Clinical Research Research Activities
Interventional Radiology A) HCC relapse after left lobectomy B)CT 1 month after TAE C)CT scan 6 months after TAE D) CT scan 15 months after TAE
Clinical needs for local tumor control, by means of minimally invasive approach more than classical invasive, risky and expensive surgical ones, represents the main reason for the very fast developing of new hyper-technological branches in Oncology. Due to the high specialization required for most of the interventional procedures in Oncology, the appellative of “Interventional Oncology” currently defines this field. Image guidance for very precise treatments and low invasiveness, compared with more traditional options, are common elements among all interventional procedures For academic purposes Interventional Radiology may be divided into two different main fields: Vascular treatments and Percutaneous procedures. The use of blood stream for delivering drugs and/or particles directly and selectively to the tumor is the aim of all Vascular treatments in Interventional Oncology and they are mainly oriented for liver tumor control. Percutaneous procedures include all image-guided tumor ablative techniques which require percutaneous insertion of dedicated devices (such as needle for radiofrequency). Moreover, a totally new locoregional therapy for tumor ablation has been very recently added to the IR armamentarium: High Intensity Focused Ultrasound (HIFU-see dedicated chapter). Vascular treatments Introducing the multimodal approach for hepatic lesions Hepatic lesions represent a main challenge in clinical oncology, both for primary and metastatic tumours. It is mainly due to the crucial role this organ represents for the prognosis. In hepatocellular carcinoma, the simultaneous presence of cirrhosis and hepatic tumour masses, in the majority of patients, limits the indication
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for an aggressive local approach, because of the high risk of post-treatment liver failure. Moreover, the high rate in developing new nodules after any local treatment (>80% after 4 years), plays a key role in the decision making on the treatment strategy. Regarding liver metastases, local treatments such as surgery for liver metastases (mainly from colorectal cancer) after systemic chemotherapy seems to induce better results than chemotherapy alone. Minimally invasive local techniques are therefore being continuously developed in order to supplement the surgical resection. Super-selective micro bland arterial embolization with micro-particles. Hepatocellular Carcinoma: Intra-arterial treatments such as transarterial chemoembolization (TACE) and transarterial embolization (TAE), are considered a palliative therapy for multifocal HCC not suitable for surgical resection or percutaneous ablation therapies (mainly indicated for intermediate stage), but the efficacy of intra-arterial treatment in patient with single HCC is not well defined (7,8,9). However, it is still not really clear whether embolization alone gives the same survival advantage (5) nor whether specific patient characteristics affect outcome or any particular technique in performing transarterial therapy is better than any other. A very interesting study on the assessment of feasibility and local response in patients affected by unresectable hepatocellular carcinoma, was carried out in IEO: patients were treated with mbTAE (micro bland TAE) by using very small sized fine-calibrated microparticles (40 and 100 μ). Between October 2007 and september 2009 63 HCC patients underwent 100 TAE, and a total of 87 target lesions were embolized with a super-selective technique. In all cases liver perfusion scintigraphy was performed by injecting Tc-99 labelled albumin macro-aggregates (MAA)
via the main hepatic artery, just before treatment in order to rule out patients with a pulmonary shunt higher than 10%. In four patients a 3-5 % amount of pulmonary shunting was observed and embolization was performed by upsizing microparticles to 100 μ in order to reduce the risk of pulmonary embolism. Twentyfour hours after treatment, upper abdomen MDCT was performed in order to assess the early local result after embolization. Local outcomes on target lesions at 1 year follow-up in these 29 patients are: 6 complete response (CR ), 5 partial response (PR ), 7 stable disease (SD ), and 9 progressive disease (PD ) for new lesions (i.e. new nodules) while 2 PD on treated lesions.
Metastases: The aim of this new field is to assess the feasibility and efficacy in metastatic lesion control with a new kind of coated small particles: 40 and 100 microns EMBOZENE® Between October 2007 and september 2009 42 patients with liver metastatic disease underwent mbTAE: 10 CRC, 17 NET, 5 breast cancer, and 10 from other malignancies. The same technique described for liver HCC for vascular access and microspheres injection was used also for this group of patients. In patients with NET metastases, the
Bland embolization is an effective therapeutic modality in the treatment of unresectable HCC. In our initial experience with Embozene™ 40 and 100 µm we observed a very good handiness in embolization, obtaining good results in lesion and disease control, at a median follow-up of 12 month. Microparticles 40 and 100 µm in diameter are very effective in local response, with good clinical outcomes, compared with other vascular techniques (see Survival Tab), but patients must be very carefully selected in order to reduce major complications. HCC overall survival: TACE vs. DEB-TACE vs mb-TAE
1 year 2 years 3 years
Lo
2002
57%
31%
26%
Llovet
2002
82%
63%
29%
Varela
2006
92,5%
88,9%
Malagari
2007
97,5%
91,1%
Reyes
2009
65%
55%
Martin
2011
75%
MSK
2008
85%
68%
42%
IEO
2010
96%
92%
68%
67,4%
A) liver NET metastases before treatment B) 3 months after TAE with 40 microns
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