lenalidomide (L) plus rituximab (R) for untreated indolent B-NHL

[Guest guest]

Comments: I believe a more informative randomized study will be published

soon comparing R vs. R+L vs. L alone in untreated FL. Thankfully!

The reported CR rate (66%) is encouraging. The use of GELF need-to-treat

criteria is a plus; helps define the study population.

Weaknesses: lacks data on duration of response (short follow up), or

toxicity relative to other approaches. Mixed histologies (FL, MZL, CLL)

waters down the finding. Patient-selection bias ... the usual list of

complaints for single arm studies, such as how well would patients with same

eligibility criteria have done with R or L alone ... for efficacy and risk?

~ Karl

==

High response rates with lenalidomide plus rituximab for untreated indolent

B-cell non-Hodgkin lymphoma, including those meeting GELF criteria.

http://abstract.asco.org/AbstView_102_82567.html

Abstract:

Background:

Lenalidomide has been shown to have single-agent activity in relapsed NHL,

and rituximab ® is effective alone and in combination with chemotherapy in

untreated patients. The aim of this phase II, single arm study is to

evaluate the efficacy and safety of lenalidomide and rituximab in pts with

untreated, advanced stage, indolent NHL.

Methods: Pts with measurable (>1.5 cm) untreated indolent NHL received 20

mg/day of lenalidomide on days 1-21 and rituximab 375 mg/m2 on day 1 of each

28 day cycle.

Prophylactic growth factors were not used. Response was assessed every 3

cycles using the 1999 International Working Group Response Criteria.

Results: 75 pts have completed 6 cycles of treatment or are off-study, and

70 pts are evaluable for response.

Histologies included:

CLL/SLL n=15,

FL n=41, and

marginal zone lymphoma n=19.

The median age was 57 (35-84) years, and 55% were male.

The overall response (OR) rate for all pts was 90% with 66% attaining a

complete response (CR). Seventeen pts (25%) had a partial response, and

stable disease was noted in 6 (9%). OR and CR rates were impressive in FL,

with nearly all evaluable patients 34/39 (87%) attaining a CR.

At study entry, 80% of FL pts had a FLIPI score of ? 2, and 54% met GELF

criteria for high tumor burden. Responses were high regardless of FLIPI

score or GELF (CR/CRu 90% with and 83% without GELF) criteria.

Following cycle 6, nearly all FL patients demonstrated molecular response

with the absence of detectable BCL-2 by PCR. At a median follow up of 14.4

(7-32.5) months, 4 patients experienced progression of disease.

The most common grade ? 3 non-hematologic toxicities included rash (7 pts),

muscle pain (7pts), thrombosis (3pts) and infection (3pts).

Grade ?3 neutropenia and thrombocytopenia occurred in 20 (27%) and 4 (5%)

pts respectively.

Five pts stopped treatment due to adverse events, all of which occurred

during the first two cycles.

Conclusions: The biologic agents lenalidomide and rituximab used as front

line therapy produce excellent overall and complete response rates with

manageable toxicity in pts with indolent B cell NHL. Randomized studies are

planned utilizing this regimen in untreated follicular lymphoma.

Author(s): F. Samaniego, F. Hagemeister, P. Mclaughlin, L. W. Kwak, J.

Romaguera, M. A. Fanale, S. S. Neelapu, L. Fayad, R. Z. Orlowski, M. Wang,

L. Lacerte, N. H. Fowler; University of Texas M. D. Cancer Center,

Houston, TX

Patients Against Lymphoma

www.Lymphomation.org

Evidence-based information on lymphoma, independent of health industry

funding