Contemporary Assessment of Adhesiolysis and Resection for Adhesive Small Bowel Obstruction in the State of New York.

BACKGROUND: Adhesive small bowel obstruction (aSBO) is a common surgical problem, with some advocating for a more aggressive operative approach to avoid recurrence. Contemporary outcomes in a real-world setting were examined. STUDY DESIGN: A retrospective cohort study was performed using the New York Statewide Planning and Research Cooperative database to identify adults admitted with aSBO, 2016-2020. Patients were stratified by the presence of inflammatory bowel disease (IBD) and cancer history. Diagnoses usually requiring resection were excluded. Patients were categorized into four groups: non-operative, adhesiolysis, resection, and 'other' procedures. In-hospital mortality, major complications, and odds of undergoing resection were compared. RESULTS: 58,976 patients were included. 50,000 (84.8%) underwent non-operative management. Adhesiolysis was the most common procedure performed (n = 4,990, 8.46%), followed by resection (n = 3,078, 5.22%). In-hospital mortality in the lysis and resection groups was 2.2% and 5.9% respectively. Non-IBD patients undergoing operation on the day of admission required intestinal resection 29.9% of the time. Adjusted odds of resection were highest for those with a prior aSBO episode (OR 1.29 95%CI 1.11-1.49), delay to operation ≥3 days (OR1.78 95%CI 1.58-1.99), and non-New York City (NYC) residents being treated at NYC hospitals (OR1.57 95%CI 1.19-2.07). CONCLUSION: Adhesiolysis is currently the most common surgery for aSBO, however nearly one-third of patients will undergo a more extensive procedure, with an increased risk of mortality. Innovative therapies are needed to reduce the risk of resection.

Results from Lung Cancer Screening Outreach Utilizing a Mobile CT Scanner in an Urban Area.

INTRODUCTION: Lung cancer screening using low-dose (LD) CT reduces lung cancer-specific and all-cause mortality in high-risk individuals, although significant barriers to screening remain. We assessed the outreach of a mobile lung cancer screening program to increase screening accessibility and early detection of lung cancer. METHODS: We placed a mobile CT unit in a high-traffic area in New York City and offered free screening to all eligible patients. Characteristics of the mobile screening cohort were compared with those of our hospital-based screening cohort. RESULTS: Between December 9, 2019, and January 30, 2020, a total of 216 patients underwent mobile LDCT screening. Compared with the hospital-based screening cohort, mobile screening participants were significantly more likely to be younger, be uninsured, and have lower smoking intensity and were less likely to meet 2013 US Preventive Services Task Force guidelines (but would meet their 2021 guidelines) and self-identify as White race and Hispanic ethnicity. Asian New Yorkers were substantially underrepresented in both hospital and mobile screening cohorts, compared with their level of representation in New York City. Two patients were diagnosed with lung cancer and were treated. Potentially clinically significant non-lung cancer findings were identified in 28.2%, most commonly moderate-severe coronary artery calcification and emphysema. CONCLUSIONS: Mobile LDCT screening is useful and effective in detecting lung cancer and other significant findings and may engage a distinct high-risk patient demographic. Disproportionately low screening rates among certain high-risk populations highlight the imperative of implementing strategies aimed at understanding health behaviors and access barriers for diverse populations. Effective care-navigation services, facilitating high-quality care for all patients, are critical.

A Collaborative Emergency Medicine and Radiology Pulmonary Nodule Program: Identification of Associated Efficacy and Outcomes.

