Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia

• Autoři: WIERDA William G.; KIPPS Thomas J.; DÜRIG Jan; GRISKEVICIUS Laimonas; STILGENBAUER Stephan; MAYER Jiří; SMOLEJ Lukáš; HESS Georg; GRINIUTE Rasa; HERNANDEZ-ILIZALITURRI Francisco J.; PADMANABHAN Swaminathan; GORCZYCA Michael; CHANG Chai-Ni; CHAN Geoffrey; GUPTA Ira; NIELSEN Tina G.; RUSSELL Charlotte A.
• Rok publikování: 2011
• Druh: Článek v odborném periodiku
• Časopis / Zdroj: Blood
• Fakulta / Pracoviště MU: Lékařská fakulta
• www: http://bloodjournal.hematologylibrary.org/content/117/24/6450.full
• Doi: http://dx.doi.org/10.1182/blood-2010-12-323980
• Obor: Onkologie a hematologie
• Klíčová slova: FLUDARABINE PLUS CYCLOPHOSPHAMIDE; INITIAL THERAPY; MONOCLONAL-ANTIBODIES; HUMAN CD20; RITUXIMAB; OFATUMUMAB; TRIAL; CHLORAMBUCIL; CALGB-9712; GUIDELINES
• Popis: We conducted an international phase 2 trial to evaluate 2 dose levels of ofatumumab, a human CD20 mAb, combined with fludarabine and cyclophosphamide (O-FC) as frontline therapy for chronic lymphocytic leukemia (CLL). Patients with active CLL were randomized to ofatumumab 500 mg (n = 31) or 1000 mg (n = 30) day 1, with fludarabine 25 mg/m2 and cyclophosphamide 250 mg/m2 days 2-4, course 1; days 1-3, courses 2-6; every 4 weeks for 6 courses. The first ofatumumab dose was 300 mg for both cohorts. The median age was 56 years; 13% of patients had a 17p deletion; 64% had B2-microglobulin > 3.5 mg/L. Based on the 1996 National Cancer Institute Working Group (NCI-WG) guidelines, the complete response (CR) rate as assessed by an independent review committee was 32% for the 500-mg and 50% for the 1000-mg cohort; the overall response (OR) rate was 77% and 73%, respectively. Based on univariable regression analyses, B2-microglobulin and the number of O-FC courses were significantly correlated with CR and OR rates and progression-free survival (PFS). The most frequent Common Terminology Criteria (CTC) grade 3-4 investigator-reported adverse events were neutropenia (48%), thrombocytopenia (15%), anemia (13%), and infection (8%). O-FC is active and safe in treatment-naive patients with CLL, including high-risk patients.