Avelumab plus axitinib in unresectable or metastatic type B3 thymomas and thymic carcinomas (CAVEATT): a single-arm, multicentre, phase 2 trial.

BACKGROUND: Patients with advanced type B3 thymoma and thymic carcinoma resistant to chemotherapy have few treatment options. We report the efficacy and safety results of the combination of the anti-PD-L1 inhibitor avelumab with the anti-angiogenesis drug axitinib in patients with advanced type B3 thymoma and thymic carcinoma. METHODS: CAVEATT was a single-arm, multicentre, phase 2 trial, conducted in two Italian centres (the European Instituteof Oncology and the Humanitas Institute, Milan) in patients with histologically confirmed type B3 thymoma or thymic carcinoma, with advanced stage of disease who had progressed after at least one line of platinum-based chemotherapy. Previous treatment with an anti-angiogenesis drug was allowed but not with immune checkpoint inhibitors. Other inclusion criteria were age 18 years or older, an Eastern Cooperative Oncology Group performance status of 0-2, progressive disease, and presence of measurable disease according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1. Patients received avelumab 10 mg/kg intravenously every 2 weeks and axitinib 5 mg orally twice daily until disease progression or unacceptable toxicity. The primary endpoint was the centrally assessed overall response rate according to RECIST version 1.1. Patients who received at least one cycle of treatment and had at least one CT scan after treatment start at scheduled time point by protocol were judged assessable for response and were included in efficacy and safety analyses. This study is registered with EUDRACT, 2017-004048-38; enrolment is completed and follow-up is ongoing. FINDINGS: Between April 22, 2019, and June 30, 2021, 32 patients were enrolled. 27 patients had a thymic carcinoma, three a type B3 thymoma, and two a mixed type B3 thymoma and thymic carcinoma. 29 (91%) of 32 patients had stage IVB disease and 13 (41%) of 32 had been pretreated with an anti-angiogenesis drug. 11 of 32 patients had an overall response; thus the overall response rate was 34% (90% CI 21-50); no patients had a complete response, 11 (34%) had a partial response, 18 (56%) had stable disease, and in two patients (6%) progressive disease was the best response. The most common grade 3 or 4 adverse event was hypertension (grade 3 in six [19%] of 32 patients). Four (12%) of 32 patients developed serious adverse events that were new-onset immune-related adverse events, including one grade 3 interstitial pneumonitis, one grade 4 polymyositis, and two grade 3 polymyositis. There were no treatment-related deaths. INTERPRETATION: Avelumab combined with axitinib has promising anti-tumour activity and acceptable toxicity in patients with advanced type B3 thymoma and thymic carcinoma progressing after chemotherapy, and could emerge as a new standard treatment option in this setting. FUNDING: Pfizer.

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 (ΔSDIA-ABL), and velocity of size variation (VDIA-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. ΔSDIA-ABL (p = 0.63) and VDIA-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.

Real-time US/cone-beam CT fusion imaging for percutaneous ablation of small renal tumours: a technical note.

INTRODUCTION: Fusion imaging is gaining attention as an imaging technique to assist minimally invasive tumour ablation. Ultrasound (US) and computed tomography (CT) are the most common imaging modalities to guide thermal ablation of renal tumours, yet cone-beam CT (CBCT) has recently been described to successfully assist percutaneous renal interventions. Our goal was to evaluate primary technical success and correct lesion targeting of US/CBCT fusion imaging to guide the ablation of kidney masses < 2 cm in a small group of patients. MATERIAL AND METHODS: Six renal lesions (maximum diameter 11-17 mm) were treated with RFA in 5 different patients using real-time US/CBCT. Fusion imaging was used to identify and monitor tumour ablation. Demographics, tumour characteristics and mean serum creatinine levels were recorded before and after the procedure. Primary technical success and correct lesion targeting represented the main endpoints of the study. Primary technique efficacy was confirmed at 1-month and 3-month contrast-enhanced CT follow-ups. RESULTS: In all cases, a confident US/CBCT synchronisation was reached and allowed for a correct targeting and a successful percutaneous ablation. Primary technique efficacy was 100%. No recurrence was observed at the follow-up that ranged from 8 to 26 months (mean 16 months). CONCLUSIONS: US/CBCT fusion proved to be a viable method to precisely guide safe and effective percutaneous thermal ablation in patients with small renal tumours, especially when hardly detectable on US. KEY POINTS: • US/CBCT fusion imaging for renal ablation is safe and feasible. • US/CBCT fusion imaging allows for an improved targeting and complete ablation of small RCC with poor US-conspicuity.