PURPOSE: Incidental radiologic findings are commonplace, but the episodic nature of emergency department (ED) care makes it challenging to ensure that patients obtain appropriate follow-up. Rates of follow-up range from 30% to 77%, with some studies demonstrating that more than 30% have no follow-up at all. The aim of this study is to describe and analyze the outcomes of a collaborative emergency medicine and radiology initiative to establish a formal workflow for the follow-up of pulmonary nodules identified during ED care. METHODS: A retrospective analysis was performed of patients referred to the pulmonary nodule program (PNP). Patients were divided into two categories: those with follow-up and those who do not have post-ED follow-up. The primary outcome was determining follow-up rates and outcomes, including patients referred for biopsy. The characteristics of patients who completed follow-up compared with those lost to follow-up were also examined. RESULTS: A total of 574 patients were referred to the PNP. Initial follow-up was established in 390 (69.1%); 30.8% were considered lost to follow-up, and more than half of these patients did not respond to initial contact. There were minimal differences in characteristics between patients in these two categories. Of the 259 patients who completed PNP follow-up, 26 were referred for biopsy (13%). CONCLUSIONS: The PNP provided effective transitions of care and potentially improved patient health care. Strategies to further enhance follow-up adherence will provide iterative improvement of the program. The PNP provides an implementation framework for post-ED pulmonary nodule follow-up in other health care systems and can be modified for use with other incidental diagnostic findings.

Retrospective cohort study on the correlation analysis among peri-procedural factors, complications, and local tumor progression of lung tumors treated with CT-guided microwave ablation.

Background: Despite adherence to guidelines, recurrence of lesions remains possible in lung tumor microwave ablation (MWA) even when termination is enabled by 5-10 mm ground glass changes. Limited evidence exists regarding the correlation between timely management of perioperative complications (including pneumothorax, pleural effusion, hemorrhage, cavity formation, and infection) and local tumor progression. This retrospective study aimed to investigate the relationship among peri-procedural factors, complications, and local tumor progression in 164 cases of lung tumors treated with computed tomography-guided MWA (CT-MWA), and improve the local prognosis and reduce the complication rate of CT-guided lung tumor ablation. Methods: We reviewed 164 consecutive patients who underwent CT-MWA at Fudan University Shanghai Cancer Center's Minimally Invasive Therapy Center for lung cancer from September 2019 to May 2020. Correlative analysis was performed between peri-procedural factors, complications and outcomes (local tumor progression rates). Patients who have had prior surgery or previous MWA were excluded. Ablation was the first treatment of choice, and all patients who have had other treatments were excluded. Patients were followed every 3 months with CT. Outcomes of ablation including complications and local tumor progression were evaluated. Peri-procedural factors included demographical factors, tumor features, ablation parameters, management of intra-procedural pneumothorax, and CT features. Complications included pneumothorax, post-procedural refractory infection, and pleural effusion. Results: The study included 98 males and 68 females, with an average age of 56.1 years. Local tumor progression rate was negatively correlated with intra-procedural management of pneumothorax (R=-0.550, P=0.0003) and Hounsfield unit (HU) difference between HU before and after procedure (R=-0.855, P=0.006), and positively correlated with the average HU value of immediate post-procedural CT at the measurement points (R=0.857, P=0.00002). The correlation analysis results also showed a positive correlation between infection after procedure and pneumothorax (R=0.340, P=0.0001). Conclusions: A greater difference between HU before and after the procedure or a decrease in CT values immediately after ablation may predict a higher rate of local complete ablation. Prompt management of intraoperative pneumothorax may lower local tumor progression rates and decrease incidence of post-procedural infection.

The Latest on Lung Ablation.

Lung cancer is the second most common cancer in both men and women. Despite smoking cessation efforts and advances in lung cancer detection and treatment, long-term survival remains low. For early-stage primary lung carcinoma, surgical resection offers the best chance of long-term survival; however, only about one-third of patients are surgical candidates. For nonsurgical candidates, minimally invasive percutaneous thermal ablation therapies have become recognized as safe and effective treatment alternatives, including radiofrequency ablation, microwave ablation, and cryoablation. Lung ablation is also an acceptable treatment for limited oligometastatic and oligorecurrent diseases. This article discusses the technologies and techniques available for tumor ablation of thoracic malignancies, as well as new treatments on the horizon.

