Tagliaferri Luca, Manfrida Stefania, Fionda Bruno, Dinapoli Nicola, Barbaro Brunella, De Luca Viola, Placidi Elisa, Bertolini Roberta, Marazzi Fabio, Lancellotta Valentina, Frascino Vincenzo, Morganti Alessio Giuseppe, Gambacorta Maria Antonietta
UOC Degenze di Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini e Radioterapia Oncologica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italia; Istituto di Radiologia, Università Cattolica del Sacro Cuore, Roma, Italia.
UOC Servizi di Radioterapia Oncologica, Dipartimento di Diagnostica per Immagini e Radioterapia Oncologica, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italia.
Brachytherapy. 2025 May-Jun;24(3):439-449. doi: 10.1016/j.brachy.2025.01.006. Epub 2025 Mar 20.
The aim of this study is to investigate the outcomes in terms of survival, treatment compliance and toxicity in a cohort of patients treated with personalized chemoradiation (RCT) followed by image guided Interventional Radiotherapy (IG-IRT), stratified by clinical baseline stage and treatment response.
We analyzed patients with histologically proven squamous anal carcinoma treated using intensity modulated radiation therapy (IMRT) with curative intent, and IRT boost. External beam radiation was delivered using personalized IMRT technique with a simultaneous-integrated boost (SIB) to deliver 45 to 55 Gy in 25 fractions according to clinical stage. After the end of the RCT patients underwent clinical and imaging re-evaluation, and according to initial stage of disease and tumor response, a radiotherapy boost was administered through IG-IRT, performing MRI with IRT applicator on site (trans-anal position) and defining GTV on MRI imaging. All patients' treatments and outcomes data were collected by an internal database. The endpoints were in terms of overall treatment time (OTT), toxicity, clinical complete response (cCR), locoregional failure (LRF), colostomy free survival, overall survival (OS) and disease-free survival (DFS). Univariate survival analysis with Kaplan- Meier curves was performed to allow between-group comparison.
73 patients treated between February 2012 and January 2023 were included in the analysis. 72.6 % were female, with a median age of 65.4 years (range 39.1-89). 62 were staged T2-T4 (T2 42.5.5%, T3 19.2%, T4 27.4%) and 50 (68.5%) had positive nodes. Combined RCT was administered mainly using mitomycin C and 5-fluorouracil. The mean dose received by patients was 50 Gy; after a median time of 43 days (range 9-128) a sequential boost dose was delivered in 1-2 fractions (median dose of 4 Gy). OTT median was 85 days (range 44-225). The median follow-up period was 50.6 months. LRF was 17.8%, and at 3 and 5 years LC was 80.1% and 77.2%, CFS was 80.5 and 77.8%, DFS was 79.3% and 75.9% and OS 95.1%, 84.3% and 61.4% at 10 years. Moreover, we verified that OS was higher in patients who had an OTT lower than 93 days. Toxicity was acceptable: 45.2% of patients experienced a G1-G2 abdominal discomfort (only 5.5% had G3).
Our experience confirms that MR Image Guided Interventional Radiotherapy boost is a feasible treatment option with a significant impact on outcomes.
本研究旨在调查一组接受个体化放化疗（随机对照试验）后行影像引导介入放射治疗（IG-IRT）的患者在生存、治疗依从性和毒性方面的结果，并根据临床基线分期和治疗反应进行分层。
我们分析了经组织学证实的肛管鳞状癌患者，这些患者采用调强放射治疗（IMRT）进行根治性治疗，并进行IRT增敏。外照射采用个体化IMRT技术，同时进行同步整合增敏（SIB），根据临床分期在25次分割中给予45至55 Gy的剂量。随机对照试验结束后，患者接受临床和影像学重新评估，并根据疾病的初始阶段和肿瘤反应，通过IG-IRT进行放疗增敏，在现场（经肛门位置）使用IRT施源器进行MRI检查，并在MRI成像上定义靶区。所有患者的治疗和结果数据均由内部数据库收集。终点指标包括总治疗时间（OTT）、毒性、临床完全缓解（cCR）、局部区域失败（LRF）、无结肠造口生存、总生存（OS）和无病生存（DFS）。采用Kaplan-Meier曲线进行单因素生存分析以进行组间比较。
分析纳入了2012年2月至2023年1月期间治疗的73例患者。72.6%为女性，中位年龄为65.4岁（范围39.1 - 89岁）。62例为T2 - T4期（T2 42.5%，T3 19.2%，T4 27.4%），50例（68.5%）有阳性淋巴结。联合随机对照试验主要使用丝裂霉素C和5-氟尿嘧啶。患者接受的平均剂量为50 Gy；在中位时间43天（范围9 - 128天）后，分1 - 2次给予序贯增敏剂量（中位剂量4 Gy）。OTT中位数为85天（范围44 - 225天）。中位随访期为50.6个月。LRF为17.8%，3年和5年时局部控制率分别为80.1%和77.2%，无结肠造口生存率分别为80.5%和77.8%，DFS分别为79.3%和75.9%，10年时OS分别为95.1%、84.3%和61.4%。此外，我们证实OTT低于93天的患者OS更高。毒性是可接受的：45.2%的患者经历了1 - 2级腹部不适（只有5.5%为3级）。
我们的经验证实，MR影像引导介入放射治疗增敏是一种可行的治疗选择，对治疗结果有显著影响。