Real-Time US-CT fusion imaging for guidance of thermal ablation in of renal tumors invisible or poorly visible with US: results in 97 cases.

PURPOSE: To assess the capability of ultrasound-computed tomography (US-CT) fusion imaging to guide a precise targeting of renal tumors invisible or poorly visible with US. MATERIALS AND METHODS: From 2016 renal tumors poorly visible or inconspicuous/invisible at US were treated at our institution with the guidance of US/CT fusion in a room equipped with CT scanner. Feasibility of the procedure, accuracy of targeting, complications, and technique efficacy were evaluated. RESULTS: Of 227 patients treated from 2016 to March 2020, 91 patients (65 males and 26 females, mean age 68.5 ± 10.1 years) with 97 renal lesions (mean maximum diameter 21.6 ± 9.4 mm) inconspicuous/invisible (29/97, 29.9%) or poorly visible (68/97, 70.1%) at US underwent treatment under US-CT fusion guidance. US-CT fusion imaging guidance was always technically feasible and enabled correct targeting in 97/97/(100%) of cases. Technical success was achieved in 93/97 lesions (95.9%). Three lesions were retreated during the same ablative session, while 1 was retreated in a subsequent session. Thus, primary efficacy was achieved in one session in 96/97 (98.9%) cases and secondary efficacy in 97/97 (100%) cases. CONCLUSION: US-CT image fusion guidance allows for a correct tumor targeting of renal tumors poorly visible or inconspicuous/invisible with US alone, with a high rate of technical success and technique efficacy.

Image-guided thermal ablation of central renal tumors with retrograde cold pyeloperfusion technique: a monocentric experience.

Purpose: To evaluate feasibility, safety and efficacy of image-guided thermal ablations associated with retrograde pyeloperfusion in patients with centrally located renal tumors.Materials and methods: 48 patients (15 women, 33 men, mean age 69.1 ± 11.8) were treated with image-guided thermal ablation associated with pyeloperfusion for 58 centrally located renal tumors (mean diameter 32.3 ± 7.32 mm). 7 patients had a single kidney. Microwave and radiofrequency ablation were used. All treatments were performed with ultrasound, CT, or fusion imaging guidance under general anesthesia and simultaneous retrograde cold pyeloperfusion technique.Results: Procedure was feasible in all cases. Technical success and primary technical efficacy were reached in 51/58 (88%) and 45/54 tumors (83%). With a second ablation performed in 5 tumors, secondary technical efficacy was achieved in 50/50 (100%) tumors. Minor and major complications occurred in 8/58 (13%) and 5/58 (8%) tumors. No significative change in renal function occurred after treatment.During follow-up, 5 recurrences occurred, that were retreated with a second ablation. At last follow up (mean 32.2 ± 22.0 months), 41/48 (85%) treated patients were free from disease. The median TTP and PFS were 27.0 (range, 2.3-80.0) and 26.5 months (range, 2.3-80.0), respectively.Conclusion: Image-guided thermal ablation associated with protective pyeloperfusion is a feasible, safe, and effective treatment option for patients with central renal tumors with a minimal impact on renal function and relevant potential to avoid nephrectomy.

Pancreatic ablation: minimally invasive treatment options.

