Publications by authors named "Thierry de Baere"

235 Publications

Cancer surgery during the COVID-19 pandemic: The experience of a comprehensive cancer center performing preoperative screening by RT-PCR and chest CT scan.

J Surg Oncol 2021 Mar 1;123(4):815-822. Epub 2021 Feb 1.

Surgical and Interventional Department, Paris-Saclay University, Gustave Roussy, Villejuif, France.

Background And Objectives: During the worldwide pandemic of coronavirus disease 2019 (COVID-19), oncological procedures considered to be urgent could not be delayed, and a specific procedure was required to continue surgical activity. The objective was to assess the efficacy of our preoperative screening algorithm.

Methods: This observational retrospective study was performed between the 25th of March and the 12th of May 2020 in a comprehensive cancer center in France. Patients undergoing elective oncologic surgery were tested by preoperative nasopharyngeal reverse-transcription polymerase chain reaction (RT-PCR) that could be associated with a chest computerized tomography (CT) scan.

Results: Of the 510 screening tests (in 477 patients), only 5% (15/477) were positive for COVID-19 in 24 patients (18 RT-PCR+ and 7 CT scan+/RT-PCR-). Four patients were ultimately false positives based on the CT scan. In total, only 4.2% (20/477) of the patients were COVID-19+. The positivity rate decreased with time after the containment measures were implemented (from 7.4% to 0.8%). In the COVID-19+ group, 20% of the patients had postoperative pulmonary complications, whereas this was the case for 5% of the patients in the COVID-19 group.

Conclusions: Maintaining secure surgical activity is achievable and paramount in oncology care, even during the COVID-19 pandemic, with appropriate screening based on preoperative RT-PCR.
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http://dx.doi.org/10.1002/jso.26335DOI Listing
March 2021

Locoregional therapies in the era of molecular and immune treatments for hepatocellular carcinoma.

Nat Rev Gastroenterol Hepatol 2021 Jan 28. Epub 2021 Jan 28.

Department of Radiology, University of Pisa School of Medicine, Pisa, Italy.

Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer-related mortality and has an increasing incidence worldwide. Locoregional therapies, defined as imaging-guided liver tumour-directed procedures, play a leading part in the management of 50-60% of HCCs. Radiofrequency is the mainstay for local ablation at early stages and transarterial chemoembolization (TACE) remains the standard treatment for intermediate-stage HCC. Other local ablative techniques (microwave ablation, cryoablation and irreversible electroporation) or locoregional therapies (for example, radioembolization and sterotactic body radiation therapy) have been explored, but have not yet modified the standard therapies established decades ago. This understanding is currently changing, and several drugs have been approved for the management of advanced HCC. Molecular therapies dominate the adjuvant trials after curative therapies and combination strategies with TACE for intermediate stages. The rationale for these combinations is sound. Local therapies induce antigen and proinflammatory cytokine release, whereas VEGF inhibitors and tyrosine kinase inhibitors boost immunity and prime tumours for checkpoint inhibition. In this Review, we analyse data from randomized and uncontrolled studies reported with ablative and locoregional techniques and examine the expected effects of combinations with systemic treatments. We also discuss trial design and benchmarks to be used as a reference for future investigations in the dawn of a promising new era for HCC treatment.
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http://dx.doi.org/10.1038/s41575-020-00395-0DOI Listing
January 2021

Risk factors for local tumor progression after RFA of pulmonary metastases: a matched case-control study.

Eur Radiol 2021 Jan 20. Epub 2021 Jan 20.

Institut Gustave Roussy, 114 Rue Edouard Vaillant, 94800, Villejuif, France.

Objectives: Curative treatment of oligometastatic pulmonary disease aims at eradication of all metastases. Radiofrequency ablation (RFA) has been shown to be an efficient method and the frequency of local tumor progression (LTP) should be minimized. The objective of this study was to determine the morphological and treatment-related risk factors for LTP after RFA of pulmonary metastases.

Materials And Methods: All patients treated with RFA for pulmonary metastases from 2002 to 2014 were reviewed. All LTPs from 2011 to 2014 were individually matched on the basis of tumor size, number, and histology. In total, 48 LTPs and 112 controls were blindly analyzed for morphological factors including vicinity of bronchus and vessels as well as treatment-related factors such as the size of the ablation zone and ablation margins.

Results: In the simple regression analysis, the significant predictive variables were ≤ 5-mm distance to a large bronchus (OR = 4.94; p = 0.0095) or large vessel (OR = 7.09; p < 0.001), minimal ablation margin (≤ 5 mm (OR = 42.67; p < 0.001), and a central-peripheral ablation offset/ablation zone size > 0.36 (OR = 13.83; p = 0.013). In the multiple regression model, only a minimal ablation margin ≤ 5 mm remained a significant risk factor for LTP.

Conclusion: Only the minimal ablation margin remains significant in the multiple regression analysis; the other factors are presumably surrogates of an insufficient ablation margin. Improvement of lung RFA outcomes can probably be obtained by immediate post RFA evaluation of ablation margins to ensure a minimal ablation margin of at least 5 mm.

Key Points: • A distance < 5 mm to a bronchus or vessel of over 3 mm diameter is associated with insufficient ablation margin and thus risk factors for local tumor progression after pulmonary radiofrequency ablation. • A minimal ablation margin of > 5 mm after pulmonary RFA is associated with significantly less local tumor progression and should be looked for at the end of treatment session before needle removal in order to decrease local tumor progression. • Tumor location, pleural contact, occurrence of intra-alveolar hemorrhage, pulmonary atelectasis, and pneumothorax are not associated with an increased risk of local tumor progression.
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http://dx.doi.org/10.1007/s00330-020-07675-yDOI Listing
January 2021

Sustained-hepatic arterial infusion of oxaliplatin: pharmacokinetic advantages over hepatic arterial infusion using a preclinical animal tumour model.

Drug Deliv Transl Res 2021 Jan 11. Epub 2021 Jan 11.

