Scientific Advisory Committee on Oncology Therapies (SAC-OT) April 15th, 2010 Teleconference

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Contact: Bureau of Policy, Science and International Programs Enquiries

Agenda

Place: Holland Cross, Tower B, Room 2000

Chairperson: Dr. Alexander Paterson
Science Advisor: Bob Li
Science and Regulatory Officer: Larissa Lefebvre
Participants: SAC-OT members and Health Canada representatives

1. Opening remarks
   Chair
2. Affiliations and Interests / Review of Agenda
   Chair
3. Introduction / Issue Analysis Summary
   Dr. Martha Harczy
4. Deliberations and Answers to General Questions
   SAC-OT members
   • Question 1
     The cited literature recommends overall survival as primary endpoint for randomized clinical trials aiming at advanced NSCLC. This should apply to maintenance therapy. Would the SAC-OT concur with that opinion?
   • Question 2
     If so, what is a clinically meaningful OS advantage that the SAC-OT would consider for maintenance therapy?
   • Question 3
     What patient follow-up schedule would the SAC-OT recommend in future clinical trials aiming at maintenance therapy for NSCLC which would be relevant to Canadian practice?
   • Question 4
     Should all the common metastatic predilection sites (lung, bone, liver, adrenal glands, brain) of NSCLC be scanned at baseline and prospectively followed up for all the patients taking part in a clinical trial?
   • Question 5
     For an incurable disease such as advanced NSCLC where the intent of therapy is palliation is it acceptable that health-related quality of life (HRQL) is either impaired on therapy or not improved?
5. Closing Remarks and Adjournment of Meeting
   Chair