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L. De La Cruz



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    P1.12 - Poster Session/ Community Practice (ID 232)

    • Event: WCLC 2015
    • Type: Poster
    • Track: Community Practice
    • Presentations: 4
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      P1.12-003 - Acquistion of and Early Clinical Results of Electromagnetic Navigational Bronchoscopy for Diagnosis of Lung Cancer in a Community Setting (ID 956)

      09:30 - 17:00  |  Author(s): L. De La Cruz

      • Abstract

      Background:
      Electromagnetic Navigational Bronchoscopy (ENB) is an emerging technology to assist in obtaining a tissue diagnosis from suspicious lung nodules or masses. Despite the recognized advantages of having access to ENB technology, there are barriers to procure such expensive technology and effectively implement it. Acquiring and leveraging ENB technology is dependent on diverse considerations for community need, financial feasibility, patient / referral work flow and synergy with complimentary diagnostics and programs, proper coding and revenue cycle management and associated service development and marketing. There are many elements to implementing and achieving acceptable results which include the initial capital planning and service optimization, maximizing utilization, learning the techniques with enhanced competency and the handling and management of the specimens once obtained. Herein, we describe our approach to procuring the technology and early clinical results.

      Methods:
      ENB technology was purchased after partnering with the parent company (Covidien) and our health system's business development department, to perform a market analysis as well as a return on investment that integrated multiple service lines and hospital costs centers. From these data, a business plan was created and ultimately approved by the Foundation Board. All ENBs (SuperDimension®) were performed under general anesthesia by a single thoracic surgeon in the operating room, using a therapeutic bronchoscope inserted through a 9 endotracheal tube. Almost all procedures utilized fine needle aspiration, brushings, biopsies and washings. The biopsy phase of the procedure was done under fluoroscopy. Cytologic slide review via Rapid Onsite Evaluation (ROSE) was performed by a pathologist in the operating room in 100% of the cases. Results were obtained by retrospective review of a prospective database. Time period of study was 12/11/13-03/30/14.

      Results:
      72 total ENB cases were performed in the time period of which 52 were for suspected malignancy. There were no pneumothoraces or bleeding complications. Two patients had to be admitted for 23 hours secondary to poor respiratory function following procedure. Of the 52 suspected malignancies, 33 (64%) were found to be a primary lung cancer, 7 were atypical and 12 benign or non-diagnostic. 5 of the patients with atypia went on to surgical resection and were found to have lung adenocarcinoma.

      Conclusion:
      ENB is an emerging technology with promising results for tissue diagnosis of lung nodules suspected of being malignant. Implementing new and costly technologies in smaller healthcare systems, such as a regional hospital, can be challenging. Some of the barriers to implementation are finding the capital and justification for procuring the technology, perfecting the technique and securing support from pathology, anesthesiology and operating room time. By partnering with industry and our business department, we were able to justify procurement of ENB technology. In our first 72 cases, 52 were for suspected malignancy. A diagnosis of lung cancer was achieved in 64% of lung lesions, with a low complication rate (2/72). Our results compare favorably to published results of trans thoracic needle biopsies as well as within our own health system. Initiating and implementing an ENB program in a community setting is feasible with acceptable results.

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      P1.12-004 - Early Results of Endobronchial Ultrasound for Lung Cancer Mediastinal Nodal Staging in a Community Setting (ID 1610)

      09:30 - 17:00  |  Author(s): L. De La Cruz

      • Abstract

      Background:
      Endobronchial Ultrasound (EBUS) has become an established modality for pathological mediastinal staging for lung cancer and in some centers, is used at the exclusion of mediastinoscopy, the traditional gold standard. Herein, we describe our early results of EBUS, in a community setting, for mediastinal pathologic staging for lung cancer and compare it to concomitant mediastinoscopy.

      Methods:
      All EBUS procedures were performed in the operating room under general anesthesia, with a Pentax scope introduced through a 9 endotracheal tube, by a single thoracic surgeon. The Pentax needle was used early in the series and the Cook needle later. Rapid Onsite Evaluation (ROSE) for immediate cytologic evaluation of specimens was performed in 100% of the cases. For lung cancer staging patients, mediastinoscopy was performed immediately after the EBUS under the same anesthetic. This was an outpatient procedure. Study period was 04/21/14-04/13/15. Data was collected from a retrospective review of a prospective database.

