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David L Ball

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    PC 01 - 1-1. Surgery vs Non-Surgical Local Treatment for Small-Sized NSCLC (ID 581)

    • Event: WCLC 2017
    • Type: Pros & Cons
    • Track: Early Stage NSCLC
    • Presentations: 3
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      PC 01.01 - SABR as First Line Treatment Option (ID 7822)

      15:45 - 16:45  |  Presenting Author(s): Hak Choy

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Surgery has historically been the primary treatment option for patients with Stage I non–small-cell lung cancer (NSCLC). Although Stage I NSCLC is technically curable, the presence of significant co morbidity increases the risk of postoperative complications and reduces the potential role of surgery even early stage NSCLC. Because nonsurgical treatment options such as conventional radiotherapy have historically achieved suboptimal outcomes, some have argued that the risks associated with surgery in patients with severe COPD were justified. The reason for poor tumor control with conventional radiation therapy has been shown to be due to insufficient total radiation doses which is usually 60 Gy or lower. Dose escalation with CRT have shown that a total dose of just above 80 Gy seems to be tolerable while doses exceeding 90 Gy, necessary for optimal tumor control, were associated with high risk of unacceptable lung toxicity. Since the 2000s, stereotactic body radiation therapy has rapidly spread as medical physics improved. Stereotactic body radiation therapy has been revealed to be equivalent to surgery in tumor ablation. With stereotactic body radiotherapy (SBRT) the radiation dose to normal tissue is minimized and the dose per fraction can be increased resulting in biologic doses up to twice as high as in CRT. This has resulted in improvement of local tumor control rates up to 88% to 100%, comparable to the rates after surgery. SBRT is a safe and effective treatment option for these patients, with outcomes that do not appear to be inferior to surgery. SBRT is not associated with the considerable initial risks of operative mortality and prolonged hospitalization. Patients who do undergo surgery may benefit from avoiding open lobectomy, instead using less invasive approaches such as video-assisted thoracoscopic surgery or open segmentectomy. All patients with Stage I NSCLC and severe COPD should be evaluated in a multidisciplinary setting and afforded an informed decision of the risks and benefits of both surgery and SBRT. In role of SBRT can also be extended even in patients with oligometastases and oligo-recurrence, the oligometastases and oligo-recurrence who sometimes cured with only local therapy. Radiotherapy (RT) can cause immunogenic tumor cell death resulting in cross-priming of tumor-specific T-cells, acting as an in situ tumor vaccine; however, SBRT alone has limit in inducing effective anti-tumor immunity resulting in systemic tumor rejection. Immunotherapy can complement SBRT to help overcome tumor-induced immune suppression, as demonstrated in many pre-clinical tumor models. There are many trials underway for combinations of different immunotherapies and SBRT.

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      PC 01.02 - Surgery as First Line Treatment Option (ID 7823)

      15:45 - 16:45  |  Presenting Author(s): Robert John Downey

      • Abstract
      • Presentation
      • Slides

      Abstract:
      Surgery as First Line Treatment Option for Small-Sized NSCLC Surgical resection has been the preferred standard of care for patients with well established expectations for survival after resection. A standard of care for patients who are deemed medically inoperable is definitive radiation therapy. Because of the proven effectiveness of radiation therapy in treating the medically inoperable patient with lung cancer, consideration is being given to treating medically operable lung cancer patients with definitive radiation therapy instead of surgery. However, recent clinical guidelines issued by ASTRO (Videtic et al) based on a review of the published data include among other recommendations, that ‘For stage I NSCLC patients with anticipated risk of operative mortality of <1.5%, SBRT is not recommended as an alternative to surgery outside of clinical trial settings. The recommended treatment for these patients remains lobectomy with systematic mediastinal lymph node evaluation’. The problem with such recommendations is as follows. The operative morbidity and mortality following pulmonary resection for the overall population of patients undergoing surgery have also been established. The morbidity and mortality in the overall population of patients following definitive radiation therapy is also well documented. What is not available is reliable data on the treatment-related risks faced by subgroups of patients treated with surgery or with definitive chemotherapy who differ in terms of competing risk factor for death, including age (Eguchi et al.) or their overall functional status ((or what is becoming known as the ‘fitness’ or conversely, the ‘frailty’ of a patient) Korc et al)). Emerging data shows that the frailty of a patient affects the likelihood of survival after surgery of diverse types and for diverse diseases. We have found that frail patients undergoing diverse surgeries for diverse malignancies require ICU admission after a given grade of complication at rates far above those required for fit patients (after Grade I complication 0% vs 20%, after Grade 2 complication 6% vs. 17%, and after Grade 3 complication 5% vs. 35% for fit vs. frail respectively) After ICU admission, frail patients remain at a persistent increased risk of death lasting at least to 600 days when compared to fit patients (50% survival vs. 90% survival for frail patients vs. fit patients after ICU care at 600 days) (unpublished data courtesy of Armin Sharokhni, MD). Similar data is not available for patients with NSCLC treated with definitive radiation therapy. Because of this lack of information, objective comparisons of the feasibility and effectiveness of surgical resection with definitive radiation therapy are likely prone to error due to selection biases.A plausible hypothesis is that the population of patients referred for definitive radiation therapy for NSCLC are frailer, and the decreased long-term survival after radiation therapy is due to frailty rather than cancer-related. In this talk, we will review the data available on: 1. Current perioperative morbidity and mortality following lung resections including MIS and sub-lobar procedures 2. Current likelihood of long-term survival following curative lung cancer surgery 3. The competing risks for short- and long-term survival after surgery including age and frailty 4. The methods of risk stratification, including frailty, for a patient being considered for lung cancer surgery 5. The methods of risk stratification that have been used in retrospective and prospective comparisons of surgery and definitive radiation therapy Based on this review, proposals for prospective trials comparing SBRT and surgery for objectively defined medically operable early stage NSCLC will be made. References: Eguchi et al. Impact of Increasing Age on Cause-Specific Mortality and Morbidity in Patients With Stage I Non-Small-Cell Lung Cancer: A Competing Risks Analysis. J Clin Oncol. 2017;35:281-290 Korc-Grodzicki et al. Surgical considerations in older adults with cancer. J Clin Oncol 2014;32:2647-53.. Videtic et al. Stereotactic body radiation therapy for early-stage non-small cell lung cancer: Executive Summary of an ASTRO Evidence-Based Guideline. Practical Radiation Oncology (in press)

