Bernhard Gebauer

Survival advantage for irinotecan versus best supportive care as second-line chemotherapy in gastric cancer – A randomised phase III study of the Arbeitsgemeinschaft Internistische Onkologie (AIO)

BACKGROUND The value of second-line therapy for metastatic gastric cancer is unclear. So far there are no randomised phase III data comparing second-line chemotherapy to best supportive care (BSC). In this prospective, multicenter, open label, randomised phase III study we compared irinotecan to BSC to evaluate the impact on survival of second-line chemotherapy. METHODS Eligible patients (pts) had metastatic or locally advanced gastro-oesophageal junction or gastric adenocarcinoma, objective tumour progression during or within 6months after first-line chemotherapy and ECOG performance status 0-2. Stratification for time of progression after first-line therapy, ECOG PS and pretreatment secured even distribution of important prognostic factors. TREATMENT Arm A: Irinotecan 250mg/m(2)q3w (first cycle) to be increased to 350mg/m(2), depending on toxicity. Arm B: BSC. FINDINGS Between 10/2002 and 12/2006 40 pts were randomised. The study was closed prematurely due to poor accrual. Responsefor arm A (19 pts evaluable): No objective responses, SD 53%, PD 47%. Improvement of tumour related symptoms: Arm A 50% of pts, arm B 7%. Overall Survival: (all events in 40 pts have occurred): The hazard ratio for death was reduced to 0.48 (95%CI 0.25-0.92) in the irinotecan-arm (p=0.012). Median survival arm A: 4.0months (95% CI 3.6-7.5), arm B: 2.4months (95% CI 1.7-4.9). INTERPRETATION Irinotecan as second-line chemotherapy significantly prolongs overall survival compared to BSC in the studied pts. Second-line chemotherapy can now be considered as a proven treatment option for metastatic or locally advanced gastric cancer. FUNDING The study was supported by a research grant from Aventis and Pfizer.

Image-guided surgery of liver metastases by three-dimensional ultrasound-based optoelectronic navigation

Vessel‐oriented surgery and tumour‐free resection margins are essential for resection of liver metastases to preserve liver parenchyma and improve oncological outcome. Preoperative three‐dimensional models reconstructed from imaging data could facilitate surgical planning with the use of navigation technology.

Osteoid Osteoma: Experience with Laser- and Radiofrequency-Induced Ablation

The purpose of this study was to analyze the clinical outcome of osteoid osteoma treated by thermal ablation after drill opening. A total of 17 patients and 20 procedures were included. All patients had typical clinical features (age, pain) and a typical radiograph showing a nidus. In 5 cases, additional histological specimens were acquired. After drill opening of the osteoid osteoma nidus, 12 thermal ablations were induced by laser interstitial thermal therapy (LITT) (9F Power-Laser-Set; Somatex, Germany) and 8 ablations by radiofrequency ablation (RFA) (RITA; StarBurst, USA). Initial clinical success with pain relief has been achieved in all patients after the first ablation. Three patients had an osteoid osteoma recurrence after 3, 9, and 10 months and were successfully re-treated by thermal ablation. No major complication and one minor complication (sensible defect) were recorded. Thermal ablation is a safe and minimally invasive therapy option for osteoid osteoma. Although the groups are too small for a comparative analysis, we determined no difference between laser- and radiofrequency-induced ablation in clinical outcome after ablation.

Magnetic resonance-guided biopsy of suspicious breast lesions with a handheld vacuum biopsy device.

Purpose: To evaluate a handheld vacuum-assisted device system for magnetic resonance image (MRI)-guided breast lesion biopsy. Material and Methods: In 32 patients, a total of 42 suspicious breast lesions (mean diameter 7.5 mm for mass lesions, 11.6 mm for non-masslike diffuse lesions) seen with MRI (no suspicious changes in breast ultrasound or mammography) were biopsied (27 lateral, 15 medial) using a 10G vacuum-assisted breast biopsy device under MR guidance. Histology of biopsy specimens was compared with final histology after surgery or follow-up in benign lesions. Results: In all biopsies, technical success was achieved. Histology revealed 11 lesions with ductal carcinoma in situ (DCIS) or invasive cancer, three with intermediate lesions (LCIS) and 28 with benign breast lesions (adenosis, infected hematoma). In one patient with discordant results of MRI and histology, surgical excision revealed medullary cancer. In the follow-up (mean 18 months) of the histological benign lesions, no breast cancer development was observed. Besides minor complications (hematoma, n = 6), with no further therapeutic interventions, no complications occurred. Conclusion: MRI-guided breast lesion biopsy using a handheld vacuum-assisted device is a safe and effective method for the work-up of suspicious lesions seen with breast MRI without changes in mammography or ultrasound. In the case of discordant histology of vacuum biopsy and breast MRI appearance, surgical excision is recommended.