      Results:
      There were 40 EBUS cases performed during the study period. There were no complications. 36 were performed for cancer diagnosis/staging and 21 for lung cancer staging specifically. 27 cases had EBUS and mediastinoscopy performed concomitantly under one anesthetic and thus could be directly compared. 46 total # of lymph node stations were evaulated with EBUS and 16 (35%) resulted in no lymphocytes or diagnosis. Regarding the 21 lung cancer patients who were being evaluated for pre-treatment pathologic mediastinal staging, the average # of lymph node stations was 1.1 for EBUS vs. 3.4 for mediastinoscopy. Using mediastinoscopy as the reference for pathologic staging, the sensitivity of EBUS was 80% and specificity 100%. If the EBUS stations that yielded no lymphocytes or diagnosis were eliminated from the analysis, the sensitivity was 89% and specificity 100%.

      Conclusion:
      EBUS has become an established technique to pathologically stage mediastinal nodes for lung cancer. In some centers, it is used at the exclusion of mediastinoscopy (the gold standard) and in others, selectively. Our early results with the adoption of this technique and comparing it to mediastinoscopy performed concommitantly, has an acceptable sensitivity and specificity. However, we experienced a relatively high rate of absence of lymphocytes/non-diagnostic (35%), compared to mediastinoscopy (0%), and fewer nodal stations biopsied per procedure (avg. 1.1) compared to mediastinoscopy (avg. 3.4). This does represent an early experience and likely not beyond the learning curve. We will continue to utilize EBUS for lung cancer staging but will be liberal to employ concomitant mediastinoscopy until we can approach the results of our mediastinoscopy with respect to yield of lymphocytes/diagnosis and # of stations biopsied per procedure.

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      P1.12-005 - Concomitant Electromagnetic Navigational Bronchoscopy and Endobronchial Ultrasound to Diagnose and Stage Lung Cancer in a Community Setting (ID 2410)

      09:30 - 17:00  |  Author(s): L. De La Cruz

      • Abstract

      Background:
      Delays in lung cancer diagnosis and adequate staging can both delay and affect appropriate care. It is not uncommon to take months from the time of the first suspicion of lung cancer on imaging to diagnosis, staging and treatment. We have recently adopted both electromagnetic navigational bronchoscopy (ENB) and endobronchial ultrasound (EBUS) technologies as part of our comprehensive lung cancer program. By cultivating an early referral system, within the primary care network, of suspected lung cancer and with the understanding of which patients should have pathologic mediastinal staging, we are able to both diagnose a primary lung cancer and pathologically stage the mediastinal nodes in one setting under the same anesthetic. This combined approach by a lung cancer expert, saves many potential delays of separate serial procedures often ordered by those not as familiar with lung cancer evaluation and staging. Herein, we describe our early results with this approach.

      Methods:
      Criteria for patient selection was a lung nodule/mass suspicious for lung cancer and either clinically positive hilar or mediastinal lymph nodes (>1cm on short axis or > 2.5 SUV on PET) or central primary, >4 cm primary or >10 SUV of suspected primary lung cancer. All procedures were performed by a single thoracic surgeon, in the operating room with the patient under general anesthesia. The Superdimension® ENB system was utilized and the Pentax® EBUS system. Rapid Onsite Evaluation (ROSE) for immediate cytologic evaluation of specimens was performed in 100% of the cases. The study period was 04/21/14-04/13/15. Data was evaluated retrospectively from a prospective collected database.

      Results:
      21 patients had a combination of ENB and EBUS and/or mediastinoscopy or both. 19 patients had lung cancer and constitute this analysis. A diagnosis of lung cancer was achieved in 16 patients (84%). EBUS/Mediastinoscopy was negative for cancer in 11 (59%) patients and positive for cancer in 8. (41%). There were no complications and all procedures were outpatient. The subsequent treatment of the patients were as follows: 5 definitive chemoradiation, 3 lobectomy followed by chemotherapy, 1 lobectomy followed by radiation to chest wall, 1 lobectomy, 2 clinical trials, 1 neoadjuvant chemotherapy followed by lobectomy (intent), 2 chemoradiation followed by lobectomy (intent), 1 radiation, 2 chemotherapy, 1 hospice.

