Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update
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 systemi...
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Elsevier
2025-04-01
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| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2473952925000618 |
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| author | Eva Kimby Sämi Schär Maria Cristina Pirosa Anna Vanazzi Ulrich M. Mey Daniel Rauch Björn E. Wahlin Felicitas Hitz Micaela Hernberg Ann-Sofie Johansson Peter de Nully Brown Hans Hagberg Andrés José María Ferreri Fatime Krasniqi Michèle Voegeli Urban Novak Thilo Zander Hanne Bersvendsen Christoph Mamot Walter Mingrone Anastasios Stathis Stefan Dirnhofer Stefanie Hayoz Bjørn Østenstad Emanuele Zucca |
| author_facet | Eva Kimby Sämi Schär Maria Cristina Pirosa Anna Vanazzi Ulrich M. Mey Daniel Rauch Björn E. Wahlin Felicitas Hitz Micaela Hernberg Ann-Sofie Johansson Peter de Nully Brown Hans Hagberg Andrés José María Ferreri Fatime Krasniqi Michèle Voegeli Urban Novak Thilo Zander Hanne Bersvendsen Christoph Mamot Walter Mingrone Anastasios Stathis Stefan Dirnhofer Stefanie Hayoz Bjørn Østenstad Emanuele Zucca |
| author_sort | Eva Kimby |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-9726e4649b994aef9e58b72f9ca26a49 |
| institution | DOAJ |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-9726e4649b994aef9e58b72f9ca26a492025-08-20T02:54:39ZengElsevierBlood Advances2473-95292025-04-01971712171910.1182/bloodadvances.2024014840Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year updateEva Kimby0Sämi Schär1Maria Cristina Pirosa2Anna Vanazzi3Ulrich M. Mey4Daniel Rauch5Björn E. Wahlin6Felicitas Hitz7Micaela Hernberg8Ann-Sofie Johansson9Peter de Nully Brown10Hans Hagberg11Andrés José María Ferreri12Fatime Krasniqi13Michèle Voegeli14Urban Novak15Thilo Zander16Hanne Bersvendsen17Christoph Mamot18Walter Mingrone19Anastasios Stathis20Stefan Dirnhofer21Stefanie Hayoz22Bjørn Østenstad23Emanuele Zucca24Division of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden; Correspondence: Eva Kimby, Karolinska Institutet, Department of Medicine Huddinge, Center for Hematology and Regenerative Medicine (HERM), Medicinaren 25/Neo, HERM 7th floor, 141 83 Stockholm, Sweden;Swiss Group for Clinical Cancer Research, Bern, SwitzerlandOncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, SwitzerlandClinical Hemato-Oncology, Istituto Europeo di Oncologia IRCCS, Milan, ItalyOncology and Hematology, Cantonal Hospital Grisons, Chur, SwitzerlandDivision of Oncology, Spital Thun Simmental, Thun, SwitzerlandDepartment of Hematology, Karolinska University Hospital and Karolinska Institutet, Stockholm, SwedenOncology/Hematology, Kantonsspital St. Gallen, St. Gallen, SwitzerlandDepartment of Oncology, Helsinki University Hospital Comprehensive Cancer Center, Helsinki, FinlandDepartment of Oncology, Norrlands University Hospital Umeå, Umeå, SwedenDepartment of Hematology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkDepartment of Oncology, Uppsala University Hospital, Uppsala, SwedenUnit of Lymphoid Malignancies, Department of Onco-Haematology, IRCCS San Raffaele Scientific Institute, Milan, ItalyDepartment of Oncology, University Hospital Basel, Basel, SwitzerlandDepartment of Hematology and Oncology, Kantonsspital Baselland, Liestal, SwitzerlandDepartment of Medical Oncology, Inselspital, Bern University Hospital, Bern, SwitzerlandDepartment of Oncology, Luzerner Kantonsspital, Luzern, SwitzerlandDepartment of Oncology, University Hospital of North Norway, Tromsø, NorwayDivision of Hematology/Oncology, Kantonsspital Aarau, Aarau, SwitzerlandDepartment of Medical Oncology, Kantonsspital Olten, Olten, SwitzerlandOncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, SwitzerlandInstitute of Pathology and Medical Genetics, University Hospital Basel, Basel, SwitzerlandSwiss Group for Clinical Cancer Research, Bern, SwitzerlandDepartment of Oncology, Oslo University Hospital, Oslo, NorwayOncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland; Institute of Oncology Research, Bellinzona, SwitzerlandAbstract: 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.http://www.sciencedirect.com/science/article/pii/S2473952925000618 |
| spellingShingle | Eva Kimby Sämi Schär Maria Cristina Pirosa Anna Vanazzi Ulrich M. Mey Daniel Rauch Björn E. Wahlin Felicitas Hitz Micaela Hernberg Ann-Sofie Johansson Peter de Nully Brown Hans Hagberg Andrés José María Ferreri Fatime Krasniqi Michèle Voegeli Urban Novak Thilo Zander Hanne Bersvendsen Christoph Mamot Walter Mingrone Anastasios Stathis Stefan Dirnhofer Stefanie Hayoz Bjørn Østenstad Emanuele Zucca Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update Blood Advances |
| title | Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update |
| title_full | Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update |
| title_fullStr | Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update |
| title_full_unstemmed | Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update |
| title_short | Six-month rituximab-lenalidomide regimen in advanced untreated follicular lymphoma: SAKK 35/10 trial 10-year update |
| title_sort | six month rituximab lenalidomide regimen in advanced untreated follicular lymphoma sakk 35 10 trial 10 year update |
| url | http://www.sciencedirect.com/science/article/pii/S2473952925000618 |
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