A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study)

Zhao, Yuanyuan; Yang, Yunpeng; Gao, Fangfang; Hu, Chang-Lu; Zhong, Diansheng; Lu, Miaozhen; Yuan, Zhiyong; Zhao, Jingbo; Miao, Jinlin; Li, Yan; Zhu, J.; Wang, Chunbin; Han, Jianjun; Zhao, Yanqiu; Huang, Yan; Zhang, Li

doi:10.1016/j.eclinm.2022.101771

Cited by 14 publications

(8 citation statements)

References 37 publications

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“…The 2015 recommendation was a three-drug combination of a 5-HT 3 -RA plus DEX and aprepitant for the prevention of acute nausea and vomiting and DEX for delayed nausea and vomiting [ 1 ]. Previous multiple-day chemotherapy studies were incorporated in this review, as well as newly published data, including a large phase III study [ 8 ].…”

Section: Resultsmentioning

confidence: 99%

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2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting

Rapoport,

Herrstedt,

Snow

et al. 2023

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Purpose This review is an update of the MASCC/ESMO 2015 recommendations for the prophylaxis of acute and delayed nausea and vomiting induced by multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting. Methods A systematic literature search was conducted using PubMed from June 1, 2015, through February 1, 2023. Results We identified 56 references (16 were duplications or invalid), leaving 40 manuscripts for this search. The panel classified level I evidence (three manuscripts) and level II evidence (14 manuscripts). High-dose chemotherapy and stem cell transplant were discussed in four of these manuscripts, and multiple-day chemotherapy treatment in 15. Some manuscripts covered both topics. Additionally, a search for breakthrough nausea and vomiting resulted in 12 “hits.” No new relevant studies were identified. Conclusions The recommendations for patients receiving high-dose chemotherapy with stem cell transplants and patients undergoing multiple-day cisplatin were updated. For patients receiving high-dose chemotherapy for stem cell transplant, a combination of a 5-HT3 receptor antagonist with dexamethasone and aprepitant is recommended. Olanzapine could be considered part of the antiemetic regimen. Patients receiving multiple-day cisplatin should receive a 5-HT3 receptor antagonist plus dexamethasone plus aprepitant plus olanzapine. For patients experiencing breakthrough nausea and vomiting, the available evidence suggests using a single dose of olanzapine daily for 3 days.

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Section: Resultsmentioning

confidence: 99%

“…The OFFER study [ 8 ] was a randomized, double-blind, placebo-controlled phase 3 trial conducted in 22 hospitals in China. Eligible patients were between 18 and 75 years old and had the diagnosis of malignant solid tumors.…”

Section: Resultsmentioning

confidence: 99%

2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting

Rapoport,

Herrstedt,

Snow

et al. 2023

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“…Researchers tried the novel definition of CINV phase for multi-day cisplatin chemotherapy: the current study team defined the acute phase as day1–3, the delayed phase as day4 -day7, and the period beyond the risk phase as from day 8 to 21 in our prior studies about 3-day cisplatin (Li et al 2022 ; Wei et al 2023 ). Another Chinese trial focused on 3-day cisplatin regimen defined the acute phase as day1-day3, the delayed phase as day4-day8 (Zhao et al 2023 ). In our study, the acute phase of CINV was defined as day1-3, the delayed phase as day 4–7, while the CIVN beyond the risk period was identified as day 8–21 of the chemotherapy cycle.…”

Section: Discussionmentioning

confidence: 99%

Two doses of fosaprepitant included prophylactic treatment for the three-day cisplatin-based chemotherapy induced nausea and vomiting

Li,

Wan,

Yang

et al. 2024

J Cancer Res Clin Oncol

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Purpose Neurokinin 1 receptor antagonists included prophylactic treatment was recommended for patients who receive one-day cisplatin chemotherapy. It is unclear whether the prolonged administration of fosaprepitant is effective for three-day cisplatin-based chemotherapy induced nausea and vomiting (CINV). We aim to explore the prophylactic antiemetic efficacy and safety of two doses of fosaprepitant included regimen in the patients receiving multiple-day cisplatin chemotherapy. Methods This randomized, parallel-group, open-labelled study was conducted in nine hospitals between February 2021 and February 2023. Patients diagnosed as lung cancer and chemotherapy naive were screened. Eligible participants were scheduled to be treated with highly emetogenic chemotherapy regimen which including three days of cisplatin. Then they were randomly divided into the experimental group (two doses of fosaprepitant, Group 2DF) and the control group (one dose of fosaprepitant, Group C). The primary endpoints included the safety and the average none CINV days (NCDs). This study was registered on the website of chictr.org.cn, number ChiCTR2100042665. Results Overall, 204 participants were randomly assigned, and 198 patients were analyzed. No statistical difference in adverse events was found between the two groups. All treatment-related adverse effects for fosaprepitant observed were of grade 1–2. The average NCDs of Group 2DF was significantly more than Group C (18.21 ± 3.40 days vs 16.14 ± 5.20 days, P = 0.001). Furthermore, the better life function score was achieved in Group 2DF according to FLIE questionnaire. Conclusion The administration of two-dose fosaprepitant was safe and more effective than one dose in protecting patients from CINV induced by three-day cisplatin included chemotherapy.

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“…A multicentre, randomised, double-blind, placebo-controlled, phase III trial, adequately powered, evaluated the efficacy of olanzapine combined with triple antiemetic therapy for the prevention of CINV in patients receiving multi-day ChT. 68 The study was conducted in 349 Chinese patients with solid tumours scheduled to receive 3-day cisplatin-based (≥75 mg/m 2 ) ChT. Patients were randomly assigned to receive either 5 mg olanzapine or placebo p.o.…”

Section: Prevention Of Nausea and Vomiting In Patients Treated With H...mentioning

confidence: 99%

2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting

Herrstedt,

Clark-Snow,

Ruhlmann

et al. 2024

ESMO Open

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A multicenter, randomized, double-blind, placebo-controlled, phase 3 trial of olanzapine plus triple antiemetic regimen for the prevention of multiday highly emetogenic chemotherapy-induced nausea and vomiting (OFFER study)

Cited by 14 publications

References 37 publications

2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting

2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following multiple-day chemotherapy, high-dose chemotherapy, and breakthrough nausea and vomiting

Two doses of fosaprepitant included prophylactic treatment for the three-day cisplatin-based chemotherapy induced nausea and vomiting

2023 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting

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