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25 result(s) for "Varano, Gianluca Maria"
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A New Option for the Treatment of Intrahepatic Cholangiocarcinoma: Percutaneous Hepatic Perfusion with CHEMOSAT Delivery System
Liver metastases are a major management problem; since they occur in tumors of different origin, they are often multiple, difficult to visualize and can lie dormant for many years. Patients with liver metastases usually die of their disease, mostly due to liver failure, since systemic treatments are unable to eradicate micro-metastasis, and interventional loco-regional procedures cannot treat all existing ones. Cholangiocarcinoma (CCA) is the second most common primary liver tumor, showing a poor overall prognosis. When resection is not possible, treatment options include tumor-focused or local ablative therapy, organ-focused or regional therapy and systemic therapy. We reviewed available loco-regional therapeutic options, with particular focus on the CHEMOSAT® Melphalan/Hepatic Delivery System (CS-HDS), which is uniquely positioned to perform a percutaneous hepatic perfusion (PHP), in order to treat the entire liver as a standalone or as complementary therapy. This system isolates the liver circulation, delivers a high concentration of chemotherapy (melphalan), filters most chemotherapy out of the blood and is a repeatable procedure. Most CS-HDS benefits are demonstrated in liver-predominant diseases, like liver metastasis from uveal melanoma (UM), hepatocarcinoma (HCC) and CCA. More than 650 procedures have been performed in Europe to date, mostly to treat liver metastases from UM. In CCA, experience is still limited, but retrospective analyses have been reported, while phase II and III studies are closed, waiting for results or ongoing.
Predicting Peri-Operative Outcomes in Patients Treated with Percutaneous Thermal Ablation for Small Renal Masses: The SuNS Nephrometry Score
Our objective was to develop a new, simple, and ablation-specific nephrometry score to predict peri-operative outcomes and to compare its predictive accuracy to PADUA and RENAL scores. Overall, 418 patients were treated with percutaneous thermal ablation (microwave and radiofrequency) between 2008 and 2021. The outcome of interest was trifecta status (achieved vs. not achieved): incomplete ablation or Clavien–Dindo ≥ 3 complications or postoperative estimated glomerular filtration rate decrease ≥ 30%. First, we validated the discrimination ability of the PADUA and RENAL scoring systems. Second, we created and internally validated a novel scoring (SuNS) system, according to multivariable logistic regression models. The predictive accuracy of the model was tested in terms of discrimination and calibration. Overall, 89 (21%) patients did not achieve trifecta. PADUA and RENAL scores showed poor ability to predict trifecta status (c-indexes 0.60 [0.53–0.67] and 0.62 [0.55–0.69], respectively). We, therefore, developed the SuNS model (c-index: 0.74 [0.67–0.79]) based on: (1) contact surface area; (2) nearness to renal sinus or urinary collecting system; (3) tumour diameter. Three complexity classes were created: low (3–4 points; 11% of no trifecta) vs. moderate (5–6 points; 30% of no trifecta) vs. high (7–8 points; 65% of no trifecta) complexity. Limitations include the retrospective and single-institution nature of the study. In conclusion, we developed an immediate, simple, and reproducible ablation-specific nephrometry score (SuNS) that outperformed PADUA and RENAL nephrometry scores in predicting peri-operative outcomes. External validation is required before daily practice implementation.
Image-guided laser ablation in the treatment of recurrence of renal tumours: technique and preliminary results
Abdominal recurrences of renal cell carcinoma (RCC) after surgery might represent a challenge for treatment, often requiring difficult surgeries or anticipated systemic therapy. Our aim is to illustrate a novel application of laser ablation for the treatment of abdominal recurrences of RCC. Patients with abdominal recurrences of renal cancer were treated under ultrasound/computed tomography guidance with a diode laser inserted into the lesion through a thin 21-G needle. A fixed 3-W power protocol was used, changing the illumination time according to lesion dimension and shape. Also, technical success, technical efficacy, local tumour progression, and major and minor complications were retrospectively analysed. Three patients were treated with image-guided laser ablation for abdominal recurrences of RCC. In all cases, it was possible to perform ablation as preoperatively planned and all three nodules (size of 6, 8, and 12 mm) were completely ablated with no evidence of residual enhancement after 6 weeks at contrast-enhanced CT. No minor or major complications were observed. No local tumour progression was reported up to 12 months from ablation. Image-guided laser ablation holds the potential to offer a minimally invasive treatment to patients with abdominal recurrence of RCC. Further studies are needed to evaluate the clinical role of this technique.