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      PC 01.03 - Other First Line Treatment Options (ID 7824)

      15:45 - 16:45  |  Presenting Author(s): Hiran Fernando

      • Abstract
      • Presentation
      • Slides

      Abstract:
      The approach that has most commonly been reported as an alternative to surgery or SBRT for non-small lung cancer (NSCLC) is thermal ablation. There are also different ablative modalities, of which radiofrequency ablation (RFA) has been the most widely reported. RFA was reported for human lung tumors in 2000 [1]. RFA has been shown to be feasible and safe in several studies[2,3]. However, many studies have involved heterogeneous patient populations that included patients with metastatic tumors and NSCLC. Additionally, in those series focusing on NSCLC, patients with different stages. Have been included. Another consideration is that in several centers, these procedures have been performed by interventional radiologists, who are not traditionally part of the multidisciplinary oncology team, and rarely have follow-up clinics, so accurate reporting of recurrence and survival rates has not been optimal. Lastly, other modalities such as microwave or cryoablation, are gaining in popularity [4],[5] Despite some perceived improvements in technology, there is no clinical data that supports one ablative modality over another with respect to cancer outcomes[6] . Currently thermal ablation is reserved for medically inoperable patients with NSCLC. In those series that have reported outcomes specifically for stage I NSCLC outcomes have been good, and comparable with studies of SBRT, when looking at survival rates. One study included 56 patients with stage I NSCLC[7]. Median survival was 29 months. A prospective multi-center phase II trial involving 54 patients was recently reported[8]. Overall survival was 87.3% at 1-year, and 69.8% at two-years. Two-year survival was superior in patients with tumors <2cm (83%). There were only two grade 4, and one grade 5 event within 90 days (not attributable to the RFA). Our group has also treated 21 patients with stage Ia NSCLC (submitted for publication). Three-year survival in our series was 52%. One issue when comparing results of trials using different modalities is how comparable are patient groups. The medically inoperable group in this prospective phase II trial were compared to a medically group in an RTOG phase II trial of SBRT[9]. Although both groups were labelled medically inoperable, lung function was significantly better in patients treated with SBRT. This argues for the need for prospective studies comparing these modalities for medically inoperable patients. The main issue with thermal ablation has been higher rates of local recurrence in most studies. Tumor size is important, and results are better for tumors <2cm[7,8]. This certainly would be an argument for SBRT over RFA. However how recurrence is measured and defined may impact on reporting of local control, and there are differences in how these have been identified in different studies. In the absence of a prospective trial using similar end-point recording, overall survival is the cleanest endpoint with which to make comparisons. In summary, thermal ablation remains a viable option for small stage I NSCLC patients who are deemed medically inoperable. Future innovations include developments in energy source and, also in bronchoscopic delivery to peripheral tumors[10]. References 1. Dupuy DE, Zagoria RJ, Akerley W, et al: Percutaneous radiofrequency ablation of malignancies in the lung. AJR Am J Roentgenol 174:57-9, 2000 2. Ambrogi MC, Fanucchi O, Cioni R, et al: Long-term results of radiofrequency ablation treatment of stage I non-small cell lung cancer: a prospective intention-to-treat study. J Thorac Oncol 6:2044-51, 2011 3. Lencioni R, Crocetti L, Cioni R, et al: Response to radiofrequency ablation of pulmonary tumours: a prospective, intention-to-treat, multicentre clinical trial (the RAPTURE study). Lancet Oncol 9:621-8, 2008 4. Zhong L, Sun S, Shi J, et al: Clinical analysis on 113 patients with lung cancer treated by percutaneous CT-guided microwave ablation. J Thorac Dis 9:590-597, 2017 5. Ahrar K, Littrup PJ: Is cryotherapy the optimal technology for ablation of lung tumors? J Vasc Interv Radiol 23:303-5, 2012 6. Vogl TJ, Nour-Eldin NA, Albrecht M, et al: Thermal Ablation of Lung Tumors: Focus on Microwave Ablation. Rofo, 2017 7. Simon CJ, Dupuy DE, DiPetrillo TA, et al: Pulmonary radiofrequency ablation: long-term safety and efficacy in 153 patients. Radiology 243:268-75, 2007 8. Dupuy DE, Fernando HC, Hillman S, et al: Radiofrequency ablation of stage IA non-small cell lung cancer in medically inoperable patients: Results from the American College of Surgeons Oncology Group Z4033 (Alliance) trial. Cancer 121:3491-8, 2015 9. Crabtree T, Puri V, Timmerman R, et al: Treatment of stage I lung cancer in high-risk and inoperable patients: comparison of prospective clinical trials using stereotactic body radiotherapy (RTOG 0236), sublobar resection (ACOSOG Z4032), and radiofrequency ablation (ACOSOG Z4033). J Thorac Cardiovasc Surg 145:692-9, 2013 10. Koizumi T, Tsushima K, Tanabe T, et al: Bronchoscopy-Guided Cooled Radiofrequency Ablation as a Novel Intervention Therapy for Peripheral Lung Cancer. Respiration 90:47-55, 2015