Intralesional therapies for vascular malformations of the head and neck.

Vascular malformations of the head and neck represent a spectrum of complex vascular anomalies, requiring a multidisciplinary approach toward diagnosis and treatment. Several intralesional therapeutic agents have been devised and pioneered over the years, some of which are now primary and standard of care for the management of these lesions. In this article, the authors discuss the currently available intralesional therapeutic agents for the management of vascular malformations in the head and neck region.

Management of Incidental Pulmonary Nodules: Influencing Patient Care Through Subspecialized Imaging Review.

OBJECTIVE: To evaluate whether thoracic radiologist review of computed tomography-detected incidental pulmonary nodules initially reported by non-thoracic imagers would change management recommendations. MATERIALS AND METHODS: The Radiology Consultation Service identified 468 computed tomography scans (one per patient) performed through the adult emergency department from August 2018 through December 2020 that mentioned the presence of a pulmonary nodule. Forty percent (186/468) were read by thoracic radiologists and 60% (282/468) were read by non-thoracic radiologists. The Radiology Consultation Service contacted all patients in order to assess risk factors for lung malignancy. Sixty-seven patients were excluded because they were unreachable, declined participation, or were actively followed by a pulmonologist or oncologist. A thoracic radiologist assessed the nodule and follow up recommendations in all remaining cases. RESULTS: A total of 215 cases were re-reviewed by thoracic radiologists. The thoracic radiologist disagreed with the initial nodule recommendations in 38% (82/215) of cases and agreed in 62% (133/215) of cases. All discordant cases resulted in a change in management by the thoracic radiologist with approximately one-third (33%, 27/82) decreasing imaging utilization and two-thirds (67%, 55/82) increasing imaging utilization. Nodules were deemed benign and follow up eliminated in 11% (9/82) of discordant cases. DISCUSSION: Our study illustrates that nodule review by thoracic radiologists results in a change in management in a large percentage of patients. Continued research is needed to determine whether subspecialty imaging review results in increased or more timely lung cancer detection.

Neoadjuvant durvalumab with or without stereotactic body radiotherapy in patients with early-stage non-small-cell lung cancer: a single-centre, randomised phase 2 trial.

