本帖最后由 橙色雨丝 于 2015-2-3 14:36 编辑
这是2011年7月10号发表在美国《临床肿瘤期刊》的一篇文章,文章的标题是:一项国际二期临床试验的最终结果-以R-CHOP21,CNS预防和对侧放疗作为一线方案治疗睾丸原发弥漫大B淋巴瘤。文章摘要如下:
Purpose 目的
Primary testicularlymphoma (PTL) has poor prognosis with failures in contralateral testis, CNS, andextranodal sites. To prevent these events, we designed an international phaseII trial (International Extranodal Lymphoma Study Group 10 [IELSG-10]) thataddressed feasibility and activity of conventional chemoimmunotherapyassociated with CNS prophylaxis and contralateral testis irradiation.The trial was conducted by the IELSG and the Italian Lymphoma Foundation.
睾丸原发淋巴瘤(PTL)常因出现对侧睾丸、中枢神经系统和结外复发而预后不良。为了避免这些事件的发生,我们设计了一个国际二期临床试验来评估常规化疗加中枢神经系统预防和对侧放疗的可行性和效果。这个试验是由IELSG和意大利淋巴瘤基金会主办的。
Patients and Methods患者和方法
Fifty-three patients(age 22 to 79 years) with untreated stage I or II PTL were treated with six to eightcourses of rituximab added to cyclophosphamide, doxorubicin, vincristine, andprednisone (R-CHOP) every 21 days (R-CHOP21); four doses of intrathecalmethotrexate (IT-MTX) and radiotherapy (RT) to the contralateral testis (30 Gy)for all patients and to regional lymph nodes (30 to 36 Gy) for stage IIdisease.
共有53例(22岁到79岁)未经治疗的I期和II期PTL患者接受了6到8个疗程的R-CHOP21加上四次甲氨蝶呤鞘内注射和对侧放疗(30格瑞),其中II期患者还对局部淋巴结区进行了放疗(30-36格瑞)。
Results 结果
All patientsreceived R-CHOP21, 50 received CNS prophylaxis, and 47 received testicular RT.With a median follow-up of 65 months, 5-year progression-free survival andoverall survival rates were 74% (95% CI, 59% to 84%) and 85% (95% CI, 71% to92%), respectively. Ten patients relapsed or progressed: two in lymph nodes,five in extranodal organs, and three in the CNS. The 5-year cumulative incidenceof CNS relapse was 6% (95% CI, 0% to 12%). No contralateral testis relapses occurred.Ten patients died: lymphoma (n _ 6), secondary leukemia (n _ 2), heart failure (n_ 1), and gastric cancer (n _ 1). Grade 3 to 4 toxicities were neutropenia,28%; infections, 4%; and neurologic, 13%. No deaths occurred as a result oftoxicity.
全部患者接受了R-CHOP21治疗,50例患者做了中枢神经系统预防,47例患者接受了对侧睾丸放疗。中例随访期为65个月,5年无进展生存率和总生存率分别为74%和85%。10例患者复发或者出现进展:2例在淋巴结,5例在结外器官,3例在中枢神经系统。5年累计中枢神经系统复发率例6%。未发现对侧睾丸复发。10例患者去世:淋巴瘤6例,继发白血病2例,心脏衰竭1例,胃癌1例。三到四度的毒性反应包括中性粒细胞缺乏,28%;感染,4%;神经反应,13%。未见因细胞毒性死亡的病例。
Conclusion 结论
This internationalprospective trial shows that combined treatment with R-CHOP21, IT-MTX, and testicularRT was associated with a good outcome in patients with PTL. RT avoided contralateraltestis relapses, but CNS prophylaxis deserves further investigation.
这个国际前瞻性临床试验显示联合R-CHOP21, MTX鞘内注射和睾丸放疗在PTL患者中取得了良好的治疗效果。对侧放疗避免了对侧睾丸复发的风险,但是关于中枢神经系统预防还需要进一步研究。
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