Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

doi:10.1007/s40487-022-00188-2

. 2022 Jun;10(1):253-262.

doi: 10.1007/s40487-022-00188-2. Epub 2022 Mar 4.

Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

Affiliations

¹ Department of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, 8-5-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. akitohata@hotmail.com.
² Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
³ Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
⁴ Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.
⁵ Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
⁶ Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.
⁷ Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.
⁸ Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
⁹ Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
¹⁰ Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
¹¹ Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
¹² Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
¹³ Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.

PMID: 35246827
PMCID: PMC9098704
DOI: 10.1007/s40487-022-00188-2

Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

Akito Hata et al. Oncol Ther. 2022 Jun.

. 2022 Jun;10(1):253-262.

doi: 10.1007/s40487-022-00188-2. Epub 2022 Mar 4.

Authors

Affiliations

¹ Department of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, 8-5-1 Minatojima-minamimachi, Chuo-ku, Kobe, Hyogo, 650-0047, Japan. akitohata@hotmail.com.
² Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
³ Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Hamamatsu, Japan.
⁴ Department of Surgical Oncology, Hiroshima University, Hiroshima, Japan.
⁵ Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
⁶ Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan.
⁷ Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.
⁸ Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
⁹ Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
¹⁰ Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
¹¹ Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
¹² Department of Breast Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
¹³ Thoracic Center, St. Luke's International Hospital, Tokyo, Japan.

PMID: 35246827
PMCID: PMC9098704
DOI: 10.1007/s40487-022-00188-2

Abstract

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.

Keywords: Antiemetic; Aprepitant; CINV; Fosaprepitant; Fosnetupitant; NEPA; Palonosetron.

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Figures

**Fig. 1**
Complete response rates during the traditional and extended time intervals: exploratory analysis

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References

1. Navari RM, Aapro M. Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med. 2016;374(14):1356–1367. doi: 10.1056/NEJMra1515442. - DOI - PubMed
1. Jordan K, Jahn F, Aapro M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. Ann Oncol. 2015;26(6):1081–1090. doi: 10.1093/annonc/mdv138. - DOI - PubMed
1. Kuchuk I, Bouganim N, Beusterien K, et al. Preference weights for chemotherapy side effects from the perspective of women with breast cancer. Breast Cancer Res Treat. 2013;142(1):101–107. doi: 10.1007/s10549-013-2727-3. - DOI - PubMed
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1. Fernández-Ortega P, Caloto MT, Chirveches E, et al. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients’ quality of life. Support Care Cancer. 2012;20(12):3141–3148. doi: 10.1007/s00520-012-1448-1. - DOI - PubMed

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[1] Navari RM, Aapro M. Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med. 2016;374(14):1356–1367. doi: 10.1056/NEJMra1515442. - DOI - PubMed

[2] Navari RM, Aapro M. Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med. 2016;374(14):1356–1367. doi: 10.1056/NEJMra1515442. - DOI - PubMed

[3] Jordan K, Jahn F, Aapro M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. Ann Oncol. 2015;26(6):1081–1090. doi: 10.1093/annonc/mdv138. - DOI - PubMed

[4] Jordan K, Jahn F, Aapro M. Recent developments in the prevention of chemotherapy-induced nausea and vomiting (CINV): a comprehensive review. Ann Oncol. 2015;26(6):1081–1090. doi: 10.1093/annonc/mdv138. - DOI - PubMed

[5] Kuchuk I, Bouganim N, Beusterien K, et al. Preference weights for chemotherapy side effects from the perspective of women with breast cancer. Breast Cancer Res Treat. 2013;142(1):101–107. doi: 10.1007/s10549-013-2727-3. - DOI - PubMed

[6] Kuchuk I, Bouganim N, Beusterien K, et al. Preference weights for chemotherapy side effects from the perspective of women with breast cancer. Breast Cancer Res Treat. 2013;142(1):101–107. doi: 10.1007/s10549-013-2727-3. - DOI - PubMed

[7] Sun CC, Bodurka DDC, Weaver CB, et al. Rankings and symptom assessments of side effects from chemotherapy: insights from experienced patients with ovarian cancer. Support Care Cancer. 2005;13(4):219–227. doi: 10.1007/s00520-004-0710-6. - DOI - PubMed

[8] Sun CC, Bodurka DDC, Weaver CB, et al. Rankings and symptom assessments of side effects from chemotherapy: insights from experienced patients with ovarian cancer. Support Care Cancer. 2005;13(4):219–227. doi: 10.1007/s00520-004-0710-6. - DOI - PubMed

[9] Fernández-Ortega P, Caloto MT, Chirveches E, et al. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients’ quality of life. Support Care Cancer. 2012;20(12):3141–3148. doi: 10.1007/s00520-012-1448-1. - DOI - PubMed

[10] Fernández-Ortega P, Caloto MT, Chirveches E, et al. Chemotherapy-induced nausea and vomiting in clinical practice: impact on patients’ quality of life. Support Care Cancer. 2012;20(12):3141–3148. doi: 10.1007/s00520-012-1448-1. - DOI - PubMed

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Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

Affiliations

Exploratory Analysis Comparing Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting (CINV): A Randomized, Double-Blind, Phase 3 Study (CONSOLE)

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