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    PC 01 - 1-2. What is the Role of Local Therapy in Non-CNS Oligometastatic NSCLC? (ID 592)

    • Event: WCLC 2017
    • Type: Pros & Cons
    • Track: Advanced NSCLC
    • Presentations: 2
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      PC 01.04 - There is a Role of Surgery in Non-CNS Oligometastatic Disease (ID 7825)

      16:45 - 17:30  |  Presenting Author(s): Young Tae Kim

      • Abstract
      • Presentation
      • Slides

      Abstract:
      For certain extra-pulmonary malignancies, such as colorectal cancer or sarcomas, the existence of curable oligometastatic disease state has been well established. Oligometastasis is a state of stage IV disease associated with limited spread of disease at the time of diagnosis. This condition may reflect a more indolent phenotype than that associated with more widespread disease at presentation. Recently, it becomes more clear that the patients with Stage IV NSCLC are heterogenous and hence, some patients have high disease burden whereas others have isolated metastatic lesions. In the 8th TNM staging system, M-stage was reclassified into M1a, M1b, M1c, and the patients with M1b may represents the oligometastatic status of NSCLC. It has been demonstrated that the predominant pattern of failure in patients with oligometastasis treated with the first-line systemic chemotherapy was mainly a local failure, the fact which leads an idea that the local treatment may improve cure rates in such patients. The incidence of oligometastasis in NSCLC has been reported 7-26% of NSCLC [1, 2], with the major sites of metastases being bone, brain, adrenal glands and liver. In general, the successful treatment of patients with oligometastasis requires the ability to eradicate the primary site, the ability to image all sites of metastatic disease, the ability to ablate all metastatic sites, and having effective systemic therapy to eradicate undetected micrometastatic disease. Recently, routine use of improved diagnostic imaging tools such as PET-CT or Brain MRI, can better detect latent metastases in patients who would otherwise have been thought to have a localized disease, and hence, the diagnosis of “true” oligometastatic disease may be increasing [3]. Development of local treatment modalities such as minimally invasive surgery (MIS) or stereotactic radiotherapy (SABR) enabled effective local abrasion of the metastatic sites without major morbidities. Above all, rapid development of effective molecular target agents and immune check point agents in the treatment of NSCLC are encouraging to reconsider surgery for the treatment of oligometastatic NSCLC patients. Most evidence of treatment effect of local treatment for oligometastasis derives from the survival data from retrospective patients groups. For brain metastases, 5-year survival rates have been reported 6.6-35% and adrenal gland metastases showed similar results (5-year survival rates 12-40%). In a well-designed propensity score matching study suggested an improvement in survival favoring local abrasive therapy, but definite conclusions on the efficacy of local therapy for the treatment of extra-cranial oligometastatic NSCLC could not be reached [4]. A meta-analysis which included 49 studies, suggested overall median overall survival of 19 months after local ablative treatment (5.9-52 months)[5]. Most recent study by Gomez and colleagues demonstrated a progression free survival benefit favoring local consolidative therapy [6]. Hopefully, ongoing prospective trials may provide more strong evidence of the effect of local ablative therapy for oligometastasis in near future. Despite many reports that support local treatment for oligometastasis, the lack of control data in almost all reports is a problematic issue. Since local treatment for the oligometastasis is only performed in selected patients with relatively indolent disease, there is often no actual denominator for the entire group of patients who developed metastasis [7]. Thus, determining the survival advantage of ablative local treatment of oligometastasis compared to palliative systemic therapy is difficult because the majority of existing data are with a substantial degree of selection bias. In the other aspect, however, we have learned that the patient selection is critical for the application of local treatment on the oligometastasis. In general, local treatment is indicated in metastatic NSCLC patients with favorable prognostic factors including absence of mediastinal lymph node metastasis, small number of metastases, complete control of primary lesion, meta-chronous metastasis, and good performance status of the patients. Although there are relatively large numbers of papers on the brain or adrenal metastases, the reports of extra-cranial or extra-adrenal metastases are rare. In a meta-analysis, the 5 year overall survival rates of extra-cranial / extra-adrenal metastasis was 50% and the prognosis was mainly influenced by lymph node metastasis status[ 8]. First used in the literature in 2012 [9], the concept of oligoprogressive disease has been rapidly adopted. It can be best described in patients with tumors harboring actionable mutations who are treated with molecular targeted therapies. Initially, the response rate is great but the duration of response is relatively short, with resistance to therapy generally emerging within a year of start of treatment as a result of various genetic mechanisms. Not uncommonly, disease progression during molecular targeted therapy occurs at a limited number of anatomic sites. Recently, several studies reported improved progression free survival and overall survival in either intra-cranial or extra-cranial oligopregressive diseases by applying local abrasive therapy on those acquired resistant oligoprogressive diseases and by resuming target agents [10]. Furthermore, the combination of immune check point agents and SABR on primary tumor and/or metastatic sites may be promising for treating oligometastatic NSCLC, due to a possible abscopal effect. In conclusion, although current evidence of local treatment of oligometastases is limited in NSCLC, with aid of recent diagnostic tools by which more stringent patient selection is possible, local ablative treatment of metastatic lesions can lead improved survival of patients with oligometastasis in conjunction with molecular target agents or immune check point agents. 1. Albain KS, Crowley JJ, LeBlanc M, et al. Survival determinants in extensive-stage non-small-cell lung cancer: the Southwest Oncology Group experience. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 1991;9:1618-1626. 2. Parikh RB, Cronin AM, Kozono DE, et al. Definitive primary therapy in patients presenting with oligometastatic non-small cell lung cancer. International journal of radiation oncology, biology, physics 2014;89:880-887. 3. Tonnies S, Tonnies M, Kollmeier J, et al. Impact of preoperative 18F-FDG PET/CT on survival of resected mono-metastatic non-small cell lung cancer. Lung cancer (Amsterdam, Netherlands) 2016;93:28-34. 4. Sheu T, Heymach JV, Swisher SG, et al. Propensity score-matched analysis of comprehensive local therapy for oligometastatic non-small cell lung cancer that did not progress after front-line chemotherapy. International journal of radiation oncology, biology, physics 2014;90:850-857. 5. Ashworth A, Rodrigues G, Boldt G, et al. Is there an oligometastatic state in non-small cell lung cancer? A systematic review of the literature. Lung cancer (Amsterdam, Netherlands) 2013;82:197-203. 6. Gomez DR, Blumenschein GR, Jr., Lee JJ, et al. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. The Lancet Oncology 2016;17:1672-1682. 7. Fiorentino F, Treasure T. Pulmonary metastasectomy: a call for better data collection, presentation and analysis. Future oncology (London, England) 2015;11:19-23. 8. Salah S, Tanvetyanon T, Abbasi S. Metastatectomy for extra-cranial extra-adrenal non-small cell lung cancer solitary metastases: systematic review and analysis of reported cases. Lung cancer (Amsterdam, Netherlands) 2012;75:9-14. 9. Weickhardt AJ, Scheier B, Burke JM, et al. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2012;7:1807-1814. 10. Iyengar P, Kavanagh BD, Wardak Z, et al. Phase II trial of stereotactic body radiation therapy combined with erlotinib for patients with limited but progressive metastatic non-small-cell lung cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2014;32:3824-3830.

