Rebiopsy Rate Research Articles

Clinical experiences with robotic computed tomography-guided interventions: A comparison with manual technique

Background: Image-guided biopsies have become standard practice; however, challenges such as multiple punctures and re-attempts can complicate procedures. The introduction of robotic guidance systems, such as MAXIO offers a potential solution for improving planning and navigation. This study evaluated the efficacy of the MAXIO needle-guiding robotic device in computed tomography (CT)-guided interventions compared with conventional manual techniques. Aims and Objectives: This study aimed to evaluate the performance of the MAXIO robotic system for CT-guided biopsies at the Barnard Institute of Radiology and compare it with the conventional manual technique. Materials and Methods: A total of sixty patients who underwent CT-guided biopsies were retrospectively divided into two groups: Group A (manual procedure) and Group B (robot-assisted procedure). The MAXIO device was utilized in combination with a Siemens 32-slice CT scanner for robot-assisted biopsies. Key parameters analyzed between the two groups included the volume CT dose index, dose-length product (DLP), target location, target depth, target size, distance from the entry point, needle angulation, procedural time, number of punctures, complications, and re-biopsy rates. Results: Significant differences were found between the two groups in the number of punctures (p = 0.002), DLP (p = 0.0001), and degree of needle angulation (p = 0.0002), with the robotic technique demonstrating a better performance. Although the procedural time was reduced in the robotic group, this difference was not statistically significant (p = 0.104). Other assessed parameters, such as complications and rebiopsy rates, showed no significant differences. Conclusion: Robotic-assisted CT-guided procedures using the MAXIO system showed improved diagnostic accuracy and safety, with reductions in radiation dose, needle manipulations, and punctures, compared to conventional manual techniques.

The role of PSA kinetics in men with a negative MRI-targeted prostate biopsy.

To evaluate rebiopsy rates and clinicopathologic outcomes in patients after a negative MRI-guided biopsy to better inform the management of these patients. Patients were included with a clinical suspicion of prostate cancer (PCa) referred for fusion biopsy for a PI-RADS v2.1 lesion ≥ 3 on multiparametric MRI and a negative MRI fusion biopsy. Biopsies included targeted and systematic cores. Patients with a prior cancer diagnosis were excluded. Both baseline and follow-up clinicopathological data, and long-term PSA values were examined in these patients. Statistical analyses included Wilcoxon rank-sum test and one-way tests. Of 685 total patients, 188 (27%) had a negative fusion biopsy. Of these 88 (47%), 74 (39%), and 26 (14%) had PI-RADS 3, 4, 5 lesions, respectively. Complete follow-up was available for 182/188 patients (97%), with a median of 24 months (interquartile range: 12-38). Post-biopsy PSA levels decreased the first and the second year (-0.24; and -0.84 ng/ml/yrs respectively). In follow-up, 44 patients had an MRI (24%) and 20 had a biopsy (10%). A positive PSA velocity was the only predictive variable for repeat MRI in univariate analysis. On repeat MRI, 9 (27%) patients had disappearance of the initial lesion, 21 (48%) had a lower PIRADS score and 14 (32%) higher. Only 12/182 (6.6%) were found to have PCa during follow-up, of those 7 (3.8%) were clinically significant. For patients with nonmalignant biopsy findings after an initial mpMRI showing a suspicious PI-RADS lesion, the majority of patients will have their PSAs return to baseline over time. To support this, repeat MRI frequently demonstrated a disappearance or downgrading of PIRADS lesions. These data support monitoring patients with this clinical scenario.

Serum prostate-specific antigen trends and prostate cancer detection on follow-up in men with a prior negative biopsy: A cohort study

ABSTRACT Introduction: Elevated serum prostate-specific antigen (PSA) is the most common trigger for a prostate biopsy. However, the range of normal PSA is poorly defined in many populations. Men with “elevated” PSA may not harbor cancer, and it is unclear if such men with a prior negative prostate biopsy should be biopsied again. We conducted a cohort study to assess the PSA trends and cancer detection rates in such men. Methods: In an Institutional Review Board-approved ambispective study, men who underwent prostate biopsy between January 2016 and December 2021 for PSA > 4 ng/mL were identified. Among them, those whose biopsy was negative for malignancy were contacted either telephonically or reviewed in person, and the most recent PSA and histopathology of any repeat prostate biopsy were determined. These were evaluated to assess the PSA trend, re-biopsy rate, and cancer detection rate. Results: During the study period, prostate biopsies were performed in a total of 1260 men; out of which 444 were negative for malignancy and 241 patients fulfilled the inclusion criteria. Their median prebiopsy PSA was 9.81 ng/mL (interquartile range [IQR]: 7.14–15.6), and the median follow-up PSA was 5.08 (IQR: 3.18–8.4). At a median follow-up of 53 months (range: 6–77 months), PSA had decreased in 177 (73.4%) patients, was static in 48 (19.9%) patients, and increased in only 16 (6.6%) patients. Repeat biopsy was performed on 20 patients; of whom seven had cancer (35%) with an overall positivity rate of 2.9% among the 241 patients. Although the positivity rate was higher in men with increased PSA, it was not statistically different from those with lower or similar PSA. No factors could be identified to predict a positive repeat biopsy. Conclusions: PSA, the sole trigger for a prostate biopsy, declined in nearly three-quarters of men with a negative first biopsy, and <3% of men were detected to have cancer on a repeat biopsy. This information could help appropriately counsel patients and allay anxiety after a negative biopsy.

