Use of a retrievable vena cava filter with low-intensity anticoagulation for prevention of pulmonary embolism in patients with cancer: an observational study in 106 cases.

PURPOSE: To evaluate a retrievable inferior vena cava (IVC) filter in combination with low-intensity oral anticoagulation for prevention of pulmonary embolism (PE) in patients with malignancy complicated by thromboembolic disease. MATERIALS AND METHODS: From October 2005 to December 2009, 107 Bard G2 filters were placed in 106 patients. Forty-eight patients had deep vein thrombosis (DVT) alone, 53 had PE with DVT, and five had PE with no evidence of DVT. After an initial period of anticoagulation with heparin, low-intensity oral anticoagulant therapy to achieve a target International Normalized Ratio of 1.5-2.0 was instituted. Follow-up computed tomography to evaluate the pulmonary circulation, IVC, and lower limbs was performed at 3 and 6 months. RESULTS: PE recurred in three of 58 patients (5.2%). None of the 48 patients with DVT alone developed PE, nor was there any recurrence of DVT. The filter was removed in 14 patients (13.2%). No complications occurred during the retrieval procedure. A total of 16 complications occurred in seven patients: one migration (0.9%); four cases of vena cava thrombosis (3.7%), three of which were associated with recurrent PE (2.8%); one filter fracture (0.9%); and one IVC penetration (0.9%). Filter tilting greater than 15° occurred in six patients (5.7%) and was associated with other complications in five (4.7%). CONCLUSIONS: In patients with malignancies complicated by venous thromboembolic disease, an IVC filter together with low-intensity anticoagulation may be a possible treatment strategy for PE prophylaxis. Controlled studies are warranted.

Pulmonary nodules: volume repeatability at multidetector CT lung cancer screening.

PURPOSE: To assess in vivo volumetric repeatability of an automated software algorithm in pulmonary nodules detected during a lung cancer screening trial. MATERIALS AND METHODS: This study was approved by an institutional review board. Written informed consent was obtained from all participants. Data were collected from the Multicentric Italian Lung Detection project, a randomized controlled lung cancer screening trial. The first 1236 consecutive baseline computed tomographic (CT) studies performed at the Istituto Nazionale Tumori of Milan were evaluated. Among the enrolled participants, those who underwent repeat low-dose CT after 3 months and had at least one indeterminate nodule with a volume of more than 60 mm(3) (diameter of 4.8 mm or greater) were considered. Nonsolid, part-solid, and pleural-based nodules were excluded from this study. A descriptive analysis was performed by calculating means and standard deviations of nodule volumes at three assessment times (at baseline and 3 and 12 months later). The volume measurement repeatability was determined by using the approach described by Bland and Altman. RESULTS: One hundred one subjects (70 men, 31 women; mean age, 58 years) with 233 eligible nodules (mean volume, 98.3 mm(3); range, 5-869 mm(3)) were identified. The 95% confidence interval for difference in measured volumes was in the range of +/-27%. About 70% of measurements had a relative difference in nodule volume of less than 10%. No malignant lesions were registered during the follow-up of these subjects. CONCLUSION: Semiautomatic volumetry is sufficiently accurate and repeatable and may be useful in assisting with lung nodule management in a lung cancer screening program.

FNA and CNB in the diagnosis of pulmonary lesions: a single-center experience on 665 patients, comparison between two periods.

PURPOSE: To evaluate the diagnostic yield and complication rate of 2 different biopsy techniques (fine-needle aspiration, FNA, and core-needle biopsy, CNB) in the diagnosis of pulmonary lesions in 2 distinct periods, 2010-2012 and 2013-2015. METHODS: We retrospectively analyzed the results of 691 CT-guided lung biopsies in 665 patients who were divided into 2 groups: cohort 1 (January 2010 to December 2012) was composed of 271 consecutive patients with 284 procedures either by FNA or CNB; cohort 2 (January 2013 to December 2015) was composed of 394 patients with 407 CNBs. Univariate and multivariate logistic regression modeling was used for selected outcomes including diagnostic yield, bleeding and pneumothorax. RESULTS: Cohort 1 comprised 165 men and 106 women (mean age 68.5 years) with 180 FNAs and 104 CNBs; cohort 2 comprised 229 men and 165 women (mean age 66.4 years) with 407 CNBs. The diagnostic yield increased in cohort 2 with respect to cohort 1. There was a slight increase in CT procedure complications (pneumothorax and bleeding) from cohort 1 to cohort 2. The overall risk of complications was greater for lesions ≤20 mm and for lesions at >20 mm distance from the pleura. CONCLUSIONS: CT-guided CNB had a higher diagnostic yield than discretional use of either FNA or CNB; there was a slight but acceptable increase in complication rates.

