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R. Pirker

Moderator of

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    E03 - Chemotherapy for NSCLC (ID 3)

    • Event: WCLC 2013
    • Type: Educational Session
    • Track: Medical Oncology
    • Presentations: 4
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      E03.1 - Maximising the Benefit of Chemotherapy for Advanced NSCLC (ID 382)

      14:00 - 15:30  |  Author(s): G. Giaccone

      • Abstract
      • Presentation
      • Slides

      Abstract
      Chemotherapy is still standard treatment for the majority of patients with advanced NSCLC, who do not have specific molecular markers (i.e. EGF mutations, ALK translocations). Platinum based doublets remain standard treatment for most patients and the choice of regimen is based mainly on side effect profile. There is a preference for pemetrexed based therapies for patients with adenocarcinoma histologies, based on one randomized study. Benefit of chemotherapy can be extented by maintenance chemotherapy (pemetrexed), in terms of increased progression-free survival and overall survival. Maintenance with erlotinib has also been approved, although the largest effects are really seen in EGFR mutant patients. Very few chemotherapy doublet regimens have been improved by addition of a third agent, chemotherapy or biological. Bevacizumab was shown to increase response rate, progression-free survival as well as overall survival in one study where carboplatin-paclitaxel was the backbone. Bevacizumab is continued as maintenance. Cetuximab improved survival in addition to cisplatin-vinorelbine, and again cetuximab was continued after the end of chemotherapy. Unfortunately most of the other combinations of biologicals with chemotherapy have been disappointing. Novel agents with different mechanisms of action from the classical tyrosine kinase inhibitors might obtain better results (e.g. PD-1/PD-L1 antibodies). Results of randomzied studies are awaited. The HSP-90 inhibitor gatenespib, in combination with docetaxel gave promising results in a relatively large randomized phase II study, and a phase III study is now underway.

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      E03.2 - Selecting Patients for Maintenance Therapy (ID 383)

      14:00 - 15:30  |  Author(s): L. Paz-Ares

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      E03.3 - Optimal Adjuvant Chemotherapy: Selection of Patients and Agents (ID 384)

