Tatjana Gruber-Rouh

Microwave Ablation Therapy: Clinical Utility in Treatment of Pulmonary Metastases

PURPOSE To prospectively evaluate the safety and efficacy of microwave ablation therapy of unresectable pulmonary metastases. MATERIALS AND METHODS All patients provided informed consent for this prospective institutional review board-approved study. Eighty patients (30 men, 50 women; mean age, 59.7 years ± 6.4; range, 48-68 years) underwent computed tomography-guided percutaneous microwave ablation of pulmonary metastatic lesions in 130 sessions. The tumors represented metastases from colorectal carcinoma, breast carcinoma, hepatocellular carcinoma, renal cell carcinoma, and bronchogenic carcinoma; there was no evidence of extrapulmonary metastasis for any tumor. Logistic regression analysis was used for evaluation of the statistical significance of factors affecting the end result of microwave ablation therapy. The Kaplan-Meier method was used for estimation of survival rates. RESULTS Complete, successful ablation was achieved in 95 (73.1%) of 130 lesions. Successful tumor ablation was significantly more frequent for lesions with a maximal axial diameter of 3 cm or smaller (90 of 110) than for lesions greater than 3 cm in maximal axial diameter (five of 20) (P < .0001) and for peripheral lesions (80 [80%] of 100) than for centrally located lesions (15 [50%] of 30) (P = .002). The histopathologic type of the metastasis did not significantly correlate with the ablation result (P > .3). The 12- and 24-month survival rates were 91.3% and 75%, respectively. There was no intraprocedural death, and the overall 60-day mortality rate after ablation was 0%. Higher survival rates were observed in patients with tumor-free states after successful ablation than in patients with failed ablation (P = .001). The incidence of pneumothorax was 8.5% (11 of 130). An intercostal chest tube was applied in one (0.8%) of the 11 sessions. Pulmonary hemorrhage developed in eight (6.2%) of 130 sessions. CONCLUSION Microwave ablation therapy may be safely and effectively used as a therapeutic tool for treatment of pulmonary metastases. The efficacy of the treatment is primarily determined by preablation tumor size and location in relation to the hilum.

MR-compatible Assistance System for Biopsy in a High-Field-Strength System: Initial Results in Patients with Suspicious Prostate Lesions

PURPOSE To examine the feasibility and safety of magnetic resonance (MR)-guided biopsy by using a transgluteal approach in patients with suspicious prostate lesions by using an MR-compatible robotic system and a 1.5-T MR system. MATERIALS AND METHODS The study was approved by the institutional review board of University Frankfurt, and informed consent was obtained from each patient. A total of 20 patients (age range, 57.8-71.9 years; mean age, 65.1 years) underwent biopsy in a closed-bore high-field-strength MR system. Biopsy was performed with an MR-compatible pneumatically driven robotic system. T1-weighted gradient-echo fast low-angle shot and T2-weighted true fast imaging with steady-state precession sequences were used to plan and guide the intervention with a transgluteal access on the external planning computer of the assistance system. The system calculated the trajectory and then moved the guiding arm to the insertion point. The cannula was advanced manually, and biopsies were performed with the coaxial technique by using a 15-gauge pencil tip needle. Intervention time, complications, and biopsy findings were documented. RESULTS The MR-compatible robotic system did not interfere with image quality, nor did MR imaging cause dysfunction of the robot. In one patient, the interventionist caused a fail-safe system shutdown. This was due to inadvertent displacement of the guiding arm during cannula insertion. This problem was solved by increasing the displacement threshold. Accurate coaxial cannula biopsy could be performed in all subsequent patients. Sufficient histopathologic assessment was performed in 19 patients. Insufficient material was retrieved in the patient who experienced fail-safe system shutdown. The median intervention time was 39 minutes (23-65 minutes). No procedure-related complications were observed. CONCLUSION Preliminary results indicate that MR-guided robot-assisted biopsy is feasible and can be performed safely with highly accurate cannula placement.

Transarterial chemoembolization in the treatment of patients with unresectable cholangiocarcinoma: Results and prognostic factors governing treatment success

