Giuditta Chiloiro

@policlinicogemelli.it

Fondazione Policlinico Gemelli



              

https://researchid.co/gchiloiro
95

Scopus Publications

Scopus Publications

  • Analysis of patients with locally advanced rectal cancer given neoadjuvant radiochemotherapy with or without RT dose intensification: A multicenter retrospective study – ATLANTIS part I
    Luca Nicosia, Marco Lorenzo Bonù, Ilaria Angelicone, Gianluigi Lunardi, Rita Marina Niespolo, Micol Zannetti, Linda Agolli, Giuditta Chiloiro, Angela Romano, Fatemeh Jafari,et al.

    Elsevier BV

  • Assessing Quality of Life with the Novel QLQ-CAX24 Questionnaire and Body Composition Parameters in Rectal Cancer Patients: A Single-Center Prospective Study
    Marco Cintoni, Marta Palombaro, Pauline Raoul, Giuditta Chiloiro, Angela Romano, Elisa Meldolesi, Flavia De Giacomo, Elena Leonardi, Gabriele Egidi, Futura Grassi,et al.

    MDPI AG
    Background: Patients with rectal cancer (RC) are at risk of developing cancer-related cachexia, a complex metabolic syndrome that can negatively impact quality of life (QoL), treatment tolerance, and clinical response. Objectives: The aim of the study was to explore the possible associations of the novel European Organization for Research and Treatment of Cancer QoL Questionnaire—Cancer Cachexia (EORTC QLQ-CAX24) scores with body composition parameters and physical performance in patients with locally advanced RC (LARC). Methods: This prospective observational study involved RC patients evaluated at the dedicated outpatient clinic of Clinical Nutrition at the Fondazione Policlinico Agostino Gemelli IRCCS. Patients with a confirmed diagnosis of LARC were enrolled between January and December 2023. The body composition parameters were measured using the preoperative computed tomography scan at the level of the third lumbar vertebra as well as using bioimpedance analysis before and after the radiotherapy treatment. QoL was measured by the EORTC QLQ-C30 and EORTC QLQ-CAX24 questionnaires. Results: A total of 56 RC patients were enrolled. Significant associations (p < 0.05) were found between EORTC QLQ-CAX24 values and the presence of cachexia, body composition, handgrip strength, and malnutrition diagnosis. Muscle mass was significatively also associated with EORTC QLQ-CAX24 results, suggesting a link between subjective perception of QoL and objectively measured body composition. Conclusions: The EORTC CAX24 questionnaire can be an effective tool for monitoring changes in cachexia status during radiotherapy, enabling early detection of cachexia-related complications and timely intervention.

  • Radiotherapy & total neoadjuvant therapy for recurrent rectal cancer in previously irradiated patients, (RETRY): a multicenter prospective observational study
    Maria Antonietta Gambacorta, Angela Romano, Luciana Caravatta, Gabriella Macchia, Giuditta Chiloiro, Elena Galofaro, Francesca Valvo, Viviana Vitolo, Daniela Alterio, and Giovanna Mantello

    Springer Science and Business Media LLC

  • MOREOVER: multiomics MR-guided radiotherapy optimization in locally advanced rectal cancer
    Luca Boldrini, Giuditta Chiloiro, Silvia Di Franco, Angela Romano, Lana Smiljanic, Elena Huong Tran, Francesco Bono, Diepriye Charles Davies, Loris Lopetuso, Maria De Bonis,et al.