      14:00 - 15:30  |  Author(s): K. Kelly

      • Abstract
      • Presentation
      • Slides

      Abstract
      Optimal adjuvant chemotherapy: selection of patients and agents Patients with early stage, resectable non-small cell lung cancer (NSCLC) have the best chance to be cured with 5 year survival rates ranging from 73% for patients with pathological stage IA disease to 24% for patients with pathological stage IIIA disease. However, the presence of micro-metastases will lead to the development of systemic relapse and death in the majority of patients. To improve survival of these patients adjuvant chemotherapy following complete tumor resection has been studied. Three phase III trials with cisplatin-based regimens and the LACE meta-analysis demonstrated increased cure rates by adjuvant chemotherapy and established adjuvant chemotherapy as the standard of care. Randomized Trials The first trial to demonstrate a survival advantage for adjuvant chemotherapy was the International Adjuvant Lung Cancer Trial Cooperative Group (IALT) study. This trial enrolled 1867 patients; 932 patients were randomized to receive chemotherapy (cisplatin plus etoposide, vinorelbine, vinblastine, or vindesine for 3-4 cycles) and 935 patients were randomized to observation. The 5 year overall survival rate significantly favored the chemotherapy arm (Hazard Ratio [HR] 0.86; 95% CI 0.76-0.98; P <0.03). Disease free survival (DFS) was also superior in the treated arm (HR 0.83; 95% CI 0.74-0.94; P=0.003). With longer follow up of 8 years, the HR for overall survival was not significant (HR 91; 95% CI 0.81-1.02; P=0.10) while the HR for DFS retained significance (HR 0.88; 95% CI 0.78-0.98; P=0.02). In 2005, the National Cancer Institute of Canada Cancer Treatment Group (NCIC CTG) reported the results of JBR10. Patients with completely resected stage IB or stage II NSCLC were randomized to receive cisplatin plus vinorelbine (242 patients) or observation (240 patients). An impressive overall survival benefit was observed for the treated group (HR 0.69; 95% CI 0.52-0.91; P=0.04) corresponding to an absolute survival improvement of 15%. In a subgroup analysis, the survival benefit was restricted to patients with Stage II disease. An update of this study, with > 9 years of follow up continued to show a survival benefit for the treated group with an absolute improvement in the 5 year overall survival (OS) rate of 11% (67% versus 56%, respectively) with a HR of .78; 95% CI 0.62-0.99; P=0.04 (11). Subsequently, the results from the ANITA trial (Adjuvant Navelbine International Trialist Association) solidify the role of adjuvant systemic treatment. A total of 840 patients with Stage IB, II, and IIIA NSCLC were randomized to cisplatin plus vinorelbine versus observation. The HR for death was significantly lower for the chemotherapy group (HR= 0.80, 95% CI 0.66-0.96; P=0.017). The 5 and 7 year overall survival was improved by 8.6% and 8.4% in the chemotherapy group, respectively. No benefit was seen in the subset of patients with Stage IB disease (HR 1.10; 95% CI 0.76-1.57; P=NS). To identify which patients might have the greatest benefit from adjuvant chemotherapy, the LACE (Lung Adjuvant Cisplatin Evaluation) meta-analysis was conducted. Individual patient data was collected and pooled from 4,584 patients in 5 trials (BLT, ALPI, IALT, JBR10 and ANITA). The HR of death was 0.89; 95% CI 0.82-0.96; P=0.005, which corresponded to a 5-year absolute survival benefit of 5.4% with chemotherapy. This benefit varied with stage of disease and was not seen for stage IA patients. A positive chemotherapy effect was seen in patients with performance status (PS) 0-1 whereas chemotherapy was potentially harmful for patients with a PS of 2. Other subgroups analyzed including age, sex, histology, type of surgical resection, planned radiation, dose of cisplatin or the second agent used did not affect overall or disease free survival. Elderly patients Since the majority of patients diagnosed with lung cancer are 70 years old or greater, an additional analysis of the LACE data set by age was conducted. Elderly patients (age > 70 years) accounted for 9% of the patients. Their HR of death was better with treatment at .90 (95% CI 0.74-1.16) and was similar to the HR of death for treated patients < 65 years old at .86 (95% CI 0.78-.94). Elderly patients achieved a survival benefit despite having received lower cisplatin doses and fewer number of chemotherapy cycles than their younger counterparts. Tumor size The Cancer and Leukemia Group B (CALGB) trial 9633 evaluated four cycles of adjuvant paclitaxel and carboplatin versus observation in stage IB patients. With mature follow up of 74 months, overall survival was not significantly different between the two groups (HR 0.83; 95% CI 0.64-1.08; P=0.12). No significant improvement in DFS was observed. In an unplanned subgroup analysis based on tumor size a survival advantage for paclitaxel and carboplatin was seen in patients who had tumors >4 cm (HR, 0.69; 95% CI 0.48-0.99; P = .043). In support of this finding, a retrospective analysis of patients with stage IB disease on JBR 10 was conducted according to tumor size of < or > 4 cms. Patients with smaller tumors did not benefit from adjuvant therapy while treated patients with tumors > 4 cm had a favorable 5 year OS rate of 79% compared to 59% for untreated patients (HR .66; 95% CI 0.39-1.14; P=0.13). It is important to remember that in the 7[th] TNM staging system, patients with tumors of > 4 cm could be Stage IB, IIA or IIB. Chemotherapy regimen In the clinical trials described above vinorelbine plus cisplatin was the most commonly used regimen. In a subgroup analysis of LACE, adjuvant cisplatin plus vinorelbine improved survival at 5 years by 8.9% in the vinorelbine cohort and this outcome was superior to the “other” cohort. Today more modern regimens are frequently used based on their activity in advanced disease including cisplatin and gemcitabine, cisplatin and docetaxel and cisplatin and pemetrexed. In summary, adjuvant cisplatin based chemotherapy is the standard of care for patients with resectable Stage II-III NSCLC with a good performance status and should be considered for patients with tumor size > 4 cm. Current strategies to improve outcome of adjuvant chemotherapy focuses on the integration of targeted therapies, tumor vaccines and the identification of prognostic and predictive biomarkers.

