Author of

• 11692

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  P2.10 - Poster Session 2 - Chemotherapy (ID 207)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Medical Oncology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/29/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 11739

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    P2.10-047 - The three-drugs regimen CPBev (Cis-platinum, Pemetrexed and Bevacizumab) is very active when used as first-line therapy for locally advanced or metastatic adenocarcinoma of the lung: final results of a phase III trial. (ID 3077)

    09:30 - 09:30  |  Author(s): F. Latteri
    • Abstract

    Background
    During the past seven years paradigms of advanced lung cancer therapy dramatically changed; Bevacizumab and Pemetrexed, when administered separately in association with platinum salts, demonstrated to improve survival in patients with non-squamous histologies. In the aim to investigate activity and safety of a three-drugs regimen containing both these agents plus cis-platinum, we conducted a multi-institutional phase II trial.

    Methods
    Eligible criteria were: chemo-naive patients with proven histology of non-squamous non-small celle lung cancer, PS-ECOG-WHO equal or lesser than 2, adequate hematological, liver and renal functions, no previous history of hemoptysis, stage III/B or IV without brain metastases, at least one measurable lesion, no uncontrolled hypertension or other severe comorbidities, no anamnestic episodes of venous thromboembolism. We adopt a two-stage of Simon model as statistical design of the study; the main end-point was overall response rate. No maintenance therapy was allowed.

    Results
    Thirty-two patients were enrolled; their main characteristics were: male/female: 20/12, median age (years): 59, ECOG-WHO PS 0/1: 21/11. We administered 183 cycles of CPBev: main grade 3 adverse events were neutropenia (28%), emesis (19%), asthenia (9%), and hypertension (9%). In terms of overall response rate we registered 20/32 (62.5%) partial responses, 8/32 (25%) stable diseases and 4/32 (12.5%) progressive diseases, with a clinical benefit rate of 28/32 (87.5%). The median overall survival of the entire series was 16.9 months; 1 and 2-years-overall survival were respectively 61.4 and 32.1%; the median progression-free-survival was 9.3 months, with a 1 and 2-progression-free-survival of 43.2 and 7%, respectively.

    Conclusion
    On the basis of our data, we may affirm that CPBev regimen have a good toxicity profile and is extremely active iwhen administered to advanced non-squamous, non-small celle lung carcinomas. Data concerning outcome parameters seems to be very interesting: CPBev deserves to be compared to actual standard regimens in a phase III trial in this population of patients.

• 12441

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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
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 12476

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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): F. Latteri
    • 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.