Pooled analysis of phase III clinical studies of palonosetron versus ondansetron, dolasetron, and granisetron in the prevention of chemotherapy-induced nausea and vomiting (CINV)

Purpose Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT 3 RAs in preventing CINV associated with moderately or highly emetogen...

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Bibliographic Details
Published in:Supportive care in cancer 2014-02, Vol.22 (2), p.469-477
Main Authors: Schwartzberg, Lee, Barbour, Sally Y., Morrow, Gary R., Ballinari, Gianluca, Thorn, Michael D., Cox, David
Format: Article
Language:English
Subjects:
Antiemetics - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Cancer
Chemotherapy
Clinical trials
Comparative studies
Double-Blind Method
Female
Granisetron - administration & dosage
Humans
Indoles - administration & dosage
Isoquinolines - administration & dosage
Male
Medical research
Medicine
Medicine & Public Health
Medicine, Experimental
Middle Aged
Nausea
Nausea - chemically induced
Nausea - prevention & control
Neoplasms - drug therapy
Nursing
Nursing Research
Oncology
Ondansetron - administration & dosage
Original
Original Article
Pain Medicine
Preventive medicine
Quinolizines - administration & dosage
Quinuclidines - administration & dosage
Rehabilitation Medicine
Serotonin Antagonists - administration & dosage
Treatment Outcome
Vomiting
Vomiting - chemically induced
Vomiting - prevention & control
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Summary:Purpose Preventing chemotherapy-induced nausea and vomiting (CINV) is integral to treatment success in patients with cancer. This analysis was undertaken to assess the relative efficacy and safety of palonosetron versus older 5HT 3 RAs in preventing CINV associated with moderately or highly emetogenic chemotherapy. Methods Patient-level data from four randomized, double-blind, phase III trials comparing palonosetron 0.25 or 0.75 mg with ondansetron 32 mg, dolasetron 100 mg, or granisetron 40 μg/kg were analyzed. Endpoints included complete response (CR: no emesis and no rescue antiemetics) in the acute (0–24 h), delayed (>24–120 h), and overall (0–120 h) postchemotherapy periods (primary), complete control (CC: no emesis, no rescue antiemetics, and no more than mild nausea), number of emetic episodes, and nausea severity. Results CR rates were significantly higher for palonosetron ( n  = 1,787) versus older 5HT 3 RAs ( n  = 1,175) in the delayed (57 vs 45 %, P  
ISSN:0941-4355
1433-7339
DOI:10.1007/s00520-013-1999-9