Despite the significant improvement of knowledge and technologies in tumor treatments, pancreatic tumor remains a complex disease still characterized by a poor prognosis. The increasing role of minimally invasive techniques started to drive the effort of scientific medicine to evaluate the possibilities of application of these techniques to pancreatic cancer. The purpose of this paper is to present a brief summary of the different ablative techniques available and proposed for pancreatic tumor treatment considering invasive, noninvasive, thermal and non-thermal techniques.

Ultrasound and cone beam CT fusion for liver ablation: technical note.

PURPOSE: To assess the feasibility of fusion imaging between intraprocedural ultrasound (US) and contrast-enhanced cone-beam CT (CBCT) for small (< 2 cm) hepatocellular carcinoma (HCC). MATERIALS AND METHODS: Six patients (five males, one female, age range 58-80, mean 69 years), with small (mean diameter 16.8 mm) HCC poorly visible at US underwent percutaneous microwave ablation under US/CBCT fusion guidance. During general anesthesia with apnea control, a contrast- enhanced CBCT was acquired with an active tracker. Subsequently, real time US images were fused with CBCT images, and treatment performed under fusion imaging guidance. Feasibility of fusion imaging and percutaneous ablation were assessed, correct targeting (distance from center of tumor and center of ablation area <5 mm) and one-month primary technical efficacy were evaluated. Major and minor complications as well as overall procedural time were recorded. RESULTS: US/CBCT fusion was feasible in all cases, allowing for completion of the treatment as previously planned (technical success 100%). Correct targeting was achieved in 4/6 cases (66%), while in two cases, center of tumor and center of ablated area were respectively 7 and 8 mm distant. At 1 month CT scan, all tumors were completely ablated (primary technical efficacy 100%). No major or minor complications occurred. Mean overall procedure time was 127 min. CONCLUSIONS: US/CBCT fusion is a feasible technique for liver ablation, and might represent a useful tool to increase the correct targeting of poorly US-visible HCC nodules in the angio suite.

Ultrasound guided high intensity focused ultrasound (USgHIFU) ablation for uterine fibroids: Do we need the microbubbles?

PURPOSE: The aim of this study was to assess the safety and effectiveness of contrast-enhanced ultrasound (CEUS) on ultrasound guided high intensity focused ultrasound (USgHIFU) ablation of uterine fibroids. METHODS: Thirty-three patients (37 fibroids) were randomly assigned to two groups: group A (17 patients, 20 fibroids) in which CEUS was used before, during and after HIFU treatment, and group B (16 patients, 17 fibroids) in which CEUS was not administered at all. Follow-up including contrast-enhanced magnetic resonance imaging (MRI) and a clinical questionnaire was performed, and technical success, ablation efficacy, volume reduction and complications were assessed. RESULTS: Technical success was 100% in both groups. CEUS revealed residual enhancement in 40% of the patients in group A and the treatment was continued until the completion of ablation. MRI at 1 month after treatment revealed significant difference in the relative fibroid volume reduction rate between the two groups: 16.1% in group A versus 4.8%, in group B (p = 0.01). There was no statistically significant relative volume reduction rate for the results at 3, 6 and 12 months and no significant changes in the quality of life results or the complication rate. CONCLUSIONS: CEUS was safe and effective in enhancing US guidance during HIFU ablation of uterine fibroids. Moreover, the use of CEUS during HIFU sonication increased the ablation efficacy, leading to a more relevant fibroid volume reduction at 1 and 3 months. This gap disappeared after 6 months, when there were no differences between the two groups of patients at MRI. However, in our experience, USgHIFU represented a very effective method for the treatment of uterine fibroids, and the use of CEUS during HIFU procedure reduced the treatment time and treatment repetitions for incomplete fibroid ablation.

Cost effectiveness of different central venous approaches for port placement and use in adult oncology patients: evidence from a randomized three-arm trial.

