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D. Galetta



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    MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Advanced NSCLC
    • Presentations: 1
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      MA14.06 - Nivolumab in Never Smoker Patients with Advanced Squamous NSCLC: Results from the Italian Expanded Access Programme (EAP) (ID 4765)

      16:00 - 17:30  |  Author(s): D. Galetta

      • Abstract
      • Presentation
      • Slides

      Background:
      Nivolumab is the first checkpoint inhibitor approved for the treatment of Sq-NSCLC to show a survival benefit vs the standard of care docetaxel in the randomised, phase III, CheckMate 017 study. In the nivolumab development program, a greater clinical benefit was shown in current and former smokers than in never smokers. Nevertheless, no data are available in this respect from a real world setting. For this reason, we decided to use the data collected in the EAP in order to assess the effectiveness and tolerability of nivolumab treatment in the never smoker patient population.

      Methods:
      Nivolumab was provided upon physician request for patients aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events.

      Results:
      Of 372 patients with Sq-NSCLC participating in the EAP in Italy, 38 (10.2%) were never smokers, a proportion very similar to the one observed in Checkmate 017 (10%). With a median number of doses of 8 (range, 1–22) and a median follow-up of 5.6 months, the disease control rate in this group was 50%, including 9 patients with a partial response and 10 with stable disease. Eight patients were treated beyond RECIST-defined progression, with 4 of them achieving disease control. As of April 2016, median progression-free survival and overall survival were 3.5 months and not reached, respectively. 17 patients (44.7%) discontinued treatment for any reason except toxicity and 5 (13.1%) discontinued due to AE.

      Conclusion:
      These preliminary results, although obtained from a small sample size, suggest that nivolumab is effective and well tolerated in a never smoker group of patients with advanced Sq-NCLCS in the real life and warrant further investigation in this area.

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    P1.02 - Poster Session with Presenters Present (ID 454)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Biology/Pathology
    • Presentations: 1
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      P1.02-045 - Discordance (FISH+, IHC-) between FISH and IHC Analysis of ALK Status in Advanced Non Small Cell Lung Cancer (NSCLC): A Unexpected Issue in 7 Cases (ID 5757)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract
      • Slides

      Background:
      Anaplastic lymphoma kinase (ALK ) rearrangement represents a landmark in the targeted therapy of NSCLC. Several reports showed that IHC is sensitive and specific to detect ALK protein expression, possibly alternative to ALK FISH assay. In this study the concordance between the ALK status by FISH and IHC assay has been determined in a series of 95 advanced NSCLCs; discordant cases were evaluated on the basis of the percentage and the rearrangement pattern of ALK.

      Methods:
      95 lung NSCLC specimens were tested for ALK rearrangements by IHC assay (ALK D5F3 antibody Ventana,CE-IVD system) and by fluorescence in situ hybridization (FISH). Clinical characteristic and response to crizotinib were reviewed.

      Results:
      Seven cases (7.3%) showed discordant results with ALK FISH-positive and IHC negative. Among these cases the mean number of FISH positive rearranged nuclei was 40.2% (range 20-54%). All cases showed coexistent split signals pattern positivity with mean percentage 19.1% (range 10-32%.), 5' deletions pattern positivity with mean percentage 21.7% (range 12-34%) and one case also had gene amplifications pattern positivity with percentage of 64%. The polysomy was observed in all cases with mean percentage of 45.7% (range of 16-72%). Five patients with discordant ALK FISH and IHC results received crizotinib; of them, four progressed and one has stable disease.

      Conclusion:
      In most of discordant cases, a coexistent complex pattern of rearrangements (deleted, invertited and amplified/polysomic patterns) of ALK positive cells in FISH analysis was observed; these complex rearranged cases were not detectable by IHC, probably due to the lack of protein expression. Considering that crizotinib inhibits the ALK protein and not specifically ALK rearrangements, it could be speculated that NSCLCs without IHC ALK expression could be not sensitive to crizotinib. The ALK FISH+/IHC negative discordant group showed a loweer percentage of nuclei positive for ALK rearrangement (19.1% in split signals and 21.7% in 5' deletions) as compared with 64% of gene amplification in one case and with polysomy (45.7%) observed in all cases. These preliminary data highlight the role of IHC analysis and of the percentage of the genetic pattern of ALK rearranged cells in FISH analysis to select patients for anti ALK treatment. Further investigation is suggested about the correlation of complex mutational findings and clinical outcome.

