肿瘤科
氟达拉滨
淋巴瘤
弥漫性大B细胞淋巴瘤
无进展生存期
作者
Carola Boccomini,Marco Ladetto,Luigi Rigacci,Benedetta Puccini,Sara Rattotti,Stefano Volpetti,Simone Ferrero,Annalisa Chiarenza,Roberto Freilone,Mattia Novo,Paolo Corradini,Luca Nassi,Chiara Rusconi,Caterina Stelitano,Silvia Bolis,Anna Marina Liberati,Alessandra Tucci,Luca Baldini,Monica Balzarotti,Andrea Evangelista,Giovannino Ciccone,Umberto Vitolo
摘要
Treatment for follicular lymphoma (FL) in the elderly is not well standardized. A phase II, multicentre, single arm trial was conducted in this setting with a brief chemoimmunotherapy regimen. Treatment consisted in four monthly courses of rituximab, bendamustine and mitoxantrone (R-BM) followed by 4 weekly rituximab as consolidation; rituximab maintenance was not applied because the drug was not licensed at the time of enrolment. The primary endpoint was the complete remission rate (CR). Seventy-six treatment-naive FL patients (aged 65-80 and a FIT score, according to the Comprehensive Geriatric Assessment) were enrolled. CR was documented in 59/76 patients (78%), partial remission in 12 (16%) and stable/progressive disease in five (6%) with an overall response rate in 71/76 (94%). Median follow-up was 44 months with 3-year progression-free-survival (PFS) and overall-survival of 67% and 92% respectively. Nine deaths occurred, three of progressive disease. The regimen was well tolerated and the most frequent severe toxicity was neutropenia (18% of the cycles). Bcl-2/IGH rearrangement was found in 40/75 (53%) of evaluated patients. R-BM was highly effective in clearing polymerase chain reaction-detectable disease: 29/31 (96%) evaluated patients converted to bcl-2/IGH negativity at the end of treatment. A brief R-BM regimen plus rituximab consolidation is effective and safe in FIT elderly, treatment-naive, FL patients, inducing high CR and molecular remission rates with prolonged PFS.
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