Adjuvant Hepatic Arterial Infusion Pump Chemotherapy After Resection of Colorectal Liver Metastases: Results of a Safety and Feasibility Study in The Netherlands

Background: The 10-year overall survival with adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastases (CRLMs) was 61% in clinical trials from Memorial Sloan Kettering Cancer Center. A pilot study was performed to evaluate the safety and feasibility of adjuvant HAIP chemotherapy in patients with resectable CRLMs. Study Design: A phase II study was performed in two centers in The Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients underwent complete resection and/or ablation of CRLMs and pump implantation. Safety was determined by the 90-day HAIP-related postoperative complications from the day of pump placement (Clavien–Dindo classification, grade III or higher) and feasibility by the successful administration of the first cycle of HAIP chemotherapy. Results: A total of 20 patients, with a median age of 57 years (interquartile range [IQR] 51–64) were included. Grade III or higher HAIP-related postoperative complications were found in two patients (10%), both of whom had a reoperation (without laparotomy) to replace a pump with a slow flow rate or to reposition a flipped pump. No arterial bleeding, arterial dissection, arterial thrombosis, extrahepatic perfusion, pump pocket hematoma, or pump pocket infections were found within 90 days after surgery. After a median of 43 days (IQR 29–52) following surgery, all patients received the first dose of HAIP chemotherapy, which was completed un

Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial

Background Recurrences are reported in 70% of all patients after resection of colorectal liver metastases (CRLM), in which half are confined to the liver. Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy aims to reduce the risk of intrahepatic recurrence. A large retrospective propensity score analysis demonstrated that HAIP chemotherapy is particularly effective in patients with low-risk oncological features. The aim of this randomized controlled trial (RCT) --the PUMP trial-- is to investigate the efficacy of adjuvant HAIP chemotherapy in low-risk patients with resectable CRLM. Methods This is an open label multicenter RCT. A total of 230 patients with resectable CRLM without extrahepatic disease will be included. Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients are allowed to have no more than two out of five poor prognostic factors (disease-free interval less than 12 months, node-positive colorectal cancer, more than 1 CRLM, largest CRLM more than 5 cm in diameter, serum Carcinoembryonic Antigen above 200 μg/L). Patients randomized to arm A undergo complete resection of CRLM without any adjuvant treatment, which is the standard of care in the Netherlands. Patients in arm B receive an implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy 4–12 weeks after surgery, with 6 cycles of floxuridine scheduled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness. Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy. In a side study, the accuracy of CT angiography will be compared to radionuclide scintigraphy to detect extrahepatic perfusion. We hypothesize that adjuvant HAIP chemotherapy leads to improved survival, improved quality of life, and

Intramuscular metastases on FDG PET-CT: a review of the literature

Objective Intramuscular metastases (IM) are both rare and difficult to detect using routine anatomical computed tomography (CT) imaging. However, since the introduction of F-18-fluoro-deoxy-glucose (FOG) PET-CT, the number of detected IM has increased. We review the available literature to illustrate the relevance of these findings for staging and patient management. Methods In a review of the literature, we found one series and 33 case reports of IM shown on FDG PET-CT. No cases were reported before 2005. Furthermore, we present a patient with nonsmall cell lung cancer and a solitary distant metastasis in the left musculus infraspinatus that was not detected on diagnostic CT, but was found on FDG PET-CT. Results For a total of 39 recorded cases of IM, we found that FDG PET-CT had a significant impact on patient management in at least 51% of cases. Where reported, lesions were either isodense or hypodense on CT compared with the surrounding muscle tissue. The lesions that were also analyzed with MRI showed heterogeneous intensity. Five out of 39 patients had metastases in the extraocular muscles of one or both orbits. Conclusion FOG PET-CT appears to be a sensitive tool for detecting IM, with important impact on management in many cases. Nucl Med Commun 33:117-120 (C) 2012 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins

Changes in body weight and body composition in patients with active rheumatoid arthritis aged 65+ treated with 2-year low-dose add-on prednisolone in the randomised double-blind placebo-controlled GLORIA trial