Combined therapy with dabrafenib and trametinib in BRAF-mutated metastatic melanoma in a real-life setting: the INT Milan experience.

PURPOSE: Combination therapy with dabrafenib and trametinib is safer and more effective than BRAF inhibitor-based monotherapy for metastatic melanoma. METHODS: We retrospectively analyzed BRAF-mutated metastatic melanoma patients treated at our institution with daily oral dabrafenib 300 mg and trametinib 2 mg from November 2013 to April 2016. This clinical record included both untreated and previously treated stage IV melanomas. Physical examination and laboratory examinations were performed monthly and disease re-evaluations were performed every 3 months. RESULTS: A total of 48 patients (24 male, 24 female) with BRAF-mutated metastatic melanoma received dabrafenib and trametinib; median age was 48 years (range 23-75). Median follow-up was 362.5 days (range 72-879). Best overall response rate consisted of 6.2% (3 patients) complete response, 64.6% (31) partial response, and 25% (12) stable disease; median time to best response was 11 weeks (range 5.7-125.5). Progression of disease was seen in 19 patients (39.6%), with median time to progression (TTP) of 26 weeks (range 8-54). A total of 15 patients (31.2%) died due to progression of disease. Median progression-free survival and median overall survival were not reached. To date, 30 patients (62.5%) are still under treatment. A total of 27 (56.2%) patients had at least one adverse event (AE); grade 3-4 AEs were seen in 4 cases (8.3%). The main toxicities were fever (25%), skin rash (14.6%), arthralgias (10.4%), and aspartate aminotransferase/alanine aminotransferase increase (8.3%). Treatment dose was reduced in 7 subjects (14.6%), with only one case of discontinuation due to AE. CONCLUSIONS: Our data, using combined targeted therapy, are in line with the scientific literature in terms of both safety and effectiveness in a real-life setting.

Thoracic paravertebral anesthesia for percutaneous radiofrequency ablation of hepatic tumors.

STUDY OBJECTIVE: To present our preliminary experience using a thoracic paravertebral block (TPVB) as the sole anesthetic in percutaneous hepatic radiofrequency ablation (RFA). DESIGN: Retrospective case series of 12 ASA physical status 1, 2, and 3 patients of average risk scheduled for RFA. SETTING: University medical center. MEASUREMENTS: The first 12 procedures performed using TPVB were analyzed to evaluate the efficacy and safety of this anesthetic technique. Data collected included patients' characteristics, procedure, pain referred during paravertebral punctures, and RFA (verbal numerical scale; VNS). Anesthesia and medical records also were reviewed for any major complications that occurred during or after the RFA. MAIN RESULTS: Ten of the 12 patients presented for hepatocellular carcinoma; the other two patients had melanoma metastasis. Nine patients were ASA physical status 1 or 2; the other three patients were ASA physical status 3. Nine had liver cirrhosis. All patients had normal coagulation profiles. The TPVBs were performed in a median time of 6.5 (4-15) minutes. Onset of sensory loss to pinprick test occurred approximately 15 to 20 minutes after the injections. No evidence of bilateral blockade was seen in any patient. In most cases, the extent of anesthesia ranged from T6 to T11 or T12. In one patient (no. 2), the stimulating needle elicited no sensory or motor response at the T7 level; the local anesthetic was then injected one cm beyond the transverse process. All patients were very pleased with their anesthetic care; all were discharged from the hospital with no procedure-related complications. CONCLUSION: The use of thoracic paravertebral block as the sole anesthetic for RFA of liver produced satisfactory unilateral anesthesia and minor adverse events.

