RETROSPECTIVE and PROSPECTIVE OBSERVATIONAL TRIAL with REDUCED FIXED-DOSE DUAL CHEMOTHERAPY in COMBINATION with FULL-DOSE MONOCLONAL ANTIBODY in PATIENTS AGED 70 YEARS and OLDER in the FIRST-LINE TREATMENT of METASTATIC COLORECTAL CANCER

In this prospective, retrospective observational study, the case series of patients undergoing first-line treatment for metastatic colorectal adenocarcinoma with doublet fixed-dose and reduced-dose chemotherapy in combination with full-dose monoclonal antibody in patients aged 70 years or older is collected.

开始日期2025-04-01

申办/合作机构

Ente Ospedaliero Ospedali Galliera

NCT06364267

/ Not yet recruiting临床2期IIT

Randomized Double Blind Phase II Trial of Baby Exemestane Vs Baby Tamoxifen in Post-menopausal Women At High Risk for Breast Cancer.

The purpose of the study is to to compare low dose of exemestane (babyexe) versus low dose of tamoxifen (babytam) in terms of change of quality of life from baseline to 12 months.

开始日期2025-04-01

申办/合作机构

Ente Ospedaliero Ospedali Galliera

[+4]

NCT06718647

/ Not yet recruitingN/AIIT

Efficacy and Tolerability of Low-Dose Versus Standard-Dose Enzalutamide in Advance Prostate Cancer: a Real-World Evidence Study

Prostate cancer is the most common cancer in men in the United States and the second leading cause of cancer-related mortality in males. Since 2014, its incidence has increased by 3% annually, primarily due to a rise in advanced-stage cases. In Italy, over 41.000 cases were diagnosed in 2023, with 8.200 deaths. Enzalutamide, an androgen receptor inhibitor, is effective in treating metastatic prostate cancer but often requires dose reductions to improve tolerability in frail patients. Recent studies have shown that lower doses (≤ 80 mg per day) can maintain efficacy while improving safety and tolerability, with outcomes comparable to the standard dose (160 mg per day) in terms of overall survival, progression-free survival, and prostate-specific antigen response.
Based on the results observed in these studies, the investigators expect that in our retrospective cohort of patients with metastatic prostate cancer, those who received low doses of enzalutamide will have a 1 year progression-free survival comparable to the full dose. The investigators will also expect a lower rate of adverse events.

开始日期2025-03-01

申办/合作机构

Ente Ospedaliero Ospedali Galliera

100 项与 Ente Ospedaliero Ospedali Galliera 相关的临床结果

登录后查看更多信息

0 项与 Ente Ospedaliero Ospedali Galliera 相关的专利（医药）

登录后查看更多信息

256

项与 Ente Ospedaliero Ospedali Galliera 相关的文献（医药）

2025-03-01·EJSO

CT-radiomics and pathological tumor response to systemic therapy: A predictive analysis for colorectal liver metastases. Development and internal validation of a clinical-radiomic model

Article

作者: Ragaini, Elisa Maria ; Viganò, Luca ; Balbo Mussetto, Annalisa ; Cavinato, Lara ; Procopio, Fabio ; Gallo, Teresa ; Savino, Matteo Stefano ; Russolillo, Nadia ; Ammirabile, Angela ; Akpinar, Reha ; Ferrero, Alessandro ; Francone, Marco ; Di Tommaso, Luca ; Fiz, Francesco ; De Rosa, Giovanni ; Ieva, Francesca ; Ferro, Carola Anna Paolina ; Torzilli, Guido ; Terracciano, Luigi Maria ; Lanza, Ezio

INTRODUCTION:

The standard treatment of colorectal liver metastases (CRLM) is surgery with perioperative chemotherapy. A tumor response to systemic therapy confirmed at pathology examination is the strongest predictor of survival, but it cannot be adequately predicted in the preoperative setting. This bi-institutional retrospective study investigates whether CT-based radiomics of CRLM and peritumoral tissue provides a reliable non-invasive estimation of the pathological tumor response to chemotherapy.

METHODS:

All consecutive patients undergoing liver resection for CRLM at the two institutions were considered. Only patients with a radiological partial response or stable disease at chemotherapy and with a preoperative/post-chemotherapy CT performed <60 days before surgery were included. The pathological response was evaluated according to the tumor regression grade (TRG). The tumor (Tumor-VOI) was manually segmented on the portal phase of the CT and a 5-mm ring of peritumoral tissue was automatically generated (Margin-VOI). The predictive models underwent internal validation.

RESULTS:

Overall, 222 patients were included; 64 had a pathological response (29 %, TRG1-3). Two-third of patients displaying a radiological response (111/170) did not have a pathological one (TRG4-5). For TRG1-3 prediction, the clinical model performed fairly (Accuracy = 0.725, validation-AUC = 0.717 95%CI = 0.652-0.788). Radiomics improved the results: the model combining the clinical data and Tumor-VOI features had Accuracy = 0.743 and validation-AUC = 0.729 (95%CI = 0.665-0.798); the full model (clinical/Tumor-VOI/Margin-VOI) achieved Accuracy = 0.820 and validation-AUC = 0.768 (95%CI = 0.707-0.826).