    Springer Science and Business Media LLC
    Abstract Background Complete response prediction in locally advanced rectal cancer (LARC) patients is generally focused on the radiomics analysis of staging MRI. Until now, omics information extracted from gut microbiota and circulating tumor DNA (ctDNA) have not been integrated in composite biomarkers-based models, thereby omitting valuable information from the decision-making process. In this study, we aim to integrate radiomics with gut microbiota and ctDNA-based genomics tracking during neoadjuvant chemoradiotherapy (nCRT). Methods The main hypothesis of the MOREOVER study is that the incorporation of composite biomarkers with radiomics-based models used in the THUNDER-2 trial will improve the pathological complete response (pCR) predictive power of such models, paving the way for more accurate and comprehensive personalized treatment approaches. This is due to the inclusion of actionable omics variables that may disclose previously unknown correlations with radiomics. Aims of this study are: - to generate longitudinal microbiome data linked to disease resistance to nCRT and postulate future therapeutic strategies in terms of both type of treatment and timing, such as fecal microbiota transplant in non-responding patients. - to describe the genomics pattern and ctDNA data evolution throughout the nCRT treatment in order to support the prediction outcome and identify new risk-category stratification agents. - to mine and combine collected data through integrated multi-omics approaches (radiomics, metagenomics, metabolomics, metatranscriptomics, human genomics, ctDNA) in order to increase the performance of the radiomics-based response predictive model for LARC patients undergoing nCRT on MR-Linac. Experimental design The objective of the MOREOVER project is to enrich the phase II THUNDER-2 trial (NCT04815694) with gut microbiota and ctDNA omics information, by exploring the possibility to enhance predictive performance of the developed model. Longitudinal ctDNA genomics, microbiome and genomics data will be analyzed on 7 timepoints: prior to nCRT, during nCRT on a weekly basis and prior to surgery. Specific modelling will be performed for data harvested, according to the TRIPOD statements. Discussion We expect to find differences in fecal microbiome, ctDNA and radiomics profiles between the two groups of patients (pCR and not pCR). In addition, we expect to find a variability in the stability of the considered omics features over time. The identified profiles will be inserted into dedicated modelling solutions to set up a multiomics decision support system able to achieve personalized treatments.

  • REPeated mAgnetic resonance Image-guided stereotactic body Radiotherapy (MRIg-reSBRT) for oligometastatic patients: REPAIR, a mono-institutional retrospective study
    Giuditta Chiloiro, Giulia Panza, Luca Boldrini, Angela Romano, Lorenzo Placidi, Matteo Nardini, Matteo Galetto, Claudio Votta, Maura Campitelli, Francesco Cellini,et al.

    Springer Science and Business Media LLC
    Abstract Background Oligo-progression or further recurrence is an open issue in the multi-integrated management of oligometastatic disease (OMD). Re-irradiation with stereotactic body radiotherapy (re-SBRT) technique could represent a valuable treatment option to improve OMD clinical outcomes. MRI-guided allows real-time visualization of the target volumes and online adaptive radiotherapy (oART). The aim of this retrospective study is to evaluate the efficacy and toxicity profile of MRI-guided repeated SBRT (MRIg-reSBRT) in the OMD setting and propose a re-SBRT classification. Methods We retrospectively analyzed patients (pts) with recurrent liver metastases or abdominal metastatic lesions between 1 and 5 centimeters from liver candidate to MRIg-reSBRT showing geometric overlap between the different SBRT courses and assessing whether they were in field (type 1) or not (type 2). Results Eighteen pts completed MRIg-reSBRT course for 25 metastatic hepatic/perihepatic lesions from July 2019 to January 2020. A total of 20 SBRT courses: 15 Type 1 re-SBRT (75%) and 5 Type 2 re-SBRT (25%) was delivered. Mean interval between the first SBRT and MRIg-reSBRT was 8,6 months. Mean prescribed dose for the first treatment was 43 Gy (range 24–50 Gy, mean BEDα/β10=93), while 41 Gy (range 16–50 Gy, mean BEDα/β10=92) for MRIg-reSBRT. Average liver dose was 3,9 Gy (range 1–10 Gy) and 3,7 Gy (range 1,6–8 Gy) for the first SBRT and MRIg-reSBRT, respectively. No acute or late toxicities were reported at a median follow-up of 10,7 months. The 1-year OS and PFS was 73,08% and 50%, respectively. Overall Clinical Benefit was 54%. Conclusions MRIg-reSBRT could be considered an effective and safe option in the multi-integrated treatment of OMD.

  • Magnetic Resonance Imaging Guided Radiation Therapy for Splenomegaly: Clinical Experiences and Technical Tips
    Angela Romano, Lorenzo Placidi, Luca Boldrini, Giuditta Chiloiro, Nicola Dinapoli, Matteo Galetto, Ciro Mazzarella, Guenda Meffe, Matteo Nardini, Giulia Panza,et al.

    Elsevier BV

  • Stereotactic radiotherapy for liver oligometastases: a pooled analysis following the estro/eortc consensus recommendations
    D. Pezzulla, G. Chiloiro, E. M. Lima, G. Macchia, C. Romano, S. Reina, G. Panza, S. Cilla, A. G. Morganti, F. Cellini,et al.

