Aims of the study were long term follow-up (FU) of bisphosphonates-associated osteonecrosis of the jaw (ONJ) in 35 cases observed by Gruppo Italiano Studio Linfomi (GISL) between 2002-2005 and the ...evaluation of its frequency in multiple myeloma patients over time. We asked the centres to up-date cases with ONJ, and to report new cases of ONJ diagnosed between 2006 and 2008. After a median FU of 31 months, 19 patients are alive, 13 died, mainly from progression of the primary disease, and 3 patients are lost to follow-up. Treatment was mainly conservative, however 9 patients underwent surgery. Overall improvement was reported in 13 patients, 11 stabilized and 8 patients progressed. One patient relapsed after dental procedure. ONJ impacted quality of life, causing pain and interfering with the ability to eat. Although the frequency of ONJ in myeloma patients in the period 2006-2008 was slightly increased (3.6% versus 1.9% in 2002-2005), we confirm the rarity of the complication.
Abstract 1801
Velcade ® (V) and Mabthera ® (M) have demonstrated an individual considerable efficacy in the treatment of non Hodgkin's lymphoma. The aim of this study was to evaluate the efficacy and ...safety of the combination of V and M in patients with relapsed Follicular lymphoma (FL).
Patients (pts) with histologic documentation of CD20+ FL, measurable and active disease, received : 1.3 mg/m2 of V on days 1–4-8-11 every 21 days for 6 cycle and M 375 mg/m2 on day 1 of each cycle from cycle III to VI. Two additional doses of M were administered alone after cycle VI, every 21 days (cycle VII and VIII). Response was assessed after 2 and 8 cycles using the NCI recommendations for Non-Hodgkin's Lymphomas.
At the time of current analysis, initial planned accrual of 41 evaluable pts was not completed. From 2007 to now 37 pts entered into the trial. The pts characteristics at baseline were: median age 66 years (range: 46–84), male 51%, stage IV 43 % elevated values of LDH, 27%, and of Beta2microglobulin 41%. The FLIPI score was calculated in 34 pts (92%) and 11 pts (31%) had a poor prognostic score (> 3). The median number of previous immuno/chemotherapy regimens was 2 (range:1-3), and the median duration of last remission before registration into trial was 23 months (range: 3–67).
In four out of the 37 pts who entered into the trial, the treatment is ongoing and thirty-three pts were evaluable for response. The overall response rate in the intent to treat analysis was 58% (19 pts), of which 16 pts (49%) obtained complete response (CR) and 3 (9%) partial response (PR). Stable disease was seen in 1 pt (3%). Eight pts (24%) had progressive disease and 2 (6%) pts were lost at follow-up. Three pts (9%) had to stop the treatment: one pt (3%) for grade IV peripheral neuropathy, one pt (3%) refused to continue the treatment after 2 cycle and one pt (3%) died during the treatment for toxicity . After a median follow up of 14 month (0-44), the median overall survival and the event free survival were not reached. Overall, 2 pts relapsed (10 %) and 1 pt (5 %) showed a progression of disease. A total of five pts died, four because of lymphoma progression, and one for toxicity during treatment.
Complete response are ongoing in 14 pts .
Toxicity was evaluable in 33 patients. We observed the following grade 1/2 adverse events: neuropathy (10 pts), neutropenia (2 pts), infection (5 pts), constipation (4 pts), rash (2 pts), fatigue (1 pt). Further we saw the following grade 3/4 adverse events: thrombocytopenia (5 pts), neuropathy (5 pts), neutropenia (1 pt) and infection with fever(1 pt). Three patient interrupted the treatment due to severe neuropathy.
The combination of V+M is associated with acceptable toxicity and a promising percentage of response. Further follow-up is required to evaluate the response duration and survival in the whole group of patients
Sacchi:Janssen-Cilag: Research Funding. Off Label Use: Velcade is not approved in Italy for the treatment of Follicular lymphomas. However,we have perfomed with study has I have thought that the association with Mabthera could have efficacy and low toxicity in the treatment of NHL.
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