The efficacy of single dose palonosetron in highly emetogenic chemotherapy protocols compared to oral aprepitant and ondansetron

  • Yaala Saady Raof Al-Bairmany Al-Andalus Private Hospital for Cancer Patients, Baghdad, Iraq
  • Noor Kasib Hadi Al Yarmook Teaching Hospital, Baghdad, Iraq
  • Abdul Karim Nazar University of Baghdad, Baghdad, Iraq
Keywords: Nausea, Vomiting, Emetogenic, Chemotherapy, Palonosetron, Aprepitant, Ondansetron

Abstract

Background: Chemotherapy-induced nausea and vomiting (CINV) is a common problem during cancer treatment and its proper management is essential. The primary objective of this study was to compare the efficacy of a single dose palonosetron in the control of chemotherapy-induced nausea and vomiting (CINV) to that of oral aprepitant and ondansetron.  The secondary objective is to determine age, gender, morning sickness, motion sickness, as well as chemotherapy protocols as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV).

Methods: This is a prospective cohort study carried out at Al-Andalus Private Hospital for Cancer Patients in Baghdad, Iraq. The study included 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol. Patients were divided into 3 arms according to the antiemetic received. Arm 1 received aprepitant and ondansetron, arm 2 received ondansetron, and arm 3 received palonosetron. The primary endpoint was the response rate defined as the percentage of patients without nausea or vomiting episodes during the chemotherapy treatment cycles. Other secondary endpoints such as age, gender, morning sickness, motion sickness, as well as chemotherapy protocols, were measured as risk factors in increasing chemotherapy-induced nausea and vomiting (CINV).

Results: A total of 296 patients, diagnosed with cancer, and receiving high emetogenic chemotherapy protocol were evaluated. There was no significant association between age or gender and CINV. The incidence of nausea and vomiting with ondansetron was more than the incidence of nausea and vomiting with aprepitant, and the incidence of nausea and vomiting with palonosetron was less than the incidence of nausea and vomiting with aprepitant. There was no significant association between morning sickness and nausea or vomiting. On the other hand, there was a significant association between motion sickness and nausea or vomiting. The most common cycle reported in nausea and vomiting was cycle 3. Regarding suffering from nausea and vomiting with some chemotherapy drugs, the most common drugs were adriamycin cyclophosphamide (AC) and carboplatin.

Conclusion: The results of the present study confirm the previous reports on the superiority of palonosetron over ondansetron and its aprepitant in reducing the incidence of CINV. Regarding risk factors, motion sickness, chemotherapy cycle 3, as well as adriamycin cyclophosphamide (AC) and carboplatin were risk factors inducing CINV in high emetogenic chemotherapy protocols.

Author Biographies

Yaala Saady Raof Al-Bairmany , Al-Andalus Private Hospital for Cancer Patients, Baghdad, Iraq

Head of the Medical Oncology department

Noor Kasib Hadi , Al Yarmook Teaching Hospital, Baghdad, Iraq

Medical oncology resident

Abdul Karim Nazar, University of Baghdad, Baghdad, Iraq

Clinical Pharmacist

References

Adel, N. (2017). Overview of chemotherapy-induced nausea and vomiting and evidence-based therapies. Am J Manag Care, 23(14 Suppl), S259-S265.

Berger, M. J., Ettinger, D. S., Aston, J., Barbour, S., Bergsbaken, J., Bierman, P. J., . . . Hughes, M. (2017). NCCN Guidelines Insights: Antiemesis, Version 2.2017. J Natl Compr Canc Netw, 15(7), 883-893. doi:10.6004/jnccn.2017.0117

Chow, R., Tsao, M., Chiu, L., Popovic, M., Milakovic, M., Lam, H., & DeAngelis, C. (2018). Efficacy of the combination neurokinin-1 receptor antagonist, palonosetron, and dexamethasone compared to others for the prophylaxis of chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis of randomized controlled trials. Ann Palliat Med, 7(2), 221-233. doi:10.21037/apm.2018.03.09

Clark-Snow, R., Affronti, M. L., & Rittenberg, C. N. (2018). Chemotherapy-induced nausea and vomiting (CINV) and adherence to antiemetic guidelines: results of a survey of oncology nurses. Support Care Cancer, 26(2), 557-564. doi:10.1007/s00520-017-3866-6

