Table 2.
Key trials in the development of the serotonin (5-HT)3-receptor antagonist granisetron
| References | Design | Investigational arm | Comparator | Chemotherapy | Primary parameter | Result |
|---|---|---|---|---|---|---|
| Warr et al. [83] |
R, DB, P n = 152 |
GRA 80 μg/kg IV | PCP 10 mg IV + DEX 10 mg IV | Dactinomycin, CIS, AC, or MEC | Severity of nausea and number of EE 0–24 h | GRA > PCP + DEX |
| Warr et al. [84] |
R, DB, P n = 149 |
GRA 80 μg/kg IV | DEX 10 mg IV + DPH 10 mg IV + MCP 2 mg/kg IV every 2 h for 5 doses | CIS | Severity of nausea and number of patients with no EE 0–24 h | GRA = DEX + MCP + DPH |
| Perez et al. [85] |
R, DB, P n = 1085 |
GRA 2 mg PO ± DEX | OND 32 mg IV ± DEX | Primarily carboplatin or C | Total control (no EE, no nausea, no rescue medications) 0–24 h and 25–48 h | GRA = OND |
| Gralla et al. [86] |
R, DB, P n = 1054 |
GRA 2 mg PO ± DEX | OND 32 mg IV ± DEX | CIS | Total control (no EE, no nausea, no rescue medications) 0–24 h | GRA = OND |
| Raftopoulos et al. [87] |
R, DB, P n = 1395 |
Sustained-release GRA 250 µg or 500 µg subcutaneously | PAL 0.25 mg IV | HEC/MEC | Complete response (no EE, no rescue medications) 0–24 h | Both doses of GRA noninferior to PAL |
A anthracycline, C cyclophosphamide, CIS cisplatin, DB double-blind, DEX dexamethasone, DPH diphenhydramine, EE emetic episodes, GRA granisetron, HEC highly emetogenic chemotherapy, IV intravenously, MCP metoclopramide, MEC moderately emetogenic chemotherapy, OND ondansetron, P parallel, PAL palonosetron, PCP prochlorperazine, PLA placebo, PO orally, R randomized