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V. Scotti



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    P2.02 - Poster Session with Presenters Present (ID 462)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Locally Advanced NSCLC
    • Presentations: 1
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      P2.02-020 - Pattern of Care of Inoperable Locally Advanced (LA) NSCLC in Elderly Patients: Analysis of the Experience of Two Academic Italian Hospitals (ID 6038)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract
      • Slides

      Background:
      Optimal treatment in LA NSCLC patients is still debated. In fit patients concomitant radio-chemotherapy (RCT) seems to be the best treatment in terms of local control (LC), progression free survival (PFS) and overall survival (OS) while sequential RCT is a good alternative in unfit patients. Moderately hypofractionated radiotherapy improve OS in recent studies. Elderly patients often cannot be offered multimodality treatments. We report our experience with over 70 years old LA NSCLC patients deemed unfit for surgery.

      Methods:

      Patients' Characteristics
      Age Median 75
      Range 70-83
      Gender Male 50 (70%)
      Female 21 (30%)
      Performance Status (ECOG) 0 29 (41%)
      1 36 (51%)
      2 6 (8%)
      Histology Adenocarcinoma 31 (44%)
      Squamous Cell Carcinoma 39 (55%)
      Large Cell Carcinoma 1 (1%)
      Stage IIa/IIb 12 (17%)
      IIIa 39 (55%)
      IIIb 20 (28%)
      Chemotherapy Concomitant 9 (13%)
      Sequential 62 (87%)
      Cycles: median 4
      Cycles: range 1-8
      Radiotherapy Median Dose 62,3 Gy
      Moderate hypofractionation 26 (37%)
      Conventional fractionation 45 (63%)
      Characteristics of patients and treatments are summarized in table 1. All patients were treated with a platinum based doublet of chemotherapy (CT). RT target volumes included the primary lung tumor and involved mediastinal lymphnodes as defined on pre-treatment contrast enhanced CT scan. Elective nodal irradiation was not performed. Acute/late toxicities were reported in accordance to 4.0 CTCAE scale. Clinical response was evaluated according to RECIST criteria.

      Results:
      At a median follow up of 10 months clinical response was evaluable in 69/71 patients obtaining a partial response in 35 of them, stable disease in 17, progressive disease in 17 patients. Twenty six patients experienced a local relapse within RT primary tumor volume, while 13 on nodal volume (5 patients both tumor and nodal relapse). 22 patients developed metastatic disease. One and 3-year OS was 62.3%(SE±6.2%) and 24,5%(SE±7.8%) respectively, while 1- and 3 year PFS was 45.1%(SE±6.9%) and 9,7%(SE±5.7%) respectively. At univariate analysis, tumor dimension (p<0,002) was the only prognostic factor statistically significant for OS. G1-G2 acute toxicity was observed in 45 patients: 36/62 in sequential CRT (3/36 developed also chronic toxicities) and 9/9 in concomitant CRT; most events were G1 oesophagitis (27 patients) and G1 cough (17 patients). No G3-4 event was reported.

      Conclusion:
      CRT is feasible in elderly patients; multidisciplinary evaluation is needed in order to reserve CRT to very fit patients.

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    P2.03a - Poster Session with Presenters Present (ID 464)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03a-017 - Chemotherapy-Induced Nausea and Vomiting (CINV) in Italian Lung Cancer Patients: Assessment by Physician, Nurse and Patient (ID 4903)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract
      • Slides

      Background:
      Despite therapeutic advances, CINV still represents a common side-effect of chemotherapy and often its perception is not equal between patients and healthcare professionals. Aims of this study were to evaluate the agreement degree among clinicians, patients and nurses about CINV and other relevant items, and to understand whether anxiety, as well as other demographical and treatment-related factors, could play a role in CINV development.