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    P1.06 - Poster Session with Presenters Present (ID 458)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.06-046 - Can We Better Manage Advanced NSCLC in the Elderly with the New Therapeutic Agents? Preliminary Analysis of a Real-Life Multicenter Study (ID 5814)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract
      • Slides

      Background:
      Systemic treatment of NSCLC has profoundly changed over the past years with novel therapeutic strategies recently implemented in clinical practice. Benefit of these novel agents in elderly patients (pts) is uncertain, given the paucity of prospective data in this population. Moreover, elderly pts are often undertreated, due to comorbidities and toxicity concerns. Therefore, we aimed to evaluate the access, safety and outcome with novel therapeutic agents in pts ≥ 70 years (yrs).

      Methods:
      We planned an observational study to retrospectively evaluate consecutive elderly patients (≥ 70 yrs) with metastatic NSCLC treated at 9 Italian Centers between January 2014 and December 2015. Data collected include clinical and pathological characteristics, treatment types, safety and outcome report.

      Results:
      220 patients with stage IV NSCLC were included in this preliminary analysis (53% IVa, 47% IVb). Median age was 74,5 (range 70-85) and 69% were male. 15% of pts aged 80 years or older. ECOG PS was 0, 1, 2 in 37%, 51% and 12% of pts, respectively. According to comprehensive geriatric assessment, 59% of pts were fit, 28% vulnerable and 13% frail. Histology was 23% squamous cell carcinoma, 72% non-squamous cell carcinoma and 5% NOS. EGFR mutation was diagnosed in 24% of cases; 1,4% and 1% of pts had ALK and ROS-1 translocations, respectively. 90% of pts received a systemic therapy: 48% a platinum doublet chemotherapy (CHT), 27% a mono-CHT, 25% an EGFR tyrosine kinase inhibitor (TKI). Only 1% of pts were treated with antiangiogenic drugs. Immunotherapy (IT) was administered in 16% of all treated pts. 7% of pts received only BSC. Second- and third-line treatment were given to 44% and 8% of pts, respectively. 51% of pts who received second line treatment and 60% of pts treated with a third line therapy had a novel therapeutic agent (II line TKI 20%, IT 31%; III line TKI 33%, IT 27%). 31% of pts were included in clinical trials. A dose reduction was reported in 41% of therapies and the discontinuation rate was 9%. Survival data are not mature at this time.

      Conclusion:
      Our data, albeit preliminary, suggest an evolution in the management of NSCLC in the elderly. The interesting activity and the good safety profile encourage the use of novel agents also in this setting of NSCLC. Adequate selection of elderly pts and personalized approach are still matters of debate. Use of adapted schedule and dose reduction could warrant a good compromise between safety and efficacy.

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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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      P2.02-061 - Role of MMP-2-1306C/T in Onset of Hematological Toxicity in Lung Cancer Patients Receiving First Line Platinum Based Therapy (ID 4589)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract
      • Slides

      Background:
      Lung cancer is the most common and lethal cancer worldwide. Totally, about 85% of lung cancer cases could be classified as Non-Small Cell Lung Cancer (NSCLC) and most are diagnosed at advanced stage. Matrix Metalloproteinases are a family of zinc endopeptidases with proteolytic activity against the extracellular matrix components playing a key role in the process of tumor growth/metastasis. Genetic variants in matrix metalloproteinase-2 (MMP-2) gene may influence the biological function of this enzyme changing his role in carcinogenesis, hematopoietic recovery from chemotherapy toxicity and cancer progression. This study has investigated the association of single nucleotide polymorphism (-1306C/T) in the MMP-2 promoter sequence, and the link with a strong hematological toxicity in lung cancer patients receiving first-line, platinum-based chemotherapy.

      Methods:
      Forthy-seven patients (36 men and 9 women) with IIIA/IV NSCLC stage were enrolled; information about hematologic toxicity (thrombocytopenia, neutropenia, anemia), gastrointestinal toxicity (nausea/vomiting), and smoking habits were collected through the clinical charts. Genotyping was performed using direct DNA sequencing.

      Results:
      25/47 patients (53%) had the CC genotype, 8/47 (17%) patients had CT genotype and 14/47 (30%) had TT genotype. A grade 2-3 anemia associated to grade 2-3 thrombocytopenia and/or G2-3 neutropenia was observed in 12/22 CC patients compared with only 4/14 TT patients and 3/8 CT patients (p<0.001), after platinum-based therapy; patients with genotype TT showed a better response to treatment as compared with those carrying CT or CC genotype. Besides, this study showed that heavy smokers had a higher allelic frequency CC and this could indicate a possible correlation between genetic polymorphism, smoking status, and clinical outcome.