BACKGROUND: No randomized trials have so far investigated the cost effectiveness of different methods for implantation and use of central venous ports in oncology patients. PATIENTS AND METHODS: Overall, 403 patients eligible for receiving intravenous chemotherapy for solid tumours were randomly assigned to implantation of a single type of port, either through a percutaneous landmark access to the internal jugular vein, an ultrasound (US)-guided access to the subclavian vein, or a surgical cut-down access through the cephalic vein at the deltoid-pectoralis groove. Insertion and maintenance costs were estimated by obtaining the charges for an average implant and use, while the costs of the management of complications were analytically assessed. The total cost was defined as the purchase cost plus the insertion cost plus the maintenance cost plus the cost of treatment of the complications, if any. RESULTS: A total of 401 patients were evaluable-132 with the internal jugular vein, 136 with the subclavian vein and 133 with the cephalic vein access. No differences were found for the rate of early complications. The US-guided subclavian insertion site had significantly lower failures. Infections occurred in 1, 3, and 3 patients (internal jugular, subclavian, and cephalic access, respectively; p = 0.464), whereas venous thrombosis was observed in 15, 8, and 11 patients, respectively (p = 0.272). Mean cost for purchase, implantation, diagnosis and treatment of complications in each patient was 2,167.85 for subclavian US-guided, 2,335.87 for cephalic, and 2,384.10 for internal jugular access, respectively (p = 0.0001). CONCLUSION: US real-time guidance to the subclavian vein resulted in the most cost-effective method of central venous port placement and use.

The Impact of pelvimetry on anastomotic leakage in a consecutive series of open, laparoscopic and robotic low anterior resections with total mesorectal excision for rectal cancer. .

BACKGROUND/AIMS: Recently, pelvic anatomy has been taken into consideration and related to surgical outcome indicators after low anterior resection (LAR). Several pelvimetric parameters have been matched with conversion rate, postoperative complications and duration of surgery in laparoscopic series, and with the quality of specimen and pathologic outcomes in further open surgical series. METHODOLOGY: In 97 consecutive patients submitted to sphincter-saving LAR with total mesorectal excision (TME) five pelvic dimensions were measured by abdominal computed tomography scan: anteroposterior and transverse diameters in the pelvic inlet (IAP and ITRA), anteroposterior and transverse diameters in the pelvic outlet (OAP and OTRA), and the pelvic depth. The endpoint evaluated was anastomotic leakage (AL) rate. RESULTS: There were 51 open, 12 laparoscopic and 34 robotic LARs. The sum of IAP OAP and OTRA (Pelvic Index) significantly predicted AL showing that starting from the cut-point of 290 mm down to a PI of 278 mm the odds-ratio of having an AL increased from 2.63 (95% CI: 1.10,5.47) to 5.07 (95% CI: 1.35,8.02). CONCLUSIONS: The sum of the 3 pelvic dimensions which we termed "Pelvic Index" was associated to AL following sphinctersaving LAR. This may be considered in planning the surgical strategy for rectal cancer patients.

Thermal Ablation for Small Renal Masses: Identifying Anthropometric Factors for Predicting Perioperative and Oncological Outcomes.

OBJECTIVES: To test for specific anthropometric parameters to predict perioperative outcomes after thermal ablation (TA) for renal cell carcinoma (RCC). MATERIALS AND METHODS: Retrospective single center (2008-2022) analysis of 538 T1a-b RCC patients treated with TA. We tested for specific anthropometric parameters, namely skin to tumor distance (STTD), perirenal fat thickness (PFT), median psoas muscle axial area (PMAA) and median paravertebral muscle axial area (PVMAA), to predict TRIFECTA achievement: (1) absence of CLAVIEN-DINDO≥ 3 complications; (2) complete ablation; (3) absence of ≥ 30% decrease in eGFR. Univariable (ULRM) and multivariable logistic regression models (MLRM) were used for testing TRIFECTA achievement. RESULTS: Overall, 103 patients (19%) did not achieve TRIFECTA. Of all anthropometric factors, only lower PMAA was associated with no TRIFECTA achievement (10 vs. 11 cm2, P = .02). However, ULRMs and MLRMs did not confirmed the aforementioned association. We than tested for the 3 specific TRIFECTA items. In separate ULRM and MLRM predicting incomplete ablation, both continuously coded STTD (Odds Ratio [OR]: 1.02; CI: 1.01-1.03; P = .02) and STTD strata (STTD > 10 cm; OR: 2.1; CI: 1.1-4.1; P = .03) achieved independent predictor status. Conversely, in separate ULRM and MLRM predicting CLAVIEN-DINDO ≥3 complications, both continuously coded PFT (OR: 1.04; CI: 1.01-1.07; P = .01) and PFT strata (PFT ≥ 14 mm; OR: 3.3; CI: 1.6-10.2; P = .003) achieved independent predictor status. Last, none of the anthropometric parameters were associated with eGFR decrease ≥ 30%. CONCLUSION: None of the tested anthropometric parameters predicted TRIFECTA achievement. However, when the 3 specific TRIFECTA items were tested, STTD and PFT were associated with, respectively, incomplete ablation and CLAVIEN-DINDO ≥ 3 complications.

