PMID- 35449368 OWN - NLM STAT- MEDLINE DCOM- 20220530 LR - 20220723 IS - 1433-7339 (Electronic) IS - 0941-4355 (Print) IS - 0941-4355 (Linking) VI - 30 IP - 7 DP - 2022 Jul TI - Olanzapine (5 mg) plus standard triple antiemetic therapy for the prevention of multiple-day cisplatin hemotherapy-induced nausea and vomiting: a prospective randomized controlled study. PG - 6225-6232 LID - 10.1007/s00520-022-07067-6 [doi] AB - OBJECTIVE: A prospective randomized controlled trial was conducted to compare 5 mg olanzapine plus standard triple antiemetic therapy for the prevention of nausea and vomiting induced by multiple-day cisplatin chemotherapy. METHODS: Patients who received a 3-day cisplatin-based chemotherapy (25 mg/m(2)/d) were given either 5 mg olanzapine plus triple therapy with aprepitant, tropisetron, and dexamethasone (quadruple group) or 5 mg olanzapine plus tropisetron and dexamethasone, omitting aprepitant (triplet group). The primary endpoint was the complete response (CR) in the overall phase (OP) (0-120 h) between quadruple group and triplet group. The secondary endpoints were the CR in the acute phase (AP) (0-24 h) and delayed phase (DP) (25-120 h) between two groups. The first time of vomiting was also compared by Kaplan-Meier curves. The impact of chemotherapy-induced nausea and vomiting (CINV) on the quality of life was assessed by the Functional Living Index-Emesis (FLIE). Aprepitant-related adverse effects (AEs) were also recorded. RESULTS: (1) The primary endpoint CR during OP was 76.0% (45/59) vs 67.0% (41/61) between the quadruple group and triplet group (P = 0.271). The secondary endpoint CR during the AP was significantly higher in the quadruple group than in the triplet group, which was 100.0% (59/59) vs 93.0% (57/61) (P = 0.045). The difference of CR during delayed phase between the groups was especially higher in the quadruple group compared to the triplet group (76.0% (45/59) vs 67.0% (41/61) (P = 0.271)). The rate of patients who achieved total protection in the overall phase was also higher in the quadruple group than the triplet group (28.8% (17/59) vs 23.0% (14/61) (P = 0.463)). During the OP, the incidence of no vomiting in the quadruple group and the triplet group was 93.2% (55/59) vs 80.3% (49/61) (P = 0.038), respectively. (2) Kaplan-Meier curves of time to first emesis were obviously longer in the quadruple group compared with the triplet group (P = 0.031). According to FLIE, no impact of CINV on daily life was defined as total score of questionnaire > 108; this study exhibited identical life quality between two groups. (3) The most common aprepitant- or olanzapine-related AEs included sedation, fatigue, and constipation. The occurrences between two groups were identical. CONCLUSION: It may been recommended that 5 mg olanzapine plus tropisetron and dexamethasone, omitting aprepitant triplet regimen as an alternative therapy in prevention CINV induced by multiple-day cisplatin chemotherapy due to the excellent CINV control rate and safety. CI - (c) 2022. The Author(s). FAU - Gao, Jiali AU - Gao J AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Zhao, Jun AU - Zhao J AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Jiang, Caihong AU - Jiang C AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Chen, Feng AU - Chen F AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Zhao, Lanzhen AU - Zhao L AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Jiang, Ying AU - Jiang Y AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Li, Hui AU - Li H AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Wang, Wenjuan AU - Wang W AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Wu, Yungaowa AU - Wu Y AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Jin, Yilan AU - Jin Y AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Da, Lenggaowa AU - Da L AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Liu, Guang AU - Liu G AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Zhang, Yajuan AU - Zhang Y AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Li, Hongxia AU - Li H AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Zhang, Zewei AU - Zhang Z AD - Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China. FAU - Jin, Gaowa AU - Jin G AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. FAU - Li, Quanfu AU - Li Q AD - Department of Medical Oncology, Ordos Central Hospital, Ordos, 017000, China. 1729259137@qq.com. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220421 PL - Germany TA - Support Care Cancer JT - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer JID - 9302957 RN - 0 (Antiemetics) RN - 0 (Antineoplastic Agents) RN - 1NF15YR6UY (Aprepitant) RN - 6I819NIK1W (Tropisetron) RN - 7S5I7G3JQL (Dexamethasone) RN - N7U69T4SZR (Olanzapine) RN - Q20Q21Q62J (Cisplatin) SB - IM MH - *Antiemetics/therapeutic use MH - *Antineoplastic Agents/adverse effects MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects MH - Aprepitant/therapeutic use MH - Cisplatin/adverse effects MH - Dexamethasone/therapeutic use MH - Humans MH - Nausea/chemically induced/drug therapy/prevention & control MH - Olanzapine/therapeutic use MH - Prospective Studies MH - Quality of Life MH - Tropisetron/therapeutic use MH - Vomiting/chemically induced/drug therapy/prevention & control PMC - PMC9135873 OTO - NOTNLM OT - Aprepitant OT - CINV OT - Multiple-day cisplatin chemotherapy OT - Olanzapine COIS- The authors declare no competing interests. EDAT- 2022/04/23 06:00 MHDA- 2022/05/31 06:00 PMCR- 2022/04/21 CRDT- 2022/04/22 06:04 PHST- 2021/05/27 00:00 [received] PHST- 2022/04/13 00:00 [accepted] PHST- 2022/04/23 06:00 [pubmed] PHST- 2022/05/31 06:00 [medline] PHST- 2022/04/22 06:04 [entrez] PHST- 2022/04/21 00:00 [pmc-release] AID - 10.1007/s00520-022-07067-6 [pii] AID - 7067 [pii] AID - 10.1007/s00520-022-07067-6 [doi] PST - ppublish SO - Support Care Cancer. 2022 Jul;30(7):6225-6232. doi: 10.1007/s00520-022-07067-6. Epub 2022 Apr 21.