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恶性黑色素瘤淋巴结手术后辅助性术后放射治疗的前瞻性II期研究——跨塔斯曼放射肿瘤学组(TROG)96.06研究

A prospective phase II study of adjuvant postoperative radiation therapy following nodal surgery in malignant melanoma-Trans Tasman Radiation Oncology Group (TROG) Study 96.06.

作者信息

Burmeister Bryan H, Mark Smithers B, Burmeister Elizabeth, Baumann Kathryn, Davis Sidney, Krawitz Hedley, Johnson Carol, Spry Nigel

机构信息

University of Queensland, Melanoma Clinic, Princess Alexandra Hospital, Brisbane, Australia.

出版信息

Radiother Oncol. 2006 Nov;81(2):136-42. doi: 10.1016/j.radonc.2006.10.001. Epub 2006 Oct 24.

DOI:10.1016/j.radonc.2006.10.001
PMID:17064803
Abstract

BACKGROUND

The role of adjuvant postoperative therapy after resection of localised malignant melanoma involving regional lymph nodes remains controversial. There are no randomised trials that confirm that postoperative radiation conveys a benefit in terms of regional control or survival.

METHODS

Two hundred and thirty-four patients with melanoma involving lymph nodes were registered on a prospective study to evaluate the effect of postoperative radiation therapy. The regimen consisted of 48Gy in 20 fractions to the nodal basin using recommended treatment guidelines for each of the major node sites. The primary endpoints were regional in-field relapse and late toxicity. Secondary endpoints were adjacent relapse, distant relapse, overall survival, progression-free survival and time to in-field progression.

RESULTS

Adjuvant radiation therapy was well tolerated by all of the patients. As the first site of relapse, regional in-field relapses occurred in 16/234 patients (6.8%). The overall survival was 36% at 5 years. The progression-free survival and regional control rates were 27% and 91%, respectively, at 5 years. Patients with more than 2 nodes involved had a significantly worse outcome in terms of distant relapse, overall and progression-free survival.

CONCLUSION

We believe that adjuvant radiation therapy following nodal surgery could offer a possible benefit in terms of regional control. These results require confirmation in a randomised trial.

摘要

背景

局部恶性黑色素瘤伴区域淋巴结转移患者术后辅助治疗的作用仍存在争议。尚无随机试验证实术后放疗在区域控制或生存方面有获益。

方法

234例有淋巴结转移的黑色素瘤患者登记参与一项前瞻性研究,以评估术后放疗的效果。治疗方案为根据各主要淋巴结部位的推荐治疗指南,对淋巴结引流区给予20次分割、总剂量48Gy的放疗。主要终点为区域野内复发和晚期毒性。次要终点为邻近复发、远处复发、总生存、无进展生存和野内进展时间。

结果

所有患者对辅助放疗耐受性良好。作为首次复发部位,234例患者中有16例(6.8%)出现区域野内复发。5年总生存率为36%。5年无进展生存率和区域控制率分别为27%和91%。有2个以上淋巴结转移的患者在远处复发、总生存和无进展生存方面结局明显更差。

结论

我们认为淋巴结手术后辅助放疗在区域控制方面可能有益。这些结果需要在随机试验中得到证实。

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