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短程 R-CHOP 序贯 90Y-替伊莫单抗替奥昔单抗治疗未经治疗的高危老年弥漫大 B 细胞淋巴瘤患者的 II 期临床试验。

Phase II trial of short-course R-CHOP followed by 90Y-ibritumomab tiuxetan in previously untreated high-risk elderly diffuse large B-cell lymphoma patients.

机构信息

Institute of Hematology and Medical Oncology L. e A. Seràgnoli, Policlinico Sant'Orsola-Malpighi, University of Bologna, Via Massarenti 9, Bologna, Italy.

出版信息

Clin Cancer Res. 2010 Aug 1;16(15):3998-4004. doi: 10.1158/1078-0432.CCR-10-0162. Epub 2010 Jun 11.

DOI:10.1158/1078-0432.CCR-10-0162
PMID:20542986
Abstract

PURPOSE

This study aimed to evaluate the efficacy and safety of the treatment with (90)Y-ibritumomab tiuxetan following a short-course of rituximab with cyclophosphamide-adriamycin-vincristine-prednisone (R-CHOP) in high-risk elderly patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

EXPERIMENTAL DESIGN

From December 2006 to October 2008, 55 high-risk elderly (age > or =60 years) untreated DLBCL patients were treated in seven Italian institutions with a short-course of chemotherapy consisting of four cycles of R-CHOP21 followed by (90)Y-ibritumomab tiuxetan 6 to 10 weeks later.

RESULTS

Of the 55 patients, 48 underwent radioimmunotherapy. The overall response rate to the entire treatment regimen was 80%, including 73% complete remissions and 7% partial remissions. Eight (50%) of the 16 patients who achieved less than a complete response with CHOP improved their remission status after (90)Y-ibritumomab tiuxetan administration. With a median follow-up of 18 months, the 2-year progression-free survival was estimated to be 85%, with a 2-year overall survival of 86%. (90)Y-ibritumomab tiuxetan toxicity consisted of grade 3 to 4 hematologic toxicity in 28 of 48 patients, mainly neutropenia (23 patients) and thrombocytopenia (15 patients). Red cells and/or platelets transfusions were given to three patients.

CONCLUSION

This study evaluated the feasibility, efficacy, and safety of a short-course R-CHOP21 regimen followed by (90)Y-ibritumomab tiuxetan in high-risk elderly DLBCL patients.

摘要

目的

本研究旨在评估在先前未经治疗的弥漫性大 B 细胞淋巴瘤(DLBCL)的高危老年患者中,采用利妥昔单抗联合环磷酰胺、阿霉素、长春新碱和泼尼松(R-CHOP)短疗程治疗后,使用(90)Y-依鲁替尼替昔单抗治疗的疗效和安全性。

实验设计

从 2006 年 12 月至 2008 年 10 月,7 家意大利机构对 55 名未经治疗的高危老年(年龄≥60 岁)DLBCL 患者进行了治疗,采用包含四个周期 R-CHOP21 的短疗程化疗,然后在 6-10 周后进行(90)Y-依鲁替尼替昔单抗治疗。

结果

55 例患者中有 48 例接受了放射性免疫治疗。整个治疗方案的总体缓解率为 80%,包括 73%的完全缓解和 7%的部分缓解。在接受 CHOP 治疗后缓解程度低于完全缓解的 16 名患者中,有 8 名(50%)在接受(90)Y-依鲁替尼替昔单抗治疗后改善了缓解状态。中位随访 18 个月时,2 年无进展生存率估计为 85%,2 年总生存率为 86%。(90)Y-依鲁替尼替昔单抗的毒性包括 48 例患者中有 28 例(28%)发生 3-4 级血液学毒性,主要为中性粒细胞减少症(23 例)和血小板减少症(15 例)。有 3 名患者需要输血红细胞和/或血小板。

结论

本研究评估了在高危老年 DLBCL 患者中采用 R-CHOP21 短疗程治疗后,再使用(90)Y-依鲁替尼替昔单抗的可行性、疗效和安全性。

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