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Riccardo Lencioni

Publications and source records attributed to Riccardo Lencioni.

At least 19 recordsLinked to original sources
PubMed2026

Durvalumab and tremelimumab, with or without lenvatinib, combined with transarterial chemoembolisation in participants with embolisation-eligible hepatocellular carcinoma (EMERALD-3): a global, randomised, open-label, sponsor-blinded, phase 3 study.

BACKGROUND: Transarterial chemoembolisation (TACE), a standard treatment for embolisation-eligible hepatocellular carcinoma (HCC), induces tumour immune responses. Single tremelimumab regular interval durvalumab (STRIDE) is a standard treatment in advanced HCC. In this phase 3 trial, we assessed the efficacy and safety of STRIDE, with or without lenvatinib, plus TACE, in participants with embolisation-eligible HCC. METHODS: EMERALD-3 is a phase 3, randomised, open-label, sponsor-blinded study, conducted at 177 medical sites in 21 countries. Eligible participants were 18 years or older (aged &#x2265;21 years in Egypt or Singapore) at screening and had confirmed HCC (by imaging or histopathologically from biopsy specimen, surgery, or both) not amenable to curative surgery, curative ablation, or transplantation but amenable to TACE. Participants had Child-Pugh class A liver function, an Eastern Cooperative Oncology Group performance status of 0-1, and at least one measurable target intrahepatic lesion per modified Response Evaluation Criteria in Solid Tumours. Participants were randomly allocated in a 1:1:1 ratio to receive STRIDE plus lenvatinib plus TACE, STRIDE plus TACE, or TACE until each group reached its preplanned enrolment target of 175 participants. After the STRIDE plus TACE group reached its enrolment target, randomisation was adjusted to continue in a 1:1 ratio between the STRIDE plus lenvatinib plus TACE group and TACE group until approximately 275 participants were enrolled in each of these two groups. Randomisation used a centrally assigned interactive response technology system, stratified by region, baseline tumour burden, and previous palliative embolisation. In the STRIDE plus lenvatinib plus TACE group, on the first day, participants were given 300 mg tremelimumab intravenously, followed by 1500 mg durvalumab plus oral lenvatinib (8 mg for <60 kg bodyweight or 12 mg for &#x2265;60 kg bodyweight); participants then received 1500 mg durvalumab every 4 weeks plus once-daily lenvatinib for up to 36 cycles. In the STRIDE plus TACE group, participants were given 300 mg tremelimumab and 1500 mg durvalumab intravenously on the first day, followed by 1500 mg durvalumab every 4 weeks. The technique and number of TACE procedures were at the investigators' discretion, with the first procedure administered at least 7 days after the first dose of durvalumab in the two investigation treatment groups and within 7 days of random allocation in the TACE group. The primary endpoint was progression-free survival for STRIDE plus lenvatinib plus TACE versus TACE. Key secondary endpoints were overall survival for STRIDE plus lenvatinib plus TACE versus TACE and progression-free survival and overall survival for STRIDE plus TACE versus TACE. This study was registered with ClinicalTrials.gov (NCT05301842), with enrolment completed. FINDINGS: From March 28, 2022, to Nov 20, 2024, 1124 participants were screened. The full analysis set comprised 760 participants, who were randomly allocated to STRIDE plus lenvatinib plus TACE (n=293), STRIDE plus TACE (n=175), or TACE (n=292). 633 (83%) participants were male and 127 (17%) were female; 548 (72%) were Asian. At the first data cutoff (Sept 2, 2025); the overall median follow-up for progression-free survival was 10&#xb7;0 months (IQR 4&#xb7;6-17&#xb7;2); median follow-up for progression-free survival was 11&#xb7;0 months (IQR 4&#xb7;8-18&#xb7;4) for STRIDE plus lenvatinib plus TACE and 8&#xb7;3 months (4&#xb7;1-15&#xb7;5) for TACE. Median progression-free survival was 13&#xb7;0 months (95% CI 12&#xb7;2-16&#xb7;7) for STRIDE plus lenvatinib plus TACE versus 9&#xb7;8 months (8&#xb7;0-11&#xb7;4) for TACE (HR 0&#xb7;70 [95% CI 0&#xb7;57-0&#xb7;86]; p=0&#xb7;0007). At the second data cutoff (Feb 23, 2026) and a median follow-up for overall survival of 24&#xb7;6 months (IQR 16&#xb7;5-31&#xb7;5) for STRIDE plus lenvatinib plus TACE and 22&#xb7;9 months (14&#xb7;9-30&#xb7;2) for TACE, median overall survival was 39&#xb7;5 months (95% CI 34&#xb7;1-not reached) for STRIDE plus lenvatinib plus TACE and 34&#xb7;7 months (28&#xb7;8-not reached) for TACE (HR 0&#xb7;84 [95% CI 0&#xb7;65-1&#xb7;09]; p=0&#xb7;18). At this data cutoff, median progression-free survival was 12&#xb7;9 months (95% CI 10&#xb7;2-15&#xb7;9) for STRIDE plus TACE and 8&#xb7;1 months (6&#xb7;5-10&#xb7;2) for the first 175 participants randomised to TACE (HR 0&#xb7;71 [95% CI 0&#xb7;56-0&#xb7;91]), with median follow-up of 10&#xb7;3 months (IQR 4&#xb7;6-23&#xb7;7) for STRIDE plus TACE and 7&#xb7;7 months (3&#xb7;0-18&#xb7;5) for the first 175 participants randomly allocated to TACE. The most common adverse events of maximum grade 3 or 4 were hypertension (34 [12%] of 287) for STRIDE plus lenvatinib plus TACE, post-embolisation syndrome and anaemia (ten [6%] of 175 each) for STRIDE plus TACE, and post-embolisation (17 [6%] of 290) for TACE. 184 (64%) participants receiving STRIDE plus lenvatinib plus TACE, 89 (51%) receiving STRIDE plus TACE, and 68 (23%) receiving TACE had serious adverse events. Treatment-related adverse events with an outcome of death during the treatment-emergent period occurred in seven (2%) of 287 participants who received STRIDE plus lenvatinib plus TACE (two for myocarditis; and one each for hepatic failure, haemophagocytic lymphohistiocytosis, septic shock, cardiac failure, and unknown cause), none of 175 participants who received STRIDE plus TACE, and two (1%) of 290 participants who received TACE (one each for acute myocardial infarction and unknown cause). INTERPRETATION: STRIDE plus lenvatinib plus TACE showed a statistically significant progression-free survival improvement versus TACE. These findings support a STRIDE-based regimen as a potential new treatment option for people with embolisation-eligible HCC; additional follow-up is being conducted for final analysis of overall survival across treatment groups. FUNDING: AstraZeneca.

