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E. Capelletto



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    P2.18 - Poster Session 2 - Pathology (ID 176)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Pathology
    • Presentations: 1
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      P2.18-014 - Impact of Non Small Cell Lung Cancer (NSCLC) immunophenotyping in chemotherapy response. (ID 2679)

      09:30 - 09:30  |  Author(s): E. Capelletto

      • Abstract

      Background
      The vast majority of non small cell lung cancers (NSCLC) presents as advanced disease and histological diagnosis is widely based on small biopsy or cytological samples. Recently, the adoption of new pharmaceutical agents targeting individual histotypes requires a precise subtyping of NSCLC. This task is often difficult according to morphological criteria only and the use of immunohistochemistry (IHC) is recommended for small samples or undifferentiated tumors to define the most probable histotype. However, the real impact of IHC characterization of NSCLC-Not otherwise Specified (NOS) in terms of response to therapy and outcome (compared to cases classified by morphology, only) is not well established.

      Methods
      A large series of 224 advanced "non-squamous" NSCLC diagnosed from year 2005 to 2010 on small biopsy or cytological samples and homogeneously treated, was retrospectively selected, all with adequate follow-up data available. All diagnoses were reviewed resulting in two groups of adenocarcinoma (ADC) and NSCLC-NOS. The latter were further characterized by IHC to identify the most probable differentiation lineage. Disease Control Rate (DCR) and Response Rate (RR) were calculated and Overall Survival (OS) curves were analyzed by Kaplan Meier.

      Results
      After review 120/224 (53.6%) cases were ADC based on morphological examination, only (“ADC morphology”) and 104/224 (46.4%) remained NSCLC-NOS. In terms of response to therapy no significant difference was found between the two groups (“ADC morphology” had DCR= 0.66 and RR=0.31; NSCLC-NOS had DCR=0.64 and RR=0.35; Chi-Square p=0.83). The NSCLC-NOS cases that underwent IHC profiling resulted in 66/104 (63.5%) cases that had an ADC phenotype (“NSCLC favor ADC”) and 38/104 (36.5%) cases that lack ADC features (including 5 “NSCLC favor squamous carcinoma” and 33 “NSCLC null phenotype”). The “NSCLC favor-ADC” had DCR and RR similar to “ADC morphology” group (Chi-Square p=0.23), while the “non-ADC” NSCLC group had significantly different both DCR=0.47 and RR=0.29 (Chi-Square p=0.006). Survival curves confirmed no difference in terms of survival between the “ADC morphology” and the “NSCLC favor-ADC” groups, while showed a significantly poorer survival for the “non-ADC” NSCLC group with respect the other two groups (median survival: 8.5 vs 12.3 months, respectively; HR=0.5999; p=0.018).

      Conclusion
      These preliminary findings indicate that the practice of minimizing the NSCLC-NOS diagnoses by means of IHC has an impact on chemotherapy response. Stratifying such tumors by IHC, cases having an ADC immunoprofile had response rates comparable to those of morphologically diagnosed ADC, thus supporting the value of IHC to maximize lung cancer histological typing in the perspective of obtaining the best response to therapy.

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    P3.11 - Poster Session 3 - NSCLC Novel Therapies (ID 211)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Medical Oncology
    • Presentations: 1
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      P3.11-041 - Treatment with crizotinib in patients with IV stage non-small cell lung cancer (NSCLC) with ALK translocation: a single institution experience. (ID 2961)

      09:30 - 09:30  |  Author(s): E. Capelletto

      • Abstract

      Background
      Crizotinibis is a MET inhibitor, having also an activity on ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) pathways. The ALK translocation is described in 4% of NSCLC and these patients (pts) benefit from crizotinib therapy with a response rate (RR) ranging from 51 to 61%.The drug is already approved by FDA and EMA; in Italy crizotinib is available in first line within controlled clinical trials and, until April 2013, within expanded access program (EAP).

      Methods
      From June 2010 to February 2013, 155 pts with advanced NSCLC were analyzed for Alk translocation using fluorescence in situ hybridization (FISH) at our institution. The selection criteria were: adenocarcinoma histology, never or ex smoker, EGFR status WT. Main pts characteristics were: 59% males, median age 57,5 years (range 26-76), 77 former smoker (76 pts for more than 15 years). Tissue samples were available from primary tumor and metastases in 78 and 22%, respectively, having 73% of cases with cytological material. In 23,2% of the specimens Alk rearrangement was not evaluable due to poor quality and/or quantity issues.

      Results
      Among the 155 pts, 22 (14%) are ALK translocated: 19 were treated within PROFILE clinical trials and 3 patients in the EAP. 20 pts are currently evaluable for response and toxicity: 6 of them received crizotinib as first-line treatment, the others in subsequent lines. The response rate was equal to 70%. The total number of administered cycles is 235.The reduction of the dose (7% of cycles) was necessary in two pts: in 1 case due to bradicardia and fatigue G3 (in first line treatment) and in the other one due to neutropenia G3 (in second line).The observed toxicities were mostly grade 1-2 (fatigue 47%, bradycardia 5,8%, visual disorder 5,8%, anemia 29%, neutropenia 18% and nausea 12%); grade 3-4 was less common. The temporary cessation of treatment was required in 3 pts (range 4-15 days) for grade 3-4 toxicity (mostly neutropenia plus fatigue). No drug interruption for unacceptable toxicity was reported. The most common progression sites were brain (37%) and bone (27%).

      Conclusion
      The introduction of a selection criteria (such as negative EGFR status) leads on an increase of our cases of Alk traslocated pts compared to literature data; this selection is moreover recommended in diagnostic algorithm recently proposed by the Italian Expert Panel (Marchetti A et al, JTO 2013). Efficacy and tolerability profile are consistent with published data.

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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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      P3.19-015 - Should core biopsy with larger needle replace FNAB in assessing lung masses? (ID 2331)

      09:30 - 09:30  |  Author(s): E. Capelletto

      • Abstract

      Background
      The distinction between SCLC and NSCLC has been recently replaced by a more detailed re-classification. As 70% of patients with LC are still not eligible for surgery, tumor characterization is often based on needle biopsy. For the management of lung masses (LM), the availability of adequate samples is critical not only for pathological diagnosis, but also for additional molecular studies. In this context, our aim was to evaluate the safety and accuracy of image-guided core biopsies (CB) in our last 4-year series.

      Methods
      480 consecutive patients (325 male; 33-87 y, mean 68; LM diameter 6-150 mm, m 37,4) underwent 439 CT-guided, 35 US-guided and 6 US+CT-guided lung biopsies. In 325/480 cases (68%) a CB was preferred due to the possible requirement of molecular studies. 275 CB were performed with >=18G tru-cut needle, 50 with <18G, both by a coaxial technique (inserted in a 1G larger styleted cannula). 1 to 6 sampling per patient (m 1.5) were performed. Adverse events (including major complications) were recorded and correlated with technical issues (namely, with needle size). To assess the accuracy of CB, surgical specimens, outcome of non-surgical therapy and follow-up imaging were considered as gold standards. Sensitivity, specificity, diagnostic accuracy and positive and negative predictive values of CB were calculated.

      Results
      81/325 (24.9%) adverse events occurred, but only 23 (7%) were major complications (MC) (22 pneumothorax and 1 hemothorax, requiring drainage and prolonged hospitalization). The incidence of MC wasn’t different between either CB and FNAB group (11/155, 7%), or larger and smaller CB needle size (20/275 vs. 3/50, p=n.s). Only the depth of the LM seemed to be significant as negative predictor for MC (p=.0061). Pathological diagnosis was of benign LM in 60 CB (18.4%), malignancy in 265 (81.5%). According to the above gold standard criteria, TP were 265, FN 13, TN 47, FP 0. Sensitivity, specificity and diagnostic accuracy were 95.3%, 100% and 96%, respectively. PPV was 100%, NPV 78.3%.

      Conclusion
      CB is as safe as FNAB in characterizing LM; particularly, needle size doesn’t impact on MC rate. CB is highly accurate in morphological characterization of LM, also providing additional tissue for molecular studies, when needed.