Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy
| Autor: | Simona Berardi Vilei, Andreas Lohri, Mario Bargetzi, Ulrich Mey, Micaela Hernberg, Stefan Dirnhofer, Thilo Zander, Ann-Sofie Johansson, Peter de Nully Brown, Walter Mingrone, Eva Kimby, Bjørn Østenstad, Urban Novak, Daniel Rauch, Björn E. Wahlin, Fatime Krasniqi, Felicitas Hitz, Emanuele Zucca, Michele Ghielmini, Stefanie Hayoz, Hans Hagberg, Hanne Skjerven Bersvendsen, Hanne Hawle, Andrés J.M. Ferreri, Anna Vanazzi, Stephanie Rondeau |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Biopsy Immunology Follicular lymphoma Kaplan-Meier Estimate Neutropenia Biochemistry Gastroenterology 03 medical and health sciences 0302 clinical medicine International Prognostic Index Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Neoplasm Metastasis Lenalidomide Lymphoma Follicular Aged Neoplasm Staging Aged 80 and over business.industry Neoplasms Second Primary Cell Biology Hematology Middle Aged medicine.disease Combined Modality Therapy Chemotherapy regimen 3. Good health Regimen Treatment Outcome 030220 oncology & carcinogenesis Female Rituximab Neoplasm Grading Symptom Assessment Tomography X-Ray Computed business 030215 immunology medicine.drug |
| Zdroj: | Blood. 134:353-362 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2018-10-879643 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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