Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study

Suzuki, Kenichi; Yamanaka, T.; Hashimoto, H.; Shimada, Yasuhiro; Arata, Koji; Matsui, Reiko; Goto, Kōichi; Takiguchi, Tomomi; Ohyanagi, Fumiyoshi; Kogure, Yuki; Nogami, Naoyuki; Nakao, Masahiko; Takeda, Koji; Azuma, Keisuke; Nagase, Seisuke; Hayashi, Toshinobu; Fujiwara, Kimiko; Shimada, Tsutomu; Seki, Nobuhiko; Yamamoto, Nobuyuki

doi:10.1093/annonc/mdw220

Cited by 75 publications

(65 citation statements)

References 13 publications

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“…In general, previous phase III trials of antiemetics use a complete response ratio in the overall phase or delayed phase after the first course for each patient as a true endpoint 14, 15. In our opinion, however, there is no rationale to speculate that the present surrogate endpoint is not an appropriate assessment for antiemetic efficacy, as pharmacists reviewed all outpatients to assess CINV and other adverse events induced by chemotherapy, and consulted physicians to modify salvage antiemetic therapy as needed.…”

Section: Discussionmentioning

confidence: 99%

“…Consequently, no patients discontinued chemotherapy because of CINV in this study. Palonosetron, a second-generation 5-HT 3 RA, has a longer half-life than other first-generation 5-HT 3 RAs and is also effective against delayed phase CINV for highly emetogenic chemotherapy 14, 15. In Japan, palonosetron dosing is approved at 0.75 mg, 3-fold higher than in other countries.…”

Section: Discussionmentioning

confidence: 99%

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Antiemetic Effectiveness and Cost-Saving of Aprepitant plus Granisetron Is Superior to Palonosetron in Gastrointestinal Cancer Patients Who Received Moderately Emetogenic Chemotherapy

Toda¹,

Kawazoe²,

Yano³

et al. 2017

J. Cancer

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Purpose The therapeutic benefit of a three-drug combination of antiemetics has not been established in moderately emetogenic chemotherapy (MEC). The aim of this study was to compare the antiemetic effectiveness and cost-saving of palonosetron plus dexamethasone (control group) with aprepitant, granisetron, and dexamethasone (study group) in cancer patients who received MEC.Methods We switched the standard antiemetic treatment from the control group to the study group in gastrointestinal cancer patients who received MEC after October 2015. The antiemetics in both groups were modified using salvage antiemetic therapy at the clinicians' discretion, according to the severity of chemotherapy-induced nausea and vomiting. We retrospectively reviewed the electronic medical records from patients, before and after switching groups, from between April 2014 and March 2016.Results We evaluated 443 treatment courses in 83 patients. The proportion of courses that included salvage antiemetic therapy in the control group and the study group was 34.8 % (116/333) and 8.2 % (9/110), respectively, and was statistically significant (p < 0.001). The mean integrated costs of antiemetics per course in the control group and the study group were 193 ± 55 USD and 143 ± 38 USD, respectively. Multivariate logistic regression analysis revealed that the study group was significantly associated with a reduced risk of requiring salvage antiemetic therapy (p = 0.038).Conclusions These results suggest that the antiemetic effectiveness and cost-saving of a three-drug combination of aprepitant, generic granisetron, and dexamethasone was superior to a two-drug combination of palonosetron plus dexamethasone in gastrointestinal cancer patients who received MEC.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Antiemetic Effectiveness and Cost-Saving of Aprepitant plus Granisetron Is Superior to Palonosetron in Gastrointestinal Cancer Patients Who Received Moderately Emetogenic Chemotherapy

Toda¹,

Kawazoe²,

Yano³

et al. 2017

J. Cancer

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“…In our previous study, Suzuki et al reported a CR rate for palonosetron combined with dexamethasone and aprepitant in patients receiving high emetic risk chemotherapy (HEC) of 68% [7].…”

Section: Discussionmentioning

confidence: 98%

5-Hydroxytryptamine-3 Receptor Antagonist and Dexamethasone as Prophylaxis for Chemotherapy Induced Nausea and Vomiting during Moderately Emetic Chemotherapy for Solid Tumors: A Multicenter, Prospective, Observational Study

Matsui

Suzuki

Takiguchi

et al. 2020

Preprint

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“…The 5HT 3 receptor antagonist called palonosetron has a superior inhibitory effect on CINV in the delayed phase compared to another such drug, granisetron 9 , thus we used palonosetron in this study. During the rst course of chemotherapy, all patients received oral aprepitant 125 mg, intravenous dexamethasone 9.9 mg, and intravenous palonosetron 0.75 mg before chemotherapy on day 1.…”

Section: Antiemetic Treatmentmentioning

confidence: 99%

The Impact on Quality of Life of Highly Effective Antiemetic Therapy among Breast Cancer Patients Receiving Anthracycline Plus Cyclophosphamide-based Regimen

Tokumaru

Narui

Yamada

et al. 2018

Showa Univ J Med Sci

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Treatment for chemotherapy-induced nausea and vomiting CINV has improved signi cantly with the development of antiemetic drugs. We conducted a prospective observational study to clarify the quality of life QOL impact of antiemetic therapy recommended by the Japanese Cancer Therapy Association JSCO guidelines for Japanese breast cancer patients receiving an anthracycline plus cyclophosphamide regimen ACR. This was an open, single-center, prospective observational study conducted in Yokohama City University Medical Center. Antiemetic therapy recommended by the JSCO guidelines was implemented for all cases treated therein i.e., aprepitant, dexamethasone, and palonosetron. The primary endpoint was no impact on daily living NIDL rate during a 120-hour period following chemotherapy i.e., overall phase. We use the Japanese version of the Functional Living Index-Emesis FLIE to evaluate the impact of CINV on QOL. There were 118 analyzable cases. The NIDL rate during the overall phase was 44.9 , and was signi cantly lower than the complete response CR rate of 58.5 i.e., no emetic responses and no rescue medication ; P 0.037. Age 55 years P 0.008 and a history of morning sickness P 0.005 were identi ed as independent risk factors of NIDL P 0.05. Among Japanese breast cancer patients receiving ACR and a combination of aprepitant, dexamethasone, and palonosetron, the NIDL rate was relatively low at approximately 45. A more effective antiemetic therapy should therefore be developed for patients QOL that takes NIDL risk factors into account. In addition, our results suggested that the CR rate is insuf cient for evaluating the effect of antiemetic therapy on a patient s QOL.

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Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study

Abstract: UMIN000004863.

Cited by 75 publications

References 13 publications

Antiemetic Effectiveness and Cost-Saving of Aprepitant plus Granisetron Is Superior to Palonosetron in Gastrointestinal Cancer Patients Who Received Moderately Emetogenic Chemotherapy

Antiemetic Effectiveness and Cost-Saving of Aprepitant plus Granisetron Is Superior to Palonosetron in Gastrointestinal Cancer Patients Who Received Moderately Emetogenic Chemotherapy

5-Hydroxytryptamine-3 Receptor Antagonist and Dexamethasone as Prophylaxis for Chemotherapy Induced Nausea and Vomiting during Moderately Emetic Chemotherapy for Solid Tumors: A Multicenter, Prospective, Observational Study

The Impact on Quality of Life of Highly Effective Antiemetic Therapy among Breast Cancer Patients Receiving Anthracycline Plus Cyclophosphamide-based Regimen

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