title: Phase II trial of 131-Iodine tositumomab with high-dose chemotherapy and autologous stem cell transplantation for relapsed diffuse large B cell lymphoma.
abstract: The purpose of this study was to evaluate the standard outpatient dose of 131-Iodine tositumomab (75 cGy) combined with high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM) followed by autologous stem cell rescue for the treatment of chemotherapy-sensitive relapsed or refractory, or high-risk first complete remission (CR) patients with diffuse large B cell non-Hodgkin's lymphoma (DLBCL). Forty patients with chemotherapy-sensitive persistent or relapsed or high/intermediate or high international prognostic index DLCBL were treated in a phase II trial combining 75 cGy 131-Iodine tositumomab with high-dose BEAM followed by autologous stem cell transplantation. The CR rate after transplantation was 78%, and the overall response rate was 80%. Short-term and long-term toxicities were similar to historical control patients treated with BEAM alone. With a median follow-up of 6 years (range, 3-10 years), the 5-year overall survival (OS) was 72% (95% confidence interval [CI], 55%-83%), and the 5-year progression-free survival (PFS) rate was 70% (95% CI, 53%-82%). The PFS and OS were encouraging in this group of chemotherapy-sensitive persistent, relapsed, or high-risk patients with DLBCL. A follow-up phase III trial with 131-Iodine tositumomab/BEAM vs rituximab/BEAM was planned based on this information.
authors.affiliation: Department of Internal Medicine, Division of Hematology/Oncology, University of Nebraska Medical Center, Omaha, Nebraska 68198-7680, USA. jmvose@unmc.edu
authors.forename: Julie M
authors.initials: JM
authors.lastname: Vose
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Bierman
authors.forename: Fausto R
authors.initials: FR
authors.lastname: Loberiza
authors.forename: Charles
authors.initials: C
authors.lastname: Enke
authors.forename: Jordan
authors.initials: J
authors.lastname: Hankins
authors.forename: Robert G
authors.initials: RG
authors.lastname: Bociek
authors.forename: Wing C
authors.initials: WC
authors.lastname: Chan
authors.forename: Dennis D
authors.initials: DD
authors.lastname: Weisenburger
authors.forename: James O
authors.initials: JO
authors.lastname: Armitage
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D002330:Carmustine / Q000008:administration & dosage / Q000009:adverse effects; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000401:mortality* / Q000517:prevention & control*; D008297:Male; D008558:Melphalan / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D011034:Podophyllotoxin / Q000008:administration & dosage / Q000009:adverse effects; D012008:Recurrence; D033581:Stem Cell Transplantation; D015996:Survival Rate; D014182:Transplantation, Autologous
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D003561:Cytarabine; C119496:tositumomab I-131; D011034:Podophyllotoxin; D008558:Melphalan; D002330:Carmustine