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随机临床试验评估放疗在原发性纵隔大 B 细胞淋巴瘤中的疗效。

Randomized clinical trial to assess the efficacy of radiotherapy in primary mediastinal large B-lymphoma.

机构信息

Oncology Research Unit, Oncology Hospital, National Medical Center, IMSS, México, D. F., Mexico.

出版信息

Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1227-31. doi: 10.1016/j.ijrobp.2011.09.012. Epub 2011 Dec 13.

Abstract

PURPOSE

We developed a controlled clinical trial to assess the efficacy and toxicity of adjuvant-involved field radiotherapy (IFRT) in patients with primary mediastinal B-cell lymphoma that achieved complete response after the patients were treated with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP-14).

METHODS AND MATERIALS

Between January 2001 and June 2004, 124 consecutive patients who were in complete remission after dose dense chemotherapy and rituximab administration (R-CHOP14) were randomly assigned to received IFRT (30 Gy). Sixty-three patients received IFR, and 61 patients did not (control group).

RESULTS

The study aimed to include 182 patients in each arm but was closed prematurely because in a security analysis (June 2004), progression and early relapse were more frequent in patients that did not received IFRT. Patients were followed until March 2009, at which point actuarial curves at 10 years showed that progression free-survival was 72% in patients who received IFR and 20% in the control group (p < 0.001), overall survival was 72% and 31%, respectively (p < 0.001). Acute toxicity was mild and well tolerated.

DISCUSSION

Adjuvant radiotherapy to sites of bulky disease was the only difference to have an improvement in outcome in our patients; the use of rituximab during induction did not improve complete response rates and did affect overall survival; patients who received rituximab but not IFRT had a worse prognosis.

CONCLUSIONS

The use of IFRT in patients with primary mediastinal B-cell lymphoma who achieved complete response remain as the best treatment available, even in patients that received rituximab during induction.

摘要

目的

我们开展了一项对照临床试验,旨在评估在接受环磷酰胺、多柔比星、长春新碱、泼尼松和利妥昔单抗(R-CHOP-14)治疗后达到完全缓解的原发性纵隔 B 细胞淋巴瘤患者中,辅助累及野放疗(IFRT)的疗效和毒性。

方法和材料

在 2001 年 1 月至 2004 年 6 月期间,124 例接受密集化疗和利妥昔单抗治疗(R-CHOP14)后达到完全缓解的连续患者被随机分配接受 IFRT(30Gy)。63 例患者接受 IFRT(IFR 组),61 例患者未接受(对照组)。

结果

该研究旨在每臂纳入 182 例患者,但由于安全性分析(2004 年 6 月)显示未接受 IFRT 的患者进展和早期复发更为频繁,研究提前终止。患者随访至 2009 年 3 月,此时 10 年的生存分析显示,接受 IFR 的患者无进展生存为 72%,而对照组为 20%(p<0.001),总生存率分别为 72%和 31%(p<0.001)。急性毒性轻微且可耐受。

讨论

在我们的患者中,仅对大肿块部位进行辅助放疗是提高疗效的唯一差异;诱导期使用利妥昔单抗并未提高完全缓解率,但影响了总生存率;接受利妥昔单抗但未接受 IFRT 的患者预后更差。

结论

对于达到完全缓解的原发性纵隔 B 细胞淋巴瘤患者,即使在诱导期使用利妥昔单抗,IFRT 仍是最佳治疗选择。

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