Prolonged rituximab maintenance in follicular lymphoma patients: Long-term results of the SAKK 35/03 randomized trial

Alden A. Moccia, Christian Taverna, Sämi Schär, Anna Vanazzi, Stéphanie Rondeau, Felicitas Hitz, Walter Mingrone, Thomas Pabst, Lidija Cevreska, Auro Del Giglio, Johann Raats, Daniel Rauch, Daniel A. Vorobiof, Andreas Lohri, Céline Ruegsegger, Christine Biaggi Rudolf, Corinne Rusterholz, Stefanie Hayoz, Michele Ghielmini, Emanuele Zucca

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The Swiss Group for Clinical Cancer Research (SAKK) conducted the SAKK 35/03 randomized trial (NCT00227695) to investigate different rituximab monotherapy schedules in patients with follicular lymphoma (FL). Here, we report their long-term treatment outcome. Twohundred and seventy FL patients were treated with 4 weekly doses of rituximab monotherapy (375 mg/m-2); 165 of them, achieving at least a partial response, were randomly assigned to maintenance rituximab (375 mg/m-2 every 2 months) on a short-term (4 administrations; n 5 82) or a long-term (up to a maximum of 5 years; n 5 83) schedule. The primary end pointwas event-free survival (EFS). At amedian follow-up period of 10 years, median EFS was 3.4 years (95% confidence interval [CI], 2.1-5.5) in the short-term arm and 5.3 years (95% CI, 3.5-7.5) in the long-term arm. Using the prespecified log-rank test, this difference is not statistically significant (P = .39). There also was not a statistically significant difference in progression-free survival or overall survival (OS). Median OS was 11.0 years (95% CI, 11.0-NA) in the short-term arm and was not reached in the long-term arm (P = .80). The incidence of second cancers was similar in the 2 arms (9 patients after short-term maintenance and 10 patients after long-term maintenance). No major late toxicities emerged. No significant benefit of prolonged maintenance became evident with longer follow-up. Notably, in symptomatic patients in need of immediate treatment, the 10-year OS rate was 83% (95% CI, 73-89%). These findings indicate that single-agent rituximab may be a valid first-line option for symptomatic patients with advanced FL.

Original languageEnglish
Pages (from-to)5951-5957
Number of pages7
JournalBlood advances
Issue number23
Publication statusPublished - Dec 8 2020

ASJC Scopus subject areas

  • Hematology


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