Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL).
OBJECTIVE
The control of nausea and vomiting induced by chemotherapy is paramount for overall treatment success in cancer patients. Antiemetic therapy during chemotherapy in lymphoma patients generally consists of anti-serotoninergic drugs and dexamethasone. The aim of this trial was to evaluate the efficacy of a single dose of palonosetron, a second-generation serotonin type 3 (5-HT(3)) receptor antagonist, in patients with aggressive non-Hodgkin's lymphoma receiving moderately emetogenic chemotherapy (MEC) containing steroids.


METHODS
Patients received a single intravenous bolus of palonosetron (0.25 mg) before administration of chemotherapy. Complete response (CR) defined as no vomiting and no rescue therapy during overall phase (0-120 h) was the primary endpoint. Complete control (CC) defined as CR and only mild nausea was a secondary endpoint.


RESULTS
Eighty-six evaluable patients entered in the study. A CR was observed in 74 patients (86.0%) during the overall phase; the CR during the acute (0-24 h) and delayed (24-120 h) phases was 90.7% and 88.4%, respectively. CC was 89.5% during the acute and 84.9% during the delayed phase; the overall CC was 82.6%.


CONCLUSIONS
This was the first trial, which demonstrated the efficacy of a single dose of palonosetron in control CINV in patients with aggressive non-Hodgkin's lymphoma receiving MEC regimen containing steroids.
Di Renzo
Nicola
N
UO di Ematologia e Trapianto di Cellule Staminali, Ospedale Vito Fazzi, Piazza Filippo Muratore, 73100 Lecce, Italy. direnzo.ematolecce@libero.it
Montanini
Antonella
A
Mannina
Donato
D
Dondi
Alessandra
A
Muci
Stefania
S
Mancuso
Salvatrice
S
De Paolis
M Rosaria
MR
Plati
Caterina
C
Stelitano
Caterina
C
Patti
Catia
C
Olivieri
Attilio
A
Liardo
Eliana
E
Buda
Gabriele
G
Cantaffa
Renato
R
Federico
Massimo
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D000077924:Palonosetron; D011446:Prospective Studies; D011812:Quinuclidines / Q000627:therapeutic use*; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult
D000932:Antiemetics; D005938:Glucocorticoids; D007546:Isoquinolines; D011812:Quinuclidines; D058831:Serotonin 5-HT3 Receptor Antagonists; D000077924:Palonosetron; D003907:Dexamethasone