A prospective study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in malignant lymphoma patients following highly emetogenic chemotherapy
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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.
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.
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.
The present study demonstrated that a single dose of palonosetron was highly effective and safe for the prevention of CINV in lymphoma patients.
KeywordsChemotherapy Nausea Vomiting Lymphoma Palonosetron
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.
- 1.Japan Society of Clinical Oncology (2015) Guideline: appropriate use of antiemetics version 2.0 (in Japanese). Kanehara & Co., Ltd., TokyoGoogle Scholar
- 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
- 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.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.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
- 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