Interventional Radiology Department, Gustave Roussy, Villejuif, France.

Hepatic arterial infusion (HAI) of oxaliplatin allows greater liver tumour drug exposure compared to systemic infusion. However, the therapeutic index of HAI oxaliplatin remains poor. Using Pickering emulsion technology, we developed a platform able to provide sustained releases of oxaliplatin. The goal of this study was to evaluate the pharmacokinetic advantages of sustained-HAI oxaliplatin over HAI using a preclinical animal tumour model. Injections of 0.6 mg oxaliplatin in 20 min were selectively done in left hepatic arteries of 20 rabbits bearing a VX2 liver tumour in the middle left-lobe, using HAI (n = 10) or sustained-HAI (n = 10). In each group, half of the rabbits were sacrificed at 24 h and half at 72 h. Mass spectrometry was used to quantify drug pharmacokinetics in blood and oxaliplatin concentrations in tumour tissues, right- and middle left-liver lobes, spleen and lung. Compared to HAI, sustained-HAI of oxaliplatin resulted in lower plasmatic peak (Cmax: 275 ± 41 vs. 416 ± 133 ng/mL, p = 0.02) and higher concentration in the tumour at 24 h (2118 ± 2107 vs. 210 ± 93 ng/g, p = 0.008). After HAI, oxaliplatin concentration in tumours was significantly higher than in lung at 24 h (p = 0.03) but no other difference was found between oxaliplatin concentrations in tumours and in liver lobes, spleen or lung, neither at 24 h nor at 72 h. On the opposite, sustained-HAI resulted in higher concentrations of oxaliplatin in tumour compared to oxaliplatin concentrations in the middle left lobe (163 ± 86 ng/g at 24 h, p = 0.01, and 90 ± 15 ng/g at 72 h, p = 0.04), right lobe (174 ± 112 ng/g at 24 h, p = 0.01, and 112 ± 35 ng/g, p = 0.04 at 72 h), spleen (142 ± 21 ng/g at 24 h, p = 0.01, and 98 ± 12 ng/g at 72 h, p = 0.04), and lung (85 ± 11 ng/g at 24 h, p = 0.01, and 52 ± 4 ng/g at 72 h, p = 0.03). Sustained-HAI improves the therapeutic index of HAI oxaliplatin and offers a great potential for patients suffering from unresectable colorectal liver metastases or hepatocellular carcinoma.
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http://dx.doi.org/10.1007/s13346-020-00881-7DOI Listing
January 2021

Interventional radiology for local immunotherapy in oncology.

Clin Cancer Res 2021 Jan 8. Epub 2021 Jan 8.

Département de Radiologie, Institut Gustave Roussy.

Human intratumoral immunotherapy (HIT-IT) is under rapid development with promising preliminary results and high expectations for current phase 3 trials. While outcomes remain paramount for patients and the referring oncologists, the technical aspects of drug injection are critical to the interventional radiologist in order to ensure optimal and reproducible outcomes. The technical considerations for HIT-IT impact the safety, efficacy and further development of this treatment option. Image-guided access to the tumor allows to enhance the therapeutic index of a treatment by increasing the intra-tumoral drug concentration while minimizing its systemic exposure and associated on-target off-tumor adverse events. Direct access to the tumor also enables the acquisition of cancer tissue for sequential sampling in order to better understand the pharmacodynamics of the injected immunotherapy and its efficacy through correlation of immune responses, pathological responses and imaging tumor response. The aim of this review is to share the technical insights of HIT-IT, with particular consideration for patient selection, lesion assessment, image-guidance, and technical injection options. In addition, the organization of a standard patient workflow is discussed, so as to optimize HIT-IT outcome and the patient experience.
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http://dx.doi.org/10.1158/1078-0432.CCR-19-4073DOI Listing
January 2021

Response to Is Cryoablation Really Safe and Efficacious: Analyzing Results Within SOLSTICE Trial.

J Thorac Oncol 2021 Jan;16(1):e6-e7

Department of Interventional Radiology, Gustave Roussy-Cancer Campus, Villejuif, France.

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http://dx.doi.org/10.1016/j.jtho.2020.11.010DOI Listing
January 2021

Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry.

Cancers (Basel) 2020 Nov 17;12(11). Epub 2020 Nov 17.

Gastroentérologie Médicale, Hôpital Erasme, Université Libre de Bruxelles, 1070 Brussels, Belgium.

Background And Aim: Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B hepatocellular carcinoma (HCC) and stage 0-A unsuitable for curative treatments. We assessed efficacy and safety along with hepatobiliary toxicities (HBT) of DEM-TACE using a novel microsphere, LifePearl, loaded with anthracyclines.

Materials And Methods: 97 patients diagnosed with HCC were prospectively enrolled and treated using LifePearl loaded with doxorubicin (77%) or idarubicin (23%). Safety and tolerability were assessed using CTCAE, HBT by CT/MRI scans, and tumor response by applying modified Response Evaluation Criteria in Solid Tumors (mRECIST). Follow-up was after 2 years.

Results: Adverse events (AE) were reported in 73.2% of patients, majority being Grade 1-2. Grade ≥ 3 AE reported in 13.4% of patients were mainly related to postembolization syndrome. HBT were observed after 15.5% (29/187) of the DEM-TACEs. Objective response and disease control rates were 81% and 99%, respectively, as the best responses. Survival rates at one and two years were 81% and 66%, respectively, while the median overall survival (OS) was not reached. Median progression free survival was 13.7 months (95% CI: 11.3; 15.6) and median time to TACE untreatable progression was 16.7 months (95% CI: 12.7; not estimable (n.e.)).

Conclusions: DEM-TACE using LifePearl provides a high tumor response rate in HCC patients. HBT rates within or below previously reported results for cTACE and DEM-TACE indicate a good safety profile for LifePearl. The trial was registered in ClinicalTrials.gov National Library of Medicine (ID: NCT03053596).
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http://dx.doi.org/10.3390/cancers12113405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7698357PMC
November 2020

Personalised versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial.

