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放射肿瘤学组92 - 02方案的十年随访:局部晚期前列腺癌选择性雄激素剥夺持续时间的III期试验

Ten-year follow-up of radiation therapy oncology group protocol 92-02: a phase III trial of the duration of elective androgen deprivation in locally advanced prostate cancer.

作者信息

Horwitz Eric M, Bae Kyounghwa, Hanks Gerald E, Porter Arthur, Grignon David J, Brereton Harmar D, Venkatesan Varagur, Lawton Colleen A, Rosenthal Seth A, Sandler Howard M, Shipley William U

机构信息

Fox Chase Cancer Center, Department of Radiation Oncology, 333 Cottman Ave, Philadelphia, PA 19111-2497, USA.

出版信息

J Clin Oncol. 2008 May 20;26(15):2497-504. doi: 10.1200/JCO.2007.14.9021. Epub 2008 Apr 14.

DOI:10.1200/JCO.2007.14.9021
PMID:18413638
Abstract

PURPOSE

To determine whether adding 2 years of androgen-deprivation therapy (ADT) improved outcome for patients electively treated with ADT before and during radiation therapy (RT).

PATIENTS AND METHODS

Prostate cancer patients with T2c-T4 prostate cancer with no extra pelvic lymph node involvement and prostate-specific antigen (PSA) less than 150 ng/mL were included. All patients received 4 months of goserelin and flutamide before and during RT. They were randomized to no further ADT (short-term ADT [STAD] + RT) or 24 months of goserelin (long-term ADT [LTAD] + RT). A total of 1,554 patients were entered. RT was 45 Gy to the pelvic nodes and 65 to 70 Gy to the prostate. Median follow-up of all survival patients is 11.31 and 11.27 years for the two arms.

RESULTS

At 10 years, the LTAD + RT group showed significant improvement over the STAD + RT group for all end points except overall survival: disease-free survival (13.2% v 22.5%; P < .0001), disease-specific survival (83.9% v 88.7%; P = .0042), local progression (22.2% v 12.3%; P < .0001), distant metastasis (22.8% v 14.8%; P < .0001), biochemical failure (68.1% v 51.9%; P <or= .0001), and overall survival (51.6% v 53.9%, P = .36). One subgroup analyzed consisted of all cancers with a Gleason score of 8 to 10 cancers. An overall survival difference was observed (31.9% v 45.1%; P = .0061), as well as in all other end points herein.

CONCLUSION

LTAD as delivered in this study for the treatment of locally advanced prostate cancer is superior to STAD for all end points except survival. A survival advantage for LTAD + RT in the treatment of locally advanced tumors with a Gleason score of 8 to 10 suggests that this should be the standard of treatment for these high-risk patients.

摘要

目的

确定在放疗前及放疗期间增加2年雄激素剥夺治疗(ADT)是否能改善接受选择性ADT治疗的患者的预后。

患者与方法

纳入T2c - T4期前列腺癌患者,无盆腔外淋巴结受累且前列腺特异性抗原(PSA)低于150 ng/mL。所有患者在放疗前及放疗期间接受4个月的戈舍瑞林和氟他胺治疗。他们被随机分为不再接受ADT(短期ADT [STAD] +放疗)或接受24个月戈舍瑞林治疗(长期ADT [LTAD] +放疗)。共纳入1554例患者。盆腔淋巴结放疗剂量为45 Gy,前列腺放疗剂量为65至70 Gy。两组所有存活患者的中位随访时间分别为11.31年和11.27年。

结果

在10年时,除总生存外,LTAD +放疗组在所有终点指标上均显著优于STAD +放疗组:无病生存(13.2%对22.5%;P <.0001)、疾病特异性生存(83.9%对88.7%;P =.0042)、局部进展(22.2%对12.3%;P <.0001)、远处转移(22.8%对14.8%;P <.0001)、生化失败(68.1%对51.9%;P≤.0001),总生存(51.6%对53.9%,P =.36)。分析的一个亚组包括所有Gleason评分8至10分的癌症。观察到总生存存在差异(31.9%对45.1%;P =.0061),本研究中的所有其他终点指标也存在差异。

结论

本研究中用于治疗局部晚期前列腺癌的LTAD在除生存外的所有终点指标上均优于STAD。LTAD +放疗在治疗Gleason评分8至10分的局部晚期肿瘤方面具有生存优势,表明这应成为这些高危患者的治疗标准。

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