BACKGROUND: Previous phase 2 trials of neoadjuvant anti-PD-1 or anti-PD-L1 monotherapy in patients with early-stage non-small-cell lung cancer have reported major pathological response rates in the range of 15-45%. Evidence suggests that stereotactic body radiotherapy might be a potent immunomodulator in advanced non-small-cell lung cancer (NSCLC). In this trial, we aimed to evaluate the use of stereotactic body radiotherapy in patients with early-stage NSCLC as an immunomodulator to enhance the anti-tumour immune response associated with the anti-PD-L1 antibody durvalumab. METHODS: We did a single-centre, open-label, randomised, controlled, phase 2 trial, comparing neoadjuvant durvalumab alone with neoadjuvant durvalumab plus stereotactic radiotherapy in patients with early-stage NSCLC, at NewYork-Presbyterian and Weill Cornell Medical Center (New York, NY, USA). We enrolled patients with potentially resectable early-stage NSCLC (clinical stages I-IIIA as per the 7th edition of the American Joint Committee on Cancer) who were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. Eligible patients were randomly assigned (1:1) to either neoadjuvant durvalumab monotherapy or neoadjuvant durvalumab plus stereotactic body radiotherapy (8 Gy × 3 fractions), using permuted blocks with varied sizes and no stratification for clinical or molecular variables. Patients, treating physicians, and all study personnel were unmasked to treatment assignment after all patients were randomly assigned. All patients received two cycles of durvalumab 3 weeks apart at a dose of 1·12 g by intravenous infusion over 60 min. Those in the durvalumab plus radiotherapy group also received three consecutive daily fractions of 8 Gy stereotactic body radiotherapy delivered to the primary tumour immediately before the first cycle of durvalumab. Patients without systemic disease progression proceeded to surgical resection. The primary endpoint was major pathological response in the primary tumour. All analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrial.gov, NCT02904954, and is ongoing but closed to accrual. FINDINGS: Between Jan 25, 2017, and Sept 15, 2020, 96 patients were screened and 60 were enrolled and randomly assigned to either the durvalumab monotherapy group (n=30) or the durvalumab plus radiotherapy group (n=30). 26 (87%) of 30 patients in each group had their tumours surgically resected. Major pathological response was observed in two (6·7% [95% CI 0·8-22·1]) of 30 patients in the durvalumab monotherapy group and 16 (53·3% [34·3-71·7]) of 30 patients in the durvalumab plus radiotherapy group. The difference in the major pathological response rates between both groups was significant (crude odds ratio 16·0 [95% CI 3·2-79·6]; p<0·0001). In the 16 patients in the dual therapy group with a major pathological response, eight (50%) had a complete pathological response. The second cycle of durvalumab was withheld in three (10%) of 30 patients in the dual therapy group due to immune-related adverse events (grade 3 hepatitis, grade 2 pancreatitis, and grade 3 fatigue and thrombocytopaenia). Grade 3-4 adverse events occurred in five (17%) of 30 patients in the durvalumab monotherapy group and six (20%) of 30 patients in the durvalumab plus radiotherapy group. The most frequent grade 3-4 events were hyponatraemia (three [10%] patients in the durvalumab monotherapy group) and hyperlipasaemia (three [10%] patients in the durvalumab plus radiotherapy group). Two patients in each group had serious adverse events (pulmonary embolism [n=1] and stroke [n=1] in the durvalumab monotherapy group, and pancreatitis [n=1] and fatigue [n=1] in the durvalumab plus radiotherapy group). No treatment-related deaths or deaths within 30 days of surgery were reported. INTERPRETATION: Neoadjuvant durvalumab combined with stereotactic body radiotherapy is well tolerated, safe, and associated with a high major pathological response rate. This neoadjuvant strategy should be validated in a larger trial. FUNDING: AstraZeneca.

Role of interventional radiology in the treatment of COVID-19 patients: Early experience from an epicenter.

OBJECTIVE: To highlight the role of interventional radiology (IR) in the treatment of patients hospitalized with coronavirus disease 2019 (COVID-19). METHODS: Retrospective review of hospitalized patients who tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and had one or more IR procedures at a tertiary referral hospital in New York City during a 6-week period in April and May of 2020. RESULTS: Of the 724 patients admitted with COVID-19, 92 (12.7%) underwent 124 interventional radiology procedures (79.8% in IR suite, 20.2% at bedside). The median age of IR patients was 63 years (range 24-86 years); 39.1% were female; 35.9% in the intensive care unit. The most commonly performed IR procedures were central venous catheter placement (31.5%), inferior vena cava filter placement (9.7%), angiography/embolization (4.8%), gastrostomy tube placement (9.7%), image-guided biopsy (10.5%), abscess drainage (9.7%), and cholecystostomy tube placement (6.5%). Thoracentesis/chest tube placement and nephrostomy tube placement were also performed as well as catheter-directed thrombolysis of massive pulmonary embolism and thrombectomy of deep vein thrombosis. General anesthesia (10.5%), monitored anesthesia care (18.5%), moderate sedation (29.8%), or local anesthetic (41.1%) was utilized. There were 3 (2.4%) minor complications (SIR adverse event class B), 1 (0.8%) major complication (class C), and no procedure-related death. With a median follow-up of 4.3 months, 1.1% of patients remain hospitalized, 16.3% died, and 82.6% were discharged. CONCLUSION: Interventional radiology participated in the care of hospitalized COVID-19 patients by performing a wide variety of necessary procedures.

Technical and safety performance of CT-guided percutaneous microwave ablation for lung tumors: an ablate and resect study.