    Springer Science and Business Media LLC

  • Rectal Sparing Approach after preoperative Radio- and/or Chemo-therapy (ReSARCh): a prospective, multicenter, observational study
    Gaya Spolverato, Quoc Riccardo Bao, Paolo Delrio, Mario Guerrieri, Monica Ortenzi, Nicola Cillara, Angelo Restivo, Simona Deidda, Antonino Spinelli, Carmela Romano,et al.

    Ovid Technologies (Wolters Kluwer Health)
    Background: Rectal-sparing approaches for patients with rectal cancer who achieved a complete or major response following neoadjuvant therapy constitute a paradigm of a potential shift in the management of patients with rectal cancer, however their role remains controversial. The aim of this study was to investigate the feasibility of rectal-sparing approaches to preserve the rectum without impairing the outcomes. Methods: This prospective, multicentre, observational study investigated the outcomes of patients with clinical stage II-III mid-low rectal adenocarcinoma treated with any neoadjuvant therapy, and either transanal local excision or watch-and-wait approach, based on tumor response (major or complete) and patient/surgeon choice. The primary endpoint of the study was rectum preservation at a minimum follow-up of two years. Secondary endpoints were overall, disease-free, local and distant recurrence-free, and stoma-free survival at three years. Results: Of 178 patients enrolled in 16 centres, 112 (62.9%) were managed with local excision and 66 (37.1%) with watch-and-wait. At a median (interquartile range) follow-up of 36.1 (30.6-45.6) months, the rectum was preserved in 144 (80.9%) patients. The 3-year rectum-sparing, overall, disease-free, local recurrence-free, distant recurrence-free survival was 80.6% (95%CI 73.9-85.8), 97.6% (95%CI 93.6-99.1), 90.0% (95%CI 84.3-93.7), 94.7% (95%CI 90.1-97.2), and 94.6% (95%CI 89.9-97.2), respectively. The 3-year stoma-free survival was 95.0% (95%CI 89.5-97.6). The 3-year regrowth-free survival in the watch-and-wait group was 71.8% (95%CI 59.9-81.2). Conclusions: In rectal cancer patients with major or complete clinical response after neoadjuvant therapy, the rectum can be preserved in about 80% of cases, without compromise the outcomes.

  • Uterus motion analysis for radiotherapy planning optimization. The innovative contribution of on-board hybrid MR imaging
    A. Romano, C. Votta, M. Nardini, G. Chiloiro, Giulia Panza, L. Boldrini, D. Cusumano, Elena Galofaro, L. Placidi, Marco Valerio Antonelli,et al.



  • Impact of body composition parameters on radiation therapy compliance in locally advanced rectal cancer: A retrospective observational analysis
    Giuditta Chiloiro, Marco Cintoni, Marta Palombaro, Angela Romano, Sara Reina, Gabriele Pulcini, Barbara Corvari, Silvia Di Franco, Elisa Meldolesi, Gabriele Egidi,et al.

    Elsevier BV

  • Oncological outcomes of patients not undergoing Total Mesorectal Excision after local excision: rethinking surgical indications
    Quoc Riccardo Bao, Stefania Ferrari, Giulia Capelli, Giuditta Chiloiro, Daniela Rega, Salvatore Pucciarelli, Gaya Spolverato, Gaya Spolverato, Quoc Riccardo Bao, Paolo Delrio,et al.

    Oxford University Press (OUP)

  • High-tailored Anal Canal Radiotherapy (HIT-ART): Outcomes of a 10-Year Single Center Clinical Experience
    STEFANIA MANFRIDA, BRUNO FIONDA, SILVIA MARIANI, VIOLA DE LUCA, ROBERTA BERTOLINI, BRUNELLA BARBARO, GIUDITTA CHILOIRO, VINCENZO FRASCINO, LUCA TAGLIAFERRI, and MARIA ANTONIETTA GAMBACORTA

