Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

Emanuele Zucca; Stephanie Rondeau; Anna Vanazzi; Bjørn Østenstad; Ulrich J M Mey; Daniel Rauch; Björn E Wahlin; Felicitas Hitz; Micaela Hernberg; Ann-Sofie Johansson; Peter de Nully Brown; Hans Hagberg; Andrés J M Ferreri; Andreas Lohri; Urban Novak; Thilo Zander; Hanne Bersvendsen; Mario Bargetzi; Walter Mingrone; Fatime Krasniqi; Stefan Dirnhofer; Stefanie Hayoz; Hanne Hawle; Simona Berardi Vilei; Michele Ghielmini; Eva Kimby; Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group

doi:10.1182/blood-2018-10-879643

Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

Emanuele Zucca, Stephanie Rondeau, Anna Vanazzi, Bjørn Østenstad, Ulrich J M Mey, Daniel Rauch, Björn E Wahlin, Felicitas Hitz, Micaela Hernberg, Ann-Sofie Johansson, Peter de Nully Brown, Hans Hagberg, Andrés J M Ferreri, Andreas Lohri, Urban Novak, Thilo Zander, Hanne Bersvendsen, Mario Bargetzi, Walter Mingrone, Fatime KrasniqiStefan Dirnhofer, Stefanie Hayoz, Hanne Hawle, Simona Berardi Vilei, Michele Ghielmini, Eva Kimby, Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group

Department of Clinical Medicine

24 Citations (Scopus)

Abstract

The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.

Original language	English
Journal	Blood
Volume	134
Issue number	4
Pages (from-to)	353-362
Number of pages	10
ISSN	0006-4971
DOIs	https://doi.org/10.1182/blood-2018-10-879643
Publication status	Published - 25 Jul 2019

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Zucca, E., Rondeau, S., Vanazzi, A., Østenstad, B., Mey, U. J. M., Rauch, D., Wahlin, B. E., Hitz, F., Hernberg, M., Johansson, A.-S., Brown, P. D. N., Hagberg, H., Ferreri, A. J. M., Lohri, A., Novak, U., Zander, T., Bersvendsen, H., Bargetzi, M., Mingrone, W., ... Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group (2019). Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy. Blood, 134(4), 353-362. https://doi.org/10.1182/blood-2018-10-879643

Zucca, E, Rondeau, S, Vanazzi, A, Østenstad, B, Mey, UJM, Rauch, D, Wahlin, BE, Hitz, F, Hernberg, M, Johansson, A-S, Brown, PDN, Hagberg, H, Ferreri, AJM, Lohri, A, Novak, U, Zander, T, Bersvendsen, H, Bargetzi, M, Mingrone, W, Krasniqi, F, Dirnhofer, S, Hayoz, S, Hawle, H, Vilei, SB, Ghielmini, M, Kimby, E & Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group 2019, 'Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy', Blood, vol. 134, no. 4, pp. 353-362. https://doi.org/10.1182/blood-2018-10-879643

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abstract = "The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.",

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T1 - Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

AU - Zucca, Emanuele

AU - Rondeau, Stephanie

AU - Vanazzi, Anna

AU - Østenstad, Bjørn

AU - Mey, Ulrich J M

AU - Rauch, Daniel

AU - Wahlin, Björn E

AU - Hitz, Felicitas

AU - Hernberg, Micaela

AU - Johansson, Ann-Sofie

AU - Brown, Peter de Nully

AU - Hagberg, Hans

AU - Ferreri, Andrés J M

AU - Lohri, Andreas

AU - Novak, Urban

AU - Zander, Thilo

AU - Bersvendsen, Hanne

AU - Bargetzi, Mario

AU - Mingrone, Walter

AU - Krasniqi, Fatime

AU - Dirnhofer, Stefan

AU - Hayoz, Stefanie

AU - Hawle, Hanne

AU - Vilei, Simona Berardi

AU - Ghielmini, Michele

AU - Kimby, Eva

AU - Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group

PY - 2019/7/25

Y1 - 2019/7/25

N2 - The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.

AB - The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group, compared the activity of rituximab vs rituximab plus lenalidomide in untreated follicular lymphoma patients in need of systemic therapy. Patients were randomized to rituximab (375 mg/m2 IV on day 1 of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab (same schedule) in combination with lenalidomide (15 mg orally daily for 18 weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to the combination (47% poor-risk Follicular Lymphoma International Prognostic Index score in each arm). A significantly higher CR/CRu rate at 6 months was documented in the combination arm by the investigators (36%; 95% confidence interval [CI], 26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates and longer progression-free survival (PFS) and time to next treatment (TTNT) were observed for the combination. Overall survival (OS) rates were similar in both arms (≥90%). Toxicity grade ≥3 was more common in the combination arm (56% vs 22% of patients), mainly represented by neutropenia (23% vs 7%). Addition of lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, with expected higher, but manageable toxicity. The excellent OS in both arms suggests that chemotherapy-free strategies should be further explored. This trial was registered at www.clinicaltrials.gov as #NCT01307605.

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DO - 10.1182/blood-2018-10-879643

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SP - 353

EP - 362

JO - Blood

JF - Blood

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ER -

Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy

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