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Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in need of first-line therapy
Oncol Inst Southern Switzerland, Div Med Oncol, Bellinzona, Switzerland;Inst Oncol Res, Bellinzona, Switzerland;Bern Univ Hosp, Dept Med Oncol, Inselspital, Bern, Switzerland.ORCID-id: 0000-0002-5522-6109
SAKK Coordinating Ctr, Bern, Switzerland.
European Inst Oncol IRCCS, Clin Hematooncol, Milan, Italy.
Oslo Univ Hosp, Dept Oncol, Oslo, Norway.
Vise andre og tillknytning
2019 (engelsk)Inngår i: Blood, ISSN 0006-4971, E-ISSN 1528-0020, Vol. 134, nr 4, s. 353-362Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

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(2) 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.

sted, utgiver, år, opplag, sider
AMER SOC HEMATOLOGY , 2019. Vol. 134, nr 4, s. 353-362
HSV kategori
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URN: urn:nbn:se:uu:diva-391364DOI: 10.1182/blood-2018-10-879643ISI: 000477070300006PubMedID: 31101627OAI: oai:DiVA.org:uu-391364DiVA, id: diva2:1354078
Tilgjengelig fra: 2019-09-24 Laget: 2019-09-24 Sist oppdatert: 2019-09-24bibliografisk kontrollert

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