Abstract
Abstract 1639
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.
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 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.
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.
Response after R-BMD induction in patients with R/R FL after 1st line with R-ChemoT
| Response after 3rdcycle . | Better 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 3rdcycle . | Better 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.
No relevant conflicts of interest to declare.
Author notes
Asterisk with author names denotes non-ASH members.