Cui, J., Zhang, Q., Zhang, H., Spinelli, T., Nicolas, P., & Li, W. (2020). Oral versus intravenous palonosetron in Chinese cancer patients receiving moderately emetogenic chemotherapy: A non-inferiority phase III trial. Eur J Cancer Care (Engl), 29(4), e13245. doi:10.1111/ecc.13245

D'Souza, A., Pawar, D., Ramaswamy, A., Turkar, S., Bhargava, P., Kapoor, A., . . . Ostwal, V. (2020). Chemotherapy-Induced Nausea and Vomiting (CINV) with GI Cancer Chemotherapy: Do We Need CINV Risk Score Over and Above Antiemetic Guidelines in Prescribing Antiemetic Regime? South Asian J Cancer, 9(4), 240-244. doi:10.1055/s-0041-1726136

Di Mattei, V. E., Carnelli, L., Carrara, L., Bernardi, M., Crespi, G., Rancoita, P. M. V., . . . Mangili, G. (2016). Chemotherapy-Induced Nausea and Vomiting in Women With Gynecological Cancer: A Preliminary Single-Center Study Investigating Medical and Psychosocial Risk Factors. Cancer Nurs, 39(6), E52-E59. doi:10.1097/NCC.0000000000000342

Dranitsaris, G., Mazzarello, S., Smith, S., Vandermeer, L., Bouganim, N., & Clemons, M. (2016). Measuring the impact of guideline-based antiemetic therapy on nausea and vomiting control in breast cancer patients with multiple risk factors. Support Care Cancer, 24(4), 1563-1569. doi:10.1007/s00520-015-2944-x

Dranitsaris, G., Molassiotis, A., Clemons, M., Roeland, E., Schwartzberg, L., Dielenseger, P., . . . Aapro, M. (2017). The development of a prediction tool to identify cancer patients at high risk for chemotherapy-induced nausea and vomiting. Ann Oncol, 28(6), 1260-1267. doi:10.1093/annonc/mdx100

Fujii, H., Iihara, H., Kajikawa, N., Kobayashi, R., Suzuki, A., Tanaka, Y., . . . Itoh, Y. (2017). Control of Nausea Based on Risk Analysis in Patients with Esophageal and Gastric Cancer Who Received Cisplatin-based Chemotherapy. Anticancer Res, 37(12), 6831-6837. doi:10.21873/anticanres.12144

Gilmore, J., D'Amato, S., Griffith, N., & Schwartzberg, L. (2018). Recent advances in antiemetics: new formulations of 5HT3-receptor antagonists. Cancer Manag Res, 10, 1827-1857. doi:10.2147/CMAR.S166912

Hamano, H., Mitsuhashi, C., Suzuki, Y., Zamami, Y., Tsujinaka, K., Okada, N., . . . Ishizawa, K. (2021). Effects of Palonosetron on Nausea and Vomiting Induced by Multiple-Day Chemotherapy: A Retrospective Study. Biol Pharm Bull, 44(4), 478-484. doi:10.1248/bpb.b20-00609

Hayashi, T., Shimokawa, M., Matsuo, K., Iihara, H., Kawada, K., Nakano, T., & Egawa, T. (2021). Chemotherapy-induced nausea and vomiting (CINV) with carboplatin plus pemetrexed or carboplatin plus paclitaxel in patients with lung cancer: a propensity score-matched analysis. BMC Cancer, 21(1), 74. doi:10.1186/s12885-021-07802-y

Hayashi, T., Shimokawa, M., Miyoshi, T., Toriyama, Y., Yokota, C., Taniguchi, J., . . . Koyabu, M. (2017). A prospective, observational, multicenter study on risk factors and prophylaxis for low emetic risk chemotherapy-induced nausea and vomiting. Support Care Cancer, 25(9), 2707-2714. doi:10.1007/s00520-017-3679-7

Herrstedt, J., Roila, F., Warr, D., Celio, L., Navari, R. M., Hesketh, P. J., . . . Aapro, M. S. (2017). 2016 Updated MASCC/ESMO Consensus Recommendations: Prevention of Nausea and Vomiting Following High Emetic Risk Chemotherapy. Support Care Cancer, 25(1), 277-288. doi:10.1007/s00520-016-3313-0

