Economic analysis of palonosetron versus granisetron in the standard triplet regimen for preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy in Japan (TRIPLE phase III trial)

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Abstract

Background

We conducted an economic assessment using test data from the phase III TRIPLE study, which examined the efficacy of a 5-hydroxytryptamine 3 receptor antagonist as part of a standard triplet antiemetic regimen including aprepitant and dexamethasone in preventing chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC).

Methods

We retrospectively investigated all medicines prescribed for antiemetic purposes within 120 h after the initiation of cisplatin administration during hospitalization. In the TRIPLE study, patients were assigned to treatment with granisetron (GRA) 1 mg ( n = 413) or palonosetron (PALO) 0.75 mg ( n = 414). The evaluation measure was the cost-effectiveness ratio (CER) assessed as the cost per complete response (CR; no vomiting/retching and no rescue medication). The analysis was conducted from the public healthcare payer’s perspective.

Results

The CR rates were 59.1% in the GRA group and 65.7% in the PALO group ( P = 0.0539), and the total frequencies of rescue medication use for these groups were 717 (153/413 patients) and 573 (123/414 patients), respectively. In both groups, drugs with antidopaminergic effects were chosen as rescue medication in 86% of patients. The costs of including GRA and PALO in the standard triplet antiemetic regimen were 15,342.8 and 27,863.8 Japanese yen (JPY), respectively. In addition, the total costs of rescue medication use were 73,883.8 (range, 71,106.4–79,017.1) JPY for the GRA group and 59,292.7 (range, 57,707.5–60,972.8) JPY for the PALO group. The CERs (JPY/CR) were 26,263.4 and 42,628.6 for the GRA and PALO groups, respectively, and the incremental cost-effectiveness ratio (ICER) between the groups was 189,171.6 (189,044.8–189,215.5) JPY/CR.

Conclusions

We found that PALO was more expensive than GRA in patients who received a cisplatin-based HEC regimen.

Electronic supplementary material

The online version of this article (10.1186/s40780-018-0128-9) contains supplementary material, which is available to authorized users.

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Most cited references 19

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Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

Ethan Basch, Ann Prestrud, Paul J Hesketh … (2011)

To update the American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology. A systematic review of the medical literature was completed to inform this update. MEDLINE, the Cochrane Collaboration Library, and meeting materials from ASCO and the Multinational Association for Supportive Care in Cancer were all searched. Primary outcomes of interest were complete response and rates of any vomiting or nausea. Thirty-seven trials met prespecified inclusion and exclusion criteria for this systematic review. Two systematic reviews from the Cochrane Collaboration were identified; one surveyed the pediatric literature. The other compared the relative efficacy of the 5-hydroxytryptamine-3 (5-HT(3)) receptor antagonists. Combined anthracycline and cyclophosphamide regimens were reclassified as highly emetic. Patients who receive this combination or any highly emetic agents should receive a 5-HT(3) receptor antagonist, dexamethasone, and a neurokinin 1 (NK(1)) receptor antagonist. A large trial validated the equivalency of fosaprepitant, a single-day intravenous formulation, with aprepitant; either therapy is appropriate. Preferential use of palonosetron is recommended for moderate emetic risk regimens, combined with dexamethasone. For low-risk agents, patients can be offered dexamethasone before the first dose of chemotherapy. Patients undergoing high emetic risk radiation therapy should receive a 5-HT(3) receptor antagonist before each fraction and for 24 hours after treatment and may receive a 5-day course of dexamethasone during fractions 1 to 5. The Update Committee noted the importance of continued symptom monitoring throughout therapy. Clinicians underestimate the incidence of nausea, which is not as well controlled as emesis.

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The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group.

K Beck, Sant P Chawla, Alexandra D Carides … (2003)

