Efficacy and safety of palonosetron as salvage treatment in the prevention of chemotherapy-induced nausea and vomiting in patients receiving low emetogenic chemotherapy (LEC).
The purpose of this study is to evaluate the efficacy and safety of intravenous (IV) palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with cancer who had incomplete control of CINV during their previous cycle of low emetogenic chemotherapy (LEC).
Patients with histologically or cytologically confirmed cancer, ≥18 years of age, with a Karnofsky Performance Scale score of ≥50% who had received LEC that induced vomiting and/or at least moderate nausea during their previous treatment cycle received palonosetron 0.25 mg IV 30 min before chemotherapy. Outcomes were recorded in patient diaries over 120 h and at an end-of-study visit on days 6, 7, or 8 after LEC administration. The primary efficacy variable was the complete response rate, defined as no emetic episodes and no rescue medication at 0-24 h (acute post-chemotherapy phase), 24-120 h (delayed phase), and 0-120 h (overall).
Complete responses among the intent-to-treat study population (n = 34) were recorded for 88.2 % of patients in the acute phase, 67.6% in the delayed phase, and 67.6% overall. No emetic episodes occurred in 91.2 and 79.4% of patients during the acute and delayed phases, respectively, and no nausea in 73.5 and 52.9%, respectively. Palonosetron was well tolerated; only two patients experienced treatment-related adverse events.
Among the patients with cancer who had a history of CINV with LEC, palonosetron was effective in preventing CINV in both the acute and delayed post-chemotherapy phases, and was well tolerated. Randomized comparative studies in larger populations of patients receiving LEC are needed to confirm these findings.
Department of Hematology Oncology, Lahey Clinic Medical Center, Burlington, MA 01805, USA. Paul.Hesketh@Lahey.org
SourceSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer 20:10 2012 Oct pg 2633-7
Pub Type(s)Clinical Trial, Phase II
Research Support, Non-U.S. Gov't