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      PC 01.05 - There is No Role of Surgery in Non-CNS Oligometastatic Disease (ID 7826)

      16:45 - 17:30  |  Presenting Author(s): Egbert F Smit

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    MA 04 - Advocacy: Listen to the Patients (ID 655)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Patient Advocacy
    • Presentations: 1
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      MA 04.06 - Developing a Lung Cancer Clinical Quality Registry Framework to Collect Longitudinal Patient-Reported Outcomes (ID 8197)

      11:00 - 12:30  |  Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Background:
      When captured by psychometrically-sound patient-reported outcomes measures (PROMs), patients’ appraisals of their symptoms, quality of life and functional status can provide powerful data to better inform clinicians about the impact of health conditions and the consequences of medical care. Reviewing and reporting on integrated PROMs alongside clinical data may translate to health service improvements and efficiencies. There are, however, many challenges including the need to find sustainable and cost-efficient methods for the routine collection of PROMs across the whole patient journey. This two-phase study set out to develop a lung cancer clinical quality registry framework to collect longitudinal patient-reported outcome measures. Phase 1 focused on the development of the data collection framework and phase 2 sees a 12-month implementation and mixed-method evaluation of the feasibility of implementing the framework. We will report on development of the framework and provide preliminary results on the implementation phase.

      Method:
      The development phase utilised a formative evaluation method to decide on essential aspects of the PROMs framework. Specifically, a Delphi process was employed to seek consensus on PROMs to administer and the schedule of assessments, with a specific focus on clinical relevance and feasibility of administration. The first Delphi round consisted of individual interviews with lung cancer clinical experts to generate a list of domains to be included in the PROMs. In the second round, aggregated results were presented to the panel and domains of interest were considered alongside PROMs meeting minimum measurement standards. Then, four patients previously treated for lung cancer were invited to provide feedback on the content of PROMs and data collection methods.

      Result:
      From Delphi findings, it was determined that the EORTC QLQ-C30 and the lung cancer-specific module (QLQ LC13) would be administered at baseline and two, six and 12 months after baseline, and a brief social isolation measure (PROMIS) would be administered at baseline only. A clearly defined subset of patients about to commence chemo-radiation treatment for lung cancer was chosen for the implementation phase and commenced on October 31 2016. To date, 74% (14/19) of eligible patients have been recruited thus far. Preliminary data indicate high adherence to baseline assessments (100%). Adherence is much lower at two months (50%), with non-adherence frequently due to side effects or ill health (38%).

      Conclusion:
      Identifying and deciding which PROMs to collect, the overall purpose of PROMs collection, data completeness and utility requires careful consideration and evaluation to determine framework sustainability.

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    MA 17 - Locally Advanced NSCLC (ID 671)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      MA 17.12 - Comparison of EORTC, PERCIST, PeterMac & Deauville PET Response Criteria after Radical ChemoRT in Non-Small-Cell Lung Cancer (ID 8169)

      15:45 - 17:30  |  Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Background:
      Response criteria for 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) for thoracic malignancies include European Organization for Research and Treatment of Cancer (EORTC) criteria, Positron Emission tomography Response Criteria In Solid Tumors 1.0 (PERCIST), PeterMac Metabolic Visual Criteria and Deauville Criteria. It is unknown which criteria have the highest prognostic value in NSCLC.

      Method:
      Between 2004 and 2016, three NSCLC prospective trials included patients treated with radical radiotherapy (RT) or chemoRT with baseline and post-treatment FDG-PET imaging. For each patient, the four FDG-PET response criteria were reported retrospectively and blinded to outcome. Responses to therapy were categorized as complete metabolic response (CMR), partial metabolic response (PMR), stable metabolic disease (SMD) or progressive metabolic disease (PMD) and correlated with subsequent survival using Cox proportional hazard models, c-statistic, r[2] and Akaike information criterion (AIC).

