Risk factors associated with chemotherapy-induced nausea and vomiting in the triplet antiemetic regimen including palonosetron or granisetron for cisplatin-based chemotherapy: analysis of a randomized, double-blind controlled trial
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The triplet antiemetic regimen is recommended for cisplatin-based highly emetogenic chemotherapy, in the current guidelines for antiemetic prophylaxis. Although risk factors related to chemotherapy-induced nausea and vomiting (CINV) have been identified by several prior studies, there are only few studies evaluating risk factors associated with the prophylactic triplet antiemetic therapy, particularly in palonosetron use. The present study aimed to reveal the risk factors related to CINV development in patients receiving cisplatin and to compare CINV risk factors between palonosetron and granisetron use.
In total, 825 patients in a phase III trial receiving palonosetron with graniestron were evaluated. Multivariate logistic regression models were used to predict risk factors associated with CINV development. Additionally, risk factors associated with CINV development were separately evaluated in each treatment group.
Multivariate analysis of the entire study group revealed that sex, age, cisplatin dose, and granisetron use were significant and independent factors affecting CINV development in the overall phase. Similarly, sex and age were risk factors for CINV in both treatment groups. Kaplan–Meier curves classified by each treatment group showed no significant difference between the groups among patients without any risk factors for CINV (P = 0.353). Conversely, complete response rates for patients with at least one risk factor were higher in patients receiving palonosetron (P = 0.049).
This analysis revealed the importance of previously reported CINV risk factors when using triplet antiemetics. Palonosetron might be preferred for patients with at least one risk factor.
KeywordsChemotherapy-induced nausea and vomiting (CINV) Risk factors Granisetron Palonosetron Aprepitant
We wish to thank all the patients and staff at all study institutions who participated in this study.
Compliance with ethical standards
Conflict of interest
DT reports grants from Yakult and personal fees from Chugai, Kyowa Hakko Kirin, Sawai, Taiho, and Nippon Kayaku outside the submitted work. KS reports personal fees from Taiho, Eli Lilly, Bristol-Myers Squibb, Astra Zeneca, Ono, and MSD outside the submitted work. KG reports grants and personal fees from Chugai, Taiho, and Ono; grants from Takeda, during the conduct of the study; grants and personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, MSD, Novartis, Pfizer, Kyowa Hakko Kirin, Merck Serono, RIKEN GENESIS, and GlaxoSmithKline; grants from Eisai, Sumitomo Dainippon Pharma, Oxonc, Astellas Pharma, AbbVie Stemcentrx, and Ignyta; personal fees from Nippon Kayaku, ABBOTT, Quintiles, Life Technologies Japan, and SRL, outside the submitted work. RM reports personal fees from Chugai, Taiho, Yakult, Novartis, Boehringer Ingelheim, Meiji Seika Pharma, Janssen, and Sawai outside the submitted work. NS reports grants and personal fees from Boehringer Ingelheim, personal fees from Eli Lilly, Astra Zeneca, Daiichi Sankyo, MSD, Chugai, Taiho, Ono, and Bristol-Myers Squibb outside the submitted work. HH reports personal fees from Taiho, Ono, and Eli LIlly outside the submitted work. TH reports grants from Yakult, and Sawai, personal fees from Meiji Seika Pharma, and Towa outside the submitted work. TY reports grants and personal fees from Taiho, and Takeda, personal fees from Chugai, and Boehringer Ingelheim outside the submitted work. NY reports grants and personal fees from KYORIN, Ono, Taiho, Pfizer, Chugai, MSD, Daiich Sankyo, and Astra Zeneca, personal fees from M3., Otsuka Pharmaceutical, JASMIN, Bristol-Myers Squibb, Eli Lilly, Novartis Pharma, and FUJIFIRM, grant from Maruho, Shionogi, Meiji Seika Pharma, Quintiles, PAREXEL International, and ACMEDICAL outside the submitted work. All remaining authors have declared no conflicts of interest.
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