PMID- 37851143
OWN - NLM
STAT- MEDLINE
DCOM- 20231023
LR  - 20231214
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Linking)
VI  - 31
IP  - 12
DP  - 2023 Oct 18
TI  - Efficacy of fosaprepitant combined with tropisetron plus dexamethasone in 
      preventing nausea and emesis during fractionated radiotherapy with weekly 
      cisplatin chemotherapy: interim analysis of a randomized, prospective, clinical 
      trial using competing risk analysis.
PG  - 640
LID - 10.1007/s00520-023-08111-9 [doi]
AB  - PURPOSE: There are no well-recognized guidelines for antiemesis during concurrent 
      chemoradiotherapy (CCRT) for cervical cancer (CC) and nasopharyngeal cancer (NPC) 
      until now. The study was designed to assess the efficacy and safety of 
      fosaprepitant combined with tropisetron and dexamethasone in preventing nausea 
      and vomiting during 5 weeks of fractionated radiotherapy and concomitant weekly 
      low-dose cisplatin chemotherapy in patients with CC or NPC. METHODS: Patients 
      with CC or NPC were scheduled to receive fractionated radiotherapy and weekly 
      cisplatin (25-40 mg/m(2)) chemotherapy for at least 5 weeks. Patients stratified 
      by tumor type and induction chemotherapy were 1:1 randomly assigned to receive 
      fosaprepitant, tropisetron, and dexamethasone or tropisetron plus dexamethasone 
      as an antiemetic regimen. Efficacy was assessed primarily by the cumulative 
      incidence of emesis after 5 weeks of treatment, and safety by adverse events 
      (AEs). RESULTS: Between July 2020 and July 2022, 116 patients consented to the 
      study of whom 103 were included in this interim analysis (fosaprepitant group 
      [N = 52] vs control group [N = 51]). The cumulative incidence of emesis at 
      5 weeks (competing risk analysis) was 25% (95% CI 14.2-37.4) for the 
      fosaprepitant group compared with 59% (95% CI 43.9-71.0) for the control group. 
      There was a significantly lower cumulative risk of emesis in the fosaprepitant 
      group (HR 0.35 [95% CI 0.19-0.64]; p < 0.001). Fosaprepitant was well tolerated 
      as the incidences of adverse events in the two groups were comparable. 
      CONCLUSION: The addition of fosaprepitant to tropisetron plus dexamethasone 
      significantly reduced the risk of nausea and vomiting during 5 weeks of CCRT in 
      patients with CC or NPC, and fosaprepitant was well tolerated. TRIAL 
      REGISTRATION: The trial was registered with ClinicalTrials.gov on October 3, 
      2022, number NCT05564286.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, 
      part of Springer Nature.
FAU - Xie, Song
AU  - Xie S
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Shantou University Medical College, Shantou, China.
FAU - Huang, Ruihong
AU  - Huang R
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Zhan, Yizhou
AU  - Zhan Y
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Cai, Qingxin
AU  - Cai Q
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Wu, Yanxuan
AU  - Wu Y
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Huang, Kang
AU  - Huang K
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Department of Radiation Oncology, Zhongshan City People's Hospital, Zhongshan, 
      China.
FAU - Lin, Xiaoluan
AU  - Lin X
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Shantou University Medical College, Shantou, China.
FAU - Wang, Ruoheng
AU  - Wang R
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Yan, Yudong
AU  - Yan Y
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Shantou University Medical College, Shantou, China.
FAU - Xie, Renxian
AU  - Xie R
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Shantou University Medical College, Shantou, China.
FAU - Wang, Siyan
AU  - Wang S
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
AD  - Shantou University Medical College, Shantou, China.
FAU - Zeng, Chengbing
AU  - Zeng C
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China.
FAU - Chen, Chuangzhen
AU  - Chen C
AD  - Department of Radiation Oncology, Cancer Hospital of Shantou University Medical 
      College, 7 Raoping Road, Shantou, China. czchen2@stu.edu.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT05564286
GR  - 220428166491813/Shantou Medical and Health Science and Technology Planning 
      Project/
GR  - 210408216492660/Shantou Medical and Health Science and Technology Planning 
      Project/
GR  - N0201424 (to CC and JC)/Shantou University Medical College Clinical Research 
      Enhancement Initiative/
GR  - 2019-132 (to CC)/Science and Technology Special Fund of Guangdong Province of 
      China/
GR  - 180918114960704 (to CC)/Strategic and Special Fund for Science and Technology 
      Innovation of Guangdong Province of China/
GR  - 82173079 (to CC)/Innovative Research Group Project of the National Natural 
      Science Foundation of China/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20231018
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  - Q20Q21Q62J (Cisplatin)
RN  - 6I819NIK1W (Tropisetron)
RN  - 6L8OF9XRDC (fosaprepitant)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antiemetics)
SB  - IM
MH  - Female
MH  - Humans
MH  - Cisplatin
MH  - Tropisetron/therapeutic use
MH  - Dexamethasone
MH  - *Antineoplastic Agents/adverse effects
MH  - Vomiting/chemically induced/prevention & control
MH  - *Nasopharyngeal Neoplasms
MH  - Prospective Studies
MH  - Nausea/etiology/prevention & control/drug therapy
MH  - *Antiemetics/therapeutic use
MH  - *Uterine Cervical Neoplasms/drug therapy
MH  - Dose Fractionation, Radiation
MH  - Drug Therapy, Combination
OTO - NOTNLM
OT  - Antiemetics
OT  - CRINV
OT  - Competing risk analysis
OT  - Fosaprepitant
OT  - Weekly cisplatin
EDAT- 2023/10/18 12:42
MHDA- 2023/10/23 01:18
CRDT- 2023/10/18 11:08
PHST- 2022/10/26 00:00 [received]
PHST- 2023/10/09 00:00 [accepted]
PHST- 2023/10/23 01:18 [medline]
PHST- 2023/10/18 12:42 [pubmed]
PHST- 2023/10/18 11:08 [entrez]
AID - 10.1007/s00520-023-08111-9 [pii]
AID - 10.1007/s00520-023-08111-9 [doi]
PST - epublish
SO  - Support Care Cancer. 2023 Oct 18;31(12):640. doi: 10.1007/s00520-023-08111-9.