This study is a multi-center, non-interventional retrospective medical records review. The study will involve identification of medical records of patients with confirmed locally advanced unresectable or metastatic ES, who initiated systemic therapy between January 1, 2000 and December 31, 2017. Data for the chart review will be extracted retrospectively from eligible subjects' charts (electronic or paper). Information on prior surgical treatment and neoadjuvant/adjuvant therapies for ES will also be collected for ineligible subjects with a locally advanced or metastatic ES diagnosis who did not initiated systemic therapy. Data collected will be anonymized by the investigators and will not be traceable back to individual subjects by the sponsor (i.e., no protected health information \[PHI\] will be collected).
The sampling period will span from January 1, 2000 to December 31, 2017. As the chart abstraction dates may be different across institutions due to contracting and other logistical issues, to avoid seeing biased outcomes that may be related to this type of heterogeneity, a consistent study end date will be imposed for all patients when conducting the analysis. Information before this study end date will be analyzed and used to conduct the analysis.
Study Type
OBSERVATIONAL
Enrollment
74
University of Colorado Cancer Center
Denver, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Real-word overall response rate (rwORR)
Proportion of patients who have a documented radiological scan showing clinician-assessed complete response or less-than-complete response, of any duration, defined for each regimen and by line
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Real-world duration of response (rwDOR)
Duration of time between the first radiological scan showing documented tumor response (any time of response excluding SD) to first noted disease progression, or treatment discontinuation if no progression occurred. This is defined for each line of therapy and by regimen.
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Time from treatment initiation to treatment discontinuation
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Time from treatment initiation to treatment failure
Treatment failure is defined as discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Real-world disease control rate (rwDCR)
Proportion of patients who have documented radiological scans showing clinician-assessed complete response or less-than-complete response, or stable disease lasting at least 32 weeks
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to treatment failure
Overall survival (OS)
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to death
Real-world time to tumor progression (rwTTP)
Time frame: Initiation of treatment with any systemic anti-cancer therapy for the treatment between January 1, 2000 and December 31, 2017 to tumor progression
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