Yttrium-90-Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy after Cytoreduction with ESHAP Chemotherapy in Patients with Relapsed Follicular Non-Hodgkin Lymphoma: Final Results of a Phase II Study

Oncology. 2018;94(5):274-280. doi: 10.1159/000486788. Epub 2018 Feb 22.

Abstract

Background: Radioimmunotherapy (RIT) is effective in treating relapsed/refractory follicular lymphoma (FL), with durable remissions in first-line consolidation. We hypothesized that RIT with ibritumomab tiuxetan (Zevalin®) would result in durable remissions by eliminating minimal residual disease after cytoreduction.

Methods: Patients with FL received 2 cycles of ESHAP (etoposide, methylprednisolone, cytarabine, cisplatin) every 28 days, followed by Zevalin 4-6 weeks later if there was no disease progression and bone marrow biopsy showed < 25% involvement.

Results: Twenty-eight patients were treated, with a median age of 61 years, median of 3 prior therapies, 49% high-risk disease (Follicular Lymphoma International Prognostic Index, FLIPI), and 39% progressive disease. Three patients did not receive Zevalin due to residual bone marrow involvement. The main toxicities were cytopenias, with 11% febrile neutropenia. The overall response rate (ORR) was 72%, with 45% achieving complete response. With a median follow-up of 73 months, 1-year progression-free survival (PFS) was 38%, and median PFS was 10 months, but median overall survival (OS) was not reached.

Conclusion: The study did not reach its primary endpoint of a 1-year PFS of 67.3%. Reasons for this could include low accrual, high-risk disease, and inadequate debulking provided by 2 cycles of ESHAP. However, this protocol was associated with tolerable toxicity, high ORR, and high OS. Further studies would optimize debulking and focus on high-risk FL patients.

Keywords: CD20; Follicular lymphoma; Indolent non-Hodgkin lymphoma; Phase II trial; Relapsed/refractory lymphoma.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Antibodies, Monoclonal / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Cisplatin / therapeutic use
  • Clinical Trials, Phase II as Topic
  • Combined Modality Therapy
  • Cytarabine / therapeutic use
  • Disease-Free Survival
  • Etoposide / therapeutic use
  • Female
  • Humans
  • Lymphoma, Follicular / drug therapy*
  • Lymphoma, Follicular / mortality
  • Lymphoma, Follicular / radiotherapy*
  • Lymphoma, Non-Hodgkin / drug therapy*
  • Lymphoma, Non-Hodgkin / mortality
  • Lymphoma, Non-Hodgkin / radiotherapy*
  • Male
  • Methylprednisolone / therapeutic use
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Radioimmunotherapy*
  • Remission Induction

Substances

  • Antibodies, Monoclonal
  • Cytarabine
  • ibritumomab tiuxetan
  • Etoposide
  • Cisplatin
  • Methylprednisolone

Supplementary concepts

  • ESAP protocol