Table 3.
Key trials in the development of the serotonin (5-HT)3-receptor antagonist palonosetron
| References | Design | Investigational arm | Comparator | Chemotherapy | Primary parameter | Result | |
|---|---|---|---|---|---|---|---|
| Gralla et al. [88] |
R, DB, P n = 563 |
a) PAL 0.25 mg IV b) PAL 0.75 mg IV |
OND 32 mg IV | Low-dose CIS, various MEC | Complete response (no EE, no rescue medication) 0–24 h | Both doses of PAL noninferior to OND | |
| Eisenberg et al. [89] |
R, DB, P n = 569 |
a) PAL 0.25 mg IV b) PAL 0.75 mg IV |
DOL 100 mg IV | Low-dose CIS, AC or various MEC | Complete response (no EE, no rescue medication) 0–24 h | Both doses of PAL noninferior to DOL | |
| Aapro et al. [90] |
R, DB, P n = 667 |
a) PAL 0.25 mg IV ± DEX 20 mg IV b) PAL 0.75 mg IV ± DEX 20 mg IV |
OND 32 mg IV ± DEX 20 mg IV | Various HEC, primarily CIS | Complete response (no EE, no rescue medication) 0–24 h | Both doses of PAL noninferior to OND | |
| Saito et al. [91] |
R, DB, P n = 1119 |
PAL 0.75 mg IV + DEX 16 mg IV on day 1 + DEX 8 mg IV (CIS) or 4 mg PO (AC) ×1 on days 2–3 | GRA 40 µg/kg IV + DEX 16 mg IV on day 1 + DEX 8 mg IV (CIS) or 4 mg PO (AC) ×1 on days 2–3 | CIS or AC | Complete response (no EE, no rescue medication) 0–24 h and 25–120 h | PAL + DEX noninferior 0–24 h and PAL + DEX superior to GRA + DEX 25–120 h | |
A anthracycline, C cyclophosphamide, CIS cisplatin, DB double-blind, DEX dexamethasone, DOL dolasetron, EE emetic episodes, GRA granisetron, HEC highly emetogenic chemotherapy, IV intravenously, MEC moderately emetogenic chemotherapy, OND ondansetron, P parallel, PAL palonosetron, PLA placebo, PO orally, R randomized