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Clinical Studies

Reply to L. Celio et al.

British Journal of Cancer (2024)Cite this article

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Celio et al. [1] pointed out the difficulty of interpreting the significant increase in mild to moderate nausea and appetite loss in the Dexamethasone (DEX)-sparing arm in the SPARED trial [2], referring the LUNG-LUNA trial [3]. Although the LUNG-LUNA trial indicated that DEX-sparing did not affect daily food intake, all patients in the LUNG-LUNA trial had non-small cell lung cancer. The SPARED trial included approximately 60% of patients with pharyngolaryngeal and esophageal cancer, who may be more likely to experience increased anorexia and decreased food intake during DEX sparing. This is why cross-trial comparison is generally frowned upon and also why we concluded that the result of the SPARED trial should be carefully applied on a patient-by-patient basis after a comprehensive evaluation.

DEX-sparing showed a high antiemetic effect for highly emetogenic chemotherapy (HEC) in these two trials and the patient-centered data should be interpreted depending on the indicator used in each trial. Celio et al. [3] raised the question of why the significant increase in mild to moderate nausea and appetite loss in the DEX-sparing arm in the SPARED trial [2] did not lead to the difference in global health score in EORTC QLQ-C 30 between the two arms. We dared to select this scale, because the quality of life of patients receiving chemotherapy can be affected not only by chemotherapy Induced Nausea and Vomiting (CINV), and quality of life should be totally assessed even in the clinical trials concerning CINV. Actually, we could speculate about the influence of mild to moderate nausea on the global health score and on the physical functioning score based on the patient-centered data in the SPARED trial.

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References

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Authors and Affiliations

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

    Hiroko Minatogawa

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

    Naoki Izawa & Takako Eguchi Nakajima

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

    Takako Eguchi Nakajima

Authors
  1. Hiroko Minatogawa
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  3. Takako Eguchi Nakajima
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Contributions

HM, NI, and TEN contributed to the conception of the manuscript. HM and NI contributed to the initial draft of the manuscript. TEN contributed to critically reviewing and revising the manuscript. HM, NI, and TEN approved the final version of the manuscript.

Corresponding author

Correspondence to Takako Eguchi Nakajima.

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Competing interests

NI reports grant from Taiho Pharmaceutical Co., Ltd., 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.

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Minatogawa, H., Izawa, N. & Nakajima, T.E. Reply to L. Celio et al.. Br J Cancer (2024). https://doi.org/10.1038/s41416-024-02708-5

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