The purpose of the study was to assess the use of Multikinase Inhibitors (MKIs) in the treatment of patients with a progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) who do not have any symptoms.
The primary objective of this study was to compare time to symptomatic progression (TTSP) from study entry in asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to initiate MKIs at study entry with that of asymptomatic patients with RAI-refractory progressive DTC for whom there is a decision to not initiate MKIs at study entry.
Study Type
OBSERVATIONAL
Enrollment
667
Patients can get sorafenib at any time during study.
Patients can get MKIs at any time during study.
Unnamed facility
Birmingham, Alabama, United States
Time to symptomatic progression (TTSP) from study entry
TTSP is defined as the time interval from the day of study entry to the date of first symptomatic progression. Patients who do not have a symptomatic progression at the time of analysis will be censored at the date of their last evaluable assessment.
Time frame: Up to 6 years
Overall survival (OS) from time of study entry
Defined as the time interval from the date of study entry to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
Time frame: Up to 6 years
Progression free survival (PFS) from time of study entry
Defined as the time interval from the date of study entry to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
Time frame: Up to 6 years
OS from time of being diagnosed as radioactive iodine (RAI) refractory
Defined as the time interval from the day of being diagnosed as RAI refractory to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
Time frame: Up to 6 years
Post-progression survival (PPS) from time of symptomatic progression
Defined as the time interval from the date of symptomatic progression to death due to any cause. Patients without symptomatic progression will be excluded from analysis and patients who are alive at the time of analysis will be censored at the last date when they were known to be alive.
Time frame: Up to 6 years
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Unnamed facility
Los Angeles, California, United States
Unnamed facility
Torrance, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Plantation, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Honolulu, Hawaii, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
New Orleans, Louisiana, United States
...and 24 more locations
OS from initiation of the first Multikinase Inhibitor (MKI)
Defined as the time interval from the day of start of the first MKI to death due to any cause. Patients alive at the time of analysis will be censored at the last date when they were known to be alive.
Time frame: Up to 6 years
PFS from initiation of first MKI
Defined as the time interval from the day of start of first MKI to date of first progression or death due to any cause, whichever comes first. The actual date of tumor assessments will be used for this calculation. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
Time frame: Up to 6 years
OS from initiation of any systemic treatment regimen
Defined as the time interval from the date of start of any systemic treatment regimen to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
Time frame: Up to 6 years
PFS from initiation of any systemic treatment regimen
Defined as the time interval from the date of start of any systemic treatment regimen to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
Time frame: Up to 6 years
Duration of each systemic treatment regimen
Defined as the time interval from the day of start of a treatment to the date of permanent discontinuation of a treatment (regardless of the reason for discontinuation including death). It includes interruption or drug holiday.
Time frame: Up to 6 years
Response assessment to each systemic treatment regimen according to the categories "Complete Response", "Partial Response", "Stable Disease", "Clinical Progression", "Radiological Progression", and "Not evaluable at this visit"
In case of "Clinical Progression" the CRF will ask for the presence of specific symptoms.
Time frame: Up to 6 years
OS from initiation of sorafenib
Defined as the time interval from the day of start of sorafenib to death due to any cause. Patients alive at the time of analysis will be censored at the last date known to be alive.
Time frame: Up to 6 years
PFS from initiation of sorafenib
Defined as the time interval from the date of start of sorafenib to date of first progression or death due to any cause, whichever comes first. Patients without a progression or death will be censored at their last evaluable date of tumor evaluation.
Time frame: Up to 6 years
Daily dose of sorafenib per patient throughout the treatment period
Time frame: Up to 6 years
Number of adverse events during treatment with sorafenib
Time frame: Up to 6 years