      Conclusion:
      The ability to both diagnose lung cancer and pathologically stage the mediastinum under one anesthetic with utilization of ROSE, has several potential advantages. It allows an efficient and expeditious diagnosis and staging in select patients so they move expeditiously to the appropriate treatment and potentially skip several serial appointments and tests. Like most centers, we selectively pathologically stage the mediastinum for lung cancer patients and this is likely why in this series there is a relatively high percentage of pathologic N2 nodes (41%) found on pre-treatment pathologic staging and relatively high percentage of patients having adjuvant treatment after lobectomy. We believe this is an efficient approach for patients with a suspected lung cancer and meet criteria for pathologic mediastinal staging. Future studies will focus on quantifying the time savings differential between this approach and the more traditional approaches.

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      P1.12-008 - Components of Creating and Implementing a Comprehensive Lung Cancer Program in a Community Setting (ID 2424)

      09:30 - 17:00  |  Author(s): L. De La Cruz

      • Abstract

      Background:
      Many communities do not have a comprehensive, evidence based approach to lung cancer diagnosis, staging and treatment. This is often secondary to lack of providers in the area with expertise in lung cancer as well as lack of appropriate diagnostic and treatment modalities. Herein we describe the creation and implementation of a comprehensive lung cancer program in a community setting.

      Methods:
      A regional health system that serves a population with a relatively high incidence of lung cancer, recruited an experienced general thoracic surgeon, with expertise in the diagnosis, staging and treatment of lung cancer. The community had a pre-existing cardiac surgery program, a cancer center that provided chemotherapy and traditional radiation, a PET scanner and 2 CT scanners.

      Results:
      The study period was 9/1-2012 to 4/1/2015 which spans the time after the introduction of the general thoracic surgeon in the community to present. Under the leadership of the thoracic surgeon, the following was accomplished: 1. An extensive outreach campaign to primary care physicians as well as directly to the community regarding lung cancer awareness, modern diagnostic, staging and treatment modalities. 2. Establishment of a pulmonary nodule clinic to provide expertise and continuity in the evaluation of pulmonary nodules. 3. The establishment of a lung cancer CT screening program, 4. Evolution of the tumor board from a once a month meeting, reviewing an average of 3.1 patients retrospectively and an average attendance of 3.6 attendees to currently meeting weekly, prospectively reviewing an average of 8.6 cases per meeting (>90% lung cancer) and an average attendance of 9.3 attendees including thoracic surgery, medical and radiation oncology, pathology, social work and a rotation of surgeons, pulmonologists and primary care physicians. 5. The procurement and implementation of Electromagnetic Navigational Bronchoscopy to the community to obtain tissue diagnosis of suspected lung lesions. 6. The procurement and implementation of Endobronchial Ultrasound for the minimally invasive pathologic staging of appropriate lung cancer patients. 7. The procurement and participation in the Society of Thoracic Surgery (STS) General Thoracic Surgery Database for registration of patient outcomes and national comparison. 8. The introduction of VATS lobectomies and complex open resections. 9 400 new thoracic surgical cases to the Regional Medical Center. 10. 54 cases of multimodallity therapy for lung cancer patients compared with 4 the previous two years. 11. The establishment of stereotactic body radiation therapy (SBRT) as a treatment alternative to surgery for medically inoperable stage I lung cancer patients.

      Conclusion:
      It is possible to create a de novo comprehensive lung cancer program in a community setting with the appropriate expertise and leadership. General thoracic surgeons with expertise in current lung cancer diagnostics, staging and treatment options are uniquely positioned to provide the expertise and leadership to create a comprehensive lung cancer program as they are integrally part of assessing pulmonary nodules, establishing diagnosis, rigorously staging lung cancer and treatments including surgery, radiation chemotherapy and multimodality regimens. This approach could serve as a paradigm for similar communities to bring current, evidence based lung cancer diagnostics and treatment to their region.