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      E03.4 - Lung Cancer in Women (ID 385)

      14:00 - 15:30  |  Author(s): T. Vavala', S. Novello

      • Abstract
      • Presentation
      • Slides

      Abstract
      At the beginning of 20th century only a few hundred cases of lung cancer were diagnosed annually, but the progressive huge spread of tobacco consumption caused a dramatic increase of the incidence of this disease among men and later on among female smokers. US data shows that the prevalence of smoking in American women peaked in 1965 at 33% and remained at that level throughout the 1970s, before beginning to slowly decrease in 1980. In contrast, more than half of American men smoked before 1965, but the prevalence dramatically decreased during the subsequent 20 years. Currently, 18% of American women smoke compared with 23% of men, reflecting the earlier and more marked decline in the prevalence of tobacco use in men. Nowadays, more women in United States die from lung cancer each year than from breast, ovarian and uterine cancer combined: lung cancer is the leading cause of cancer death with more than 110,000 new cases and more than 72,000 estimated deaths in 2013. In European countries there are more than 79,000 new cases of lung cancer in female sex per year and 82,000 is the estimated death number in 2013, that means 9,024 more than what was reported in 2009. Approximately 80% - 85% of lung cancers in women are caused by cigarette smoking. Wang et al. investigated the association of both active and passive smoking on lung cancer risk in a prospective cohort of more than 90,000 post-menopausal women: the results of the Women’s Health Initiative Observational Study (WHI-OS) have been presented at 2013 ASCO annual meeting and evidenced an higher lung cancer incidence, particularly small cell lung cancers and squamous lung cancers, in current smokers (Hazard Ratio, HR 13.44, 95%, CI 10.80-16.75) and former smokers (HR 4.20, 95% CI 3.48-5.08) compared to never smokers. In the same study, among never smoking women, passive exposure, as an adult at home for > 30 years, was associated with a trend of increased risk (HR 1.61, 95% CI 1.00-2.58) for lung cancer, confirming findings of previous prospective cohort studies. In recent times, an increased proportion of non-smoking female patients, with earlier age at diagnosis and a majority of adenocarcinoma has been observed, particularly in Asian countries. Prevalence of lung cancer in females without history of tobacco smoking is estimated to represent 19% compared with 9% of male lung carcinoma in the United States. Freedman et al. reported, on a cohort of nearly 500,000 individuals, aged from 50 to 71 years, a significant increase in the rate of lung cancer for women who did not smoke, compared with male non-smokers, whereas no increased risk was described in current and former female smokers compared with matched males. Hormonal status is one of the potential explanations for gender differences. Estrogens are involved in lung tumorigenesis and progesterone receptor expression has been described in non small cell lung cancers (NSCLC). Combination of estrogen and progesterone works synergistically in vitro to promote vascular endothelial growth factor secretion increasing tumor-associated angiogenesis. Chlebowski et al. examined estrogen plus progestin (E+P) association with lung cancer incidence and outcome evaluating more than 30,000 postmenopausal women. Results have been presented at 2013 ASCO annual meeting: in non users of E+P, lung cancer incidence and deaths from lung cancer were significantly and substantially greater in current smokers versus never smokers (p< 0.0001 for both comparisons). In current smokers, lung cancer incidence and deaths from lung cancer were significantly and substantially greater in E+P users versus non-users (p=0.0021 and 0.0005, respectively), nearly doubling a smoker’s already high risk of death from lung cancer. Conversely, the role of androgens remains unclear. Harlos et al. evaluated more than 3,000 men with lung cancer evidencing that exposure to androgen deprivation therapy (ADT) is associated with significantly better survival when compared with no exposure. Patients exposed to ADT after their diagnosis were found to have a significantly better survival than those not exposed (HR 0.36 p=0.0007). This effect was also seen in those who received ADT before and after diagnosis (HR 0.53 p<0.0001). With regard to specific gene alterations there are relevant differences in men and women. The most widely recognized is the epidermal growth factor receptor (EGFR) mutation, that is found at a much higher frequency in adenocarcinomas, women, Asians and never smokers. Mutations in HER2 gene, although much rarer, target the same subpopulations. Mutations in EGFR (and HER2) are mutually exclusive of K-ras mutations: these are primarily observed in smokers and historically associated with male sex, but there are also publications demonstrating an higher frequency in women of “non-classical” type of K-ras mutations even if these data need further validations. The echinoderm microtubule associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation has been evidenced to occur more frequently in young patients, light or never smokers, while no major differences have been clearly stated between genders. B-Raf (V600) is described in 2% of patients with lung adenocarcinoma in western countries, related with worse prognosis and it is noted more frequently in women. An analysis of the p53 mutation databases indicated that the different spectra of p53 mutational patterns among smoker and never smoker cancers were almost entirely a result of differences between lung cancers in women, whereas male tumours did not show significant differences. Finally, recent studies investigated the role of telomere shortening in lung cancer. Kim et al. hypothesized that relative telomere length may be associated with recurrence in early stage NSCLC after curative resection. Longer telomeres were significantly associated with higher risk of developing recurrence in female (HR 2.25; 95% CI, 1.02-4.96, P= 0.044) and adenocarcinoma subgroups (HR 2.19; 95% CI, 1.05-4.55). All these findings provide multiple evidence for the specificities of lung cancer in women. The different expression of specific biomarkers, which could be targeted by therapy, will improve research towards personalized sex-based investigations, stimulating the development of further gender-based approaches in thoracic oncology.