Cost Savings of Expedited Care with Upfront Next-Generation Sequencing Testing versus Single-Gene Testing among Patients with Metastatic Non-Small Cell Lung Cancer Based on Current Canadian Practices.

This study assessed the total costs of testing, including the estimated costs of delaying care, associated with next-generation sequencing (NGS) versus single-gene testing strategies among patients with newly diagnosed metastatic non-small cell lung cancer (mNSCLC) from a Canadian public payer perspective. A decision tree model considered testing for genomic alterations using tissue biopsy NGS or single-gene strategies following Canadian guideline recommendations. Inputs included prevalence of mNSCLC, the proportion that tested positive for each genomic alteration, rebiopsy rates, time to test results, testing/medical costs, and costs of delaying care based on literature, public data, and expert opinion. Among 1,000,000 hypothetical publicly insured adult Canadians (382 with mNSCLC), the proportion of patients that tested positive for a genomic alteration with an approved targeted therapy was 38.0% for NGS and 26.1% for single-gene strategies. The estimated mean time to appropriate targeted therapy initiation was 5.1 weeks for NGS and 9.2 weeks for single-gene strategies. Based on literature, each week of delayed care cost CAD 406, translating to total mean per-patient costs of CAD 3480 for NGS and CAD 5632 for single-gene strategies. NGS testing with mNSCLC in current Canadian practice resulted in more patients with an identified mutation, shorter time to appropriate targeted therapy initiation, and lower total testing costs compared to single-gene strategies.

Total cost of testing for genomic alterations associated with next-generation sequencing versus polymerase chain reaction testing strategies among patients with metastatic non-small cell lung cancer

Background To assess the total cost of testing associated with next-generation sequencing (NGS) versus polymerase chain reaction (PCR) testing strategies among patients with metastatic non-small cell lung cancer (mNSCLC) from a Medicare and US commercial payer’s perspective. Materials and Methods A decision tree model considered testing for genomic alterations in EGFR, ALK, ROS1, BRAF, KRAS, MET, HER2, RET, NTRK1 among patients with newly diagnosed mNSCLC using (1) liquid or tissue biopsy NGS tests, (2) exclusionary mutation (KRAS) test followed by sequential PCR tests, (3) sequential PCR tests, or (4) hotspot panel PCR tests. The alteration test sequence followed clinical guideline recommendations. Inputs based on literature, expert opinion, or assumptions included prevalence of mNSCLC, proportion of patients using each testing strategy (50% NGS [90% tissue, 10% liquid], 10% exclusionary, 10% sequential, 30% hotspot), proportion testing positive for each genomic mutation, rebiopsy rates, and costs for testing and associated medical care. Time to appropriate targeted therapy initiation and total costs were calculated for NGS, each PCR testing strategy, and all PCR strategies combined. Results Among a hypothetical plan of 1,000,000 members (75% commercial, 25% Medicare), 1,119 patients were estimated to have mNSCLC and be eligible for testing. Estimated mean time to appropriate targeted therapy was 2 weeks for NGS and 6 weeks for PCR (sequential: 9 weeks, exclusionary: 8 weeks, hotspot: 3 weeks). Mean per patient costs were $4,932 for NGS and $6,605 for PCR (exclusionary: $5,563, sequential: $6,263, hotspot: $7,066). Per patient costs were higher from a commercial perspective (NGS: $6,225; PCR: $8,430) relative to Medicare (NGS: $2,099; PCR: $2,646); nevertheless, NGS was the least costly testing strategy across plan types. Conclusion NGS was associated with the fastest time to appropriate targeted therapy initiation and lowest total cost of testing compared to PCR testing strategies for newly diagnosed patients with mNSCLC.

PET/CT-Guided Biopsy of Suspected Lung Lesions Requires Less Rebiopsy Than CT-Guided Biopsy Due to Inconclusive Results.