Lancet Gastroenterol Hepatol 2021 01 7;6(1):17-29. Epub 2020 Nov 7.

Centre de Lutte Contre le Cancer Eugène Marquis, Rennes, France; INSERM, LTSI-UMR 1099, F-35000 Rennes, France.

Background: All randomised phase 3 studies of selective internal radiation therapy for advanced hepatocellular carcinoma published to date have reported negative results. However, these studies did not use personalised dosimetry. We aimed to compare the efficacy of a personalised versus standard dosimetry approach of selective internal radiation therapy with yttrium-90-loaded glass microspheres in patients with hepatocellular carcinoma.

Methods: DOSISPHERE-01 was a randomised, multicentre, open-label phase 2 trial done at four health-care centres in France. Patients were eligible if they were aged 18 years or older and had unresectable locally advanced hepatocellular carcinoma, at least one measurable lesion 7 cm or more in size, a hepatic reserve of at least 30% after selective internal radiation therapy, no extrahepatic spread (other than to the lymph nodes of the hilum, with a lesion <2 cm in size), and no contraindications to selective internal radiation therapy, as assessed by use of a technetium-99m macro-aggregated albumin scan. Patients were randomly assigned (1:1) by use of a permutated block method, with block sizes of four and without stratification, to receive either standard dosimetry (120 ± 20 Gy) targeted to the perfused lobe; standard dosimetry group) or personalised dosimetry (≥205 Gy targeted to the index lesion; personalised dosimetry group). Investigators, patients, and study staff were not masked to treatment. The primary endpoint was the investigator-assessed objective response rate in the index lesion, according to European Association for the Study of the Liver criteria, at 3 months after selective internal radiation therapy in the modified intention-to-treat population. Safety was assessed in all patients who received at least one selective internal radiation therapy injection, and analysed on the basis of the treatment actually received (defined by central dosimetry assessment). The trial is registered with ClinicalTrials.gov, NCT02582034, and has been completed.

Findings: Between Dec 5, 2015, and Jan 4, 2018, 93 patients were assessed for eligibility. Of these patients, 60 were randomly assigned: 31 to the personalised dosimetry group and 29 to the standard dosimetry group (intention-to-treat population). 56 (93%) patients (28 in each group) were treated (modified intention-to-treat population). In the modified intention-to-treat population, 20 (71% [95% CI 51-87]) of 28 patients in the personalised dosimetry group and ten (36% [19-56]) of 28 patients in the standard dosimetry group had an objective response (p=0·0074). In the safety analysis population, a least one serious adverse event was reported in seven (20%) of the 35 patients who received personalised dosimetry, and in seven (33%) of the 21 patients who received standard dosimetry. The most frequent (ie, occurring in >5% of patients) grade 3 or higher adverse events were ascites (one [3%] patient who received personalised dosimetry vs two [10%] patients who received standard dosimetry), hepatic failure (two [6%] vs none), lymphopenia (12 [34%] vs nine [43%]), increased aspartate aminotransferase concentrations (three [9%] vs two [10%]), increased alanine aminotransferase concentrations (three [9%] vs none), anaemia (two [6%] vs one [5%]), gastrointestinal haemorrhage (none vs two [10%]), and icterus (none vs two [10%]). One treatment-related death occurred in each group.

Interpretation: Compared with standard dosimetry, personalised dosimetry significantly improved the objective response rate in patients with locally advanced hepatocellular carcinoma. The results of this study suggest that personalised dosimetry is likely to improve outcomes in clinical practice and should be used in future trials of selective internal radiation therapy.

Funding: Biocompatibles UK, a Boston Scientific Group company.
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http://dx.doi.org/10.1016/S2468-1253(20)30290-9DOI Listing
January 2021

Image-guided Percutaneous Fixation with Internal Cemented Screws of Impending Femoral Neck Pathologic Fractures in Patients with Metastatic Cancer: Safety, Efficacy, and Durability.

Radiology 2020 12 6;297(3):721-729. Epub 2020 Oct 6.

From the Interventional Radiology Unit, Department of Imaging (M.D., C.R., L.T., A.D., S.Y., C.T., A.H., M.A.A., T.d.B., F.D.), and Department of Visceral Surgery (M.F.), Gustave Roussy-Cancer Center, 114 Rue Édouard Vaillant, 94805 Villejuif, France; Faculty of Medicine, University Paris-Sud, Le Kremlin Bicêtre, France (L.T., T.d.B.); Laboratory of Translational Research in Immunology, Institut National de la Santé et de la Recherche Médicale Unit 1015, Villejuif, France (L.T.); and Department of Biostatistics and Epidemiology, Institut National de la Santé et de la Recherche Médicale Unit 1018, Center for Epidemiology and Population Health Oncostat Team, Paris, France (M.F.).

Background Prophylactic image-guided procedures performed by interventional radiologists for impending pathologic fractures are becoming more pertinent, as patients with metastatic cancer have extended overall survival because of advanced therapies. Purpose To evaluate the efficacy, safety, and palliative durability of collimated-beam CT-guided percutaneous fixation with internal cemented screws (FICS) for impending pathologic fractures of the femoral neck. Materials and Methods This single-institute retrospective study examined all patients with metastatic cancer treated between February 2010 and October 2019 with collimated-beam CT-guided percutaneous FICS procedures for preventive consolidation of impending femoral neck pathologic fractures. The short-term palliative efficacy was assessed through comparison of visual analog scale (VAS) scores before and 1 month after FICS. A review of cross-section imaging and clinic reports identified any procedural complications. Long-term consolidation efficacy was defined as the absence of any screw dislodgement or development of a pathologic fracture at completion of the study. The Wilcoxon test was used for the mean comparison of paired nonparametric variables. Results Sixty-one consecutive patients (mean age, 59 years ± 11 [standard deviation]; 35 women) underwent preventive FICS for consolidation of impending pathologic femoral neck fracture with a mean follow-up of 533 days ± 689. Two patients died of cancer within the first month. Complications were limited to three self-resolving hematomas. The mean VAS score decreased 1 month after FICS from 4.2 ± 3.2 to 1.8 ± 2.0 ( < .001). The long-term consolidation efficacy was 92% (54 of 59 patients), with three of 59 patients (5%) subsequently developing fractures despite FICS and an additional two of 59 patients (3%) with durable FICS undergoing definitive total hip arthroplasty surgery because of local tumor progression. Conclusion Percutaneous fixation with internal cemented screws as performed by the interventional radiologist is a safe nonsurgical treatment that provides an effective palliative result and durable prevention for impending pathologic fractures of the femoral neck. © RSNA, 2020
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http://dx.doi.org/10.1148/radiol.2020201341DOI Listing
December 2020

Scientific Societies Should Start Sponsoring Observational Studies.