Radiological Interventions for Correction of Central Venous Port Catheter Migrations

PurposeThe purpose of this study was to evaluate radiological-interventional central venous port catheter corrections in migrated/malpositioned catheter tips.Materials and MethodsThirty patients with migrated/malpositioned port catheter tips were included in this retrospective analysis. To visualize the catheter patency a contrast-enhanced port catheter series was performed, followed by transfemoral port catheter correction with various 5-F angiographic catheters (pigtail; Sos Omni), gooseneck snares, or combinations thereof.ResultsOne patient showed spontaneous reposition of the catheter tip. In 27 of 29 patients (93%), radiological-interventional port catheter correction was successful. In two patients port catheter malposition correction was not possible, because of the inability to catch either the catheter tip or the catheter in its course, possibly due to fibrin sheath formation with attachment of the catheter to the vessel wall. No disconnection or port catheter dysfunction was observed after correction.ConclusionsWe conclude that in migrated catheter tips radiological-interventional port catheter correction is a minimally invasive alternative to port extraction and reimplantation. In patients with a fibrin sheath and/or thrombosis port catheter correction is often more challenging.

Response to Preoperative Short-Course Radiotherapy in Locally Advanced Rectal Cancer: Value of 18F-Fluorodeoxyglucose Positron Emission Tomography

Background:18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is increasingly used to monitor response to multimodality cancer treatment. Preoperative short-course radiotherapy (SCRT) has been shown to improve outcome in locally advanced rectal cancer (LARC). We evaluated the value of FDGPET in monitoring response to SCRT. Patients and Methods: 32 patients with LARC scheduled for SCRT underwent FDG-PET, magnetic resonance imaging and endorectal ultrasound both before and after SCRT. A comparison group of 16 patients, undergoing preoperative radiochemotherapy (RCT), received an extra FDG-PET 17 days after starting RCT (effective dose of 30.6 Gy). For response assessment, FDG uptake (maximum standardized uptake value, SUVmax), percent SUVmax difference, tumor regression grade (TRG), and UICC downstaging and downsizing were considered. Results: SCRT resulted in a significant median SUVmax reduction of 39.3%. Median SUVmax reduction did differ between SCRT and the early scans after 17 days of RCT (39.3 vs. 50.8%). Downstaging after SCRT was observed in 16/32, downsizing in 7/32 patients. There was no correlation between SUVmax reduction and downstaging/ downsizing or TRG. Conclusion: For the first time, we were able to demonstrate functional response after SCRT. In contrast to morphological imaging and histopathology, our results indicate that FDG-PET can monitor early effects of SCRT. Further followup is warranted to establish SUVmax reduction as a surrogate marker for the response of SCRT.

Portal vein embolization with plug/coils improves hepatectomy outcome

BACKGROUND Portal vein embolization (PVE) has become the standard of care before extended hepatectomy. Various PVE methods using different embolization materials have been described. In this study, we compared PVE with polyvinyl alcohol particles alone (PVA only) versus PVA with plug or coils (PVA + plug/coils). MATERIALS AND METHODS Patients undergoing PVE before hepatectomy were included. PVA alone was used until December 2013, thereafter plug or coils were placed in addition. The volume of left lateral liver lobe (LLL), clinical parameters, and liver function tests were measured before PVE and resection. RESULTS A total of 43 patients were recruited into the PVA only group and 42 were recruited into the PVA + plug/coils group. There were no major differences between groups except significantly higher total bilirubin level before PVE in the PVA only group, which improved before hepatectomy. Mean LLL volume increased by 25.7% after PVE in the PVA only group and by 44% in the PVA + plug/coils group (P < 0.001). Recanalization was significantly less common in the PVA + plug/coils group. In multivariate regression, initial LLL volume and use of plug or coils were the only parameters influencing LLL volume increase. The postoperative liver failure rate was significantly reduced in PVA + plug/coils group (P = <0.001). CONCLUSIONS PVE using PVA particles together with plug or coils is a safe and efficient method to increase future liver remnant volume. The additional central embolization with plug or coils led to an increased hypertrophy, due to lower recanalization rates, and subsequently decreased incidence of postoperative liver failure. No additional procedure-specific complications were observed in this series.