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    HOD2 - Mondays Highlights of the Day - Medical Oncology, Biology and Pathology (ID 225)

    • Event: WCLC 2013
    • Type: Highlight of the Day Session
    • Track: Medical Oncology
    • Presentations: 3
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      HOD2.1 - Medical Oncology (ID 4039)

      07:00 - 08:00  |  Author(s): M. Edelman

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      HOD2.2 - Medical Oncology and Biology (ID 4040)

      07:00 - 08:00  |  Author(s): P. Lara

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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      HOD2.3 - Pathology (ID 4041)

      07:00 - 08:00  |  Author(s): E. Brambilla

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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Author of

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    MO06 - NSCLC - Chemotherapy I (ID 108)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO06.09 - DISCUSSANT (ID 3938)

      16:15 - 17:45  |  Author(s): R. Pirker

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    P1.10 - Poster Session 1 - Chemotherapy (ID 204)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.10-022 - Central European Initiative against Lung Cancer: Results of the Inaugural Workshop (ID 1401)

      09:30 - 16:30  |  Author(s): R. Pirker

      • Abstract

      Background
      Lung cancer is a major health problem in Central Europe where some of the countries have the world-wide highest incidence rates of this cancer. The CENTRAL EUROPEAN INITIATIVE AGAINST LUNG CANCER aims at decreasing the burden of lung cancer in this region. The Inaugural Workshop of this Initiative was planned in order develop strategies to achieve this goal.

      Methods
      Participation at the Workshop was by invitation and more than 100 lung cancer experts from several Central European Countries and Israel did participate. The participants discussed the current status of lung cancer management and suggested strategies for improvement in the various areas of lung cancer management.

