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Purpose: Prostate cancer treatments paradigms are in continuous evolution, especially in the metastatic setting. In this context, the Genito-Urinary Group of Italian Association of Radiotherapy and Clinical Oncology aimed to create a consensus on radiation therapy indication in de novo metastatic hormone-sensitive prostate cancer both on primary tumor and metastatic sites., Methods: A panel of experts, involved in clinical management of prostate cancer, through the estimate-talk-estimate method, developed a list of items and correspondent statements on the identified topic., Results: Seven conclusive items were identified with 12 statements about the chosen topic, radiation therapy in metastatic hormone-sensitive prostate cancer on primary tumor and metastatic sites., Conclusions: This consensus might help clinicians in prostate cancer managing in daily clinical practice., Competing Interests: Disclosures Barbara Alicja Jereczek-Fossa reported research funding from ACCURAY, IBA, AIRC (Italian Association for Cancer Research) and Fondazione IEO-CCM (Istituto Europeo di Oncologia-Centro Cardiologico Monzino). Niccolò Giaj Levra reported funds from AstraZeneca, Amgen, Janseen. Andrea Lancia, Anna Rita Alitto, Giovanni Pappagallo, Francesco Pasqualetti, Luca Triggiani, Elisa Ciurlia, Alessandro Magli, Sergio Fersino, Giulio Francolini, Alessia Reali, Rolando D'Angelillo, and Corrado Spatola had no funds to report., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background/aim: Sinonasal metastases arising from renal cell cancer are rare and usually managed with surgery. Few studies describe the use of radiotherapy in this specific setting, while the use of stereotactic body radiotherapy (SBRT) has been rarely reported as well., Case Report: We present the case of a solitary left sinonasal metastasis in a 65-year-old man with clear cell renal cancer who also received bilateral nephrectomy and subsequent kidney transplantation. The patient received subtotal surgery and subsequently he was candidate to SBRT to avoid systemic treatment, due to renal comorbidities., Conclusion: The patient was treated with SBRT for a total dose of 35 Gy in 5 fractions and after 24 months of follow-up there is no evidence of local relapse. No major side-effects were reported. Our experience supports SBRT as a safe and feasible treatment option in the case of sinonasal metastases from RCC., (Copyright © 2023, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Introduction: Breast cancer is the most common tumor in women and represents the leading cause of cancer death. Radiation therapy plays a key-role in the treatment of all breast cancer stages. Therefore, the adoption of evidence-based treatments is warranted, to ensure equity of access and standardization of care in clinical practice., Method: This national document on the highest evidence-based available data was developed and endorsed by the Italian Association of Radiation and Clinical Oncology (AIRO) Breast Cancer Group.We analyzed literature data regarding breast radiation therapy, using the SIGN (Scottish Intercollegiate Guidelines Network) methodology (www.sign.ac.uk). Updated findings from the literature were examined, including the highest levels of evidence (meta-analyses, randomized trials, and international guidelines) with a significant impact on clinical practice. The document deals with the role of radiation therapy in the treatment of primary breast cancer, local relapse, and metastatic disease, with focus on diagnosis, staging, local and systemic therapies, and follow up. Information is given on indications, techniques, total doses, and fractionations., Results: An extensive literature review from 2013 to 2021 was performed. The work was organized according to a general index of different topics and most chapters included individual questions and, when possible, synoptic and summary tables. Indications for radiation therapy in breast cancer were examined and integrated with other oncological treatments. A total of 50 questions were analyzed and answered.Four large areas of interest were investigated: (1) general strategy (multidisciplinary approach, contraindications, preliminary assessments, staging and management of patients with electronic devices); (2) systemic therapy (primary, adjuvant, in metastatic setting); (3) clinical aspects (invasive, non-invasive and micro-invasive carcinoma; particular situations such as young and elderly patients, breast cancer in males and cancer during pregnancy; follow up with possible acute and late toxicities; loco-regional relapse and metastatic disease); (4) technical aspects (radiation after conservative surgery or mastectomy, indications for boost, lymph node radiotherapy and partial breast irradiation).Appendixes about tumor bed boost and breast and lymph nodes contouring were implemented, including a dedicated web application. The scientific work was reviewed and validated by an expert group of breast cancer key-opinion leaders., Conclusions: Optimal breast cancer management requires a multidisciplinary approach sharing therapeutic strategies with the other involved specialists and the patient, within a coordinated and dedicated clinical path. In recent years, the high-level quality radiation therapy has shown a significant impact on local control and survival of breast cancer patients. Therefore, it is necessary to offer and guarantee accurate treatments according to the best standards of evidence-based medicine.

