Prevention of delayed nausea: a University of Rochester Cancer Center Community Clinical Oncology Program study of patients receiving chemotherapy.
OBJECTIVE
We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3.


METHODS
Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017.


RESULTS
Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: -0.01 (95% CI, -0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, -0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: -0.03 (95% CI, -0.24 to 0.19; P = .56).


CONCLUSIONS
The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.
University of Rochester Cancer Center Community Clinical Oncology Program Research Base, University of Rochester Medical Center, Rochester, NY 14642, USA. Joseph_Roscoe@urmc.rochester.edu
Joseph A
JA
Roscoe
Charles E
CE
Heckler
Gary R
GR
Morrow
Supriya G
SG
Mohile
Shaker R
SR
Dakhil
James L
JL
Wade
J Philip
JP
Kuebler
D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D000077608:Aprepitant; D003907:Dexamethasone / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D017829:Granisetron / Q000008:administration & dosage; D006801:Humans; D057194:Intention to Treat Analysis; D007546:Isoquinolines / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D064729:Neurokinin-1 Receptor Antagonists; D000077924:Palonosetron; D011346:Prochlorperazine / Q000008:administration & dosage; D011812:Quinuclidines / Q000008:administration & dosage; D012702:Serotonin Antagonists / Q000008:administration & dosage
D000932:Antiemetics; D000970:Antineoplastic Agents; D000077608:Aprepitant; D003907:Dexamethasone; D017829:Granisetron; D007546:Isoquinolines; D009025:Morpholines; D064729:Neurokinin-1 Receptor Antagonists; D000077924:Palonosetron; D011346:Prochlorperazine; D011812:Quinuclidines; D012702:Serotonin Antagonists