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Comparison Study: Cyberknife Robotic Radiosurgery or Percutaneous Radiofrequency Ablation for salvage treatment of colorectal liver metastases.

Comparison Study: Cyberknife Robotic Radiosurgery or Percutaneous Radiofrequency Ablation for salvage treatment of colorectal liver metastases.

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Published by Jacob Repko
Stereotactic radiation therapy is an evolving modality to treat otherwise unresectable liver metastases. In this analysis, two local therapies: 1) single session robotic radiosurgery (RRS) and 2) percutaneous radiofrequency ablation (RFA) were compared in a total of 60 heavily pretreated colorectal cancer patients.
Stereotactic radiation therapy is an evolving modality to treat otherwise unresectable liver metastases. In this analysis, two local therapies: 1) single session robotic radiosurgery (RRS) and 2) percutaneous radiofrequency ablation (RFA) were compared in a total of 60 heavily pretreated colorectal cancer patients.

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12/31/2013

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 Correspondence: S. Stintzing, Department of Medical Oncology and Comprehensive Cancer Center Klinikum Grosshadern, LMU, Marchioninistrasse 15,81377 Munich, Germany. Tel:
ϩ
 49 89 70952208. Fax:
ϩ
 49 89 70955256. E-mail: sebastian.stintzing@med.uni-muenchen.de
(Received 22 November 2012 ; accepted 9 January 2013 )
ORIGINAL ARTICLE
Percutaneous radiofrequency ablation (RFA) or robotic radiosurgery(RRS) for salvage treatment of colorectal liver metastases
SEBASTIAN STINTZING
1
 , ALEXANDER GROTHE
2
 , SASKIA HENDRICH
1
 ,RALF-THORSTEN HOFFMANN
3
 , VOLKER HEINEMANN
1
 , MARKUS RENTSCH
4
 ,CHRISTOPH FUERWEGER 
5
 , ALEXANDER MUACEVIC
5
& CHRISTOPH G. TRUMM
2
 
1
 Department of Medical Oncology and Comprehensive Cancer Center, Klinikum Grosshadern, LMU, Munich,Germany,
2
 Department of Clinical Radiology, University Hospital Grosshadern, LMU Munich, Munich, Germany,
3
 Department and Policlinics of Diagnostic Radiology, Universit ätsklinikum Carl Gustav Carus Dresden, Germany,
4
 Department of Surgery, University Hospital Grosshadern, LMU Munich, Munich, Germany and 
5
 European Cyberknife Center Munich, Munich, Germany
Abstract
Background.
Stereotactic radiation therapy is an evolving modality to treat otherwise unresectable liver metastases. In thisanalysis, two local therapies: 1) single session robotic radiosurgery (RRS) and 2) percutaneous radiofrequency ablation(RFA) were compared in a total of 60 heavily pretreated colorectal cancer patients.
 Methods.
Thirty patients with a total of 35 colorectal liver metastases not qualifying for surgery that were treated in curative intent with RRS were prospectivelyfollowed. To compare efficacy of both treatment modalities, patients treated with RFA during the same period of time werematched according to number and size of the treated lesions. Local tumor control, local disease free survival (DFS), andfreedom from distant recurrence (FFDR) were analyzed for efficacy. Treatment-related side effects were recorded for com-parison.
Results.
The median diameter of the treated lesions was 33 mm (7 – 53 mm). Baseline characteristics did not differsignificantly between the groups. One- and two-year local control rates showed no significant difference but favored RRS(85% vs. 65% and 80% vs. 61%, respectively). A significantly longer local DFS of patients treated with RRS compared toRFA (34.4 months vs. 6.0 months; p
Ͻ
0.001) was found. Both, median FFDR (11.4 months for RRS vs. 7.1 months forRFA p
ϭ
0.25) and the recurrence rate (67% for RRS and 63% for RFA, p
Ͼ
0.99) were comparable.
Conclusion.
Singlesession RRS is a safe and effective method to treat colorectal liver metastases. In this analysis, a trend towards longer DFSwas seen in patients treated with RRS when compared to RFA.
Stereotactic body radiation therapy (SBRT) andstereotactic radiosurgery (SRS) to treat liver metas-tasis are new and rapidly evolving techniques toextent the multidisciplinary treatment options of col-orectal liver metastasis [1]. Although not formallytested in a head to head design with local therapies,surgery is accepted to be the gold standard in thetreatment of single or oligo-colorectal liver metasta-ses [2,3]. Patients not qualifying for surgical proce-dures are offered local treatment options. Amongthose there are thermal ablation techniques likeradiofrequency ablation (RFA) [2,4], microwaveablation or laser-induced thermal treatment (LITT)[5] and different radiation therapies [1]. Amongthe non-surgical therapies, RFA has superseded dur-ing the last decade other ablative therapies in thetreatment of colorectal liver metastases [6]. Next toRFA, radiation therapy to treat liver and lungmetastases with SBRT or RRS is a comparativelynew field in radiation oncology and is still in theprocess of evaluation of treatment effects and long-term outcome. Robotic radiosurgery (RRS) usingreal time tumor tracking is able to apply high localablative radiation doses in a single treatment sessionand therefore can compete with other local therapiessuch as RFA and microwave ablation [7,8].
 Acta Oncologica,
2013; Early Online: 1–7
ISSN 0284-186X print/ISSN 1651-226X online © 2013 Informa HealthcareDOI: 10.3109/0284186X.2013.766362
   A  c   t  a   O  n  c  o   l   D  o  w  n   l  o  a   d  e   d   f  r  o  m    i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m    b  y   U  n   i  v  e  r  s   i   t  y  o   f   S  o  u   t   h  e  r  n   C  a   l   i   f  o  r  n   i  a  o  n   0   2   /   1   4   /   1   3   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .
 
