PMID- 9310469
OWN - NLM
STAT- MEDLINE
DCOM- 19971020
LR  - 20231120
IS  - 0006-4971 (Print)
IS  - 0006-4971 (Linking)
VI  - 90
IP  - 6
DP  - 1997 Sep 15
TI  - IDEC-C2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with 
      relapsed low-grade non-Hodgkin's lymphoma.
PG  - 2188-95
AB  - IDEC-C2B8 is a chimeric monoclonal antibody (MoAb) directed against the 
      B-cell-specific antigen CD20 expressed on non-Hodgkin's lymphomas (NHL). The MoAb 
      mediates complement and antibody-dependent cell-mediated cytotoxicity and has 
      direct antiproliferative effects against malignant B-cell lines in vitro. Phase I 
      trials of single doses up to 500 mg/m2 and 4 weekly doses of 375 mg/m2 showed 
      clinical responses with no dose-limiting toxicity. We conducted a phase II, 
      multicenter study evaluating four weekly infusions of 375 mg/m2 IDEC-C2B8 in 
      patients with relapsed low-grade or follicular NHL (Working Formulation groups 
      A-D). Patients were monitored for adverse events, antibody pharmacokinetics, and 
      clinical response. Thirty-seven patients with a median age of 58 years (range, 29 
      to 81 years) were treated. All patients had relapsed after chemotherapy (median 
      of 2 prior regimens) and 54% had failed aggressive chemotherapy. Infusional side 
      effects (grade 1-2) consisting of mild fever, chills, respiratory symptoms, and 
      occasionally hypotension were observed mostly with the initial antibody infusion 
      and were rare with subsequent doses. Peripheral blood B-cell depletion occurred 
      rapidly, with recovery beginning 6 months posttreatment. There were no 
      significant changes in mean IgG levels and infections were not increased over 
      what would be expected in this population. Clinical remissions were observed in 
      17 patients (3 complete remissions and 14 partial remissions), yielding an intent 
      to treat response rate of 46%. The onset of these tumor responses was as soon as 
      1 month posttreatment and reached a maximum by 4 months posttreatment. In the 17 
      responders, the median time to progression was 10.2 months (5 patients exceeding 
      20 months). Likelihood of tumor response was associated with a follicular 
      histology, with the ability to sustain a high serum level of antibody after the 
      first infusion, and with a longer duration of remission to prior chemotherapy. 
      One patient developed a detectable but not quantifiable immune response to the 
      antibody that had no clinical significance. IDEC-C2B8 in a dose of 375 mg/m2 
      weekly for 4 weeks has antitumor activity in patients with relapsed low-grade or 
      follicular NHL. Results with this brief, outpatient treatment compare favorably 
      with results with standard chemotherapy, and IDEC-C2B8 has a better safety 
      profile. Further studies evaluating IDEC-C2B8 in other types of lymphoma either 
      alone or combined with chemotherapy are warranted.
FAU - Maloney, D G
AU  - Maloney DG
AD  - Department of Medicine, Stanford University, CA, USA.
FAU - Grillo-Lopez, A J
AU  - Grillo-Lopez AJ
FAU - White, C A
AU  - White CA
FAU - Bodkin, D
AU  - Bodkin D
FAU - Schilder, R J
AU  - Schilder RJ
FAU - Neidhart, J A
AU  - Neidhart JA
FAU - Janakiraman, N
AU  - Janakiraman N
FAU - Foon, K A
AU  - Foon KA
FAU - Liles, T M
AU  - Liles TM
FAU - Dallaire, B K
AU  - Dallaire BK
FAU - Wey, K
AU  - Wey K
FAU - Royston, I
AU  - Royston I
FAU - Davis, T
AU  - Davis T
FAU - Levy, R
AU  - Levy R
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Murine-Derived)
RN  - 0 (Antigens, CD20)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 4F4X42SYQ6 (Rituximab)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antibodies, Anti-Idiotypic/biosynthesis
MH  - Antibodies, Monoclonal/adverse effects/pharmacokinetics/*therapeutic use
MH  - Antibodies, Monoclonal, Murine-Derived
MH  - Antigens, CD20/*immunology
MH  - B-Lymphocytes/cytology
MH  - Female
MH  - Humans
MH  - Immunotherapy
MH  - Lymphocyte Depletion
MH  - Lymphoma, Non-Hodgkin/*therapy
MH  - Male
MH  - Middle Aged
MH  - Recombinant Fusion Proteins
MH  - Rituximab
MH  - Survival Analysis
EDAT- 1997/10/06 00:00
MHDA- 1997/10/06 00:01
CRDT- 1997/10/06 00:00
PHST- 1997/10/06 00:00 [pubmed]
PHST- 1997/10/06 00:01 [medline]
PHST- 1997/10/06 00:00 [entrez]
AID - S0006-4971(20)58013-0 [pii]
PST - ppublish
SO  - Blood. 1997 Sep 15;90(6):2188-95.