Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.
Association of Bone Metastatic Burden With Survival Benefit From Prostate Radiotherapy in Patients With Newly Diagnosed Metastatic Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.
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DOI：
10.1001/jamaoncol.2020.7857
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发表时间：
2021-04-01
期刊：
影响因子：
28.4
通讯作者：
Clarke NW
中科院分区：
文献类型：
--
作者：
Ali A;Hoyle A;Haran ÁM;Brawley CD;Cook A;Amos C;Calvert J;Douis H;Mason MD;Dearnaley D;Attard G;Gillessen S;Parmar MKB;Parker CC;Sydes MR;James ND;Clarke NW
本研究对一项随机临床试验进行了探索性分析，评估了新诊断的转移性前列腺癌患者接受前列腺放疗后骨转移计数和部位与生存获益的关系。对于新诊断的转移性前列腺癌，在标准的全身治疗中加入前列腺放疗（RT）是否能使骨转移负担和部位与生存相关？这项对1939名随机临床试验参与者的探索性分析表明，随着骨转移数量的增加，前列腺放射治疗后的生存获益逐渐减少，其中骨转移最多3个的患者生存获益最为明显。前列腺RT与只有非区域淋巴结转移（M1a）或3个或更少骨转移而无内脏转移的患者的总生存率和无失败生存率相关。在前列腺癌患者中，骨转移负荷和转移位置可能有助于预测前列腺放疗的生存获益。前列腺放疗（RT）可提高低负荷转移性前列腺癌患者的生存率。然而，由于转移负担标准的二分性，目前尚不清楚这种益处如何随骨转移计数和转移部位而变化。为了评估骨转移计数和位置与前列腺放疗的生存获益之间的关系。这项基于常规影像学（计算机断层扫描/磁共振成像和骨扫描）确定的转移部位和程度的治疗结果的探索性分析评估了STAMPEDE试验中随机分配的新诊断的转移性前列腺癌患者的转移M1 RT比较。基线骨转移计数与总生存期（OS）和无故障生存期（FFS）的关联使用多变量分数多项式相互作用程序进行评估。在亚组中进行进一步分析。患者随机接受标准治疗（雄激素剥夺治疗加或不加多西他赛）或标准治疗加前列腺放疗。主要结果为OS和FFS。2061名男性共纳入1939例（年龄中位数[四分位数间距]为68[63-73]岁）；1732例（89%）发生骨转移。骨转移计数与前列腺移植的OS和FFS获益相关。随着骨转移数量的增加，生存获益持续下降，在3个骨转移时获益最为明显。估计治疗效果的图显示，95% CI的上限超过等效线（风险比[HR]， 1），超过3个骨转移，没有可检测到的变化点。基于子组的进一步分析表明,受益于增加的大小RT是更大的患者低转移性前列腺负担只有nonregional淋巴结(M1a)或3或更少骨转移没有内脏转移(人力资源系统,0.62;95%置信区间,0.46 - -0.83;人力资源FFS, 0.57; 95%可信区间,0.47 - -0.70)比4或更多的骨转移患者或其他内脏/转移(人力资源系统,1.08;95%置信区间,0.91 - -1.28;P = .003交互;人力资源FFS, 0.87;95% ci, 0.76-0.99；相互作用P = .002)。在一项随机临床试验的探索性分析中，骨转移计数和基于常规影像学的转移位置与M1疾病中前列腺RT的OS和FFS获益相关。ClinicalTrials.gov标识符：NCT00268476；标识符：ISRCTN78818544
This exploratory analysis of a randomized clinical trial evaluates the association of bone metastasis count and location with survival benefit from prostate radiotherapy in patients with newly diagnosed metastatic prostate cancer. Are bone metastatic burden and site associated with survival benefit from the addition of prostate radiotherapy (RT) to standard-of-care systemic therapy in newly diagnosed metastatic prostate cancer? This exploratory analysis of 1939 participants in a randomized clinical trial shows that survival benefit following prostate RT gradually diminished with increasing bone metastasis number, with survival benefit most pronounced in patients with up to 3 bone metastases. Prostate RT was associated with greater overall and failure-free survival in patients with only nonregional lymph node metastasis (M1a) or 3 or fewer bone metastases without visceral metastasis. In patients with prostate cancer, bone metastatic burden and metastasis location may be useful in predicting survival benefit from prostate RT. Prostate radiotherapy (RT) improves survival in men with low-burden metastatic prostate cancer. However, owing to the dichotomized nature of metastatic burden criteria, it is not clear how this benefit varies with bone metastasis counts and metastatic site. To evaluate the association of bone metastasis count and location with survival benefit from prostate RT. This exploratory analysis of treatment outcomes based on metastatic site and extent as determined by conventional imaging (computed