Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

The Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group conducted the SAKK 35/10 randomized phase 2 trial to compare rituximab (R) alone vs R plus lenalidomide (L) as initial treatment for follicular lymphoma (FL). Patients with grade 1 to 3A FL, requiring systemic therapy, were randomized to either R (n = 77; 375 mg/m2 IV × 1, weeks 1-4) or rituximab-lenalidomide (RL) (n = 77; R on the same schedule and L at 15 mg daily continuously). Responders (evaluated at 10 weeks) repeated R during weeks 12 to 15 with or without L (for a total of 18 weeks). Both arms had 47% of patients with a poor risk score on the FL International Prognostic Index. The primary end point, complete response (CR)/CR unconfirmed rates at 6 months, was superior with the combination, and after a median follow-up of 9.5 years, this has translated into a longer duration of response (median, not reached vs 3.2 years; hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21-0.86; P = .014), progression-free survival (9.3 vs 2.3 years; HR, 0.57; 95% CI: 0.37-0.89; P = .0128), and time to next treatment (median, not reached vs 2.1 years; HR, 0.43; 95% CI, 0.27-0.67; P < .001). Over 60% of RL responders remained in first CR at 10 years. Overall survival was similar in both arms (77% vs 78% at 10 years; P = .881). Toxicity was more common with RL but manageable. The SAKK 35/10 trial's long-term results confirmed a durable benefit of a short-term chemotherapy-free first-line RL regimen in symptomatic FL. This trial was registered at www.clinicaltrials.gov as #NCT0137605.

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Publication Details

Journal
Blood Advances
Published
2025-04-01
DOI
https://doi.org/10.1182/bloodadvances.2024014840
Citations
2
Primary Topic
Lymphoma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
2.94

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article

Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

Anna Vanazzi, Daniel Rauch, Felicitas Hitz, Thilo Zander et al.
2 citations
Blood Advances
Lymphoma Diagnosis and Treatment
2.94
article

Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update

Anna Vanazzi, Daniel Rauch, Felicitas Hitz, Thilo Zander, Hanne Bersvendsen, Michèle Voegeli, Maria Cristina Pirosa, Peter de Nully Brown, Hans Hagberg, Fatime Krasniqi, Sämi Schär, Ulrich Mey, Anastasios Stathis, Stefanie Hayoz, Walter Mingrone, Eva Kimby, Micaela Hernberg, Björn E. Wahlin, Urban Novak, Bjørn Østenstad, Christoph Mamot, Andrés J.M. Ferreri, Stefan Dirnhofer, Emanuele Zucca, Ann‐Sofie Johansson
article en
2 citations

Abstract

The Swiss Group for Clinical Cancer Research (SAKK) and the Nordic Lymphoma Group conducted the SAKK 35/10 randomized phase 2 trial to compare rituximab (R) alone vs R plus lenalidomide (L) as initial treatment for follicular lymphoma (FL). Patients with grade 1 to 3A FL, requiring systemic therapy, were randomized to either R (n = 77; 375 mg/m2 IV × 1, weeks 1-4) or rituximab-lenalidomide (RL) (n = 77; R on the same schedule and L at 15 mg daily continuously). Responders (evaluated at 10 weeks) repeated R during weeks 12 to 15 with or without L (for a total of 18 weeks). Both arms had 47% of patients with a poor risk score on the FL International Prognostic Index. The primary end point, complete response (CR)/CR unconfirmed rates at 6 months, was superior with the combination, and after a median follow-up of 9.5 years, this has translated into a longer duration of response (median, not reached vs 3.2 years; hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.21-0.86; P = .014), progression-free survival (9.3 vs 2.3 years; HR, 0.57; 95% CI: 0.37-0.89; P = .0128), and time to next treatment (median, not reached vs 2.1 years; HR, 0.43; 95% CI, 0.27-0.67; P < .001). Over 60% of RL responders remained in first CR at 10 years. Overall survival was similar in both arms (77% vs 78% at 10 years; P = .881). Toxicity was more common with RL but manageable. The SAKK 35/10 trial's long-term results confirmed a durable benefit of a short-term chemotherapy-free first-line RL regimen in symptomatic FL. This trial was registered at www.clinicaltrials.gov as #NCT0137605.

Blood AdvancesVol. 9(7)
Oslo University Hospital (NO), University Hospital of North Norway (NO), Karolinska University Hospital (SE), Uppsala University Hospital (SE), Kantonsspital St. Gallen (CH), Helsinki University Hospital (FI), University Hospital of Bern (CH), University Hospital of Basel (CH), Copenhagen University Hospital (DK), Rigshospitalet (DK), Karolinska Institutet (SE), Kantonsspital Baselland (CH), Ente Ospedaliero Cantonale (CH), Spital STS (CH), University Hospital of Umeå (SE), Institute of Oncology Research (CH), Luzerner Kantonsspital (CH), Kantonsschule Olten (CH), Swiss Group For Clinical Cancer Research (CH), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Kantonsspital Aarau (CH), Università della Svizzera italiana (CH), European Institute of Oncology (IT)
Celgene, Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung
Openalex Percentile: Top 12%
Lymphoma Diagnosis and Treatment
2.94
DOIOpen Access PDFOpenAlex
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