2
S. Stintzing et al.
Here we compare treatment efficacy and toxicityof the widely used percutaneous, computed tomog-raphy (CT)-guided, RFA and RRS for salvage treat-ment of colorectal liver metastases.
Methods
This analysis included patients that were treatedeither with percutaneous RFA or RRS therapy forcolorectal liver metastases. Hepatic lesions had to bedeemed surgical unresectable by the multidisci-plinary gastrointestinal tumor board of the Univer-sity Hospital Grosshadern, University of Munich.This board includes experienced hepatobiliary sur-geons, radiation oncologists, medical oncologists andinterventional radiologists. All metastases had to betreated in curative intent. Therefore, no extrahepaticdisease and no other lesions to the liver than thoseto be treated with local therapy had to be detectableprior to therapy. The decision if percutaneous RFAor RRS should be applied was based on the followingalgorithm: the standard procedure to treat unresect-able colorectal liver metastases was RFA. RRSwas preferred if one of the following reasons werepresent: vicinity of the metastasis to great vessels, asthose might cause a heat sink effect, location close tothe liver capsule, as RFA is more painful to thosepatients and patient wish. A maximum diameter of the lesion exceeding 30 mm has been a factor favor-able for the use of RRS during the last two years of the study [9].
Robotic radiosurgery (RRS)
Thirty consecutive patients with one to three livermetastases from colorectal cancer were treated incurative intent with single session RRS at theEuropean Cyberknife Center Munich as describedbefore [8,10] from May 2005 to May 2011. In short,a radiosurgical device (Cyberknife
TM
 , Accuray Inc.CA, USA) with real time tumor tracking was used.Prior to radiation, one or two gold fiducials (CPMedical Inc., Portland, OR, USA) were placed insideor next to the metastases via an 18G needle underlocal anesthesia and CT fluoroscopy guidance in theinterventional radiology unit. Contrast enhanceddynamic CT (arterial and portalvenous phase) ormagnetic resonance imaging (MRI) (using liver-specific contrast agents) was used to exclude addi-tional intrahepatic tumors. A dedicated liver MRIexamination either performed with a Gadolinium-based extracellular [Magnevist
®
 
(GadopentetateDimeglumine) or Gadovist
®
 
(Gadobutrol), BayerHealthCare Pharmaceuticals Diagnostic Imaging,Germany] or a liver cell-specific [Primovist
®
 
(GadoxeticAcid), Bayer HealthCare Pharmaceuticals DiagnosticImaging, Germany] contrast agent, and character-ized by dynamic contrast-enhanced T1 weighted 3DFLASH sequences (Volumetric Interpolated Breath-hold Examination; VIBE; Siemens Healthcare, Erlan-gen, Germany) with a slice thickness of 3 mm wasfused to the planning CT in all cases by means of rigid image registration provided by the system soft-ware (Multiplan, Accuray Inc.). It was aimed to scanthe patient in the same breathing phase during CTand MRI to get a fusion result as good as possible.In difficult cases the fusion was directed to the lesionitself and not to the outer margins of the liver. Addi-tionally, a margin of 6 mm was added to the tumordiameter in all three dimensions to accommodate fortumor cell spread around the tumor. The set-up inac-curacy for the RRS system used in this analyses is
Ͻ
1 mm [11]. In a single session treatment, a totalof 24 – 26 Gy to the 70% isodose (dose maximum34 – 37 Gy) were administered to the target volume,using a 6 MV compact linear accelerator (LINAC)mounted on a six-axis robotic manipulator. Allpatients were pretreated with ondansetrone onthe day of treatment to prevent radiation-inducednausea.During treatment, respiratory motion tracking of the target volume was done as previously described[12]. The whole procedure lasted about one hour,and patients were discharged from the instituteimmediately after treatment.
Radiofrequency ablation (RFA)
RFA treatment was performed by interventionalradiologists with at least five years of experienceunder single-shot antibiotics, pulse oximetry andconscious sedation using midazolam, dipyrone andpethidine or piritramide, respectively. All RFA pro-cedures were done on a 4-, 16-, or 128-row CT scan-ner (Siemens Healthcare, Erlangen, Germany) underCT fluoroscopy guidance with angular beam modu-lation (tube voltage, 120 kV; tube current – time prod-uct per reconstructed image, 15 – 25 mAs). The lesionswere to be treated in a single session. If tumor sizewas too big, a second treatment was planned for thefollowing day. The subsequent RFA systems wereused: 1) AngioDynamics/RITA Medical Systems(Queensbury, NY, USA): 1500X RF Generator(max. 250W of power) with StarBurst
®
 
