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Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia : final analysis of the PROLONG study
- Source :
- BLOOD CANCER JOURNAL, Blood Cancer Journal, Vol 9, Iss 12, Pp 1-9 (2019), Blood cancer journal, 9(12):98. Nature Publishing Group, Blood Cancer Journal
- Publication Year :
- 2019
-
Abstract
- 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 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.
- Subjects :
- Male
Lymphoma
Cancer therapy
MULTICENTER
Gastroenterology
THERAPY
chemistry.chemical_compound
DOUBLE-BLIND
Antineoplastic Agents, Immunological
0302 clinical medicine
Recurrence
Medicine and Health Sciences
Medicine
VENETOCLAX
030212 general & internal medicine
IBRUTINIB
Aged, 80 and over
RITUXIMAB MAINTENANCE
Hazard ratio
Hematology
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
OPEN-LABEL
Treatment Outcome
Oncology
030220 oncology & carcinogenesis
Ibrutinib
Retreatment
Female
Adult
medicine.medical_specialty
Neutropenia
Antibodies, Monoclonal, Humanized
Ofatumumab
lcsh:RC254-282
Article
Maintenance Chemotherapy
03 medical and health sciences
Chemoimmunotherapy
Internal medicine
Humans
Progression-free survival
CHEMOIMMUNOTHERAPY
Aged
business.industry
Venetoclax
medicine.disease
Leukemia, Lymphocytic, Chronic, B-Cell
LENALIDOMIDE MAINTENANCE
chemistry
business
Febrile neutropenia
RESISTANCE
Subjects
Details
- Language :
- English
- ISSN :
- 20445385
- Database :
- OpenAIRE
- Journal :
- BLOOD CANCER JOURNAL, Blood Cancer Journal, Vol 9, Iss 12, Pp 1-9 (2019), Blood cancer journal, 9(12):98. Nature Publishing Group, Blood Cancer Journal
- Accession number :
- edsair.doi.dedup.....f29c71ed30d2020e9002d061532af293