Scientific Advisory Committee on Oncology Therapies (SAC-OT)

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Record of Proceedings

April 15, 2010

Teleconference

Committee Members Present:

Alexander Paterson (Chair), Charles Butts, Diana M. Ermel, Stan Gertler, Kong Khoo, Natasha Leighl, Lynne Nakashima, Lesley K. Seymour, Ian Tannock (provided written response), Maureen A. Trudeau, George Wells

Health Canada Representatives Present:

Office of Science: Marilyn Davis, Larissa Lefebvre, Bob Li, Yinghua Su, Bin Wei Bureau of Metabolism, Oncology and Reproductive Sciences: Karen Johns, Martha Harczy, Wilfred Lim, Barbara Rotter, Kathy Soltys

Acronyms used in this record:

HRQL - Health-related Quality of Life
NSCLC- Non-Small Cell Lung Cancer
OS - Overall Survival
PFS - Progression-Free Survival
QOL - Quality of Life
SAC-OT - Scientific Advisory Committee on Oncology Therapies

This teleconference of the Scientific Advisory Committee on Oncology Therapies (SAC-OT) was called in order to seek expert advice on maintenance therapy in advanced non-small cell lung cancer.

Opening Remarks

The Chair of SAC-OT opened the meeting, and thanked all Committee members for their time and effort in preparing and participating in this teleconference.

Introduction and Affiliations and Interests Declaration

The Chair led the Committee in round-table introductions and declarations of affiliations and interest. Upon completion of the declarations, it was unanimously agreed that all members could participate fully in the meeting with the Chair encouraging free and open discussion.

The following questions were posed and deliberated by the SAC-OT members. Each is followed by the committee's final recommendations to Health Canada.

General Questions on Maintenance Therapy in Advanced Non-Small Cell Lung Cancer (NSCLC)

1. The cited literature ⁸,⁹,¹⁷ recommends overall survival as primary endpoint for randomized clinical trials aiming at advanced NSCLC. This should apply to maintenance therapy¹⁹. Would the SAC-OT concur with that opinion?

   The SAC-OT agrees that Overall Survival (OS) should be recommended as the primary endpoint for randomized clinical trials examining maintenance therapy for NSCLC.

2. If so, what is a clinically meaningful OS advantage that the SAC-OT would consider for maintenance therapy?

   The SAC-OT considers a clinically meaningful OS advantage to be dependant on factors such as toxicity, relief of symptoms and quality of life (QOL) and might range from 8 - 12 weeks, depending on these factors.

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?

   The SAC-OT recommends follow-up examinations every 6 - 12 weeks in clinical trials. While a 6-- 8 week schedule is appropriate for regimens given every 3 to 4 weeks, less frequent examinations (for example, every 12 weeks) may be appropriate for long term follow-up (that is, off treatment) or with oral medications.

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?

   The SAC-OT recommends that since OS is the preferable primary endpoint, then close follow-up of these sites is not required, and may be best performed every 6 - 8 weeks or on development of symptoms. If progression-free survival (PFS) is the primary endpoint, then it must be precisely ascertained and necessitates regular site-specific scans/examinations. However, the trial results may then become less relevant to current oncology practice. It should also be recognised that there are inherent difficulties in using bone scans to assess response in patients with bone metastases.

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?

   Generally it is not acceptable that the HRQL is impaired by an investigational therapy for an incurable disease such as NSCLC unless it is counterbalanced by a significantly improved survival.

   If HRQL improvement is plausible with the investigative therapy, then it should be measured and reported.

Next Steps, Closing Remarks and Adjournment of the meeting

The Chair thanked the members for their time and valuable contributions and recommendations on this issue. The next SAC-OT teleconference has yet to be scheduled.