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K.A. Roberts



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    P2.14 - Poster Session 2 - Mesothelioma (ID 196)

    • Event: WCLC 2013
    • Type: Poster Session
    • Track: Mesothelioma
    • Presentations: 1
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      P2.14-013 - A randomised phase II trial of oral vinorelbine as second-line therapy for patients with malignant pleural mesothelioma (MPM) expressing BRAC1 - VIM trial (ID 1937)

      09:30 - 09:30  |  Author(s): K.A. Roberts

      • Abstract

      Background
      Mesothelioma is increasing worldwide. However there is no approved therapy in the second-line setting. Vinorelbine exhibits promising activity, however there has been no randomised evaluation or validation of biomarkers to support patient stratification. We have recently reported that BRCA-1 is an essential regulator of mesothelioma sensitivity to vinorelbine, and its expression is lost in approximately 38%. The UK National Cancer Research Institute Lung Clinical Studies Group have therefore developed this clinical trial to investigate whether or not giving second-line vinorelbine in addition to active symptom control (ASC) will benefit patients in terms of overall survival. The study is funded by a research grant from Cancer Research UK (CRUK/12/056) and free vinorelbine, labeling and distribution from Pierre Fabre Ltd. The trial is sponsored by Leicester University, and coordinated by the Wales Cancer Trials Unit, Cardiff, UK.

      Methods
      A UK multicentre open-label randomised phase II trial. Eligible patients include histological diagnosis of mesothelioma, received at least one line standard platinum doublet based chemotherapy, age >=18 years, measurable lesions by modified RECIST, radiological evidence of disease progression and informed consent. Patients will be randomised to either control of active symptom control (ASC) or ASC plus vinorelbine using a 1:2 allocation ratio. ASC will be administered as per local practice, continuing follow-up until evidence of radiological progression. Vinorelbine will administered at a dose of 60mg/m[2 ]po od on day 1 (equivalent to 25mg/m[2 ]iv day 1) weekly for 3 weeks for the first cycle, incrementing to 80mg/m[2 ]weekly (equivalent to 30mg/m[2 ]iv) in the absence of haematological toxicity for subsequent cycles. Patients will continue chemotherapy until evidence of radiological progression (or unacceptable toxicity or patient withdrawal). The primary endpoint of the trial is overall survival with secondary endpoints of tolerability, response rate, change in tumour volume and progression-free survival. BRCA1 expression IHC will be evaluated as a stratification factor. The median OS for patients in the control arm is expected to be 1.5 months. With 90% power and a one-sided α of 0.2, 114 participants are required (76 in the vinorelbine arm and 38 in the control arm) to detect a hazard ratio of 0.65, based on the logrank test. The primary analysis of data will be analysed after 111 OS events.

      Results
      not applicable

      Conclusion
      not applicable