Cardiovasc Intervent Radiol 2020 Dec 25;43(12):1865-1867. Epub 2020 Sep 25.

Service de Radiologie Interventionelle, Gustave Roussy, Cancer Campus, Villejuif, France.

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http://dx.doi.org/10.1007/s00270-020-02649-5DOI Listing
December 2020

The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis.

Cardiovasc Intervent Radiol 2021 Jan 24;44(1):50-62. Epub 2020 Sep 24.

Assistance Publique Hôpitaux de Paris, Service d'hepatogastroentérologie et d'oncologie digestive, Hôpital Européen Georges Pompidou, Université Paris Descartes, Sorbonne Paris-Cité, 20 Rue Leblanc, 75015, Paris, France.

Purpose: Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible for curative treatment approaches. This interim analysis focuses on feasibility of the planned statistical analysis regarding data distribution and completeness, treatment intention, safety and health-related quality of life (HRQOL) of the first 50 patients prospectively enrolled in the CIrse REgistry for LifePearl™ microspheres (CIREL), an observational multicentre study conducted across Europe.

Methods: In total, 50 patients ≥ 18 years diagnosed with CRLM and decided to be treated with irinotecan-eluting LifePearl™ microspheres TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint is the categorisation of treatment intention, and secondary endpoints presented in this interim analysis are safety, treatment considerations and HRQOL.

Results: LP-irinotecan TACE was conducted in 42% of patients as salvage therapy, 20% as an intensification treatment, 16% as a first-line treatment, 14% a consolidation treatment and 8% combination treatment with ablation with curative intent. Grade 3 and 4 adverse events were reported by 4% of patients during procedure and by 10% within 30 days. While 38% reported a worse, 62% reported a stable or better global health score, and 54% of patients with worse global health score were treated as salvage therapy patients.

Conclusion: This interim analysis confirms in a prospective analysis the feasibility of the study, with an acceptable toxicity profile. More patients reported a stable or improved HRQOL than deterioration. Deterioration of HRQOL was seen especially in salvage therapy patients.

Trial Registration: NCT03086096.
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http://dx.doi.org/10.1007/s00270-020-02646-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7728640PMC
January 2021

Feasibility and first reports of the MATCH-R repeated biopsy trial at Gustave Roussy.

NPJ Precis Oncol 2020 8;4:27. Epub 2020 Sep 8.

Université Paris-Saclay, Institut Gustave Roussy, Inserm U981, Biomarqueurs prédictifs et nouvelles stratégies thérapeutiques en oncologie, 94800 Villejuif, France.

Unravelling the biological processes driving tumour resistance is necessary to support the development of innovative treatment strategies. We report the design and feasibility of the MATCH-R prospective trial led by Gustave Roussy with the primary objective of characterizing the molecular mechanisms of resistance to cancer treatments. The primary clinical endpoints consist of analyzing the type and frequency of molecular alterations in resistant tumours and compare these to samples prior to treatment. Patients experiencing disease progression after an initial partial response or stable disease for at least 24 weeks underwent a tumour biopsy guided by CT or ultrasound. Molecular profiling of tumours was performed using whole exome sequencing, RNA sequencing and panel sequencing. At data cut-off for feasibility analysis, out of 333 inclusions, tumour biopsies were obtained in 303 cases (91%). From these biopsies, 278 (83%) had sufficient quality for analysis by high-throughput next generation sequencing (NGS). All 278 samples underwent targeted NGS, 215 (70.9%) RNA sequencing and 222 (73.2%) whole exome sequencing. In total, 163 tumours were implanted in NOD scid gamma (NSG) or nude mice and 54 patient-derived xenograft (PDX) models were established, with a success rate of 33%. Adverse events secondary to invasive tumour sampling occurred in 24 patients (7.6%). Study recruitment is still ongoing. Systematic molecular profiling of tumours and the development of patient-derived models of acquired resistance to targeted agents and immunotherapy is feasible and can drive the selection of the next therapeutic strategy.
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http://dx.doi.org/10.1038/s41698-020-00130-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478969PMC
September 2020

Intratumoral Immunotherapy: From Trial Design to Clinical Practice.

Clin Cancer Res 2021 Feb 17;27(3):665-679. Epub 2020 Sep 17.

Département d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Gustave Roussy, Université Paris Saclay, Villejuif, France.

Systemic immunotherapies such as immune checkpoint blockade targeted at PD(L)1 and CTLA4 have demonstrated their ability to provide durable tumor responses and long-term overall survival benefits for some patients in several solid tumor types. However, a majority of patients remain resistant to these treatments and a significant proportion of them develop severe autoimmune and inflammatory adverse events. Preclinical studies have demonstrated that intratumoral injections of immunostimulatory products (oncolytics, pattern recognition receptor agonists,…) that are able to trigger type I IFN release and enhance tumor antigen presentation on immune cells could generate a strong antitumor immunity and overcome the resistance to systemic immune checkpoint blockade therapies. The intratumoral immunotherapy strategies that are currently in clinical development offer a unique therapeutic and exploratory setting to better understand the immune contexture across tumor lesions of patients with metastatic cancer. Also these local therapeutic products could turn cold tumors into hot and improve the response rates to cancer immunotherapies while diminishing their systemic exposure and toxicities. Intratumoral immunotherapies could prime or boost the immunity against tumors and therefore radically change the combinatorial therapeutic strategies currently pursued for metastatic and local cancers to improve their long-term survival. We aimed to review and discuss the scientific rationale for intratumoral immunotherapy, the challenges raised by this strategy in terms of drug development within clinical trials and the current state-of-the-art regarding the clinical practice of this innovative approach.
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http://dx.doi.org/10.1158/1078-0432.CCR-20-0473DOI Listing
February 2021

Safety and Efficacy of Multilevel Thoracolumbar Vertebroplasty in the Simultaneous Treatment of Six or More Pathologic Compression Fractures.