BACKGROUND: Percutaneous image-guided thermal ablation has an increasing role in the treatment of primary and metastatic lung tumors. Achieving acceptable clinical outcomes requires better tools for pre-procedure prediction of ablation zone size and shape. METHODS: This was a prospective, non-randomized, single-arm, multicenter study conducted by Medtronic (ClinicalTrials.gov ID: NCT02323854). Subjects scheduled for resection of metastatic or primary lung nodules underwent preoperative percutaneous microwave ablation. Ablation zones as measured via CT imaging following ablation immediately and before resection surgically versus predicted ablation zones as prescribed by the investigational system software were compared. This CT scan occurred after the ablation was finished but the antenna still in position. Time (minutes) from antenna placement to removal was 23.7±13.1 (n=14); median: 21.0 (range, 6.0 to 48.0). The definition of the secondary endpoint of complete ablation was 100% non-viable tumor cells based on nicotinamide adenine dinucleotide hydrogen (NADH) staining. Safety endpoints were type, incidence, and severity of adverse events. RESULTS: Fifteen patients (mean age 58.9 years; 67% male; 33% female) were enrolled in the study, 33.3% (5/15) with previous thoracic surgery, 73% (11/15) with metastasis, and 27% (4/15) with primary lung tumors. All underwent percutaneous microwave ablation followed by surgical resection the same day. Complete ablation was detected in 54.4% (6/11), incomplete ablation in 36.4% (4/11), and delayed necrosis in 9.1% (1/11). There were no device-related adverse events. Ablation zone volume was overestimated in all patients. CONCLUSIONS: Histological complete ablation was observed in 55% of subjects. CT scanning less than an hour after ablation and tissue shrinkage may account for the smaller zone of ablation observed compared to predicted by the investigational system software.

Endovascular simulation as a supplemental training tool during the COVID-19 national emergency.

The ongoing COVID pandemic raises many concerns as our healthcare system is pushed to its limits and as a consequence, Interventional Radiology training may be compromised. Endovascular simulators allow trainees many benefits to build and maintain endovascular skills in a safe environment. Our experience demonstrates a methodology to maintain IR training with use of didactic and simulation supplementation during the COVID-19 pandemic, which may be helpful for incorporation at other institutions facing similar challenges.

Multicenter Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation (SOLSTICE).

OBJECTIVE: To assess the safety and local recurrence-free survival in patients after cryoablation for treatment of pulmonary metastases. METHODS: This multicenter, prospective, single-arm, phase 2 study included 128 patients with 224 lung metastases treated with percutaneous cryoablation, with 12 and 24 months of follow-up. The patients were enrolled on the basis of the outlined key inclusion criteria, which include one to six metastases from extrapulmonary cancers with a maximal diameter of 3.5 cm. Time to progression of the index tumor(s), metastatic disease, and overall survival rates were estimated using the Kaplan-Meier method. Complications were captured for 30 days after the procedure, and changes in performance status and quality of life were also evaluated. RESULTS: Median size of metastases was 1.0 plus or minus 0.6 cm (0.2-4.5) with a median number of tumors of 1.0 plus or minus 1.2 cm (one to six). Local recurrence-free response (local tumor efficacy) of the treated tumor was 172 of 202 (85.1%) at 12 months and 139 of 180 (77.2%) at 24 months after the initial treatment. After a second cryoablation treatment for recurrent tumor, secondary local recurrence-free response (local tumor efficacy) was 184 of 202 (91.1%) at 12 months and 152 of 180 (84.4%) at 24 months. Kaplan-Meier estimates of 12- and 24-month overall survival rates were 97.6% (95% confidence interval: 92.6-99.2) and 86.6% (95% confidence interval: 78.7-91.7), respectively. Rate of pneumothorax that required pleural catheter placement was 26% (44/169). There were eight grade 3 complication events in 169 procedures (4.7%) and one (0.6%) grade 4 event. CONCLUSION: Percutaneous cryoablation is a safe and effective treatment for pulmonary metastases.

