High-dose sequential chemotherapy and rituximab (R-HDS) supported by autologous stem cell transplantation (ASCT) in patients (pts) with systemic B-cell lymphoma with CNS involvement (SCNSL) at diagnosis or relapse: Interim analysis of feasibility and activity of a phase II trial.

• DOI: 10.1200/jco.2010.28.15_suppl.8081
• Publication Date: 2017-02-23T21:41:10Z
• Authors: A. Assanelli; K. Patti; S. Cortelazzo; L. Rigacci; L. Devizzi; M. Foppoli; A. Mule'; F. Ciceri; C. Tarella; A. J. Ferreri
• Keywords: Autologous stem-cell transplantation; ThioTEPA

8081 Background: High-dose (HD) chemotherapy supported by ASCT exhibited promising results in a few, small retrospective series of SCNSL. Herein we report the interim analysis phase II trial (ClinicalTrials.gov #NCT00801216) addressing new R-HDS combination with these poor-prognosis pts. Methods: Pts (≤65 ys old; ECOG PS 0-3) SCNSL at diagnosis or relapse were treated 2 c. HD-methotrexate + HD-cytarabine (induction); 3 sequential HD-cyclophosphamide, HD-cytarabine, HD-etoposide (R-HDS); BCNU-thiotepa-based conditioning and ASCT. received 6 doses i.v. rituximab 4 intrathecal liposomal cytarabine. CNS residual disease referred to RT. The 2-year EFS is primary endpoint (P0 40%; P1 60%; 38 pts required). This approach will be considered active if ≥21 progression free yrs. Results: first 13 registered (median age 52 ys, 31-65; M/F ratio 1.6) analyzed. Six diagnosis; 8 had systemic disease; no pt positive CSF. Histotypes diffuse large B-cell (10), mantle cell (2) follicular (1) lymphomas. Bulky (1), ECOG-PS 2-3 (4) B-symptoms uncommon; elevated LDH levels observed 10 Treatment was completed pts, ongoing (R-HDS), interrupted 2: before poor mobilizer after course due PD. There toxic deaths. G4 neutropenia thrombocytopenia reported all febrile 7, other septic complications 5. G3-4 non-hematological toxicity not reported. PBSC collection successful 9 9.35 × 109/kg). Nine (69%) achieved CR, PR (ORR 92%), 1 No At median f-up 15 m, experienced relapse/PD (CNS 3, extra-CNS 1), 2-yr 46%; are alive OS 54%. Conclusions: feasible ≤65 old Preliminary this intensive encouraging condition, otherwise dismal prognosis. significant financial relationships disclose.