Effective downsizing but enhanced intratumoral heterogeneity following neoadjuvant sorafenib in patients with non-metastatic renal cell carcinoma

Objectives To evaluate the safety and feasibility of sorafenib prior to surgery for downsizing tumors in patients with non-metastatic cT1-3 renal tumors together with a characterization of functional intratumoral heterogeneity (ITH). Materials and methods The effects of 4-week sorafenib prior to cur...

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Published in:Langenbeck's archives of surgery 2017-06, Vol.402 (4), p.637-644
Main Authors: Hatiboglu, Gencay, Hohenfellner, Markus, Arslan, Aysenur, Hadaschik, Boris, Teber, Dogu, Radtke, Jan Philipp, Hallscheidt, Peter, Tolstov, Yanis, Roth, Wilfried, Grüllich, Carsten, Huesing, Johannes, Duensing, Stefan, Pahernik, Sascha
Format: Article
Language:English
Subjects:
Abdominal Surgery
Adult
Aged
Antineoplastic Agents - therapeutic use
Carcinoma, Renal Cell - drug therapy
Carcinoma, Renal Cell - pathology
Carcinoma, Renal Cell - surgery
Cardiac Surgery
Double-Blind Method
Female
General Surgery
Hepatectomy
Humans
Kidney Neoplasms - drug therapy
Kidney Neoplasms - pathology
Kidney Neoplasms - surgery
Male
Medicine
Medicine & Public Health
Middle Aged
Neoadjuvant Therapy
Niacinamide - analogs & derivatives
Niacinamide - therapeutic use
Original Article
Phenylurea Compounds - therapeutic use
Pilot Projects
Prospective Studies
Thoracic Surgery
Traumatic Surgery
Treatment Outcome
Vascular Surgery
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Summary:Objectives To evaluate the safety and feasibility of sorafenib prior to surgery for downsizing tumors in patients with non-metastatic cT1-3 renal tumors together with a characterization of functional intratumoral heterogeneity (ITH). Materials and methods The effects of 4-week sorafenib prior to curative surgery were assessed in a prospective, single-center, randomized, placebo-controlled, double-blinded, pilot trial in patients with T1–3N0M0 renal cell carcinoma (RCC). Patients received sorafenib or placebo for 28 days prior to surgery. MRI was performed at baseline and prior to surgery to calculate tumor volume. The clinical responses were further characterized on the molecular level by immunohistochemical stainings for Ki-67, cleaved caspase-3, and CD31. Results After enrolling 20 patients into the study, 14 patients were randomized, of which 12 patients were available for analysis. While no significant change in tumor volume was seen for placebo (range = −24.2–0.2%) a reduction of 29.0% (range = −4.9–61.1%) was detected for sorafenib ( p  
ISSN:1435-2443
1435-2451
DOI:10.1007/s00423-016-1543-8