The purpose of this study was to compare 18F-FDG PET/CT and CT performance in guiding percutaneous biopsies with histologic confirmation of lung lesions. Methods: We prospectively evaluated 341 patients, of whom 216 underwent 18F-FDG PET/CT-guided biopsy and 125 underwent CT-guided biopsy. The pathology results, lesion size, complications, and rebiopsy rate in the 2 groups were evaluated. Results: Of the 216 biopsies with PET/CT guidance, histology demonstrated 170 lesions (78.7%) to be malignant and 46 (21.3%) to be benign. In the CT-guided group, of 125 lesions, 77 (61.6%) were malignant and 48 (38.4%) were benign (P = 0.001). Inconclusive results prompted the need for a second biopsy in 18 patients: 13 of 125 (10.4%) in the CT group and 5 of 216 (2.3%) in PET group (P = 0.001). Complications were pneumothorax (13.2%), hemothorax (0.8%), and hemoptysis (0.6%). No life-threatening adverse events or fatalities were reported. The difference in complication rates between the 2 groups was not significant (P = 0.6). Malignant lesions showed a greater mean size than benign lesions regardless of the group (P = 0.015). Conclusion: PET/CT-guided biopsy of lung lesions led to fewer inconclusive biopsies than CT-guided biopsy, with similar complication rates.

Rebiopsy rate after transperineal or transrectal prostate biopsy.

BackgroundIn recent years, transperineal biopsies gained popularity for prostate cancer diagnosis; lower infective complications and improved sampling of the prostate are the main advantages of this technique. One question that remains unclear is whether an initial transperineal biopsy confers a lower risk for rebiopsy compared with the transrectal approach.MethodsSix hundred seventy-one men were prospectively followed after an initial negative prostate biopsy for a median period of 49.50 (IQR: 37.62–61.17) months. Rebiopsy rate was analyzed attending to first biopsy approach (transrectal versus transperineal systematic) and clinical variables.ResultsDiagnostic rate was similar for transrectal and transperineal systematic biopsies. Targeted biopsies outperformed any systematic approach, and transperineal targeted in particular was superior to transrectal targeted. Rebiopsy rates were 15.4% and 5.26% for the transrectal and transperineal systematic groups, respectively. Prostate-specific antigen density and type of first biopsy were identified as rebiopsy predictors.ConclusionMen undergoing transperineal systematic biopsies had a three times lower rate of rebiopsy over the study period compared with the traditional transrectal approach. This advantage could be added to the already described potential benefits of transperineal biopsies. Targeted biopsies had lower rebiopsy rate over the study period. Further innovations that decreased the cost of transperineal biopsies could favor this approach in the future.

Abstract P4-03-03: Accuracy of stereotactic vacuum-assisted breast biopsy for investigating suspicious calcifications in 1,809 patients a public hospital in Brazil

Abstract Background: The gold standard for breast biopsy procedures is currently an open excision of the suspected lesion. However, an excisional biopsy inevitably makes a scar. The cost and morbidity associated with this procedure has prompted many physicians to evaluate less invasive, alternative procedures. Stereotactic vacuum assisted breast biopsy (VASB) can provide a more accurate diagnosis and completely remove the lesion under real-time ultrasonic guidance. The advantage of complete lesion removal with VASB is to reduce or eliminate sampling error, to decrease the likelihood of a histological underestimation, to decrease imaging-histological discordance, to decrease the re-biopsy rate, and to diminish the likelihood of subsequent growth on follow-up, especially when stereotactic VASB is used to investigate microcalcifications. This method is expensive but cost effective when used to investigate microcalcifications classified as BI-RADS 4 and 5. Objectives: To evaluate the accuracy of VASB in the investigation of suspicious calcifications. Methods: We’ve performed a retrospective study from July, 2012 to June, 2019, in which 1,809 women with suspicious calcifications detected on mammography (BI-RADS 4 and 5) had VASB performed at Hospital Estadual Pérola Byington, a public Hospital in São Paulo, Brazil. The device used was Surus Pearl (Hologic, Malbolrough, Massachusetts, USA), with probe gauge 9. Fragments were obtained and sent to anatomopathological study; a metal clip was placed on the biopsy site. Four groups were analyzed, based on the biopsy results: benign, precursor lesions, Ductal Carcinoma In Situ (DCIS) and malignant. Most patients with positive or discordant cases underwent surgical treatment and the previous biopsy results were compared to surgery results. Results: patients median age was 55y (49-63). Pathology results on VASB and surgery were classified respectively as benign n=1,179 (65.1%), precursor lesions n=97 (5.4%), DCIS n=414 (22.9%) and malignant n=119 (6.6%). Benign and lesion precursor lesions results were clustered to form a new group (lower risk lesions) and so DCIS and malignant lesions (higher risk lesions). ROC curve and AUC were calculated to compare the results of lower and higher risk lesions groups according to VASB and surgery results (AUC=0,642). The X2 test was performed between the groups (p<0,05). The sensitivity of the method was 84.4 %, specificity was 96.1%, false negative rate was 4.5%, positive predictive value (PPV) was 89.8%, negative predictive value (NPV) was 93.8%. Conclusion: the VASB method has a good accuracy to distinguish lower and higher risk lesions groups comparing to the gold standard. It has high predictive value in both benign and malignant lesions, guiding therapeutic planning. Keywords: Calcifications; Vacuum-assisted stereotactic biopsy; Breast cancer; Diagnosis Citation Format: Andressa Amorim, Marcellus N. M. Ramos, André Mattar, Maria Isabela B. A. C. Sawada, Jorge Y. Shida, Luiz H. Gebrim. Accuracy of stereotactic vacuum-assisted breast biopsy for investigating suspicious calcifications in 1,809 patients a public hospital in Brazil [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-03-03.