      Results
      The Workshop focused on all aspects of lung cancer. There was agreement that lung cancer is a major health problem in all Central European countries and that improvement in all aspects of lung cancer management must be attempted. Prevention strategies have steadily been improved but remain insufficient in most countries. The potential of screening was recognized but routine implementation of screening was not considered to be feasible in most Central European countries at this time. Access to modern radiological imaging such as PET-CT must be improved in many centers. A future project will assess the accuracy of radiological staging in several hospitals. Molecular diagnosis is increasingly implemented in most countries but patient selection for molecular analyses varies between countries. A major area of discussion was the implementation of standard treatments. Multidisciplinary tumor boards have been established in most centers but participants disagreed on whether all or only selected patients should be presented during tumor board meetings. Concerning stage III NSCLC, great heterogeneity with regard to both staging and treatment has been recognized. A future project plans to assess current management of patients with stage III NSCLC and to define areas for improvement. Access to systemic treatment has improved over the years but timely access to novel and expensive drugs remains challenging in several countries. Strategies to increase the scientific co-operation and education have also been discussed and should increasingly be implemented in the future.

      Conclusion
      The Workshop did outline the current status including challenges in the management of patients with lung cancer in Central Europe. Next projects will assess staging accuracy and detailed treatment of patients with locally advanced NSCLC. Future events such as the 14th Central European Lung Cancer Congress in 2014 and the 17th World Congress on Lung Cancer in 2016 in Vienna should also have a major impact on decreasing the burden of lung cancer in Central European countries.

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    P2.11 - Poster Session 2 - NSCLC Novel Therapies (ID 209)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 2
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      P2.11-018 - EGFR mutations in NSCLC patients in Central Europe: the INSIGHT observational study (ID 1635)

      09:30 - 16:30  |  Author(s): R. Pirker

      • Abstract

      Background
      Central European countries are among those with the highest incidence rates of lung cancer and most of these cancers are smoking-related. The INSIGHT observational study aimed at assessing prevalence and treatment of patients with EGFR mutations in clinical practice in Central Europe. Here we report on the overall findings of this study.

      Methods
      Patients with NSCLC and tested for EGFR mutations between 15 November 2011 and 31 March 2013 in 14 centers from 6 Central European countries (Austria, Czech Republic, Hungary, Poland, Slovakia, Slovenia) were enrolled. EGFR mutations were determined by sequencing, PCR or other techniques.

      Results
      Here we report data on 1009 NSCLC patients who had been enrolled into the INSIGHT study. The patients had the following characteristics: median age 64 (range 29-93), 62% male, 38% female, 99.9% Caucasians, ECOG performance status 0-1, 2 and 3-4 in 79%, 17% and 4%; 19% never-smokers, 46% former smokers, 35% current smokers; 79% adenocarcinomas, 2% adenosquamous carcinomas, 7% squamous cell carcinomas, 9% NSCLC NOS and 3% others; tumor stages I-II, III and IV in 15.5%, 24% and 60.5% of the patients. EGFR mutations were found in 163 (16%) patients. Patients with mutations had the following characteristics: age median 66 (range 34-89) years, 46% male, 54% female, 47% never-smokers, 38% former smokers, 15% current smokers; performance status was recorded in 153 patients and was 0, 1, 2 and 3 in 30%, 50%, 14% and 6% of the patients. The mutation-positive tumors had the following characteristics: 85% adenocarcinomas, 4% adenosquamous carcinomas, 4% squamous cell carcinomas, 2% NSCLC NOS, and 5% others. Among patients with mutations, exon 18 mutations were seen in 7% of the patients, exon 19 mutations in 50% of the patients including deletions in 39%, exon 20 mutations in 12%, exon 21 mutations in 39% including L858R in 28% of the patients. Detailed data on systemic treatment were available for 122 patients with advanced EGFR mutation-positive NSCLC and most of these patients received EGFR-directed tyrosine kinase inhibitors during the course of their disease.

      Conclusion
      The INSIGHT observational study demonstrated that EGFR mutation testing has been established in the participating centres in Central Europe. The mutation rate of 16% is on the upper limit of the range seen in Western European countries but a potential selection bias for testing of patients with higher likelihood of harboring EGFR mutations cannot be excluded. Systemic treatment in patients with EGFR mutations is similar to treatment patterns observed in other countries. This study was supported by Boehringer Ingelheim Regional Center Vienna.