Adult↗
PubMed2006

Impact of European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) guidelines on the use of contrast agents in liver ultrasound.

The introduction of microbubble contrast agents and the development of contrast-specific techniques have opened new prospects in liver ultrasound. Over the past few years several reports have shown that contrast ultrasound can substantially improve detection and characterization of focal liver lesions with respect to baseline studies. The advent of second-generation agents and low mechanical index real-time scanning techniques has been instrumental in improving the easiness and the reproducibility of the examination. With the publication of the guidelines for the use of contrast agents in liver ultrasound by the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB), contrast ultrasound enters into clinical practice. The guidelines define the indications and recommendations for the use of contrast ultrasound in focal liver lesion detection, characterization, and follow-up after tumor ablation procedures. We discuss the impact of EFSUMB guidelines on diagnostic protocols currently adopted in liver imaging.

Contrast Media↗
PubMed2006

Electrodes and multiple electrode systems for radio frequency ablation: a proposal for updated terminology.

OBJECTIVE: Research on technology for soft tissue radio frequency (RF) ablation is ever advancing. A recent proposal to standardize terminology of RF electrodes only deals with the most frequently used commercial electrodes. The aim of this study was to develop a logical, versatile, and unequivocal terminology to describe present and future RF electrodes and multiple electrode systems. MATERIALS AND METHODS: We have carried out a PubMed search for the period from January 1st 1990 to July 1st 2004 in seven languages and contacted the six major companies that produce commercial RF electrodes for use in the liver. In a first step, names have been defined for the five existing basic designs of single-shaft electrode. These names had to be unequivocal, descriptive of the electrode's main working principle and as short as possible. In a second step, these basic names have been used as building blocks to describe the single-shaft electrodes in combination designs. In a third step, using the same principles, a logical terminology has been developed for multiple electrode systems, defined as the combined use of more than one single-shaft RF electrode. RESULTS: Five basic electrode designs were identified and defined: plain, cooled, expandable, wet, and bipolar electrodes. Combination designs included cooled-wet, expandable-wet, bipolar-wet, bipolar-cooled, bipolar-expandable, and bipolar-cooled-wet electrodes. Multiple electrode systems could be characterized by describing several features: the number of electrodes that were used (dual, triple, etc.), the electric mode (monopolar or bipolar), the activation mode (consecutive, simultaneous or switching), the site of the inserted electrodes (monofocal or multifocal), and the type of single-shaft electrodes that were used. CONCLUSION: In this terminology, the naming ofthe basic electrode designs has been based on objective criteria. The short and unequivocal names of the basic designs can easily be combined to describe current and future combination electrodes. This terminology provides an exact and complete description of the versatile novel multiple electrode systems.