Discordant hormone receptor and human epidermal growth factor receptor 2 status in bone metastases compared to primary breast cancer.

BACKGROUND: In patients with metastatic breast cancer, the evaluation of the biological characteristics of metastatic bone deposits may be a valuable adjunct in clinical practice. We assessed the discordance in expression levels for estrogen receptor (ER), progesterone receptor (PgR) and human epidermal growth factor receptor 2 (HER2) between primary tumor and bone metastases and its clinical impact on patient management. MATERIAL AND METHODS: We retrospectively reviewed 363 CT-guided bone biopsies performed from January 1997 to December 2009. The proportions of ER, PgR and HER2 positive tumors at primary diagnosis and bone metastases, determined by IHC and/or FISH, were compared using McNemar's test. The impact of the biopsy reassessment on treatment choice was evaluated with Fisher's exact test. RESULTS: We selected 109 metastatic breast cancer patients with histologically confirmed bone metastases. Among 107 assessable patients the overall discordance rate was detected in 22 (20.5%) and in 47 (43.9%) patients for ER and PgR, respectively, and in six of 86 assessable patients (6.9%) for HER2 status. The indication to change endocrine therapy occurred in 62% and 30% of patients with ER discordance and ER concordance, respectively (p = 0.01). The indication to change targeted therapy occurred in 67% and 8% of patients with HER2 discordance and HER2 concordance, respectively (p = 0.002). CONCLUSIONS: We confirm that biopsy of metastases, including bone metastases, for reassessment of biology should be considered, since it is likely to impact on treatment choice.

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.

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.

Sarcoid-like reaction in breast cancer: a long-term follow-up series of eight patients.

PURPOSE: Finding an intrathoracic or axillary mass in a breast cancer patient should raise suspicion of a pulmonary or mediastinal nodal metastasis or axillary recurrence. Surprisingly, noncaseating epithelioid cell granuloma can be found in this type of lesion, as in sarcoidosis or a sarcoid-like reaction. METHODS: This series included eight breast cancer patients in whom a late sarcoid-like reaction developed: as an intrathoracic lesion in six, and as an ipsilateral axillary lesion in two. The latency period from oncological surgery to the diagnosis of sarcoidosis was 40 months and the average follow-up after the diagnosis of sarcoidosis was 63.38 months. RESULTS: None of the patients suffered relapse or oncological events during the period of this study. CONCLUSION: To avoid misdiagnosis and overtreatment, pathological examination should always be carried out. We do not recommend any specific treatment for sarcoidosis in a breast cancer patient, but routine oncological follow-up is appropriate. A larger series with statistical analysis is necessary to evaluate the prognosis.

Small-size (40 µm) Beads Loaded with Irinotecan in the Treatment of Patients with Colorectal Liver Metastases.

PURPOSE: The 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 METHODS: Between 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. RESULTS: Local 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. CONCLUSION: Chemoembolization 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.

Thermal ablation for small renal masses: Identifying the most appropriate tumor size cut-off for predicting perioperative and oncological outcomes.

