A phase II trial of olanzapine, dexamethasone, and palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a Hoosier oncology group study.
OBJECTIVE
The purpose of this study is to determine the control of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) and highly emetogenic chemotherapy (HEC) with the combined use of palonosetron and olanzapine, and dexamethasone with the dexamethasone given on day 1 only.


METHODS
Forty chemotherapy-naive patients received on the day of chemotherapy, day 1, an anti-emetic regimen consisting of dexamethasone, palonosetron, and olanzapine. Patients continued olanzapine for days 2-4 after chemotherapy administration. Patients recorded daily episodes of emesis, daily symptoms utilizing the M.D. Anderson Symptom Inventory, and the utilization of rescue therapy.


RESULTS
For the first cycle of chemotherapy, the complete response (no emesis, no rescue) for the acute period (24 h post-chemotherapy) was 100%, the delayed period (days 2-5 post-chemotherapy) 75%, and the overall period (0 120 h post-chemotherapy) 75% in 8 patients receiving HEC and was 97, 75, and 72% in 32 patients receiving MEC. Patients with no nausea for the acute period was 100%, the delayed period 50%, and the overall period 50% in 8 patients receiving HEC and was 100, 78, and 78% in 32 patients receiving MEC.


CONCLUSIONS
The complete response and control of nausea in subsequent cycles of chemotherapy were not significantly different from cycle one.


CONCLUSIONS
Olanzapine combined with a single dose of dexamethasone and a single dose of palonosetron was very effective in controlling acute and delayed CINV in patients receiving both HEC and MEC.
Navari
Rudolph M
RM
Notre Dame Cancer Institute, University of Notre Dame, 224 Raclin-Carmichael Hall, Notre Dame, IN 46556, USA. Navari.1@nd.edu.|Indiana University School of Medicine South Bend, South Bend, IN, USA. Navari.1@nd.edu.
Einhorn
Lawrence H
LH
Division of Hematology-Oncology, Indiana University Medical Center, Indianapolis, IN, USA.|Indiana University Cancer Center, Indianapolis, IN, USA.
Loehrer
Patrick J
PJ
Division of Hematology-Oncology, Indiana University Medical Center, Indianapolis, IN, USA.|Indiana University Cancer Center, Indianapolis, IN, USA.
Passik
Steven D
SD
Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Vinson
Jake
J
Hoosier Oncology Group, Indianapolis, IN, USA.
McClean
John
J
Medical and Surgical Specialists, Galesburg, IL, USA.
Chowhan
Naveed
N
Cancer Care Center, New Albany, IN, USA.
Hanna
Nasser H
NH
Division of Hematology-Oncology, Indiana University Medical Center, Indianapolis, IN, USA.|Indiana University Cancer Center, Indianapolis, IN, USA.
Johnson
Cynthia S
CS
Division of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000494:pharmacology* / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001569:Benzodiazepines / Q000494:pharmacology* / Q000627:therapeutic use; D003907:Dexamethasone / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000494:pharmacology* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D009369:Neoplasms / Q000188:drug therapy; D000077152:Olanzapine; D017063:Outcome Assessment, Health Care; D000077924:Palonosetron; D011812:Quinuclidines / Q000494:pharmacology* / Q000627:therapeutic use; D014481:United States; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
D000932:Antiemetics; D000970:Antineoplastic Agents; D007546:Isoquinolines; D011812:Quinuclidines; D001569:Benzodiazepines; D000077924:Palonosetron; D003907:Dexamethasone; D000077152:Olanzapine