      Result:
      Eighty-seven NSCLC patients underwent FDG-PET before and after radical RT (n=7) or chemoRT (n=80). Follow-up FDG-PET scans were performed at a median of 89 days (range 47-123 days) after RT. After a median follow-up of 49 months, median survival after PET response imaging was 28 months. Both qualitative response criteria (PeterMac and Deauville) showed perfect agreement (kappa = 1.0). Both semiquantitative criteria (EORTC and PERCIST) showed almost perfect agreement (kappa = 0.96). All four response criteria showed statistically significant associations with overall survival. The PeterMac and the Deauville criteria showed stronger survival associations (AIC=357.9) compared to EORTC (AIC=362.3) and PERCIST (AIC=362.6). The two qualitative criteria also performed better in the distinction between CMR and non-CMR (HR = 1.9, CI 1.0-3.4, p=0.047) versus EORTC (HR=1.2, CI 0.6-2.3, p=0.566) and PERCIST (HR 1.2, CI 0.6-2.3, p=0.548). Only 1, 4 and 6 patients had SMD in respectively PeterMac/Deauville, EORTC and PERCIST. Figure 1



      Conclusion:
      The visual PeterMac and Deauville criteria showed stronger predictive capacity than EORTC and PERCIST criteria, especially for distinguishing CMR from non-CMR.

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    MA 18 - Global Tobacco Control and Epidemiology II (ID 676)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
    • Presentations: 1
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      MA 18.12 - Quality of Data Informing Epidemiological Studies in Patients with Lung Cancer  (ID 7550)

      15:45 - 17:30  |  Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Background:
      Epidemiological studies commonly use data from clinical (i.e. medical records) and administrative (i.e. claims data) datasets for the purposes of exploratory analyses, as well as clinical and quality reporting, benchmarking, risk adjustment, and machine learning. Validity is contingent on accurate and detailed reporting of data, demanding robust methodological validation.

      Method:
      Single centre retrospective comparative study assessing completeness and agreement (kappa-statistic (κ)) of data reporting for key prognostic variables across three independent data sources, among patients with lung cancer. The study population was formed by random selection of patients from an Australian single centre prospective study. Prospectively collected research study-data (SD) was extracted, and then compared to data extracted from individual patient medical records (MR) as well as International Classification of Diseases (ICD) coding from administrative data (AD).

      Result:
      The study population included 10% of patients from an Australian lung cancer cohort (n=111/1090), and represented the overall cohort in terms of patient demographics and disease characteristics. Prognostic data for stage, comorbidities, smoking history, performance status, and weight loss at diagnosis, was reported for >96% of patients in SD. Comparatively, AD did not report any prognostic data for 42% (47/111) of patients treated in ambulatory settings, and indeed when reported was grossly inaccurate. By way of examples, according to AD, 23% of patients had ≥1 comorbidity versus 68% by MR and 64% by SD; 38% had positive smoking history versus 78% by MR and 81% by SD; 2% had respiratory comorbidity versus 28% by MR and 37% by SD. Similar patterns were observed for other comorbid conditions. Complete TNM staging was captured in only 45% of MR at the time of first treatment, although with good concordance with SD (κ=0.9, 95%CI 0.7, 1.0). Equally when factors were documented in MR they were reasonably concordant with SD: smoking status (completeness 96.4%, κ=0.9, 95%CI 0.8, 1.0), performance status (completeness 82.0%, κ=0.5, 95%CI 0.4, 0.7) and weight loss (completeness 71.1%, κ=0.3, 95%CI 0.1, 0.5).

      Conclusion:
      Poor capture of factors (either omission or inaccuracy) limit the potential contribution of both MR and AD for use in clinical, epidemiological, and machine learning research – particularly when being utilised to derive diagnostic, prognostic and classification systems. Use of this data for purposes other than intended may misinform estimates of comorbidity disease burden and fail to appropriately adjust for competing mortality risks in models that inform outcomes reporting and ensuing policy decisions.

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    MTE 04 - Radiotherapy for SCLC (Sign Up Required) (ID 553)

    • Event: WCLC 2017
    • Type: Meet the Expert
    • Track: Radiotherapy
    • Presentations: 1
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      MTE 04.02 - General Principles of PCI in the Treatment of SCLC (ID 7779)

      07:00 - 08:00  |  Presenting Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Abstract:
      The brain is a well recognized sanctuary site for micrometastases in patients with small cell lung cancer (SCLC) treated with chemotherapy. The administration of prophylactic cranial irradiation (PCI) in patients responding to chemotherapy reduces the incidence of clinically detectable brain metastases in patients with both limited [1] and extensive disease [2, 3]. In patients with limited disease, this translated into a survival benefit in a meta-analysis of 987 complete responders , but in patients with extensive disease, one trial of 286 responders to chemotherapy showed a survival benefit [2], whilst in another of224 patients it did not [3]. The design of this latter trial suggested that regular surveillance with MRI and treatment at the time of metastasis detection might be an equally effective strategy. This could reduce the incidence of the most serious toxicity of PCI which is delayed neurotoxicity. Limiting the total dose is another possible means of reducing neurotoxicity. A randomized trial of three dose prescriptions restricted to patients with limited disease showed no difference in rate of brain metastases between 25 Gy in 10 fractions versus two higher dose schedules , but there was a higher mortality associated with the higher doses, due to an unexplained increase in disease progression [4]. In spite of this high level evidence there are still numerous uncertainties facing the clinician when deciding whether to recommend PCI. 1. Is the classification limited versus extensive disease still appropriate when selecting patients? 2. Are there subgroups of patients with metastatic disease more likely to benefit from PCI than others because their overall prognosis is better? [5] 3. Should there be an upper age limit? 4. Are pre-existing neurologic conditions or paraneoplastic syndromes contraindications? 5. In patients with extensive disease, is pretreatment MRI required? 6. Is MRI surveillance cost effective? 7. Is there a role for hippocampal sparing techniques or neuroprotective agents? 8. Is there a place for lower dose/shorter fractionation schedules? 9. In patients with extensive disease having consolidative chest irradiation, is there any difference between giving PCI simultaneously versus sequentially? 10. What will be the role of PCI in the era of immunotherapy? Question 7 is currently the subject of an actively recruiting randomized trial (NRG-CC003), but for the other questions, physician and patient discretion will be required for the forseeable future. References 1. Auperin, A., et al., Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med, 1999. 341: 476-84. 2. Slotman, B., et al., Prophylactic Cranial Irradiation in Extensive Small-Cell Lung Cancer N Engl J Med, 2007. 357: 664-672. 3. Takahashi, T., et al., Prophylactic cranial irradiation versus observation in patients with extensive-disease small-cell lung cancer: a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol, 2017. 18: 663-671.. 4. Le Pechoux, C., et al., Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol, 2009. 10:467-74. 5. Eberhardt, W.E., et al., The IASLC Lung Cancer Staging Project: Proposals for the Revision of the M Descriptors in the Forthcoming Eighth Edition of the TNM Classification of Lung Cancer. J Thorac Oncol, 2015. 10:1515-22.

