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P. Schnabel



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    MO24 - NSCLC - Chemotherapy III (ID 110)

    • Event: WCLC 2013
    • Type: Mini Oral Abstract Session
    • Track: Medical Oncology
    • Presentations: 1
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      MO24.08 - Survival outcomes among NSCLC patients in Europe receiving platinum-based therapies as first-line treatment: results from the FRAME observational study (ID 1944)

      10:30 - 12:00  |  Author(s): P. Schnabel

      • Abstract
      • Presentation
      • Slides

      Background
      FRAME was a European non-interventional prospective observational study of patients with advanced or metastatic non-small cell lung cancer (NSCLC) initiating platinum-based therapies as first-line treatment (FLT).

      Methods
      Patients were enrolled between April 2009 and February 2011. Consenting adult NSCLC (Stage III/IV) patients initiating FLT with a platinum-based doublet chemotherapy, with or without an additional targeted agent, were eligible for the study. The choice of FLT was left to physician discretion, as per routine clinical practice. The primary objective of FRAME was to evaluate overall survival (OS) among different platinum-based treatment cohorts in patients with and without additional targeted therapy. Secondary objectives included the evaluation of OS in patients with different histological subtypes of NSCLC. Survival outcomes were assessed using Kaplan-Meier analysis, and unadjusted estimates are presented.

      Results
      A total of 1564 eligible patients from 11 EU countries were observed. Patient cohorts were: pemetrexed + platinum, gemcitabine + platinum, vinorelbine + platinum, taxanes + platinum and other therapy + platinum. Table 1 shows a subset of baseline patient characteristics, which varied across several parameters in the treatment cohorts, including age, performance status (PS), stage and histology. The median OS across the 4 main treatment cohorts was 10.3 months (95% CI: 9.5-11.2). A subset of overall survival estimates in the different treatment cohorts is shown in Table 1.

      Table 1. Select baseline patient characteristics and overall survival
      Baseline Patient Characteristics Overall Survival Estimates (unadjusted)
      Treatment Cohort[a] Age ≥70 Years (%) ECOG PS of 2/3 (%) Stage IV (%) Non-squamous Histology (%) All patients Median OS in Months (95% CI) Non-squamous Median OS in Months (95% CI) Non-squamous Cisplatin[b] Median OS in Months (95% CI)
      Pemetrexed + Platinum[b ](n=569) 23 18 86 97 10.7 (9.4-12.3) [n=569] 10.6 (9.4-12.0) [n=553] 11.6 (9.9-13.8) [n=374]
      Gemcitabine + Platinum[b] (n=360) 35 11 74 56 10.0 (8.4-11.8) [n=360] 8.4 (7.0-10.6) [n=201] 8.4 (6.7-10.8) [n=107]
      Taxanes + Platinum[b ](n=295) 36 23 75 64 9.1 (8.0-11.3) [n=295] 8.1 (7.4-10.1) [n=189] 9.6 (7.1-14.1) [n=44]
      Vinorelbine + Platinum[b] (n=300) 28 15 67 53 10.7 (8.9-12.8) [n=300] 10.1 (8.0-13.1) [n=160] 9.9 (7.2-13.4) [n=91]
      [a]A fifth cohort, the ‘other’ + platinum cohort contained a small number of subjects (n=40) and it was not included in the analyses presented here [b]Cisplatin is the platinum agent in the EMA approved prescription drug label

      Conclusion
      This observational study of first-line treatment for advanced NSCLC provides data describing patients and their survival outcomes in a real-world European practice setting between 2009 and 2012.

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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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      P2.24-053 - 11-Year Survival of a Patient with Untreated, EGFR Positive, Pulmonary Adenocarcinoma (ID 3229)

      09:30 - 16:30  |  Author(s): P. Schnabel

      • Abstract

      Background
      Lung cancer is the most common cancer related death and the fourth most common cause of death in Germany. The five-year survival rate in European and North American countries is in between 5,5% and 15,7%. In the last couple of years though, significant progress has been made concerning personalized medicine in this disease entity. Novell targeted therapies with tyrosin kinase inhibitors (TKI) for patients with a mutation in the EGFR gene offer a new treatment option.

      Methods
      A 78-year old male patient was referred to the Thoraxklinik Heidelberg with atypical thoracic pain after cardiologic assessment. In 2001 he was given the diagnosis of pulmonary adenocarcinoma of the right upper lobe in the Asklepios Hospital Munich-Gauting. Because of his overall good clinical condition the patient had declined any treatment to this point. A new PET- CT was conducted and compared to the computer tomography of 2001 revealed a significantly grown lesion in the right upper lobe as well as new, small bipulmonar lesions suspicious of lung metastasis.

      Results
      A new histological assessment was performed on an endobronchial forceps biopsy of the now occluded right upper lobe. The diagnosis of a partial lepidic differentiated adeno-carcinoma was consistent with the diagnosis as well as the preserved specimens of 2001. We were able to perform an EGFR mutation analysis of the 2001,- as well as of the new tumor specimens through PCR-amplification and bidirectional sequencing of exons 18, 19 and 21. In each of the probes we detected a deletion combined with an insertion c.2127_29del (p.E709_T710delinsD) in exon 18.

      Conclusion
      The above mentioned mutation has already been described in the literature but there is no information concerning the responsiveness of tyrosine kinase inhibitors in this particular mutation. Now that the cancer had spread we decided to start treatment with erlotinib. Due to cutaneous side effects the patient decided to discontinue this therapy. Since then he has been in regular follow-up showing a stable disease and good general state of health.

