Prospective evaluation of percutaneous hepatic perfusion with melphalan as a treatment for unresectable liver metastases from colorectal cancer.

PURPOSE: Percutaneous hepatic perfusion with melphalan (M-PHP) is increasingly used in patients with liver metastases from various primary tumors, yet data on colorectal liver metastases (CRLM) are limited. The aim of this study was to prospectively evaluate the efficacy and safety of M-PHP in patients with CRLM. MATERIALS AND METHODS: Prospective, single-center, single-arm phase II study of M-PHP with hemofiltration in patients with unresectable CRLM. Proven, extrahepatic metastatic disease was one of the exclusion criteria. Primary outcomes were overall response rate (ORR) and best overall response (BOR). Secondary outcomes were overall survival (OS), progression-free survival (PFS), hepatic PFS (hPFS), and safety. RESULTS: A total of 14 M-PHP procedures were performed in eight patients between March 2014 and December 2015. All patients (median age 56 years, ranging from 46 to 68) had received (extensive) systemic chemotherapy before entering the study. The ORR was 25.0%, with two out of eight patients showing partial response as BOR. Median OS was 17.3 months (ranging from 2.6 to 30.9) with a one-year OS of 50.0%. Median PFS and hPFS were 4.4 and 4.5 months, respectively. No serious adverse events occurred. Grade 3/4 hematologic adverse events were observed in the majority of patients, though all were transient and well-manageable. CONCLUSION: M-PHP is a safe procedure with only limited efficacy in patients with unresectable CRLM who already showed progression of disease after receiving one or more systemic treatment regimens.

Assessing the value of volume navigation during ultrasound-guided radiofrequency- and microwave-ablations of liver lesions.

PURPOSE: The goal of our study was to determine the influence of ultrasound (US)-coupled volume navigation on the use of computed tomography (CT) during minimally-invasive radiofrequency and microwave ablation procedures of liver lesions. METHOD: Twenty-five patients with 40 liver lesions of different histological origin were retrospectively analysed. Lesions were ablated following standard protocol, using 1) conventional US-guidance, 2) manual registered volume navigation (mVNav), 3) automatic registered (aVNav) or 4) CT-guidance. In case of ultrasonographically inconspicuous lesions, conventional US-guidance was abandoned and mVNav was used. If mVNav was also unsuccessful, the procedure was either continued with aVNav or CT-guidance. The number, size and location of the lesions targeted using the different approaches were documented. RESULTS: Of the 40 lesions, sixteen (40.0 %) could be targeted with conventional US-guidance only, sixteen (40.0 %) with mVNav, three (7.5 %) with aVNav and five (12.5 %) only through the use of CT-guidance. Of the three alternatives (mVNav, aVNav and CT only) the mean size of the lesions targeted using mVNav (9.1 ± 4.6 mm) was significantly smaller from those targeted using US-guidance only (20.4 ± 9.4 mm; p < 0.001). The location of the lesions did not influence the selection of the modality used to guide the ablation. CONCLUSIONS: In our cohort, mVNav allowed the ablation procedure to become less dependent on the use of CT. mVNav supported the ablation of lesions smaller than those that could be ablated with US only and doubled the application of minimally-invasive US-guided ablations.

Percutaneous Hepatic Perfusion with Melphalan in Patients with Unresectable Ocular Melanoma Metastases Confined to the Liver: A Prospective Phase II Study.

BACKGROUND: Ocular melanoma is the most common primary intraocular malignancy and has a very poor prognosis once liver metastases occur. The aim of this study was to prospectively assess the efficacy and safety of percutaneous hepatic perfusion with melphalan (M-PHP) using the new second-generation (GEN 2) hemofiltration system in patients with ocular melanoma metastases confined to the liver. METHODS: Prospective, single-center, single-arm, phase II study including patients with unresectable ocular melanoma metastases confined to the liver. Treatment consisted of two M-PHP procedures at 6-8 weeks interval. Procedures were performed using the CHEMOSAT (GEN 2) system with 3 mg/kg melphalan. Primary endpoints were overall response rate (ORR) and best overall response (BOR). Secondary endpoints included overall survival (OS), progression-free survival (PFS), hepatic PFS (hPFS), and safety. RESULTS: Sixty-four M-PHP procedures were performed in 35 patients between February 2014 and June 2017. The ORR was 72%. BOR was as follows: complete response in 3%, partial response in 69%, stable disease in 13%, and progressive disease in 16%. There was no treatment-related mortality. Fourteen serious adverse events occurred. At a median follow-up of 19.1 months (range 5.6-69.5), median OS was 19.1 months and was significantly longer in responders than in nonresponders (27.5 vs. 11.9 months, p < 0.001). The 1- and 2-year OS was 77% and 43%, respectively. PFS and hPFS were 7.6 and 11.2 months, respectively. CONCLUSIONS: M-PHP using the GEN 2 filter can achieve a high ORR and prolonged survival in patients with liver-only ocular melanoma metastases.

Central venous access related adverse events after trabectedin infusions in soft tissue sarcoma patients; experience and management in a nationwide multi-center study.

BACKGROUND: Trabectedin has shown efficacy against soft tissue sarcomas (STS) and has manageable toxicity. Trabectedin is administered through central venous access devices (VAD), such as subcutaneous ports with tunneled catheters, Hickman catheters and PICC lines. Venous access related adverse events are common, but have not yet been reported in detail. METHODS: A retrospective analysis of patient files of STS patients receiving trabectedin monotherapy between 1999 and 2014 was performed in all five STS referral centers in the Netherlands. This survey focused on adverse events related to the VAD and the actions taken in response to these events. RESULTS: In the 127 patients included in this analysis, 102 venous access ports (VAP), 15 Hickman catheters and 10 PICC lines were used as primary means of central venous access. The most frequently reported adverse events at the VAD site were erythema (30.7%), pain (28.3%), inflammation (11.8%) and thrombosis (11.0%). Actions taken towards these adverse events include oral antibiotics (17.3%), VAD replacement (15.0%) or a wait-and-see policy (13.4%). In total, 45 patients (35.4%) with a subcutaneous port developed a varying degree of inflammation along the trajectory of the tunneled catheter. In all but three patients, this was a sterile inflammation, which was considered a unique phenomenon for trabectedin. Microscopic leakage of trabectedin along the venous access device and catheter was considered the most plausible cause for this adverse event. Placing the catheter deeper under the skin resolved the issue almost completely. CONCLUSION: Trabectedin infusion commonly leads to central venous access related adverse events. Sterile inflammation along the catheter trajectory is one of the most common adverse events and can be prevented by placing the catheter deeper under the skin.

[Ascites drainage at home]. / Ascitesdrainage in de thuissituatie.

Ascites can lead to many symptoms, and often occurs in patients with an end-stage malignancy such as ovarian, pancreatic, colonic, or gastric cancer. Intermittent ascites drainage is applied in these patients as a palliative measure. As frequent drainage is necessary, a subcutaneously tunnelled permanent ascites catheter is a good alternative for intermittent drainage. The patient can open - and then re-close - the catheter when abdominal pressure increases. We inserted 35 subcutaneously permanent ascites catheters in the course of the past 3.5 years in the Leiden University Medical Centre. The success rate was 100% and the complication risk was 2.9%. A subcutaneously tunnelled ascites catheter is an effective and safe palliative treatment for patients with end-stage malignant disease and suffering from ascites.

Impact on Patient Safety and Satisfaction of Implementation of an Outpatient Clinic in Interventional Radiology (IPSIPOLI-Study): A Quasi-Experimental Prospective Study.

PURPOSE: Interventional radiology (IR) procedures are associated with high rates of preparation and planning errors. In many centers, pre-procedural consultation and screening of patients is performed by referring physicians. Interventional radiologists have better knowledge about procedure details and risks, but often only get acquainted with the patient in the procedure room. We hypothesized that patient safety (PS) and patient satisfaction (PSAT) in elective IR procedures would improve by implementation of a pre-procedural visit to an outpatient IR clinic. MATERIAL AND METHODS: IRB approval was obtained and informed consent was waived. PS and PSAT were measured in patients undergoing elective IR procedures before (control group; n = 110) and after (experimental group; n = 110) implementation of an outpatient IR clinic. PS was measured as the number of process deviations. PSAT was assessed using a questionnaire measuring Likert scores of three dimensions: interpersonal care aspects, information/communication, and patient participation. Differences in PS and PSAT between the two groups were compared using an independent t test. RESULTS: The average number of process deviations per patient was 0.39 in the control group compared to 0.06 in the experimental group (p < 0.001). In 9.1 % patients in the control group, no legal informed consent was obtained compared to 0 % in the experimental group. The mean overall Likert score was significantly higher in the experimental group compared to the control group: 2.68 (SD 0.314) versus 2.48 (SD 0.381) (p < 0.001). CONCLUSION: PS and PSAT improve significantly if patients receive consultation and screening in an IR outpatient clinic prior to elective IR procedures.