Abstract P3-04-01: The value of stereotactic vacuum-assisted biopsy in the investigation of microcalcifications in 1354 patients in public Brazilian hospital

Abstract Background: The gold standard for breast biopsy procedures is currently an open excision of the suspected lesion. However, an excisional biopsy inevitably makes a scar. The cost and morbidity associated with this procedure has prompted many physicians to evaluate less invasive, alternative procedures. More recently, image-guided percutaneous core-needle biopsy has become a frequently used method for diagnosing palpable and non-palpable breast lesions. Although sensitivity rates for core-needle biopsy are high, it has the disadvantage of histological underestimation, which renders the management of atypical ductal hyperplasia, papillary lesions, and fibroepithelial lesions somewhat difficult. Stereotactic vacuum assisted breast biopsy (VABB) was developed to overcome some of these negative aspects of core-needle biopsy. VABB allows for a sufficient specimen to be obtained with a single insertion and can provide a more accurate diagnosis and completely remove the lesion under real-time ultrasonic guidance. The advantage of complete lesion removal with VABB is to reduce or eliminate sampling error, to decrease the likelihood of a histological underestimation, to decrease imaging-histological discordance, to decrease the re-biopsy rate, and to diminish the likelihood of subsequent growth on follow-up, especially when stereotactic VABB is used to investigate microcalcifications. This method is expensive but cost effective when used to investigate microcalcifications classified as BI-RADS 4 and 5. Methodology: We performed a review in 1,354 patients with suspicious mammography microcalcifications, classified as BI-RADS 4 or 5 that were seen in Perola Byington Hospital from July 2012 to July 2017 in São Paulo-Brazil. We have used aHologic Lorad Multicare Platinum Stereotactic Prone Breast Biopsy and a Surus Pearl (Hologic, Malbolrough, Massachusetts, USA), with gauge 9 probe. Four to eight fragments (median of 6) were obtained with the placement of a metal clip in the bed that the biopsy was performed, and histopathological analysis was made. Results:The histopathological study of the lesions revealed benign alterations in 956 (68%) of our patients. The findings were positive for malignancy in 358 patients (29%) and the precursor lesions were diagnosed in 40 (3%). In 81 cases (5.9%) the findings were discordant. The sensitivity of the method was 84.4%, specificity was 96.1%, false negative rate was 4.5%, positive predictive value (PPV) was 89.8%, negative predictive value (NPV) was 93.8%. In literature review the sensitivity varies 91.5-100%, specificity 81.9-110%, false negative rate 0-3.3%, PPV 92.2-100% and NPV 80.5-99.5%. All patients with positive or discordant cases underwent surgical treatment to increase the margin or complete removal of the lesion. Conclusions: The VABB is an outpatient procedure that avoids hospital admissions for diagnostic elucidation in most of cases suspected of malignancy. It has high predictive value in both benign and malignant lesions, guiding therapeutic planning. In addition to presenting the cost lower than the surgical biopsy it indirect increases the supply of hospital beds for cancer treatment. Citation Format: Mattar A, Amorim AG, Ramos MdNM, Shida JY, Fonseca GR, Hegg R, Gebrim LH. The value of stereotactic vacuum-assisted biopsy in the investigation of microcalcifications in 1354 patients in public Brazilian hospital [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P3-04-01.

Re-biopsy status among Chinese non-small-cell lung cancer patients who progressed after icotinib therapy.

ObjectiveAcquired T790M mutations account for 50%–60% of tyrosine kinase inhibitor (TKI)-resistant mechanisms in EGFR mutation-positive (m+) non-small-cell lung cancer (NSCLC) patients, and re-biopsy is recommended to detect these mutations. We investigated the re-biopsy status and the T790M incidence rate in patients after treatment with icotinib, which is the first-generation EGFR-TKI widely used in China.Patients and methodsTarget patients had EGFRm+NSCLC, who were progressed after icotinib therapy. The primary end point was the re-biopsy rate (number of cases in which re-biopsies were performed successfully/total number of patients progressed after icotinib therapy). Secondary end points included the T790M mutation incidence rate, differences between the first biopsy and re-biopsy, and details of why re-biopsy was not performed in relevant patients.ResultsA total of 77 adenocarcinoma patients were evaluated (median age, 58 years). Tissue re-biopsy was successful in 41 patients (53.2%). Compared with the first biopsy, percutaneous tissue biopsies increased from 51.2% to 70.7% (P=0.008), while bronchoscopy biopsies and the surgical rate decreased from 19.5% to 14.6% (P<0.001) and 17.1% to 7.3% (P<0.001), respectively. Primary lung lesions were more common in the first biopsy than in re-biopsy (80.5% vs 65.9%, P=0.008), but metastatic lesions were more often selected for re-biopsy (14/41 [34.1%], including metastases in the bone, lymph nodes, and liver). The incidence rate of T790M was 56.1% (23/41). The reasons for not performing re-biopsies included lesion sizes and/or locations unsuitable for biopsy (n=17), a positive circulating tumor DNA (ctDNA) result (n=3), patient unwillingness (n=7), older age or severe comorbidity (n=4), and poor health (n=5). No severe complications were found.ConclusionIn this real-world study, the re-biopsy rate was 53.2% and the incidence rate of T790M mutations was 56.1%. Further efforts are needed to increase the re-biopsy rate in patients who progress after icotinib therapy.