CONCLUSION:

CT-based radiomics of CRLM allows an insightful non-invasive assessment of TRG. The combined analysis of the tumor and peritumoral tissue improves the prediction. In association with clinical data, the radiomic indices outperform standard radiological and clinical evaluation.

2025-01-01·DIGESTIVE AND LIVER DISEASE

CT-based radiogenomics of intrahepatic cholangiocarcinoma

Article

作者: Ragaini, Elisa Maria ; Ammirabile, Angela ; Cerri, Luca ; Viganò, Samuele ; Viganò, Luca ; Ieva, Francesca ; Francone, Marco ; Fiz, Francesco ; Terracciano, Luigi Maria ; Di Tommaso, Luca ; Laino, Maria Elena ; Zanuso, Valentina ; Rimassa, Lorenza

BACKGROUND:

Intrahepatic cholangiocarcinoma (ICC) is an aggressive disease with increasing incidence and its genetic alterations could be the target of systemic therapies.

AIMS:

To elucidate if radiomics extracted from computed tomography (CT) may non-invasively predict ICC genetic alterations.

METHODS:

All consecutive patients with a diagnosis of a mass-forming ICC (01/2016-06/2022) were considered. Inclusion criteria were availability of a high-quality contrast-enhanced CT and molecular profiling by NGS or FISH for FGFR2 fusion/rearrangement. The CT scan at diagnosis was considered. Genetic analyses were performed on surgical specimens (resectable patients) or biopsies (unresectable ones). The radiomic features were extracted using the LifeX software. Multivariate predictive models of the commonest genetic alterations were built.

RESULTS:

In the 90 enrolled patients (58 NGS/32 FISH, median age 65 years), the most common genetic alterations were FGFR2 (20/90), IDH1 (10/58), and KRAS (9/58). At internal validation, the combined clinical-radiomic models achieved the best performance for the prediction of FGFR2 (AUC = 0.892) and IDH1 status (AUC = 0.819), outperforming the pure clinical and radiomic models. The radiomic model for predicting KRAS mutations achieved an AUC = 0.767 (vs. 0.660 of the clinical model) without further improvements with the addition of clinical features.

CONCLUSIONS:

CT-based radiomics provides a reliable non-invasive prediction of ICC genetic status with a major impact on therapeutic strategies.

2024-11-01·HNO

Review

作者: Sittel, Christian ; Rüller, Karina ; Torre, Michele ; Fiz, Francesco ; Burghartz, Marc ; Fiz, Ivana ; D'Agostino, Roberto

BACKGROUND:

Suprastomal collapse (SSC) is considered a major late complication of paediatric tracheostomy and can be responsible for decannulation failure in up to 20% of tracheostomised children. Depending on the severity of SSC, surgery may be required. Various strategies and techniques are available, of which the treating with airway team should be aware.

OBJECTIVE:

This article intends to summarise the aetiology of SSC, its classification, clinical presentation, and the gold standard diagnostic and therapeutic algorithms according to the current literature.

MATERIALS AND METHODS:

A panel of experts reviewed the available literature on SSC. Published evidence on the different surgical techniques and their advantages and disadvantages was reviewed in detail, and a treatment algorithm created.

RESULTS:

The gold standard diagnostic procedure for SSC is flexible transnasal laryngotracheoscopy in spontaneous breathing followed by microlaryngoscopy (MLS) under general anaesthesia. Two main types of SSC can be differentiated, which differ in terms of surgical treatment. Purely anterior SSC is usually treated by tracheoplasty using an anterior costal cartilage graft (ACCG). Simple closure of the tracheostomy or excision of SSC with a potassium-titanyl-phosphate (KTP) laser are also described as less invasive approaches. For anterolateral SSC, segmental tracheal resection with end-to-end anastomosis or tracheoplasty with ACCG represent promising treatment options. Tracheal reinforcement with absorbable microplates is also discussed in the literature. With both types of SSC and depending on severity and the age of the child, a watch-and-wait strategy should always be considered.

CONCLUSION:

Dynamic airway endoscopy in spontaneous breathing followed by MLS in general anaesthesia should always be performed before decannulation. It is particularly important to visualise all segments of the airway during spontaneous breathing. The decision regarding the best surgical option for each child is based on the type and localisation of SSC, as well as on the patient's medical and surgical history and age.

100 项与 Ente Ospedaliero Ospedali Galliera 相关的药物交易

登录后查看更多信息

100 项与 Ente Ospedaliero Ospedali Galliera 相关的转化医学

登录后查看更多信息