In the literature, there have been only two head to head trials investigating first and second generation 5HT3 receptor antagonists in triplet antiemetic regimens in cancer patients receiving high emetogenic chemotherapy (HEC). In these two Japanese studies, granisetron(G) was compared with 0.75 mg palonosetron(P). However, P is approved as 0.25 mg in Turkey and most other countries. Therefore, we aimed to investigate the efficacy of 0.25 mg of P and G in triplet antiemetic regimen for HEC.
This study was carried out between April 2017 and December 2017 at four different cancer center in Turkey. Patients with nonmetastatic breast cancer who received HEC (doxorubicin or epirubicin plus cyclophosphamide (AC/EC)) were enrolled in this study. The prophylactic triplet antiemetic regimens were used during the first cycle of HEC as intravenous dexamethasone and P (0.25 mg) or G (3mg) as well as oral aprepitant(125 mg on day 1 and 80 mg/day on days 2–3). The choice of P or G was left to the doctor's preference. The primary endpoint was complete response rate (CCR) in acute and delayed chemotherapy-induced nausea and vomiting (CINV). MASCC Antiemesis Tool was used to assess the CINV.
A total of 118 female patients were included in the study. None of them had alcohol consumption story. The mean age of the patients was 51 years. Patients received AC (83%), EC (3%), and dose-dense AC (14%) as adjuvant (88%) or neoadjuvant (12%). The majority of patients received P (59%) containing antiemetic treatment. The dexamethasone dose used in the majority was 8 mg (%80). The CCRs on vomiting were high in two arms and not statistically different with P and G (acute 87% vs. 96%, p = 0.089; delayed 90% vs. 92%, p = 0.508), respectively. Nevertheless, the CCRs of either acute or delayed nausea were lower than compared with vomiting (acute 50% vs. 53%, p = 0.475; delayed 41% vs 31%, p = 0.186), respectively.
To best our knowledge, this is the first study that compared 0.25 mg P and G in triplet antiemetic regimens in cancer patients receiving HEC. There were no differences between P and G, in terms of CCRs of acute and delayed CINV.
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