Hesketh, P. J., Kris, M. G., Basch, E., Bohlke, K., Barbour, S. Y., Clark-Snow, R. A., . . . Lyman, G. H. (2020). Antiemetics: ASCO Guideline Update. J Clin Oncol, 38(24), 2782-2797. doi:10.1200/JCO.20.01296

Hesketh, P. J., Kris, M. G., Basch, E., Bohlke, K., Barbour, S. Y., Clark-Snow, R. A., . . . Lyman, G. H. (2017). Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol, 35(28), 3240-3261. doi:10.1200/JCO.2017.74.4789

Hsu, Y. C., Chen, C. Y., Tam, K. W., & Hsu, C. Y. (2021). Effectiveness of palonosetron versus granisetron in preventing chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis. Eur J Clin Pharmacol, 77(11), 1597-1609. doi:10.1007/s00228-021-03157-2

Iihara, H., Fujii, H., Yoshimi, C., Yamada, M., Suzuki, A., Matsuhashi, N., . . . Itoh, Y. (2016). Control of chemotherapy-induced nausea in patients receiving outpatient cancer chemotherapy. Int J Clin Oncol, 21(2), 409-418. doi:10.1007/s10147-015-0908-2

Jordan, K., Feyer, P., Holler, U., Link, H., Wormann, B., & Jahn, F. (2017). Supportive Treatments for Patients with Cancer. Dtsch Arztebl Int, 114(27-28), 481-487. doi:10.3238/arztebl.2017.0481

Kamiya, T., Sakurai, M., Kikuchi, T., Okayama, M., Mizuno, K., Tanigawa, T., . . . Mori, T. (2021). Efficacy of ondansetron against emesis induced by a multiple-day cisplatin-based chemotherapy regimen for malignant lymphoma. Hematology, 26(1), 945-949. doi:10.1080/16078454.2021.2001150

Kawazoe, H., Murakami, A., Yamashita, M., Nishiyama, K., Kobayashi-Taguchi, K., Komatsu, S., . . . Kamei, Y. (2018). Patient-related Risk Factors for Nausea and Vomiting with Standard Antiemetics in Patients with Breast Cancer Receiving Anthracycline-based Chemotherapy: A Retrospective Observational Study. Clin Ther, 40(12), 2170-2179. doi:10.1016/j.clinthera.2018.10.004

Kovacs, G., Wachtel, A., Basharova, E., Spinelli, T., Nicolas, P., & Kabickova, E. (2014). 1479O - Efficacy/Safety of Palonosetron Vs Ondansetron in Preventing Chemotherapy-Induced Nausea and Vomiting (Cinv) in Pediatric Patients Receiving Moderately or Highly Emetogenic Chemotherapy (Mec/Hec). Annals of Oncology, 25, iv517. doi:https://doi.org/10.1093/annonc/mdu356.1

Kovacs, G., Wachtel, A. E., Basharova, E. V., Spinelli, T., Nicolas, P., & Kabickova, E. (2016). Palonosetron versus ondansetron for prevention of chemotherapy-induced nausea and vomiting in paediatric patients with cancer receiving moderately or highly emetogenic chemotherapy: a randomised, phase 3, double-blind, double-dummy, non-inferiority study. Lancet Oncol, 17(3), 332-344. doi:10.1016/S1470-2045(15)00520-3

Lorusso, V., Russo, A., Giotta, F., & Codega, P. (2020). Management of Chemotherapy-Induced Nausea and Vomiting (CINV): A Short Review on the Role of Netupitant-Palonosetron (NEPA). Core Evid, 15, 21-29. doi:10.2147/CE.S203634

Mattiuzzi, G. N., Cortes, J. E., Blamble, D. A., Bekele, B. N., Xiao, L., Cabanillas, M., . . . Kantarjian, H. (2010). Daily palonosetron is superior to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting in patients with acute myelogenous leukemia. Cancer, 116(24), 5659-5666. doi:10.1002/cncr.25365

Mizuno, M., Hiura, M., Kikkawa, F., Numa, F., Yaegashi, N., Narahara, H., . . . Kamura, T. (2016). A prospective observational study on chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer by the CINV Study Group of Japan. Gynecol Oncol, 140(3), 559-564. doi:10.1016/j.ygyno.2015.12.029