OBJECTIVES: To test TRIFECTA achievement [1) absence of CLAVIEN-DINDO ≥3 complications; 2) complete ablation; 3) absence of ≥30% decrease in eGFR] and local recurrence rates, according to tumor size, in patients treated with thermal ablation (TA: radiofrequency [RFA] and microwave ablation [MWA]) for small renal masses. METHODS: Retrospective analysis (2008-2020) of 432 patients treated with TA (RFA: 162 vs. MWA: 270). Tumor size was evaluated as: 1) continuously coded variable (cm); 2) tumor size strata (0.1-2 vs. 2.1-3 vs. 3.1-4 vs. >4 cm). Multivariable logistic regression models and a minimum P-value approach were used for testing TRIFECTA achievement. Kaplan-Meier plots depicted local recurrence rates over time. RESULTS: Overall, 162 (37.5%) vs. 140 (32.4%) vs. 82 (19.0%) vs. 48 (11.1%) patients harboured, respectively, 0.1 to 2 vs. 2.1 to 3 vs. 3.1 to 4 vs. >4 cm tumors. In multivariable logistic regression models, increasing tumor size was associated with higher rates of no TRIFECTA achievement (OR:1.11; P< 0.001). Using a minimum P-value approach, an optimal tumor size cut-off of 3.2 cm was identified (P< 0.001). In multivariable logistic regression models, 3.1 to 4 cm tumors (OR:1.27; P< 0.001) and >4 cm tumors (OR:1.49; P< 0.001), but not 2.1 to 3 cm tumors (OR:1.05; P= 0.3) were associated with higher rates of no TRIFECTA achievement, relative to 0.1 to 2 cm tumors. The same results were observed in separate analyses of RFA vs. MWA patients. After a median (IQR) follow-up time of 22 (12-44) months, 8 (4.9%), 8 (5.7%), 11 (13.4%), and 5 (10.4%) local recurrences were observed in tumors sized 0.1 to 2 vs. 2.1 to 3 vs. 3.1 to 4 vs. >4 cm, respectively (P= 0.01). CONCLUSION: A tumor size cut-off value of ≤3 cm is associated with higher rates of TRIFECTA achievement and lower rates of local recurrence over time in patients treated with TA for small renal masses.

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.

Optimizing Loco Regional Management of Oligometastatic Colorectal Cancer: Technical Aspects and Biomarkers, Two Sides of the Same Coin.

Colorectal cancer (CRC) is the third most common cancer worldwide and has a high rate of metastatic disease which is the main cause of CRC-related death. Oligometastatic disease is a clinical condition recently included in ESMO guidelines that can benefit from a more aggressive locoregional approach. This review focuses the attention on colorectal liver metastases (CRLM) and highlights recommendations and therapeutic locoregional strategies drawn from the current literature and consensus conferences. The different percutaneous therapies (radiofrequency ablation, microwave ablation, irreversible electroporation) as well as trans-arterial approaches (chemoembolization and radioembolization) are discussed. Ablation margins, the choice of the imaging guidance as well as characteristics of the different ablation techniques and other technical aspects are analyzed. A specific attention is then paid to the increasing role of biomarkers (in particular molecular profiling) and their role in the selection of the proper treatment for the right patient. In conclusion, in this review an up-to-date state of the art of the application of locoregional treatments on CRLM is provided, highlighting both technical aspects and the role of biomarkers, two sides of the same coin.

Neobladder and ablative pelvic radiotherapy: still a taboo?

The presence of a neobladder constitutes a limitation for the radiation oncologist, as there is no clear evidence about its tolerance to radiotherapy (RT). The limited literature only concerns the conventional postoperative treatment in patients with bladder cancer after cystectomy. Here we report a case of a patient with neobladder who underwent a stereotactic RT for a pelvic recurrence of disease, with response to treatment and no toxicity to the neobladder. This case represents a promising example of the chance to perform RT with ablative intent, using advanced techniques, even on lesions close to the neobladder.