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1.
J Clin Oncol ; 23(9): 1984-92, 2005 Mar 20.
Article in English | MEDLINE | ID: mdl-15668467

ABSTRACT

PURPOSE: Mantle cell lymphoma (MCL) is characterized by a poor prognosis with a low to moderate sensitivity to chemotherapy and a median survival of only 3 to 4 years. In an attempt to improve outcome, the German Low Grade Lymphoma Study Group (GLSG) initiated a randomized trial comparing the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) and rituximab (R-CHOP) with CHOP alone as first-line therapy for advanced-stage MCL. PATIENTS AND METHODS: One hundred twenty-two previously untreated patients with advanced-stage MCL were randomly assigned to six cycles of CHOP (n = 60) or R-CHOP (n = 62). Patients up to 65 years of age achieving a partial or complete remission underwent a second randomization to either myeloablative radiochemotherapy followed by autologous stem-cell transplantation or interferon alfa maintenance (IFNalpha). All patients older than 65 years received IFNalpha maintenance. RESULTS: R-CHOP was significantly superior to CHOP in terms of overall response rate (94% v 75%; P = .0054), complete remission rate (34% v 7%; P = .00024), and time to treatment failure (TTF; median, 21 v 14 months; P = .0131). No differences were observed for progression-free survival. Toxicity was acceptable, with no major differences between the two therapeutic groups. CONCLUSION: The combined immunochemotherapy with R-CHOP resulted in a significantly higher response rate and a prolongation of the TTF as compared with chemotherapy alone. Hence, R-CHOP may serve as a new baseline regimen for advanced stage MCL, but needs to be further improved by novel strategies in remission.


Subject(s)
Antibodies, Monoclonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cyclophosphamide/therapeutic use , Doxorubicin/therapeutic use , Interferon-alpha/therapeutic use , Lymphoma, Mantle-Cell/drug therapy , Prednisone/therapeutic use , Vincristine/therapeutic use , Aged , Antibodies, Monoclonal, Murine-Derived , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cyclophosphamide/adverse effects , Doxorubicin/adverse effects , Female , Germany , Humans , Lymphoma, Mantle-Cell/mortality , Lymphoma, Mantle-Cell/radiotherapy , Male , Middle Aged , Prednisone/adverse effects , Rituximab , Stem Cell Transplantation , Treatment Failure , Vincristine/adverse effects
2.
Blood ; 105(7): 2677-84, 2005 Apr 01.
Article in English | MEDLINE | ID: mdl-15591112

ABSTRACT

Mantle-cell lymphoma (MCL) is characterized by poor prognosis with a median survival of only 3 to 4 years. To improve clinical outcome, the European MCL Network initiated a randomized trial comparing consolidation with myeloablative radiochemotherapy followed by autologous stem cell transplantation (ASCT) to alpha-interferon maintenance (IFN alpha) in first remission. Patients 65 years of age or younger with advanced-stage MCL were assigned to ASCT or IFN alpha after achievement of complete or partial remission by a cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)-like induction therapy. According to the International Prognostic Index (IPI), 43% of patients had a low-risk, 41% a low-intermediate, 11% a high-intermediate, and 6% a high-risk profile. Sixty-two of 122 patients proceeded to ASCT and 60 received IFN alpha. Patients in the ASCT arm experienced a significantly longer progression-free survival (PFS) with a median of 39 months compared with 17 months for patients in the IFN alpha arm (P = .0108). The 3-year overall survival (OS) was 83% after ASCT versus 77% in the IFN group (P = .18). Early consolidation by myeloablative radiochemotherapy followed by ASCT is feasible and results in a significant prolongation of PFS in advanced-stage MCL. Longer follow-up is needed to determine the effect on OS.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cyclophosphamide/administration & dosage , Doxorubicin/administration & dosage , Hematopoietic Stem Cell Transplantation , Lymphoma, Mantle-Cell/drug therapy , Lymphoma, Mantle-Cell/radiotherapy , Prednisone/administration & dosage , Vincristine/administration & dosage , Whole-Body Irradiation , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Combined Modality Therapy , Cyclophosphamide/adverse effects , Disease-Free Survival , Doxorubicin/adverse effects , Europe , Female , Humans , Lymphoma, Mantle-Cell/mortality , Male , Middle Aged , Prednisone/adverse effects , Remission Induction , Survival Analysis , Transplantation, Autologous , Vincristine/adverse effects
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