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Long-term molecular remissions in patients with indolent lymphoma treated with rituximab as a single agent or in combination with interferon alpha-2a: A randomized phase II study from the Nordic Lymphoma Group

Kimby, Eva ; Jurlander, Jesper ; Geisler, Christian ; Hagberg, Hans ; Holte, Harald ; Lehtinen, Tuula ; Östenstad, Björn ; Hansen, Mads ; Österborg, Anders and Lindén, Ola LU , et al. (2008) In Leukemia & Lymphoma 49(1). p.102-112
Abstract
The purpose of this phase II randomized trial was to evaluate the effect and safety of interferon-2a (IFN) in combination with extended dosing rituximab in patients with symptomatic, advanced indolent lymphoma responding to a standard single course of rituximab. Totally 123 patients were treated with rituximab 375mg/m2 once weekly for 4 weeks leading to 14 complete response (CR; 11%), 56 partial response (PR; 46%), and 13 minor responses (MR; 11%). Patients achieving either PR or MR were randomized to four more infusions of rituximab alone (n=36) or in combination with five weeks of IFN (n=33), with an overall response rate (CR+PR) of 78% and 94%, respectively. Significantly more patients in the combination arm improved their response from... (More)
The purpose of this phase II randomized trial was to evaluate the effect and safety of interferon-2a (IFN) in combination with extended dosing rituximab in patients with symptomatic, advanced indolent lymphoma responding to a standard single course of rituximab. Totally 123 patients were treated with rituximab 375mg/m2 once weekly for 4 weeks leading to 14 complete response (CR; 11%), 56 partial response (PR; 46%), and 13 minor responses (MR; 11%). Patients achieving either PR or MR were randomized to four more infusions of rituximab alone (n=36) or in combination with five weeks of IFN (n=33), with an overall response rate (CR+PR) of 78% and 94%, respectively. Significantly more patients in the combination arm improved their response from PR/MR to CR (P0.05) and more maintained their responses for 24 months (72% versus 50%), respectively. Overall, 26 out of the 52 patients who achieved CR underwent minimal residual disease (MRD) evaluation. Totally 17 of these (65%) achieved MRD negativity, 14 of whom remain in CR after 4.8 years' follow-up. The addition of IFN to rituximab was generally safe, but reversible thrombocytopenia and neutropenia were noted in one and six patients, respectively, requiring a reduction in the IFN dose. Extended rituximab is effective and well tolerated and combination with IFN seems to improve both the quality and duration of the responses, providing the opportunity to achieve long-term molecular CRs and prolonged failure-free survival without chemotherapy. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
follicular lymphoma, molecular remission, indolent lymphoma, randomized phase II trial, rituximab, interferon
in
Leukemia & Lymphoma
volume
49
issue
1
pages
102 - 112
publisher
Taylor & Francis
external identifiers
  • wos:000252458200021
  • scopus:38549100096
  • pmid:18203019
ISSN
1042-8194
DOI
10.1080/10428190701704647
language
English
LU publication?
yes
id
6a2c81d2-db9f-4d9f-ba16-75a927947736 (old id 1199829)
date added to LUP
2016-04-01 13:15:29
date last changed
2022-01-27 18:13:11
@article{6a2c81d2-db9f-4d9f-ba16-75a927947736,
  abstract     = {{The purpose of this phase II randomized trial was to evaluate the effect and safety of interferon-2a (IFN) in combination with extended dosing rituximab in patients with symptomatic, advanced indolent lymphoma responding to a standard single course of rituximab. Totally 123 patients were treated with rituximab 375mg/m2 once weekly for 4 weeks leading to 14 complete response (CR; 11%), 56 partial response (PR; 46%), and 13 minor responses (MR; 11%). Patients achieving either PR or MR were randomized to four more infusions of rituximab alone (n=36) or in combination with five weeks of IFN (n=33), with an overall response rate (CR+PR) of 78% and 94%, respectively. Significantly more patients in the combination arm improved their response from PR/MR to CR (P0.05) and more maintained their responses for 24 months (72% versus 50%), respectively. Overall, 26 out of the 52 patients who achieved CR underwent minimal residual disease (MRD) evaluation. Totally 17 of these (65%) achieved MRD negativity, 14 of whom remain in CR after 4.8 years' follow-up. The addition of IFN to rituximab was generally safe, but reversible thrombocytopenia and neutropenia were noted in one and six patients, respectively, requiring a reduction in the IFN dose. Extended rituximab is effective and well tolerated and combination with IFN seems to improve both the quality and duration of the responses, providing the opportunity to achieve long-term molecular CRs and prolonged failure-free survival without chemotherapy.}},
  author       = {{Kimby, Eva and Jurlander, Jesper and Geisler, Christian and Hagberg, Hans and Holte, Harald and Lehtinen, Tuula and Östenstad, Björn and Hansen, Mads and Österborg, Anders and Lindén, Ola and Sundström, Christer}},
  issn         = {{1042-8194}},
  keywords     = {{follicular lymphoma; molecular remission; indolent lymphoma; randomized phase II trial; rituximab; interferon}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{102--112}},
  publisher    = {{Taylor & Francis}},
  series       = {{Leukemia & Lymphoma}},
  title        = {{Long-term molecular remissions in patients with indolent lymphoma treated with rituximab as a single agent or in combination with interferon alpha-2a: A randomized phase II study from the Nordic Lymphoma Group}},
  url          = {{http://dx.doi.org/10.1080/10428190701704647}},
  doi          = {{10.1080/10428190701704647}},
  volume       = {{49}},
  year         = {{2008}},
}