      Methods:
      A dedicated survey was designed in agreement with a psychologist: 11 aspects (anxiety, mood, weakness, appetite, nausea, vomiting, pain, somnolence, breath, general status, and trust in treatments) were investigated through Numerical Rating Scale in four consecutive evaluations (T0, T1, T2 and T3) during first-line chemotherapy. From August 2015 to February 2016, the survey was administered in 11 Oncologic Institutions to 188 stage III/IV lung cancer patients and to their oncologists and nurses. Clinician versus patient (CvP), nurse versus patient (NvP) and clinician versus nurse (CvN) agreements were estimated in relation with the investigated items, applying Weighted Cohen's kappa and the grid of Landis and Koch. A multivariate logistic model was applied to evaluate factors possibly influencing anticipatory CINV development as perceived by patients before initiating chemotherapy (T0). Generalized Equation Estimates (GEE) for repeated measures were used to evaluate factors possibly influencing CINV development overall at T1, T2 and T3.

      Results:
      The incidence of CINV as reported by patients varied from 40.3% at T0 to 71.3% at T3. Both CvP and NvP concordances on the investigated items were mainly moderate, slightly increasing over time and becoming substantial for some items, in particular when evaluating NvP concordances. Pre-chemotherapy anxiety in all its mild (Odds Ratio [OR]: 4.99; 95% Confidence Interval [CI]: 1.26 – 19.81), moderate (OR: 4.89; 95% CI: 1.29; 18.50) and severe (OR: 4.70; 95% CI: 1.10; 19.98) manifestations, as well as mild (OR: 10.02; 95% CI: 3.27; 30.64), moderate (OR: 11.23; 95% CI: 3.54; 35.67) and severe (OR: 12.86; 95% CI: 2.83; 58.48) anxiety experienced after chemotherapy start, exposed patients to a higher risk of anticipatory CINV and of acute/delayed CINV respectively, as confirmed by the multivariate logistic model at T0 and by GEE overtime.

      Conclusion:
      Even if clinical staff revealed to be aware and sensitive about patients status and perceptions, CINV still represents a problem among patients undergoing chemotherapy, with this study further confirming that particular attention should be given to anxiety due to its key role in CINV development.

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    P2.03b - Poster Session with Presenters Present (ID 465)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03b-063 - Molecular Profiling in Advanced Non-Small-Cell Lung Cancer: Preliminary Data of an Italian Observational Prospective Study (ID 4529)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract
      • Slides

      Background:
      Molecular profiling of advanced non-small-cell lung cancer (NSCLC) is recommended according to patients’ histological and clinical features. Despite the existence of national guidelines, routine care is still heterogeneous. Aim of this observational study was to obtain prospectively a clinical practice picture of molecular testing and therapeutic choices in advanced NSCLC patients.

      Methods:
      Newly diagnosed metastatic or recurrent NSCLC patients enrolled in 38 Italian centres, from November 2014 to November 2015, have been included in the study. Baseline information were collected about molecular profiling performed and therapies.

      Results:
      A total of 1787 patients were enrolled (64% males, 36% females; median age 67 years-old; 22% never smokers, 31% current smokers, 47% former smokers; 75% adenocarcinoma, and 73% with PS ECOG 0 or 1). The 73.9% of diagnosis was histological, while 26.1% was cytological. 1382 (77%) patients were tested for one or more molecular analysis during the history of disease, for a total of 3532 molecular tests. Only 405 patients did not receive any molecular test. 32.3% of patients presented a genetic alteration: EGFR mutation was reported in 17.8% of cases (319/1787), ALK translocation in 8.8% (82/926), KRAS mutation in 31.9% (154/482), MET amplifications in 15.8% (10/63), BRAF mutations in 3.7% (9/241), ROS1 translocation in 4% (11/269), HER2 mutation in 3.3% (3/89) of cases and FGFR alteration was found in 3 cases (only 15 tested). Considering patients younger than 45 years, never smokers and females, an EGFR mutation was detected in 25.4%, 43.5% and 30.6%, respectively. While 15.6%, 9.5% and 6.3% were ALK rearranged, respectively. For patients receiving an EGFR tyrosine-kinase inhibitor as first-line treatment, among those whose data are evaluable (79.2%), the median interval from diagnosis to first-line was 35 days. EGFR mutated patients received first-line erlotinib, gefitinib and afatinib in 9.4%, 39.1% and 33.8% of cases, respectively. At time of analysis, ALK-rearranged patients received an ALK inhibitor (crizotinib, alectinib or ceritinib) as first and/or second-line in 71.9% of cases. 29.3% of all patients received a maintenance therapy, mainly with pemetrexed (91.2% of cases).

