Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90- ibritumomab tiuxetan in untreated mantle-cell lymphoma: Eastern Cooperative Oncology Group study E1499

Mitchell R. Smith, Hailun Li, Leo Gordon, Randy D. Gascoyne, Elisabeth Paietta, Andres Forero-Torres, Brad S. Kahl, Ranjana Advani, Fangxin Hong, Sandra J. Horning

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58 Scopus citations

Abstract

Purpose: To test the hypothesis that consolidation therapy with yttrium-90 ( 90Y) -ibritumomab tiuxetan after brief initial therapy with four cycles of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated mantle-cell lymphoma would be a well-tolerated regimen that would improve outcomes compared with historical R-CHOP data. Patients and Methods: Patients ≥ 18 years old with histologically confirmed mantle-cell lymphoma expressing CD20 and cyclin D1 who had not received any previous therapy and had an Eastern Cooperative Oncology Group performance status of 0 to 2 and adequate organ function were eligible. The study enrolled and treated 57 patients, of whom 56 patients were eligible. Fifty-two patients (50 eligible patients) received 90Y-ibritumomab tiuxetan. The study design required 52 eligible patients to detect a 50% improvement in the median time to treatment failure (TTF) compared with that reported for six cycles of R-CHOP. Results: With 56 analyzed patients (median age, 60 years; men, 73%), the overall response rate was 82% (55% complete response/complete response-unconfirmed). With a median follow-up of 72 months, the median TTF was 34.2 months. The median overall survival (OS) has not been reached, with an estimated 5-year OS of 73% (79% for patients ≤ age 65 years v 62% for patients > age 65 years; P = .08 [log-rank test]). There were no unexpected toxicities. Conclusion: R-CHOP given for four cycles followed by 90Y-ibritumomab tiuxetan compared favorably with historical results with six cycles of R-CHOP in patients with previously untreated mantle-cell lymphoma. This regimen was well tolerated and should be applicable to most patients with this disease.

Original languageEnglish (US)
Pages (from-to)3119-3126
Number of pages8
JournalJournal of Clinical Oncology
Volume30
Issue number25
DOIs
StatePublished - Sep 1 2012

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ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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