International Journal of Clinical Oncology

, Volume 23, Issue 1, pp 189–194 | Cite as

A prospective study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in malignant lymphoma patients following highly emetogenic chemotherapy

  • Tsutomu Takahashi
  • Takahiro Okada
  • Fumiyoshi Ikejiri
  • Shunsuke Ito
  • Yusuke Okada
  • Fumimasa Takahashi
  • Satoshi Kumanomido
  • Yumi Jo
  • Koji Adachi
  • Chie Onishi
  • Koshi Kawakami
  • Takaaki Miyake
  • Masaya Inoue
  • Ritsuro Suzuki
  • Junji Suzumiya
Original Article
  • 267 Downloads

Abstract

Background

Chemotherapy-induced nausea and vomiting (CINV) is a troublesome issue in chemotherapy for cancer patients. A second-generation 5HT3 receptor antagonist (5HT3RA), palonosetron, is effective and safe for the prevention of CINV in breast cancer patients treated with cyclophosphamide and anthracycline, but there is little data for malignant lymphoma. We conducted a prospective phase 2 study at a single institution to clarify the efficacy and safety of palonosetron in lymphoma patients.

Methods

Chemotherapy-naïve lymphoma patients who were treated with highly emetogenic chemotherapy (HEC) received a single intravenous bolus of palonosetron, 0.75 mg/body, before chemotherapy on day 1 during the first course of chemotherapy. The occurrence of CINV was assessed using the Multinational Association for Supportive Care in Cancer (MASCC) antiemesis tool, which was recorded by patients during the first course of chemotherapy.

Results

A total of 59 patients were enrolled, and 49 patients were eligible and evaluated. The complete response (CR) rate was 93.9% (95% confidence interval 83.1–98.7%) at 0–120 h post-chemotherapy. The proportion of patients who developed nausea of any grade and vomiting at 0–120 h post-chemotherapy was 34.7 and 6.1%, respectively. Although treatment-related adverse events were observed in 36 (73.5%) patients, these were mild and they recovered by the next cycle of chemotherapy.

Conclusion

The present study demonstrated that a single dose of palonosetron was highly effective and safe for the prevention of CINV in lymphoma patients.

Keywords

Chemotherapy Nausea Vomiting Lymphoma Palonosetron 

Notes

Compliance with ethical standards

Conflict of interest

Tsutomu Takahashi received honoraria from Kyowa Hakko Kirin Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Takaaki Miyake received honoraria from Kyowa Hakko Kirin Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Ritsuro Suzuki received honoraria from Kyowa Hakko Kirin Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Junji Suzumiya received honoraria from Chugai Pharmaceutical Co., Ltd., and received research funding from Kyowa Hakko Kirin Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Astellas Pharma Inc. The other authors have no conflicts of interest to declare.

Supplementary material

10147_2017_1173_MOESM1_ESM.docx (18 kb)
Supplementary material 1 (DOCX 18 kb)

