A 4-weekly course of rituximab is safe and improves tumor control for patients with minimal residual disease persisting 3 months after autologous hematopoietic stem-cell transplantation: results of a prospective multicenter phase II study in patients with follicular lymphoma

• Published in: Annals of oncology Vol. 23; no. 10; pp. 2687 - 2695
• Main Authors: Morschhauser, F., Recher, C., Milpied, N., Gressin, R., Salles, G., Brice, P., Vey, N., Haioun, C., Colombat, P., Rossi, J.F., Deconinck, E., Lazreg, F., Bergougnoux, L., Delsol, G., Attal, M.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.10.2012; Oxford University Press; Elsevier
• Subjects: Adolescent; Adult; Aged; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal, Murine-Derived - therapeutic use; Antineoplastic Agents; Antineoplastic Agents - therapeutic use; autologous stem cell transplantation; Biological and medical sciences; follicular lymphoma; Hematologic and hematopoietic diseases; Hematopoietic Stem Cell Transplantation; Humans; Immunology; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Life Sciences; Lymphoma, Follicular; Lymphoma, Follicular - drug therapy; Lymphoma, Follicular - pathology; Medical sciences; Middle Aged; minimal residual disease; Neoplasm, Residual; Pharmacology. Drug treatments; Polymerase Chain Reaction; Prospective Studies; Rituximab; Young Adult; minimal residual disease; follicular lymphoma; rituximab; autologous stem cell transplantation; Antineoplastic agent; Stem cell; Multicenter study; Hematopoietic cell; Administration schedule; Monoclonal antibody; Prospective; Control; Lymphoproliferative syndrome; Immunotherapy; Phase II trial; Autologous hematopoietic stem cell transplantation; Human; Minimal residual disease; Rituximab; Patient; B cell neoplasm; Malignant hemopathy; Malignant tumor; Lymphoid neoplasm; Non Hodgkin lymphoma; Treatment; Follicular lymphoma; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mds202

This study explored the efficacy and safety of rituximab as treatment of clinical or molecular residual disease after autologous stem-cell transplantation (ASCT) in follicular lymphoma (FL). Forty patients with CD20+ FL and clinically (group A, n = 14) or clono-specific PCR-detectable (group B, n = 25) residual disease persisting 3 months after ASCT received rituximab 375 mg/m² once weekly for 4 weeks. Response rate at day 50 was 36% [90% confidence interval (CI) 15–61] in group A (World Health Organization criteria) and 52% (90% CI 34–70) in group B (conversion PCR-undetectable status to undetectable status). The best response rate was 71% [nine complete responses (CRs) and one partial response] in group A and 76% in group B. At 36 months, all 10 responses persisted in group A, whereas 46% of patients in group B still had PCR-undetectable disease. Furthermore, 68% of patients in group B were still in clinical CR. Rituximab after ASCT was safe with few grade 3–4 toxic effects (15% patients), mainly acute reactions and infections. Rituximab induced a high rate of durable CRs in patients with clinically detectable disease, as well as durable eradication of PCR-detectable disease in patients with FL after ASCT. Continued molecular responses assessed with a highly sensitive and clono-specific PCR technique were correlated with an excellent disease control.