In early clinical trials with patients receiving highly emetogenic chemotherapy, the neurokinin antagonist aprepitant significantly enhanced the efficacy of a standard antiemetic regimen consisting of a type-three 5-hydroxytryptamine antagonist and a corticosteroid. This multicenter, randomized, double-blind, placebo-controlled phase III study was performed to establish definitively the superiority of the aprepitant regimen versus standard therapy in the prevention of chemotherapy-induced nausea and vomiting (CINV). Patients receiving cisplatin > or = 70 mg/m2 for the first time were given either standard therapy (ondansetron and dexamethasone on day 1; dexamethasone on days 2 to 4) or an aprepitant regimen (aprepitant plus ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2 to 3; dexamethasone on day 4). Patients recorded nausea and vomiting episodes in a diary. The primary end point was complete response (no emesis and no rescue therapy) on days 1 to 5 postcisplatin, analyzed by a modified intent-to-treat approach. Treatment comparisons were made using logistic regression models. Tolerability was assessed by reported adverse events and physical and laboratory assessments. The percentage of patients with complete response on days 1 to 5 was significantly higher in the aprepitant group (72.7% [n = 260] v 52.3% in the standard therapy group [n = 260]), as were the percentages on day 1, and especially on days 2 to 5 (P <.001 for all three comparisons). Compared with standard dual therapy, addition of aprepitant was generally well tolerated and provided consistently superior protection against CINV in patients receiving highly emetogenic cisplatin-based chemotherapy.

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Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America.

Maria José de Freitas Rodrigues, K. Taro Eldridge, Alexandra D Carides … (2003)

Aprepitant is a novel neurokinin 1 (NK(1)) antagonist that has been shown to improve control of chemotherapy-induced nausea and vomiting (CINV) when added to a standard antiemetic regimen of a 5-hydroxytriptamine-3 antagonist plus a corticosteroid. The authors sought to evaluate further the efficacy and tolerability of aprepitant plus standard therapy in a large clinical trial. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-groups, Phase III study. Patients with cancer who were scheduled to receive treatment with high-dose cisplatin chemotherapy were randomized to receive 1 of 2 treatment regimens; the standard therapy group received intravenous ondansetron 32 mg and oral dexamethasone 20 mg on Day 1, and oral dexamethasone 8 mg twice daily on Days 2-4. The aprepitant group received oral aprepitant 125 mg, intravenous ondansetron 32 mg, and oral dexamethasone 12 mg on Day 1; oral aprepitant 80 mg and oral dexamethasone 8 mg once daily on Days 2-3; and oral dexamethasone 8 mg on Day 4. Patients recorded episodes of emesis, use of rescue therapy, and severity of nausea in a diary. A modified intent-to-treat approach was used to analyze the efficacy data. The primary endpoint was complete response (no emesis and no rescue therapy) during the 5-day period postcisplatin. Treatment comparisons were made using logistic regression models, and reported adverse events and physical and laboratory assessments were used to assess tolerability. A total of 523 patients were evaluated for efficacy, and 568 patients were evaluated for safety. During the 5 days after chemotherapy, the percentages of patients who achieved a complete response were 62.7% in the aprepitant group (163 of 260 patients) versus 43.3% in the standard therapy group (114 of 263 patients; P < 0.001). For Day 1, the complete response rates were 82.8% for the aprepitant group and 68.4% for the standard therapy group (P < 0.001); for Days 2-5, the complete response rates were 67.7% in the aprepitant group and 46.8% in the standard therapy group (P < 0.001). The overall incidence of adverse events was similar between the 2 treatment groups (72.8% in the aprepitant group [206 of 283 patients] and 72.6% in the standard therapy group [207 of 285 patients]) as were rates of serious adverse events, discontinuations due to adverse events, and deaths. In patients with cancer who are receiving high-dose cisplatin-based chemotherapy, therapy consisting of aprepitant (125 mg on Day 1 and 80 mg on Days 2-3) plus a standard regimen of ondansetron and dexamethasone provided superior antiemetic protection compared with standard therapy alone and was generally well tolerated. Copyright 2003 American Cancer Society.

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Author and article information

Contributors

Hisanori Shimizu:

ORCID: http://orcid.org/0000-0002-5623-6464

+81-3-3784-8467 , h-shimizu@cmed.showa-u.ac.jp

Kenichi Suzuki: kenichi.suzuki@jfcr.or.jp

Takeshi Uchikura: take-u@cmed.showa-u.ac.jp

Daiki Tsuji: d-tsuji@u-shizuoka-ken.ac.jp

Takeharu Yamanaka: takeharu.yamanaka@gmail.com

Hironobu Hashimoto: hhashimo@ncc.go.jp

Koichi Goto: kgoto@east.ncc.go.jp

Reiko Matsui: rmatsui@east.ncc.go.jp

Nobuhiko Seki: nseki@med.teikyo-u.ac.jp

Toshikazu Shimada: toshi-s@med.teikyo-u.ac.jp

Shunya Ikeda: ikeda@shunya.jp

Naoki Ikegami: nikegami1949@gmail.com

Toshihiro Hama: toshihiro.hama@jfcr.or.jp

Nobuyuki Yamamoto: nbyamamo@wakayama-med.ac.jp

Tadanori Sasaki: t-sasaki@pharm.showa-u.ac.jp

Journal

Journal ID (nlm-ta): J Pharm Health Care Sci

Journal ID (iso-abbrev): J Pharm Health Care Sci

Title: Journal of Pharmaceutical Health Care and Sciences

Publisher: BioMed Central (London )

