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Palonosetron in combination with 1-day versus 3-day dexamethasone to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin

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Abstract

Purpose

The aim of the present study was to evaluate the efficacy and toxicity of palonosetron (PAL) and dexamethasone (DEX) on day 1 only in patients with gynecologic cancer receiving paclitaxel combined with carboplatin (TC). The primary endpoint was to evaluate the complete response (CR) rate in the delayed phase.

Methods

This study was a randomized phase 2. Regardless of assignment to either study arm, all patients received an intravenous prophylactic regimen of DEX (20 mg) within 15 min and then an intravenous dose of PAL (0.75 mg) as a bolus given 30 min before initiation of TC on day 1. Patients in the DEX 1-day group received no additional DEX on days 2 and 3. Patients in the DEX 3-day group received DEX (8 mg) orally on days 2 and 3.

Results

Eighty-two patients had evaluable data on the primary outcome. The CR rates in the delayed phase between the two groups were not statistically significantly different (3-day group, 76.9 % [30/39]; 1-day group 69.8 % [30/43]; p = 0.4652). The frequency of constipation and insomnia which were antiemetic treatment-related adverse events was similar between two groups, and no serious adverse events occurred.

Conclusions

Administration of a combination of PAL and DEX 1 day may prevent chemotherapy-induced nausea and vomiting (CINV) in the delayed phase for TC as well as administration of DEX 3 days. Further evaluation of the antiemetic regimen of combination of PAL and DEX 1 day for TC is warranted in future phase 3 trials.

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Acknowledgment

The authors are grateful to Dr. Ryuji Kawaguchi and Dr. Shozo Yoshida for the continuing interest and helpful discussions.

Conflict of interest

The authors have no conflict of interest.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Nara Prefecture Western Medical Center, 1-14-16 Mimuro, Sango-cho, Ikoma-gun, Nara, 636-0802, Japan

    Naoto Furukawa

  2. Department of Obstetrics and Gynecology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan

    Seiji Kanayama, Yasuhito Tanase & Fuminori Ito

Authors
  1. Naoto Furukawa
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  2. Seiji Kanayama
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  3. Yasuhito Tanase
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  4. Fuminori Ito
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Correspondence to Naoto Furukawa.

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Furukawa, N., Kanayama, S., Tanase, Y. et al. Palonosetron in combination with 1-day versus 3-day dexamethasone to prevent nausea and vomiting in patients receiving paclitaxel and carboplatin. Support Care Cancer 23, 3317–3322 (2015). https://doi.org/10.1007/s00520-015-2760-3

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  • DOI: https://doi.org/10.1007/s00520-015-2760-3

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