R-High-CHOP/CHASER/LEED with autologous stem cell transplantation in newly diagnosed mantle cell lymphoma: JCOG0406 STUDY

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

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.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antigens, Neoplasm / analysis
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Combined Modality Therapy
  • Cyclophosphamide / therapeutic use
  • Cytarabine / therapeutic use
  • Dexamethasone / therapeutic use
  • Disease-Free Survival
  • Doxorubicin / therapeutic use
  • Etoposide / therapeutic use
  • Female
  • Hematopoietic Stem Cell Transplantation*
  • Humans
  • Immunotherapy / methods
  • Lymphoma, Mantle-Cell / pathology
  • Lymphoma, Mantle-Cell / therapy*
  • Male
  • Melphalan / therapeutic use*
  • Middle Aged
  • Prednisone / therapeutic use
  • Rituximab / therapeutic use*
  • Transplantation, Autologous
  • Vincristine / therapeutic use
  • Young Adult

Substances

  • Antigens, Neoplasm
  • Cytarabine
  • Rituximab
  • Vincristine
  • Etoposide
  • Dexamethasone
  • Doxorubicin
  • Cyclophosphamide
  • Melphalan
  • Prednisone

Supplementary concepts

  • CHASE protocol
  • CHOP protocol