The aim of the study was to evaluate the effectiveness of transarterial chemoembolization (TACE) with four chemotherapeutic protocols in terms of local tumor control and survival of patients with unresectable cholangiocarcinoma (CCC) and to identify the prognostic factors governing treatment success. In the single‐centre study, 115 patients (mean ages = 60.4 years) with unresectable CCC were repeatedly treated with TACE. In total, 819 chemoembolization sessions were performed in 4 week intervals with a mean of 7.1 (range, 3–30) sessions per patient. The chemotherapeutic used was Mitomycin C only in 20.9% of patients, Gemcitabine only in 7%, Mitomycin C with Gemcitabine in 47% and combination of Gemcitabine, Mitomycin C and Cisplatin in 25.1%. Local tumor response was evaluated by MRI according to RECIST. Survival data were calculated according to the Kaplan–Meier method. Prognostic factors for patients survival were evaluated using log‐rank‐test. The local tumor controls were: partial response 8.7%, stable disease 57.4% and progressive disease 33.9% of patients. The median and mean survival times from the start of TACE were 13 and 20.8 months. Survival rate from the start of TACE was 52% after 1‐year, 29% after 2‐years and 10% after 3‐years. Initial tumor response, high tumor vascularity and Child‐Pugh class A were statistically significant factors for patients survival. No statistically significant difference between patients treated with different chemotherapy protocols was noted. In conclusion, TACE is a palliative and safe treatment option for patients with unresectable CCC. Child Pugh class B, tumor hypovascularity and initially progressive disease were poor prognostic factors for patient survival.

First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)

The objective of this pilot clinical study was to assess the safety, technical feasibility, pharmacokinetic (PK) profile and tumour response of DC Bead™ with irinotecan (DEBIRI™) delivered by intra-arterial embolisation for the treatment of metastatic colorectal cancer. Eleven patients with unresectable liver metastases from CRC, tumour burden <30% of liver volume, adequate haematological, liver and renal function, performance status of <2 were included in this study. Patients received up to 4 sessions of TACE with DEBIRI at 3-week intervals. Feasibility of the procedure, safety and tumour response were assessed after each cycle. PK was measured after the first cycle. Patients were followed up to 24 weeks. Only mild to moderate adverse events were observed. DEBIRI is a technically feasibile procedure; no technical complications were observed. Average Cmax for irinotecan and SN-38 was 194 ng/ml and 16.7 ng/ml, respectively, with average t½ of 4.6 h and 12.4 h following administration of DEBIRI. Best overall response during the study showed disease control in 9 patients (2 patients with partial response and 7 with stable disease, overall response rate of 18%). Our study shows that transarterial chemoembolisation with irinotecan-loaded DC beads (DEBIRI) is safe, technically feasible and effective with a good PK profile.

Transarterial chemoembolization of unresectable systemic chemotherapy-refractory liver metastases from colorectal cancer: long-term results over a 10-year period.

The aims of the study were to evaluate therapeutic efficacy and to determine the prognostic factors for treatment success in patients with liver metastases from colorectal cancer (CRC) treated with transarterial chemoembolization (TACE). A total of 564 patients (mean age, 60.3 years) with liver metastases of CRC were repeatedly treated with TACE. In total, 3,384 TACE procedures were performed (mean, six sessions per patient). The local chemotherapy protocol consisted of mitomycin C alone (43.1%), mitomycin C with gemcitabine (27.1%), mitomycin C with irinotecan (15.6%) or mitomycin C with irinotecan and cisplatin (15.6%). Embolization was performed with lipiodol and starch microspheres. Tumor response was evaluated using magnetic resonance imaging or computed tomography. The change in tumor size was calculated and the response was evaluated according to the RECIST‐Criteria. Survival rates were calculated according to the Kaplan–Meier method. Prognostic factors for patients survival were evaluated using log‐rank test. Evaluation of local tumor control showed partial response in 16.7%, stable disease in 48.2% and progressive disease in 16.7%. The 1‐year survival rate after chemoembolization was 62%, the 2‐year survival rate was 28% and the 3‐year survival rate was 7%. Median survival from the start of chemoembolization treatment was 14.3 months. The indication (p = 0.001) and initial tumor response (p = 0.015) were statistically significant factors for patients survival. TACE is a minimally invasive therapy option for controlling local metastases and improving survival time in patients with hepatic metastases from CRC. TN stage, extrahepatic metastases, number of lesions, tumor location within the liver and choice of chemotherapy protocol of TACE are none significant factors for patients survival.

Transarterial chemoembolisation (TACE) with gemcitabine: Phase II study in patients with liver metastases of breast cancer

