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Consolidation anti-CD22 fractionated radioimmunotherapy with 90 Y-epratuzumab tetraxetan following R-CHOP in elderly patients with diffuse large B-cell lymphoma: a prospective, single group, phase 2 trial.
- Source :
-
The Lancet. Haematology [Lancet Haematol] 2017 Jan; Vol. 4 (1), pp. e35-e45. Date of Electronic Publication: 2016 Dec 08. - Publication Year :
- 2017
-
Abstract
- Background: Radioimmunotherapy represents a potential option as consolidation after chemoimmunotherapy in patients with diffuse large B-cell lymphoma who are not candidates for transplantation. We aimed to assess activity and toxicity of fractionated radioimmunotherapy using anti-CD22 <superscript>90</superscript> Y-epratuzumab tetraxetan as consolidation after front-line induction chemoimmunotherapy in untreated elderly patients with diffuse large B-cell lymphoma.<br />Methods: We did a prospective, single-group, phase 2 trial at 28 hospitals in France, with patients recruited from 17 hospitals. Eligible patients were aged 60-80 years with bulky stage 2-3 or stage 3-4 CD20-positive diffuse large B-cell lymphoma, previously untreated, and not eligible for transplantation. Patients received six cycles of R-CHOP (rituximab [375 mg/m <superscript>2</superscript> ], cyclophosphamide [750 mg/m <superscript>2</superscript> ], doxorubicin [50 mg/m <superscript>2</superscript> ], and vincristine [1·4 mg/m <superscript>2</superscript> , up to 2 mg] all on day 1, and prednisone [40 mg/m <superscript>2</superscript> ] daily for 5 days), administered every 14 days. 6-8 weeks after R-CHOP, responders received two doses of 15 mCi/m <superscript>2</superscript> (555 MBq/m <superscript>2</superscript> ) <superscript>90</superscript> Y-epratuzumab tetraxetan administered 1 week apart. The primary endpoint was 2 year event-free survival in all registered eligible patients who received at least 1 day of study treatment; the safety analysis was done in the same population. This trial is registered with ClinicalTrials.gov, number NCT00906841.<br />Findings: Between Oct 22, 2008, and Dec 16, 2010, we recruited 75 patients, of whom four (5%) were excluded after central pathology review; hence, 71 (95%) patients were included in the analysis. All patients started induction treatment; 57 (80%) received radioimmunotherapy. With a median follow-up of 37 months (IQR 30-44), the estimated 2 year event-free survival was 75% (95% CI 63-84). Radioimmunotherapy toxicity consisted of grade 3-4 thrombocytopenia in 48 (84%) of 57 patients and neutropenia in 45 (79%) of 57 patients. One patient developed myelodysplastic syndrome 28 months after receiving radioimmunotherapy and one patient developed acute myeloid leukaemia 5 months after receiving radioimmunotherapy.<br />Interpretation: Fractionated radioimmunotherapy with <superscript>90</superscript> Y-epratuzumab tetraxetan might be appropriate for response consolidation after induction chemotherapy in older patients with advanced diffuse large B-cell lymphoma, but further comparative studies are needed.<br />Funding: Immunomedics, Amgen, Canceropôle Grand Ouest, the GOELAMS/LYSA group and the French National Agency for Research (Investissements d'Avenir).<br /> (Copyright © 2017 Elsevier Ltd. All rights reserved.)
- Subjects :
- Aged
Antibodies, Monoclonal, Murine-Derived therapeutic use
Cyclophosphamide therapeutic use
Doxorubicin therapeutic use
Female
Humans
Lymphoma, Large B-Cell, Diffuse drug therapy
Lymphoma, Large B-Cell, Diffuse radiotherapy
Male
Middle Aged
Prednisone therapeutic use
Prospective Studies
Rituximab
Sialic Acid Binding Ig-like Lectin 2 antagonists & inhibitors
Treatment Outcome
Vincristine therapeutic use
Antibodies, Monoclonal, Humanized therapeutic use
Antineoplastic Agents, Immunological therapeutic use
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Lymphoma, Large B-Cell, Diffuse therapy
Radioimmunotherapy methods
Yttrium Radioisotopes therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 2352-3026
- Volume :
- 4
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- The Lancet. Haematology
- Publication Type :
- Academic Journal
- Accession number :
- 27964867
- Full Text :
- https://doi.org/10.1016/S2352-3026(16)30168-5