TY - JOUR
T1 - Safety and efficacy of NEPA, an oral fixed combination of netupitant and palonosetron, in older patients
AU - Aapro, Matti
AU - Jordan, Karin
AU - Gralla, Richard J.
AU - Rizzi, Giada
AU - Rossi, Giorgia
AU - Palmas, Marco
AU - Alyasova, Anna V.
AU - Lisyanskaya, Alla S.
AU - Bošnjak, Snežana M.
AU - Hesketh, Paul J.
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2017/1/1
Y1 - 2017/1/1
N2 - Objectives Prevention of chemotherapy-induced nausea and vomiting is critical in older patients with cancer. NEPA is an oral fixed combination of netupitant 300 mg, a new NK1 receptor antagonist (RA), and palonosetron 0.5 mg, a pharmacologically distinct 5-HT3 RA. This retrospective analysis evaluated the efficacy and safety of NEPA in older patients. Methods Patients aged ≥ 65 and ≥ 70 years from one phase II and two phase III trials were considered. Chemotherapy-naive patients with malignant tumors were treated with anthracycline–cyclophosphamide (AC), non-AC-based moderately emetogenic chemotherapy (non-AC MEC), or highly emetogenic chemotherapy (HEC). Following single-dose NEPA, patients received oral dexamethasone on day 1 (AC and non-AC MEC) or days 1–4 (HEC). Efficacy was evaluated through complete response (CR) in cycle 1. Safety was evaluated by AEs and ECGs. Data were summarized by descriptive statistics. Results Overall, 214 patients were ≥ 65 years and 80 were ≥ 70 years. A higher CR was observed in older patients versus the total population; in the acute phase > 90% of patients ≥ 65 years experienced CR. Efficacy was maintained over multiple cycles of chemotherapy. No significant nausea rates were generally higher in the older patients versus total population. Similar rates of AEs in the first treatment cycle were reported for patients ≥ 65 years, ≥ 70 years, and total population (72.9% vs 67.5% vs 70.0%, respectively). No cardiac safety concerns were raised. Conclusion NEPA is highly effective in older patients receiving MEC or HEC regimens. NEPA is also well tolerated, demonstrating suitability for use in older patients who may have comorbidities.
AB - Objectives Prevention of chemotherapy-induced nausea and vomiting is critical in older patients with cancer. NEPA is an oral fixed combination of netupitant 300 mg, a new NK1 receptor antagonist (RA), and palonosetron 0.5 mg, a pharmacologically distinct 5-HT3 RA. This retrospective analysis evaluated the efficacy and safety of NEPA in older patients. Methods Patients aged ≥ 65 and ≥ 70 years from one phase II and two phase III trials were considered. Chemotherapy-naive patients with malignant tumors were treated with anthracycline–cyclophosphamide (AC), non-AC-based moderately emetogenic chemotherapy (non-AC MEC), or highly emetogenic chemotherapy (HEC). Following single-dose NEPA, patients received oral dexamethasone on day 1 (AC and non-AC MEC) or days 1–4 (HEC). Efficacy was evaluated through complete response (CR) in cycle 1. Safety was evaluated by AEs and ECGs. Data were summarized by descriptive statistics. Results Overall, 214 patients were ≥ 65 years and 80 were ≥ 70 years. A higher CR was observed in older patients versus the total population; in the acute phase > 90% of patients ≥ 65 years experienced CR. Efficacy was maintained over multiple cycles of chemotherapy. No significant nausea rates were generally higher in the older patients versus total population. Similar rates of AEs in the first treatment cycle were reported for patients ≥ 65 years, ≥ 70 years, and total population (72.9% vs 67.5% vs 70.0%, respectively). No cardiac safety concerns were raised. Conclusion NEPA is highly effective in older patients receiving MEC or HEC regimens. NEPA is also well tolerated, demonstrating suitability for use in older patients who may have comorbidities.
KW - 5-Hydroxytryptamine receptor antagonist
KW - CINV
KW - Highly emetogenic chemotherapy
KW - Moderately emetogenic chemotherapy
KW - Multiple chemotherapy cycles
KW - NEPA
KW - Netupitant
KW - Neurokinin-1 receptor antagonist
KW - Older patients
KW - Palonosetron
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U2 - 10.1016/j.jgo.2016.09.002
DO - 10.1016/j.jgo.2016.09.002
M3 - Article
C2 - 27889278
AN - SCOPUS:85007170278
SN - 1879-4068
VL - 8
SP - 56
EP - 63
JO - Journal of Geriatric Oncology
JF - Journal of Geriatric Oncology
IS - 1
ER -