      Conclusion:
      These preliminary findings suggest that MMP-2 promoter polymorphism could be correlated with therapeutic response, in particular, the patients with TT genotype seem more protected from the hematological toxicity due to chemotherapy.

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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 - 15:45  |  Author(s): D. Galetta

      • 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 - 15:45  |  Author(s): D. Galetta

      • 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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    P3.02c - Poster Session with Presenters Present (ID 472)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 3
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      P3.02c-085 - Neutrophil/Lymphocyte  Ratio in Advanced Non-Small Cell Lung Cancer: Correlation with Prognosis and  Response to Anti-PD1 Therapy (ID 5772)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract

      Background:
      The Neutrophil/Lymphocyte ratio (NLR), calculated from peripheral blood tests, represents an independent and easily available prognostic biomarker in numerous cancers, including lung cancer. This study aimed to investigate the prognostic role and the correlation with the therapeutical response of baseline NLR in patients with advanced Non-small cell lung cancer (a-NSCLC) submitted to anti-PD1 therapy.

      Methods:
      Nivolumab (3 mg/kg intravenously by rapid injection every 14 days) was administered to 47 patients (6 women , 41 men) with a-NSCLC. The mean age of patients was 47 years (range 40-83, SD 9.07), while the histotype was: 28 adenocarcinoma, 18 squamous, 1 adenosquamous. 68% of patients were current/former smokers. 25/47 patients (53%) received more than 2 previous lines of therapy. The baseline absolute neutrophil and lymphocytes count and the Neutrophil /Lymphocytes ratio were recorded. Time to progression (TTP) was statistically evaluated by Kaplan-Meyer method; univariate analysis was conducted by Cox regression method .

      Results:
      A median of 7.8 (range 1-20) cycles of therapy was administered . A better TTP (3 months vs 1,5 months; Cox regression rate (Hazard Ratio ) 1.000118, p= 0.003 (CI 1.000041-1.000195) was observed in patients with a lower absolute baseline Neutrophil count (Less than 7500); conversely, a higher absolute Lymphocyte baseline count was linked with a longer TTP (3.7 months vs 1.8; Cox regression rate (HR) 0.9994947, p= 0.055 (CI 0.9989785-1.000011). NLR was correlated with Time to Progression (TTP), that was longer in patients with NLR less than 4 (3.71 months vs 1.87 ; Cox regression rate (HR) 1.144335, p= 0.001 (CI 1.068327-1.22575) (Figure) Figure 1



      Conclusion:
      These preliminary findings highlight the correlation between the NLR and clinical outcome of a-NSCLC patients treated with anti-PD1. Further investigation in this setting is warranted, both to confirm the prognostic role and to investigate if NLR and the microenviromental inflammatory alterations could predict the response to immune-checkpoint inhibitors.

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      P3.02c-092 - Nivolumab in Multi-Treated Patients with Advanced Sq-NSCLC: Data from the Italian Cohort of Expanded Access Programme (EAP) (ID 4792)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract
      • Slides

      Background:
      The prognosis of patients with advanced Sq-NSCLC worsens with the increase of the number of treatment linesand no effective therapeutic options were available for those refractory patients so far.Nivolumab demonstrated significant benefits against the SoC docetaxel in 2[nd] line treatment of advanced sq-NSCLC. In the real life experience of the EAP we could assess the clinical activity and tolerability of nivolumab not only in patients treated in 2[nd] line but also in patients who had received at least 2 lines of therapy prior than nivolumab.

      Methods:
      Nivolumab was provided upon physician request for patients aged ≥18 years who had relapsed after a minimum of 1 prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (version 4.03).

      Results:
      210 patients, corresponding to 56.4% of the entire Italian cohort (n=372), received nivolumab after at least 2 prior lines of chemotherapy in the EAP: 120 (57.1%), 69 (32.9%) and 21 (10%) had received 2, 3 and > 3 prior lines of therapy, respectively. Response was evaluable in 204 patients: with a median number of 8 doses (range, 1–24) and a median follow-up of 5.1 months, the disease control rate was 47%, with 3 patients (1%) in complete response, 30 patients (14%) in partial response and 66 patients (32%) in stable disease. 36 patients (17%) were treated beyond RECIST-defined progression, with 11 of them achieving disease control. As of April 2016, median progression-free survival and median overall survival were respectively 3.8 and 11.2 months. 117/210 patients (55.7%) discontinued treatment for any reason except toxicity; 11 out of 210 (5.2%) discontinued due to AEs.