Ablation Planning Software for Optimizing Treatment: Challenges, Techniques, and Applications.

Percutaneous ablation can deliver effective anticancer therapy with minimal side effects; however, undertreatment can lead to disease recurrence and overtreatment can lead to unnecessary complications. Ablation planning software can support the procedure during the planning, treatment, and follow-up phases. In this review, 2 examples of microwave ablation software are described with attention to how the software can influence procedural choices. In the future, ablation software will entail larger source datasets and more refined algorithms to better model the in vivo ablation zone. Moreover, ablation simulation has the potential to augment clinical care beyond the interventional suite, such as procedural demonstration for patients, clinical consultation with referring providers, documentation for the medical record, and educational simulation for trainees.

Pulmonary Cryoablation Zones: More Aggressive Ablation Is Warranted In Vivo.

OBJECTIVE: The objective of our study was to determine the effective cryoablation zone when treating pulmonary tumors in vivo and to create pulmonary-specific ablation maps to guide clinical procedure planning. MATERIALS AND METHODS: Ablation volume was measured retrospectively in human patients after pulmonary tumor cryoablation with a triple-freeze protocol. Single-probe ablations were performed with 17-, 14-, and 13-gauge cryoprobes; multiple-probe ablations were performed with two or three 17-gauge probes. Statistical comparisons of ablation volumes to manufacturer reference values were calculated using the Wilcoxon rank-sum test. Comparisons of ablation sizes by the number of probes were evaluated by the Kruskal-Wallis test. RESULTS: Mean volume of in vivo lung ablation with a single 17-gauge cryoprobe measured 3.0 cm3, which is a statistically significant difference compared with the in vitro -20°C isotherm volume of 22.6 cm3 (p < 0.01). Mean ablation volume of larger 13- and 14-gauge cryoprobes were 4.3 and 1.8 cm3, respectively, both of which are smaller than the in vitro -20°C isotherm volume. Mean cryoablation zone was not significantly affected by distance to the pleura (p = 0.54) or distance to a vessel (p = 0.55). Ablation volume was significantly increased (p < 0.01) with the use of multiple cryoprobes, at a rate of a 10.8-cm3 increase per additional probe. The increased ablation zone size was more attributable to increased short-axis width (9.6-mm increase per probe) compared with long-axis length (5.6-mm increase per probe). CONCLUSION: The in vivo effective pulmonary cryoablation zone is significantly smaller than the manufacturer-published in vitro isotherm. Larger ablation margins in lung are best achieved by using multiple cryoprobes.

The role of antibiotics in preventing totally implantable venous access device (TIVAD) infections; is there a population that would benefit?

PURPOSE: To assess the role for prophylactic antibiotics in preventing totally implantable venous access device (TIVAD) infections and identify populations that may benefit from antibiotics. METHODS: 1284 patients undergoing TIVAD placement were retrospectively reviewed to determine association between infection rate, prophylactic antibiotics, and clinical data including white blood cell (WBC) count, platelets, and coagulation profile. Patients were further sub-categorized based on hospital admission status and leukopenia. Patients who received antibiotics were compared to those who did not using chi-square test or Fisher's exact tests and Student's t-tests. Additionally, multivariable logistic regression analysis was used to determine factors associated with infections. RESULTS: A total of 7 infections were identified with an infection rate of 0.5%. 1010 patients received antibiotics (78.7%), and infection rate in these patients was 0.7% compared to 0% in patients who did not receive antibiotics. 21 patients were under the age of 18, eight of which received antibiotics. No infections occurred in the pediatric group. Upon multivariate analysis, developing TIVAD infection was significantly associated with inpatient placement (p < 0.0001, OR 29.1, 95% CI 3.1-272.1), while utilization of double lumen ports was not (OR 3.0, 95% CI 0.5-17.4). There were no significant associations between infections and antibiotic use (p = 0.36), leukopenia (p = 0.47), pediatric patients (p = 1) or other demographic or laboratory data. CONCLUSION: Routine use of prophylactic antibiotics with TIVAD placement should be avoided. Antibiotics may not benefit even those with greater risk for infection.

