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Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study

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Abstract

Purpose

We investigated the intensity and duration of nausea as well as its impact on health-related quality of life among cisplatin-treated patients who participated in a study of dexamethasone (DEX)-sparing regimens based on NEPA (netupitant/palonosetron).

Methods

This retrospective analysis included chemo-naive patients from a trial evaluating non-inferiority of DEX on day 1 (DEX1 arm) combined with NEPA, compared with the same regimen with DEX administered on days 1–4 (DEX4; reference arm) following cisplatin (≥ 70 mg/m2) administration. Nausea intensity was self-rated using a four-point Likert scale. Extended nausea duration was considered ≥ 3 days within the 5 days post-chemotherapy. Patients completed the Functional Living Index-Emesis (FLIE) questionnaire on day 6.

Results

In the DEX1 arm, more patients (20/76) experienced acute nausea, influencing the outcome of delayed nausea (38/76). During days 1 to 5, 51.3% (39/76) and 39.5% (30/76) of patients experienced nausea in the DEX1 and DEX4 arms, respectively (P = 0.192). Of these, 43.6% and 60% reported moderate-to-severe nausea, respectively, in the DEX1 and DEX4 arms (P = 0.200), while 74.4% and 56.7% of patients experienced extended nausea duration (P = 0.122). Similar between-arm rates of nauseated patients reported an impact on daily life (79.5% vs. 70%; P = 0.408). In analyses stratified for antiemetic regimen, moderate-to-severe nausea or extended nausea duration was associated with an impact on daily life (P ≤ 0.001).

Conclusion

Despite the higher incidence, there was no suggestion of any strong adverse effect of NEPA plus single-dose DEX on the characteristics of nausea as well as its impact on daily life in patients with cisplatin-induced nausea. Further prospective controlled study is warranted.

Trial registration

ClinicalTrials.gov identifier: NCT04201769. Registration date: 17/12/2019.

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Data availability

The datasets analyzed during the current study are available from the corresponding author on reasonable request.

References

  1. Navari RM, Aapro M (2016) Antiemetic prophylaxis for chemotherapy-induced nausea and vomiting. N Engl J Med 374:1356–1367. https://doi.org/10.1056/NEJMra1515442

    Article  CAS  PubMed  Google Scholar 

  2. Rapoport L (2017) Delayed chemotherapy-induced nausea and vomiting: pathogenesis, incidence, and current management. Front Pharmacol 8:19. https://doi.org/10.3389/fphar.2017.00019

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Bosnjak SM, Gralla RJ, Schwartzberg L (2017) Prevention of chemotherapy-induced nausea: the role of neurokinin-1 (NK1) receptor antagonists. Support Care Cancer 25:1661–1671. https://doi.org/10.1007/s00520-017-3585-z

    Article  PubMed  PubMed Central  Google Scholar 

  4. Grunberg SM (2007) Antiemetic activity of corticosteroids in patients receiving cancer chemotherapy: dosing, efficacy, and tolerability analysis. Ann Oncol 18:233–240. https://doi.org/10.1093/annonc/mdl347

    Article  CAS  PubMed  Google Scholar 

  5. Okada Y, Oba K, Furukawa N et al (2019) One-day versus three-day dexamethasone in combination with palonosetron for the prevention of chemotherapy-induced nausea and vomiting: a systematic review and individual patient data-based meta-analysis. Oncologist 24:1593–1600. https://doi.org/10.1634/theoncologist.2019-0133

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Celio L, Bonizzoni E, Zattarin E, Codega P, de Braud F, Aapro M (2019) Impact of dexamethasone-sparing regimens on delayed nausea caused by moderately or highly emetogenic chemotherapy: a meta-analysis of randomised evidence. BMC Cancer 19:1268. https://doi.org/10.1186/s12885-019-6454-y

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Hesketh PJ, Kris MG, Basch E et al (2020) Antiemetics: ASCO guideline update. J Clin Oncol 38:2782–2797. https://doi.org/10.1200/JCO.20.01296

    Article  CAS  PubMed  Google Scholar 

  8. Herrstedt J, Celio L, Hesketh PJ et al (2023) 2023 MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agents. Support Care Cancer 32:47. https://doi.org/10.1007/s00520-023-08221-4