Catheter Ablation↗
PubMed2005

Electrodes and multiple electrode systems for radiofrequency ablation: a proposal for updated terminology.

Research on technology for soft tissue radiofrequency (RF) ablation is ever advancing. A recent proposal to standardise terminology of RF electrodes only deals with the most frequently used commercial electrodes. The aim of this study was to develop a logical, versatile and unequivocal terminology to describe present and future RF electrodes and multiple electrode systems. We have carried out a PubMed search for the period from January 1 1990 to July 1 2004 in seven languages and contacted the six major companies that produce commercial RF electrodes for use in clinic. In a first step, names have been defined for the five existing basic designs of single-shaft electrode. These names had to be unequivocal, descriptive of the electrode's main working principle and as short as possible. In a second step, these basic names have been used as building blocks to describe the single-shaft electrodes in combination designs. In a third step, using the same principles, a logical terminology has been developed for multiple electrode systems, defined as the combined use of more than one single-shaft RF electrode. Five basic electrode designs were identified and defined: plain, cooled, expandable, wet and bipolar electrodes. Combination designs included cooled-wet, expandable-wet, bipolar-wet, bipolar-cooled, bipolar-expandable and bipolar-cooled-wet electrodes. Multiple electrode systems could be characterised by describing several features: the number of electrodes that were used (dual, triple, ...), the electric mode (monopolar or bipolar), the activation mode (consecutive, simultaneous or switching), the site of the inserted electrodes (monofocal or multifocal), and the type of single shaft electrodes that were used. In this terminology, the naming of the basic electrode designs has been based on objective criteria. The short and unequivocal names of the basic designs can easily be combined to describe current and future combination electrodes. This terminology provides an exact and complete description of the versatile novel multiple electrode systems.

Catheter Ablation↗
PubMed2005

Early-stage hepatocellular carcinoma in patients with cirrhosis: long-term results of percutaneous image-guided radiofrequency ablation.

PURPOSE: To perform a prospective, intention-to-treat clinical trial to determine the long-term survival rates of patients with hepatic cirrhosis and early-stage hepatocellular carcinoma (HCC) in whom percutaneous image-guided radiofrequency (RF) ablation was used as the sole first-line anticancer treatment. MATERIALS AND METHODS: The study was performed with approval of the ethics committee, and written informed consent was obtained for all patients. From June 1, 1996, to January 1, 2003, 206 patients (143 men, 63 women; age range, 51-81 years; mean age, 67 years +/- 7) who were excluded from surgery and who had Child class A or B cirrhosis with either a single HCC less than or equal to 5 cm in diameter or multiple (as many as three) HCCs less than or equal to 3 cm in diameter each were enrolled. RF ablation was performed in 187 (91%) of 206 patients; 19 (9%) were excluded from RF treatment because of unfavorable tumor location. Follow-up ranged from 3 to 78 months (mean, 24 months +/- 21) and included measurement of alpha-fetoprotein level, ultrasonography at 3-month intervals, and spiral computed tomography at 6-month intervals. Patients were observed for recurrence of the treated tumor and for the emergence of new HCC tumors. Survival probabilities were estimated with the Kaplan-Meier method, and differences between survival curves were evaluated with the log-rank test. RESULTS: At the end of the study, 145 patients were alive, and 61 were dead. In the intention-to-treat analysis, overall survival rates were 97% at 1 year, 67% at 3 years, and 41% at 5 years. Median survival was 49 months. In the 187 patients treated with RF ablation, overall survival rates were 97% at 1 year, 71% at 3 years, and 48% at 5 years. Median survival was 57 months. The difference between the two survival curves was not statistically significant (P=.5094). Survival of patients treated with RF ablation was dependent on Child class (P=.0006) and tumor multiplicity (P=.0133). Patients who had Child class A cirrhosis with solitary HCC (n=116) had 1-, 3-, and 5-year survival rates of 100%, 89% and 61%; median survival was 65 months. The 1-, 3-, and 5-year recurrence rates were 14%, 49%, and 81% for the emergence of new tumors and 4%, 10%, and 10% for local tumor progression. CONCLUSION: RF ablation is an effective first-line treatment for cirrhotic patients with early-stage HCC who were excluded from surgery.