J Vasc Interv Radiol 2020 10 10;31(10):1683-1689.e1. Epub 2020 Sep 10.

Interventional Radiology Unit and Imaging Department and Anesthesiology Unit, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, Villejuif 94805, France; Université Paris-Sud, Le Kremlin Bicêtre, France.

Purpose: To assess the safety and efficacy of multilevel thoracolumbar vertebroplasty in the simultaneous treatment of ≥ 6 painful pathologic compression fractures.

Materials And Methods: Retrospective review was conducted of 50 consecutive patients treated with vertebroplasty for ≥ 6 pathologic compression fractures in a single session for pain palliation at a tertiary single cancer center from 2015 to 2019. Outcomes measured included procedural safety according to Common Terminology Criteria for Adverse Events (CTCAE), change in 4-week postprocedure back pain by numeric rating scale (NRS), comparison of daily opioid medication consumption, and development of skeletal-related events.

Results: A total of 397 pathologic compression fractures were treated during 50 sessions (mean, 7.9 per patient ± 1.5). Mean procedure duration was 162 minutes ± 35, mean postoperative hospitalization duration was 1.6 days ± 0.9, and mean follow-up duration was 401 days ± 297. Seven complications were recorded, including 1 case of symptomatic polymethyl methacrylate pulmonary embolism. No major complications (CTCAE grade 4/5) were reported. NRS pain score was significantly decreased (5.0 ± 1.8 vs 1.7 ± 1.4; P < .0001), with a mean score decrease of 3.3 points (66%). Opioid agent use decreased significantly (76 mg/24 h ± 42 vs 45 mg/24 h ± 37; P = .0003), with a mean decrease of 30 mg/24 h (39%). Skeletal-related events occurred in 7 patients (14%).

Conclusions: Multilevel vertebroplasty for ≥ 6 pathologic compression fractures is safe and provides significant palliative benefit when performed simultaneously.
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http://dx.doi.org/10.1016/j.jvir.2020.03.011DOI Listing
October 2020

Lung microwave ablation - an swine tumor model experiment to evaluate ablation zones.

Int J Hyperthermia 2020 ;37(1):879-886

Département d' Anesthésie, Chirurgie et Interventionel, Gustave Roussy, Villejuif, France.

Purpose: To evaluate microwave ablation (MWA) algorithms, comparing pulsed and continuous mode in an lung tumor mimic model.

Materials And Methods: A total of 43 lung tumor-mimic models of 1, 2 or 3 cm were created in 11 pigs through an intra-pulmonary injection of contrast-enriched minced muscle. Tumors were ablated under fluoroscopic and 3D-CBCT-guidance using a single microwave antenna. Continuous (CM) and pulsed mode (PM) were used. According to tumor size, 3 different algorithms for both continuous and pulsed mode were used. The ablation zones were measured using post-procedural 3D-CBCT and on pathologic specimens.

Results: Two radiologists measured the ablation zones on CBCT and they significantly correlated with macroscopic and microscopic pathological findings:  = 0.75 and 0.74 respectively ( < 0.0001) (inter-observer correlation  = 0.9). For 1, 2 and 3 cm tumors mimics lesions (TMLs), mean maximal and transverse ablation diameters were 3.6 [Formula: see text] 0.3 × 2.2 [Formula: see text] 0.3 cm; 4.1 [Formula: see text] 0.5 × 2.6 [Formula: see text] 0.3 cm and 4.8 [Formula: see text] 0.3 × 3.2 [Formula: see text] 0.3 cm respectively using CM; And, 3.0 [Formula: see text] 0.2 × 2.1 [Formula: see text] 0.2 cm; 4.0 [Formula: see text] 0.4 × 2.7 [Formula: see text] 0.4 cm and 4.6 [Formula: see text] 0.4 × 3.2 [Formula: see text] 0.4 cm respectively for PM, without any significant difference except for 1 cm TMLs treated by PM ablation which were significantly smaller ( = 0.009) The sphericity index was 1.6, 1.6, 1.5 and 1.4, 1.5, 1.4 at 1, 2 and 3 cm for CM and PM respectively,  = 0.07, 0.14 and 0.13 for 1, 2 and 3 cm tumors mimics.

Conclusion: Microwave ablation for 1-3 cm lung tumors were successfully realized but with a moderate reproducibility rate, using either CM or PM. Immediate post ablation CBCT can accurately evaluate ablation zones.
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http://dx.doi.org/10.1080/02656736.2020.1787530DOI Listing
January 2020

A multicentre, international, observational study on transarterial chemoembolisation in colorectal cancer liver metastases: Design and rationale of CIREL.

Dig Liver Dis 2020 08 30;52(8):857-861. Epub 2020 Jun 30.

Université Paris Descartes, Sorbonne Paris-Cité, Assistance Publique Hôpitaux de Paris, Service d'hepatogastroentérologie et d'oncologie digestive, Hôpital Européen Georges Pompidou, 20 Rue Leblanc, 75015 Paris, France.

Background: About 70-80% of patients with colorectal liver metastases appear as ineligible for a curative treatment approach. Transarterial chemoembolisation (TACE) using irinotecan-eluting beads has emerged as a promising treatment option in cases with irresectable liver metastases. Despite being in clinical practice for years, little is known about the treatment characteristics and outcomes when used as per routine hospital practice.

