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

Publication

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

Journal Paper/Review - May 17, 2019

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

Citation

Zucca E, Zander T, Bersvendsen H, Bargetzi M, Mingrone W, Krasniqi F, Dirnhofer S, Hayoz S, Hawle H, Vilei S, Ghielmini M, Kimby E, Novak U, Lohri A, Ferreri A, Rondeau S, Vanazzi A, Østenstad B, Mey U, Rauch D, Wahlin B, Hitz F, Hernberg M, Johansson A, de Nully Brown P, Hagberg H, Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group. Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy. Blood 2019; 134:353-362.

Type

Journal Paper/Review (English)

Journal

Blood 2019; 134

Publication Date

May 17, 2019

Issn Electronic

1528-0020

Pages

353-362

Brief description/objective

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/m 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.