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R. Gironés



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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): R. Gironés

      • 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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    P1.11 - Poster Session 1 - NSCLC Novel Therapies (ID 208)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P1.11-005 - EVEREST Study: Evolution of disease-related symptoms of patients (p) with advanced non-small cell lung cancer (NSCLC) and its correlation with response to first-line (1L) treatment. (ID 3277)

      09:30 - 09:30  |  Author(s): R. Gironés

      • Abstract

      Background
      The control of symptoms to maintain the health-related quality of life continues to be a priority in the treatment of advanced NSCLC. The aim of our study was to assess the evolution of the disease-related symptoms and, due to the lack of evidence, to evaluate its correlation with the response to 1L treatment in p with advanced NSCLC.

      Methods
      EVEREST is an observational prospective study carried out in 33 Spanish institutions. A total of 155 p with advanced NSCLC initiating standard platinum-based 1L treatment were included. Disease-related symptoms were assessed at baseline and after completing 4-6 cycles of 1L treatment (final visit) with the Lung Cancer Symptom Scale (LCSS) and an ad-hoc specific questionnaire evaluating their frequency. Response to treatment was assessed according to RECIST criteria.

      Results
      Baseline characteristics of the 155 p enrolled were: 76.1% male, 96.1% Caucasian, 70.3% adenocarcinoma, 16.8% squamous-cell carcinoma; median age was 62 years. ECOG PS 0/1/2: 26.5%/54.8%/14.8%. 65.3% and 12.9% of p maintained or improved the ECOG status during the study, respectively. 118 p completed at least 4 cycles of treatment. Best response to 1L treatment was: 1.7% complete response, 68.4% partial response and 26.5% stable disease. Most frequent disease-related symptoms were asthenia and pain. 1L treatment did not deteriorate disease-related symptoms compared to baseline (LCSS score was reduced 1.4 points) and an improvement in cough was observed (p=0.026). The frequency of cough (p<0.001), dyspnea (p=0.025), pain (p=0.009) and discomfort (p=0.034) were significantly reduced. No significant correlation with response to treatment and the evolution of symptomology between visits was found.

      Conclusion
      1L treatment was associated with a reduction of the frequency (cough, dyspnea, pain and discomfort) and intensity (cough) of disease-related symptoms in p with advanced NSCLC, irrespective of the response achieved.

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    P3.09 - Poster Session 3 - Combined Modality (ID 214)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Combined Modality
    • Presentations: 1
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      P3.09-016 - A phase II study of cisplatin and oral vinorelbine concomitantly with radiotherapy in locally advanced non-small-cell lung cancer treatment: Eficacy and safety results. (ID 2687)

      09:30 - 09:30  |  Author(s): R. Gironés

      • Abstract

      Background
      It has been shown an improvement in survival with concurrent chemoradiation versus the sequential administration of both treatment modalities. In patients with unresectable stage III disease, chemotherapy may best be started soon after the diagnosis of unresectable NSCLC has been made. Cisplatin (CDDP) plus oral vinorelbine (OV) as induction and concomitant regimen with radiotherapy (RT) has shown good efficacy outcomes and safety profile (Vokes, Fournel, Krzakowski). The objective of this study was to evaluate the effectiveness and toxicities of the combination of CDDP and OV given at full doses concomitantly with RT in locally advanced (LA) non-small-cell lung cancer (NSCLC).

      Methods
      Between February 2010 and December 2011, 48 chemo-naïve patients (p) with histologically confirmed unresectable stage IIIA/IIIB LA NSCLC were treated. Treatment consisted of 4 cycles (cy) of OV 60 mg/m[2] on days 1 and 8 and CDDP 80 mg/m[2] every 3 weeks plus RT 66 Gy starting on day 1, cy 2. The primary objective is the overall response rate (ORR) using RECIST 1.0. A standard Fleming two stage design was used. The sample size calculated with a type 1 error of 0.05 and type 2 error of 0.01, taking P~0~ 20% and P~1~ 40%. The study was approved by the local Ethical Committees of the participating institutions.

      Results
      Patient’s characteristics were: Median age 61 years (range 34-72); ≥ 65y 42%; males 89.6%; PS0 42% / PS1 58%; smokers 52%; adenocarcinoma 30% / squamous 64%; stage IIIA 46% / IIIB 54%. Median of days between initial diagnosis and study start was 28 days. 75% p completed the treatment as per protocol. Relative dose intensities of OV and CDDP were 97%/98%, respectively. 14.7% of cy were delayed, 11.8% due to toxicity. Dose of day 8 OV was canceled or delayed in 8.2% of cy. Hematological toxicities (% p): grade (g) 3/4 neutropenia 33.3%; g3 anemia 12.5%; g3/4 thrombocytopenia 16.6%; febrile neutropenia concomitant during CT-RT 14.6%. Non-hematological toxicities (% p): g3 esophagitis 12.5%; g3 dyspnea 4.2%, g3 vomiting 4.2%, g3-4 infection 4.2%. 2 treatment-related deaths were reported, both during cycle 1. 42 p (87.5%) received RT, 7.1% under 60 Gy, 23.8% with RT delays or interruptions due to adverse events. 44 p were evaluable for response. ORR 77.3% [CI 95%, 62.2-88.5], DCR 88.6% [CR 2 p (4.5%), PR 32 p (72.7%), SD 5 p (11.4%)]. Median follow-up was 19 months (m) (range 0.47-39.4). Median progression free survival (PFS), 12 m [CI 95%, 7.3-16.6]; 1-year PFS, 48.3% [CI 95%, 33.6-63], 2-year PFS, 30% [CI 95%, 15.8-44.2]. Median time to progression (TTP), 13.3 m [CI 95%, 9.7-16.9]; 1-year TTP, 51.7% [CI 95%, 36.9-66.6], 2-year TTP, 33.3% [18.5-48.1]. Median overall survival was not reached; 1-year and 2-year survival rates were, 72.3% [CI 95%, 59.6-85.1] and 49.4% [CI 95%, 33.8-64.9], respectively.

      Conclusion
      This prospective phase II trial shows that the schedule of cisplatin plus oral vinorelbine concomitant with radiotherapy from 2[nd] cycle obtains a good efficacy with an acceptable safety profile. Clinical trial information: EudraCT Number: 2009-010436-17