Methods: Patients with hepatic metastases from colorectal cancer origin, admitted to contributing centres to receive TACE with drug-eluting LifePearl® Microspheres loaded with irinotecan, as part of their standard care, will be consecutively added to the registry. Data will be collected until the end of study, loss to follow-up or death. Primary endpoint is the characterisation of the treatment usage at the selected sites in Europe. Secondary endpoints include outcome parameters, safety and toxicity, as well as quality of life.

Conclusion And Aims: This multicentre, international, prospective observational study conducted in European centres plans to collect real-life data. This data will form an evidence-base from which conclusions can be drawn on how to improve patient selection and optimise treatment protocols when treating with TACE using irinotecan-eluting microspheres. Trial registration NCT03086096.
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http://dx.doi.org/10.1016/j.dld.2020.05.051DOI Listing
August 2020

Lung Ablation - How I Do It.

Tech Vasc Interv Radiol 2020 Jun 25;23(2):100673. Epub 2020 May 25.

Gustave Roussy Cancer Campus.

Interventional oncology and the value of thermal ablation of small tumors is increasingly recognized by the oncological community. Primary lung cancers and lung metastases have been one of the most researched applications of percutaneous ablation and as interventional oncologists gain more experience and confidence, it is becoming a more effective treatment with expanding indications. Importantly, the current literature does not demonstrate major differences in survival between ablation, sublobar resection, and stereotactic body radiation. The advantages of percutaneous ablation over other local therapies like surgery or SBRT are significantly lower morbidity, mortality, and repeatability of treatments. The focus of this essay is to highlight technical and procedural aspects of lung ablation as well as management and follow-up in a practical fashion.
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http://dx.doi.org/10.1016/j.tvir.2020.100673DOI Listing
June 2020

Liver transarterial chemoembolization and sunitinib for unresectable hepatocellular carcinoma: Results of the PRODIGE 16 study.

Clin Res Hepatol Gastroenterol 2020 Jun 21:101464. Epub 2020 Jun 21.

Department of Medical Oncology, University Hospital, Lille, France.

Background: Trans-arterial chemoembolization (TACE) is one first-line option therapy for patients with hepatocellular carcinoma (HCC) not suitable for surgical resection.

Aims: We evaluated the effects of sunitinib plus doxorubicin-TACE on bleeding or liver failure.

Methods: Seventy-eight patients with HCC were included in this randomized, double-blind study. They received one to three TACE plus either sunitinib or placebo four weeks out of six for one year. The occurrence of severe bleeding or liver failure was assessed during the week after the TACE. The safety and survival outcomes were evaluated.

Results: No bleeding complication was reported. One and two liver failures were respectively observed in sunitinib and placebo patients. Compliance to sunitinib treatment was acceptable. Sunitinib dose reduction occurred in 37% of patients due to acute toxicity. Main grade 3-4 toxicities were: thrombocytopenia, neutropenia, increased bilirubin, increased ALT and asthenia. In the sunitinib group, the median PFS and OS were 9.05 [5.81;11.63] and 25.0 [13.5;36.8] months, respectively. In the placebo group, the median PFS and OS were 5.51 [4.14;7.79] and 20.5 [15.1;30.6] months, respectively.

Conclusions: TACE plus sunitinib in the first-line therapy for patients with HCC not suitable for surgical resection was feasible. CLINICALTRIALS.

Gov Number: NCT01164202.
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http://dx.doi.org/10.1016/j.clinre.2020.05.012DOI Listing
June 2020

Pickering emulsions with ethiodized oil and nanoparticles for slow release of intratumoral anti-CTLA4 immune checkpoint antibodies.

J Immunother Cancer 2020 06;8(1)

Laboratoire de Recherche Translationnelle en Immunothérapie (LRTI), INSERM U1015, Villejuif, France.

Background: Intratumorous immunotherapy for cancer is currently thriving. The aim of such local strategy is to improve the therapeutic index of these treatments, for higher on-target/on-tumor activity and less on-target/off-tumor adverse events. Strategies allowing for slow release of anti-CTLA4 in the tumor microenvironment could improve their clinical efficacy.The purpose of the study was to develop a radiopaque delivery platform to improve the targeting and exposure of intratumorous anti-CTLA4 antibodies for cancer immunotherapy.

Methods: Pickering emulsions of anti-CTLA4 antibodies were formulated with radiopaque ethiodized oil and poly-lactic-co-glycolic acid (PLGA) nanoparticles. We characterized the microscopic aspect and stability of such emulsions using Turbiscan. We monitored the release of anti-CTLA4 over time from these emulsions and evaluated their structure using mass spectrometry. We then tested the functionality of the released antibodies by preforming ex vivo competitive binding assays. Finally, we assessed the in vivo efficacy of intratumorous anti-CTLA4 Pickering emulsions.

Results: Pickering emulsions of ethiodized oil and PLGA nanoparticles (PEEPs) resulted in a radiopaque water-in-oil emulsion with average internal phase droplet size of 42±5 µm at day 7. Confocal microscopy showed that anti-CTLA4 antibodies were effectively encapsulated by ethiodized oil with PLGA nanoparticles located at the interface between the aqueous and the oily phase. Turbiscan analysis showed that emulsions were stable with continuous and progressive release of anti-CTLA4 antibodies reaching 70% at 3 weeks. Structural and functional analysis of the released antibodies did not show significant differences with native anti-CTLA4 antibodies. Finally, intratumorous anti-CTLA4 PEEPs were able to eradicate tumors and cure mice in a syngeneic immunocompetent preclinical tumor model.

Conclusion: Pickering emulsions of ethiodized oil and PLGA is an innovative radiopaque delivery platform that does not alter the functionality of anti-CTLA4 immune checkpoint antibodies. Beyond local anti-CTLA4 applications, these emulsions might be used with other therapeutic molecules for optimal intratumorous or intra-arterial delivery of novel cancer immunotherapies.
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http://dx.doi.org/10.1136/jitc-2020-000579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7307549PMC
June 2020

Multi-Level Vertebroplasty for 6 or More Painful Osteoporotic Vertebral Body Compression Fractures Performed in the Same Procedural Setting: A Safety and Efficacy Report in Cancer Patients.

