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Clinical Studies

Dexamethasone-sparing on days 2–4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial)

British Journal of Cancer volume 130, pages 224–232 (2024)Cite this article

Subjects

Abstract

Background

This study evaluated the non-inferiority of dexamethasone (DEX) on day 1, with sparing on days 2–4 in cisplatin-based chemotherapy.

Methods

Patients with malignant solid tumors who were treated with cisplatin (≥50 mg/m²) were randomly assigned (1:1) to receive either DEX on days 1–4 (Arm D4) or DEX on day 1 (Arm D1) plus palonosetron, NK-1 RA, and olanzapine (5 mg). The primary endpoint was complete response (CR) during the delayed (24–120 h) phase. The non-inferiority margin was set at −15%.

Results

A total of 281 patients were enrolled, 278 of whom were randomly assigned to Arm D4 (n = 139) or Arm D1 (n = 139). In 274 patients were included in the efficacy analysis, the rates of delayed CR in Arms D4 and D1 were 79.7% and 75.0%, respectively (risk difference −4.1%; 95% CI –14.1%–6.0%, P = 0.023). However, patients in Arm D1 had significantly lower total control rates during the delayed and overall phases, and more frequent nausea and appetite loss. There were no significant between-arm differences in the quality of life.

Conclusion

DEX-sparing is an alternative option for patients receiving cisplatin; however, this revised administration schedule should be applied on an individual basis after a comprehensive evaluation.

Clinical Trials Registry number

UMIN000032269

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Fig. 1: CONSORT diagram.
Fig. 2: EORTC QLQ-C 30 scores.

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Data availability

Data were generated by the authors and are available on request.

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Acknowledgements

The authors thank all the patients and their families, investigators, and institutions involved in this study. We are also grateful to Tomoe Mashiko for data management, Shunsuke Oyamada for data analysis, and Yoshiki Horie for helpful discussions. This study is supported by Japan Agency for Medical Research and Development (AMED) grant number 21ck0106501h0003. AMED had and will have no involvement in the design and conduct of the study, collection, management, analysis, and interpretation of the data, and preparation, review, or approval of the manuscript. The authors would like to thank Enago (www.enago.jp) for the English language review.

Funding

This study was funded by the Japan Agency for Medical Research and Development (grant number 21ck0106501h0003).

Author information

Author notes

  1. These authors contributed equally: Hiroko Minatogawa, Naoki Izawa.

Authors and Affiliations

  1. Department of Pharmacy, St. Marianna University Hospital, Kawasaki, Japan

    Hiroko Minatogawa & Ayako Yokomizo

  2. Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan

    Naoki Izawa, Takashi Ogura & Takako Eguchi Nakajima

  3. Department of Pharmacy, Aichi Cancer Center Hospital, Nagoya, Japan

    Kazuhiro Shimomura & Naoya Hashimoto

  4. Department of Medical Oncology, Yokohama Rosai Hospital, Yokohama, Japan

    Hitoshi Arioka & Takeshi Yanagihara

  5. Department of Pharmacy, Gifu University Hospital, Gifu, Japan

    Hirotoshi Iihara

  6. Research and Education Center for Clinical Pharmacy, Kitasato University School of Pharmacy, Sagamihara, Japan

    Mitsuhiro Sugawara

  7. Department of Pharmacy, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Japan

    Hajime Morita

  8. Department of gynecology, Shizuoka Cancer Center, Shizuoka, Japan

    Ayako Mochizuki

  9. Department of Pharmacy, Showa University Northern Yokohama Hospital, Yokohama, Japan

    Shuichi Nawata & Daisuke Ichikura

  10. Department of Digestive surgery, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan

    Keisuke Mishima

  11. Department of Pharmacy, Kawasaki municipal Tama Hospital, Kawasaki, Japan

    Ayako Tsuboya

  12. Department of Clinical Trial Data Management Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Tempei Miyaji

  13. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan

    Kazunori Honda

  14. Department of Cardiology and Respiratory Medicine, Gifu University Graduate School of Medicine, Gifu, Japan

    Junki Endo & Yasushi Ohno

  15. Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Hachioji, Japan

    Takashi Kawaguchi

  16. Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan

    Naoki Furuya

  17. Department of Clinical Pharmacy, Aichi Cancer Center Hospital, Nagoya, Japan

    Yumiko Sone

  18. Department of Pharmacy, Yokohama Rosai Hospital, Yokohama, Japan

    Yusuke Inada

  19. Department of Therapeutic Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Chikatoshi Katada

  20. Department of Respiratory Internal Medicine, St. Marianna University Yokohama City Seibu Hospital, Yokohama, Japan

    Naoya Hida

  21. Department of pharmacy, Shizuoka Cancer Center, Nagaizumi, Japan

    Kana Akiyama

  22. Department of Pharmacy, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan

    Akiko Konomatsu

  23. Department of Clinical Oncology, Kawasaki municipal Tama Hospital, Kawasaki, Japan

    Takashi Ogura

  24. Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan

    Takuhiro Yamaguchi

  25. Department of Early Clinical Development, Kyoto University Graduate School of Medicine, Kyoto, Japan

    Takako Eguchi Nakajima

Authors
  1. Hiroko Minatogawa
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  2. Naoki Izawa
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  30. Takako Eguchi Nakajima
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Contributions

HM, NI and TEN contributed to the trial conception and are the principal investigators. HM, NI, TM, TK, TY, and TEN participated in the design of the study. TY did the statistical analysis. TM and TK contributed to data management. HM, NI, statistician (TY), and TEN had full access to the data, conducted data analysis and interpretation, and take responsibility for the integrity of the data and adherence to the study protocol. HM and NI contributed to the initial draft of the manuscript and are responsible for the decision to submit the manuscript for publication. All authors contributed to data collection and interpretation, and revision of the manuscript for important content.

