Hope S Rugo1, Giorgia Rossi2, Giada Rizzi2, Matti Aapro3. 1. University of California San Francisco Comprehensive Cancer Center, San Francisco, CA, 94115, USA. Electronic address: Hope.Rugo@ucsf.edu. 2. Helsinn Healthcare SA, 6912, Pazzallo, Lugano, Switzerland. 3. IMO Clinique de Genolier, CH-1272, Genolier, Vaud, Switzerland.
Abstract
OBJECTIVES:Breast cancer (BC) patients represent a high-risk population for experiencing chemotherapy-induced nausea and vomiting (CINV), since they frequently receive highly emetogenic anthracycline-cyclophosphamide-based (AC) chemotherapy, and are often female and young, two predisposing risk factors for CINV. Guidelines recommend the combination of a neurokinin-1 receptor antagonist (NK1RA), 5-hydroxytryptamine-3 RA (5-HT3RA), and dexamethasone (DEX) for CINV prophylaxis in AC-treated patients. This post-hoc analysis evaluated the efficacy of NEPA, a fixed combination of netupitant (NETU [NK1RA]) and palonosetron (PALO [5-HT3RA]) in BC patients from two phase III studies. METHODS: Overall, 1460 BC patients receivedAC (Study 1) or non-AC (Study 2) therapy over 6060 cycles. Randomized patients received DEX with either NEPA or oral PALO (Study 1), or NEPA or aprepitant+oral PALO (Study 2) before chemotherapy. RESULTS: In AC-receiving patients, overall complete response (CR) rates with NEPA+DEX were statistically significantly higher than oral PALO+DEX rates (cycles 1-4: 73.9% vs 65.9%, 80.0% vs 66.0%, 83.6% vs 69.9%, 83.6% vs 74.4%, respectively). Overall, no significant nausea (NSN) rates were also superior with NEPA+DEX vs oral PALO+DEX (respectively, 74.2%-79.9% vs 68.5%-74.9%). A greater proportion of NEPA+DEX patients experienced "no-impact-on-daily-life" due to CINV (78.4% vs 71.4%) in cycle 1. In non-AC-receiving patients, prophylaxis with NEPA+DEX resulted in high CR and NSN rates across 1-4 chemotherapy cycles; no formal comparison with the control arm was performed. CONCLUSION:NEPA+DEX administered as a single dose is an effective option for preventing CINV in BC patients receiving AC and non-AC, across multiple chemotherapy cycles. CLINICAL TRIALS REGISTRATION NUMBERS: Study 1: NCT01339260, Study 2:NCT01376297.
RCT Entities:
OBJECTIVES:Breast cancer (BC) patients represent a high-risk population for experiencing chemotherapy-induced nausea and vomiting (CINV), since they frequently receive highly emetogenic anthracycline-cyclophosphamide-based (AC) chemotherapy, and are often female and young, two predisposing risk factors for CINV. Guidelines recommend the combination of a neurokinin-1 receptor antagonist (NK1RA), 5-hydroxytryptamine-3 RA (5-HT3RA), and dexamethasone (DEX) for CINV prophylaxis in AC-treated patients. This post-hoc analysis evaluated the efficacy of NEPA, a fixed combination of netupitant (NETU [NK1RA]) and palonosetron (PALO [5-HT3RA]) in BC patients from two phase III studies. METHODS: Overall, 1460 BC patients received AC (Study 1) or non-AC (Study 2) therapy over 6060 cycles. Randomized patients received DEX with either NEPA or oral PALO (Study 1), or NEPA or aprepitant+oral PALO (Study 2) before chemotherapy. RESULTS: In AC-receiving patients, overall complete response (CR) rates with NEPA+DEX were statistically significantly higher than oral PALO+DEX rates (cycles 1-4: 73.9% vs 65.9%, 80.0% vs 66.0%, 83.6% vs 69.9%, 83.6% vs 74.4%, respectively). Overall, no significant nausea (NSN) rates were also superior with NEPA+DEX vs oral PALO+DEX (respectively, 74.2%-79.9% vs 68.5%-74.9%). A greater proportion of NEPA+DEXpatients experienced "no-impact-on-daily-life" due to CINV (78.4% vs 71.4%) in cycle 1. In non-AC-receiving patients, prophylaxis with NEPA+DEX resulted in high CR and NSN rates across 1-4 chemotherapy cycles; no formal comparison with the control arm was performed. CONCLUSION:NEPA+DEX administered as a single dose is an effective option for preventing CINV in BC patients receiving AC and non-AC, across multiple chemotherapy cycles. CLINICAL TRIALS REGISTRATION NUMBERS: Study 1: NCT01339260, Study 2:NCT01376297.
Authors: R Ienca; C Giardiello; A Scozzarro; R Schiano di Cola; N Di Lorenzo; Girish Juneja; G Lopez; F Badiuddin Journal: Obes Surg Date: 2019-09 Impact factor: 4.129