    Article  PubMed  PubMed Central  Google Scholar 

  9. Celio L, Cortinovis D, Cogoni AA et al (2021) Dexamethasone-sparing regimens with oral netupitant and palonosetron for the prevention of emesis caused by high-dose cisplatin: a randomized noninferiority study. Oncologist 26:e1854-1861. https://doi.org/10.1002/onco.13851

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Martin AR, Pearson JD, Cai B, Elmer M, Horgan K, Lindley C (2003) Assessing the impact of chemotherapy-induced nausea and vomiting on patients’ daily lives: a modified version of the Functional Living Index-Emesis (FLIE) with 5-day recall. Support Care Cancer 11:522–527. https://doi.org/10.1007/s00520-003-0482-4

    Article  CAS  PubMed  Google Scholar 

  11. Celio L, Cortinovis D, Cogoni AA et al (2022) Evaluating the impact of chemotherapy-induced nausea and vomiting on daily functioning in patients receiving dexamethasone-sparing antiemetic regimens with NEPA (netupitant/palonosetron) in the cisplatin setting: results from a randomized phase 3 study. BMC Cancer 22:915. https://doi.org/10.1186/s12885-022-10018-3

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  12. Ballatori E, Roila F, Ruggeri B et al (2007) The impact of chemotherapy-induced nausea and vomiting on health-related quality of life. Support Care Cancer 15:179–185. https://doi.org/10.1007/s00520-006-0109-7

    Article  PubMed  Google Scholar 

  13. Zhang L, Lu S, Feng J et al (2018) A randomized phase III study evaluating the efficacy of single-dose NEPA, a fixed antiemetic combination of netupitant and palonosetron, versus an aprepitant regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). Ann Oncol 29:452–458. https://doi.org/10.1093/annonc/mdx698

    Article  CAS  PubMed  Google Scholar 

  14. Hata A, Okamoto I, Inui N et al (2021) Randomized, double-blind, phase III study of fosnetupitant versus fosaprepitant for prevention of highly emetogenic chemotherapy-induced nausea and vomiting CONSOLE. J Clin Oncol 40:180–188. https://doi.org/10.1200/jco.21.01315

  15. Bloechl-Daum B, Deuson RR, Mavros P, Hansen M, Herrstedt J (2006) Delayed nausea and vomiting continue to reduce patients’ quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment. J Clin Oncol 24:4472–4478. https://doi.org/10.1200/JCO.2006.05.6382

    Article  CAS  PubMed  Google Scholar 

  16. Kris MG, Gralla RJ, Clark RA et al (1985) Incidence, course, and severity of delayed nausea and vomiting following the administration of high-dose cisplatin. J Clin Oncol 3:1379–1384. https://doi.org/10.1200/JCO.1985.3.10.1379

    Article  CAS  PubMed  Google Scholar 

  17. Hesketh PJ, Aapro M, Street JC, Carides AD (2010) Evaluation of risk factors predictive of nausea and vomiting with current standard-of-care antiemetic treatment: analysis of two phase III trials of aprepitant in patients receiving cisplatin-based chemotherapy. Support Care Cancer 18:1171–1177. https://doi.org/10.1007/s00520-009-0737-9

    Article  PubMed  Google Scholar 

  18. Italian Group for Antiemetic Research (1994) Cisplatin-induced delayed emesis: pattern ad prognostic factors during three subsequent cycles. Ann Oncol 5:585–589

    Article  Google Scholar 

  19. Navari R, Binder G, Molasiotis A et al (2023) Duration of chemotherapy-induced nausea and vomiting (CINV) as a predictor of CINV in later cycles. Oncologist 28:208–213. https://doi.org/10.1093/oncolo/oyac240

    Article  PubMed  Google Scholar 

  20. Roila F, Ruggeri B, Ballatori E, Del Favero A, Tonato M (2014) Aprepitant versus dexamethasone for preventing chemotherapy-induced delayed emesis in patients with breast cancer: a randomized double-blind study. J Clin Oncol 32:101–106. https://doi.org/10.1200/JCO.2013.51.4547