XL RFelectrode (umbrella diameter: 5 cm) and 2) BostonScientific (Natick, MA, USA): RF3000
®
 
Radio-frequency Ablation System (max. 200W of power)with LeVeen
®
 
RF electrodes (umbrella diameter: 2 – 5cm). After RFA treatment, patients were sent backto the ward for further pain management and clinicalmonitoring, and usually discharged from the hospitalafter CT follow-up 24 hours later.
   A  c   t  a   O  n  c  o   l   D  o  w  n   l  o  a   d  e   d   f  r  o  m    i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m    b  y   U  n   i  v  e  r  s   i   t  y  o   f   S  o  u   t   h  e  r  n   C  a   l   i   f  o  r  n   i  a  o  n   0   2   /   1   4   /   1   3   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .
 
Radiosurgery and radiofrequency ablation in the treatment of liver metastases
3 RRS patients were matched to patients whounderwent RFA treatment at the Institute of ClinicalRadiology, University Hospital Munich.Patients were matched according to the followingstrata: 1) number of colorectal cancer metastases and2) size of lesions [13]. To minimize bias, patientswere excluded from the analysis when both methods(RFA and RRS) were applied in the same patient.
Ethical considerations
Following the RRS patients has been approved bythe local ethic committee (Ethic Committee of theUniversity Hospital Großhadern, University of Munichproject #383-08).
Determination of treatment efficacy
Contrast enhanced CT- or MRI scans were done inthree-month intervals after treatment. After 12months, intervals were switched to six-month inter-vals [14,15]. Local recurrence was defined as anysign of growth or progression of tumorous tissuewithin or adjunct the treated liver volume. A contrastenhancement at the rim of the treated volume asseen within the first staging after RFA or RRS wasstated as treatment-related change and not as localtreatment failure.Local control rate was defined as no recurrenceof tumor tissue within the site or at the margin of the treated metastases and therefore was deemed astrong indicator of treatment efficacy. Local DFSwas defined as the time of local control of the treatedmetastases. Freedom from distant recurrence(FFDR) was measured from the start of treatmentuntil death or reappearance of any metastasis.Furthermore, overall recurrence rate
 ,
as the rate of recurrence of any metastases independent of thelocalization and overall survival as the time spanbetween treatment and death were evaluated.
Statistical analyses
Statistical analysis was performed using SPSS PASW18.0 (SPSS Inc., Chicago, IL, USA) software.Differences were calculated using two-sided Fishersexact test or Spearman correlation index. Survivaltimes were tested using the Kaplan-Meier methodand the log-rank test. Time intervals were measuredfrom the day of treatment to the date of progressionor death. A p-value
Ͻ
0.05 was regarded as statisticalsignificant.
Results
A total of 60 patients with 70 hepatic lesions weretreated between 2005 and 2011. Number and size of the lesions fitted well between the matched patientswith a maximum difference of 5% in diameter. Bothpatient groups were heavily pretreated with palliativechemotherapy (72%) and liver surgery (57%) priorto local treatment (Table I). The median follow-up
Table I. Baseline characteristics.RRS (n
 
ϭ
 
30)RFA (n
 
ϭ
 
30)pGender- male- female 21 9 17 13 0.42
*
 Age, median (years)- range (years)67.6 33 – 84 64.5 39 – 80 0.82
ϩ
 
Total number of lesions evaluated (n)3535Number of lesions per patient treated (n)- 1- 2-
Ͼ
2 26 3 1 26 3 1 0.38
#
 Number of treatments- second treatment of the same lesion30 038 8 
0
 .
005
*
 
Mean maximum diameter of lesions (mm) (range)34 (7 – 53)33 (8 – 53) 0.64
ϩ
 
Palliative chemotherapy prior to local therapy
n
(%)20 (67)23 (77)0.57
*
 Previous local therapy for liver metastases (other than RFA or RRS)
n
(%)- no- yessurgerySIRT/embolization/LITT 10 (33) 20 (67) 20 (67) 1 (3) 14 (47) 16 (53) 14 (47) 3 (10) 0.19
*
 0.61
*
 Median Time SinceDiagnosis (Months, Range)35.0(6–96)24.8(2–138)0.88
°
*
 Fishers exact test;
ϩ
 
Mann-Whitney U-test;
#
 
χ
 ²-test;
°
 log-rank test significant p-values are boldtyped.
   A  c   t  a   O  n  c  o   l   D  o  w  n   l  o  a   d  e   d   f  r  o  m    i  n   f  o  r  m  a   h  e  a   l   t   h  c  a  r  e .  c  o  m    b  y   U  n   i  v  e  r  s   i   t  y  o   f   S  o  u   t   h  e  r  n   C  a   l   i   f  o  r  n   i  a  o  n   0   2   /   1   4   /   1   3   F  o  r  p  e  r  s  o  n  a   l  u  s  e  o  n   l  y .

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