Liver Function Test (LFT) Elevations in Cancer Patients and Users of Tyrosine Kinase Inhibitor (TKI) Drugs

GlaxoSmithKline3,800 enrolled

Overview

A retrospective cohort study using the LabRx medical claims database will be performed to address these objectives. The primary objective of this project is to examine the background rates of liver function test (LFT) abnormalities in cancer patients treated with tyrosine kinase inhibitors (TKIs).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Study Type

OBSERVATIONAL

Enrollment

3,800

Conditions

Cancer

Interventions

Tyrosine kinase inhibitorsDRUG

Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (age ≥18 years) with at least two ICD-9 codes for a particular cancer (ICD-9 code 140-208.9) within a 6 month timeframe and at least one code for a TKI drug that occurs on or after the first cancer diagnosis code * At least one month (30 days) of enrolment prior to index date and three months (91 days) of follow-up post index date; and * Continuous enrolment in the LabRx database during follow-up. Exclusion Criteria: * Less than 18 years old * Less than one month (30 days) of enrolment prior to index date or three months (91 days) of follow-up post index date; and * Not continuously enrolled in the LabRx database during follow-up.

Outcomes

Primary Outcomes

Number of Patients With ALT (Alanine Transaminase) >=3x (Times) Upper Limit of Normal (ULN)

Prevalence of patients with an ALT elevation \>=3x ULN among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Incidence of ALT >=3x ULN

Number of patients with ALT \>=3 times ULN among patients with a normal ALT measurement during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT \<1 times ULN at baseline.

Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Number of Hy's Law Patients (ALT or AST >= 3x ULN and ALP <2x ULN and BIL >= 2x ULN)

Prevalence of patients with Hy's Law (ALT or AST \>=3x ULN and ALP \<2x ULN and BIL \>=2x ULN, where AST = aspartate transaminase, ALP = alkaline phosphatase, BIL= bilirubin) among patients who had liver function testing during the baseline period (30 days prior to initiation of TKI drug).

Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Incidence of Hy's Law (ALT or AST >=3x ULN and ALP <2x ULN and BIL >=2x ULN)

Number of patients with Hy's Law (ALT or AST \>= 3x ULN and ALP \<2x ULN and BIL \>= 2x ULN) among patients with normal ALT, AST, ALP, and BIL measurements during the baseline period (30 days prior to initiation of TKI drug). Normal is defined as an ALT AST, ALP, and BIL \<1 times ULN at baseline.

Time frame: Study period was October 1, 2004-June 30, 2009. Patients had at least 91 days of follow-up post index date.

Secondary Outcomes

Maximum ALT Elevation Reached During Follow-up

Data from ClinicalTrials.gov

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