Accepted Manuscript Preoperative fine-needle aspiration tumour biopsy does not affect the oncologic course of patients with transplantable HCC Fuks David, Cauchy Francois, Fusco Grazia, Paradis Valerie, Durand Francois, Belghiti Jacques PII: DOI: Reference:

S0168-8278(14)00310-9 http://dx.doi.org/10.1016/j.jhep.2014.04.046 JHEPAT 5152

To appear in:

Journal of Hepatology

Received Date: Revised Date: Accepted Date:

19 December 2013 17 April 2014 21 April 2014

Please cite this article as: David, F., Francois, C., Grazia, F., Valerie, P., Francois, D., Jacques, B., Preoperative fine-needle aspiration tumour biopsy does not affect the oncologic course of patients with transplantable HCC, Journal of Hepatology (2014), doi: http://dx.doi.org/10.1016/j.jhep.2014.04.046

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Preoperative fine-needle aspiration tumour biopsy does not affect the oncologic course of patients with transplantable HCC Running title: Preoperative HCC biopsy and liver transplantation Fuks David1, Cauchy Francois1, Fusco Grazia1, Paradis Valerie2, Durand Francois3, Belghiti Jacques1 Departments of (1) HPB surgery, (2) Pathology, (3) Hepatology Beaujon Hôpital, 100 boulevard Général Leclerc, 92110 Clichy, France

Corresponding author: Jacques Belghiti MD, Department of Surgery, Hospital Beaujon, HPB Surgery, Beaujon Hôpital, 100 boulevard Général Leclerc, 92110 Clichy, France Ph: (33)-1-40-87-58-95; Fax: (33)-1-40-87-17-24 E-mail: [email protected] Word count: 3672 Number of tables and figures: Three Tables and one Figure Abbreviations: Preoperative fine-needle aspiration biopsy (PFNAB); hepatocellular carcinoma (HCC); liver transplantation (LT); chronic liver disease (CLD); magnetic resonance imaging (MRI); computed tomography (CT); Fine needle aspiration (FNA); Radiofrequency ablation (RFA); Alpha-fetoprotein (AFP) level; Ultrasound (US)

Conflicts of interest: DF, FC, GF, VP, FD and JB have no conflict of interest No financial support

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ABSTRACT (251 words) Background. Preoperative fine-needle aspiration biopsy (PFNAB) allows obtaining reliable hepatocellular carcinoma (HCC) diagnosis before liver transplantation (LT) in doubtful situations, but may result in higher recurrence rates following LT. This study aimed to evaluate whether PFNAB actually jeopardized the outcome of patients with transplantable HCC. Methods. From 2002 to 2012, among 309 HCC patients listed for LT, 80 (26%) underwent PFNAB (PFNAB+). Their characteristics, modalities of recurrence and survivals were retrospectively compared to those of the 229 (74%) patients without PFNAB (PFNAB-). Results. The two groups (PFNAB+ vs. PFNAB-) were similar in terms of demography, rates of lesions within the Milan criteria (81%vs.79%, p=0.676) and duration on the waiting list (7.0 vs. 6.9 months, p=0.891). Dropout following tumour progression was similar between both groups (6%vs.11%, p=0.424). Among the 278 (90%) transplanted patients, pathological analysis revealed that 11 (4%) patients had non-HCC lesions including 10 among PFNABpatients. Median follow-up was 34 months (12-135) and recurrence after LT was observed in 25 (9%) patients with no difference between both groups (9.3%vs.8.9%, p=0.904). Parietal recurrence was observed in one PFNAB+ patient and in 2 PFNAB- patients after radiofrequency ablation (p=0.797). On an intention to treat basis, 1-, 3- and 5-year overall survivals (89%, 69% and 60% vs. 85%, 67% and 61%, p=0.601) were not significantly different between PFNAB+ and PFNAB- patients. Conclusion: This study supports that preoperative tumour biopsy does not negatively influence the oncologic course of HCC patients eligible for LT. Hence, there is no argument to restrict biopsy in doubtful situations. Key-words: HCC; liver biopsy; liver transplantation; tumour recurrence

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INTRODUCTION Liver transplantation (LT) is the most effective treatment for early hepatocellular carcinoma (HCC) in patients with chronic liver disease (CLD) [1]. Yet, the current existing imbalance between the increasing number of candidates and organ shortage [2–3] requires that a reliable diagnostic should be preoperatively obtained to avoid two major issues: first, to perform an unnecessary LT in case of benign dysplastic nodules and second, to transplant patients with HCC of poor histological prognosis [4-5]. Even though recent advances in imaging modalities have obviated the need for tissue confirmation in most hepatocellular carcinomas (HCCs), percutaneous biopsy of the tumour could solve these two concerns. Yet, both existence of false positive and risk of tumour cells seeding along the needle track following capsular rupture [6–8] currently discourages many authors [9-10] from performing preoperative tumour biopsy in patients with transplantable HCC. Nevertheless, while these arguments seem somehow intuitive, they have not been validated in large series. In this setting, it still remains to be elucidated whether tumour biopsy could actually lead to increased recurrence rates in a context of immunosuppression and negatively influence the oncologic course of patients qualifying for LT. The objective of the current study was therefore to assess whether PFNAB itself could jeopardize the long-term outcomes in large series of patients with HCC eligible for liver transplantation (LT) on an intention to treat basis.

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MATERIALS AND METHODS Patient' selection Between January 2002 and December 2011, 309 patients with suspected HCC occurring on chronic liver disease qualifying and listed for LT at our institution were retrospectively analyzed. Diagnosis of HCC was retained either (i) morphologically for lesions >2 cm showing both early hyperenhancement and delayed hypoenhancement (washout) on at least two concordant imaging studies including triple-phase computed tomography (CT) and/or magnetic resonance imaging (MRI); or (ii) histologically for lesions

Preoperative tumour biopsy does not affect the oncologic course of patients with transplantable HCC.

Preoperative fine-needle aspiration biopsy (PFNAB) allows obtaining reliable hepatocellular carcinoma (HCC) diagnosis before liver transplantation (LT...
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