    Anticancer Research USA Inc.
    BACKGROUND/AIM The current standard for anal cancer treatment is essentially a 'one size fits all' approach where the dose of radiotherapy is similar whether the tumor is very small or very large. Trials are ongoing to evaluate dose de-escalation or escalation in localized disease depending on tumor size. The aim of the study was to assess results of a personalized approach involving dose stratification by stage and boost dose adjusted according to tumor early response. PATIENTS AND METHODS We retrospectively reviewed squamous cell anal cancer (SCAC) patients treated between 2011 and 2021 by long-course intensity-modulated radiotherapy (IMRT) and concomitant chemotherapy (CT); a sequential boost could be administered by IMRT or interventional radiotherapy (IRT) to obtain a total equivalent dose in 2 Gy (EQD2) of 54-60 Gy. RESULTS We analyzed 110 patients (61% T3-4 stage, 71% node-positive). A total of 68.2% of patients received a sequential boost, mainly by IRT; median total EQD2 to primary site was 59.3 Gy. Acute ≥G3 toxicity rate was 36.4%. Median follow-up (FUP) was 35.4 months. A total of 83% of patients achieved clinical complete response (cCR); locoregional recurrence (LRR) occurred in 20.9% and distant metastases in 6.4% of cases. A total of 12.7% patients underwent salvage surgery. A total of 25.5% of patients reported ≥G2 and 4.5% ≥G3 late toxicity. The estimated 3-year overall survival, disease-free survival and colostomy-free survival were 92%, 72% and 84% respectively; 3-year-LRR was 22%. Nodal stage was associated with poorer cCR probability and higher LRR (p<0.05). CONCLUSION Our results on a large cohort of patients with locally advanced SCAC and long FUP time confirmed the efficacy of IMRT; high local control and manageable toxicity also suggest IRT as a promising method in treatment personalization.

  • Impact of data transfer between treatment planning systems on dosimetric parameters
    Guenda Meffe, Claudio Votta, Gabriele Turco, Elena Chillè, Matteo Nardini, Angela Romano, Giuditta Chiloiro, Giulia Panza, Matteo Galetto, Amedeo Capotosti,et al.

    Elsevier BV

  • Four steps in the evolution of rectal cancer managements through 40 years of clinical practice: Pioneering, standardization, challenges and personalization
    Vincenzo Valentini, Sergio Alfieri, Claudio Coco, Domenico D'Ugo, Antonio Crucitti, Fabio Pacelli, Roberto Persiani, Luigi Sofo, Aurelio Picciocchi, Giovanni Battista Doglietto,et al.

    Elsevier BV

  • Radiomics-enhanced early regression index for predicting treatment response in rectal cancer: a multi-institutional 0.35 T MRI-guided radiotherapy study
    Luca Boldrini, Giuditta Chiloiro, Davide Cusumano, Poonam Yadav, Gao Yu, Angela Romano, Antonio Piras, Claudio Votta, Lorenzo Placidi, Sara Broggi,et al.

    Springer Science and Business Media LLC

  • Magnetic resonance imaging for assessment of rectal cancer nodes after chemoradiotherapy: A single center experience
    Brunella Barbaro, Maria Rachele PIa Carafa, Laura Maria Minordi, Priscilla Testa, Giulia Tatulli, Davide Carano, Claudio Fiorillo, Giuditta Chiloiro, Angela Romano, Vincenzo Valentini,et al.

    Elsevier BV

  • Auto-segmentation of pelvic organs at risk on 0.35T MRI using 2D and 3D Generative Adversarial Network models
    Marica Vagni, Huong Elena Tran, Angela Romano, Giuditta Chiloiro, Luca Boldrini, Konstantinos Zormpas-Petridis, Maria Kawula, Guillaume Landry, Christopher Kurz, Stefanie Corradini,et al.

    Elsevier BV

  • Evaluation of clinical parallel workflow in online adaptive MR-guided Radiotherapy: A detailed assessment of treatment session times
    Claudio Votta, Sara Iacovone, Gabriele Turco, Valerio Carrozzo, Marica Vagni, Aurora Scalia, Giuditta Chiloiro, Guenda Meffe, Matteo Nardini, Giulia Panza,et al.

    Elsevier BV

  • Response prediction for neoadjuvant treatment in locally advanced rectal cancer patients-improvement in decision-making: A systematic review
    Luca Boldrini, Diepriye Charles-Davies, Angela Romano, Matteo Mancino, Ilaria Nacci, Huong Elena Tran, Francesco Bono, Edda Boccia, Maria Antonietta Gambacorta, and Giuditta Chiloiro

    Elsevier BV

  • Risks of Organ Preservation in Rectal Cancer: Data From Two International Registries on Rectal Cancer
    Laura M. Fernandez, Guilherme P. São Julião, Carlos Cerdan Santacruz, Andrew G. Renehan, Oscar Cano-Valderrama, Geerard L. Beets, Jose Azevedo, Blas F. Lorente, Rocío S. Rancaño, Sebastiano Biondo,et al.