Objectives To investigate the effect of 2 years of add-on prednisolone 5 mg/day on body weight and composition in patients with active rheumatoid arthritis (RA) aged 65+ and the relation with disease activity.Methods The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis trial, a pragmatic, placebo-controlled, double-blind, randomised controlled trial investigated the balance of benefit and harm of 2 years of prednisolone 5 mg/day added to standard care in 451 patients with active RA aged 65+. In the current study, 449 patients were included, and body weight and Disease Activity Score of 28 Joints were measured at baseline and after 3, 6, 12, 18 and 24 months. In 57 patients, body composition was assessed at baseline and after 2 years with dual-energy X-ray absorptiometry. Data were analysed with longitudinal mixed models.Results The mean (95% CI) change in body weight was 0.9 (0.3 to 1.6) kg in the prednisolone group and –0.4 (–1.1 to 0.2) kg in the placebo group (difference 1.3 (0.5–2.2), (p<0.01)). The treatment effect was independent of disease activity suppression and comprised mostly increase in (appendicular) lean mass after 2 years. There was no significant increase in total fat mass, nor redistribution of fat mass from peripheral to central tissues.Conclusions Patients with active RA aged 65+ treated with prednisolone 5 mg/day for 2 years gained about 1 kg in weight, compared with minimal—non-significant—weight loss on placebo. Our data suggest that the small increase in weight is mostly lean mass, rather than increase or redistribution of fat mass traditionally associated with glucocorticoid treatment

Persistent dyspnea after acute pulmonary embolism is related to perfusion defects and lower long-term quality of life

Background: The rate or persistent perfusion defects after acute pulmonary embolism (PE) varies from 30 % to 50 % after 6 months of treatment. Moreover, PE patients may suffer from persistent dyspnea and decreased quality of life (QoL). However, it is unknown whether persistent dyspnea results from perfusion defects and if either may affect QoL on the very long term. This study assessed the rate of persistent dyspnea and perfusion defects after PE and their association with long-term QoL. Methods: This observational study included consecutive patients with acute PE. At 6 months, a perfusion scan (Q-scan) was performed, patient-reported dyspnea was assessed, and of both the cumulative incidence rates with 95 % confidence intervals (CI) were calculated. After five years, disease-specific QoL was assessed with the PEmb-QoL questionnaire. Differences in PEmb-QoL between patients with and without dyspnea and between patients with and without persisting perfusion defects were calculated with the Mann-Whitney U test. Results: In 179 PE patients, the rate of persistent dyspnea was 24 % (95 % CI:17–30 %). Of these patients, 57 % (95 % CI:40–72 %) had persistent perfusion defects at 6 months which was significantly related to the persistent dyspnea (OR: 2.3 (95 % CI:1.1–4.9); p = 0.027). Perfusion defects did not result a difference in PEmb-QoL at five years. However, patients with persistent dyspnea had significantly worse PEmb-QoL after 5 years (38 % [18–55 %] versus 11 % [4.2–25 %]; p < 0.001). Conclusion: Persistent dyspnea after acute PE was associated with a lower QoL on the long term, however no relation was found between persistent perfusion defects and a lower QoL

Adjuvant Hepatic Arterial Infusion Pump Chemotherapy After Resection of Colorectal Liver Metastases: Results of a Safety and Feasibility Study in The Netherlands

Background. The 10-year overall survival with adjuvant hepatic arterial infusion pump (HAIP) chemotherapy after resection of colorectal liver metastases (CRLMs) was 61% in clinical trials from Memorial Sloan Kettering Cancer Center. A pilot study was performed to evaluate the safety and feasibility of adjuvant HAIP chemotherapy in patients with resectable CRLMs. Study Design. A phase II study was performed in two centers in The Netherlands. Patients with resectable CRLM without extrahepatic disease were eligible. All patients underwent complete resection and/or ablation of CRLMs and pump implantation. Safety was determined by the 90-day HAIP-related postoperative complications from the day of pump placement (Clavien-Dindo classification, grade III or higher) and feasibility by the successful administration of the first cycle of HAIP chemotherapy. Results. A total of 20 patients, with a median age of 57 years (interquartile range [IQR] 51-64) were included. Grade III or higher HAIP-related postoperative complications were found in two patients (10%), both of whom had a reoperation (without laparotomy) to replace a pump with a slow flow rate or to reposition a flipped pump. No arterial bleeding, arterial dissection, arterial thrombosis, extrahepatic perfusion, pump pocket hematoma, or pump pocket infections were found within 90 days after surgery. After a median of 43 days (IQR 29-52) following surgery, all patients received the first dose of HAIP chemotherapy, which was completed uneventfully in all patients. Conclusion. Pump implantation is safe, and administration of HAIP chemotherapy is feasible, in patients with resectable CRLMs, after training of a dedicated multidisciplinary team

Validity of Simplified 3 '-Deoxy-3 '-[F-18]Fluorothymidine Uptake Measures for Monitoring Response to Chemotherapy in Locally Advanced Breast Cancer

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