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Clinical Trial
. 2022 Oct;198(10):949-957.
doi: 10.1007/s00066-022-01958-7. Epub 2022 May 30.

Antiemetic prophylaxis for chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma: a prospective phase II trial

Zekun Wang  1 , Wenyang Liu  1 , Jianghu Zhang  1 , Xuesong Chen  1 , Jingbo Wang  1 , Kai Wang  1 , Yuan Qu  1 , Xiaodong Huang  1 , Jingwei Luo  1 , Jianping Xiao  1 , Guozhen Xu  1 , Li Gao  1 , Junlin Yi  2   3 , Ye Zhang  4
Affiliations
Clinical Trial

Antiemetic prophylaxis for chemoradiotherapy-induced nausea and vomiting in locally advanced head and neck squamous cell carcinoma: a prospective phase II trial

Zekun Wang et al. Strahlenther Onkol. 2022 Oct.

Abstract

Background: There is sparse research reporting effective interventions for preventing nausea and emesis caused by concurrent chemoradiotherapy (CCRT) in locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Methods: Treatment-naïve LA-HNSCC patients received intensity-modulated radiotherapy with concomitant cisplatin 100 mg/m2 (33 mg/m2/days [d]1-3) every 3 weeks for two cycles. All patients were given oral aprepitant 125 mg once on d1, then 80 mg once on d2-5; ondansetron 8 mg once on d1; and dexamethasone 12 mg once on d1, then 8 mg on d2-5. The primary endpoint was complete response (CR). Pursuant to δ = 0.2 and α = 0.05, the expected CR rate was 80%.

Results: A total of 43 patients with LA-HNSCC were enrolled. The median age was 53 years, and 86.0% were male. All patients received radiotherapy and 86.0% of patients completed both cycles as planned. The overall CR rate was 86.0% (95% confidence interval [CI]: 72.1-94.7). The CR rates for cycles 1 and 2 were 88.4% (95% CI: 74.9-96.1) and 89.2% (95% CI: 74.6-97.0). The complete protection rate in the overall phase was 72.1% (95% CI: 56.3-84.7). The emesis-free and nausea-free responses in the overall phase were 88.4% (95% CI: 74.9-96.1) and 60.5% (95% CI: 44.4-75.0), respectively. The adverse events related to antiemetics were constipation (65.1%) and hiccups (16.3%), but both were grade 1-2. There was no grade 4 or 5 treatment-related toxicity with antiemetic usage.

Conclusion: The addition of aprepitant into ondansetron and dexamethasone provided effective protection from nausea and emesis in patients with LA-HNSCC receiving radiotherapy and concomitant high-dose cisplatin chemotherapy.

Keywords: Antiemetic regimen; Concomitant chemotherapy; Intensity-modulated radiotherapy; Side effects; Complete response.

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Conflict of interest statement

Z. Wang, W. Liu, J. Zhang, X. Chen, J. Wang, K. Wang, Y. Qu, X. Huang, J. Luo, J. Xiao, G. Xu, L. Gao, J. Yi, and Y. Zhang declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The trial procedure. IMRT intensity-modulated radiotherapy, QOL quality of life
Fig. 2
Fig. 2
The distribution of patients with different grades of emesis
Fig. 3
Fig. 3
The distribution of patients with different grades of nausea based on the NVAS score
Fig. 4
Fig. 4
The percentages and grades of toxicities related to the antiemetics
See this image and copyright information in PMC

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References

    1. Navari RM, Aapro M. Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med. 2016;374:1356–1367. doi: 10.1056/NEJMra1515442. - DOI - PubMed
    1. Herrstedt J, Roila F, Warr D, et al. Updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high emetic risk chemotherapy. Support Care Cancer. 2016;2017(25):277–288. doi: 10.1007/s00520-016-3313-0. - DOI - PubMed
    1. Razvi Y, Chan S, McFarlane T, et al. ASCO, NCCN, MASCC/ESMO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in adult patients. Support Care Cancer. 2019;27:87–95. doi: 10.1007/s00520-018-4464-y. - DOI - PubMed
    1. Feyer P, Jahn F, Jordan K. Prophylactic management of radiation-induced nausea and vomiting. Biomed Res Int. 2015;2015:893013. doi: 10.1155/2015/893013. - DOI - PMC - PubMed
    1. Enblom A, Bergius Axelsson B, Steineck G, et al. One third of patients with radiotherapy-induced nausea consider their antiemetic treatment insufficient. Support Care Cancer. 2009;17:23–32. doi: 10.1007/s00520-008-0445-x. - DOI - PubMed

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