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    OA 01 - The New Aspect of Radiation Therapy (ID 652)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Radiotherapy
    • Presentations: 1
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      OA 01.01 - A Randomized Trial of SABR vs Conventional Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: TROG 09.02 (CHISEL) (ID 8628)

      11:00 - 12:30  |  Presenting Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Background:
      Although stereotactic ablative body radiotherapy (SABR) is now well established as a treatment for stage I non-small cell lung cancer (NSCLC), there is limited evidence that it is as or more effective than conventional fully fractionated radiotherapy (CRT). We conducted a randomized trial to determine if SABR results in longer time to local failure than CRT.

      Method:
      This was a multicentre trial of the Trans-Tasman Radiation Oncology Group (TROG) and Australasian Lung Cancer Trials Group, registration number NCT01014130. Patients were eligible if they had biopsy proven stage I (T1- T2a N0M0) NSCLC based on PET and were medically inoperable or refused surgery. Patients had to be performance status ECOG 0 or 1, and the tumor had to be at least 2 cm or more from the bifurcation of the lobar bronchus. Patients were randomized 2:1 to SABR (54 Gy in 3 fractions, or 48 Gy in 4 fractions, depending on proximity to the chest wall, to the isodose covering the PTV) or to CRT (66 Gy in 33 fractions or 50 Gy in 20 fractions). The primary objective was to compare time to local failure between arms. Assuming that the rate of local failure at 2 years would be 10% in patients randomized to SABR versus 30% in patients randomized to CRT, 100 patients were required. All living patients were followed for a minimum of 2 years. Analysis was based on the intention to treat principle. Funding: In Australia: Grant #1060822 was awarded through Cancer Australia. In New Zealand, The Cancer Society of New Zealand and the Genesis Oncology Trust.

      Result:
      Between 12/09 and 6/15, 101 patients were enrolled. There were 56 males and 45 females with a median age of 74 years (range 55-89), ECOG performance status – 28 were 0, 71 were 1 and 1 was 2. TNM stage was T1N0M0 in 71 and T2aN0M0 in 30. Sixty six patients were randomized to SABR and 35 patients to CRT. Patients randomized to SABR had superior freedom from local failure (HR = 0.29, 95% CI 0.130, 0.662, P=0.002) and longer overall survival (HR = 0.51, 95% CI 0.51, 0.911, P=0.020). Worst toxicities by arm were: CRT grade 3, 2 patients; SABR grade 4, 1 patient and grade 3, 9 patients.

      Conclusion:
      In patients with inoperable stage I NSCLC, compared with CRT, SABR resulted in superior freedom from local failure and was associated with an improvement in overall survival.

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-033 - Thrombogenic Biomarkers in Patients with NSCLC – Associations with Thrombosis, Progression, and Survival (ID 8852)

      09:30 - 16:00  |  Author(s): David L Ball

      • Abstract
      • Slides

      Background:
      For patients with NSCLC, the risk of thromboembolism (TE) is high but heterogeneous. We aimed to profile biomarkers among NSCLC patients receiving anticancer therapy to identify patients and time periods of high TE risk where intervention with proven preventative strategies is likely to achieve maximal benefit.

      Method:
      We assessed the association between baseline biomarker levels and longitudinal biomarker changes, with subsequent incidence of TE (venous (VTE) or arterial (ATE)), disease progression and overall survival. Biomarkers (thromboelastography, d-dimer, fibrinogen, haemoglobin, white cell count, platelet count, neutrophil/lymphocyte ratio (NLR), and platelet/lymphocyte ratio (PLR)) were sequentially assessed at commencement of anticancer therapy (baseline), weeks 1, 4 and 12, and 3-monthly until 12 months.