      Conclusion:
      Routine molecular assessing is properly performed according to the national guidelines. A selection bias in including only those patients performing molecular tests, may explain the high proportion of patients with a molecular alteration. The low number of patients tested for ALK could be partially related to the impossibility to prescribe Crizotinib in first- line. In more than 70% of cases EGFR mutated patients received gefitinib or afatinib as first-line treatment.

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    P2.04 - Poster Session with Presenters Present (ID 466)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
    • Presentations: 1
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      P2.04-021 - Role of Adjuvant Radiotherapy and Prognostic Factor Analysis in Thymic Malignancies: A Retrospective Analysis of 129 Consecutive Patients (ID 5004)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract

      Background:
      To evaluate the impact of histological subtypes, stage and therapeutic approaches on outcomes of a retrospective consecutive series of patients (pts) treated in 2 different Radiation Oncology Italian Centers

      Methods:
      One-hundred twenty nine pts were treated between 1982 and 2012.Sixty-six pts were male,63female;mean age was 58 years.The series was reclassified according to WHO 2004 staging:42 pts had epithelial/ mixed thymoma(type A/AB),72pts had cortical/medullary/atypical thymoma(B1/B2/B3) and 15 thymic carcinoma(type C).All pts were also staged using Masaoka classification(MKc) resulting in 43pts in stage I,30 stage IIA,13 stage IIB,24 stage III and 19 stage IVA.Radical surgery(thymectomy +/- mediastinal nodes sampling)was performed in all pts,30 of whom had positive margins,while 80 were also submitted to adjuvant thoracic RT(ART)due to their final pathological stage and/or surgical margins status. All pts were evaluated for clinical outcomes(overall survival-OS,progression free survival-PFS and local control-LC) and secondary malignancies incidence.

      Results:
      After a median follow up of 9.6 years,at time of analysis 103 pts were alive with a 5- and 10 year OS of 90.1%(SE±2,7)and 81.7(SE±3.7) respectively and a PFS of 84.8(SE±3.2) and 77.3(SE±4.0). Finally,5- and 10-year LC were respectively 94,1% (SE±2,2) and 89.2%(SE±3.2).In terms of OS, MKc advanced stage was found as a negative prognostic factors(p<0.0001) such as Performance Status (PS) with a p<0.0001, Tstage (p< 0,0001), aggressive histology (p=0.0001) and surgical positive margins (p< 0,0001) at univariate analysis. Regarding PFS,advanced MK stage,T stage, positive surgical margins and aggressive histology were confirmed as negative prognostic factor (p< 0,0001, p<0,0001, p<0,01, p<0,0001). Using Cox regression analysis ART seems to have a protective effect if stratified by MKc clinical stage (p< 0,03) just in terms of OS.Concerning local recurrence, a significant difference was found by T stage(p<0,001), surgical margins (p<0,03) and WHO classification(p=0.0001). At multivariate analysis PS, Surgical Margins and histology were statistically significant (p<0.0001, p<0.002 and p<0,001 respectively) with a negative impact on OS for PS>1, positive margins and thymic carcinoma differentiation. At the same analysis only thymic carcinoma differentiation influenced PFS when compared with PS, T and MKc stage, surgical margins and ART. During follow up secondary/methacronous neoplasms were diagnosed in 29 pts (22.5%)

      Conclusion:
      PS, surgical margins and WHO classification seems to be the most important indicators for long term survival. ART showed positive impact in terms of OS in advanced MKc clinical stage (Stage II-III) pts.

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    P2.05 - Poster Session with Presenters Present (ID 463)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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      P2.05-019 - Stereotactic Body Radiotherapy (SBRT) for Central Lung Tumors: The Experience of Florence University-Careggi Hospital Radiotherapy (ID 6047)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract
      • Slides

      Background:
      Stereotactic body radiotherapy (SBRT) for central lung tumors, defined as tumor within 2 cm or touching the zone of the proximal bronchial tree or tumors immediately adjacent to the mediastinal or pericardial pleura (Adebahr S. et al. BJR 2015) is debated because of toxicities to organs at risk. No evidences from phase III trial are available.