      Conclusion:
      These findings showed that nivolumab provided clinical activity with a manageable safety profile in patients with advanced, refractory Sq-NSCLC. These data suggest that nivolumab can be a treatment option for patients failing more than one line of chemotherapy.

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      P3.02c-095 - Italian Nivolumab Expanded Access Programme: Efficacy and Safety Data in Squamous Non Small Cell Lung Cancer Patients (ID 5159)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract

      Background:
      Nivolumab monotherapy has shown survival benefit in patients (pts) with melanoma, lung cancer, renal cell carcinoma and head and neck cancer. The experience of pts and physicians in routine clinical practice is often different from those in a controlled clinical trial setting. Here, we report efficacy and safety of nivolumab monotherapy in pts with squamous non small cell lung cancer (Sq-NCSLC) treated in the nivolumab Expanded Access Programme in Italy.

      Methods:
      Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg wass administered intravenously every 2 weeks to a maximum of 24 months. Pts included in the analysis had received at least 1 dose of nivolumab and were monitored for adverse events (AE) using Common Terminology Criteria for Adverse Events.

      Results:
      In total, 371 Italian pts participated in the EAP across 96 centres and 363 patients were evaluable for response. With a median follow-up of 5.2 months (range 0-12.9) and a median of 7 doses, the best overall response rate (BORR) was 18%, with 3 complete responses (CR) and 62 partial responses (PR), and the disease control rate (DCR) was 47%. DCR was comparable among pts regardless previous lines of therapy, brain metastasis, age and smoking habits. A non-conventional benefit was observed in 23 (17 SD and 6 PR) out of 66 pts treated beyond RECIST defined progression. As of April 2016, median progression-free survival and median overall survival were 3.9 (95% CI: 3.2-4.6) and 9.1 (95% CI: 6.7-11.5) months, respectively. Regarding the safety profile, 267 out of 371 pts (72%) had at least one AE of any grade, considered to be drug-related in 106 pts (29%). Grade 3/4 AE were reported in 66 pts and considered to be drug-related in 20 pts (5%). AE were generally manageable following the specific guidelines.

      Conclusion:
      To date, this is the largest clinical experience with nivolumab in a real-world setting. These preliminary EAP data seems to confirm the efficacy and safety data of nivolumab from registrational trials, supporting its use in current clinical practice for pre-treated pts with Sq-NCSLC.

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    P3.05 - Poster Session with Presenters Present (ID 475)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Palliative Care/Ethics
    • Presentations: 1
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      P3.05-004 - Psycho-Social Function and Caregiver's Burden in Patients with Advanced Lung Cancer (ID 4469)

      14:30 - 15:45  |  Author(s): D. Galetta

      • Abstract
      • Slides

      Background:
      Patients with advanced lung cancer (a-LC) are often characterized by high tumor burden and comorbidities also correlated to anxiety and depression. The Authors report the preliminary results of a pilot experience on early simultaneous interdisciplinary palliative approach in a-LC patients, referring to the Thoracic Oncology outpatient department of a Clinical Cancer Center. The first aim of the study was to evaluate the quality of life and health status of these patients. Secondly, the caregiver’s burden of care has been investigated.

      Methods:
      32 patients with a-LC (mean age 65 years; Standard Deviation (SD)= 8,3) were enrolled. Psychological distress and health status were assessed by Hospital Anxiety and Depression Scale (HADS), and Short Form 36 Health Survey (SF-36). 23 caregivers (mean age 57 years; SD= 14) compiled the Caregiver Burden Inventory (CBI) to evaluate their burden of care.

      Results:
      55% of patients showed higher score in the total scale of anxiety and depression. 35% of caregivers reported higher level of burden. Among caregivers, women reported higher levels of feelings of fatigue (Physical Burden) as compared to men (F= 4,45, p = 0.05) that reported higher levels of Emotional Burden (F= 7,55, p <0.05); the patient’s sons reported higher scores of Emotional Burden with respect to partners (F= 4,75, p <0.05). Finally, younger caregivers showed higher scores about the Social (F= 10,73, p <0.01) and Emotional Burden (F= 26,6, p <0.01). The correlations among the questionnaires are shown in table 1.

      Conclusion:
      In our sample of a-LC patients, psychological distress was correlated with general quality of life. The highest burden reported by caregivers was linked to the time dedicated to the assistance and to the feeling of fatigue. Our findings suggest to provide psychological support to caregivers, in particular for women to achieve a private and personal space, and for sons to the emotional management.Figure 1



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