Radiation Oncology, University Medical Centre Utrecht, Utrecht, The Netherlands.
Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.
Eur Urol. 2022 Sep;82(3):252-257. doi: 10.1016/j.eururo.2021.12.012. Epub 2021 Dec 23.
Focal dose escalation in external beam radiotherapy (EBRT) showed an increase in 5-yr biochemical disease-free survival in the Focal Lesion Ablative Microboost in Prostate Cancer (FLAME) trial.
To analyze the effect of a focal boost to intraprostatic lesions on local failure-free survival (LFS) and regional + distant metastasis-free survival (rdMFS).
DESIGN, SETTING, AND PARTICIPANTS: Patients with intermediate- or high-risk localized prostate cancer were included in FLAME, a phase 3, multicenter, randomized controlled trial.
Standard treatment of 77 Gy to the entire prostate in 35 fractions was compared to an additional boost to the macroscopic tumor of up to 95 Gy during EBRT.
LFS and rdMFS, measured via any type of imaging, were compared between the treatment arms using Kaplan-Meier and Cox regression analyses. Dose-response curves were created for local failure (LF) and regional + distant metastatic failure (rdMF) using logistic regression.
A total of 571 patients were included in the FLAME trial. Over median follow-up of 72 mo (interquartile range 58-86), focal boosting decreased LF (hazard ratio [HR] 0.33, 95% confidence interval [CI] 0.14-0.78) and rdMF (HR 0.58, 95% CI 0.35-0.93). Dose-response curves showed that a greater dose to the tumor resulted in lower LF and rdMF rates.
A clear dose-response relation for LF and rdMF was observed, suggesting that adequate focal dose escalation to intraprostatic lesions prevents undertreatment of the primary tumor, resulting in an improvement rdMF.
Radiotherapy is a treatment option for high-risk prostate cancer. The FLAME trial has shown that a high dose specifically targeted at the tumor within the prostate will result in better disease outcome, with less likelihood of regional and distant disease spread. The FLAME trial is registered on ClinicalTrials.gov as NCT01168479.
在《前列腺癌焦点病变消融微强化的外照射放疗（FLAME）试验》中，外照射放疗（EBRT）的焦点剂量升级显示出 5 年生化无病生存率的提高。
分析对前列腺内病变进行焦点强化对局部无失败生存（LFS）和区域+远处转移无失败生存（rdMFS）的影响。
设计、地点和参与者：这项多中心、随机对照的 3 期临床试验（FLAME）纳入了中高危局限性前列腺癌患者。
标准治疗为 77 Gy 分 35 次照射整个前列腺，与 EBRT 期间对宏观肿瘤进行高达 95 Gy 的额外强化照射相比。
使用 Kaplan-Meier 和 Cox 回归分析比较治疗组之间的 LFS 和 rdMFS，通过任何类型的影像学进行测量。使用逻辑回归为局部失败（LF）和区域+远处转移失败（rdMF）创建剂量反应曲线。
FLAME 试验共纳入 571 例患者。在中位数随访 72 个月（四分位距 58-86）后，焦点强化降低了 LF（风险比 [HR] 0.33，95%置信区间 [CI] 0.14-0.78）和 rdMF（HR 0.58，95% CI 0.35-0.93）。剂量反应曲线表明，肿瘤的剂量越高，LF 和 rdMF 的发生率越低。
观察到 LF 和 rdMF 存在明确的剂量反应关系，表明对前列腺内病变进行适当的焦点剂量升级可防止对原发性肿瘤的治疗不足，从而改善 rdMF。
放疗是治疗高危前列腺癌的一种选择。FLAME 试验表明，专门针对前列腺内肿瘤的高剂量治疗将导致更好的疾病结果，区域和远处疾病扩散的可能性更小。FLAME 试验在 ClinicalTrials.gov 上注册为 NCT01168479。