References

  1. 1.
    Japan Society of Clinical Oncology (2015) Guideline: appropriate use of antiemetics version 2.0 (in Japanese). Kanehara & Co., Ltd., TokyoGoogle Scholar
  2. 2.
    Basch E, Prestrud AA, Hesketh PJ et al (2011) American Society of Clinical Oncology. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol 29:4189–4198CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    National Comprehensive Cancer Network (2016) NCCN Clinical practice guidelines in oncology: antiemesis version 2. [http://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf]. Accessed Feb 2017
  4. 4.
    Roila F, Molassiotis A, Herrstedt J et al (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–v133CrossRefPubMedGoogle Scholar
  5. 5.
    Tamura K, Aiba K, Saeki T et al (2015) Testing the effectiveness of antiemetic guidelines: results of a prospective registry by the CINV Study Group of Japan. Int J Clin Oncol 20:855–865CrossRefPubMedGoogle Scholar
  6. 6.
    Takahashi T, Kumanomidou S, Takami S et al (2016) A retrospective study of R-CHOP/CHOP therapy-induced nausea and vomiting in non-Hodgkin’s lymphoma patients: a comparison of intravenous and oral 5-HT3 receptor antagonists. Int J Hematol 104:378–383CrossRefPubMedGoogle Scholar
  7. 7.
    Wong EH, Clark R, Leung E et al (1995) The interaction of RS 25259-197, a potent and selective antagonist, with 5-HT3 receptors, in vitro. Br J Pharmacol 114:851–859CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Rojas C, Stathis M, Thomas AG et al (2008) Palonosetron exhibits unique molecular interactions with the 5-HT3 receptor. Anesth Analg 107:469–478CrossRefPubMedGoogle Scholar
  9. 9.
    Saito M, Aogi K, Sekine I et al (2009) Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol 10:115–124CrossRefPubMedGoogle Scholar
  10. 10.
    Suzuki K, Yamanaka T, Hashimoto H et al (2016) Randomized, double-blind, phase III trial of palonosetron versus granisetron in the triplet regimen for preventing chemotherapy-induced nausea and vomiting after highly emetogenic chemotherapy: TRIPLE study. Ann Oncol 27:1601–1606CrossRefPubMedGoogle Scholar
  11. 11.
    Di Renzo N, Montanini A, Mannina D et al (2011) Single-dose palonosetron for prevention of chemotherapy-induced nausea and vomiting in patients with aggressive non-Hodgkin’s lymphoma receiving moderately emetogenic chemotherapy containing steroids: results of a phase II study from the Gruppo Italiano per lo Studio dei Linfomi (GISL). Support Care Cancer 19:1505–1510CrossRefPubMedGoogle Scholar
  12. 12.
    Choi BS, Borsaru GP, Ballinari G et al (2014) Multicenter phase IV study of palonosetron in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with non-Hodgkin lymphomas undergoing repeated cycles of moderately emetogenic chemotherapy. Leuk Lymphoma 55:544–550CrossRefPubMedGoogle Scholar
  13. 13.
    Miyata Y, Yakushijin K, Inui Y et al (2016) A prospective study of the antiemetic effect of palonosetron in malignant lymphoma patients treated with the CHOP regimen. Int J Hematol 104:682–691CrossRefPubMedGoogle Scholar
  14. 14.
    Molassiotis A, Coventry PA, Stricker CT et al (2007) Validation and psychometric assessment of a short clinical scale to measure chemotherapy-induced nausea and vomiting: the MASCC antiemesis tool. J Pain Symptom Manage 34:148–159CrossRefPubMedGoogle Scholar
  15. 15.
    Kanda Y (2013) Investigation of the freely available easy-to-use software ‘EZR’ for medical statistics. Bone Marrow Transplant 48:452–458CrossRefPubMedGoogle Scholar
  16. 16.
    Sekine I, Segawa Y, Kubota K et al (2013) Risk factors of chemotherapy-induced nausea and vomiting: index for personalized antiemetic prophylaxis. Cancer Sci 104:711–717CrossRefPubMedGoogle Scholar
  17. 17.
    Talley NJ, Phillips SF, Haddad A et al (1990) GR 38032F (ondansetron), a selective 5HT3 receptor antagonist, slows colonic transit in healthy man. Dig Dis Sci 35:477–480CrossRefPubMedGoogle Scholar
  18. 18.
    Popovic M, Warr DG, Deangelis C et al (2014) Efficacy and safety of palonosetron for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV): a systematic review and meta-analysis of randomized controlled trials. Support Care Cancer 22:1685–1697CrossRefPubMedGoogle Scholar
  19. 19.
    Aapro M, Rugo H, Rossi G et al (2014) A randomized phase III study evaluating the efficacy and safety of NEPA, a fixed-dose combination of netupitant and palonosetron, for prevention of chemotherapy-induced nausea and vomiting following moderately emetogenic chemotherapy. Ann Oncol 25:1328–1333CrossRefPubMedPubMedCentralGoogle Scholar
  20. 20.
    Navari RM, Qin R, Ruddy KJ et al (2016) Olanzapine for the prevention of chemotherapy-induced nausea and vomiting. N Engl J Med 375:134–142CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Japan Society of Clinical Oncology 2017

Authors and Affiliations

  • Tsutomu Takahashi
    • 1
  • Takahiro Okada
    • 1
  • Fumiyoshi Ikejiri
    • 1
  • Shunsuke Ito
    • 1
  • Yusuke Okada
    • 1
  • Fumimasa Takahashi
    • 1
  • Satoshi Kumanomido
    • 1
  • Yumi Jo
    • 1
  • Koji Adachi
    • 2
  • Chie Onishi
    • 1
  • Koshi Kawakami
    • 3
  • Takaaki Miyake
    • 1
  • Masaya Inoue
    • 1
  • Ritsuro Suzuki
    • 1
  • Junji Suzumiya
    • 1
  1. 1.Department of Oncology/HematologyShimane University HospitalIzumo-shiJapan
  2. 2.Department of Hematology and OncologyNational Hospital Organization, Yonago Medical CenterYonagoJapan
  3. 3.Department of Clinical OncologyShimane Prefectural Central HospitalIzumoJapan

Personalised recommendations