Introduction: In this observational, retrospective, multicenter study, we aimed to assess the safety of the combination of local metastasis-directed radiotherapy (RT) and immunotherapy (IT) in a cohort of advanced non-small-cell lung cancer (aNSCLC) patients., Material and Methods: We collected clinical data of aNSCLC patients who received concomitant RT and anti-PD-1/PD-L1 inhibitors in seven Italian centers from September 2015 to June 2019. Concomitant RT was defined as delivered ≤4 weeks before or after the first or last administration of immunotherapy, or within two consecutive cycles of ICI. All adverse events apparently related to RT and/or IT were graded according to the Common Terminology Criteria for Adverse Events, version 4.0, and reported in terms of incidence and severity as immune related or RT related, or combined., Results: We analyzed the clinical charts of 187 patients. Median follow-up time was 23 months, and median overall survival was 16.5 months (range, 3-162). Thirteen patients developed pure RT-related side effects, and 43 patients (23.9%) developed immune-related side effects. No additive toxic effects were observed. A case of grade 5 pulmonary toxicity was recorded as a possible consequence of a combined effect., Conclusion: This analysis suggests that the combination of concomitant RT and anti-PD-1/PD-L1 agents is safe, and the two toxicity profiles are independent., (Published by Elsevier Inc.)

Purpose: To investigate the role of radiotherapy (RT) in the management of EGFR- or ALK-mutated metastatic non-small cell lung cancer (NSCLC) treated with TKI., Materials and Methods: Clinical data of 106 patients (pts) from five Institutions treated with RT concomitant to TKI were retrospectively revised. Overall survival (OS) and toxicities were analyzed as endpoints of the study., Results: Median age of pts was 65 years. TKIs were given for EGFR (81%)- or ALK (19%)-mutated metastatic NSCLC. Stereotactic RT (SRT) was delivered to 49 pts (46%). Patients with four or less metastasis were defined as oligometastatic/oligoprogressive (OM/OP); sites of RT were brain, bone, lung or others in 46%, 27%, 14% and 13%, respectively. Median OS was 23 months. At univariate analysis SRT, ECOG PS 0-1, OM/OP disease, lung sites and a TKI duration longer than median favorably affected OS (all p < 0.001). Multivariate analysis confirmed SRT (HR 0.355, CI 95% 0.212-0.595; p < 0.001) and median duration of TKI > 14 months (HR 0.17, 95% CI 0.10-0.30; p < 0.001) as independent factors related to better OS. Toxicities were rare., Conclusions: SRT seems to positively affect OS with limited toxicity in selected patients.

Aim: To investigate the role of conventional radiotherapy (RT) and stereotactic body radiotherapy (SBRT) in patients with epidermal growth factor (EGFR)-mutant or anaplastic lymphoma kinase (ALK) rearrangement-positive metastatic non-small cell lung cancer (NSCLC)., Patients and Methods: Fifty patients with EGFR-mutated or ALK rearrangement-positive NSCLC were treated at our Institution. Radiotherapy was delivered before, after or concomitantly with tyrosine kinase inhibitors (TKIs). Acute toxicities and overall survival (OS) were assessed., Results: Radiotherapy was performed within 30 days before TKI, concomitantly with TKI and within 30 days after TKI in eight (16%), 33 (66%) and 9 (18%) cases, respectively. The median duration of TKI therapy in the whole series was 11.9 months. The median OS was 19.3 months and 1- and 2-year OS was 71.5% and 36.5%, respectively. The group treated with SBRT had a significant benefit in terms of OS (p=0.043). Only two grade 3 toxicities were reported., Conclusion: RT concomitantly or close to TKI administration in stage IV NSCLC was shown to be feasible and safe. Intriguing data on OS were also reported., (Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)

Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients., Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq., Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events., Conclusion: Weekly cisplatin and volumetric-modulated arc therapy-simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated.

Aim: To report preliminary results of a prospective study using pelvic volumetric-modulated arc therapy and simultaneous integrated boost (SIB-VMAT) on vaginal cuff postoperatively in patients with endometrial cancer (EC)., Patients and Methods: Fifty consecutive patients, submitted surgery for EC, were recruited to SIB-VMAT prescribing a dose of 54 Gy to the pelvis and 66 Gy to the vaginal cuff in 30 fractions. A 2 mm transvaginal probe and magnetic resonance imaging were used to define the vaginal cuff. Toxicity data were collected according to Common Terminology Criteria for Adverse Events v4.0; clinical outcomes were analyzed., Results: The median follow-up was 26 (range=12 to 39) months. According to International Federation of Gynecology and Obstetrics 2009, the stages were: IB1 in 20%, IB2 in 28%, IIA2 in 16%, IIB in 6%, IIIA in 2%, and IIIC in 28%. The 2-year Overall Survival and Local Control were 96% and 100%, respectively. Two pelvic node failures were registered. Acute gastrointestinal toxicity was: G0 in 12%, G1 in 52%, G2 in 36%; no case of toxicity G3 or more was observed. Acute genitourinary toxicity was: G0 in 10%, G1 in 42%, G2 in 48%; no case of toxicity G3 or more was observed. No late severe gastrointestinal or genitourinary toxicities were reported. A statistical correlation was found between acute G2 gastrointestinal toxicity with bowel V20 Gy ≥ 30%, V20 ≥ 40%, V30 ≥ 30%, Dmax ≥ 45 Gy. Acute G2 genitourinary toxicity was threefold higher with chemotherapy., Conclusion: In patients with EC, SIB-VMAT is feasible, and well tolerated. Preliminary data of clinical outcome are promising. Further prospective studies are advocated., (Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.)

