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M.T. Almodovar



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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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      MO06.06 - Oral vinorelbine (NVBo) and cisplatin (P) or pemetrexed (Pem) and P as first-line chemotherapy for non squamous (NS) metastatic or locally advanced non small cell lung cancer (M or LA NSCLC): Final results of a prospective randomised phase II trial (NAVoTrial 1) (ID 276)

      16:45 - 16:50  |  Author(s): M.T. Almodovar

      • Abstract
      • Presentation
      • Slides

      Background
      NVBo and P are an established regimen in advanced NSCLC. The approval of Pem and P in NS NSCLC recognises histology as treatment driver even if the higher chemosensitivity of NS NSCLC is recognised and reported with other chemotherapies (Ardizzoni. JNCI 2007). NVBo + P also showed better survival in NS NSCLC than in Squamous NSCLC (Tan. Ann.Oncol. 2009). The current randomised (2:1) phase II trial assessed disease control (DCR) (SD + PR + CR) of NVBo/CDDP or PEM/CDDP in NS NSCLC.

      Methods
      Stage IIIB/IV untreated/relapsed NS NSCLC pts were randomised to receive q3w NVBo 80 mg/m² D1D8 (60 at Cycle 1) + P 80 mg/m² D1 (Arm A) or Pem 500 mg/m² + P 75 mg/m² D1 (Arm B). After 4 cycles of combination, non PD pts received single agent NVBo (Arm A) or PEM (Arm B) as maintenance until progression or toxicity. Pts were randomised on a 2/1 basis and stratified according to Stage (IIIB - IV - relapse), non SCC confirmed by histology or cytology, gender, smoking status and centre.

      Results
      From 11/09 to 02/11, 153 patients were enrolled in 31 centers and randomised to Arm A (102 pts) or Arm B (51 pts). DCR after combination and maintenance was 75.0% (95% CI, 65.3 to 83.1) in Arm A and 76.5% (95% CI, 62.5 to 87.2) in Arm B. Median PFS was 4.2 (95% CI, 3.6 to 4.7) and 4.3 months (95% CI, 3.8 to 5.6) in Arm A and Arm B, respectively. Median OS was 10.2 months (95% CI, 7.8 to 11.9) and 10.8 months (95% CI, 7.0 to16.4) in Arm A and Arm B, respectively. During the combination period Grade 3/4 neutropenia was 44.0% in Arm A and 18.3% in Arm B but febrile neutropenia was 2% in both arms; grade 3/4 thrombopenia was 0% and 6% in Arm A and Arm B, respectively.

      Conclusion
      Both doublets reported good efficacy and acceptable tolerability. The maintenance allowed continuation of effective treatment with either oral vinorelbine or pemetrexed as single agent, with an acceptable safety with both agents. These results are sufficiently compelling to consider whether a phase III randomised non inferiority study with oral vinorelbine maintenance after induction vinorelbine/cddp could be as effective as pemetrexed maintenance. An oral maintenance may be a definite advantage over intravenous maintenance.

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    P1.18 - Poster Session 1 - Pathology (ID 175)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Pathology
    • Presentations: 1
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      P1.18-018 - Diagnosis of lung cancer: performance of pre-operative procedures in clinical practice correlated with characteristics of the tumor. (ID 3086)

      09:30 - 09:30  |  Author(s): M.T. Almodovar

      • Abstract

      Background
      Recent treatments for advanced non-small cell carcinoma (NSCLC) have increased the demand for accurate diagnosis of NSCLC rendered by histology or cytology. However precise classification is not always possible

      Methods
      We investigated the performance characteristics of preresection procedures for diagnosis of NSCLC Database was searched for resected NSCLCs during 2008-2011 with corresponding preresection cytology and/or biopsy cases. The pre-resection diagnoses were correlated with resection diagnosis considering the type of bronchoscopic or transthoracic procedure, size, location of tumor in bronchoscopy and distance from thoracic wall in transthoracic cases. Pathologic data were reviewed by two pathologists and TAC by two pulmonologists. Pathology of resection was categorized as adenocarcinoma- AD, squamous cell- SQ, adenosquamous carcinoma (ADSQ), and large cell carcinoma-LCC. The bronchoscopy (BF) procedures- bronchial biopsy BB, distal biopsy DB, bronchial washing (BW), bronchial brushing (BBr), endobronchial/transbronchial biopsy (ETBX), and trans-thoracic procedures (TT)—transthoracic fineneedle aspiration(TT-FNA) and transthoracic needlecore biopsy(TT-NCB) were identified. Sensitivity of procedures was determined taking surgical pathology as reference; 95% confidence intervals were estimated by Wilson method. Agreement was evaluated using Cohen’sKappa. Univariate and multivariate logistic regression was used to evaluate factors possibly associated with absence of pre-surgery tumor diagnosis and lack of agreement in the subset with pre-surgical diagnosis.

