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A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients

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Abstract

Background

The granisetron transdermal system (GTS) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting (CINV) during multiday chemotherapy. We compared the efficacy and safety of GTS with that of intravenous and oral granisetron in Korean patients receiving moderately emetogenic chemotherapy (MEC).

Patients and methods

A total of 276 patients were randomized into GTS (n = 139, one patch on days 1–4) or control group (n = 137, intravenous on day 1 and oral on days 2–4). The primary endpoint was the percentage of patients achieving complete response (CR) from chemotherapy initiation until 24 h after the final administration.

Results

Out of 234 patients (112 in GTS and 122 in control group) included in the per protocol analysis, 97.9 % had gastrointestinal cancer and 76.9 % received 3-day chemotherapy. The GTS showed non-inferior efficacy achieving CR in 75.0 % of the patients; 74.6 % of the patients in the control group achieved CR (95 % confidence interval −10.73 to 11.55 %). The CR rate did not change after subgroup analyses by sex, age, and chemotherapy naivety and analysis per day and overall days of treatment. The GTS group showed sustained CR from day 1 to day 4. Patients’ satisfaction, assessed using Functional Living Index—Emesis (FLI-E), showed no difference. Both treatments were well tolerated and safe.

Conclusion

The GTS showed non-inferior efficacy to intravenous and oral granisetron. The safety, tolerability, and FLI-E scores of the GTS were comparable to those of control group. The GTS offers a convenient alternative option for relieving CINV in patients receiving MEC.

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Funding

This work was sponsored by the LG Life Sciences Ltd (Seoul, Korea).

Conflict of interest

None.

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Authors and Affiliations

  1. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil Songpa-gu, Seoul, 138-736, South Korea

    Jeong Eun Kim, Yong Sang Hong, Jae-Lyun Lee, Kyu-Pyo Kim, Seong Joon Park & Tae Won Kim

  2. Division of Hematology and Medical Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University School of Medicine, Incheon, South Korea

    Sun Jin Sym & Dong Bok Shin

  3. Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 135-710, South Korea

    Jeeyun Lee, Young Suk Park & Jin Seok Ahn

Authors
  1. Jeong Eun Kim
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  2. Yong Sang Hong
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  3. Jae-Lyun Lee
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  4. Kyu-Pyo Kim
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  5. Seong Joon Park
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  6. Sun Jin Sym
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  7. Dong Bok Shin
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  8. Jeeyun Lee
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  9. Young Suk Park
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  10. Jin Seok Ahn
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  11. Tae Won Kim
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Corresponding authors

Correspondence to Jin Seok Ahn or Tae Won Kim.

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Kim, J.E., Hong, Y.S., Lee, JL. et al. A randomized study of the efficacy and safety of transdermal granisetron in the control of nausea and vomiting induced by moderately emetogenic chemotherapy in Korean patients. Support Care Cancer 23, 1769–1777 (2015). https://doi.org/10.1007/s00520-014-2507-6

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  • DOI: https://doi.org/10.1007/s00520-014-2507-6

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