The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.
The following abbreviations were used in the Adverse Event section: * international normalized ratio (inr) * Common Terminology Criteria for Adverse Events (ctcae) * Not Otherwise Specified (nos) * Gastrointestinal (gi) * Central nervous system (cns) * Absolute Neutrophil Count (anc) * Alanine aminotransferase (ALT) * Aspartate aminotransferase (AST) * Creatine phosphokinase (cpk) * Gammaglutamyltransferase (ggt) * Genitourinary (gu) * Atrioventricular (av)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
602
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.
Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Overall Survival (OS)
Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Time frame: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment
Time to Symptomatic Progression (TTSP)
TTSP was defined as the time from randomization to the first documented symptomatic progression.
Time frame: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
Time to Progression (TTP)
TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
Time frame: from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment
Disease Control (DC)
The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Time frame: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Orange, California, United States
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San Francisco, California, United States
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Stanford, California, United States
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Farmington, Connecticut, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
...and 168 more locations
PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.
Time frame: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment