![]() 6 pts died of toxicity during consolidation treatment (2 arm A and 4 arm B), and 6 pts died of unrelated causes while relapse-free (5 arm A and 1 arm B). To date, there were 79 PFS events: 67 pts experienced progressive disease after randomization (47 for arm A and 20 for arm B). Consolidation treatment with R-DEVIC or HDC-ASCT resulted in a substantial increase of pts with CR (65% in arm A and 68% in arm B, respectively p= 0.71). ![]() 13 (3.8%) pts died of treatment-related complications during induction treatment, 11 of them due to neutropenic infectious complications. Both consolidation strategies were well tolerated: R-DeVIC and HDC-ASCT were completed in 100 (87%) and 111 (97%) pts, respectively. 239 of 346 (69%) pts responded to induction treatment, 27% achieved a complete remission (CR) and 52% a partial remission (PR). Median follow-up of all registered patients is 44 months (range 0,2-86). Distribution of patient characteristics were well balanced between arms. Median age of the randomized pts was 59 years (range 21 - 70) with 22.3% of pts being 65 years or older. Main reasons for not reaching randomization were toxicities (n= 87 25%) and disease progression (n= 36 10%). RESULTS: Between July 2014 and August 2019, 368 pts were registered 346 started treatment, 260 (75%) completed the induction therapy, and 115 and 114 pts were randomly assigned to arm A and arm B, respectively. The primary endpoint progression-free survival (PFS) was analyzed with a Cox proportional hazards model, containing the randomized treatment as hypothesis variable and the stratification variable response status as a covariate. Pts achieving at least partial response (PR) after completion of induction were randomly allocated to either arm A with two courses of R-DeVIC regimen (375 mg/m 2 day 0 dexamethasone 40 mg/d days 1 to 3 etoposide 100 mg/m 2/d days 1 to 3 ifosfamide 1500 mg/m 2/d days 1 to 3 carboplatin 300 mg/m 2 day 1) or arm B, consisting of HDC with BCNU 400 mg/m 2 (day -6) and thiotepa 2 x 5 mg/kg/d days -5 & -4) followed by ASCT. ![]() Stem cell harvest was conducted after the 2nd cycle. Induction consisted of 4 cycles of MATRix regimen (rituximab 375 mg/m 2/d days 0 & 5 methotrexate 3.5 g/m 2 day 1 cytarabine 2 × 2 g/m 2/d days 2 & 3 thiotepa 30 mg/m 2 day 4, every 21 days). Main eligibility criteria included newly diagnosed PCNSL, HIV-negative, age 18-65 years irrespective of ECOG PS or 66-70 years with ECOG PS ≤ 2, and adequate organ function. METHODS: This open label, randomized phase III trial was conducted in 56 centers of 5 countries (Germany, Italy, Denmark, Norway, Switzerland). Kroschinsky, Francesca Re, Elisa Pulczynski, Lorella Orsucci, Lisa Pospiech, Martina Deckert, Maurilio Ponzoni, Julia Wendler, Elke Valk, Teresa Calimeri, Benjamin Kasenda, Martin Trepel, Heidi Fricker, Philipp von Gottberg, Elvira Burger, Gabriele Ihorst, Olga Grishina, Claudia Hader, Emanuele Zucca, Jürgen Finke, Elisabeth Schorb Effects on Survival of Non-Myeloablative Chemoimmunotherapy Compared to High-Dose Chemotherapy Followed By Autologous Stem Cell Transplantation (HDC-ASCT) As Consolidation Therapy in Patients with Primary CNS Lymphoma - Results of an International Randomized Phase III Trial (MATRix/IELSG43). Larsen, Hans Salwender, Ralph Naumann, Georg Hess, Lorenz Thurner, Tobias Pukrop, Ulrich Keller, Anne Kirsti Blystadt, Frank P. ![]() ![]() Ferreri, Mascha Binder, Peter Borchmann, Justin Hasenkamp, Stephan Stilgenbauer, Alexander Roeth, Thomas Weber, Gerlinde Egerer, Thomas Ernst, Bernd Hertenstein, Georg Lenz, Guido Kobbe, Uta Brunnberg, Christian Schmidt, Michael Kneba, Martin Dreyling, Robert Möhle, Jens Panse, Thomas Heinicke, Sebastian Schroll, Thomas S. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |