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Targeted Therapies Formerly
BioOncology Watch www.tgt-therapies.com |
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FEBRUARY 2005 CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) Rituximab plus fludarabine. John
Byrd and colleagues report a retrospective analysis comparing treatment
outcomes of previously untreated CLL patients enrolled into 2 multicenter
Cancer and Leukemia Group B (CALGB) trials and treated with fludarabine plus
rituximab (CALGB 9712) or fludarabine alone (CALGB 9011). The eligibility criteria of these 2 studies
were virtually identical. Patients enrolled
into study CALGB 9712 were randomized to receive rituximab either concurrently
or sequentially with fludarabine therapy. Progression free survival (PFS) and
overall survival (OS) were similar for each treatment group. Patients enrolled into CALGB 9011 were
randomized to receive fludarabine, chlorambucil, or fludarabine plus chlorambucil;
data from the fludarabine-only group were utilized in the current
analysis. PFS and OS were greater in
the fludarabine plus rituximab group than in the fludarabine-only group (p
< 0.0001 and p = 0.0006, respectively).
The 2-year PFS probabilities were 0.67 versus 0.45, and the 2-year OS
probabilities were 0.93 versus 0.81.
The safety profiles were similar between the 2 groups. Possible differences between the 2 patient
populations in this retrospective analysis could confound the data. Thus, a
prospective, randomized trial is required to confirm these results. (Byrd JC, et al. Blood 2005;105:49-53) NON-HODGKIN'S LYMPHOMA (NHL) Long-term follow-up after treatment with rituximab plus CHOP
(R-CHOP). Myron
Czuczman and others present updated outcome data, after a 9-year follow-up,
on 38 patients with low-grade and follicular NHL treated in the original phase
II trial investigating R-CHOP. Of the 38 patients, 9 (24%) patients had
received prior chemotherapy. Patients
received 6 cycles of CHOP chemotherapy and 6 infusions of rituximab during
the treatment period of the study. The
overall response rate was 100%, and 87% of patients achieved a complete
response or an unconfirmed complete response.
The median duration of response was 83.5 months; the median time to
disease progression was 82.3 months.
Among 8 patients who had bcl-2 positive disease at baseline, 7
achieved molecular remission (molecular remission was sustained in 3
cases). This analysis shows that
R-CHOP therapy was associated with durable responses in patients with
relapsed or newly diagnosed indolent NHL.
(Czuczman MS, et al. J Clin
Oncol 2004;22:4711-4716) Clinical outcome after idiotype vaccination. Wen-Kai Weng et al. analyzed 136
patients with follicular lymphoma who had received immunoglobulin idiotype
(Id) vaccination. All patients had
been treated with induction chemotherapy to achieve maximum clinical response
prior to vaccination. Patients who
mounted anti-Id humoral immune responses were observed to have longer median PFS
times than those who did not (8.21 vs. 3.38 years; p = 0.018). In addition, the presence of the
immunoglobulin G Fc receptor (FcγR) IIIa polymorphism (158 valine/valine
genotype) was found to predict for longer PFS. The results of this study indicate that
antibodies induced against a tumor antigen are beneficial. Moreover, cells bearing FcγR can
mediate an antitumor effect by killing antibody-coated tumor cells. (Weng W-K, et al. J Clin Oncol 2004;22:4717-4724) ACUTE PROMYELOCYTIC LEUKEMIA (APL) Results of all-trans
retinoic acid (ATRA) and anthracycline monochemotherapy in the elderly. The
marked improve-ments in clinical outcomes for patients with APL resulting
from the combination of ATRA and anthracycline chemotherapy have been less
dramatic for the elderly. Miguel Sanz
and coworkers report the findings from 104 consecutive patients with newly
diagnosed APL, 60 years or older, who were enrolled into 2 successive PETHEMA
Group studies. These studies involved induction therapy with ATRA plus idarubicin,
consolidation with anthracycline monochemotherapy with or without ATRA, and
maintenance therapy with ATRA plus low-dose chemotherapy. Induction therapy produced
complete remission in 87 (84%) patients. Five patients relapsed and 7
patients died during remission. The leukemia-free survival rate at 6 years
was 91%. This analysis shows that induction and consolidation treatments with
ATRA and anthracycline monochemotherapy have high antileukemic efficacy and
are well tolerated in elderly patients with APL. (Sanz MA, et al. Blood 2004;104:3490-3493) METASTATIC BREAST CANCER Phase III study of oral marimastat. Joseph Sparano and colleagues
from the Eastern Cooperative Oncology Group (ECOG) conducted a double-blind,
multicenter phase III study (ECOG E2196) in which 179 patients with
metastatic breast cancer who had responsive or stable disease after
first-line doxorubicin- and/or taxane-containing chemotherapy were randomized
to receive the matrix metalloproteinase inhibitor marimastat (10 mg bid
orally) or placebo. No differences in PFS
or OS were observed between the 2 treatment groups (p = 0.16 and 0.86,
respectively). Marimastat-treated
patients who developed grade 2 or 3 musculoskeletal toxicity had a shorter
median OS than did patients who had grade 0 or 1 musculoskeletal toxicity
(22.5 months vs. 28.2 months; p = 0.04). These data demonstrated that therapy
with marimastat after first-line chemotherapy for patients with metastatic
breast cancer did not prolong PFS or OS compared with placebo
treatments. (Sparano JA, et al. J Clin Oncol 2004;22:4683-4690) |
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