Aged↗
PubMed2005

Clinical management of hepatic malignancies: ferucarbotran-enhanced magnetic resonance imaging versus contrast-enhanced spiral computed tomography.

This study compares ferucarbotran-enhanced magnetic resonance (MR) imaging with spiral computed tomography (CT) in the clinical management of patients with suspected hepatic malignancy. One hundred fifty-nine patients with suspected liver malignancy were included in a prospective, multicenter, phase IIIB clinical trial. Patients were examined with baseline plus contrast-enhanced spiral CT and with baseline plus ferucarbotran-enhanced MR imaging. For each patient, four maps of liver lesions were constructed by a trusted blind party on the basis of (a) baseline plus contrast-enhanced spiral CT, (b) baseline MR imaging, (c) baseline plus ferucarbotran-enhanced MR imaging, and (d) final diagnosis. Three blinded experts evaluated the treatment options for each map. The concordance of the treatment choice based on imaging with the treatment choice based on final diagnosis was verified. The final therapeutic decision was radical therapy for 85 patients, palliative therapy for 49 patients, and no treatment for 25 patients who had a final diagnosis of benign lesion. Proper treatment allocation was achieved in 121 (76%) of 159 patients when the evaluation was based on liver maps obtained from spiral CT, in 97 (61%) of 159 patients when the evaluation was based on liver maps obtained from baseline MR imaging, and in 136 (85%) of 159 patients when the evaluation was based on liver maps obtained from baseline plus ferucarbotran-enhanced MR imaging. MR imaging with ferucabotran was significantly superior to spiral CT for correct treatment allocation (P = 0.0167). Ferucarbotran-enhanced MR imaging is superior to spiral CT in clinical management of patients with suspected hepatic malignancy.

Adult↗
PubMed2005

A critical appraisal of the literature on local ablative therapies for hepatocellular carcinoma.

Image-guided percutaneous ablation is currently accepted as the best therapeutic option for nonsurgical patients with early-stage hepatocellular carcinoma. Ethanol injection is the seminal technique for local tumor treatment, and may achieve 50% 5-year survival in selected Child A patients. Radiofrequency ablation constitutes the most assessed alternative technique. On the basis of the identified evidence, radiofrequency ablation seems to reach higher recurrence-free survival rates compared with ethanol injection. Further randomized trials are needed to establish the clinical efficacy of radiofrequency ablation with respect to other percutaneous treatments and to devise an unbiased therapeutic strategy.

Carcinoma, Hepatocellular↗
PubMed2005

Imaging diagnosis.

The diagnosis of hepatocellular carcinoma (HCC) is based on imaging examinations in combination with clinical and laboratory findings. Despite technological advances, imaging cirrhotic patients remains a challenging issue because nonmalignant hepatocellular lesions, such as dysplastic nodules, mimic a small HCC. One of the key pathologic factors for differential diagnosis that is reflected in imaging appearances is the vascular supply to the lesion. It is accepted that imaging techniques may establish the diagnosis of HCC in nodules larger than 2 cm showing characteristic arterial hypervascularization. In lesions ranging from 1 to 2 cm, biopsy is still recommended, although a negative response can never be used to rule out malignancy completely. Although ultrasonography is widely accepted for HCC surveillance, spiral computed tomography (CT) or dynamic magnetic resonance imaging is required for diagnostic confirmation and intrahepatic tumor staging. These examinations have replaced invasive procedures, such as lipiodol CT, but remain relatively insensitive for the detection of tiny HCC lesions and tumor vascular invasion into peripheral portal vein branches.

Carcinoma, Hepatocellular↗
PubMed2004

Radiofrequency ablation of lung malignancies: where do we stand?

Percutaneous radiofrequency (RF) ablation is a minimally invasive technique used to treat solid tumors. Because of its ability to produce large volumes of coagulation necrosis in a controlled fashion, this technique has gained acceptance as a viable therapeutic option for unresectable liver malignancies. Recently, investigation has been focused on the clinical application of RF ablation in the treatment of lung malignancies. In theory, lung tumors are well suited to RF ablation because the surrounding air in adjacent normal parenchyma provides an insulating effect, thus facilitating energy concentration within the tumor tissue. Experimental studies in rabbits have confirmed that lung RF ablation can be safely and effectively performed via a percutaneous, transthoracic approach, and have prompted the start of clinical investigation. Pilot clinical studies have shown that RF ablation enables successful treatment of relatively small lung malignancies with a high rate of complete response and acceptable morbidity, and have suggested that the technique could represent a viable alternate or complementary treatment method for patients with non-small cell lung cancer or lung metastases of favorable histotypes who are not candidates for surgical resection. This article gives an overview of lung RF ablation, discussing experimental animal findings, rationale for clinical application, technique and methodology, clinical results, and complications.