Molassiotis, A., Lee, P. H., Burke, T. A., Dicato, M., Gascon, P., Roila, F., & Aapro, M. (2016). Anticipatory Nausea, Risk Factors, and Its Impact on Chemotherapy-Induced Nausea and Vomiting: Results From the Pan European Emesis Registry Study. J Pain Symptom Manage, 51(6), 987-993. doi:10.1016/j.jpainsymman.2015.12.317

Molassiotis, A., Stamataki, Z., & Kontopantelis, E. (2013). Development and preliminary validation of a risk prediction model for chemotherapy-related nausea and vomiting. Support Care Cancer, 21(10), 2759-2767. doi:10.1007/s00520-013-1843-2

Mosa, A. S. M., Hossain, A. M., Lavoie, B. J., & Yoo, I. (2020). Patient-Related Risk Factors for Chemotherapy-Induced Nausea and Vomiting: A Systematic Review. Front Pharmacol, 11, 329. doi:10.3389/fphar.2020.00329

Murakami, M., Hashimoto, H., Yamaguchi, K., Yamaguchi, I., Senba, S., & Siraishi, T. (2014). Effectiveness of palonosetron for preventing delayed chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy in patients with gastrointestinal cancer. Support Care Cancer, 22(4), 905-909. doi:10.1007/s00520-013-2046-6

National Comprehensive Cancer Network. (2021). NCCN Clinical Practice Guildelines in Oncology (NCCN Guidelines): antiemesis (version 1). Retrieved from www. nccn. org. Accessed 24 May 2021

Nawa-Nishigaki, M., Kobayashi, R., Suzuki, A., Hirose, C., Matsuoka, R., Mori, R., . . . Itoh, Y. (2018). Control of Nausea and Vomiting in Patients Receiving Anthracycline/Cyclophosphamide Chemotherapy for Breast Cancer. Anticancer Res, 38(2), 877-884. doi:10.21873/anticanres.12297

Parathoduvil, A. A., Sisupalan, A., & Rema, P. L. (2017). Comparison of Antiemetic Effectiveness of Palonosetron Versus Ondansetron in Patients on Cancer Chemotherapy: A Prospective Observational Study in South Indians. J Clin Diagn Res, 11(5), FC10-FC14. doi:10.7860/JCDR/2017/25129.9818

Petrella T., C. M., Joy A., Young S., Callaghan W., Dranitsaris G.,. (2009). Identifying patients at high risk for nausea and vomiting after chemotherapy: the development of a practical validated prediction tool. II. Delayed nausea and vomiting. J. Support Oncol,, 7, W9–W16. .

Piechotta, V., Adams, A., Haque, M., Scheckel, B., Kreuzberger, N., Monsef, I., . . . Skoetz, N. (2021). Antiemetics for adults for prevention of nausea and vomiting caused by moderately or highly emetogenic chemotherapy: a network meta-analysis. Cochrane Database Syst Rev, 11, CD012775. doi:10.1002/14651858.CD012775.pub2

Rha, S. Y., Park, Y., Song, S. K., Lee, C. E., & Lee, J. (2016). Controlling chemotherapy-induced nausea requires further improvement: symptom experience and risk factors among Korean patients. Support Care Cancer, 24(8), 3379-3389. doi:10.1007/s00520-016-3146-x

Roila, F., Molassiotis, A., Herrstedt, J., Aapro, M., Gralla, R. J., Bruera, E., . . . participants of the, M. E. C. C. C. (2016). 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol, 27(suppl 5), v119-v133. doi:10.1093/annonc/mdw270

Ruktrirong, J., Traivaree, C., Monsereenusorn, C., Photia, A., Lertvivatpong, N., & Rujkijyanont, P. (2021). Single daily dosing versus divided dosing intravenous ondansetron to prevent chemotherapy-induced nausea and vomiting among children: A comparative randomized double-blind controlled trial. Pediatr Blood Cancer, 68(6), e29002. doi:10.1002/pbc.29002

Scotte, F. (2017). Identifying predictive factors of chemotherapy-induced nausea and vomiting (CINV): a novel approach. Ann Oncol, 28(6), 1165-1167. doi:10.1093/annonc/mdx120

Sekine, I., Segawa, Y., Kubota, K., & Saeki, T. (2013). Risk factors of chemotherapy-induced nausea and vomiting: index for personalized antiemetic prophylaxis. Cancer Sci, 104(6), 711-717. doi:10.1111/cas.12146

