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Novel systemic therapies for breast cancer are being rapidly implemented into clinical practice. These drugs often have different mechanisms of action and side-effect profiles compared with traditional chemotherapy. Underpinning practice-changing clinical trials focused on the systemic therapies under investigation, thus there are sparse data available on radiotherapy. Integration of these new systemic therapies with radiotherapy is therefore challenging. Given this rapid, transformative change in breast cancer multimodal management, the multidisciplinary community must unite to ensure optimal, safe, and equitable treatment for all patients. The aim of this collaborative group of radiation, clinical, and medical oncologists, basic and translational scientists, and patient advocates was to: scope, synthesise, and summarise the literature on integrating novel drugs with radiotherapy for breast cancer; produce consensus statements on drug–radiotherapy integration, where specific evidence is lacking; and make best-practice recommendations for recording of radiotherapy data and quality assurance for subsequent studies testing novel drugs.

Purpose: This systematic review aims to analyze the literature on the application of AI in predicting patient outcomes and treatment-related toxicity in those undergoing SBRT or SRS across heterogeneous tumor sites. Materials and methods: Our review conformed to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. PubMed, EMBASE and Scopus were systematically searched for English-language human studies evaluating AI for outcome and toxicity prediction in patients undergoing SBRT or SRS for solid tumors. Search terms included (“Stereotactic Body Radiotherapy” OR “SBRT” OR “Stereotactic Radiosurgery” OR “SRS” OR “Stereotactic Ablative Radiotherapy” OR “SABR”) AND (“Artificial Intelligence” OR “AI” OR “Machine Learning” OR “Deep Learning” OR “Radiomics”) AND (“Response Prediction” OR “Response to Treatment” OR “Outcome Prediction”) AND (“Toxicity” OR “Side Effects” OR “Treatment Toxicities” OR “Adverse Events”). Results: The search yielded 29 eligible retrospective studies, published between 2020 and 2025. Eight studies addressed early-stage primary lung cancer, highlighting the potential of AI-based models in predicting radiation-induced pneumonitis, fibrosis and local control. Five studies investigated AI models for predicting hepatobiliary toxicity following SBRT for liver tumors. Sixteen studies involved SRS-treated patients with brain metastases or benign intracranial neoplasms (e.g., arteriovenous malformations, vestibular schwannomas, meningiomas), exploring AI algorithms for predicting treatment response and radiation-induced changes. In the results, AI might have been exploited to both reaffirm already known clinical predictors and to identify novel imaging, dosimetric or biological biomarkers. Examples include predicting radiation pneumonitis in lung cancer, residual liver function in hepatic tumors and local recurrence in brain metastases, thus supporting tailored treatment decisions. Conclusions: Combining AI with SBRT could greatly enhance personalized cancer care by predicting patient-specific outcomes and toxicity. AI models analyze complex datasets, including imaging and clinical data, to identify patterns that traditional methods may miss, thus enabling more accurate risk stratification and reducing variability in treatment planning. With further research and clinical validation, this integration could make radiotherapy safer, more effective and contribute to advancement in precision oncology.

Lack of clinically significant drug interactions between abemaciclib and proton pump inhibitors in breast cancer patients Proton pump inhibitors (PPIs) are the most commonly used anti-acid drugs worldwide, including among cancer patients. However, drug-drug interactions between PPIs and other agents may lead to decreased drug absorption with possible reduced therapeutic benefit, or even increased toxicity. Unfortunately, only scarce data exist regarding the safety of concomitant PPI use with anti-cancer agents. In this research article we describe the clinical outcome (progression-free survival, PFS) in hormone receptor-positive/HER2-negative metastatic breast cancer patients treated with the CDK4/6 inhibitor abemaciclib who were or were not taking proton pump inhibitors. This retrospective study demonstrates no statistically significant difference in PFS between the two groups ( p = 0.77). In conclusion, no clinically significant drug interaction occurs between abemaciclib and PPIs.

