Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis.
Maintenance with rituximab after autologous stem cell transplantation in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL): CORAL final analysis.
复制标题
CD20 弥漫性大 B 细胞淋巴瘤 (DLBCL) 复发患者自体干细胞移植后利妥昔单抗维持治疗：CORAL 最终分析。
DOI：
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发表时间：
2011
影响因子：
45.3
通讯作者：
N. Schmitz
中科院分区：
文献类型：
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作者：
C. Gisselbrecht;B. Glass;G. Laurent;Devinder Gill;M. Linch;Marek Trněný;Dominique Bron;Ofer Shpilberg;Hans Hagberg;M. Bargetzi;David D.F. Ma;J. Brière;C. Moskowitz;N. Schmitz
8004背景：化疗后自体干细胞移植（ASCT）是化疗敏感复发DLBCL的标准治疗方法。没有研究比较不同的挽救治疗和评估ASCT后的维持治疗。
方法
将首次复发或一线治疗后难治的DLBCL CD 20+患者随机分配至R ICE（利妥昔单抗、异环磷酰胺、依托泊苷、卡铂）或R DHAP（利妥昔单抗、地塞米松、阿糖胞苷和顺铂）。有反应的患者接受BEAM和ASCT，并在观察或利妥昔单抗维持治疗之间随机分配，每2个月1年（Gisselbrecht J Clin Oncol; 2010 28：4184 - 4190）。
结果
对477名患者进行ITT分析，其中R ICE：243名患者和R DHAP：234名患者：255名复发> 12个月，213名难治性/早期复发; 306名患者先前暴露于利妥昔单抗;继发性IPI 0 - 1：281名患者; s IPI 2 - 3：181名患者。R-ICE和R-DHAP的有效率分别为63.6%和64.3%。4年时，R ICE和R DHAP之间的EFS（26% vs 37%，p = 0.2）和OS（43% vs 51%，p = 0.3）无差异。影响4年EFS、PFS和OS的因素包括：既往接受过利妥昔单抗治疗;早期复发<12个月; IPI 2 - 3。在255名患者中进行了ASCT，242名患者随机接受维持治疗：122名患者接受利妥昔单抗（R），120名患者接受观察（O）。R/O组之间的分布分别为：中位年龄54/53岁，男性76/83;女性46/37;继发性IPI 0 - 1：84/81; sIPI 2 - 3：36/36。89/76例复发> 12个月，33/41例难治性/早期复发。中位随访时间为44个月，发生111起事件。4年EFS为52.8%（CI 46 - 59），OS为63%（CI 56 - 69）。R组和O组的EFS、PFS和OS无差异。在多变量分析中，sIPI2 - 3显著影响EFS、PFS、OS（p = 0.0004）。女性（83例患者）的4年EFS 63%优于男性（159例患者）37%（p = 0.01）。仅R组存在差异（p = 0.004）。在R组中，性别是一个独立的预后因素。毒性为轻度，SAE为12%，R/O组为4%。
结论
R-ICE和R-DHAP之间以及ASCT后维持与R或O之间无差异。女性在ASCT后使用利妥昔单抗治疗效果明显更好。早期复发的前期利妥昔单抗为基础的化疗预后不良。
8004 Background: Chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard treatment for chemosensitive relapses DLBCL. No study has compared different salvage therapies and evaluated maintenance post ASCT.
METHODS
DLBCL CD 20+ in first relapse or pts refractory after first line therapy were randomized between R ICE (rituximab, ifosfamide, etoposide, carboplatinum) or R DHAP (rituximab dexamethasone cytarabine and cisplatinum). Responding patients received BEAM and ASCT and were randomized between observation or maintenance with rituximab every 2 months for 1 yr (Gisselbrecht J Clin Oncol; 2010 28:4184-4190).
RESULTS
ITT analysis was made on 477 pts with R ICE: 243 pts and R DHAP: 234 pts: 255 relapses >12m, 213 refractory/early relapses; 306 pts with prior exposure to rituximab; secondary(s) IPI 0-1: 281 pts; s IPI 2-3:181pts. There was no difference in response rate between R ICE 63.6% and R DHAP 64.3%. There was no difference between R ICE and R DHAP at 4 yrs for EFS (26% vs 37% p=0.2) and OS (43% vs 51%, p=0.3). Factors affecting 4 yrs EFS, PFS and OS were: prior treatment with rituximab; early relapse < 12 m; s IPI 2-3. ASCT was performed in 255 pts and 242 randomized for maintenance:122pts rituximab (R), 120 pts observation(O). Distribution between R/O arms were respectively: median age 54 /53 yrs,Male 76/83; female 46/37;secondary IPI 0-1: 84/81; sIPI 2-3: 36/36. 89/76 relapses >12m., 33/41 refractory/early relapses. Median follow up was 44 m with 111 events. 4 yrs EFS was 52.8 % (CI 46-59) with 63% (CI 56-69) OS. There was no difference in EFS, PFS and OS between R and O arms. In multivariate analysis, sIPI2-3 significantly affected EFS, PFS, OS (p=0.0004). Women (83pts) had a better 4 yrs EFS 63% than male (159pts) 37% (p=0.01). The difference was only in the R arm (p=0.004). Gender was an independent prognostic factor in the R arm. Toxicity was mild with 12% SAE versus 4% for R /O respectively.
CONCLUSIONS
There was no difference between R-ICE and R-DHAP and between post ASCT maintenance with R or O. Women did significantly better after ASCT with rituximab. Early relapses to upfront rituximab-based chemotherapy have a poor prognosis.