The use of transrectal ultrasound-guided biopsy following the introduction of prostate-specific antigen testing in Denmark: a population-based analysis

Objective: Incidence rates of prostate cancer in Denmark resemble those of countries that endorse prostate-specific antigen (PSA) screening. So far, no studies have described the consequences of PSA testing on diagnostic activity on a population level. The aim of this study was to describe the frequency of systematic transrectal ultrasound-guided biopsy (TRUS-gb) activity, including rebiopsy rates, in Denmark between 1995 and 2011.Materials and methods: All men who underwent TRUS-gb during the period were identified in the Danish Prostate Cancer Registry. In total, 83,041 biopsy sets from 64,430 individuals were identified. The diagnostic rate and the frequency of rebiopsy were analyzed. Age, histology and PSA were compared at the time of biopsy.Results: The number of TRUS-gb per 100,000 men per year increased 4.6-fold. The mean number of TRUS-gb procedures per individual increased from 1.08 in 1995 to 1.46 in 2011 (p = .0001), and the proportion of men with negative initial biopsy sets who underwent rebiopsy increased from 22% in 1995 to 41% in 2004, later decreasing to 31% in 2009.Conclusions: The diagnostic activity in Denmark and the rebiopsy rates in men with initial negative TRUS-gb have increased substantially, and guidelines for the management of men with a negative initial biopsy are highly warranted.

3:09 PM Abstract No. 92 Impact of rapid onsite pathology evaluation (ROSE) on biopsy adequacy: a retrospective review of 610 image-guided biopsies

Rapid onsite evaluation (ROSE) for percutaneous biopsy is a system in which a cytopathologist is available at the time of procedure to evaluate sample adequacy. The aim of our study is to evaluate sample adequacy rates at two academic hospitals staffed by the same group of interventional radiologists, one which uses ROSE and one which does not. We hypothesize ROSE improves the rate of diagnostic specimens obtained and decreases both the number of needle passes and the need for repeat biopsy. IRB approval was obtained at center 1 (with ROSE) and waived at center 2 (without ROSE) for this retrospective review of 610 liver, lung and thyroid biopsies. Center 1 included 96 thyroid, 110 liver, and 114 lung biopsies; center 2 included 117 thyroid, 60 liver, and 112 lung biopsies. The two groups were compared using the t-test and ANOVA for age and sex, respectively. Comparisons of the number of needle passes were done using least squares regression, adjusting for age, sex, and target site. Comparison of whether a specimen was diagnostic was done using a multivariate logistic regression model. After performing multivariate analysis adjusting for age, sex, and tissue type, the odds of having a diagnostic specimen were almost 4 times greater at center 1 than at center 2 (OR 3.97, p<0.01). The rebiopsy rate was significantly lower at center 1 when compared to center 2 (p<0.01). There was no significant difference in the number of needle passes taken per biopsy site when compared between the two centers. ROSE improves the diagnostic yield of image-guided liver, lung, and thyroid biopsies. Our large study presents evidence that on-site cytopathology is a valuable resource; it improves the time to diagnosis by increasing the diagnostic yield at the time of procedure, and it decreases the need for rebiopsy. Thus, centers that utilize image-guided percutaneous biopsy should allocate resources to cover on-site cytopathologic evaluation.

The reasons why re-biopsies were not performed after failure with EGFR-TKI.

