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Preprints

Efficacy and Safety of Nepa in Preventing Nausea and Vomiting Induced by Multiple-day Chemotherapy in Patients With Refractory/relapsed Aggressive Non-hodgkin’s Lymphoma Undergoing Stem Cell Mobilization Prior to Autologous Hematopoietic Stem Cell Transplantation

Renzo ND, Musso M, Scimè R, Cupri A, Perrone T, De Risi C, Pastore D, Guarini A, Mengarelli A, Benedetti F, Mazza P, Capria S, Chiusolo P, Cupelli L, Federico V, Bozzoli V, Messa AR, Matera R, Seripa D, Codega P, Bonizzoni E, Specchia G.
Preprint from
Research Square
30 April 2021
PPR
PPR319554
Abstract

Purpose:

Prevention of chemotherapy-induced nausea and vomiting (CINV) is particularly challenging for patients receiving highly emetogenic preparative regimens before autologous stem cell transplantation (ASCT) due to the daily and continuous emetogenic stimulus of the multiple day chemotherapy (MD-CT). While studies have shown effective prevention of CINV during the conditioning phase with NK 1 receptor antagonist (NK 1 RA)-containing regimens, there have been no studies evaluating antiemetic use with MD-CT administered for mobilization of hematopoietic stem cells prior to ASCT.

Methods:

This multicenter, open-label, phase IIa study evaluated the efficacy of every-other-day dosing of NEPA administered during MD-CT being given for mobilization of stem cells prior to ASCT in patients with relapsed-refractory aggressive non-Hodgkin’s lymphoma. Eighty-one patients participated.

Results:

Response rates were 77.8% for complete response (no emesis and no rescue use), 72.8% for complete control (complete response and no more than mild nausea), 86.4% for no emesis, and 82.7% for no rescue use during the overall phase (duration of MD-CT through 48 hours after). NEPA was well tolerated with no treatment-related adverse events reported.

Conclusion:

NEPA, administered with a simplified every-other-day schedule, show to be very effective in preventing CINV in patients at high risk of CINV undergoing MD-CT for mobilization of hematopoietic stem cells prior to ASCT.