Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Oct;23(10):2917-23.
doi: 10.1007/s00520-015-2657-1. Epub 2015 Feb 28.

Efficacy and safety of oral palonosetron compared with IV palonosetron administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid tumors receiving cisplatin-based highly emetogenic chemotherapy (HEC)

Meinolf Karthaus  1 , Csőszi Tibor, Vito Lorusso, Rajender Singh-Arora, Alexander Filippov, Giada Rizzi, Maria Elisa Borroni, Giorgia Rossi, Steven M Grunberg
Affiliations
Randomized Controlled Trial

Efficacy and safety of oral palonosetron compared with IV palonosetron administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with solid tumors receiving cisplatin-based highly emetogenic chemotherapy (HEC)

Meinolf Karthaus et al. Support Care Cancer. 2015 Oct.

Abstract

Purpose: This study aims to compare the efficacy and safety of oral palonosetron with intravenous (IV) palonosetron for the prevention of cisplatin-related chemotherapy-induced nausea and vomiting (CINV).

Methods: A multinational, randomized, double-blind study enrolling adult chemotherapy-naive patients with malignant solid tumors scheduled to receive cisplatin-based highly emetogenic chemotherapy (HEC). Patients received oral palonosetron (0.50 mg) or IV palonosetron (0.25 mg), each with oral dexamethasone. The primary objective was to demonstrate non-inferiority in terms of patients with a complete response (CR, no emesis/no rescue medication) within the acute phase (0-24 h after chemotherapy administration).

Results: Of the 743 patients randomized, 739 received study medications and 738 were included in the full analysis set. The CR rate in the acute phase was high for both groups (oral 89.4 %; IV 86.2 %). As this difference in proportions (stratum-adjusted Cochran-Mantel-Haenszel method) was 3.21 % (99 % confidence interval (CI) -2.74 to 9.17 %), non-inferiority was demonstrated (since the lower limit of the 99 % CI was closer to zero than the predefined margin of 15 %). Treatment-emergent adverse events (TEAEs) related to the study drug were rare (oral 3.2 %; IV 6.5 %). No TEAEs related to study drug leading to discontinuation were reported.

Conclusion: Non-inferiority of oral versus IV palonosetron was demonstrated. The CR rate in the acute phase was >86 % in both patient groups. The safety profiles were comparable.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Complete response rates during the acute, delayed, and overall phases (full analysis set)
See this image and copyright information in PMC

References

    1. Griffin AM, Butow PN, Coates AS, Childs AM, Ellis PM, Dunn SM, Tattersall MH. On the receiving end. V: patient perceptions of the side effects of cancer chemotherapy in 1993. Ann Oncol. 1996;7(2):189–195. doi: 10.1093/oxfordjournals.annonc.a010548. - DOI - PubMed
    1. Laszlo J, Lucas VS., Jr Emesis as a critical problem in chemotherapy. N Engl J Med. 1981;305(16):948–949. doi: 10.1056/NEJM198110153051609. - DOI - PubMed
    1. Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, Bria E, Clark-Snow RA, Espersen BT, Feyer P, Grunberg SM, Hesketh PJ, Jordan K, Kris MG, Maranzano E, Molassiotis A, Morrow G, Olver I, Rapoport BL, Rittenberg C, Saito M, Tonato M, Warr D, Group EMGW Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010;21(Suppl 5):v232–v243. doi: 10.1093/annonc/mdq194. - DOI - PubMed
    1. Boccia R, Grunberg S, Franco-Gonzales E, Rubenstein E, Voisin D. Efficacy of oral palonosetron compared to intravenous palonosetron for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: a phase 3 trial. Support Care Cancer. 2013;21(5):1453–1460. doi: 10.1007/s00520-012-1691-5. - DOI - PMC - PubMed
    1. Navari RM. Palonosetron for the prevention of chemotherapy-induced nausea and vomiting in patients with cancer. Future Oncol. 2010;6(7):1073–1084. doi: 10.2217/fon.10.74. - DOI - PubMed

Publication types

MeSH terms