Bortezomib, Doxorubicin, Cyclophosphamide, Dexamethasone Induction Followed by Stem Cell Transplantation for Primary Plasma Cell Leukemia: A Prospective Phase II Study of the Intergroupe Francophone du Myélome

Bruno Royer 1, * Stéphane Minvielle 2 Momar Diouf 1 Murielle Roussel 3 Lionel Karlin 4 Cyrille Hulin 5 Bertrand Arnulf 6 Margaret Macro 7 Sylvie Cailleres 8 Annie Brion 9 Sabine Brechignac 10 Karim Belhadj 11 Marie Lorraine Chretien 12 Marc Wetterwald 13 Carine Chaleteix 14 Mourad Tiab 15 Xavier Leleu 16 Laurent Frenzel 17 Laurent Garderet 18 Sylvain Choquet 19 Jean Gabriel Fuzibet 20 Charles Dauriac 21 Luc-Matthieu Forneker 22 Lofti Benboubker 23 Thierry Facon 24 Philippe Moreau 24 Hervé Avet-Loiseau 3 Jean Pierre Marolleau 1
Abstract : PURPOSE: Primary plasma cell leukemia (pPCL) is a rare and aggressive malignancy with a poor prognosis. With conventional chemotherapy, patients typically die within 1 year. In all but one of the retrospective studies reported to date, bortezomib and lenalidomide seem to improve survival. We conducted a prospective phase II trial in patients with pPCL to assess the efficacy of an alternate regimen that combines standard chemotherapy, a proteasome inhibitor, and high-dose melphalan and autologous stem cell transplantation (HDM/ASCT) followed by either allogeneic transplantation or bortezomib/lenalidomide maintenance. PATIENTS AND METHODS: Patients 70 years old and younger with newly diagnosed pPCL received four alternating cycles of bortezomib, dexamethasone plus doxorubicin or cyclophosphamide. Peripheral blood stem cells were collected from responding patients with < 1% of circulating plasma cells before HDM/ASCT. As consolidation, young patients received a reduced-intensity conditioning allograft, whereas the remaining patients underwent a second HDM/ASCT followed by 1 year of bortezomib, lenalidomide, dexamethasone. The primary end point was progression-free survival (PFS). RESULTS: Forty patients (median age, 57 years; range, 27 to 71 years) were enrolled. The median follow-up was 28.7 months. In the intention-to-treat analysis, the median PFS and overall survival were 15.1 (95% CI, 8.4; -) and 36.3 (95% CI, 25.6; -) months, respectively. The overall response rate to induction was 69%. One patient underwent a syngeneic allograft and 25 HDM/ASCT (16 of whom subsequently received a reduced-intensity conditioning allograft and seven a second ASCT followed by maintenance). CONCLUSION: In this prospective trial in patients with pPCL, we show that bortezomib, dexamethasone plus doxorubicin or cyclophosphamide induction followed by transplantation induces high response rates and appears to significantly improve PFS.
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Bruno Royer, Stéphane Minvielle, Momar Diouf, Murielle Roussel, Lionel Karlin, et al.. Bortezomib, Doxorubicin, Cyclophosphamide, Dexamethasone Induction Followed by Stem Cell Transplantation for Primary Plasma Cell Leukemia: A Prospective Phase II Study of the Intergroupe Francophone du Myélome. Journal of Clinical Oncology, American Society of Clinical Oncology, 2016, 34 (18), pp.2125 - 2132. ⟨10.1200/JCO.2015.63.1929⟩. ⟨inserm-01822878⟩

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