Interferon Toxicities in Melanoma Treatment (ITMT)

Analysis of the Clinical and Economic Impact of Adverse Events and Medication-related Toxicities Associated With Interferon (IFN) Treatment for Patients With Stage III Melanoma

The primary objective of this study is to quantify and compare the prevalence of adverse events (AEs) in patients with stage III melanoma before and after initiation of interferon (IFN) therapy in a real-world setting. A secondary objective is to quantify annual costs and resource utilization before and after IFN initiation among patients with stage III melanoma in a real-world setting.

Study Overview

• Status: Completed
• Conditions: Stage III Melanoma

• