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Over the past 2 decades, a number of quality of life assessment tools and patient-reported
outcome measures have been widely used and validated, and about one third of phase III
clinical trials in MBC, according to 1 report [36] , now incorporate quality of life measures. This
has been strongly encouraged by US regulators, who have determined that valid quality of life
endpoints can serve as meaningful indicators of clinical benefit when assessing drug efficacy
and safety. In 2009, the US Food and Drug Administration issued guidance for industry for
incorporating patient-reported outcome measures into drug registration trials [37] . As in other
areas of medicine, in oncology, researchers and KOLs have issued a strong call for treating the
patient as a whole person, rather than merely as a disease or a cluster of symptoms. However,
cost constraints and sobering recent assessments demonstrate that there is still a very long
way to go before what has been learned is widely applied [38] .

Methods of the Quality of Life Landscape Analysis

Over 150 published, peer-reviewed research articles relevant to the experiences and needs
of people with advanced cancers, including quantitative and qualitative studies of patients
living with MBC and their families, were reviewed. The intent of this literature review was not
to examine the methods used to measure quality of life but rather to summarize some of the
more important recent research findings about the reality of living with MBC. Results of 13
surveys completed by 7939 respondents living with MBC were reviewed (see Appendix 5). The
surveys are from 2006–2014; most were designed by breast cancer organizations, usually with
the financial support of pharmaceutical partners or research grants (see Table 6).

Table 6: 13 Surveys Completed by Respondents Living With MBC

Date Survey Name Sponsor
2006 Silent Voices: Advanced (Metastatic) Breast Cancer Needs Living Beyond Breast Cancer
Assessment Survey
2009, BRIDGE Survey: Identifying the Unmet Needs of the MBC Pfizer with various support
2010 Community organizations
2011 A pan-European Survey of Patients with MBC Eisai; Imperial College, London
2011 Key Support and Lifestyle Needs of MBC Patients METAvivor

2011 Preferences of Patients with MBC Research Advocacy Network (RAN),
Department of Defense, Breast
Cancer Research Program Center of
Excellence
2011 HER2+ MBC Patient Experiences on Treatment in the Biologic Genentech with various support
Era organizations
Metastatic Breast Cancer in Canada: The Lived Experience of Canadian Breast Cancer Network
2012 Patients and Caregivers and RETHINK Breast Cancer
2012 Informational Needs and QOL in 1 Year MBC Dana Farber Embrace Trial
st
2012 Impact of Toxicity on Patient Treatment Choices for MBC RAN, Genentech
2013 Count Us, Know Us, Join Us International Survey Novartis with various breast cancer
organizations and Harris Interactive

2013 Control of Symptoms and Side Effects in MBC AdvancedBC.org
2013 Surveying Young Women with MBC Young Survival Coalition 59
2014 Cancer Experience Registry Cancer Support Community
MBC = Metastatic Breast Cancer, QOL = Quality of Life