Bronchopleural Fistula after Lobectomy for Lung Cancer: How to Manage This Life-Threatening Complication Using Both Old and Innovative Solutions
Backgrounds: Our goal is to evaluate the correct management of broncho-pleural fistula (BPF) after lobectomy for lung cancer. Methods: We retrospectively reviewed our 25-years’ experience and reported our strategies and our diagnostic algorithm for the management of post-lobectomy broncho-pleural fistula. Results: Five thousand one hundred and fifty (5150) patients underwent lobectomy for lung cancer in the period between 1998 and 2023. A total of 44 (0.85%) out of 5150 developed post-operative BPF. In 11 cases, BPF was solved by non-invasive treatment. In nine cases, direct surgical repair of the bronchial stump allowed BPF resolution. In 14 cases, a completion intervention was performed. In six cases, we performed open window thoracostomy (OWT) after lobectomy; in two cases, the BPF was closed by percutaneous injection of an n-butyl cyanoacrylate glue mixture. In two cases, no surgical procedure was performed because of the clinical status of the patient at the time of fistula developing. Thirty-day and ninety-day mortality from fistula onset was, respectively, 18.2% (eight patients) and 22.7% (ten patients). Thirty-day and ninety-day mortality after completion pneumonectomy (12 patients) was, respectively, 8.3% (one patient) and 16.6% (two patients). Conclusions: The correct management of BPF depends on various factors: timing of onset, size of the fistula, anatomic localization, and the general condition of the patient. In the case of failure of various initial therapeutic approaches, completion intervention or OWT could be considered.
Multi-institutional analysis of outcomes for thermosphere microwave ablation treatment of colorectal liver metastases: the SMAC study
Objectives Oligometastatic colorectal cancer benefits of locoregional treatments but data concerning microwave ablation (MWA) are limited and interactions with systemic therapy are still debated. The aim of this study is to evaluate safety and effectiveness of Thermosphere™ MWA (T-MWA) of colorectal liver metastases (CLM) and factors affecting local tumor progression-free survival (LTPFS). Methods In this multi-institutional retrospective study (January 2015–September 2019), patients who underwent T-MWA for CLM were enrolled. Complications according to SIR classification were collected, primary efficacy and LTP were calculated. Analyzed variables included CLM size at diagnosis and at ablation, CLM number, ablation margins, intra-segment progression, chemotherapy before ablation (CBA), variations in size (ΔS DIA-ABL ), and velocity of size variation (V DIA-ABL ) between CLM diagnosis and ablation. Uni/multivariate analyses were performed using mixed effects Cox model to account for the hierarchical structure of data, patient/lesions. Results One hundred thirty-two patients with 213 CLM were evaluated. Complications were reported in 6/150 procedures (4%); no biliary complications occurred. Primary efficacy was achieved in 204/213 CLM (95.7%). LTP occurred in 58/204 CLM (28.4%). Six-, twelve-, and eighteen-month LTPFS were 88.2%, 75.8%, and 69.9%, respectively. At multivariate analysis, CLM size at ablation ( p  = 0.00045), CLM number ( p  = 0.046), ablation margin < 5 mm ( p  = 0.0035), and intra-segment progression ( p  < 0.0001) were statistically significant for LTPFS. ΔS DIA-ABL ( p  = 0.63) and V DIA-ABL ( p  = 0.38) did not affect LTPFS. Ablation margins in the chemo-naïve group were larger than those in the CBA group ( p  < 0.0001). Conclusion T-MWA is a safe and effective technology with adequate LTPFS rates. Intra-segment progression is significantly linked to LTPFS. CBA does not affect LTPFS. Anticipating ablation before chemotherapy may take the advantages of adequate tumor size with correct ablation margin planning. Key Points • Thermosphere™-Microwave ablation is a safe and effective treatment for colorectal liver metastases with no registered biliary complications in more than 200 ablations. • Metastases size at time of ablation, intra-segment progression, and minimal ablation margin < 5 mm were found statistically significant for local tumor progression-free survival. • Chemotherapy before ablation modifies kinetics growth of the lesions but deteriorates ablation margins and does not significantly impact local tumor progression-free survival.
Small-size (40 µm) Beads Loaded with Irinotecan in the Treatment of Patients with Colorectal Liver Metastases
PurposeThe purpose of this study was to investigate survival outcomes and safety after chemoembolization using irinotecan-loaded small-size beads (DEB-IRI) in patients with colorectal liver metastases unresponsive to standard chemotherapy.Materials and methodsBetween December 2013 and August 2019, fifty-five patients (32 males, median age 64.5 years) with pretreated colorectal liver metastases unresponsive to standard chemotherapy underwent 197 chemoembolization procedures (mean 3.6 ± 2.3 SD per patient). Thirty patients (30/55; 55%) had extrahepatic disease metastatic to the lungs, lymph nodes or peritoneum. Local tumor control was evaluated at 3, 6, 9 and 12 months. Median overall survival, survival rates at 1 and 2 year and adverse events were evaluated.ResultsLocal tumor control was achieved in 32/55 (58%), 12/55 (22%), 4/55 (7%) and 2/55 (4%) patients at 3, 6, 9 and 12 months, respectively. Median overall survival was 9.9 months (95% CI: 6.2–14.2 months) with 1- and 2-year survival rates of 45% and 15%, respectively. A total of 30 (15%) G1-G3 treatment-related adverse events occurred across all embolization procedures. No severe treatment-related adverse events occurred.ConclusionChemoembolization using irinotecan-loaded small-size beads is a safe and effective procedure as a salvage treatment in patients with colorectal liver metastases, showing good results in terms of liver-specific progression free survival and overall survival.