    Article  CAS  PubMed  Google Scholar 

  21. Li Y, Sun Y, Liu B et al (2022) Prolonged administration of aprepitant improves cisplatin-based chemotherapy-induced nausea and vomiting. Future Oncol 18:2533–2543. https://doi.org/10.2217/fon-2021-1523

    Article  CAS  PubMed  Google Scholar 

  22. Sun Y, Zheng Y, Yang X et al (2021) Incidence of chemotherapy-induced nausea and vomiting among cancer patients receiving moderately to highly emetogenic chemotherapy in cancer centers in Sichuan, China. J Cancer Clin Oncol 147:2701–2708. https://doi.org/10.1007/s00432-021-03554-1

    Article  CAS  Google Scholar 

  23. Celio L, Cortinovis D, Cogoni AA et al (2023) Exploratory analysis of the effect of a dexamethasone-sparing regimen for prophylaxis of cisplatin-induced emesis on food intake (LUNG-NEPA study). Sci Rep 13:1257. https://doi.org/10.1038/s41598-023-28464-9

    Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

  24. Ito Y, Tsuda T, Minatogawa H et al (2018) Placebo-controlled, double-blind phase III study comparing dexamethasone on day 1 with dexamethasone on days 1 to 3 with combined neurokinin-1 receptor antagonist and palonosetron in high-emetogenic chemotherapy. J Clin Oncol 36:1000–1006. https://doi.org/10.1200/JCO.2017.74.4375

    Article  CAS  PubMed  Google Scholar 

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Acknowledgements

The authors thank patients, physicians, nurses, and data managers who participated in the study.

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Authors and Affiliations

  1. Medical Oncology Unit 4, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy

    Luigi Celio

  2. Cancer Center, Clinique de Genolier, Genolier, Switzerland

    Matti Aapro

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  1. Luigi Celio
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Contributions

L.C. and M.A. contributed to the study conception and design. Material preparation and data collection were performed by L.C. Statistical analysis was performed by L.C. The first draft of the manuscript was written by L.C. M.A. critically reviewed and revised the manuscript. L.C. and M.A. read and approved the final manuscript.

Corresponding author

Correspondence to Luigi Celio.

Ethics declarations

Ethics approval

This exploratory analysis was conducted retrospectively from clinical data obtained for investigational purposes from a multicenter, randomized trial. This study was performed in accordance with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of the Coordinating Center (Comitato Etico per la Sperimentazione Clinica delle province di Verona e Rovigo).

Consent to participate

All patients included in the phase 3 study provided written, informed consent.

Consent for publication

Not applicable.

Competing interests

L.C. has received consulting fees from Italfarmaco SpA, Berlin Chemie, and Helsinn. M.A. has received consulting fee from Accord Pharmaceuticals, Amgen, BMS, Celgene, Clinigen Group, Daiichi Sankyo, Eisai, Eli Lilly, Genomic Health, G1 Therapeutics, GlaxoSmithKline, Helsinn, Hospira, Johnson and Johnson, Merck, Merck Serono, Mundipharma, Novartis, Pfizer, Pierre Fabre, Roche, Sandoz, Tesaro, Teva Pharmaceuticals, and Vifor Pharma; has received honoraria from Astellas, Bayer HealthCare Pharmaceuticals, Biocon, Boeringer Ingelheim, Cephalon, Chugai Pharmaceutical, Dr Reddy's Laboratories, Glenmark Pharmaceuticals, Ipsen, Janssen Biotech, Kyowa Kirin Group, Sanofi, and Taiho Pharmaceutical; has received grants from Amgen, Eisai, Genomic Health, Helsinn, Hospira, Novartis, Merck, Mundipharma, Pfizer, Roche, Sandoz, Tesaro, Teva Pharmaceuticals, Vifor Pharma.

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Celio, L., Aapro, M. Characteristics of nausea and its impact on health-related quality of life in cisplatin-treated patients receiving dexamethasone-sparing prophylaxis: an analysis of the LUNG-NEPA study. Support Care Cancer 32, 204 (2024). https://doi.org/10.1007/s00520-024-08406-5

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