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      P2.11-019 - Treatment strategies in patients with advanced EGFR mutation-positive NSCLC in Central Europe: Findings from the INSIGHT observational study (ID 1640)

      09:30 - 16:30  |  Author(s): R. Pirker

      • Abstract

      Background
      The INSIGHT observational study aimed at assessing the management of NSCLC patients with EGFR mutations in clinical practice in 10 centres from 6 Central European countries. As part of this project, the treatment strategies used in these patients have been determined.

      Methods
      Between 15 November 2011 and 31 March 2013, EGFR mutations were determined by one of the established methods in 1009 patients with NSCLC. The systemic treatments of patients with EGFR mutation positive NSCLC were assessed.

      Results
      Comprehensive data on systemic treatment were available for 122 patients with EGFR mutation-positive tumors. Mutations were located in exon 19 (52.5%), exon 21 (38.5%), exon 20 (10.7%), and exon 18 (6.6%). In 8 patients, mutations were present in 2 or 3 exons. Patients with mutation-positive tumors had the following characteristics: median age 66 (range 41-83) years; 58 (48%) males, 64 (52%) females; 51 (42%) never smokers, 51 (42%) former smokers, and 19 (16%) current smokers; performance status at diagnosis ECOG 0, 1, and equal or above 2 in 28 (23%), 60 (49%), 20 (16.5%) of patients; in 14 (11.5%) patients PS was not recorded; adenocarcinomas 98 (80%), adenosquamous 6 (5%), squamous 7 (6%), not otherwise specified 2 (2%) and 9 (7%) patients had other types of carcinoma. A total of 116 patients presented with stage IIIB or IV and received the following first-line therapy: gefitinib in 66 (57%), erlotinib in 4 (3%), chemotherapy in 43 (37%), and chemotherapy plus bevacizumab in 3 (3%) patients, respectively. In 22 (19%) patients EGFR test results were obtained after initiation of first-line therapy and the majority of these patients (n=20) received chemotherapy as first-line therapy. For patients tested before the first-line treatment initiation, median time between the date of test result and initiation of first-line therapy was 16 days. Regardless of the lines of treatment, EGFR-directed tyrosine kinase inhibitors were administered to 90 out of 116 (78%) patients. No major differences in treatment strategies between various countries were observed.

      Conclusion
      The INSIGHT observational study demonstrated that most patients with advanced EGFR mutation-positive NSCLC had been treated with EGFR-directed tyrosine kinase inhibitors either in the first- or second-line setting. This study was supported by Boehringer Ingelheim Regional Center Vienna.

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    P2.24 - Poster Session 2 - Supportive Care (ID 157)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 1
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      P2.24-047 - Palliative Care Units in the management of patients with advanced lung cancer - the experience of the Medical University of Vienna (ID 2857)

      09:30 - 16:30  |  Author(s): R. Pirker

      • Abstract

      Background
      Patients with advanced lung cancer suffer from a high burden of tumor-related symptoms. Thus palliative care is an important treatment modality in these patients. Palliative care units have been established in many comprehensive cancer centers in order to achieve this. Here we report on the experience we have obtained at the Palliative Care Unit of the Medical University of Vienna in the management of patients with advanced lung cancer.

      Methods
      We retrospectively reviewed medical records of 86 patients with advanced lung cancer who were treated at our Palliative Care Unit between June 2010 and March 2013. We determined reasons for admission, duration of hospitalization, non-invasive as well as invasive medical interventions, and clinical outcome.

