Clinical lymphoma, myeloma & leukemia · 2011
Bortezomib (Velcade), rituximab, cyclophosphamide, and dexamethasone combination regimen is active as front-line therapy of low-grade non-Hodgkin lymphoma.
Клиническое исследование II фазыСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Nabhan Chadi, Villines Dana, Dalal Neil, Tolzien Kathy, Kozolff Mark, Starr Alexander
Аннотация
OBJECTIVE: To evaluate the efficacy and toxicity of the combination of VRCD (velcade/rituximab/cyclophosphamide/dexamethasone) in chemotherapy-naïve low-grade non-Hodgkin lymphoma or patients with transplantation-ineligible mantle cells.
METHODS: The patients were treated with velcade, at 1.6 mg/m(2), on days 1, 8, 15, and 22 on every 35-day cycle. Rituximab was given at 375 mg/m(2) on the same days as velcade during cycle 1 and then only on day 1 in subsequent cycles. Dexamethasone was given orally at 40 mg on days 1, 2, 8, 9, 15, 16, 22, and 23. Cyclophosphamide was administered orally at 400 mg/m(2) on days 1-4. The patients had to meet criteria to initiate therapy and had to demonstrate adequate performance status and organ function.
RESULTS: Twelve patients were enrolled, after which the study was closed due to a lack of funding. The median age was 68 years (37-83 years), with 83% having stage III/IV disease. Five patients had marginal zone, 4 had follicular, 2 had small lymphocytic, and 1 had mantle cell histologies. The overall response rate was 90% (complete response, 54%). At a median follow-up of 22 months, 9 (75%) patients remain alive, and the median time to progression has not been reached. A third of the patients required dose reductions after a median of 6.5 cycles. No grade 3 or 4 peripheral neuropathy was witnessed.
CONCLUSIONS: Although the number of studied patients is small, VRCD appears safe and active as front-line therapy for low-grade non-Hodgkin lymphoma. Further studies are justified.
METHODS: The patients were treated with velcade, at 1.6 mg/m(2), on days 1, 8, 15, and 22 on every 35-day cycle. Rituximab was given at 375 mg/m(2) on the same days as velcade during cycle 1 and then only on day 1 in subsequent cycles. Dexamethasone was given orally at 40 mg on days 1, 2, 8, 9, 15, 16, 22, and 23. Cyclophosphamide was administered orally at 400 mg/m(2) on days 1-4. The patients had to meet criteria to initiate therapy and had to demonstrate adequate performance status and organ function.
RESULTS: Twelve patients were enrolled, after which the study was closed due to a lack of funding. The median age was 68 years (37-83 years), with 83% having stage III/IV disease. Five patients had marginal zone, 4 had follicular, 2 had small lymphocytic, and 1 had mantle cell histologies. The overall response rate was 90% (complete response, 54%). At a median follow-up of 22 months, 9 (75%) patients remain alive, and the median time to progression has not been reached. A third of the patients required dose reductions after a median of 6.5 cycles. No grade 3 or 4 peripheral neuropathy was witnessed.
CONCLUSIONS: Although the number of studied patients is small, VRCD appears safe and active as front-line therapy for low-grade non-Hodgkin lymphoma. Further studies are justified.
Предметные рубрики MeSH
AdultAgedAged, 80 and overAlopeciaAntibodies, Monoclonal, Murine-DerivedAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibCyclophosphamideDexamethasoneDisease-Free SurvivalDrug Administration ScheduleFatigueFemaleHumansKaplan-Meier EstimateLeukopeniaLymphoma, Non-HodgkinMaleMiddle AgedNeoplasm GradingPyrazinesRituximabTreatment Outcome