OBJECTIVE Evaluation of the efficacy and tolerability of transarterial chemoembolization with gemcitabine in patients with inoperable liver metastases of breast cancer. MATERIALS AND METHODS Open-label, prospective non-randomized single-center study design; patients had previous chemotherapy including anthracyclines and/or taxanes in the metastatic setting, adequate bone marrow reserve, sufficient liver/renal function, no centralnervous system metastases, Karnovsky-performance-status >70%, and life expectancy >12 weeks. Forty-three patients were enrolled (median 58 years, range 48-71). A suspension of gemcitabine 1.200mg/m(2), 2-10 ml/m(2) of Lipiodol, and 5 ml of a degradable starch microsphere (Embocept) suspension, were administered intra-arterially up to 3 times with a 4-weaks-interval. Dose-limiting toxicit is defined as grade 4 thrombocytopenia, neutropenia, or nonhematologic toxicity>grade 3. Tumor response was evaluated by magnetic resonance (MRI) and computed tomography (CT) imaging. RESULTS All patients tolerated the treatment well; with no dose limiting toxicities. Imaging follow-up according to the RECIST-criteria (Response Evaluation Criteria in Solid Tumors) revealed a partial response in 3 patients, stable disease in 16 patients and progression in 22 patients. The progression free survival was 3.3 months. A significant correlation exists only with the factor vascularization: strongly vascularized tumors show a significantly lowered response. Patients with complete or partial response and the main fraction of the stable disease group showed in the MRI and angiography only a moderate vascularization. The resulting estimate of the total survival rate amounts to a median of 10.2 months. CONCLUSION Transarterial chemoembolization with gemcitabine is well tolerated and provides an alternative treatment method for patients with liver metastases of breast cancer.

Factors Influencing Local Tumor Control in Patients With Neoplastic Pulmonary Nodules Treated With Microwave Ablation: A Risk-Factor Analysis

OBJECTIVE This study was performed to evaluate risk factors predictive of local tumor control after microwave ablation of primary and secondary lung malignancies up to 3 cm in maximal diameter. MATERIALS AND METHODS The single-antenna microwave ablation treatment of 91 index tumors in 57 patients was studied retrospectively. Time to local tumor progression was monitored on CT scans over the follow-up period. Estimation of overall time to local tumor progression was performed with the Cox regression model. Factors hypothesized to correlate with ablation response included tumor diameter, tumor shape (round or oval versus irregular), clear versus ill-defined tumor margin, adjacency to the pleura, adjacency to bronchi, presence of vessels at least 3 mm in diameter a maximum of 5 mm from the index tumor, energy applied to the index tumor, and the occurrence of cavernous formations after ablation. A logistic regression model was used to correlate the data. RESULTS Thirty of 91 (33.0%) index tumors, found in 21 of 57 (36.8%) patients, underwent local progression. The mean time to local tumor progression was 8.3 ± 5.5 months (range 2.1-25.2 months), and the estimated median time to local tumor progression was 22.6 ± 12.4 months. The risk factors that correlated significantly with local tumor progression were a maximal diameter greater than 15.5 mm (p < 0.01), irregular shape of the index tumor (p < 0.01), pleural contact (p = 0.02), and less than 26.7 J/mm(3) applied to the index tumor (p < 0.001). After regression analysis, shape of the index tumor (p = 0.03) and energy deployed per unit volume of the index tumor (p = 0.001) were found to be independent risk factors. Conversely, tumor margin definition (p = 0.06) and proximity of cavernous formations (p = 0.19), juxtatumoral vessels (p = 0.08), and bronchi (p = 0.89) did not affect tumor progression after ablation. CONCLUSION The independent predictive factors for local tumor progression in primary and secondary lung neoplasms up to 3 cm in diameter observed in this study were irregular shape of the index tumor and energy application of less than 26.7 J/mm(3) to the index tumor.

Thermal Ablation of Colorectal Lung Metastases: Retrospective Comparison Among Laser-Induced Thermotherapy, Radiofrequency Ablation, and Microwave Ablation

OBJECTIVE The purpose of this study is to retrospectively evaluate local tumor control, time to tumor progression, and survival rates among patients with lung metastatic colorectal cancer who have undergone ablation therapy performed using laser-induced thermotherapy (LITT), radiofrequency ablation (RFA), or microwave ablation (MWA). MATERIALS AND METHODS Data for this retrospective study were collected from 231 CT-guided ablation sessions performed for 109 patients (71 men and 38 women; mean [± SD] age, 68.6 ± 11.2 years; range, 34-94 years) from May 2000 to May 2014. Twenty-one patients underwent LITT (31 ablations), 41 patients underwent RFA (75 ablations), and 47 patients underwent MWA (125 ablations). CT scans were acquired 24 hours after each therapy session and at follow-up visits occurring at 3, 6, 12, 18, and 24 months after ablation. Survival rates were calculated from the time of the first ablation session, with the use of Kaplan-Meier and log-rank tests. Changes in the volume of the ablated lesions were measured using the Kruskal-Wallis method. RESULTS Local tumor control was achieved in 17 of 25 lesions (68.0%) treated with LITT, 45 of 65 lesions (69.2%) treated with RFA, and 91 of 103 lesions (88.3%) treated with MWA. Statistically significant differences were noted when MWA was compared with LITT at 18 months after ablation (p = 0.01) and when MWA was compared with RFA at 6 months (p = 0.004) and 18 months (p = 0.01) after ablation. The overall median time to local tumor progression was 7.6 months. The median time to local tumor progression was 10.4 months for lesions treated with LITT, 7.2 months for lesions treated with RFA, and 7.5 months for lesions treated with MWA, with no statistically significant difference noted. New pulmonary metastases developed in 47.6% of patients treated with LITT, in 51.2% of patients treated with RFA, and in 53.2% of patients treated with MWA. According to the Kaplan-Meier test, median survival was 22.1 months for patients who underwent LITT, 24.2 months for those receiving RFA, and 32.8 months for those who underwent MWA. The overall survival rate at 1, 2, and 4 years was 95.2%, 47.6%, and 23.8%, respectively, for patients treated with LITT; 76.9%, 50.8%, and 8.0%, respectively, for patients treated with RFA; and 82.7%, 67.5%, and 16.6%, respectively, for patients treated with MWA. The log-rank test revealed no statistically significant difference among LITT, RFA, and MWA. The progression-free survival rate at 1, 2, 3, and 4 years was 96.8%, 52.7%, 24.0%, and 19.1%, respectively, for patients who underwent LITT; 77.3%, 50.2%, 30.8%, and 16.4%, respectively, for patients who underwent RFA; and 54.6%, 29.1%, 10.0%, and 1.0%, respectively, for patients who underwent MWA, with no statistically significant difference noted among the three ablation methods. CONCLUSION LITT, RFA, and MWA can be used as therapeutic options for lung metastases resulting from colorectal cancer. Statistically significant differences in local tumor control revealed a potential advantage in using MWA. No differences in time to tumor progression or survival rates were detected when the three different ablation methods were compared.