e20540 Background: Repeat biopsy becomes important to determine subsequent treatment after failure of EGFR-TKI. However, some patients did not receive re-biopsy in real world. Here we retrospectively analyzed the reasons why the patients did not receive re-biopsy. Methods: We reviewed medical records of 235 patients treated with EGFR-TKI at our institution between January 2014 and September 2016 and analyzed the treatment, the progression site after failure of EGFR-TKI and the reasons why they did not receive re-biopsy. Results: 127 of 235 (54%) patients had tumor progression after treatment with EGFR-TKI and 93 (73.2%) of 127 patients received re-biopsy and 34 (26.8%) patients didn’t. The characteristics of 34 patients who did not received re-biopsy were; the median age, 67 years (29-83), male/ female: 12/22, PS0-1/2 ≥:27/7, stage IV/recurrence/other:20/10/4, smoking history never/ex/current: 15/17/2, histology : adeno/other 34/0, EGFR mutation type; 19del/L858R/Other = 13/15/6, prior EGFR-TKI; Gefitinib/Erlotinib/Afatinib/other: 22/9/2/1. The commonest reason why they did not receive re-biopsy was no target lesion to get biopsy (n = 13,38%). CT scans of these patients were retrospectively evaluated and it was confirmed that there were no lesions that could be accessed safely at that time. Central nervous system lesions, multiple small pulmonary lesions and bone metastasis were unaccessible lesions. Although 21 patients had accessible lesions including lung, superficial lymph nodes, pleural effusion, liver, they did not receive re-biopsy because of patient refusal (n = 9), worsening of general condition (n = 3), need for other therapy immediately (ex: chemotherapy, radiotherapy) (n = 3), old age (n = 2), existence of de novo T790M (n = 2), complications (n = 1) and physician’s choice (n = 1). Conclusions: Some patients who did not recieve re-biopsy had some target lesions and it could be increase the re-biopsy rate.

EGFR testing scenario across 111 centres in India: A questionnaire-based survey.

e13111 Background: Lung cancer diagnosis now involves routine use of biomarker testing to identify the driver mutations. We conducted a survey of 111 medical oncologists across India to understand the current pattern of EGFR mutation testing at their respective centres. Methods: Medical oncologists from 111 institutes across India were interviewed face to face using a structured questionnaire. They were divided into two groups - Group 1 with in-house EGFR testing and Group 2 who send samples to central/commercial labs. Answers of the two groups were analysed to see the prevailing patterns of EGFR mutation testing and differences between the groups if any. Results: In India, 95% of medical oncologists recommend testing for EGFR mutations in patients with adenocarcinoma histology. 40% would also recommend testing in squamous histology. 80% of medical oncologists request for biomarker testing at the time of primary biopsy. From the time of biopsy, the average time duration to get EGFR test results is 18 days. In centres with in-house testing (Group 1), results are available in 10 days. 96% of the medical oncologists from Group 1 centres request for factoring additional sample for biomarker testing compared to only 69% from Group 2. 69% of medical oncologists in Group 1 centres would prefer to wait for the test results before initiating treatment compared to 46% in Group 2. EGFR TKIs are used in 60% of patients with diagnosed EGFR mutation in the first line. For patients in whom chemotherapy is initiated while waiting for test results, 50% of medical oncologists prefer completing 4-6 cycles before switching to targeted therapy. At the time of progression, rebiopsy is possible in 25% of the patients. Rapid disease progression and poor PS were the two most common reasons given for the low rebiopsy rates. Conclusions: Application of molecular testing is ‎improving. Yield can be improved by training of multidisciplinary team involved in tumor biopsy. There is scope and need to reduce the turnaround time. This will reduce the current scenario of commencing chemotherapy while waiting for test results. Increasing application of liquid biopsy will help in initial diagnosis as well as at relapse, especially for patients with poor PS or difficult access to tumor site.

Repeat Prostate Biopsy Practice Patterns in a Statewide Quality Improvement Collaborative

We examined rebiopsies in MUSIC (Michigan Urological Surgery Improvement Collaborative) to understand adherence to guidelines recommending repeat prostate biopsy in patients with multifocal high grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. We analyzed data on men undergoing repeat biopsy, practice patterns and cancer detection rates. Multivariate regression modeling was used to calculate the proportion of patients undergoing rebiopsy. We used claims data to validate the treatment classification in MUSIC. To understand reasons for not performing rebiopsy we reviewed records of a sample of patients with atypical small acinar proliferation. We identified 5,375 men with a negative biopsy, of whom 411 (7.6%) underwent repeat biopsy. In 718 men with high grade prostatic intraepithelial neoplasia, 350 with atypical small acinar proliferation and 587 with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation or atypical small acinar proliferation alone at initial biopsy the rebiopsy rate was 20.7%, 42.5% and 55.6%, respectively. The adjusted proportion of patients with rebiopsy in each practice ranged from 0% to 17.2% (p <0.001). The overall cancer detection rate at rebiopsy was 39.3%. It was highest after atypical small acinar proliferation (adjusted probability 0.39, 95% CI 0.30-0.48), and after high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation (adjusted probability 0.50, 95% CI 0.35-0.65). The greatest Gleason 7 or greatest detection rate of 41.1% was found in patients with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation. Chart review revealed that 45.5% of patients with atypical small acinar proliferation underwent prostate specific antigen testing instead of rebiopsy while 36% failed to undergo rebiopsy despite a recommendation. Rebiopsy rates vary in Michigan practices with relatively low use in men with high grade prostatic intraepithelial neoplasia and atypical small acinar proliferation or atypical small acinar proliferation alone. Quality improvement strategies should target patients with atypical small acinar proliferation and high grade prostatic intraepithelial neoplasia as they have the highest likelihood of cancer detection.

