8 or 2.4 mg/kg IV G: 3 mg IV Cisplatin |
Prior to (<3 days) antiemetic therapy, and at 1-2 h and at 24 h after antiemetic | 1. Small increases
in PR, QRS, and QTc intervals with all regimens, but not clinically significant.
2. At 1-2 h postdose,
QTc and PR intervals statistically significantly longer (P=.0016 and P=
.0002, respectively) with D versus G, but no differences between treatments
at 24 h. No baseline specifics reported. |
D: Dolasetron; G: Granisteron; O: Ondansetron