The Safety and Suitability of DNA Sequencing of Tissue Biopsies Performed on Patients Referred to a Phase I Unit
Background: Early-phase clinical trials offer a unique opportunity for patients with cancer. These trials often mandate biopsies to collect tumor tissue for research purposes, requiring patients to undergo invasive procedures. Some trials mandate molecular prescreening, but the success of these analyses relies on the quality and quantity of the tested materials. Additionally, bioptic procedures may result in complications. Methods: We retrospectively examined the records of patients referred to the Early Drug Development (EDD) Unit of the European Institute of Oncology who underwent biopsies for research purposes between January 2014 and December 2022. Our objective was to assess the safety of biopsy procedures and adequacy of the samples for NGS testing. Results: In total, 355 out of 731 patients (48.6%) underwent protocol-mandated biopsies. The most frequent sites of biopsy were the liver, lymph nodes, skin, and breast. Histological diagnosis was achieved in 349 (98%) patients, and NGS testing was successfully conducted in 111/127 (88.4%) cases. Of the 16 unsuccessful NGS attempts, 9 were performed on liver tissue. Unsuccessful NGS testing was attributed to poor sample quality and/or quantity, and the success rate varied significantly based on the specific tests attempted. Complications occurred in a small proportion of patients (4.8%), and none were serious. Conclusions: The non-negligible failure rate of NGS testing highlights the crucial need for implementing specific guidelines and Standard Operating Procedures for samples intended for NGS. With the use of a risk-based biopsy framework to guide clinical decisions, procedure-related complications may be minimized.
Transarterial Embolization with Small-Size Particles Loaded with Irinotecan for the Treatment of Colorectal Liver Metastases: Results of the MIRACLE III Study
PurposeThis pilot study was performed to investigate safety and local tumor control following transarterial embolization with small-size particles loaded with irinotecan (DEB-IRI) in patients with colorectal liver metastases (CRLM).Materials and MethodsPatients with pretreated CRLM with mono- or bilobar lesions involving less than 60% of the liver parenchyma and Eastern Cooperative Oncology Group performance status 0 or 1 underwent superselective DEB-IRI embolization with 40 µm diameter embolic microspheres.ResultsEighteen patients (11 males, 7 females, median age 61 years) underwent 80 embolization procedures (mean 4.4, range 2–12 per patient). No serious adverse events were reported within 30 days. A total of 39 treatment-related AEs occurred across all embolization procedures. No G4 or G5 treatment-related AEs occurred. Local tumor control, defined as complete response, partial response, or stable disease, was achieved in 16/18 (88.9%), 7/17 (41.2%), and 3/17 (17.6%) patients at 3, 6, and 12 months, respectively. Median liver progression-free survival was 5.9 months (range 27–409 days), and median overall survival was 13.5 months.ConclusionIn this small series, DEB-IRI embolization with small beads was demonstrated a safe procedure in the treatment of patients with CRLM. The promising results in terms of liver-specific progression-free survival and overall survival reported deserve further confirmation in larger prospective trials.Level of EvidenceLevel 4, case series.
Image-Guided Ablations in Patients with Recurrent Renal Cell Carcinoma
Renal cell carcinoma (RCC) is one of the most frequently diagnosed tumors and a leading cause of death. The high risk of local recurrence and distant metastases represent a significant clinical issue. Different image-guided ablation techniques can be applied for their treatment as an alternative to surgery, radiotherapy or systemic treatments. A retrospective analysis was conducted at our institution, including a total number of 34 RCC patients and 44 recurrent RCC tumors in different locations (kidney, lung, adrenal gland, liver, pancreas, pararenal and other) using microwave ablation, radiofrequency ablation, cryoablation and laser ablation. The estimated time to local and distant tumor progression after treatment were 22.53 ± 5.61 months and 24.23 ± 4.47 months, respectively. Systemic treatment was initiated in 10/34 (29%) treated patients with a mean time-to-systemic-therapy of 40.92 ± 23.98 months. Primary technical success was achieved in all cases and patients while the primary efficacy rate was achieved in 43/44 (98%) cases and 33/34 (97%) patients, respectively, with a secondary technical success and efficacy rate of 100%. At a mean follow-up of 57.52 months ± 27.86 months, local tumor progression occurred in 3/44 (7%) cases and distant progression in 25/34 (74%) patients. No significant complications occurred. Image-guided ablations can play a role in helping to better control recurrent disease, avoiding or delaying the administration of systemic therapies and their significant adverse effects.