Physician Liver Function Test (LFT) Monitoring for Tykerb Pts

NCT01462552 | Completed

• 3 other identifiers: 115270WEUKSTV4275EPI40640
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

In July 2008, the lapatinib (Tykerb) Prescribing Information (label) was updated to include a boxed warning related to hepatotoxcity and detailed instructions for monitoring liver function before and during lapatanib exposure. For patient safety, it is of interest to know the extent to which providers are adherent with these guidelines for hepatic monitoring of lapatanib users. Thus, the aim of this study is to determine if physicians conduct liver function testing prior to prescribing lapatanib and at regular intervals during exposure, and if they withdraw lapatanib, and do not re-treat, for patients who demonstrate severe liver enzyme elevations while exposed. These aims will be tested in the "Pre-label" (prior to the boxed warning) and "Post-label" (after the boxed warning) periods to determine if physician adherence to the guidelines changed as a result of the warning. Specifically, the boxed warning provided the following guidance: "Hepatotoxicity (alanine transaminase or aspartate transaminase \>3 times the upper limit of normal and total bilirubin \>1.5 times the upper limit of normal) has been observed in clinical trials (\<1% of patients) and postmarketing experience. The hepatotoxicity may be severe and deaths have been reported. Causality of the deaths is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with lapatanib should be discontinued and patients should not be re-treated with lapatanib" The following objectives will be assessed and compared among patients prescribed lapatanib before and after the addition of detailed guidance on liver function testing to the product label on July 9, 2008:

• alanine transaminase (ALT)
• aspartate transaminase (AST)
• alkaline phosphatise (ALP)

Conditions

Cancer

Keywords

liver function testing; Breast cancer; lapatanib

Outcome Measures

Primary Outcomes (1)

• The change in proportion of patients that receive liver function tests prior to the initiation of lapatanib

  Within 30 days, 60 days, or 90 days prior to (and including) the day that lapatanib was initiated

Secondary Outcomes (4)

• The change in prevalence of LFT elevations prior to the initiation of lapatanib

  Within 30 days, 60 days or 90 days prior to (and including) the day that lapatanib was initiated

• The proportion of patients that have LFT performed routinely (at least every 6 weeks) while exposed to lapatanib

  During entire lapatanib exposure (Based on index date between January 2007 - June 2010).

• The incidence of LFT elevations while exposed to lapatanib

  During entire lapatanib exposure (Based on index date between January 2007 - June 2010).

• The proportion of patients with a severe LFT elevation that have lapatanib withdrawn, and are not re-treated

  During entire lapatanib exposure (Based on index date between January 2007 - June 2010).

Study Arms (2)

Metastatic breast cancer pre-label group

Patients with metastatic breast cancer who initiated lapatanib between January 1, 2007 and December 31, 2007. Follow-up time for this group will continue until June 30, 2008 to allow these patients to have at least six months of follow-up time prior to the label change.

Drug: Lapatanib

Metastatic breast cancer post-label group

Patients with metastatic breast cancer who initiated lapatanib between July 9, 2008 and December 31, 2009. Follow-up time for this group will continue until June 30, 2010 to allow these patients to have at least six month of follow-up.

Drug: Lapatanib

Interventions

Lapatanib DRUG

Prescription of lapatinib (Tykerb)

Metastatic breast cancer post-label group; Metastatic breast cancer pre-label group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female adults age \>= 19 years of age with a diagnosis of metastatic breast cancer and who initiated lapatanib from January 1, 2007 - December 31, 2009

You may qualify if:

• Female aged \>= 19 years
• A diagnosis of breast cancer with documented metastatic disease (as defined by stage at diagnosis, evidence of disease progression, and/or line of therapy);
• Documented order/prescription for lapatanib from January 1, 2007 - December 31, 2009;
• Received care at a practice utilizing the full electronic medical record capabilities of US Oncology's iKnowMed system

You may not qualify if:

• Patients participating in clinical trials
• Patients receiving care for another cancer during the study time period

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: October 31, 2011
• Study Start: December 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 15, 2015

Record last verified: 2015-04