      Results
      We report on 86 patients with advanced lung cancer (74 % NSCLC, 26 % SCLC) who had been admitted to our Palliative Care Unit within a period of 34 months. Lung cancer patients comprised the largest group of cancer patients who are admitted to our unit. Reasons for admissions were deterioration of performance status (41 %), dyspnea (13 %), pain (38 %), psychosocial reasons (7 %), and other (1 %). Re-admissions occurred in 20 % of all patients. The patients had the following characteristics: median age 62 years (range 42-85 years), 38 % females and 62 % males, ECOG performance status 0-2 38 % and >2 62%, median body mass index (BMI) 24 (range 14-39). Median duration of hospitalization was 16 days (range 1-101 days). The following treatments were delivered during hospitalization: analgesic treatment according to the WHO I-III ladder (85 %), palliative radiotherapy (31 %), palliative chemotherapy (7 %), and invasive procedures (such as thoracocentesis, pleurX drainage system, pleurodesis, bronchial stenting, invasive neurolysis and other in 26%). Antibiotic therapy was delivered in 33 % and antipressants or antipsychotropic drugs in 38 % of all patients. Palliative sedation by means of a continuous intravenous or subcutaneous infusion with midazolam was administered in 25%. Dietary counseling and spiritual as well as psychosocial support was offered to all patients and accepted by most of them. 77 % of all patients died during their stay, mostly due to disease progression. The remaining 23 % of all patients were discharged with improvements in their tumor related symptoms or stable disease and were offered home care or hospice access.

      Conclusion
      Patients with advanced lung cancer did benefit from admission to the Palliative Care Unit. Medical as well as non-medical interventions resulted in improvements of cancer-related symptoms and better coping with the disease. Thus Palliative Care Units should be part of the multidisciplinary management of patients with advanced lung cancer. Schur S and Masel EK contributed equally to this work

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    P3.18 - Poster Session 3 - Pathology (ID 177)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Pathology
    • Presentations: 1
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      P3.18-005 - EGFR mutation testing methods in clinical practice in Central Europe: findings from the INSIGHT observational study (ID 1639)

      09:30 - 16:30  |  Author(s): R. Pirker

      • Abstract

      Background
      The INSIGHT observational study aimed at assessing the management of NSCLC patients with EGFR mutations in clinical practice in Central Europe. As part of this project, pathological findings including molecular testing methods were assessed.

      Methods
      Fourteen Pathology Departments from 6 Central European countries participated. Between 15 November 2011 and 31 March 2013, EGFR mutations were determined by one of the established standard methods in patients with NSCLC.

      Results
      Here we report data on 1009 patients who had been enrolled into the INSIGHT study. These patients consisted of 626 (62%) males and 383 (38%) females, 347 (35%) smokers, 452 (46%) former smokers and 182 (19%) never-smokers. Pathological diagnosis was based on histology (41%), cytology (19%) or both (40%) and revealed the following results: 54% non-mucinous adenocarcinomas, 4% mucinous adenocarcinomas, 21% unspecified adenocarcinomas, 9% NSCLC NOS, 7% squamous cell carcinomas, 2% adenosquamous carcinomas, and 2% others. Tumor material was obtained by bronchoscopy (44%), transthoracic needle biopsy (11%), surgery (19%), or other techniques. Specimens were either from primary tumor (88%), lymph node metastases (2.5%) or distant metastases (9.5%). EGFR mutation testing was done by PCR-RFLP (43%), Roche Cobas EGFR mutation test (26%), Sanger sequencing (18%), high resolution melting followed by sequencing (13%) or another method (11%). EGFR mutations were found in 163 (16%) of the patients. Among patients with mutations, the following mutations were found: 12 (7% of mutation-positive patients) exon 18 mutations, 82 (50%) exon 19 mutations including 63 (39%) deletions, 20 (12%) exon 20 mutations including 3 (2%) T790M, 63 (39%) exon 21 mutations including 45 (28%) L858R. Multiple mutations, both common and uncommon, were found in 12 (7%) of the patients. Mutations were found in 8% of smokers, 14% of former smokers and 43% of never-smokers. Mutations rates varied between centers which most likely reflected different patient selection criteria for EGFR mutation testing.

      Conclusion
      The INSIGHT project demonstrated that EGFR mutation testing by one of the standard tests in patients with NSCLC has been established in participating centers in Central Europe. EGFR mutation distribution is similar to other European and American NSCLC patient populations. This study was supported by Boehringer Ingelheim Regional Center Vienna.