Control of nausea with palonosetron versus granisetron, both combined with dexamethasone, in patients receiving cisplatin- or anthracycline plus cyclophosphamide-based regimens.

Abstract

PURPOSE:

In a comparative phase 3 study involving 1114 Japanese patients receiving highly emetogenic chemotherapy (HEC), palonosetron (PALO) was found to be superior to granisetron (GRA) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in the delayed phase. This post hoc analysis of the phase 3 study evaluated the efficacy of PALO for the control of nausea.

METHODS:

The proportion of patients without nausea was assessed at 24-h intervals during the acute phase (0-24 h), delayed phase (24-120 h), and overall (0-120 h). No nausea rates were also evaluated by sex, type of chemotherapy (cisplatin or doxorubicin/epirubicin plus cyclophosphamide [AC/EC]), and age (<55 vs. ≥55 years). Nausea severity was categorized using a 4-point Likert scale (0 = no nausea to 3 = severe nausea).

RESULTS:

The proportion of patients without nausea was significantly higher in the PALO arm than in the GRA arm in the delayed phase (37.8 % vs. 27.2 %; p = 0.002) and overall (31.9 % vs. 25.0 %; p = 0.0117). When analyzed by stratification factors, the proportion of patients without nausea was significantly higher in the PALO arm in the delayed phase and overall in patients who were female, younger, or treated with cisplatin and in the delayed phase in patients who were older or treated with doxorubicin or epirubicin plus cyclophosphamide (all p < 0.05).

CONCLUSIONS:

PALO was more effective than GRA in prophylaxis of HEC-induced nausea in the delayed phase and overall. In addition, PALO was more effective than GRA in young and female patients, who are at high risk of CINV, both in the delayed phase and overall.

• Authors: Kaoru Kubota, Mitsue Saito, Kenjiro Aogi, Ikuo Sekine, Hirohisa Yoshizawa, Yasuhiro Yanagita, Hiroshi Sakai, Kenichi Inoue, Chiyoe Kitagawa, Takashi Ogura
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 24 Issue 9 Pg. 4025-33 (09 2016) ISSN: 1433-7339 [Electronic] Germany
• PMID: 27129842 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Chemical References

• Anthracyclines
• Antiemetics
• Isoquinolines
• Quinuclidines
• Palonosetron
• Dexamethasone
• Cyclophosphamide
• Cisplatin
• Granisetron

Topics

• Anthracyclines (administration & dosage, adverse effects)
• Antiemetics (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cisplatin (administration & dosage, adverse effects)
• Cyclophosphamide (administration & dosage, adverse effects)
• Dexamethasone (therapeutic use)
• Female
• Granisetron (therapeutic use)
• Humans
• Isoquinolines (therapeutic use)
• Male
• Middle Aged
• Nausea (chemically induced, drug therapy)
• Palonosetron
• Quinuclidines (therapeutic use)
• Vomiting (chemically induced, drug therapy)