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Rituximab ‘Surprisingly Active’ as First-Line or Maintenance Therapy for SLL and CLL

Rituximab ‘Surprisingly Active’ as First-Line or Maintenance Therapy for SLL and CLL

NASHVILLE, Tennessee—A pilot study of rituximab (Rituxan) as first-line
therapy for small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia
(CLL) found an overall response rate of 56%, according to John Hainsworth,
MD, director of clinical research at the Sarah Cannon Cancer Center in
Nashville, Tennessee. Dr. Hainsworth discussed this work in a poster session
at the 43rd Annual Meeting of the American Society of Hematology.

Although patients with SLL/CLL have CD20 expression on malignant
lymphocytes, response rates with standard rituximab courses in refractory
patients are only about 15%, compared to 60% in patients who have follicular
non-Hodgkin’s lymphoma (NHL), Dr. Hainsworth reported.

"In a previous clinical trial performed in a multicenter,
community-based setting, we treated 62 patients with indolent NHL
(follicular and SLL histologies included) with first-line single-agent
rituximab using a standard-dose 4-week schedule. Patients with initial
response or stable disease received maintenance courses of rituximab at
6-month intervals. This produced responses in 15 of 24 patients with SLL
(73%), with a median progression-free survival of 31 months. This was
similar to results in patients with follicular NHL. We have therefore
expanded our experience, and have now treated a total of 68 previously
untreated patients with either SLL (37 patients) or CLL (31 patients) with
single-agent rituximab," Dr. Hainsworth said.

Study Design

Rituximab was given at 375 mg/m² weekly by slow intravenous infusion for
4 weeks. Patients who had objective response or stable disease at the 6-week
evaluation continued maintenance courses of rituximab, using a standard
4-week schedule, every 6 months, for a maximum of four courses. The study
enrolled treatment-naive patients with stage III or IV SLL or CLL. Median
age was 66 years (range: 48-89), 13 patients (23%) had B symptoms, and 19
patients (28%) had white blood counts above 50,000/µL.

Evaluation

At the first 6-week evaluation, 33 of 66 evaluable patients (50%) had
objective responses (3% complete response rate), and 32 additional patients
(48%) had stable disease. Complete responses continued to appear during the
maintenance period (see Table 1). Current responses included complete
remissions in 8% and partial remissions in 48%, for a response rate of 56%.

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