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A. Baranzelli



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    MA10 - Facing the Real World: New Staging System and Response Evaluation in Immunotherapy (ID 393)

    • Event: WCLC 2016
    • Type: Mini Oral Session
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      MA10.10 - [18F]-FDG-PET/CT Early Response to Nivolumab in NSCLC (ID 6211)

      15:26 - 15:32  |  Author(s): A. Baranzelli

      • Abstract
      • Presentation
      • Slides

      Background:
      Nivolumab is approved for treatment of squamous and non-squamous advanced NSCLC. Since nivolumab restores antitumor immunity, it is not clear whether 18F-FDG-PET/CT is able to distinguish response from tumor progression. We evaluated early metabolic patterns of response to nivolumab in advanced NSCLC patients.

      Methods:
      We retrospectively reviewed PET/CT scans and paired CT scans from 22 patients with advanced NSCLC who received nivolumab 3mg/kg every 2 weeks and performed PET/CT before and after 4 infusions of nivulomab. Total Lesion Glycolysis (TLG) and Metabolic Tumor Volume (MTV) of every lesion up to 5 per patient were measured on baseline and follow-up PET/CT. Percentage changes in MTV (ΔMTV) and TLG (ΔTLG) between the two PET/CT were calculated. Patients were classified into responders (nivolumab for >6 months), non responders (nivolumab ≤6 months) or having pseudo-progression (PP, nivolumab and clinical benefit >6 months despite initial progressive disease according to RECIST criteria)

      Results:
      Among 22 patients, 6 (27%) were responders, 15 (68%) were non-responders and 1 (4.5%) had PP. Baseline MTV and TLG were significantly lower in responders than in non-responders (medians 27 vs. 63 mL, p=0.03 and 124 vs. 254 g, p=0.04, respectively). After 4 infusions of nivolumab, metabolic parameters were significantly lower in responders than in non-responders (median MTV : 2 vs. 148 mL, p=0.001 and median TLG : 6 vs. 835 g, p=0.002). Mean ΔMTV and ΔTLG were both -88% in responders, and +236% and +312% respectively in non-responders, which was significantly different (p=0.0005). The only patient with PP had lower ΔMTV (+11%) and ΔTLG (+41%) than non-responders patients.

      Conclusion:
      In NSCLC, objective response and disease progression upon nivolumab usually translate into early and clear-cut patterns of change in PET/CT. Early PET/CT may help to distinguish progression from pseudo-progression.

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    P1.03 - Poster Session with Presenters Present (ID 455)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiology/Staging/Screening
    • Presentations: 1
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      P1.03-018 - FDG-PET/CT in Patients with EGFR-Mutated NSCLC Treated with TKI. Can We Identify Early Lesions at Higher Risk of Progression? (ID 6159)

      14:30 - 14:30  |  Author(s): A. Baranzelli

      • Abstract

      Background:
      EGFR TKIs in EGFR-mutated NSCLC patients yield heterogeneous progression-free survivals ranging from <3 months to >3 years. Early identification of lesions that are more likely to progress may provide rationale for aggressive treatment of these lesions. We questioned whether FDG-PET/CT could identify early lesions with higher risk of progression.

      Methods:
      Eighty-nine lesions from 13 caucasian EGFR-mutated NSCLC patients treated with TKI were analyzed. Date of progression for each lesion was collected. SUVmax, Metabolic Tumor Volume (MTV), Total Lesion Glycolysis (TLG) were measured on baseline and early follow-up PET/CT performed 2-3 months later. Variations between the 2 PET/CT (ΔSUVmax, ΔMTV, ΔTLG) were calculated. Medians were used as cut-off values for statistical analysis. Risk of progression was analyzed according to PET/CT parameters and Odds Ratios (OR) were calculated.

      Results:
      The best metabolic predictors of progression were high SUVmax (>0, i.e. incomplete visual response, OR =9.6, p<0.001), high MTV (>0, OR=8.3, p<0.001) and high TLG (>0, OR=9.6, p<0.001) on the early follow-up PET/CT. ΔSUVmax<97.6% (OR=3.9, p=0.02) was also associated with early progression, whereas ΔMTV (p=0.23) and ΔTLG (p=0.17) were not.

      Conclusion:
      Lesions with incomplete visual response on early follow-up FDG-PET/CT upon EGFR TKIs in EGFR-mutated NSCLC show significantly higher risk of progression. Aggressive treatment of these lesions with residual metabolic activity may be further evaluated.

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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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      P1.06-040 - Home-Based Pulmonary Rehabilitation in Advanced Non Small Cell Lung Cancer Patients Treated by Oral Targeted Therapy: A Feasibility Study (ID 4453)

      14:30 - 14:30  |  Author(s): A. Baranzelli

      • Abstract
      • Slides

      Background:
      Pulmonary rehabilitation (PR) is valuable in the peri-operative setting of non small cell lung cancer (NSCLC) patients, but not established for stage IIIB-IV disease. Previously, we showed that home-based PR is feasible and may significantly improve quality of life (QoL) and functional status of NSCLC patients treated by chemotherapy (submitted). The goal of this study was to assess the feasibility and value of home-based PR in advanced NSCLC patients treated by oral targeted therapies.

      Methods:
      Advanced NSCLC patients with oral targeted therapy were recruited in a prospective study in 2015-2016 in Lille University Hospital, France. After written informed consent, they benefited from 8 weeks home-based PR including functional exercises, psychological and nutrition support, therapeutic education. Exclusion criteria were cardiovascular contraindication to PR, symptomatic brain metastasis, bone metastasis with high fracture risk, or severe cognitive disorder. Main endpoints were adherence, inclusion rate, and cause of refusal. Secondary endpoints were PR benefits assessed by QoL scales (EORTC QLQ C 30, FACT-L, HAD); functional capacity: 6min walk test, 6 min stepper test, spirometry, respiratory muscle strength; and global condition: nutrition, treatment tolerance. This study was approved by local Ethical Committee

      Results:
      Among 36 screened patients, the adhesion rate was 55.6% with 20 patients joining the study. Other patients refused mostly because (a) of “lack of interest for PR and they don’t want to be disturbed” (40% of cases), or (b) they considered “their physical activity already sufficient” (12%), or (c) “family constraints” (12%). Only 15 patients (41.6%) started PR (3 early deaths, 1 exclusion for intraventricular thrombosis, 1 consent withdrawal). No serious adverse event was reported but only grade 1 asthenia or musculoskeletal pain. Significant increases of FACT-L score from 84.7 to 100.2 (p=0.02) and 6 min stepper test from 140 to 195.7 steps (p=0.01) were found after PR, and preservation of patients’ autonomy reflected by stability of 6WT data. Most of other parameters exhibited a positive but not significant trend, likely due to the limited number of participants.

      Conclusion:
      Home-based PR is feasible and well-tolerated in patients with advanced NSCLC treated by oral targeted therapies. Significant improvements were obtained with PR based on 6ST and QoL FACT-L data. Moreover, PR was highly appreciated by patients, their relatives, and all medical teams raising our will to be able to propose PR to all our stage III-IV NSCLC patients. Currently, this study is still ongoing and multicentric, aiming at recruiting 50 extra patients.

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