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    P3.06 - Poster Session 3 - Prognostic and Predictive Biomarkers (ID 178)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P3.06-031 - mRNA and Splice Variant Analysis in Endobronchial Lining Fluid collected by Bronchoscopic Microsampling in Proximity of Pulmonary Nodules (ID 2445)

      09:30 - 16:30  |  Author(s): P. Schnabel

      • Abstract

      Background
      Molecular biomarkers in tissues and body fluids represent a promising source to improve cancer diagnostics. Bronchoscopic Microsampling (BMS) of endobronchial epithelial lining fluid (ELF) is a potent method to investigate potential biomarkers in lung diseases. Recent studies report that mRNA derived from ELF can be used to improve the differentiation of malignant and benign pulmonary nodules. Tenascin C (TNC) is an important component of the extracellular matrix involved in tissue remodeling and cell signaling. It has been reported that TNC is differentially expressed in malignant pulmonary nodules. We investigated whether specific splice variations of TNC are differentially expressed in ELF collected by the BMS method in proximity of pulmonary nodules.

      Methods
      ELF was collected by the BMS method from subsegmental bronchi close to the indeterminate pulmonary nodule and from the contralateral lung. Diagnosis was confirmed by transbronchial biopsy or surgery. In this study 176 ELF samples were included from a total of 88 patients (65 NSCLC and 23 benign cases) with indeterminate pulmonary nodules detected by computed tomography. Quantitative real-time PCR (RT-PCR) assays were used to detect different TNC variant patterns.

      Results
      All patients underwent BMS without complications. Quantitative RT-PCR was reliably applied to all ELF samples. A significant increase of TNC transcript variants close to malignant nodules was observed for most of the used qPCR assays. A better accuracy was observed for two protein-coding variants and an untranslated transcript indicating a distinct tumor-associated TNC variant pattern and a lower intraindividual variance.

      Conclusion
      Our results indicate that the analysis of individual TNC variants might improve the accuracy in detecting malignant nodules compared to the detection of whole TNC transcripts.

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    P3.10 - Poster Session 3 - Chemotherapy (ID 210)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.10-002 - Resource utilization of NSCLC patients receiving platinum-based therapies across Europe; results from the FRAME observational study (ID 183)

      09:30 - 16:30  |  Author(s): P. Schnabel

      • Abstract

      Background
      FRAME was a non-interventional, prospective observational study of advanced or metastatic non-small cell lung cancer (NSCLC) patients initiating first-line treatment (FLT) with platinum-based therapies in a routine practice setting across 11 European countries.

      Methods
      Patient enrollment occurred between April 2009 and February 2011. Consenting adults with Stage IIIB or IV NSCLC receiving platinum-based doublet chemotherapy with or without an additional targeted agent as FLT were eligible for this study. Patients were under routine treatment for NSCLC by their doctors and treatment choice and resource use were at the discretion of the treating physician. Secondary objectives of the study included determining resource use during FLT. Hospitalizations, outpatient visits, concomitant therapy use, transfusions and the use of colony stimulating factors (CSFs) are reported here. Cohorts were not adjusted for multivariate parameters prohibiting statistical comparisons.

      Results
      Evaluable patients (n=1564) were categorized into 4 main cohorts based on their FLTs: pemetrexed + platinum (n=569), gemcitabine + platinum (n=360), taxanes + platinum (n=295) or vinorelbine + platinum (n=300). Forty of the evaluable patients received other platinum-doublet treatments and were excluded from the analyses presented here.Across the four main cohorts, 55% of patients were hospitalized.A majority (61%) of hospitalizations were preplanned (71% in the pemetrexed cohort, 45% in the gemcitabine cohort, 67% in the taxanes cohort and 53% in the vinorelbine cohort). Among the unplanned hospitalizations, 54% were related to an adverse event (54% in the pemetrexed cohort, 54% in the gemcitabine cohort, 55% in the taxanes cohort, and 55% in the vinorelbine cohort). The mean (95%-confidence interval) duration of hospitalizations was 13 days (11.6 to 14.6) for pemetrexed (median=9 days), 11 days (9.4 to 12.8) for gemcitabine (median=7 days),17 days (14.0 to 19.7) for taxanes (median=12 days), and 13 days (11.3 to 15.0) for vinorelbine (median=9 days). Nearly half of patients (47%) were seen in an outpatient setting with most outpatient visits (82%)planned for scheduled treatments. Nineteen percent of patients received ≥1 transfusion (16% in the pemetrexed cohort, 24% in the gemcitabine cohort, 15% in the taxanes cohort and 24% in the vinorelbine cohort). Nearly all (94%) of these patients received packed red blood cells. Nineteen percent of patients received ≥1 colony stimulating factor (CSF), which included G-CSF (69%), or erythropoietin (39%). During therapy, 82% of patients used antiemetics and antinauseants, 58% used steroids, 40% used analgesics, and 24% used antibiotics. Twenty-eight percent of patients received radiation during FLT and most often radiation was delivered concurrently with chemotherapy (66% overall, 66% in the pemetrexed cohort, 54% in the gemcitabine cohort, 68% in the taxanes cohort, and 73% in the vinorelbine cohort).

      Conclusion
      The FRAME study provides unique, real-life data reflecting prospectively collected information on resource use not accessible in a clinical trial setting. This study revealed several important findings regarding real-world resource use during NSCLC therapy including data on hospitalizations, outpatient visits, transfusions, concomitant treatments, and radiation.