      Result:
      During study follow-up (median 22 months, range 6-31), 129 patients were sequentially assessed over median 5 time points (range 1-9). Patients underwent surgery (n=12), chemo-radiotherapy (CRT, n=47), palliative chemotherapy (CHT, n=36), and single modality radiotherapy (RT, n=34) – only surgical patients received thromboprophylaxis. 24 patients (19%) had documented TE, 19 (15%) VTE and 5 (4%) ATE; 79% occurred within the first 6 months with median time to TE 48 days (range 1-151). Among ambulatory patients (CHT/CRT/RT), an initial model identified as high TE risk those patients with baseline fibrinogen ≥4g/L and d-dimer ≥0.5mg/L, or d-dimer ≥1.5mg/L. Hazard ratio (HR) for TE was 8.0 (p=0.04) for high versus low risk CHT/CRT patients and 6.5 (p=0.07) for high versus low risk for CHT/CRT/RT patients. Comparatively, using an established risk score, HR for TE with Khorana score ≥3 vs. <3 was 1.3 (p=0.68) for CHT/CRT and 1.1 (p=0.91) for CHT/CRT/RT. Considering temporal changes (d-dimer ≥1.5mg/L at week 4), risk assessment was enhanced with 100% sensitivity and 34% specificity for CHT/CRT. Specificity reduced to 27% when including RT patients. NLR, PLR and platelet count were not associated with TE. High TE risk patients (Fib≥4 + d-dimer ≥0.5, d-dimer ≥1.5) also had increased risk of cancer progression (HR 2.3, p<0.01) and mortality (HR 2.5, p<0.01). Baseline NLR≥2.5 and platelet count ≥350 were associated with progression (HR 2.0, p=0.01 and HR 2.0, p<0.01 respectively) and mortality (HR 2.6, p=0.01 and HR 1.9, p=0.01 respectively); PLR was not.

      Conclusion:
      For ambulatory patients with NSCLC, d-dimer and fibrinogen were associated with TE, cancer progression, and prognosis and could easily be applied in a simple algorithm, for real-time decision-making. In spite of low specificity, consideration of thromboprophylaxis is warranted for high risk patients given substantial TE-associated adverse clinical and economic consequences.

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    P1.14 - Radiotherapy (ID 700)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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      P1.14-017 - Impact of Systematic EBUS-TBNA Mediastinal Staging on Radical Radiotherapy Planning in NSCLC (ID 8497)

      09:30 - 16:00  |  Author(s): David L Ball

      • Abstract
      • Slides

      Background:
      Radical radiotherapy often relies solely on radiological imaging to determine treatment volumes. Systematic mediastinal staging with endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) may identify PET-occult sites of mediastinal disease, or demonstrate benign causes for PET-positive LN. This study evaluated 1) Involved nodal coverage 2) Doses to organs-at-risk when planned based on PET-CT and EBUS-TBNA and 3) Incident dose to mediastinal nodes between 3D-CRT and Intensity-Modulated-Radiotherapy (IMRT).

      Method:
      Radical radiotherapy plans (60Gy/30 fractions) were created for patients with stage change following EBUS-TBNA from a prospective clinical trial. We compared lung Normal-Tissue-Complication-Probability (NTCP, pneumonitis), oesophageal and heart dose for planning to targets based on PET-CT versus PET-CT+EBUS-TBNA. The incidental dose to PET-negative/EBUS-TBNA-positive nodes from 3DCRT and IMRT was evaluated using volume receiving 35Gy as a surrogate for control of sub-clinical disease (Kepka, IJROBP, 73(5) 2009).

      Result:
      Of 30 patients enrolled, four were upstaged by EBUS-TBNA; these patients had a significant geographic miss of nodal GTV when planned to PET-positive nodes only (Figure 1). When planned based on PET-CT alone, the incidental dose to PET-negative/EBUS-TBNA-positive nodes was higher with IMRT for two patients (v35Gy increased by 17% & 6%; Figure 1a&b) and lower with IMRT (v35Gy reduced by 16% and 6%; Figure 1c&d) for two, dependent on nodal position relative to the primary. Six patients had negative pathology for PET avid nodal stations; Inclusion of EBUS-negative, PET-positive nodes resulted in an average increased lung NTCP of 5% (range 1%-13%), mean oesophagus dose of 13Gy (range 4-23Gy) and mean heart dose of 4Gy (range -0.1-11Gy) over plans based on EBUS-positive nodes alone. Figure 1



      Conclusion:
      Systematic EBUS-TBNA has the potential to improve loco-regional control and limit the probability of lung and heart toxicity. The incidental dose to adjacent tissue is inherently related to involved node/tumour position and not solely dictated by the radiation delivery technique.

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    P2.05 - Early Stage NSCLC (ID 706)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Early Stage NSCLC
    • Presentations: 1
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      P2.05-006 - Credentialing of Radiotherapy Centres in Australasia for a Phase III Clinical Trial on SABR (TROG 09.02 CHISEL) (ID 9985)

      09:30 - 16:00  |  Author(s): David L Ball

      • Abstract
      • Slides

      Background:
      A randomised phase III clinical trial comparing Stereotactic Ablative Body Radiotherapy (SABR) with conventional radiotherapy for early stage lung cancer in peripheral location has been conducted in Australia and New Zealand under the auspices of the Trans Tasman Radiation Oncology Group (TROG). As SABR technology at the commencement of the trial was new to most centres in our region and the techniques used are complex and technologically challenging a credentialing program was developed for centres wishing to join the trial.

      Method:
      The credentialing program used a prospective risk management approach with high risk elements considered to be (i) the ability to create a plan that meets all dosimetric constraints, (ii) the dose calculation in the presence of inhomogeneities and (iii) the management of motion. Participating centres were asked to develop treatment plans for two test cases made available in DICOM format, and inhomogeneity corrections and dose delivery was assessed during a site visit using a phantom with moving inserts (modified Modus Quasar).

      Result:
      Site visits were conducted in 17 Australian and 3 New Zealand radiotherapy facilities. All centres were able to produce acceptable plans for both test cases, in particular after the protocol was amended to allow delivery of 48Gy in 4 fractions for lesions close to the chest wall in addition to the original trial arm of 54Gy in 3 fractions. The tests conducted during site visit with lung and air inhomogenieties confirmed known shortcomings of the AAA algorithm for dose calculation behind the inhomogeneity. The dose was assessed using an ionisation chamber and radiochromic film in a stationary and moving cylinder (sinusoidal motion, 1cm amplitude, 4s period) in the phantom for a typical treatment delivery including at least one non-coplanar beam. The measurements confirmed in an end-to-end test that all participating centres were able to deliver SABR with the required accuracy. Overall, the site visit took 3 hours of time on the treatment unit and was well received by participating staff. For several facilities it proved to be a useful step in the process of developing a SABR program.