    American Society of Clinical Oncology (ASCO)
    PURPOSE Organ preservation has become an attractive alternative to surgery (total mesorectal excision [TME]) among patients with rectal cancer after neoadjuvant therapy who achieve a clinical complete response (cCR). Nearly 30% of these patients will develop local regrowth (LR). Although salvage resection is frequently feasible, there may be an increased risk for development of subsequent distant metastases (DM). The aim of this study is to compare the risk of DM between patients with LR after Watch and Wait (WW) and patients with near-complete pathologic response (nPCR) managed by TME at the time of reassessment of response. METHODS Data from patients enrolled in the International Watch &amp; Wait Database (IWWD) with cCR managed by WW and subsequent LR were compared with patients managed by TME (with ≤10% cancer cells—nPCR) from the Spanish Rectal Cancer Project (VIKINGO project). The primary end point was DM-free survival at 3 years from decision to WW or TME. The secondary end point was possible risk factors associated with DM. RESULTS Five hundred and eight patients with LR were compared with 893 patients with near-complete response after TME. Overall, DM rate was significantly higher among LRs (22.8% v 10.2%; P ≤ .001). Independent risk factors for DM included LR ( v TME at reassessment; P = .001), ypT3-4 status ( P = .016), and ypN+ status ( P = .001) at the time of surgery. 3-year DM-free survival was significantly worse for patients with LR (75% v 87%; P = .001). When stratified for pathologic stage, patients with LR did significantly worse through all stages ( P ≤ .009). CONCLUSION Patients with LR appear to have a higher risk for subsequent DM development than patients with nPCR managed by TME at restaging irrespective of final pathology. Leaving the primary undetectable tumor in situ until development of LR may result in worse oncologic outcomes.

  • Error-Correcting Methodology for Evaluating Compliance to Clinical Guidelines: A Case Study on Rectal Cancer
    Mariachiara Savino, Carlos Fernandez-Llatas, Roberto Gatta, Giuditta Chiloiro, Silvia Di Franco, Gema Ibanez-Sanchez, Zoe Valero-Ramon, Maria Antonietta Gambacorta, Vincenzo Valentini, and Andrea Damiani

    Springer Nature Switzerland

  • Impact of bias field correction on 0.35 T pelvic MR images: evaluation on generative adversarial network-based OARs’ auto-segmentation and visual grading assessment
    Marica Vagni, Huong Elena Tran, Francesco Catucci, Giuditta Chiloiro, Andrea D’Aviero, Alessia Re, Angela Romano, Luca Boldrini, Maria Kawula, Elia Lombardo,et al.

    Frontiers Media SA
    PurposeMagnetic resonance imaging (MRI)-guided radiotherapy enables adaptive treatment plans based on daily anatomical changes and accurate organ visualization. However, the bias field artifact can compromise image quality, affecting diagnostic accuracy and quantitative analyses. This study aims to assess the impact of bias field correction on 0.35 T pelvis MRIs by evaluating clinical anatomy visualization and generative adversarial network (GAN) auto-segmentation performance.Materials and methods3D simulation MRIs from 60 prostate cancer patients treated on MR-Linac (0.35 T) were collected and preprocessed with the N4ITK algorithm for bias field correction. A 3D GAN architecture was trained, validated, and tested on 40, 10, and 10 patients, respectively, to auto-segment the organs at risk (OARs) rectum and bladder. The GAN was trained and evaluated either with the original or the bias-corrected MRIs. The Dice similarity coefficient (DSC) and 95th percentile Hausdorff distance (HD95th) were computed for the segmented volumes of each patient. The Wilcoxon signed-rank test assessed the statistical difference of the metrics within OARs, both with and without bias field correction. Five radiation oncologists blindly scored 22 randomly chosen patients in terms of overall image quality and visibility of boundaries (prostate, rectum, bladder, seminal vesicles) of the original and bias-corrected MRIs. Bennett’s S score and Fleiss’ kappa were used to assess the pairwise interrater agreement and the interrater agreement among all the observers, respectively.ResultsIn the test set, the GAN trained and evaluated on original and bias-corrected MRIs showed DSC/HD95th of 0.92/5.63 mm and 0.92/5.91 mm for the bladder and 0.84/10.61 mm and 0.83/9.71 mm for the rectum. No statistical differences in the distribution of the evaluation metrics were found neither for the bladder (DSC: p = 0.07; HD95th: p = 0.35) nor for the rectum (DSC: p = 0.32; HD95th: p = 0.63). From the clinical visual grading assessment, the bias-corrected MRI resulted mostly in either no change or an improvement of the image quality and visualization of the organs’ boundaries compared with the original MRI.ConclusionThe bias field correction did not improve the anatomy visualization from a clinical point of view and the OARs’ auto-segmentation outputs generated by the GAN.

