Experience with rituximab immunotherapy as an early intervention in patients with Rai stage 0 to II chronic lymphocytic leukemia.
BACKGROUND
Management of asymptomatic early stage chronic lymphocytic leukemia (CLL) centered on expectant surveillance for active disease warranting chemotherapy. In CLL, elevated serum β-2 microglobulin (β2M) levels were associated with more rapid disease progression and shorter survival (OS).


METHODS
An early intervention trial was designed to assess response, time-to-progression (TTP), and OS after immunotherapy with standard-dose rituximab (375 mg/m² intravenously weekly for 8 consecutive weeks) in 34 asymptomatic untreated early stage CLL with β2M level ≥ 2 mg/dL.


RESULTS
Long-term follow-up and results are reported. The overall response rate in 34 patients was 82% (9% complete [CR]), median TTP in the 28 responders was 23 months, the median time to subsequent treatment was 43 months, and the 8-year OS rate was 74% (median follow-up, 102 months).


CONCLUSIONS
Early treatment with rituximab was well tolerated and safe. Further studies are needed to determine if this intervention can decrease CLL-related morbidity and mortality.
The University of Texas MD Anderson Cancer Center, Department of Leukemia, Houston, Texas, USA. aferrajo@mdanderson.org
Alessandra
A
Ferrajoli
Michael J
MJ
Keating
Susan
S
O'Brien
Jorge
J
Cortes
Deborah A
DA
Thomas
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D000069283:Rituximab
D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab
N Engl J Med. 1998 May 21;338(21):1506-14
9593789
J Clin Oncol. 2001 Apr 15;19(8):2153-64
11304767
Ann Oncol. 1999 Jun;10(6):655-61
10442187
Blood. 1991 Aug 15;78(4):895-9
1868250
Blood. 1996 Jun 15;87(12):4990-7
8652811
J Clin Oncol. 2003 May 1;21(9):1746-51
12721250
J Clin Oncol. 2005 Jun 20;23(18):4070-8
15767647
J Clin Oncol. 2005 Jun 20;23(18):4079-88
15767648
J Clin Oncol. 1998 Aug;16(8):2825-33
9704735
Blood. 2008 Aug 15;112(4):975-80
18411418
J Clin Oncol. 2009 Apr 1;27(10):1637-43
19224852
Blood. 2007 Jun 1;109(11):4679-85
17299097
J Natl Cancer Inst. 1999 May 19;91(10):861-8
10340906
Blood. 1990 Apr 1;75(7):1414-21
2180492
J Clin Oncol. 2001 Apr 15;19(8):2165-70
11304768
Leuk Lymphoma. 1996 Aug;22(5-6):439-47
8882957