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Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

Purpose: The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo purging before transplantation and as maintenance treatment immediately after high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed follicular...

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Hauptverfasser: Pettengell, Ruth (Verfasst von) , Schmitz, Norbert (Verfasst von) , Gisselbrecht, Christian (Verfasst von) , Smith, Graeme (Verfasst von) , Patton, William N. (Verfasst von) , Metzner, Bernd (Verfasst von) , Caballero, Dolores (Verfasst von) , Tilly, Herve (Verfasst von) , Walewski, Jan A. (Verfasst von) , Bence-Bruckler, Isabelle (Verfasst von) , To, Bik (Verfasst von) , Geisler, Christian H. (Verfasst von) , Schots, Rik (Verfasst von) , Kimby, Eva (Verfasst von) , Taverna, Christian J. (Verfasst von) , Kozák, Tomáš (Verfasst von) , Dreger, Peter (Verfasst von) , Uddin, Ruzena (Verfasst von) , Ruiz de Elvira, Carmen (Verfasst von) , Goldstone, Anthony H. (Verfasst von)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: April 1, 2013
In: Journal of clinical oncology
Year: 2013, Jahrgang: 31, Heft: 13, Pages: 1624-1630
ISSN:1527-7755
DOI:10.1200/JCO.2012.47.1862
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1200/JCO.2012.47.1862
Verlag, lizenzpflichtig, Volltext: https://ascopubs.org/doi/10.1200/JCO.2012.47.1862
Volltext
Verfasserangaben:Ruth Pettengell, Norbert Schmitz, Christian Gisselbrecht, Graeme Smith, William N. Patton, Bernd Metzner, Dolores Caballero, Herve Tilly, Jan A. Walewski, Isabelle Bence-Bruckler, Bik To, Christian H. Geisler, Rik Schots, Eva Kimby, Christian J. Taverna, Tomáš Kozák, Peter Dreger, Ruzena Uddin, Carmen Ruiz de Elvira, and Anthony H. Goldstone
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Zusammenfassung:Purpose: The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo purging before transplantation and as maintenance treatment immediately after high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed follicular lymphoma (FL). - Patients and Methods: Patients with relapsed FL who achieved either complete or very good partial remission with salvage chemotherapy were randomly assigned using a factorial design to rituximab purging (P+; 375 mg/m2 once per week for 4 weeks) or observation (NP) before HDC-ASCT and to maintenance rituximab (M+; 375 mg/m2 once every 2 months for four infusions) or observation (NM). - Results: From October 1999 to April 2006, 280 patients were enrolled. The median age was 51 years (range, 26 to 70 years), and baseline characteristics were well balanced between groups. On average, patients were 44 months (range, 3 to 464 months) from diagnosis, with 79% having received two lines and 15% three lines of prior therapy. Median follow-up was 8.3 years. In contrast to purging, 10-year progression-free survival (PFS) was 48% for P+ and 42% for NP groups (hazard ratio [HR], 0.80; 95% CI, 0.58 to 1.11; P = .18); maintenance had a significant effect on PFS (10-year PFS, 54% for M+ and 37% for NM; HR, 0.66; 95% CI, 0.47 to 0.91; P = .012). Overall survival (OS) was not improved by either rituximab purging or maintenance. - Conclusion: Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging, even in rituximab-naive patients, failed to improve PFS or OS.
Beschreibung:Gesehen am 20.01.2022
Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2012.47.1862

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