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 M. Paietta, Andres Forero-Torres, Brad S. Kahl, Ranjana Advani, Fangxin Hong, Sandra J. Horning

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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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Mantle-Cell Lymphoma
Vincristine
Prednisone
Doxorubicin
Cyclophosphamide
Treatment Failure
ibritumomab tiuxetan
Rituximab
Survival
Cyclin D1

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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

In: Journal of Clinical Oncology, Vol. 30, No. 25, 01.09.2012, p. 3119-3126.

Research output: Contribution to journalArticle

Smith, Mitchell R. ; Li, Hailun ; Gordon, Leo ; Gascoyne, Randy D. ; Paietta, Elisabeth M. ; Forero-Torres, Andres ; Kahl, Brad S. ; Advani, Ranjana ; Hong, Fangxin ; Horning, Sandra J. / 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. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 25. pp. 3119-3126.
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title = "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",
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.",
author = "Smith, {Mitchell R.} and Hailun Li and Leo Gordon and Gascoyne, {Randy D.} and Paietta, {Elisabeth M.} and Andres Forero-Torres and Kahl, {Brad S.} and Ranjana Advani and Fangxin Hong and Horning, {Sandra J.}",
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T1 - Phase II study of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone immunochemotherapy followed by yttrium-90- ibritumomab tiuxetan in untreated mantle-cell lymphoma

T2 - Eastern Cooperative Oncology Group study E1499

AU - Smith, Mitchell R.

AU - Li, Hailun

AU - Gordon, Leo

AU - Gascoyne, Randy D.

AU - Paietta, Elisabeth M.

AU - Forero-Torres, Andres

AU - Kahl, Brad S.

AU - Advani, Ranjana

AU - Hong, Fangxin

AU - Horning, Sandra J.

PY - 2012/9/1

Y1 - 2012/9/1

N2 - 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.

AB - 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.

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