Objectives: In breast cancer (BC) patients receiving mastectomy, postmastectomy radiotherapy (PMRT) improves long-term outcomes by decreasing local failure and cancer mortality. However, the optimal PMRT schedule is still under investigation. The present review aims to discuss the evidence regarding hypofractionated (HF) PMRT in BC patients in order to identify the optimal treatment approach. Additional purpose is to highlight what we have learned from COVID-19 era regarding HF schedules for PMRT in BC patients. Mechanism: Between February and November 2021, literature and database research were conducted. Key references were detected from a PubMed query. Range of publication date was between 2000 and 2021. Selection criteria included English language publications in humans. Hand searching included meeting proceedings of the European Society for Radiotherapy and Oncology (ESTRO), European Society of Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO) and American Society for Radiation Oncology (ASTRO). The website clinicaltrials.gov was also searched. Randomized controlled trials evaluating HF-PMRT were included. Findings in brief: Our research returned 87 published papers. Fourteen trials were included in our final analysis. The comparisons of several different schedules of HF-PMRT with conventional fractionated PMRT provided similar results in terms of locoregional disease control without increasing toxicity. Particularly, an acute skin toxicity incidence grade 2 or higher ranged between 10 and 25% among the studies we analyzed. Conclusions: The present paper suggests that safety and efficacy of HF-PMRT is comparable with conventional schedules and standard practice guidelines are already available. COVID-19 pandemic has emphasised the need for increasingly tailored treatment protocols. Modern HF regimens should continue to be the standard of treatment in BC patients who receive PMRT also in the post-COVID-19 era.

Introduction: Orbital lesions are rare, but are likely to become symptomatic and can impact on patients’ quality of life. Local control is often difficult to obtain, because of proximity to critical structures. CyberKnife stereotactic robotic radiotherapy could represent a viable treatment option. Materials and Methods: Data on patients treated for intraorbital lesions from solid malignancies were retrospectively collected. All patients underwent treatment with CyberKnife system. We analyzed local control, response rate, symptoms control, progression-free survival and overall survival, acute and late toxicity. Results: From January 2012 to May 2017, 20 treatments on 19 patients were performed, with dose ranging from 24 to 35 Gy in 1 to 5 fractions, prescribed at an average isodose line of 79.5% (range: 78-81). After a mean follow-up of 14.26 months (range: 0-58), overall response rate was 75%, with 2 and 4 patients presenting a partial and complete response, respectively. Mean time to best measured response was 15.16 months (range: 2-58). Thirteen patients were alive, with a local control rate of 79%. Mean time to local progression was 5 months (range: 3-7). Three patients reported improvement in symptoms after treatment. Mean planning target volume dose coverage was 97.2% (range: 93.5-99.7). Mean maximum dose (D max) to eye globe, optic nerve, optic chiasm, and lens was 2380.8 cGy (range: 290-3921), 1982.82 cGy (range: 777.3-2897.8), 713.14 cGy (range: 219.5-2273), and 867.9 cGy (range: 38-3118.5). Four patients presented acute toxicity. Conclusion: This current retrospective series demonstrated that CyberKnife robotic stereotactic radiotherapy is a feasible and tolerable approach for intraorbital lesions.

PSICHE (NCT05022914) is a prospective trial to test a [68Ga]Ga- PSMA-11 PET/CT imaging tailored strategy. All evaluable patients had biochemical relapse after surgery and underwent centralized [68Ga]Ga-PSMA-11 PET/CT imaging. The treatment was performed according pre-defined criteria. Observation and re-staging at further PSA progression were proposed to patients with negative PSMA and previous postoperative RT. Prostate bed SRT was proposed to all patients with a negative staging or positive imaging within prostate bed. Stereotactic body radiotherapy (SBRT) to all sites of disease was used for all patients with pelvic nodal recurrence (nodal disease < 2 cm under aortic bifurcation) or oligometastatic disease. At 3 months after treatment, 54.7% of patients had a complete biochemical response Only 2 patients experienced G2 Genitourinary toxicity. No G2 Gastrointestinal toxicity was recorded. A PSMA targeted treatment strategy led to encouraging results and was well tolerated.