ISSN (Electronic): 2055-0294

Publication date (Electronic): 10 December 2018

Publication date PMC-release: 10 December 2018

Publication date Collection: 2018

Volume: 4

Electronic Location Identifier: 31

Affiliations

[1 ]ISNI 0000 0000 8864 3422, GRID grid.410714.7, Department of Hospital Pharmaceutics, School of Pharmacy, , Showa University, ; Tokyo, Japan

[2 ]ISNI 0000 0004 0443 165X, GRID grid.486756.e, Department of Pharmacy, Japanese Foundation for Cancer Research, , Cancer Institute Hospital, ; Tokyo, Japan

[3 ]ISNI 0000 0000 9209 9298, GRID grid.469280.1, Department of Clinical Pharmacology & Genetics, School of Pharmaceutical Sciences, , University of Shizuoka, ; Shizuoka, Japan

[4 ]ISNI 0000 0001 1033 6139, GRID grid.268441.d, Department of Biostatistics, , Yokohama City University School of Medicine, ; Yokohama, Japan

[5 ]ISNI 0000 0001 2168 5385, GRID grid.272242.3, Division of Pharmacy, , National Cancer Center Hospital, ; Tokyo, Japan

[6 ]ISNI 0000 0001 2168 5385, GRID grid.272242.3, Department of Thoracic Oncology, , National Cancer Center Hospital East, ; Kashiwa, Japan

[7 ]ISNI 0000 0001 2168 5385, GRID grid.272242.3, Departments of Pharmacy, , National Cancer Center Hospital East, ; Kashiwa, Japan

[8 ]ISNI 0000 0000 9239 9995, GRID grid.264706.1, Division of Medical Oncology, Department of Internal Medicine, , Teikyo University School of Medicine, ; Tokyo, Japan

[9 ]ISNI 0000 0004 1769 1397, GRID grid.412305.1, Center for Clinical Reseach&Trial, , Teikyo University Hospital, ; Tokyo, Japan

[10 ]ISNI 0000 0004 0531 3030, GRID grid.411731.1, Department of Public Health, School of Medicine, , International University of Health and Welfare, ; Chiba, Japan

[11 ]ISNI 0000 0001 0318 6320, GRID grid.419588.9, Graduate School of Public Health, , St Lukes International University, ; Tokyo, Japan

[12 ]ISNI 0000 0004 1763 1087, GRID grid.412857.d, Third Department of Internal Medicine, , Wakayama Medical University, ; Wakayama, Japan

[13 ]ISNI 0000 0004 0443 9643, GRID grid.412812.c, Department of Pharmacy Services, , Showa University Hospital, ; 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666 Japan

Author information

Hisanori Shimizu http://orcid.org/0000-0002-5623-6464

Article

Publisher ID: 128

DOI: 10.1186/s40780-018-0128-9

PMC ID: 6287343

SO-VID: 0b1dd656-779e-4876-a181-39e7a4e96ec7

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 5 July 2018

Date accepted : 14 November 2018

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Keywords: highly emetogenic chemotherapy,5-ht3 receptor antagonist,palonosetron,granisetron,chemotherapy-induced nausea and vomiting,cost-effectiveness,real-world data analysis

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Keywords: highly emetogenic chemotherapy, 5-ht3 receptor antagonist, palonosetron, granisetron, chemotherapy-induced nausea and vomiting, cost-effectiveness, real-world data analysis

Economic analysis of palonosetron versus granisetron in the standard triplet regimen for preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy in Japan (TRIPLE phase III trial)

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Abstract

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Results

Conclusions

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Most cited references 19

Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

The oral neurokinin-1 antagonist aprepitant for the prevention of chemotherapy-induced nausea and vomiting: a multinational, randomized, double-blind, placebo-controlled trial in patients receiving high-dose cisplatin--the Aprepitant Protocol 052 Study Group.

Addition of the neurokinin 1 receptor antagonist aprepitant to standard antiemetic therapy improves control of chemotherapy-induced nausea and vomiting. Results from a randomized, double-blind, placebo-controlled trial in Latin America.

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