  • Uterine transposition versus uterine ventrofixation before radiotherapy as a fertility sparing option in young women with pelvic malignancies: Systematic review of the literature and dose simulation
    Matteo Pavone, Rosa Autorino, Nicolò Bizzarri, Giuditta Chilorio, Vincenzo Valentini, Giacomo Corrado, Gabriella Ferrandina, Gabriella Macchia, Maria Antonietta Gambacorta, Giovanni Scambia,et al.

    Elsevier BV


  • Preoperative Intensified Chemoradiation with Intensity-Modulated Radiotherapy and Simultaneous Integrated Boost Combined with Capecitabine in Locally Advanced Rectal Cancer: Long-Term Outcomes of a Real-Life Multicenter Study
    Marco Lupattelli, Elisa Palazzari, Jerry Polesel, Giuditta Chiloiro, Ilaria Angelicone, Valeria Panni, Luciana Caravatta, Saide Di Biase, Gabriella Macchia, Rita Marina Niespolo,et al.

    MDPI AG
    Background: Despite the feasibility and promising activity data on intensity-modulated RT and simultaneous integrated boost (IMRT-SIB) dose escalation in preoperative chemoradiation (CRT) for locally advanced rectal cancer (LARC), few data are currently available on long-term outcomes. Patients and Methods: A cohort of 288 LARC patients with cT3-T4, cN0-2, cM0 treated with IMRT-SIB and capecitabine from March 2013 to December 2019, followed by a total mesorectal excision (TME) or an organ-preserving strategy, was collected from a prospective database of 10 Italian institutions. A dose of 45 Gy in 25 fractions was prescribed to the tumor and elective nodes, while the SIB dose was prescribed according to the clinical practice of each institution on the gross tumor volume (GTV). Concurrent capecitabine was administered at a dose of 825 mg/m2 twice daily, 7 days a week. The primary objective of the study was to evaluate long-term outcomes in terms of local control (LC), progression-free survival (PFS) and overall survival (OS). The secondary objective was to confirm the previously reported feasibility, safety and efficacy (pCR, TRG1-2 and downstaging rates) of the treatment in a larger patient population. Results: All patients received a dose of 45 Gy to the tumor and elective nodes, while the SIB dose ranged from 52.5 Gy to 57.5 Gy (median 55 Gy). Acute gastrointestinal and hematologic toxicity rates of grade 3–4 were 5.7% and 1.8%, respectively. At preoperative restaging, 36 patients (12.5%) with complete or major clinical responses (cCR or mCR) were offered an organ-preserving approach with local excision (29 patients) or a watch and wait strategy (7 patients). The complete pathologic response rate (pCR) in radically operated patients was 25.8%. In addition, 4 TME patients had pT0N1 and 19 LE patients had pT0Nx, corresponding to an overall pT0 rate of 31.3%. Of the 36 patients selected for organ preservation, 7 (19.5%) required the completion of TME due to unfavorable pathologic features after LE or tumor regrowth during W-W resulting in long-term rectal preservation in 29 of 288 (10.1%) of the total patient population. Major postoperative complications occurred in 14.2% of all operated patients. At a median follow-up of 50 months, the 5-year PFS and OS rates were 72.3% (95% CI: 66.3–77.4) and 85.9% (95% CI: 80.2–90.1), respectively. The 5-year local recurrence (LR) rate was 9.2% (95% CI: 6.0–13.2), while the distant metastasis (DM) rate was 21.3% (95% CI: 16.5–26.5). The DM rate was 24.5% in the high-risk subset compared to 16.2% in the low-intermediate risk group (p = 0.062) with similar LR rates (10% and 8%, respectively). On multivariable analysis, cT4 and TRG3–5 were significantly associated with worse PFS, OS and metastasis-free survival. Conclusions: Preoperative IMRT-SIB with the moderate dose intensification of 52.5–57.5 Gy (median 55 Gy) and the full dose of concurrent capecitabine confirmed to be feasible and effective in our real-life clinical practice. Organ preservation was shown to be feasible in carefully selected, responsive patients. The favorable long-term survival rates highlight the efficacy of this intensified treatment program. The incorporation of IMRT-SIB with a more effective systemic therapy component in high-risk patients could represent a new area of investigational interest.

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