Program: Oral and Poster Abstracts
Session: 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Poster I
Methods: patients younger than 70 yrs diagnosed of DLBCL with aIPI 2-3 or aIPI 1 with elevated beta2microglobulin were eligible. The main objective was to evaluate the proportion of patients who survives free of event at 2 years. Central pathology review was performed in all cases, and samples were classified as GC vs non-GC subtypes by IHC (Hans algorithm). PET/CTs were performed at diagnosis, after 2, 4 and 6 cycles (PET2, PET4 , and PET6), and were reviewed by at least 3 experts of a central panel at real time. Response was analyzed following the visual method with the Deauville scale, and for PET2 and PET4 the semiquantitative method was used. Patients with persistent disease after 4 cycles were considered a failure of therapy and were dropped out from the trial.
Results: data from the first 76 patients were analyzed. Diagnosis of DLBCL was confirmed in all except 3 pts, 36 pts were treated in the experimental arm and 37 in the control arm. Median age was 58.2 yo (range 23-70), 37 (50.7%) were males. Characteristics at diagnosis were: non-GC subtype 18/46 (39.1%), C-myc expression 35/43 (81.4%), bcl2 expression 43/49 (87.7%), double expression cmyc/bcl2 30/42 (71%), stage III-IV 64 (87.6%), ≥2 extranodal locations 27 (42.2%), ECOG 2-3 24 (33%), elevated LDH 43 (62.3%), elevated beta 2 microglobulin 47 (75.8%), aIPI 2: 42 (57.5%), aIPI 3: 21 (28.8%). Among 160 cycles of BRCAP chemotherapy, 5 (3.1%) on day 8, and 22 (13.7%) on day 15, were given without bortezomib due to a neutrophil count below 0.5 /L. The most common toxicities are shown in table 1 without significant differences between both arms. Twenty-one (32.8%) out of 64 patients had a positive PET2. Fifteen (26.8%) out of 56 patients who have finished the 4 cycles had a positive PET4 according to central review and were withdrawn of the trial.
Table 1: Episodes of treatment-related adverse events
|
Control arm: RCHOP n=166 |
Experimental arm: BRCAP n=160 |
||
Any grade |
Grade 3-4 |
Any grade |
Grade 3-4 |
|
Anemia |
6 |
0 |
22 |
9 ( 5.6%) |
Neutropenia |
31 |
26 (15.6%) |
47 |
37 (23.1%) |
Thrombocytopenia |
9 |
4 ( 2.4%) |
16 |
5 ( 3.1%) |
Febrile neutropenia |
- |
6 ( 3.6%) |
- |
10 ( 6.2%) |
Fever |
8 |
1 ( 0.6%) |
8 |
0 |
Infection |
4 |
1 ( 0.6%) |
7 |
1 ( 0.6%) |
Nausea/vomiting |
12 |
0 |
19 |
0 |
Peripheral neuropathy |
7 |
1 ( 0.6%) |
7 |
1 ( 0.6%) |
Diarrhea |
4 |
0 |
8 |
0 |
Constipation |
7 |
0 |
4 |
0 |
Hepatotoxicity |
6 |
0 |
6 |
0 |
Conclusions: BRCAP regimen with bortezomib sc d1, 8, and 15 is feasible. Its main toxicity is hematological, and some patients cannot receive some doses of bortezomib due to neutropenia. Grade 3-4 non-hematological toxicity is rare, including peripheral neuropathy, and do not differ from RCHOP toxicity.
1.Ruan J et al, JCO 2011;29:690-7
Disclosures: Sancho: CELLTRION, Inc.: Research Funding . Lopez-Guillermo: Roche, Celgene, Mundipharma, Gilead, Novartis: Membership on an entity’s Board of Directors or advisory committees , Research Funding .
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