Purpose: To retrospectively evaluate the role of high-dose salvage radiotherapy (SRT) alone with regard to biochemical and clinical outcomes in patients with biochemical failure (BF) after radical prostatectomy (RP)., Methods: Between January 2003 and August 2011, 168 hormone-naïve localized prostate cancer patients received SRT alone for post-RP BF in a single institution and were retrospectively analyzed. Multivariate analysis was performed to determine the independent prognostic impact of clinical factors on biochemical and clinical outcomes [biochemical relapse-free survival (bRFS), clinical relapse-free survival (cRFS), cancer-specific survival (CSS) and overall survival (OS)]., Results: Median follow-up was 54 months. Actuarial bRFS, cRFS, CSS and OS at 5 years were, respectively, 64, 86.2, 94.5 and 96.3 %. On multivariate analysis, nadir PSA (nPSA) after SRT was significantly associated with bRFS (HR 15, p = 0.001) and cRFS (HR 9, p = 0.001), while CSS was associated with RT dose (≥70 Gy; HR 1.9 p = 0.023), pre-RT PSA (<1.5 vs. ≥1.5 ng/mL; HR 1.3, p = 0.008) and age (>75 years; HR 1.2, p = 0.05). OS was significantly correlated with pre-SRT PSA (linear correlation; HR 1.1, p = 0.023) and age (<75 vs. ≥ 75 years; HR 1.1, p = 0.026)., Conclusions: Effective biochemical and clinical control rates may be safely achieved administering SRT with high doses (≥72 Gy) and using conformal techniques, especially in older patients presenting with lower pre-SRT PSA values. A lower nPSA after SRT predicts for better 5 years bRFS and cRFS rates.

Purpose: A proportion of patients with localized prostate cancer is still treated with primary androgen deprivation therapy (PADT) alone. Some of these patients may develop a PSA rising despite castration. The purpose of this study was to retrospectively evaluate the potential benefit of external beam radiotherapy (EBRT) in this cohort., Methods: Forty-two patients presenting a non-metastatic castration-resistant prostate cancer after PADT were referred to our institution and underwent RT between June 2003 and July 2011. Biochemical failure (BF) after EBRT was defined according to Phoenix criteria (nadir + 2 ng/mL "at call"). Median RT dose was 78 Gy., Results: Median duration of PADT was 54 months (range 10.2-181 months). Median follow-up after EBRT was 53 months. Twenty-one patients had BF after EBRT (median time 27.4 months): 13 presented with loco-regional and/or distant metastases, while in 8 patients, a PSA rise only was observed. Ten patients died of prostate cancer (and no patient died of causes other than prostate cancer). Five-year biochemical disease-free survival (bDFS), distant metastases-free survival (DMFS) and cancer-specific survival (CSS) were, respectively, 39.4, 60 and 65 %. On multivariate analysis, GS, nadir PSA (nPSA) and a pre-EBRT PSA ≤5 ng/mL significantly affected bDFS, while Gleason score (GS) and T stage significantly affected distant metastases onset. No factors affected CSS at multivariate analysis., Conclusions: EBRT may be a suitable therapeutic option, able to provide an excellent loco-regional control and to obtain a systemic disease control in up to 60 % of patients at 5 years, especially in patients presenting with lower Gleason score and T stage at diagnosis and lower pre-RT PSA and nPSA post-RT.

Background: Adjuvant radiotherapy in non-small-cell lung cancer (NSCLC) is still controversial. The purpose of this retrospective study was to evaluate the role of postoperative radiotherapy (PORT) in terms of local control and survival in pathologic N2 NSCLC., Patients and Methods: From January 2003 to December 2008, 66 patients with pathologic N2 NSCLC received PORT. Mediastinal lymph node metastases were classified into single (12 patients) or multiple (54 patients) stations. All patients received conformal radiation therapy, with a median total dose of 50.4 Gy. Target volumes included the bronchial stump, ipsilateral hilum, all pathologically involved lymph node regions, and all the lymph nodes between 2 noncontiguous pathologic nodal stations. The pattern of failure was considered as locoregional or systemic, or a combination of both. Locoregional failure was defined as in field or out of field., Results: Median follow-up time was 34.9 months (range 3.5-62.8 months). Local control was 80% at 12 months, 77.2% at both 24 and 36 months, and 72.1% at 60 months. The pattern of failure was locoregional in 3 patients (1 out of field and 2 in field) and systemic in 25 patients, with 12 patients presenting both locoregional and distant disease. Overall survival at 12, 36, and 60 months was 77%, 44%, and 37%, respectively. Median survival time was 34 months. The number of pathologically involved lymph node stations was a prognostic factor for local control (P = .05), cancer-specific survival (CSS) (P = .04), and disease-free survival (DFS) (P = .04)., Conclusion: Despite the limitations of the present study, mainly represented by its retrospective nature, our data support the role of PORT in terms of locoregional control and overall survival benefit; the number of involved mediastinal lymph nodes represents a significant prognostic factor in patients with pathologic N2 NSCLC., (Copyright © 2013 Elsevier Inc. All rights reserved.)