Most cited article - PubMed ID 28958469
Lenalidomide maintenance therapy in previously treated chronic lymphocytic leukaemia (CONTINUUM): a randomised, double-blind, placebo-controlled, phase 3 trial
We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43-0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57-0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.
- MeSH
- Leukemia, Lymphocytic, Chronic, B-Cell diagnosis drug therapy mortality MeSH
- Adult MeSH
- Antibodies, Monoclonal, Humanized administration & dosage adverse effects therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Retreatment MeSH
- Antineoplastic Agents, Immunological administration & dosage adverse effects therapeutic use MeSH
- Recurrence MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Maintenance Chemotherapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Antibodies, Monoclonal, Humanized MeSH
- ofatumumab MeSH Browser
- Antineoplastic Agents, Immunological MeSH