      Results
      A total 189 patients were included, with 538 previous diagnostic procedures. The distribution for diagnosis was 105 AD, 48 SQ, 9 ADSQ, and 17 LC. Median (Max-Min) size of the tumor was 27mm (10-25). Median (Max-Min) distance from the thoracic wall was 7 mm (0 – 50). Procedures sensibility were: all 69% (63% - 76%), , TT 57% (46%-66,5%) , TT-NCB 71%, TT-FNA 33%,BF 54% (47%-62%)BB 63%, DB 54%, ETBX 32%, BBR 22%, BW 12%. The 131 patients in the subset with pre-surgery diagnosis agreement between pre and post-surgical diagnosis was: all procedures k=0,54, TT k=0,69, TT-NCB k=0,69, TT-FNA k=0,34, BF k=0,69, BB 0,59, DB k=0,73, ETBX k=0,80, BBR k=0,57, BW k=0,51. Concordance by histology was all procedures- AD 82%, SQ 78%; TT - AD85%, SQ 67%; NCB- AD 93%,SQ 75%; TT-FNA AD 78%, SQ 50%; BF AD 81%, SQ 87%; BB AD 82%,SQ 86; DB AD 100%, SQ 90%; ETBX 88% SQ 100%; BBR AD 79%, SQ 38%; BW AD 67%, SQ 60%. From factors possibly associated with diagnosis sensibility only the size of the tumor, in TT ODD 5% by additional mm (p=0,001), in BF ODD 3% (p=0, 0038) was significantly associated in univariated and multivariated analysis. From the factors possibly associated with agreement between pre-surgical and surgical diagnosis only the size of tumor in PATT was significantly associated in univariated and multivariated analysis.

      Conclusion
      All procedures had a substantial to almost perfect agreement in diagnosis of non-small-cell lung cancer subtype. Broncoscopy had 69% sensibility, lower than literature maybe because only operable tumors were considered, influenced by tumor size and an agreement in diagnosis independent of all factors considered. Transthoracic procedures had a sensibility lower than literature with substantial agreement influenced by tumor size. Broncoscopy was better in squamous-cell diagnosis and transthoracic procedures in adenocarcinoma maybe due to location in lung

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    P3.19 - Poster Session 3 - Imaging (ID 181)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Imaging, Staging & Screening
    • Presentations: 1
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      P3.19-008 - Positron Emission Tomography Scan in Lung Cancer: New Insights In Tumor Biology? (ID 1678)

      09:30 - 09:30  |  Author(s): M.T. Almodovar

      • Abstract

      Background
      [18]F-fluoro-2-deoxy-glucose (FDG) uptake on Positron Emission Tomography (PET) is highly accurate in the detection of mediastinal lymph node metastasis and extrathoracic metastasis and plays an important role in the staging of lung cancer. Furthermore, recent studies suggest that PET-CT and Standardized Uptake Value (SUVmax) reflects tumor metabolism and proliferation capacity, and can be used as a prognostic factor as well as to predict response to therapy.

      Methods
      Our study aims to detect SUVmax differences between different lung cancer histologic sub-types. We conducted a retrospective single centre study. All lung cancers diagnosed in 2008-2009, with a PET-TC evaluation at diagnosis, and with follow-up at IPOLFG were included. Data regarding socio-demographic factors, smoking habits, histological diagnosis, staging, and performance status were obtained from clinical chart reviews. Statistical analysis was performed using STATA

      Results
      A total of 92 patients have been included in this study to date. 64 (69.6%) of our patients were male and 28 (30.4%) were female. Median age was 64.5 years, standard-deviation of 10.16 years, minimum of 36 and maximum of 82 years. 47 patients (51.65%) were current smokers, 31 (34.07%) were former smokers, and 11 (12.09%) were non-smokers. 54% presented ³ 40 Pack years. The most frequent histologic sub-type was Adenocarcinoma (ADC) (41.3%), followed by Squamous Cell Carcinoma (SCC) (30.4%). 42 patients had stage I or II lung cancer, 31 had stage III, and 19 with stage IV. The median size of the primary tumor lesion was 4.05cm (standard-deviation of 2.62cm), and the median SUVmax was 10.11 (standard deviation of 5.86). SUVmax by primary tumor histological sub-type revealed the following characteristics: median SUVmax in the SCC group was 12.12 (standard-deviation 6.3), ADC group 8.26 (standard-deviation 4.5), Non-small Cell Carcinoma group 12.65 (standard-deviation 7.5), Neuro-endocrine Carcinoma group 7.25 (standard-deviation 5.4) and Small Cell Carcinoma 10.67 (standard-deviation 3.6). The observed differences were statistically significant between the 5 considered groups (p=0.0233, One-way ANOVA) and specifically, we observed a highly significant difference in SUVmax between SCC and ADC groups (p=0.005, t-test). We also observed a positive correlation between tumor size and SUVmax.

      Conclusion
      Our preliminary results confirm the effect of tumor biology in PET-CT and SUVmax with observed differences between different histological sub-types, and suggest that PET-CT can be specifically important in the assessment of SCC and ADC subtypes. These results support further studies regarding the usefulness of PET-CT in tumor biology characterization in SCC and ADC subgroups.