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单药高剂量率近距离放射治疗前列腺癌:54Gy 分 9 次治疗的极度超分割方案的 5 年结果。

Monotherapeutic high-dose-rate brachytherapy for prostate cancer: five-year results of an extreme hypofractionation regimen with 54 Gy in nine fractions.

机构信息

Department of Radiation Oncology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.

出版信息

Int J Radiat Oncol Biol Phys. 2011 Jun 1;80(2):469-75. doi: 10.1016/j.ijrobp.2010.02.013. Epub 2010 Jun 18.

Abstract

PURPOSE

To evaluate an extreme hypofractionation regimen with 54 Gy in nine fractions provided by high-dose-rate (HDR) brachytherapy as monotherapy for prostate cancer by reporting 5-year clinical results.

METHODS AND MATERIALS

Between 1996 and 2005, 112 patients with localized prostate cancer were treated with HDR brachytherapy without external beam radiotherapy. Of the 112 patients, 15 were considered low risk, 29 intermediate risk, and 68 as high risk. The prescribed dose was uniformly 54 Gy in nine fractions within 5 days. Of the 112 patients, 94 also received hormonal therapy. The median follow-up time was 5.4 years.

RESULTS

All the patients safely completed the treatment regimen. The 5-year prostate-specific antigen (PSA) failure-free, local control, disease-free survival, and overall survival rate was 83%, 97%, 87%, and 96%, respectively. The 5-year PSA failure-free rate for low-, intermediate-, and high-risk patients was 85% (95% confidence interval, 66-100%), 93% (95% confidence interval, 83-100%), and 79% (95% confidence interval, 69-89%), respectively. The significant prognostic factors for PSA failure were the initial PSA level (p = .029) and younger age (p = .019). The maximal toxicities observed were Grade 3 using the Common Terminology Criteria for Adverse Events, version 3.0, for both acute and late toxicity (6 and 3 patients had acute and late Grade 3 toxicity, respectively). Late Grade 2 toxicity was observed in 13 patients.

CONCLUSION

Monotherapeutic HDR brachytherapy with an extreme hypofractionation regimen of 54 Gy in nine fractions associated with hormonal therapy was feasible, and its toxicity was acceptable. The interim tumor control rate at a median 5.4 years was promising, even for patients with locally advanced disease. This dose-fractionation scheme might be referred to by other terms, such as stereotactic body radiotherapy. Studies with longer follow-up periods and from multiple institutions are needed to confirm the efficacy of this novel approach.

摘要

目的

通过报告 5 年的临床结果,评估 54Gy 共 9 次的大剂量率(HDR)近距离放疗作为前列腺癌单一疗法的极端超分割方案。

方法和材料

1996 年至 2005 年间,112 例局限性前列腺癌患者接受 HDR 近距离放疗,不联合外照射放疗。112 例患者中,15 例为低危,29 例为中危,68 例为高危。规定剂量为 54Gy 共 9 次,5 天内完成。112 例患者中有 94 例还接受了激素治疗。中位随访时间为 5.4 年。

结果

所有患者均安全完成治疗方案。5 年前列腺特异性抗原(PSA)无失败、局部控制、无疾病生存和总生存率分别为 83%、97%、87%和 96%。低危、中危和高危患者的 5 年 PSA 无失败率分别为 85%(95%置信区间,66-100%)、93%(95%置信区间,83-100%)和 79%(95%置信区间,69-89%)。PSA 失败的显著预后因素是初始 PSA 水平(p=0.029)和年龄较小(p=0.019)。观察到的最严重毒性是使用通用不良事件术语标准,版本 3.0,急性和晚期毒性均为 3 级(分别有 6 例和 3 例患者出现急性和晚期 3 级毒性)。13 例患者出现晚期 2 级毒性。

结论

联合激素治疗,9 次 54Gy 的 HDR 近距离放疗单一疗法是可行的,且毒性可接受。中位随访 5.4 年后,中期肿瘤控制率有希望,即使是局部晚期疾病患者也是如此。这种剂量分割方案可能被称为其他术语,如立体定向体部放疗。需要进行更长随访期和来自多个机构的研究来证实这种新方法的疗效。

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