Abstract 1639

Objectives

To evaluate the efficacy and safety of rituximab-bendamustine-mitoxantrone-dexamethasone (R-BMD) in patients with relapsed or refractory follicular lymphoma, (R/R FL) to first-line therapy with R-chemotherapy (R-ChemoT), followed by maintenance with R.

Methods

Phase II trial including 61 patients with R/R LF, after a 1st R-ChemoT line. Induction treatment: Rituximab 375 mg/m2 iv, day 1; bendamustine 90 mg/m2 iv, days 1 and 2; mitoxantrone 6 mg/m2/day iv, day 1; oral dexamethasone 20 mg / day, days 1 to 5. Cycles of 28 days. Evaluation of response after 3rd cycle. If stable disease or progression: withdrawal from the study. If complete response (CR) or complete response unconfirmed (CRu): administration of a 4th cycle. If partial response (PR): administration up to 6 cycles. If CR, CRu or PR at the end of induction: patients receive maintenance with R 375 mg/m2/day every 12 weeks for 2 years. Primary objective: Complete responses (CR + CRu). Results are presented as valid % and median [range].

Results

Results from 46 patients who completed induction period. 52.2% women, age 63 [32–76] years. Ann Arbor stage III / IV 75.6% (31/41) and III / IV-B 22.6% (7/31). FLIPI: intermediate risk 28.9% (11/38); high-risk 23.7% (9/38). Number of administered cycles: 4 [1–6]. Overall response 93.5% (43/46); CR: see Table 1. Progression Free Survival –median (CI95%)-: 14.5 (11.6-NA) months. The most relevant grade 3/4 toxicity: neutropenia 52% (n = 24; 17 patients received G-CSF) and thrombocytopenia 4.3% (n = 2). Infections grade 3/4: 6.5% (n = 3). One patient died due to CMV reactivation. No skin reactions were reported. There are maintenance available data from 15 patients: 3 patients sustained CR at the end of this period, and 2 patients progressed.

Conclusions

R-BMD is a treatment schedule effective and a safe alternative for patients with R/R FL, after a 1st line with R-ChemoT. No skin reactions were reported, possibly due to the inclusion of dexamethasone in the treatment scheme. Additional follow up is required to achieve more conclusive findings.

Table 1.

Response after R-BMD induction in patients with R/R FL after 1st line with R-ChemoT

Response after 3rdcycleBetter response after induction
N (%)CI 95%N (%)CI 95%
CR/CRu 27 (60,0) [44,3–74,3] CR/CRnc 33 (73,3) [58,1–85,4] 
PR 15 (33,3) [20,0–49,0] PR 10 (22,2) [11,2–37,1] 
SD 2 (4,4) [0,5–15,2] SD 2 (4,4) [0,5–15,2] 
Unknown* 1 (2,2) [0,1–11,8]    
Total^ 45 (100)  Total^ 45 (100)  
Response after 3rdcycleBetter response after induction
N (%)CI 95%N (%)CI 95%
CR/CRu 27 (60,0) [44,3–74,3] CR/CRnc 33 (73,3) [58,1–85,4] 
PR 15 (33,3) [20,0–49,0] PR 10 (22,2) [11,2–37,1] 
SD 2 (4,4) [0,5–15,2] SD 2 (4,4) [0,5–15,2] 
Unknown* 1 (2,2) [0,1–11,8]    
Total^ 45 (100)  Total^ 45 (100)  
*

Patients without evaluation after the 3rd cycle. He received an additional cycle and was evaluated after end of induction.

^

One non evaluable patient.

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Disclosures:

No relevant conflicts of interest to declare.

Topics:
bendamustine, dexamethasone, follicular lymphoma, mitoxantrone, rituximab, complete remission, chemotherapy regimen, cmv reactivation, follow-up, granulocyte colony-stimulating factor

Author notes

*

Asterisk with author names denotes non-ASH members.

© 2012 by The American Society of Hematology
2012
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