Clinical Outcomes after Pulmonary Cryoablation with the Use of a Triple Freeze Protocol.

PURPOSE: To elucidate clinical variables associated with safety and efficacy in patients after cryoablation of pulmonary tumors with the use of a triple freeze protocol. MATERIALS AND METHODS: Percutaneous cryoablation of pulmonary tumors was performed using Galil Medical cryoprobes (Arden Hills, Minnesota) with a triple freeze protocol: 67 nodules in 42 patients were treated at a single institution from 2012 to 2016. Average nodule diameter was 1.6 cm (range 0.4-5.9); 13 nodules (19.4%) were pathologically determined to be a primary lung malignancy, whereas 54 (80.6%) were metastatic nodules of extrapulmonary origin. Average patient age was 68.1 years (range 39.6-89.6), and the male-female ratio was 1.3:1. Ipsilateral thoracic surgery, intervention, or radiotherapy had been performed before the first cryoablation in 18 patients (42.9%). Mean imaging follow-up was 326 days (range 9-1,152). RESULTS: Pneumothorax occurred in 19 cases (33.9%), 7 (12.5%) requiring chest tube, the likelihood of which was significantly greater in patients with 3 or more cryoprobes (P < .01). Local tumor recurrence/residual disease occurred in 6 cases (9.0%). Local tumor recurrence was not seen after ablation of nodules measuring <1.0 cm at the time of procedure, a significant difference from the recurrence ratee of 14.3% for nodules measuring ≥1.0 cm (P < .05). Likelihood of tumor recurrence/residual disease did not correlate with tumor pathology, tumor location, or procedural factors. The estimated marginal probabilities of local recurrence were 11.4%, 11.4%, and 38.1% at 1, 2, and 3 years after ablation, respectively. CONCLUSIONS: Cryoablation of pulmonary tumors with the use of a triple freeze protocol is a viable modality with low recurrence and complication rates.

Bone biopsy protocol for advanced prostate cancer in the era of precision medicine.

BACKGROUND: Metastatic biopsies are increasingly being performed in patients with advanced prostate cancer to search for actionable targets and/or to identify emerging resistance mechanisms. Due to a predominance of bone metastases and their sclerotic nature, obtaining sufficient tissue for clinical and genomic studies is challenging. METHODS: Patients with prostate cancer bone metastases were enrolled between February 2013 and March 2017 on an institutional review board-approved protocol for prospective image-guided bone biopsy. Bone biopsies and blood clots were collected fresh. Compact bone was subjected to formalin with a decalcifying agent for diagnosis; bone marrow and blood clots were frozen in optimum cutting temperature formulation for next-generation sequencing. Frozen slides were cut from optimum cutting temperature cryomolds and evaluated for tumor histology and purity. Tissue was macrodissected for DNA and RNA extraction, and whole-exome sequencing and RNA sequencing were performed. RESULTS: Seventy bone biopsies from 64 patients were performed. Diagnostic material confirming prostate cancer was successful in 60 of 70 cases (85.7%). The median DNA/RNA yield was 25.5 ng/µL and 16.2 ng/µL, respectively. Whole-exome sequencing was performed successfully in 49 of 60 cases (81.7%), with additional RNA sequencing performed in 20 of 60 cases (33.3%). Recurrent alterations were as expected, including those involving the AR, PTEN, TP53, BRCA2, and SPOP genes. CONCLUSIONS: This prostate cancer bone biopsy protocol ensures a valuable source for high-quality DNA and RNA for tumor sequencing and may be used to detect actionable alterations and resistance mechanisms in patients with bone metastases. Cancer 2018;124:1008-15. © 2017 American Cancer Society.