The association of level of practical experience in transrectal ultrasonography guided prostate biopsy with its diagnostic outcome.

INTRODUCTION The diagnostic yield of transrectal ultrasonography (TRUS) guided prostate biopsy is influenced by many patient and procedure specific factors. However, the role of operator specific factors remains inadequately defined. This study investigated the association of diagnostic outcome of TRUS guided biopsy with operator skill level. METHODS This study looked at a consecutive cohort of 690 men undergoing their first extended pattern TRUS guided prostate biopsy by 27 operators over a 24-month period in a single institution. Logistic regression was used for statistical analysis. RESULTS Biopsies performed by consultants (odds ratio [OR]: 2.35, p=0.004) and senior trainees (OR: 2.37, p=0.002) in patients with prostate specific antigen levels of <10ng/ml were more likely to be positive than those performed by junior trainees (cancer detection rate 50.0%, 50.3% and 29.9% respectively). Furthermore, biopsies performed by junior trainees yielded a significantly higher proportion of prostate cancers with a Gleason score of ≥3+4 than those performed by senior trainees (OR: 2.11, p=0.031) and consultants (OR: 2.40, p=0.013) (81.4%, 67.5% and 64.6% respectively). No significant differences emerged between operator skill groups for complications, rebiopsy rates or the number of prostate cancers found during the follow-up period (median: 34 months) of patients with a negative biopsy. CONCLUSIONS Level of operator experience is associated with the diagnostic outcome of extended pattern TRUS guided biopsy. The findings of this study imply that case selection, self-audit and expert supervision for the duration of the learning curve should form the basis of biopsy training.

Acute Prostatitis After Transrectal Ultrasound-guided Prostate Biopsy: Comparing Two Different Antibiotic Prophylaxis Regimen

Transrectal ultrasound-guided prostate biopsies (TRUSBx) are common and increasingly performed procedure. As this procedure can be complicated by infections, antibiotic prophylaxis is widely used around the world to minimize these complications, but there is no consensus on the most appropriate prophylaxis regimen. A total number of 412 patients who were referred fo TRUSBx, was devided randomely into two groups. Group 1 received routine antibiotic prophylaxis and Group 2 did not received Amikacin. Other premedications in both groups include ciprofloxacin, metronidazole, ceftazidime and povodine iodine gel. 2 days after biopsy, all patients were investigated about significant fever(e�38°C). febrile patients were referred to urology clinic for further evaluation about acute prostatitis or septicemia. There was 210 patients in group A and 202 patients in group B. No significant difference was detected in mean age, prostatic volume, serum PSA level, re-biopsy rate and pathology report between two groups. Acute prostatitis was developed in 2 patients (0.9) in group A and 1 patient (0.5) in group B that was not statistically significant.(P>0.05) Removing amikacin from ciprofloxacin-based antibiotic prophylaxis along with local povodine iodine would not put our patients in increased risk for infectious complications after TRUSBx. © 2016, Oriental Scientific Publishing Company. All rights reserved.

Successful completion of EGFR/ALK testing in non-squamous non-small cell lung cancer (non-sq NSCLC) with the implementation of reflex testing (RT) by pathologists.

93 Background: EGFR mutation and ALK rearrangement testing is standard in the management of advanced non-sq NSCLC patients (pts). Previously at our centre, EGFR/ALK biomarker testing was requested by medical oncologists (MO). In June 2013 we implemented biomarker RT, defined as pathologists requesting EGFR/ALK at time of diagnosis of non sq-NSCLC irrespective of stage. The objective of this study was to test the hypothesis that if pathologists requested biomarker testing, appropriate tissue would be preserved and selected for testing, which would improve success rates of biomarker testing. Methods: Retrospective review of advanced non-sq NSCLC pts seen by MO at Sunnybrook Odette Cancer Centre from March 2010 to April 2014. Pt and EGFR/ALK test characteristics were compared before and after RT using Chi-square tests of association. Time outcomes were compared using Mann-Whitney U tests. Results: Of the 310 pts included, median age was 68, 44% female, 47% Caucasian, 93% adenocarcinoma, 22% EGFR+, 1% ALK+ and 84% either presented with or developed stage IV. Samples tested for EGFR and ALK were respectively: 53%, 51% core biopsies; 25%, 32% surgical resections; 20%, 16% cytology. The number of biomarker tests across all stages increased with RT (EGFR 70% vs 95%, p &lt; 0.001 / ALK 44% vs 83%, p &lt; 0.001). RT improved the rate of successfully completed tests (EGFR 86% vs 96%, p = 0.04 / ALK 83% vs 97%, p = 0.04). The remainder of tests were unsuccessful due to inconclusive results (EGFR 9% vs 4%, p = 0.25 / ALK 7% vs 2%, p = 0.25), insufficient tissue (EGFR 3% vs 0%, p = 0.33 / ALK 10% vs 0%, p = 0.03) or cancellation due to appropriate tissue not being sent from holding lab to testing lab (EGFR 2% vs 0, p = NS / ALK 0% vs 2%, p = NS). From core biopsies, there was trend to improved success of EGFR testing with RT (82% vs 97%, p = 0.06) and significant improvement of ALK testing (82% vs 100%, p = 0.04), with no impact on success from cytology samples. Rebiopsy rate for biomarker testing was low in both cohorts. Turnaround time for EGFR testing decreased [19 days (IQR 15-25) vs 17 days (IQR 12-21), p = 0.02]; ALK was unchanged. Conclusions: Implementation of RT improved successful completion of EGFR/ALK testing.