Shih, V., Wan, H. S., & Chan, A. (2009). Clinical predictors of chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant doxorubicin and cyclophosphamide. Ann Pharmacother, 43(3), 444-452. doi:10.1345/aph.1L437

Shimokawa, M., Hayashi, T., Kogawa, T., Matsui, R., Mizuno, M., Kikkawa, F., . . . Tamura, K. (2019). Evaluation of Combination Antiemetic Therapy on CINV in Patients With Gynecologic Cancer Receiving TC Chemotherapy. Anticancer Res, 39(1), 225-230. doi:10.21873/anticanres.13101

Shirley, M. (2021). Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting. Drugs, 81(11), 1331-1342. doi:10.1007/s40265-021-01558-2

Takemoto, H., Nishimura, J., Komori, T., Kim, H. M., Ota, H., Suzuki, R., . . . Multicenter Clinical Study Group of Osaka, C. C. T. G. (2017). Combination antiemetic therapy with aprepitant/fosaprepitant in patients with colorectal cancer receiving oxaliplatin-based chemotherapy in the SENRI trial: analysis of risk factors for vomiting and nausea. Int J Clin Oncol, 22(1), 88-95. doi:10.1007/s10147-016-1022-9

Tamura, K., Aiba, K., Saeki, T., Nakanishi, Y., Kamura, T., Baba, H., . . . Japan, C. S. G. o. (2015). Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan. Int J Clin Oncol, 20(5), 855-865. doi:10.1007/s10147-015-0786-7

Tsuji, Y., Baba, H., Takeda, K., Kobayashi, M., Oki, E., Gotoh, M., . . . Aiba, K. (2017). Chemotherapy-induced nausea and vomiting (CINV) in 190 colorectal cancer patients: a prospective registration study by the CINV study group of Japan. Expert Opin Pharmacother, 18(8), 753-758. doi:10.1080/14656566.2017.1317746

Uchida, M., Mori, Y., Nakamura, T., Kato, K., Kamezaki, K., Takenaka, K., . . . Akashi, K. (2017). Comparison between Antiemetic Effects of Palonosetron and Granisetron on Chemotherapy-Induced Nausea and Vomiting in Japanese Patients Treated with R-CHOP. Biol Pharm Bull, 40(9), 1499-1505. doi:10.1248/bpb.b17-00318

Wang, D. S., Hu, M. T., Wang, Z. Q., Ren, C., Qiu, M. Z., Luo, H. Y., . . . Li, Y. H. (2021). Effect of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Women: A Randomized Clinical Trial. JAMA Netw Open, 4(4), e215250. doi:10.1001/jamanetworkopen.2021.5250

Warr, D. G., Hesketh, P. J., Gralla, R. J., Muss, H. B., Herrstedt, J., Eisenberg, P. D., . . . Skobieranda, F. (2005). Efficacy and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with breast cancer after moderately emetogenic chemotherapy. J Clin Oncol, 23(12), 2822-2830. doi:10.1200/JCO.2005.09.050

Wenzell, C. M., Berger, M. J., Blazer, M. A., Crawford, B. S., Griffith, N. L., Wesolowski, R., . . . Layman, R. M. (2013). Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy. Support Care Cancer, 21(10), 2845-2851. doi:10.1007/s00520-013-1865-9

Yang, Y., & Zhang, L. (2020). A narrative review of tropisetron and palonosetron for the control of chemotherapy-induced nausea and vomiting. Chin Clin Oncol, 9(2), 17. doi:10.21037/cco.2019.11.02

Zelek, L., Debourdeau, P., Bourgeois, H., Wagner, J. P., Brocard, F., Lefeuvre-Plesse, C., . . . Scotte, F. (2021). A Pragmatic Study Evaluating NEPA Versus Aprepitant for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy. Oncologist, 26(10), e1870-e1879. doi:10.1002/onco.13888

Published
2022-09-01
How to Cite
1.
Al-Bairmany YSR, Kasib Hadi N, Nazar AK. The efficacy of single dose palonosetron in highly emetogenic chemotherapy protocols compared to oral aprepitant and ondansetron. jpadr [Internet]. 2022Sep.1 [cited 2022Sep.27];3(3):28-9. Available from: https://jpadr.com/index.php/jpadr/article/view/97