Feasibility and efficacy of percutaneous transcatheter intraarterial chemotherapy with paclitaxel in albumin nanoparticles for advanced squamous-cell carcinoma of the oral cavity, oropharynx, and hypopharynx.

PURPOSE: In view of the promising results of a phase I trial, this phase II trial was conducted to study the efficacy and safety of intraarterial induction chemotherapy with a novel nanoparticle albumin-bound paclitaxel formulation in advanced head and neck cancer. MATERIALS AND METHODS: Sixty previously untreated patients with locally advanced squamous-cell carcinoma (SCC) of the oral cavity, oropharynx, or hypopharynx in stage T3/4 and any nodal stage received two to four cycles of nanoparticle albumin-bound paclitaxel by infusion into the external carotid artery or one of its branches, without premedication, at an initial dose of 230 mg/m2 and subsequently a reduced dose of 150 mg/m2. Response was evaluated by physical examination and multidetector computed tomography in all patients, and also by positron emission tomography with [18F]fluorodeoxyglucose in 38 patients. Definitive treatment was surgery, chemotherapy, radiation therapy, or chemoradiation therapy. RESULTS: Intraarterial chemotherapy had a low incidence of complications and produced complete or partial responses in 45 of 60 treated patients (75%). Seven patients (11.67%) had stable disease and eight (13.33%) had disease progression. High-grade bone marrow depression was rare. An unexpected toxicity was reversible facial nerve palsy on the side of infusion, which occurred in six patients at initial dosage. Reduction of the dose eliminated this specific toxicity without any loss of efficacy. CONCLUSION: The promising response rates and tolerability of intraarterial chemotherapy with nanoparticle albumin-bound paclitaxel justify further investigation of this formulation, alone or in combination with other agents, in advanced SCC of the head and neck.

A novel intraarterial chemotherapy using paclitaxel in albumin nanoparticles to treat advanced squamous cell carcinoma of the tongue: preliminary findings.

OBJECTIVE: The purpose of our study was to evaluate the effectiveness of intraarterial infusion of paclitaxel incorporated into human albumin nanoparticles for use as induction chemotherapy before definitive treatment of advanced squamous cell carcinoma of the tongue. SUBJECTS AND METHODS: Twenty-three previously untreated patients (age range, 27-75 years) who had carcinoma of the tongue (stage T3-T4, any N) received intraarterial therapy with paclitaxel incorporated into albumin nanoparticles delivered by transfemoral catheterization into the external carotid artery (10 patients), selectively into the lingual artery (12 patients), or into a faciolingual trunk (1 patient). Each patient received two to four infusions, with a 3-week interval between infusions. The dose administered was 230 mg/m(2) in eight patients, 180 mg/m(2) in six patients, and 150 mg/m(2) in nine patients. Sixteen patients underwent surgery. Of these 16 patients, eight subsequently received radiotherapy, and three received a combination of chemotherapy and radiotherapy. Of the remaining seven patients, one received chemotherapy alone, four received radiotherapy alone, one received chemotherapy plus radiotherapy, and one refused any further treatment. RESULTS: Sixty-seven infusions were performed successfully. Eighteen patients (78%) had a clinical and radiologic objective response (complete, 26%; partial, 52%). Three patients (13%) showed stable disease, and two (9%) showed disease progression. The four patients with complete clinical response who underwent surgery showed microscopic residual carcinoma measuring less than 1 mm in two patients, less than 5 mm in one patient, and less than 1 cm in one patient. The toxicities encountered were hematologic (grade 3) in two patients (8.6%) and neurologic (grade 4) in two patients (reversible paralysis of the facial nerve, 8.6%). Two catheter-related complications occurred: one reversible brachiofacial paralysis and one asymptomatic occlusion of the external carotid artery. CONCLUSION: Intraarterial infusion of paclitaxel in albumin nanoparticles proved reproducible and effective and deserves further investigation as induction chemotherapy before definitive treatment of advanced tumors of the tongue, with a view to organ preservation.