Rebiopsy rate for non-small cell lung cancer patients after EGFR-TKI failure in clinical setting: Toward the third-generation EGFR-TKI era.

e19080 Background: The secondary epidermal growth factor receptor (EGFR) mutation Thr790Met (T790M) accounts for approximately half of acquired resistances to EGFR-tyrosine kinase inhibitors (TKIs)...

Mitomycin C guidelines: An improvement in department adherence through the process of audit, led by junior doctors

s / International Journal of Surgery 12 (2014) S13eS117 S104 0328: MITOMYCIN C GUIDELINES: AN IMPROVEMENT IN DEPARTMENT ADHERENCE THROUGH THE PROCESS OF AUDIT, LED BY JUNIOR DOCTORS Gerard Walls , David Curry, Hugh O'Kane. Regional Urology Unit, Belfast City Hospital, Northern Ireland, UK. Introduction: The authors intended to establish adherence to guidelines regarding time to administration of intravesical chemotherapy postTURBT, in the Regional Urology Unit. EORTC recommends Mitomycin C (MMC) instillation within 6 hours in eligible patients this reduces recurrence rates by 39%. Methods: Prospective audit of time to administration in all eligible patients during a 3 month period. Results were discussed at departmental level with a three tiered approach to improvement. Primarily, initiation of in-theatre instillation (Mostafid et al). Second, a training programme for ward staff in handling cytotoxic agents. Finally, awareness of the problem was raised to trainee urologists at the Regional Audit Meeting. A repeat three month audit series was performed six months later. The latter two processes had been implemented with plans for in-theatre administration on-going. Results: Initially, in 19 patients (40 eligible) the mean time to MMC administration was 18.3hrs (2.3-28.2hrs). 15.7% patients received MMC 3mm, first time. Unanimous, unequivocal histopathological diagnoses were achieved. Conclusions: Few biopsy devices provide satisfactory, representative and consistent samples for diagnosis. We experienced an unpredictable outcome with a 25% re-biopsy rate with various devices, however with BIGopsy forceps accurate histopathological diagnoses were achieved with a significant impact on the timely treatment for urothelial malignancies. 0401: HOW CLINICAL AUDIT HAS LED TO REDUCED RATES OF POST TRUS BIOPSY SEPSIS IN OUR TRUST Nicholas Gill , Michael Onyema, Anne Dyas, Vincent Koo, Paul Rajjayabun. Alexandra Hospital, Redditch, UK. Introduction: We recently reported the findings of a regional audit which identified rates of sepsis increasing to 1.8% following transrectal ultrasound guided prostate biopsies (TRUS). Following this audit I.V. Gentamicin 160mg was introduced as additional prophylaxis for patients undergoing TRUS biopsy. Our aim was to assess the impact of adding Gentamicin to the TRUS antibiotic prophylaxis bundle since implementation in August 2013. Methods: Analysis of all patients who underwent TRUS biopsy across our Trust between August-December 2013 with minimum 1-month follow up. Our findings were compared against our previous audit data and published literature. Results: Therewere 246 TRUS biopsy procedures carried out across the Trust following the introduction of our new antibiotic prophylaxis regime. Median age of the population examined was 67 years (range 42-84). Only 1 patient was admitted to Secondary care with significant sepsis (0.4%), 3 patients had positive urine cultures performed inPrimarycare but didnot require hospital admission (1.2%). There were no ITU admissions or mortalities. Conclusion: We conclude that the addition of I.V. Gentamicin has dramatically reduced the incidence of significant sepsis post-TRUS biopsy. This is an example of howwe have utilised audit tomodify clinical practice for the benefit of our patients. 0403: PROGNOSIS FOLLOWING PERCUTANEOUS NEPHROSTOMY INSERTION FOR MALIGNANT OBSTRUCTIVE UROPATHY: ONE CENTRE'S EXPERIENCE Nicholas Gill , Kevin Williams, Phil Holland, Chris Phillips, Fabio Conti, K. Wong, L. Delaney, L. Moore, Paul Rajjayabun. Alexandra Hospital,