Cardiovasc Intervent Radiol 2020 Jul 7;43(7):1041-1048. Epub 2020 May 7.

Department Interventional Radiology Unit, Imaging Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94805, Villejuif, France.

Purpose: To assess safety and efficacy of multi-level vertebroplasty, when treating 6 or more levels in the same procedural setting for the management of osteoporotic vertebral compression fractures (oVCF) in cancer patients.

Materials And Methods: Single institution retrospective review from 2015 to 2019 of patients treated for multi-level oVCF in a single session procedural setting by vertebroplasty of 6 or more levels. Procedure outcomes collected included procedural complications, pre- and 4 week post-procedure pain score by numeric rating scale, opioid usage, and vertebral height changes.

Results: In total, 197 vertebral levels were treated in 24 procedures (mean 8.2 ± 1.8 levels). Mean procedure duration was 167 + / - 41 min, and mean postoperative hospitalization duration was 2.1 + / - 1.9 days. Four grade I or II complications occurred according to CIRSE classification. Two patients had a symptomatic pulmonary cement embolism; although there was no statistical difference between pre- and postoperative mean blood saturation (95.9 + / - 1.7% and 94.8 + / - 2.0%, respectively, p = 0.066). Pain score significantly improved after treatment (6.5 ± 1.3 vs 3.2 + / - 1.4, p < 0.0001) with a mean decrease of 3.3 (51%). Post-procedure daily opioid use also significantly improved (mean 35.8 + / - 36.8 mg/24 h vs 18.5 + / - 27.8 mg/24 h, p = 0.0089), with a mean decrease of 17.3 mg/24 h (48%). Refracture was found in 2 of 105 levels treated (1.9%), and no difference was found in thoraco-lumbar height and angulation. Five patients experienced new painful fractures at a non-treated level.

Conclusion: Multi-level vertebroplasty for 6 or more levels is a safe and effective treatment for the management of multi-level oVCF in cancer patients.
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http://dx.doi.org/10.1007/s00270-020-02480-yDOI Listing
July 2020

CIRSE Standards of Practice on Thermal Ablation of Liver Tumours.

Cardiovasc Intervent Radiol 2020 Jul 7;43(7):951-962. Epub 2020 May 7.

Department of Interventional Radiology, University of Pisa, Pisa, Italy.

This CIRSE Standards of Practice document reviews current literature and provides best practices for image guided thermal ablation of liver tumours, including radiofrequency, microwave and cryoablation techniques.
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http://dx.doi.org/10.1007/s00270-020-02471-zDOI Listing
July 2020

Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE).

J Thorac Oncol 2020 07 7;15(7):1200-1209. Epub 2020 Mar 7.

Department of Interventional Radiology, Gustave Roussy-Cancer Campus, Villejuif, France.

Objective: To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases.

Methods: This multicenter, prospective, single-arm, phase 2 study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan-Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated.

Results: Median size of metastases was 1.0 plus or minus 0.6 cm (0.2-4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6-99.2) and 86.6% (95% confidence interval: 78.7-91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event.

Conclusion: Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.
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http://dx.doi.org/10.1016/j.jtho.2020.02.022DOI Listing
July 2020

Correction to: Preventive Vertebroplasty for Long-Term Consolidation of Vertebral Metastases.

Cardiovasc Intervent Radiol 2020 May;43(5):807

Interventional Radiology Unit, Imaging Department, Gustave Roussy Cancer Campus, 114 rue Edouard Vaillant, 94805, Villejuif, France.

In the original article, the following author name was incorrectly published and the corrected name is given below.
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http://dx.doi.org/10.1007/s00270-020-02445-1DOI Listing
May 2020

Treatment intensification with hepatic arterial infusion chemotherapy in patients with liver-only colorectal metastases still unresectable after systemic induction chemotherapy - a randomized phase II study -- SULTAN UCGI 30/PRODIGE 53 (NCT03164655)- study protocol.

BMC Cancer 2020 Jan 30;20(1):74. Epub 2020 Jan 30.

Department of Medical Oncology, Gustave Roussy, 114 rue Edouard Vaillant, 94805, Villejuif Cedex, France.

Background: Approximately 40% of colorectal cancer patients will develop colorectal liver metastases (CRLM). The most effective approach to increase long-term survival is CRLM complete resection. Unfortunately, only 10-15% of CRLM are initially considered resectable. The objective response rates (ORR) after current first-line systemic chemotherapy (sys-CT) regimens range from 40 to 80% and complete resection rates (CRR) range from 25 to 50% in patients with initially unresectable CRLM. When CRLM patients are not amenable to complete resection after induction of sys-CT, ORRs obtained with second-line sys-CT are much lower (between 10 and 30%) and consequently CRRs are also low (< 10%). Hepatic arterial infusion (HAI) oxaliplatin may represent a salvage therapy in patients with CRLM unresectable after one or more sys-CT regimens with ORRs and CRRs up to 60 and 30%, respectively. This study is designed to evaluate the efficacy of an intensification strategy based on HAI oxaliplatin combined with sys-CT as a salvage treatment in patients with CRLM unresectable after at least 2 months of first-line induction sys-CT.

Objectives And Endpoints Of The Phase Ii Study: Our main objective is to investigate the efficacy, in term of CRR (R0-R1), of treatment intensification in patients with liver-only CRLM not amenable to curative-intent resection (and/or ablation) after at least 2 months of induction sys-CT. Patients will receive either HAI oxaliplatin plus systemic FOLFIRI plus targeted therapy (i.e. anti-EGFR antibody or bevacizumab) or conventional sys-CT plus targeted therapy (i.e. anti-EGFR or antiangiogenic antibody). Secondary objectives are to compare: progression-free survival, overall survival, objective response rate, depth of response, feasibility of delivering HAI oxaliplatin including HAI catheter-related complications, and toxicity (NCI-CTCAE v4.0).