      Conclusion:
      The credentialing process including a site visit documented that participating centres were able to deliver dose to a phantom as required in the trial protocol. It also gave an opportunity to provide education about the trial and discuss technical issues such as 4D CT, small field dosimetry and patient immobilisation with staff in participating centres.

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    P2.14 - Radiotherapy (ID 715)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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      P2.14-001 - Mid-Treatment Perfusion PET/CT Is More Effective Than Ventilation PET/CT in Functionally-Adapted Radiotherapy for NSCLC (ID 8508)

      09:30 - 16:00  |  Author(s): David L Ball

      • Abstract
      • Slides

      Background:
      To assess the utility of four-dimensional (4D) ventilation/perfusion (V/Q) PET/CT lung imaging to facilitate mid-radiotherapy treatment adaption with volumetric modulated arc radiotherapy (VMAT).

      Method:
      In a prospective clinical trial, patients with non-small cell lung cancer (NSCLC) underwent [68]Ga-4D-V/Q PET/CT scanning before and during a six-week (60Gy) course of definitive chemoradiation. Functional lung volumes were delineated on both datasets as ‘highly perfused’ (HPLung) and ‘highly ventilated’ (HVLung), using a 70[th] centile SUV threshold. Three VMAT plans were created on the mid-treatment datatsets: optimised to anatomical lung, HPLung, and HVLung volumes, respectively. Functional dose volumetrics were assessed using the parameters of mean lung dose (MLD), and lung volume receiving 5, 20 or 30Gy, (V5, V20, and V30). Plan quality was assessed for consistency with respect to conformity indices, and doses to critical structures.

      Result:
      The study cohort consisted of 10 patients resulting in a total of 30 VMAT plans. PTV volumes reduced by a mean of 5.5% between scans. HVLung volume increased between scans by a median value of 39.2%. Subsequent volumetric and spatial changes were reflected in varying DICE similarity coefficients, or DSC (ranging from 0.336-0.923). HPLung decreased by a median value of 4.5% with spatial discrepancy represented by DSC of 0.568-0.805. Increase in ventilated function was most prevalent adjacent to the target, limiting the benefit of adaptive planning (Fig 1). Plan quality was consistent with the median PTV D95 ranging from 60.6-61.3Gy, and mean conformity index ranging from 1.23-1.25. Functional MLD of HPLung decreased by a mean of 7.3%, p=0.02. Plans optimised to HPLung resulted in a reduction of perfused lung V5 by a mean of 13.2%, p<0.01, with HVlung plans yielding a decrease in ventilated lung V5 of 9.6%, p=0.02. Fig 1 Figure 1



      Conclusion:
      To achieve reduced irradiation of functional lung, radiotherapy adaptation is more effectively facilitated by perfusion rather than ventilation imaging.

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    P3.13 - Radiology/Staging/Screening (ID 729)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P3.13-003 - The Lung Cancer Prognostic Index – a Risk Score to Predict Overall Survival after the Diagnosis of Non-Small Cell Lung Cancer (ID 7551)

      09:30 - 16:00  |  Author(s): David L Ball

      • Abstract
      • Slides

      Background:
      Outcomes in Non-Small Cell Lung Cancer (NSCLC) are poor but heterogeneous, even within TNM stage groups. To improve prognostic precision we aimed to develop and validate a simple model for the prediction of overall survival (OS) using patient and disease variables.

      Method:
      The study population included 1458 patients from three independent cohorts. Associations between baseline variables and OS were estimated in a derivation cohort from a prospective single-centre study (n=695) using Cox proportional hazards regression. Points were allocated to variables based on the strength of association to create the Lung Cancer Prognostic Index (LCPI). Model performance was assessed (by a c-statistic for discrimination and Cox-Snell residuals for calibration) in two independent validation cohorts (n=479 and n=284).

      Result:
      Three disease-related and six patient-related variables were found to predict OS: stage, histology, mutation status, performance status, weight loss, smoking history, respiratory comorbidity, sex and age. Patients were classified according to predicted LCPI score. Two-year OS rates according to LCPI in the derivation and two validation cohorts respectively were 84%, 77% and 68% (LCPI 1: score≤9); 61%, 61% and 42% (LCPI 2: score 10-13); 33%, 32% and 14% (LCPI 3: score 14-16); 7%, 16% and 5% (LCPI 4: score ≥15). Predictive performance (Harrell’s c-statistics) were 0·74 for the derivation cohort, 0·72 and 0·71 for the two validation cohorts.

      Conclusion:
      The LCPI contributes additional prognostic information which, in conjunction with other validated tools and evidence based management guidelines, may be applied to counsel patients, guide clinical trial eligibility, or standardise mortality risk for epidemiological analyses.

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    WS 03 - ITONF Lung Cancer and Mesothelioma Workshop (Ticketed Session) (ID 751)

    • Event: WCLC 2017
    • Type: Workshop
    • Track: Mesothelioma
    • Presentations: 1
    • Invitation / Session Details: Click here to view PDF
    • Moderators:
    • Coordinates: 10/15/2017, 12:15 - 17:55, Room 313
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      WS 03.06 - Local Treatments for Lung Cancer – Blade vs Beam: A Debate (ID 10885)

      12:15 - 17:55  |  Presenting Author(s): David L Ball

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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