Computed-tomography-guided high-dose-rate brachytherapy (CT-HDRBT) ablation of metastases adjacent to the liver hilum

PURPOSE To evaluate technical feasibility and clinical outcome of computed tomography-guided high-dose-rate-brachytherapy (CT-HDRBT) ablation of metastases adjacent to the liver hilum. MATERIALS AND METHODS Between November 2007 and May 2012, 32 consecutive patients with 34 metastases adjacent to the liver hilum (common bile duct or hepatic bifurcation ≤5 mm distance) were treated with CT-HDRBT. Treatment was performed by CT-guided applicator placement and high-dose-rate brachytherapy with an iridium-192 source. MRI follow-up was performed 6 weeks and every 3 months post intervention. The primary endpoint was local tumor control (LTC); secondary endpoints included time to progression (TTP) and overall survival (OS). RESULTS Patients were available for MRI evaluation for a mean follow-up time of 18.75 months (range: 3-56 months). Mean tumor diameter was 4.3 cm (range: 1.3-10.7 cm). One major complication was observed. Four (11.8%) local recurrences were observed after a local tumor control of 5, 8, 9 and 10 months, respectively. Twenty-two patients (68.75%) experienced a systemic tumor progression during the follow up period. Mean TTP was 12.9 months (range: 2-56 months). Nine patients died during the follow-up period. Median OS was 20.24 months. CONCLUSION Minimally invasive CT-HDRBT is a safe and effective option also for unresectable liver metastases adjacent to the liver hilum that would have been untreatable by thermal ablation.

Clinical practice in radioembolization of hepatic malignancies: A survey among interventional centers in Europe

OBJECTIVES A survey was conducted to give an overview about the practice of radioembolization in malignant liver tumors by European centers. METHODS A questionnaire of 23 questions about the interventional center, preinterventional patient evaluation, the radioembolization procedure and aftercare were sent to 45 European centers. RESULTS The response rate was 62.2% (28/45). The centers performed 1000 (median = 26) radioembolizations in 2009 and 1292 (median = 40) in 2010. Most centers perform preinterventional evaluation and radioembolization on an inpatient basis. An arterioportal shunt not amendable to preinterventional embolization is considered a contraindication. During preinterventional angiography, the gastroduodenal artery is embolized by 71%, the right gastric artery by 59%, and the cystic artery by 41%. In case of bilobar disease, yttrium-90 microspheres are infused into the common hepatic artery (14%) or separately into left and right hepatic artery (86%). 33% prefer a time interval between right and left liver lobe radioembolization to prevent radiation induced liver disease. 43% of the respondents do not prescribe prophylactic medication after radioembolization. In case of iatrogenic manipulation to the biliary duct system most centers perform radioembolization with prophylactic antibiotics. CONCLUSIONS Despite standardization of the procedure, there are some differences in how radioembolization of liver tumors is performed in Europe.

Sonographically guided venous puncture and fluoroscopically guided placement of tunneled, large-bore central venous catheters for bone marrow transplantation—high success rates and low complication rates

Background and objectiveTraditionally, large lumen, tunneled central venous catheters have been implanted by surgeons. We used a technique of sonographically guided jugular venous puncture and fluoroscopically guided catheter placement to achieve a high rate of technical success and to reduce complication rates.Materials and methodsBetween June 2002 and December 2006, 186 Patients have been referred to the Radiology Department for 211 implantations of large-lumen, tunneled, central venous catheters. Insertions were performed under maximum sterile barrier in the angio suite using combined sonographic guidance for puncture of the internal jugular vein and fluoroscopy for placement of a triple lumen 12.5 F catheter (Hickman, BARD Murray Hill, NJ, USA).All interventions were performed under local anesthesia without need for anesthesiologic surveillance. Peri- and postinterventional complications were recorded using standardized international recommendations.ResultsCatheter implantation was technically successful in 207 of 211 cases (98.1%). Technical failure resulted in four patients due to chronic occlusions of the superior vena cava. No major complications were recorded. Four (1.9%) accidental arterial punctures occurred periinterventionally; 24 (11.4%) early complications (bleeding, dysfunction, catheter rupture, and infection) and ten (4.7%) late complications (infection, dysfunction) were recorded. A clinically suspected catheter infection required catheter removal in 21 (10%) cases; 11 of 13 non-infectious catheter complications (bleeding, dysfunction, rupture) could be treated successfully by interventional-radiological treatment.ConclusionPercutaneous implantation of large-lumen, tunneled, central venous catheters can be achieved with a high technical success rate and a low complication rate under combined sonographic and fluoroscopic guidance. In cases of mechanical complications, catheter rescue by interventional techniques is possible in the vast majority of cases.