PHILADELPHIAPatients with intermediate-grade non-Hodgkins
lymphoma (NHL) whose disease progresses after high-dose chemotherapy
and stem cell transplant have few options among conventional
regimens. However, Donald E. Tsai, MD, PhD, reported at the ASH
meeting that the anti-CD20 monoclonal antibody rituximab (Rituxan) is
active in this situation.
Dr. Tsai and his colleagues at the University of Pennsylvania treated
seven such patients with rituximab, two of whom were re-treated.
There were two complete responses, four partial responses, and one
mixed response. Median duration of response was 170 days; performance
status improved to 0 in five patients.
There is no good treatment for this patient population. Most
relapse quickly after transplant. Some are still so ill from the
transplant that they are not eligible for anything else. All those we
treated with rituximab responded, and several then became eligible
for other treatments, Dr. Tsai said in an interview. We
hope that rituximab may buy these patients time to become eligible
for other therapies.
Dr. Tsai gave rituximab (375 mg/m² per week IV for 4 weeks) to
seven patients with CD20-positive, diffuse large-cell non-Hodgkins
lymphoma. All had progressive disease despite high-dose therapy with
peripheral blood stem cell transplant.
Of the five patients who were initially symptomatic from NHL, two had
complete resolution and three had improvement in their symptoms by
completion of the 4-week rituximab course.
At initial restaging (days 23 to 79) and after initiation of therapy,
six of seven patients responded (one CR and five PR) and one patient
had stable disease (SD).
Two patients (one SD and one PR) later developed progressive disease
at day +60 and day +87, respectively, and underwent re-treatment with
rituximab. One patient achieved CR and the other had a mixed response.
With a median follow-up of 170 days from initiation of therapy,
and with two patients having undergone re-treatment, there currently
are two CRs, four PRs, and one PD, Dr. Tsai said.
The median progression-free time after rituximab treatment of 170
days gives patients time to recover, get back on their feet,
let their hair grow back in. Then you can think about trying
something else, he said.
Acute complications of rituximab consisted of rash and rigors in one
patient during the first infusion only. Delayed adverse events
included three episodes of transient granulocytopenia, occurring from
day 74 to day 112 and resulting in one hospitalization for
Two of these patients were very responsive to G-CSF and bounced
back. The other recovered without treatment, Dr. Tsai said.
The incidence of granulocytopenia was higher than that seen with
rituximab in low-grade NHL but was transient and lower than with
conventional salvage chemotherapy.