Kougioumtzopoulou Andromachi, Platoni Kalliopi, Zygogianni Anna, Kounadis George, Syrigos Konstantinos N, Psyrri Adamantia, Bamias Aristotelis, Kelekis Nikolaos, Kouloulias Vasileios
Radiotherapy Unit, 2nd Department of Radiology, ATTIKON University Hospital, National & Kapodistrian University of Athens, Medical School, Athens,Greece.
Radiotherapy Unit, 1st Department of Radiology, ARETAIEION University Hospital, National & Kapodistrian University of Athens, Medical School, Athens,Greece.
Rev Recent Clin Trials. 2021;16(4):351-371. doi: 10.2174/1574887116666210509004418.
Radiotherapy represents one of the main therapeutic modalities for localized prostate cancer. In the last two decades, emerging data regarding the radiobiology of prostate cancer suggests a very low α/β value, which has led the scientific community to evaluate the potential advantage of hypofractionation.
The aim of this manuscript is to present the rationale of prostate radiobiology and the medical evidence of moderate hypofractionation for prostate cancer.
Existing literature was reviewed, including data from prospective clinical trials dealing with the efficacy and toxicity of hypofractionated radiotherapy. Fifteen prospective phase II studies, nine randomized phase III studies and ten meta-analyses were selected. For every study included, the equivalent dose was calculated for both biochemical control and late toxicity.
The efficacy of hypofractionated radiotherapy, compared to conventional radiotherapy, regarding biochemical control, was evaluated in five superiority and four non-inferiority randomized phase III studies. The majority of participants in these studies were patients with low- and intermediate- risk prostate cancer. Even though the superiority criterion of the hypofractionation was not met in all studies, the noninferiority criterion was met. Prospective phase II studies of hypofractionation reported a low rate of acute and late toxicity. In randomized phase III studies, acute and late toxicity grade 3 and higher for the bowel and bladder was comparable between hypofractionated and conventional radiotherapy. The included meta-analyses showed no difference in efficacy and toxicity.
Moderate hypofractionation is feasible and safe, and may be considered as an alternative option in low- and intermediate-risk prostate cancer patients.
放射治疗是局限性前列腺癌的主要治疗方式之一。在过去二十年中,有关前列腺癌放射生物学的新数据表明其α/β值非常低,这促使科学界评估大分割放疗的潜在优势。
本文旨在阐述前列腺癌放射生物学的基本原理以及大分割放疗治疗前列腺癌的医学证据。
对现有文献进行综述,包括来自前瞻性临床试验中有关大分割放疗疗效和毒性的数据。选取了15项前瞻性II期研究、9项随机III期研究和10项荟萃分析。对于纳入的每项研究,计算生化控制和晚期毒性的等效剂量。
在5项优效性和4项非劣效性随机III期研究中,评估了大分割放疗与传统放疗相比在生化控制方面的疗效。这些研究中的大多数参与者为低危和中危前列腺癌患者。尽管并非所有研究都满足大分割放疗的优效性标准,但满足非劣效性标准。大分割放疗的前瞻性II期研究报告的急性和晚期毒性发生率较低。在随机III期研究中,大分割放疗与传统放疗相比,肠道和膀胱3级及以上的急性和晚期毒性相当。纳入的荟萃分析显示疗效和毒性无差异。
适度大分割放疗是可行且安全的,可被视为低危和中危前列腺癌患者的一种替代选择。