In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 8025-8025
Abstract:
8025 Background: 6xCHOP-14 with 8xR given over an extended period improved 3-year EFS (67% vs. 54%; p=0.030) and OS (80% vs. 67%, p=0.034) of poor-prognosis patients (IPI=3-5) in the SMARTE-R trial compared to the RICOVER-60 trial where patients received 8xR every 2 weeks. Because we had recently shown (Mueller et al., Blood 2012) that elderly male patients have a faster R clearance (12.68 ml/h vs. 8.21 ml/h; p=0.003) and shorter serum elimination half life (t 1/2ß =24.7 vs. t 1/2ß =30.7 days; p=0.003) than females, we analyzed whether these differences translated into different outcomes by comparing the results achieved by elderly female and male patients in the RICOVER-60 and SMARTE-R trials. Methods: In SMARTE-R, 189 evaluable elderly (61-80 y) pts. with DLBCL received 6 cycles of 2-weekly CHOP-14 combined with 8xR on days -4, -1, 10, 29, 57, 99, 155, and 239. The primary endpoint was event-free survival (EFS). 306 pts treated within the RICOVER-60 trial with 6xCHOP-14 + 8 R given on days 1, 15, 29, 43, 57, 71, 85 and 99 served as controls. Results: The 3-year EFS of 51 poor-prognosis male patients in SMARTE-R was 67% compared to 47% of 66 poor-prognosis male patients treated in RICOVER-60 (p=0.037); the respective figures were 71% vs. 53% (p=0.051) for PFS and 80% vs. 60% (p=0.027) for OS. In contrast, female poor-risk patients had only a small benefit from the extended rituximab exposure in SMARTE-R (n=48) compared to RICOVER-60 (n=57): 67% vs. 61% (p=0.354) for EFS; 71% vs. 67% (p=0.489) for PFS; and 80% vs. 76% (p=0.528) for OS. Conclusions: Elderly male patients with poor-prognosis DLBCL who have a faster R clearance and shorter R serum elimination half life than female patients, benefit significantly from the longer R exposure in SMARTE-R with a gain of 20% in 3-year OS, while the outcome of female patients was only slightly improved. Even though R maintenance has failed to demonstrate any benefit in the primary treatment of DLBCL to date, these results underline the importance of a minimum exposure time of R in order to exploit its full therapeutic potential in DLBCL. Supported by Deutsche Krebshilfe.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.8025
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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