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短疗程CHOP-R方案序贯90Y-替伊莫单抗及延长利妥昔单抗治疗初治滤泡性淋巴瘤的II期试验

Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma.

作者信息

Jacobs Samuel A, Swerdlow Steven H, Kant Jeffrey, Foon Kenneth A, Jankowitz Rachel, Land Stephanie R, DeMonaco Nicholas, Joyce Judith, Osborn Jennifer L, Evans Terry L, Schaefer Patricia M, Luong The Minh

机构信息

Department of Medicine, University of Pittsburgh Medical Center Cancer Centers, Pittsburgh, Pennsylvania 15232, USA.

出版信息

Clin Cancer Res. 2008 Nov 1;14(21):7088-94. doi: 10.1158/1078-0432.CCR-08-0529.

DOI:10.1158/1078-0432.CCR-08-0529
PMID:18981007
Abstract

PURPOSE

Radioimmunotherapy has been approved for relapsed follicular lymphoma (FL), including rituximab-refractory FL. This study was designed to determine the CR rate with short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended rituximab as first-line treatment.

EXPERIMENTAL DESIGN

Between March 2004 and February 2007, 60 patients with stage II to IV symptomatic or bulky FL from a single institution supported by a large community network entered this phase II trial. Patients received CHOP-R for three treatment cycles before RIT followed by four additional weekly treatments with rituximab. Response was determined using fusion [(18) F] fluorodeoxyglucose-positron emission tomography (PET)-computed tomography (CT) imaging.

RESULTS

Of the 60 patients entering this trial, 55 patients completed all protocol therapy. The median follow up was 19.7 months (range, 0.26-35.9 months). For intent-to-treat analysis, the complete response (CR) rate after CHOP-R, as assessed by CT and PET imaging, was 40% and 46%, respectively. After RIT, the CR rate improved, as assessed by CT and PET imaging, to 82% and 89%, respectively. Ten patients have progressed, including eight from best response of CR. Seven of 18 patients who were PET positive after CHOP-R progressed compared with 3 of 37 patients who were PET negative (P=0.010).

CONCLUSIONS

In patients with previously untreated, symptomatic or bulky FL, short-course chemoimmunotherapy and consolidation RIT and extended rituximab resulted in a high CR rate. Failure to achieve an early PET CR after CHOP-R indicated high risk of relapse.

摘要

目的

放射免疫疗法已被批准用于复发滤泡性淋巴瘤(FL),包括利妥昔单抗难治性FL。本研究旨在确定以环磷酰胺、阿霉素、长春新碱、泼尼松和利妥昔单抗(CHOP-R)进行短疗程化疗免疫疗法,随后给予90钇替伊莫单抗(RIT)并延长利妥昔单抗治疗作为一线治疗的完全缓解(CR)率。

实验设计

2004年3月至2007年2月,来自一个由大型社区网络支持的单一机构的60例II至IV期有症状或肿块较大的FL患者进入该II期试验。患者在接受RIT之前接受3个周期的CHOP-R治疗,随后再接受4次每周一次的利妥昔单抗治疗。使用融合[(18)F]氟脱氧葡萄糖-正电子发射断层扫描(PET)-计算机断层扫描(CT)成像来确定反应情况。

结果

进入该试验的60例患者中,55例完成了所有方案治疗。中位随访时间为19.7个月(范围为0.26 - 35.9个月)。对于意向性分析,通过CT和PET成像评估,CHOP-R后的完全缓解率分别为40%和46%。RIT后,通过CT和PET成像评估,CR率分别提高到82%和89%。10例患者病情进展,包括8例从最佳CR反应状态进展而来。CHOP-R后PET阳性的18例患者中有7例进展,而PET阴性的37例患者中有3例进展(P = 0.010)。

结论

在先前未治疗的有症状或肿块较大的FL患者中,短疗程化疗免疫疗法、巩固性RIT和延长利妥昔单抗治疗导致了较高的CR率。CHOP-R后未能早期达到PET CR表明复发风险高。

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