Animals↗
PubMed2004

Percutaneous ablation of hepatocellular carcinoma: state-of-the-art.

Percutaneous ablation is considered the best treatment option for patients with early-stage hepatocellular carcinoma (HCC) who are not candidates for surgical resection or liver transplantation. Several methods have been developed, including intratumoral injection of ethanol or acetic acid, and thermal ablation with radiofrequency, laser, microwaves, or cryosurgery. Percutaneous ethanol injection (PEI) has been the most widely used technique. Several series have provided indirect evidence that PEI improves the natural history of HCC. Patients with Child-Pugh class A cirrhosis and either a single tumor smaller than 5 cm or as many as three lesions each smaller than 3 cm may achieve a 5-year survival of 50%. The major limitation of PEI is the high local recurrence rate, which may reach 33-43%. Radiofrequency (RF) ablation has emerged as the most powerful alternate method for percutaneous ablation. Recent studies have shown that RF ablation can achieve more effective local tumor control than PEI with fewer treatment sessions. In a randomized trial, local recurrence-free survival rates were significantly higher in patients who received RF ablation than in those treated by PEI, and treatment allocation was confirmed as an independent prognostic factor by multivariate analysis. RF ablation could therefore be considered as the percutaneous treatment of choice for patients with early-stage tumors. Further investigation is warranted to clarify whether current RF technology could offer improved results in patients with intermediate-stage HCC.

Administration, Cutaneous↗
PubMed2004

Percutaneous radiofrequency ablation of hepatic colorectal metastases: technique, indications, results, and new promises.

Surgical resection is the standard of care for colorectal metastases isolated to the liver. However, only 10-25% of the patients are eligible for resection because of extent and location of the disease in the liver or concurrent medical conditions. Image-guided radiofrequency (RF) ablation is a minimally invasive technique that is emerging as a viable alternate treatment of nonsurgical patients with limited hepatic metastatic disease. Several series have shown that RF ablation can result in complete tumor eradication in properly selected candidates and have provided indirect evidence that the treatment improves survival. In a recent multicenter trial including 423 patients, overall survival of RF-ablation treated patients reached 47% at 3 years and 24% at 5 years. RF ablation technology is undergoing continuous improvement, and its clinical application has been successfully expanded to the treatment of colorectal metastases to the lung. Randomized trials comparing RF ablation with either surgical resection or chemotherapy protocols, however, are still missing. In this article, we review technique, indications, clinical results, and future prospects of RF ablation in the therapeutic management of metastatic colorectal cancer patients.

Catheter Ablation↗
PubMed2003

Detection of colorectal liver metastases: a prospective multicenter trial comparing unenhanced MRI, MnDPDP-enhanced MRI, and spiral CT.

The aim of this study was to compare unenhanced MRI, MnDPDP-enhanced MRI, and spiral CT in the detection of hepatic colorectal metastases. Forty-four patients with hepatic colorectal metastases were examined with unenhanced and MnDPDP-enhanced MRI and with unenhanced and contrast-enhanced spiral CT. The MR examination protocol included baseline T1-weighted spin-echo (SE), T1-weighted gradient-recalled-echo (GRE), and T2-weighted fast-SE sequences; and T1-weighted SE and T1-weighted GRE sequences obtained 30-60 min after administration of 0.5 micromol/kg (0.5 ml/kg) mangafodipir trisodium (MnDPDP). Images were interpreted by three blinded readers. Findings at CT and MRI were compared with those at intraoperative US, which were used as term of reference. Intraoperative US detected 128 metastases. In a lesion-by-lesion analysis, the overall detection rate was 71% (91 of 128) for spiral CT, 72% (92 of 128) for unenhanced MRI, and 90% (115 of 128) for MnDPDP-enhanced MRI. MnDPDP-enhanced MRI was more sensitive than either unenhanced MRI ( p<0.0001) or spiral CT ( p=0.0007). In a patient-by-patient analysis, agreement with gold standard was higher for MnDPDP-enhanced MRI (33 of 44 cases) than for spiral CT (22 of 44 cases, p=0.0023) and unenhanced MRI (21 of 44 cases, p=0.0013). MnDPDP-enhanced MRI is superior to unenhanced MRI and spiral CT in the detection of hepatic colorectal metastases.

Adult↗