Corresponding author

Correspondence to Takako Eguchi Nakajima.

Ethics declarations

Competing interests

HA reports personal fees from Ono, Bristol-Myers Squibb, Daiichi-Sankyo, Takeda, Chugai, Eisai and Delta-Fly Pharma. HI reports grants from Daiichi Sankyo Co., Ltd., Nippon Kayaku Co., Ltd., Chugai,,, Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Asahi Kasei Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd.; and reports personal fees from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., Astellas Pharma Co., Ltd., Eli Lilly and Company, Daiichi Sankyo Co., Ltd., AstraZeneca plc, Nippon Kayaku Co., Ltd., Ono, Pharmaceutical Co., Ltd. and Nippon Boehringer Ingelheim Co., Ltd. TM reports grants from AC Medical, A2 Healthcare, CAC Croit Corporation, Japan Tobacco Inc, Japan Media Corporation, Medidata Solutions, Inc, Ono Pharmaceutical, FMD K&L Japan, Intellim, Welby, Nipro Corporation, New Age Trading, NOBORI Ltd. And Medrio; and reports personal fees from AYUMI, Impute, Pfizer, Welby, EISAI, Merc and Takeda. KH reports grants from Pfizer. JE reports grants from Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon, Boehringer Ingelheim Co., Ltd., Kyorin Holdings, Inc. and Nippon Kayaku Co., Ltd.; and reports personal fees from AstraZeneca plc, Chugai Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Ltd., Takeda Pharmaceutical Co., Ltd., Novartis Pharma K.K. and Daiichi Sankyo Co., Ltd. NF reports personal fees from Eli Lilly Japan, AstraZeneca, Boehringer Ingelheim Japan, Chugai, Bristol Myers Squibb, Taiho, Pfizer Japan and Novartis. TY reports grants from AC MEDICAL INC., A2 Healthcare Corporation, EP Croit Co., Ltd., ClinChoice., Japan Tobacco Inc., Japan Media Corporation, Medidata Solutions, Inc., ONO PHARMACEUTICAL CO., LTD., Kyowa Kirin Co., Ltd., TSUMURA & CO., DAIICHI, SANKYO COMPANY, LIMITED., Otsuka Pharmaceutical Co., Ltd. Eisai Co., Ltd., ASAHI, INTECC CO., LTD., 3H Clinical Trial Inc., Medrio, Inc., NIPRO CORPORATION, Intellim Corporation, Welby Inc., 3H Medi Solution Inc., NIPRO CORPORATION, Baseconnect Inc., Nobori Ltd., Puravida Technologies LLC. and Hemp Kitchen Inc.; and reports personal fees from EPS Corporation, Japan Tobacco Inc., Medidata Solutions, Inc., ONO PHARMACEUTICAL CO., LTD., Kowa Company, Ltd., CHUGAI PHARMACEUTICAL CO. LTD., TSUMURA & CO., DAIICHI SANKYO COMPANY, LIMITED., Eisai Co., Ltd., ASAHI INTECC CO., LTD., ASAHI KASEI PHARMA CORPORATION, 3H Clinical Trial Inc. Intellim Corporation, Takeda, AstraZeneca, SONIRE Therapeutics Inc., SEIKAGAKU CORPORATION, Merck & Co., Inc. and NIPRO CORPORATION. TEN reports grants from Sumitomo Dainippon Pharma Co., Ono Pharmaceutical Co., Taiho Pharmaceutical Co., Takeda Pharmaceutical Co., Chugai Pharmaceutical Co., Sanofi K.K., Nippon Kayaku Co., MSD K.K. and Eli Lilly Japan K.K.; and reports personal fees from Thyas Co. Ltd., Rebirthel Co., Ltd., Japan Clinical Research Operations, Sumitomo Dainippon Pharma Co., Boehringer Ingelheim, Bristol-Myers Squibb, Ono Pharmaceutical Co., Taiho Pharmaceutical Co., Amgen, Takeda Pharmaceutical Co., Chugai Pharmaceutical Co., Sanofi K.K., Novartis Japan, Nippon Kayaku Co., MSD K.K., Eli Lilly Japan K.K., Bayer Yakuhin, Pfizer Japan Inc., Daiichi, Sankyo Co., Yakult Honsha Co., Nipro Co, Merck Serono Co., AstraZeneca, IQVIA and GlaxoSmithKline. All other authors declare no competing interests.

Ethics approval and consent to participate

This study was conducted in accordance with the Declaration of Helsinki and was approved by the institutional review board at each site. The study was registered with the University Hospital Medical Information Network, Clinical Trials Registry number UMIN000032269. All patients included in this study provided written, informed consent.

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All patients provided written, informed consent.

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Minatogawa, H., Izawa, N., Shimomura, K. et al. Dexamethasone-sparing on days 2–4 with combined palonosetron, neurokinin-1 receptor antagonist, and olanzapine in cisplatin: a randomized phase III trial (SPARED Trial). Br J Cancer 130, 224–232 (2024). https://doi.org/10.1038/s41416-023-02493-7

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