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Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial

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Abstract

Purpose

Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial for maintaining the quality of life of cancer patients. Female patients have been underrepresented in previous clinical studies of aprepitant or palonosetron. We performed a prospective multicenter study to investigate the efficacy and safety of triple therapy comprising these two agents and dexamethasone in female cancer patients receiving chemotherapy that included cisplatin (≥50 mg/m2).

Methods

Aprepitant was administered at a dose of 125 mg before chemotherapy on day 1 and at 80 mg on days 2 and 3. Palonosetron (0.75 mg) was given before chemotherapy on day 1. Dexamethasone was administered at a dose of 9.9 mg before chemotherapy on day 1 and at 6.6 mg on days 2–4. The primary endpoint was the the proportion of patients with a complete response (CR no vomiting and no use of rescue medication) throughout the overall period (0–120 h post-chemotherapy).

Results

Ninety-six women (median age 55 years) were enrolled. The overall CR rate was 54.2 %. CR was obtained during the acute phase (0–24 h post-chemotherapy) and the delayed phase (24–120 h post-chemotherapy) in 87.5 and 56.3 % of the patients, respectively. The most common adverse reactions were constipation and fatigue (reported by three patients each).

Conclusions

Exhibition of a favorable overall CR rate over existing two-drug combinations suggests that the triple therapy regimen used in the present study is effective and tolerable in patients with gynecological malignancies receiving cisplatin-based chemotherapy. Female patients may have a higher risk of developing CINV.

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Acknowledgments

We would like to thank Dr. Noriyuki Takai for his substantial support with the conception and implementation of the present study.

Conflict of interest

The authors have no conflicts of interest to declare.

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Authors and Affiliations

  1. Department of Gynecology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Nobuhiro Takeshima & Maki Matoda

  2. Division of Gynecology, Shizuoka Cancer Center Hospital, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan

    Masakazu Abe & Yasuyuki Hirashima

  3. Department of Obstetrics and Gynecology, Faculty of Medicine, Oita University, Idaigaoka 1-1, Hasama-machi, Yufu-shi, Oita, 879-5593, Japan

    Kentaro Kai & Kaei Nasu

  4. Department of Obstetrics and Gynecology, National Defense Medical College, 3-2 Namiki, Tokorozawa, Saitama, 359-8513, Japan

    Masashi Takano & Kenichi Furuya

  5. Department of Obstetrics and Gynecology, Tottori University, School of Medicine, 36-1 Nishicho, Yonago, Tottori, 683-8504, Japan

    Seiya Sato & Hiroaki Itamochi

  6. Department of Obstetrics and Gynecology, Hyogo College of Medicine, Mukogawa 1-1, Nishinomiya, Hyogo, 663-8501, Japan

    Hiroshi Tsubamoto

  7. Department of Gynecologic Oncology, Saitama Medical University International Medical Center, 1397-1 Yamane, Hidaka-shi, Saitama, 350-1298, Japan

    Kosei Hasegawa

  8. Miyazaki Prefectural NOBEOKA Hospital, Shinkouji 2-1-10, Nobeoka-shi, Miyazaki, 882-0835, Japan

    Kiminari Terao

  9. Department of Obstetrics and Gynecology, Tohoku University, School of Medicine, 1-1, Seiryo-machi, Sendai, 980-8574, Japan

    Takeo Otsuki

  10. Kansai Rosai Hospital, 3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511, Japan

    Keiko Kuritani & Kimihiko Ito

Authors
  1. Nobuhiro Takeshima
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  2. Maki Matoda
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  3. Masakazu Abe
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  4. Yasuyuki Hirashima
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  5. Kentaro Kai
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  6. Kaei Nasu
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  7. Masashi Takano
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  8. Kenichi Furuya
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  9. Seiya Sato
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  10. Hiroaki Itamochi
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  11. Hiroshi Tsubamoto
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  12. Kosei Hasegawa
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  13. Kiminari Terao
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  14. Takeo Otsuki
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  15. Keiko Kuritani
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  16. Kimihiko Ito
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Corresponding author

Correspondence to Maki Matoda.

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Takeshima, N., Matoda, M., Abe, M. et al. Efficacy and safety of triple therapy with aprepitant, palonosetron, and dexamethasone for preventing nausea and vomiting induced by cisplatin-based chemotherapy for gynecological cancer: KCOG-G1003 phase II trial. Support Care Cancer 22, 2891–2898 (2014). https://doi.org/10.1007/s00520-014-2280-6

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  • DOI: https://doi.org/10.1007/s00520-014-2280-6

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