Bortezomib-doxorubicin-cyclophosphamide-dexamethasone induction followed by stem cell transplantation for primary plasma cell leukemia: a prospective phase II study of the IFM

Bruno Royer 1 Minvielle Stéphane 2 Momar Diouf 3 Murielle Roussel 4 Lionel Karlin 5 Cyrille Hulin 6 Bertrand Arnulf 7 Margaret Macro 8 Cailleres Sylvie 9 Annie Brion 10 Sabine Bréchignac 11 Beladj Karim 12 Marie Lorraine Chrétien 13 Marc Wetterwald 14 Carine Chaleteix 15 Mourad Tiab 16 Xavier Leleu 17, 18 Laurent Frenzel 19 Laurent Garderet 20 Sylvain Choquet 21 Jean-Gabriel Fuzibet 22 Charles Dauriac 23 Luc-Matthieu Forneker 24 Lotfi Benboubker 25 Thierry Facon 26 Philippe Moreau 27 Hervé Avet-Loiseau 28 Jean-Pierre Marolleau 29
Abstract : Purpose Primary plasma cell leukemia (pPCL) is a rare and aggressive malignancy with a poor prognosis: with conventional chemotherapy, patients typically die within one 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 pPCL patients in order to assess the efficacy of an alternate regimen combining standard chemotherapy, a proteasome inhibitor, high dose melphalan and autologous transplantation (HDM/ASCT), followed by either allogeneic transplantation or bortezomib/lenalidomide maintenance. Patients and methods Patients ≤ 70-years old with newly diagnosed pPCL received 4 alternate cycles of bortezomib-dexamethasone plus doxorubicin (PAD) or cyclophosphamide (VCD). Peripheral blood stem cells were collected for responding patients with less than 1% of circulating plasma cells prior to HDM/ASCT. As consolidation, young patients received a reduced intensity conditioning (RIC) allograft, whereas the remaining patients underwent a second HDM/ASCT followed by one year of bortezomib-lenalidomide-dexamethasone. The primary end point was progression free survival (PFS). Results Forty patients with a median age of 57 years (range 27-71) were enrolled. The median follow-up was 28.7 months. In the intent-to-treat analysis, the median PFS and overall survival (OS) were 15.1 (95%CI [8.4; -]) and 36.3 months (95%CI [25.6; -]) respectively. The overall response rate to induction was 69%. One patient underwent a syngeneic allograft and 25 HDM/ASCT: 16 of them subsequently received a RIC-allograft, 7 a second ASCT followed by maintenance. Conclusion In this prospective trial in patients with pPCL, we showed that PAD/VCD induction followed by transplantation induced high response rates and appears to significantly improve progression free survival
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Pré-publication, Document de travail
2016
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Bruno Royer, Minvielle Stéphane, 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 IFM. 2016. 〈inserm-01273359〉

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