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.

3. Patients asymptomatic; no clinically significant cardiovascular events.
D: Dolasetron; G: Granisteron; O: Ondansetron

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