TY - JOUR
T1 - Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV)
T2 - A Randomized, Double-Blind, Phase 3 Study (CONSOLE)
AU - Hata, Akito
AU - Shiraishi, Yoshimasa
AU - Inui, Naoki
AU - Okada, Morihito
AU - Morise, Masahiro
AU - Akiyoshi, Kohei
AU - Takeda, Masayuki
AU - Watanabe, Yasutaka
AU - Sugawara, Shunichi
AU - Shinagawa, Naofumi
AU - Kubota, Kaoru
AU - Saeki, Toshiaki
AU - Tamura, Tomohide
N1 - Funding Information:
The authors are grateful to all the patients, their families, and the investigators who participated in this study. A phase III, randomized, double-blind, multicenter, active control study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC) (JapicCTI-194611); CONSOLE. Sponsorship for this study was funded by Taiho Pharmaceutical Co., Ltd. The exploratory analysis was managed by Helsinn Healthcare and performed by Eros Papademetriou and Xing Liu at SmartAnalyst Inc. Support for the analytical assistance was funded by Helsinn Healthcare. The journal’s Rapid Service Fee was also funded by Helsinn Healthcare. Medical writing and editorial assistance in the preparation of this article was provided by Jennifer Vanden Burgt, an independent medical writer.
Funding Information:
Medical writing and editorial assistance in the preparation of this article was provided by Jennifer Vanden Burgt, an independent medical writer. Support for the editorial assistance was funded by Helsinn Healthcare.
Funding Information:
Sponsorship for this study was funded by Taiho Pharmaceutical Co., Ltd. The exploratory analysis was managed by Helsinn Healthcare and performed by Eros Papademetriou and Xing Liu at SmartAnalyst Inc. Support for the analytical assistance was funded by Helsinn Healthcare. The journal’s Rapid Service Fee was also funded by Helsinn Healthcare.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/6
Y1 - 2022/6
N2 - Introduction: We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK1) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX) for the prevention of highly emetogenic chemotherapy (HEC)-induced nausea and vomiting (CINV). This analysis was performed to validate the findings of the primary analysis (previously published) utilizing a last observation carried forward (LOCF) approach for missing values for the efficacy endpoint of complete response (no emetic event and no rescue medication), while also evaluating the time periods encompassing the 0–168-hour (h) “extended overall phase” interval. Methods: Patients scheduled to receive cisplatin-based chemotherapy were randomized 1:1 to fosnetupitant 235 mg or fosaprepitant 150 mg in combination with PALO 0.75 mg and DEX. Complete response rates were calculated and compared (stratified by age category and sex with a Mantel–Haenszel test) during the study’s primary overall phase (0–120 h) and during additional time intervals of interest [acute (0–24 h), delayed (24–120 h), extended delayed (> 24–168 h), beyond delayed (120–168 h), and extended overall (0–168 h)]. Results: A total of 785 patients were included (fosnetupitant N = 392, fosaprepitant N = 393). Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. Complete response rates for fosnetupitant versus fosaprepitant during the overall, acute, delayed, extended delayed, beyond delayed, and extended overall phases were 75.5% vs. 71.0% (p = 0.1530), 93.9% vs. 92.6% (p = 0.4832), 77.0% vs. 72.8% (p = 0.1682), 74.7% vs. 68.4% (p = 0.0506), 86.7% vs. 81.7% (p = 0.0523), and 73.5% vs. 66.9% (p = 0.0450), respectively. Conclusion: In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy. Infographic: [Figure not available: see fulltext.]
AB - Introduction: We describe the results of an exploratory analysis performed on the first head-to-head study (JapicCTI-194611) comparing two different intravenous (IV) neurokinin 1 (NK1) receptor antagonists, fosnetupitant and fosaprepitant, in combination with palonosetron (PALO) and dexamethasone (DEX) for the prevention of highly emetogenic chemotherapy (HEC)-induced nausea and vomiting (CINV). This analysis was performed to validate the findings of the primary analysis (previously published) utilizing a last observation carried forward (LOCF) approach for missing values for the efficacy endpoint of complete response (no emetic event and no rescue medication), while also evaluating the time periods encompassing the 0–168-hour (h) “extended overall phase” interval. Methods: Patients scheduled to receive cisplatin-based chemotherapy were randomized 1:1 to fosnetupitant 235 mg or fosaprepitant 150 mg in combination with PALO 0.75 mg and DEX. Complete response rates were calculated and compared (stratified by age category and sex with a Mantel–Haenszel test) during the study’s primary overall phase (0–120 h) and during additional time intervals of interest [acute (0–24 h), delayed (24–120 h), extended delayed (> 24–168 h), beyond delayed (120–168 h), and extended overall (0–168 h)]. Results: A total of 785 patients were included (fosnetupitant N = 392, fosaprepitant N = 393). Complete response rates were numerically higher for fosnetupitant versus fosaprepitant for all time intervals and statistically significant for the extended overall phase. Complete response rates for fosnetupitant versus fosaprepitant during the overall, acute, delayed, extended delayed, beyond delayed, and extended overall phases were 75.5% vs. 71.0% (p = 0.1530), 93.9% vs. 92.6% (p = 0.4832), 77.0% vs. 72.8% (p = 0.1682), 74.7% vs. 68.4% (p = 0.0506), 86.7% vs. 81.7% (p = 0.0523), and 73.5% vs. 66.9% (p = 0.0450), respectively. Conclusion: In this exploratory analysis, fosnetupitant appeared to be more effective than fosaprepitant in preventing CINV associated with cisplatin-based HEC during the extended 7-day period following chemotherapy. Infographic: [Figure not available: see fulltext.]
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U2 - 10.1007/s40487-022-00188-2
DO - 10.1007/s40487-022-00188-2
M3 - Article
AN - SCOPUS:85125636686
SN - 2366-1070
VL - 10
SP - 253
EP - 262
JO - Oncology and Therapy
JF - Oncology and Therapy
IS - 1
ER -