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M. Ippolito



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    P3.06 - Poster Session 3 - Prognostic and Predictive Biomarkers (ID 178)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Biology
    • Presentations: 1
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      P3.06-036 - Prospective correlative study of FDG-PET SUV and proteomic profile (VeriStrat) of Non Small Cell Lung Cancer (NSCLC) patients treated with erlotinib (ID 2693)

      09:30 - 09:30  |  Author(s): M. Ippolito

      • Abstract

      Background
      VeriStrat (VS) is a multivariate protein serum test that classifies Non Small Cell Lung Cancer (NSCLC) patients in 2 categories VS Good or VS Poor according to the overall survival (OS) of patients treated with EGFR-TKIs. Recently, the prospective Phase III PROSE study showed that the VS algorithm is predictive of differential OS benefit for erlotinib (E) vs second line standard chemotherapy (CT): VS Poor classified patients had worse OS on E compared to CT, while there was no significant difference between treatments outcome in the VSG group. Aim of the current study was to evaluate if baseline Standardized Uptake Value (SUV) of FDG-PET may help to optimize treatment choice between E or CT IN VS Good classified pts.

      Methods
      Plasma samples were collected before the beginning of E from metastatic NSCLC patients. Acquired spectra were classified according to the VS algorithm. The FDG-PET was performed tha day before the beginning of E. Survival curves were estimated using the Kaplan-Meier method.

      Results
      Thirty eight NSCLC patients on E therapy with the following characteristics were analyzed: median age 62 years old, 63% were males, 53% had adenocarcinoma histology, response rate was 26%, median OS 10 mos and TTP 3.4 mos. Twenty-six (68%) were classified as VS Good, 12 (32%) as Poor. TTP and OS for VS Good and Poor were 4.1 vs 2.1 mos (HR 0.86, log-rank p=0.6) and 11.1 vs 4.1 mos (HR 0.45,log-rank p=0.02), respectively. All VS Poor classified patients had SUV ≥ 7 and had the worst TTP and OS; VS Good classified patients with baseline SUV level ≥ 7 had worse OS (10 mos) and worse TTP (2.1 mos) compared to those who were VS Good and had SUV<7 (OS 16 mos) (TTP 13.8 mos).

      Conclusion
      The study confirmed that VS Poor classified patients had significantly shorter OS than those classified as VS Good. Patients with VS Good profile and with baseline FDG-PET SUVs levels <7 may benefit more from EGFR-TKIs than VS Good patients with higher FDG-PET SUV, suggesting that FDG-PET analysis may be a clinically useful tool for EGFR-TKIs therapy selection.

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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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      P3.19-019 - Evaluation of Erlotinib treatment response in non-small cell lung cancer using EORTC metabolic criteria, PERCIST and anatomic criteria RECIST (ID 3328)

      09:30 - 09:30  |  Author(s): M. Ippolito

      • Abstract

      Background
      PET for early prediction of tumor response to Erlotinib in patients with advanced non small cell lung cancer NSCLC has been evaluated. The aim of this prospective study was to compare the early metabolic treatment response using European Organization for Research and Treatment of Cancer (EORTC) 1999 recommendations, PET Response Criteria in Solid Tumors (PERCIST), and the standard treatment response using Response Evaluation Criteria in Solid Tumors (RECIST).

      Methods
      PET was performed before treatment and after 45 days of receiving Erlotinib 150 mgrs daily in advanced NSCLC pts. The hottest lesion in each patient was evaluated according to the EORTC 1999 recommendations, PERCIST and RECIST to assess metabolic and anatomic response. Response classifications were compared statistically using Wilcoxon signed-rank test. Overall survival (OS) and Progression-Free Survival (PFS) time were calculated by the Kaplan-Meier test.

      Results
      14 patients (10 men and 4 women, mean age: 64.1±12.0 years, range 38 to 79 years) were evaluated. Anatomic responses according to RECIST were as follows: 4 Partial Response (PR) and 10 Progressive Disease (PD). Metabolic responses according to EORTC criteria were 5 Partial Metabolic Response (PMR), 5 Stable Metabolic Disease (SMD), and 4 Progressive Metabolic Comparisons of EORTC and RECIST assessment with PERCIST were as follows:

      PERCIST
      RECIST PMR SMD PMD Total
      PR 4 0 0 4
      SD 0 0 0 0
      PD 0 6 4 10
      Total 4 6 4 14
      EORTC
      PMR 4 1 0 5
      SMD 0 5 0 5
      PMD 0 0 4 4
      Total 4 6 4 14
      There was a significant difference in the results of response classification between metabolic classifications and RECIST (p<0.04). RECIST and PERCIST (Responders vs. Non-responders) were significant factors associated with DFS ( HR =4.070; 95% CI, 1.383-11.972; p=0.002 for RECIST and HR =0.245; 95% CI, 0.0835-0.722; p=0.001 for PERCIST) and OS ( HR =2.620; 95% CI, 0.8806-7.795; p<0.046 for RECIST and HR =0.3817; 95% CI, 0.1283-1.1356; p=0.046 for PERCIST). EORTC criteria was a significant prognostic factor for predicting DFS ( HR = 0.319; 95% CI, 0.061-1.667; p=0.028) but not for OS (p=0.65).

      Conclusion
      Metabolic and anatomic response were different in NSCLC pts treated with Erlotinib. PERCIST can be considered an appropriate metabolic evaluation method of therapeutic efficacy to discriminate responders from non responders. Mature results will be presented.