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L. Calera



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    P1.06 - Poster Session 1 - Prognostic and Predictive Biomarkers (ID 161)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P1.06-016 - Anaplastic Lymphoma kinase (ALK) alterations by FISH in a cohort of Spanish Non-Small Cell Lung Cancer (NSCLC) patients analysed in a certified centre of reference (ID 1626)

      09:30 - 09:30  |  Author(s): L. Calera

      • Abstract

      Background
      Patients with NSCLC harbouring an ALK translocation exquisitely respond to ALK inhibitors. It is therefore important to know ALK status for newly diagnosed NSCLC patients. Our institution has become centre of reference in Spain for ALK determination by FISH for other hospitals. The aim of this work was to report the clinical and pathological characteristics of the samples with ALK results evaluated in our institution.

      Methods
      We entered clinical-pathological characteristics of external and in-house samples into a database. ALK was evaluated by FISH with the FDA approved test (Abbot Molecular Inc, Des Plaines, IL). Whole sections were analysed evaluating a minimum of 50 nuclei per case. The case was considered typically rearranged when separated green and orange/red signals (at least by three times the signal diameter) were identified and atypically rearranged when a single orange signal was observed. Gain (including both low or high genomic gain) was defined as a mean copy number of 3 to 5 fusion signals in >=10% of cells and amplification as the presence of >=6 copies of ALK per cell in >=10% of analysed cells (Salido et al, JTO 2010). To analyse correlations between ALK status and clinical-pathologic variables, we used the Chi-square test or Fisher’s exact test with a significance at p<0.05.

      Results
      A total of 471 cases were included in the database. Patients’ clinical characteristics are summarized in Table 1. ALK translocation was found in 15 of 471 patients (3.2%). Within the ALK translocated cases 8 were female, 11 were adenocarcinomas, 2 squamous cell histology, 1 large cell neuroendocrine carcinoma, and 1 not otherwise specified. There was a significant association between smoking status and ALK translocation (6.6% of translocations among non-smokers and 2% among smokers, p=0.042). Fourteen patients (3%) showed ALK amplification, 366 (77.7%) gain in ALK copy number, 50 (10.6%) were disomic and 5 (1%) monosomic for ALK and 20 cases were not evaluable (4.2%). EGFR mutation was found in 23 of 252 patients (9.1%) and non of these was observed in cases with ALK translocation. We observed an association between the type of sample and the ability to obtain an evaluable result for ALK with 97.5% assessable biopsies vs 84.4% citologies, (p<0.0001).

      N (%)
      Median age (range) 62.46 (32-91)
      Gender Male 330 (70.1)
      Female 141 (29.9)
      Smoking status Never 121 (25.7)
      Current/Former 350 (74.3)
      Sample origen Lung 425 (90.2)
      Pleura 15 (3.2)
      Lymph node 15 (3.2)
      Other 16 (3.3)
      Type of sample Citology 66 (14)
      Biopsy 405 (86)
      Stage I 104 (22)
      II 40 (8.5)
      III 87 (18.5)
      IV 240 (51)
      Histology Adenocarcinoma 363 (77.1)
      Squamous cell carcinoma 44 (9.3)
      Large cell carcinoma 11 (2.3)
      Other 43 (11.3)

      Conclusion
      ALK translocation is present in about 3% in Spanish NSCLC patients and is associated with adenocarcinoma histology and non-smoking status. The performance of ALK FISH in biopsy specimens is significantly better than in citologies.

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

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Supportive Care
    • Presentations: 2
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      P2.24-035 - Description of lung cancer patients with ECOG 2 at diagnosis. Experience of our Hospital (ID 2448)

      09:30 - 09:30  |  Author(s): L. Calera

      • Abstract

      Background
      Patients with advanced lung cancer presenting with ECOG 2 at diagnosis trend to be no longer included in large, randomized, registration trials and then recommendations for their treatment are more difficult. Nonetheless, they account for a significant percentage of the cases attended in a Medical Oncology Department. We describe their characteristics and outcomes in our experience.

      Methods
      Medical records of lung cancer patients with ECOG 2 that were seen in our Department between april 2009 and april 2013 have been reviewed.

