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): C. Sergi
    • 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.