A phase I/II trial of iodine-131-tositumomab (anti-CD20), etoposide, cyclophosphamide, and autologous stem cell transplantation for relapsed B-cell lymphomas.

摘要: Relapsed B-cell lymphomas are incurable with conventional chemotherapy and radiation therapy, although a fraction of patients can be cured high-dose chemoradiotherapy autologous stem-cell transplantation (ASCT). We conducted phase I/II trial to estimate the maximum tolerated dose (MTD) iodine 131 ((131)I)-tositumomab (anti-CD20 antibody) that could combined etoposide cyclophosphamide followed by ASCT in relapsed lymphomas. Fifty-two received trace-labeled infusion 1.7 mg/kg (131)I-tositumomab (185-370 MBq) serial quantitative gamma-camera imaging estimation absorbed doses tumor sites normal organs. Ten days later, therapeutic tositumomab labeled an amount (131)I calculated deliver target (20-27 Gy) critical organs (liver, kidneys, lungs). Patients were maintained isolation until their total-body radioactivity was less than 0.07 mSv/h at 1 m. They then given ASCT. The MTD safely 60 100 delivered 25 Gy estimated overall survival (OS) progression-free (PFS) all treated 2 years 83% 68%, respectively. These findings compare favorably those nonrandomized control group who underwent transplantation, external-beam irradiation, therapy during same period (OS 53% PFS 36% years), even after adjustment for confounding variables multivariable analysis.