Author of

• 10946

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  P1.19 - Poster Session 1 - Imaging (ID 179)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Imaging, Staging & Screening
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/28/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

  • 10948

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    P1.19-002 - An open-label, single arm trial to evaluate the predictive value of perfusion CT and early radiologic response to cisplatin (C) gemcitabine (G) and bevacizumab (B) in patients (pts) with advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC). (ID 723)

    09:30 - 16:30  |  Author(s): P. Arguis
    • Abstract

    Background
    Classically the evaluation of response in oncology has been based in comparing pre and post treatment tumour volume by means of studying changes in the diameter lesions. The introduction of new targeted drugs creates the need of a different evaluation of tumours and their response to treatment. Functional imaging techniques that are able to study in vivo physiological processes of tissues and tumours have lately acquired more importance. The dynamic techniques may be more appropriate for assessing response to antiangiogenic drug, such as B, whose mechanism of action appears to focus on the normalization of the tumor vasculature. Preliminary studies have demonstrated significant and very early changes in flow, blood volume and tumor perfusion with therapy. These techniques could be useful to select patients those that are going to respond to drugs with an early evaluation of response by means of functional imaging

    Methods
    IMPACT is an open-label, single arm phase II study to evaluate the predictive value and early radiologic response or perfusion CT in pts diagnosed with unresectable advanced, metastatic or recurrent nsNSCLC treated with C, G and B. Pts receive B (7.5 mg/kg IV on d1), C (80 mg/m2 on d1) and G (1250 mg/m2 on d1 and 8) up to 6 cycles of 21 d. Pts with no evidence of progression of disease continue to receive single-agent B 7.5 mg/Kg on d1 every 21 d until progression or unacceptable toxicity. Primary endpoint is to assess basal results and early tumour response (at day +7) in terms of blood flow (BF), blood volume (BV), time to enhancement peak (TTEP) and permeability (P) as compared to Objective Response Rate (ORR) in terms of RECIST at d42. Secondary objectives include to assess tumour response (at d42) in terms of BF, BV, TTEP and P as compared to ORR at d42, to assess basal results in terms BF, BV, TTEP and P as compared to PFS and OS, to assess tumour response (at d7 and d42) in terms of BF, BV, TTEP and P to PFS and OS, to describe the safety profile using NCI-CTC AE and efficacy in the subgroup of adenocarcinoma. Planned sample size is 20 pts.

    Results
    not applicable

    Conclusion
    not applicable