      Results
      124 patients (p) were found. They account for a 15.3% of the overall number of lung cancer patients attended. 106p were male (85.5%). Median age 66 years (44-83). By histology: adenocarcinoma 41p (33.1%), EGFR+ adenocarcinoma 4p (3.2%), squamous 36p (29.0%), small-cell 23p (18.5%), other 19p (15.3%), no histologic diagnosis 1p (0.8%). By stage: III 39p (31.5%), IV 85 (68.5%). By the time of analysis, 76p (61.3%) hade died, other 31p (25.0%) continued palliative care and 17 (13.7%) were still on active therapy. Initial intention of therapy was palliative in 94p (75.8%), radical/adjuvant in 9 /.3%) and 21p did not receive any active therapy beyond supportive care. Drugs administered at first line: carboplatin 43p (34.7%), cisplatin 12p (9.7%), EGFR-TKI 6p (4.8%), non-platinium chemotherapy 39p (31.5%), no Chemotherpy 24 (19.4%). No differences by gender existed in the drugs given, except for TKI which were more frequently given to women (5/6). Median overall survival was 34 weeks (IC: 26.0-41.9). No differences existed by gender (male 32 weeks, female 39 weeks) or stage (III 30 weeks, IV 36 weeks) but they differed by histology: adenocarcinoma 34 weeks, squamous 22 weeks, EGFR+ aenocarcinoma Not Reached, small cell 59 weeks.

      Conclusion
      A significant percentage of lung cancer patients are diagnosed with ECOG 2 performance status in every histological subtype. Minor differences existed with respect to clinical characteristicas and they benefit from receiving active therapy. This advantage seemed to be lesser in squanous carcinoma.

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      P2.24-036 - Erlotinib in metastatic, EGFR wild-type, Non-Small Cell Lung Cancer (NSCLC) as second or further line of therapy. (ID 3127)

      09:30 - 09:30  |  Author(s): L. Calera

      • Abstract

      Background
      Erlotinib (E) is a EGF-receptor tyrosine kinase inhibitor (TKI) approved for the treatment of NSCLC after progression to first-line chemotherapy irrespective of EGFR status. Currently EGFR mutation is usually performed upfront upon diagnosis and most mutated patients are treated with first-line TKI's. Nowadays, patients candidates for second line therapies are EGFR-wild-type.

      Methods
      Medical records of EGFR-wild-type patients treated with E in second or further linesbetween March/2008 and March/2013 were reviewed.

      Results
      85 patients (p) were found. Characteristics: Median age 61 years (38-83), 76.5% were male. Tobacco: 42.4% were smokers and 45.9% former smokers. PS 0, 16p; 1, 50p; 2, 19p; by stage: IIIb 27p, IV 58 p. Histology: adenocarcinoma 48p, squamous-cell 25p, undifferentiated or non-specified 11p, adenosquamous 1p. E was given: 40% as second, 44.7% as third and 15.3% as fourth or subsequent line. Effectivity: Partial response 9.4%, Stable disease 48.2%, Progressive disease 41.2%, Not assessable 1%. Overall Survival (OS): median 22 weeks (w) (95% CI, 17.4-26 .7), progression free survival (PFS) 12w (95% CI ,9.8-14 .2). In smokers PFS was 12w also. In squamous carcinomas 10w. In males 11w (these differences were non significant). Toxicity: 92.9%p presented some side-effect: 70.5% rash (49p, G1; 11p, G2); diarrhea 34.1%p (25p, G1; 3p, G2; 1p, G3); asthenia 29.4%p (12p, G1; 6p, G2; 7p, G3); ocular 2.4%p (2p, G1) and digestive 9.5% (2p, G1; 1p, G2; 1p, G3). Dose was reduced in 12.9%p (7p 100 and 4p 125 mg/day). Treatment was interrupted in 7.1%p (median 14 days (range 7-23)); most common causes were G3 skin rash and diarrhea.

      Conclusion
      We described the efficacy of Erlotinib in day-to-day clinical practice when was given beyond the first-line treatment in advanced and metastatic NSCLC without EGFR mutation. Our results are in accordance with has been reported from clinical trials and may reflect its efficacy in clinical practice.