      Methods:
      From 2010 to 2015, 45 central lesions in 40 pts were treated with SBRT. 14 lesions were primary lung cancer (PLC), 31 were lymphoadenopathies (LAP). PLC were treated with volumetric arc Therapy (VMAT) in 9 cases and 5 with Cyberknife®. LAP were treated with VMAT in 12 cases, with IMRT (step and shoot) in 10 and with Cyberknife® in 9 cases. Prescribed doses varied between 18 and 60 Gy (1-8 fractions) with median BED of 65 Gy (37,5-105 Gy). We evaluated Overall Survival (OS), Progression Free Survival (PFS) and Disease Specific Survival (DSS) using Kaplan-Meier method and treatment related toxicities using CTCAE version 4.0.

      Results:
      Median age was 62 years (48-86), 26 male and 14 female. PS was 0 in 9 pts, 1 in 21, 2 in 10 pts. Histology was available in all series and consisted of primary NSCLC (32 adenocarcinoma, 12 squamous cell carcinomas, 1 neuroendocrine tumour). 41 PLC were less than 2 cm from proximal bronchial tree, 4 PLC were immediately adjacent to the mediastinal or pericardial pleura. Tumor diameter was 10 to 60 mm with a median of 31 mm. Median follow up was 14,5 months. OS and DSS were 86.5% at 1 year, 55.6% at 2 years, and 49,4% at 3 years. PFS was 48,6% at 1 year, 24,1% at 2 years, and 12% at 3 years. 35 pts showed no acute toxicity; in 5 pts we recorded grade 1-2 esophagitis, in 2 pts grade 2 cough, in 2 pts, grade 1 asthenia. Chronic toxicity was present in 2 pts as grade 2 esophagitis.

      Conclusion:
      SBRT is confirmed to be a safe and effective strategy for central lung tumors. The majority of patients in the first part of our series was treated with low doses compared to current doses. Nevertheless 23 patients had clinical benefit from the treatment without life-threatening toxicities. Further studies are needed to establish the efficacy and safety of SBRT in central lung lesions.

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    P3.03 - Poster Session with Presenters Present (ID 473)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
    • Presentations: 1
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      P3.03-029 - EPP Followed by Hemithoracic IMRT - A Multicenter Study on Behalf of the Italian Association for Radiation Oncology Lung Cancer Study Group (ID 4684)

      14:30 - 14:30  |  Author(s): V. Scotti

      • Abstract

      Background:
      The treatment of MPM is not well defined. Although it has been shown that extrapleural pneumonectomy (EPP) followed by hemithoracic RT may improve survival in early-stage disease, this therapeutic approach is declining. This might be due to the recent publication of a randomized trial (SAKK 17/04) which assessed the effect of high-dose hemithoracic RT after EPP. The study reported poor outcomes and the results did not support the use of hemithoracic RT. The major weakness of the SAKK study is the heterogeneity of the radiation techniques and schedules, and that only 12 patients received IMRT. On this background we conducted the present study to assess the outcome of MPM patients treated with EPP and adjuvant IMRT.

      Methods:
      This is a retrospective multicenter study, including 5 academic centers in Italy. Seventy patients treated with EPP and adjuvant IMRT were enrolled. The majority (95%) of patients had an epithelioid histology. Sixty patients were affected by stage III-IVA disease. Fifty-four (77%) patients received neoadjuvant/adjuvant chemotherapy. The IMRT dose ranged between 50-60 Gy in 25-27 fractions. Radiation was interrupted in two patients due to systemic progression of disease.

      Results:
      Median follow-up was 14 months (range, 0-83 months). Rates of local control, loco-regional control, distant-metastases free survival (DMFS) and overall survival (OS) at 2 years were 73%, 63%, 39%, and 63%, respectively. Patients with stage I-II had a better 2-year OS and DMFS than those with advanced disease: 60% vs. 40% (p=0.09), and 78% vs. 32% (p=0.03), respectively. Three fatal pneumonitis were reported. Other major toxicities were: Grade 2-3 pneumonitis in 2 cases, 1 bronchial fistula, and 1 Grade 3 esophagitis.

      Conclusion:
      This multicenter study showed that EPP followed by hemithoracic IMRT is associated with high rate of local and loco-regional control, and showed that long-term survival can be achieved, even if some patients may experienced life-threatening lung toxicity. Distant metastasis represent the predominant pattern of failure.