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Clinical Trial
. 2018 Sep;109(9):2830-2840.
doi: 10.1111/cas.13719. Epub 2018 Jul 28.

R-High-CHOP/CHASER/LEED With Autologous Stem Cell Transplantation in Newly Diagnosed Mantle Cell Lymphoma: JCOG0406 STUDY

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Free PMC article
Clinical Trial

R-High-CHOP/CHASER/LEED With Autologous Stem Cell Transplantation in Newly Diagnosed Mantle Cell Lymphoma: JCOG0406 STUDY

Michinori Ogura et al. Cancer Sci. .
Free PMC article

Abstract

Although induction immunochemotherapy including high-dose cytarabine and rituximab followed by high-dose chemotherapy (HDC) with autologous stem cell transplantation (ASCT) is recommended for younger patients (≤65 years old) with untreated mantle cell lymphoma (MCL), no standard induction and HDC regimen has been established. We conducted a phase II study of induction immunochemotherapy of R-High-CHOP/CHASER followed by HDC of LEED with ASCT in younger patients with untreated advanced MCL. Eligibility criteria included untreated MCL, stage II bulky to IV, and age 20-65 years. Patients received 1 cycle of R-High-CHOP followed by 3 cycles of CHASER every 3 weeks. Peripheral blood stem cells (PBSC) were harvested during CHASER. LEED with ASCT was delivered to patients who responded to R-High-CHOP/CHASER. Primary endpoint was 2-year progression-free survival (PFS). From June 2008 to June 2012, 45 patients (median age 59 years; range 38-65 years) were enrolled. PBSC were successfully harvested from 36 of 43 patients. Thirty-five patients completed ASCT. Two-year PFS was 77% (80% CI 68-84), which met the primary endpoint. Five-year PFS and overall survival were 52% (95% CI 34-68%) and 71% (95% CI 51-84%), respectively. Overall response and complete response rates after induction immunochemotherapy were 96% and 82%, respectively. The most common grade 4 toxicities were hematological. In younger patients with untreated MCL, R-High-CHOP/CHASER/LEED with ASCT showed high efficacy and acceptable toxicity, and it can now be considered a standard treatment option.

Keywords: autologous stem cell transplantation; cytarabine; high-dose chemotherapy; mantle cell lymphoma; rituximab.

Figures

Figure 1
Figure 1
Study design. Ara‐C, cytarabine; CPA, cyclophosphamide; CR, complete response; Dexa, dexamethasone; DXR, doxorubicin; ETP, etoposide; L‐PAM, melphalan; MCL, mantle cell lymphoma; PBSCT, peripheral blood stem cell transplantation; PD, progression of disease; PR, partial response; PS, performance status; PSL, prednisolone; SD, stable disease; VCR, vincristine
Figure 2
Figure 2
Flowchart of clinical course. Auto‐PBSCH, autologous peripheral blood stem cell harvest; PD, progression of disease
Figure 3
Figure 3
Kaplan‐Meier curves of progression‐free survival (PFS) (A) of all 45 enrolled patients, and Kaplan‐Meier curves of PFS according to risk stratified by MIPI (n = 44) (B) and by MIPI‐c (n = 44) (C). MIPI, mantle cell lymphoma international prognostic index; MIPI‐c, modified combination of the Ki‐67 index and MIPI
Figure 4
Figure 4
Kaplan‐Meier curves of overall survival (OS) (A) of all 45 enrolled patients, and Kaplan‐Meier curves of OS according to risk stratified by MIPI (n = 44) (B) and MIPI‐c (n = 44) (C). MIPI, mantle cell lymphoma international prognostic index; MIPI‐c, modified combination of the Ki‐67 index and MIPI

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References

    1. Schmidt C, Dreyling M. Therapy of mantle cell lymphoma: current standards and future strategies. Hematol Oncol Clin North Am. 2008;22:953‐963. - PubMed
    1. Fisher RI, Dahlberg S, Nathwani BN, et al. A clinical analysis of two indolent lymphoma entities: mantle cell lymphoma and marginal zone lymphoma (including the mucosa‐associated lymphoid tissue and monocytoid B‐cell subcategories): a Southwest Oncology Group study. Blood. 1995;85:1075‐1082. - PubMed
    1. Yatabe Y, Suzuki R, Tobinai K, et al. Significance of cyclin D1 overexpression for the diagnosis of mantle cell lymphoma: a clinicopathologic comparison of cyclin D1‐positive MCL and cyclin D1‐negative MCL‐like B‐cell lymphoma. Blood. 2000;95:2253‐2261. - PubMed
    1. Howard OM, Gribben JG, Neuberg DS, et al. Rituximab and CHOP induction therapy for newly diagnosed mantle‐cell lymphoma: molecular complete responses are not predictive of progression‐free survival. J Clin Oncol. 2002;20:1288‐1294. - PubMed
    1. Dreyling M, Lenz G, Hoster E, et al. Early consolidation by myeloablative radiochemotherapy followed by autologous stem cell transplantation in first remission significantly prolongs progression‐free survival in mantle‐cell lymphoma: results of a prospective randomized trial of the European MCL Network. Blood. 2005;105:2677‐2684. - PubMed

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