Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy. / Zucca, Emanuele; Rondeau, Stephanie; Vanazzi, Anna; Østenstad, Bjørn; Mey, Ulrich J M; Rauch, Daniel; Wahlin, Björn E; Hitz, Felicitas; Hernberg, Micaela; Johansson, Ann-Sofie; Brown, Peter de Nully; Hagberg, Hans; Ferreri, Andrés J M; Lohri, Andreas; Novak, Urban; Zander, Thilo; Bersvendsen, Hanne; Bargetzi, Mario; Mingrone, Walter; Krasniqi, Fatime; Dirnhofer, Stefan; Hayoz, Stefanie; Hawle, Hanne; Vilei, Simona Berardi; Ghielmini, Michele; Kimby, Eva; Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group.
In: Blood, Vol. 134, No. 4, 2019, p. 353-362.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
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
Y1 - 2019
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.
U2 - 10.1182/blood-2018-10-879643
DO - 10.1182/blood-2018-10-879643
M3 - Journal article
C2 - 31101627
VL - 134
SP - 353
EP - 362
JO - Blood
JF - Blood
SN - 0006-4971
IS - 4
ER -
ID: 226873395