tomography/magnetic resonance imaging and bone scan) evaluated patients with newly diagnosed metastatic prostate cancer randomized within the STAMPEDE trial’s metastasis M1 RT comparison. The association of baseline bone metastasis counts with overall survival (OS) and failure-free survival (FFS) was assessed using a multivariable fractional polynomial interaction procedure. Further analysis was conducted in subgroups. Patients were randomized to receive either standard of care (androgen deprivation therapy with or without docetaxel) or standard of care and prostate RT. The primary outcomes were OS and FFS. A total of 1939 of 2061 men were included (median [interquartile range] age, 68 [63-73] years); 1732 (89%) had bone metastases. Bone metastasis counts were associated with OS and FFS benefit from prostate RT. Survival benefit decreased continuously as the number of bone metastases increased, with benefit most pronounced up to 3 bone metastases. A plot of estimated treatment effect indicated that the upper 95% CI crossed the line of equivalence (hazard ratio [HR], 1) above 3 bone metastases without a detectable change point. Further analysis based on subgroups showed that the magnitude of benefit from the addition of prostate RT was greater in patients with low metastatic burden with only nonregional lymph nodes (M1a) or 3 or fewer bone metastases without visceral metastasis (HR for OS, 0.62; 95% CI, 0.46-0.83; HR for FFS, 0.57; 95% CI, 0.47-0.70) than among patients with 4 or more bone metastases or any visceral/other metastasis (HR for OS, 1.08; 95% CI, 0.91-1.28; interaction P = .003; HR for FFS, 0.87; 95% CI, 0.76-0.99; interaction P = .002). In this exploratory analysis of a randomized clinical trial, bone metastasis count and metastasis location based on conventional imaging were associated with OS and FFS benefit from prostate RT in M1 disease. ClinicalTrials.gov Identifier: NCT00268476; ISRCTN.com Identifier: ISRCTN78818544
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影响因子：
2.1
作者：
SOLOWAY, MS;ISHIKAWA, S;TODD, B
通讯作者：
TODD, B
DOI：
10.1056/nejmoa1503747
发表时间：
2015-08-20
期刊：
The New England journal of medicine
影响因子：
--
作者：
Sweeney CJ;Chen YH;Carducci M;Liu G;Jarrard DF;Eisenberger M;Wong YN;Hahn N;Kohli M;Cooney MM;Dreicer R;Vogelzang NJ;Picus J;Shevrin D;Hussain M;Garcia JA;DiPaola RS
通讯作者：
DiPaola RS
影响因子：
45.3
作者：
Kyriakopoulos, Christos E.;Chen, Yu-Hui;Sweeney, Christopher J.
通讯作者：
Sweeney, Christopher J.
影响因子：
50.5
作者：
Parker, C.;Castro, E.;Gillessen, S.
通讯作者：
Gillessen, S.
对原发性肿瘤的放疗，用于新诊断的转移性前列腺癌（Stampede）：一项随机控制的3期试验。
DOI：
10.1016/s0140-6736(18)32486-3
发表时间：
2018-12-01
期刊：
Lancet (London, England)
影响因子：
--
作者：
Parker CC;James ND;Brawley CD;Clarke NW;Hoyle AP;Ali A;Ritchie AWS;Attard G;Chowdhury S;Cross W;Dearnaley DP;Gillessen S;Gilson C;Jones RJ;Langley RE;Malik ZI;Mason MD;Matheson D;Millman R;Russell JM;Thalmann GN;Amos CL;Alonzi R;Bahl A;Birtle A;Din O;Douis H;Eswar C;Gale J;Gannon MR;Jonnada S;Khaksar S;Lester JF;O'Sullivan JM;Parikh OA;Pedley ID;Pudney DM;Sheehan DJ;Srihari NN;Tran ATH;Parmar MKB;Sydes MR;Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators
通讯作者：
Systemic Therapy for Advanced or Metastatic Prostate cancer: Evaluation of Drug Efficacy (STAMPEDE) investigators