Author of

• 11818

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  P2.13 - Poster Session 2 - SCLC (ID 201)

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

  • 11822

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    P2.13-004 - Lithium as a neuroprotective agent in patients undergoing prophylactic cranial irradiation (PCI) for small cell lung cancer (SCLC): the TULIP study (ID 2069)

    09:30 - 09:30  |  Author(s): G. Pitson
    • Abstract

    Background
    Somnolence syndrome and cognitive dysfunction are devastating complications of cranial irradiation. Lithium (Li) has neuroprotective properties, such as induction of neuroglial growth after radiation and reduction of cognitive loss in models of cranial irradiation (PCI). It has a well-understood safety profile. PCI is offered to SCLC responders to chemo and radiotherapy. We are assessing feasibility and subsequently efficacy of lithium as a neuroprotective agent in people receiving cranial irradiation.

    Methods
    Twenty SCLC patients treated with PCI are randomised in an open label multicentre stratified feasibility study, (TULIP), to PCI +/- Li. Li is commenced after PCI at 250mg daily, and increased by 250 – 500 mg based on plasma levels for a period of 6 weeks, the average time to develop somnolence syndrome. Patients with histologically or cytologically confirmed SCLC with complete or partial response to chemotherapy and lung irradiation with no major comorbidities and good performance are eligible. Cognitive assessments are done at baseline, after Li therapy, at 3, 6 and 12 months using CogState interactive tools assessing aspects of executive function, memory and attention. Additionally, the Cognitive Failures Questionnaire, Centre for Epidemiological Studies Depression Scale, and Epworth Sleepiness Scale evaluation are completed. Feasibility is the primary endpoint of TULIP. Secondary endpoints include neurocognition and safety. FDG-PET and gadolinium MRI before and 6 weeks after Li or placebo assessing grey matter volumetrics within the hemispheres before and after Li. Differences in regional cerebral metabolic rate for glucose consumption, between baseline and after Li will be evaluated using Parametric Mapping.

    Results
    N/A

    Conclusion
    There are currently 5 patients enrolled in TULIP. Subsequent to TULIP, the definitive 2nd Li Protection Study (2LiP) will commence, aiming to randomise 138 patients with various malignancies and brain metastases treated with whole brain radiotherapy +/- Li to measure impact of Li on cognition, mood and quality of life.