DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

Systematic Reviews of Randomised Controlled Trials of Chemotherapy and Endocrine Therapy in Advanced Breast Cancer

Principal Investigator: SIMES, JOHN
Institution Receiving Award: SYDNEY, UNIVERSITY OF
Program: BCRP
Proposal Number: BC980334
Award Number: DAMD17-99-1-9392
Funding Mechanism: Idea Award
Partnering Awards:
Award Amount: $289,477.00


PUBLIC ABSTRACT

It is not possible for those involved in the management of women with advanced breast cancer to read even a small percentage of the thousands of journals that publish the findings of relevant clinical research. Review articles that summarize current knowledge should therefore provide a valuable source of information. Unfortunately many of these review articles are flawed as they are influenced by the interests and beliefs of the reviewer. Treatment decisions are therefore being made every day based on evidence that is confusing, conflicting, and perhaps even incorrect. Systematic reviews will remove these problems, but unfortunately such reviews have rarely been done in advanced breast cancer.

Systematic reviews overcome these flaws by documenting the processes to be followed in a study plan (or protocol) written before the review commences. Every attempt is then made to identify and include the results of all the best available evidence รน preferably randomized controlled trials. Although considerable resources have been invested in the conduct of randomized trials in advanced breast cancer, very little has been done to assimilate this information in a scientifically valid and meaningful fashion, and to make the resulting summaries readily available to the people who need the information to help them make treatment decisions. The main objective of the current project, therefore, is to conduct a series of systematic reviews of randomized trials addressing questions faced on a daily basis by clinicians and women with this disease, and to make them as widely available as possible. Specifically: (a) Is chemotherapy or endocrine therapy better for particular types of patient? (For example, if the cancer has just been diagnosed, is it better to receive chemotherapy now, or to receive endocrine therapy now and chemotherapy when the cancer progresses?) (b) What is optimal duration of chemotherapy? (For example, is it better to receive intensive chemotherapy that lasts for a predefined period of time, or is it better to receive less intensive chemotherapy for an indefinite period of time (or until the cancer progresses)? (c) What is the value of increasing the dose of a chemotherapy regimen? (For example, is it really worth increasing the dose of a drug considering its side effects?)

The effectiveness of each treatment will be evaluated using survival, time to disease progression, quality of life, and side effects when possible. It may also be possible to address these questions in particular subgroups of women if sufficient data is available.

The results of these systematic reviews will enable patients and clinicians to make treatment decisions that balance the ability to achieve cancer control against factors such as treatment toxicity and quality of life. Decisions should then be guided by the totality of the best available evidence rather than one individual's opinion. Further, these reviews will identify areas where further research is needed as well as those where clear answers are already available and further research is unnecessary.