Abstract Background The introduction of CDK4/6 inhibitors (CDK4/6i) has improved outcomes in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (mBC), including in patients with bone metastases. Assessing their comparative effectiveness in real-world settings is crucial. Methods This retrospective, multicenter cohort study (January 2019–December 2023; median follow-up 39 months) evaluated the real-world progression-free survival (rwPFS) of abemaciclib, ribociclib, and palbociclib combined with endocrine therapy (ET) in HR+/HER2- mBC patients with bone metastases. Overall survival (OS) was a secondary exploratory endpoint. A total of 1399 patients with ECOG PS 0–1 and at least 12 months of follow-up were included. Analyses used propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) to adjust for confounding. Results Palbociclib showed shorter rwPFS (22 months) compared to abemaciclib (32 months; HR = 1.47, p = 0.001) and ribociclib (35 months; HR = 1.49, p < 0.001). No significant difference was observed between abemaciclib and ribociclib. OS was also lower with palbociclib (47 months) versus abemaciclib (60 months; HR = 1.77, p < 0.001) and ribociclib (64 months; HR = 1.69, p = 0.001). Results were consistent after PSM and IPTW adjustment. CONCLUSION Ribociclib and abemaciclib may provide superior rwPFS and OS compared to palbociclib in HR+/HER2- mBC patients with bone metastases.

Stereotactic body radiotherapy (SBRT) and stereotactic radiosurgery (SRS) are advanced treatments used to precisely target tumors in different parts of the body. However, predicting how well patients will respond and who may experience side effects remains challenging. This study review explores how Artificial Intelligence (AI) can help improve these predictions. By analyzing medical images and patient data, AI tools may identify patterns that clinicians might not notice, helping to tailor treatment and reduce harm. Our findings suggest that using AI alongside SBRT and SRS could lead to safer and more effective cancer care.

Aromatase Inhibitors (AIs) are recommended for the adjuvant treatment of hormone receptor positive breast cancer in both high-risk pre-menopausal and post-menopausal population; arthralgia is the main cause of discontinuation of therapy and affects up to 25% of population on AI treatment. The objective of the study was to prospectively evaluate OPERA® (GAMFARMA srl, Milan, Italy), a new dietary supplement where α-Lipoic acid, Boswellia serrata, Methylsulfonylmethane and Bromelain are combined in a single hard-gelatin capsule to be taken once a day. Fifty-three patients with arthralgia (NCI-CTCAE v4.0 grade ≥ 1) occurring during AI therapy were enrolled. All patients received OPERA® from enrollment (T0) up to sixth months (T3). Patients' AI-related arthralgia was evaluated every two months with VAS Scale, PRAI questionnaire, and CTCAE scale. Primary endpoint was the number of patients with symptom resolution (G0) at T3 if compared to T0, according to CTCAE and VAS scale. Secondary endpoints were decrease in arthralgia intensity measured with PRAI score at T3 compared to baseline, safety of OPERA® and rate of AI interruption. Treatment with OPERA® supplement was overall well tolerated; no relevant toxicities related to OPERA® intake were reported. Seven subjects (13.2%) were not included in the final analysis because of consent withdrawal. 46 participants were eligible for final analysis. According to CTCAE scale, 10 out of 46 patients reported symptoms resolution at 6-month follow-up from the time of enrollment T0 ( p  = 0.0009). According to VAS score, 5 patients reported complete resolution of symptoms at T3 if compared to baseline starting situation T0 ( p  = 0.0222). Analysis of PRAI score showed a significant reduction in arthralgia-related pain perceived ( p  = 0.0001). OPERA® was able to reduce the intensity of arthralgia related to AI therapy. Randomized, double-blind studies are warranted to confirm the effectiveness of this dietary supplement.

Biochemical recurrences after radical prostatectomy (RP) can be managed with curative purpose through salvage radiation therapy (SRT). RT dose escalation, such as stereotactic RT (SSRT), may improve relapse-free survival in this setting. STARR trial (NCT05455736) is a prospective multicenter study including patients affected by macroscopic recurrence within the prostate bed after RP treated with SSRT. Recurrence was detected with a Choline or PSMA CT-PET. In the current analysis, the early biochemical response (BR) rate and toxicity profile after three months of follow-up were assessed. Twenty-five patients were enrolled, and data about BR and toxicity at three months after treatment were available for 19 cases. Overall, BR was detected after three months in 58% of cases. Four G1–G2 adverse events were recorded; no G ≥ 3 adverse events were detected. SSRT appears feasible and safe, with more than half of patients experiencing BR and an encouraging toxicity profile. The STARR trial is one of the few prospective studies aimed at implementing this promising treatment strategy in this scenario.