Repetitive transarterial chemoembolization (TACE) of liver metastases from gastric cancer: Local control and survival results

OBJECTIVE To evaluate the local tumor control and survival data after transarterial chemoembolization with different drug combinations in the palliative treatment of patients with liver metastases of gastric cancer. MATERIALS AND METHODS The study was retrospectively performed. 56 patients (mean age, 52.4) with unresectable liver metastases of gastric cancer who did not respond to systemic chemotherapy were repeatedly treated with TACE in 4-week intervals. In total, 310 chemoembolization procedures were performed (mean, 5.5 sessions per patient). The local chemotherapy protocol consisted of mitomycin alone (30.4%), mitomycin and gemcitabine (33.9%), or mitomycin, gemcitabine and cisplatin (35.7%). Embolization was performed with lipiodol and starch microspheres. Local tumor response was evaluated by MRI according to RECIST. Survival data from first chemoembolization were calculated according to the Kaplan-Meier method. RESULTS The local tumor control was: complete response in 1.8% (n=1), partial response in 1.8% (n=1), stable disease in 51.8% (n=29) and progressive disease in 44.6% (n=25) of patients. The 1-, 2-, and 3-year survival rate from the start of chemoembolization were 58%, 38%, and 23% respectively. The median and mean survival times were 13 and 27.1 months. A Statistically significant difference between patients treated with different chemotherapy protocols was noted (ρ=0.045) with the best survival time in the mitomycin, gemcitabine and cisplatin group. CONCLUSION Transarterial chemoembolization is a minimally invasive therapy option for palliative treatment of liver metastases in patients with gastric cancer.

Direct lymphangiography as treatment option of lymphatic leakage: Indications, outcomes and role in patient's management

BACKGROUND To evaluate the effectiveness of lymphography as a minimally invasive treatment option of lymphatic leakage in terms of local control and to investigate which parameters influence the success rate. METHOD This retrospective study protocol was approved by the ethic committee. Patient history, imaging data, therapeutic options and follow-up were recorded and retrospectively analyzed. Between June 1998 and February 2013, 71 patients (m:w = 42:29, mean age, 52.4; range 42–75 years) with lymphatic leakage in form of lymphatic fistulas (n = 37), lymphocele (n = 11), chylothorax (n = 13) and chylous ascites (n = 10)underwent lymphography. Sixty-four patients (90.1%) underwent successful lymphography while lymphography failed in 7 cases. Therapeutic success was evaluated and correlated to the volume of lymphatic leakage and to the volume of the applied iodized oil. RESULT Signs of leakage or contrast extravasation were directly detected in 64 patients. Of 64 patients, 45 patients (70.3%) were treated and cured after lymphography. Based on the lymphography findings, 19 patients (29.7%) underwent surgical intervention with a completely occlusion of lymphatic leakage. The lymphatic leak could be completely occluded in 96.8% of patients when the lymphatic drainage volume was less than 200 mL/day (n = 33). Even when lymphatic drainage was higher than 200 mL/day (n = 31),therapeutic lymphography was still successful in 58.1% of the patients. CONCLUSION Lymphography is an effective, minimally invasive method in the detection and treatment of lymphatic leakage. The volume of lymphatic drainage per day is a significant predictor of the therapeutic success rate.