Methods: This study is a multicenter, randomized, comparative phase II trial (power, 80%; two-sided alpha-risk, 5%). Patients will be randomly assigned in a 1:1 ratio to receive HAI oxaliplatin combined with systemic FOLFIRI plus targeted therapy (experimental arm) or the best sys-CT plus targeted therapy on the basis of their first-line prior sys-CT history and current guidelines (control arm). One hundred forty patients are required to account for non-evaluable patients.

Trial Registration: ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017.
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http://dx.doi.org/10.1186/s12885-020-6571-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6990591PMC
January 2020

Role of image-guided biopsy and radiomics in the age of precision medicine.

Chin Clin Oncol 2019 Dec;8(6):57

Interventional Radiology, Gustave Roussy, Villejuif, France; Faculté de Médecine, Université Paris-Sud, Orsay, France.

Modern oncology requires precise tumor assessment to drive effective therapies. Image-guided biopsies are the current standard of care to characterize molecular alterations safely and effectively, but have inherent limitations due to tumor heterogeneity and accessibility, as well as from procedure related risks. Advancements in radiomics analysis provide the potential to retrieve useful incremental information to characterize molecular alterations from standard imaging data in a cost-effective and non-invasive manner, but currently suffers from lack of validation and standardization. The combination of techniques may provide the optimal solution for patient-tailored care, ultimately through the development of accurate and reliable virtual biopsy. In the advancement towards that goal, image-guided biopsy can prove radiomic suspicions and conversely radiomics can guide image-guided biopsy to improve tissue yield. Joint development of these two methods will improve cancer understanding and patient outcomes.
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http://dx.doi.org/10.21037/cco.2019.12.02DOI Listing
December 2019

Robotic assistance in interventional radiology: dream or reality?

Eur Radiol 2020 Feb 4;30(2):925-926. Epub 2019 Dec 4.

Service de radiologie interventionnelle, Gustave Roussy, Villejuif, France.

Key Points: • Robotic assistance in medicine has been a revolution.• The use of robots has naturally extended to interventional radiology for percutaneous and endovascular interventions.• The guidance is mainly performed with a remote (computer or joystick) allowing the operator and his team not to be exposed to X-rays.
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http://dx.doi.org/10.1007/s00330-019-06541-wDOI Listing
February 2020

[Interventional radiology is essential throughout the entire patient treatment in oncology].

Presse Med 2019 Oct;48(10):1139-1140

Gustave Roussy Institute, 39, rue Camille Desmoulins, 94805 Villejuif, France.

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http://dx.doi.org/10.1016/j.lpm.2019.10.022DOI Listing
October 2019

Percutaneous management of metastatic osseous disease.

Chin Clin Oncol 2019 Dec 14;8(6):62. Epub 2019 Nov 14.

Department of Interventional Radiology, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France.

Metastases to the bone represent the third most common site of metastatic disease. More than 50% of patients with metastatic cancer will develop bone metastases. Associated morbidity is related to local tumor progression that destroys bone to result in pain, pathologic fracture, hypercalcemia, and neurologic deficits. Depending on the tumor biology, systemic chemotherapy or radiation therapy may not provide complete local control and may not adequately relieve associated pain. While surgical intervention may be beneficial in many patients, surgical options may also provide incomplete locoregional cure or palliation, and moreover may require extensive healing that can delay systemic therapy. Interventional oncology treatments can provide appealing alternative therapies for osseous metastases. These minimally-invasive therapies can augment existing conventional treatments and even provide a viable option for patients that have exhausted, or are not suitable candidates, for conventional treatments. Interventional oncology treatments are applied for either pain palliation, local tumor control, or both. The goals of treatment can include tumor remission or cure, as well as improved quality of life and mobility. An effective and durable interventional oncology treatment requires a tailored approach that considers the high variability in disease presentation. Osseous metastases may present throughout the skeleton, with low to high vascularity, and undulant to rapidly aggressive tumor biology. This article reviews the main percutaneous treatment for osseous metastases that include embolization, thermal ablation, vertebral augmentation, cementoplasty, and fixation by internal cemented screw (FICS).
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http://dx.doi.org/10.21037/cco.2019.10.02DOI Listing
December 2019

Salvage Therapy for Locoregional Recurrence After Stereotactic Ablative Radiotherapy for Early-Stage NSCLC.

J Thorac Oncol 2020 02 9;15(2):176-189. Epub 2019 Nov 9.

Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:

Although isolated local (LRs) and regional recurrences (RRs) constitute a minority of post-stereotactic ablative radiotherapy (SABR) relapses, their management is becoming increasingly important as the use of SABR continues to expand. However, few evidence-based strategies are available to guide treatment of these potentially curable recurrences. On behalf of the Advanced Radiation Technology Committee of the International Association for the Study of Lung Cancer, this article was written to address management of recurrent disease. Topics discussed include diagnosis and workup, including the roles of volumetric and functional imaging as well as histopathologic methods; clinical outcomes after salvage therapy; patterns of recurrence after salvage therapy; and management options. Our main conclusions are that survival for patients with adequately salvaged LRs is similar to that for patients after primary SABR without recurrence, and survival for those with salvaged RRs (regardless of nodal burden or location) is similar to that of patients with de novo stage III disease. Although more than half of patients who undergo salvage do not develop a second relapse, the predominant pattern of second failure is distant, especially for RRs. Management requires rigorous multidisciplinary coordination. Isolated LRs can be managed with resection and nodal dissection, repeat SABR, thermal ablation, or systemic therapies. RRs can be treated with combined chemoradiotherapy, radiation or chemotherapy alone, or supportive services. Finally, regular and structured follow-up is recommended after post-SABR salvage therapy.
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http://dx.doi.org/10.1016/j.jtho.2019.10.016DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7058490PMC
February 2020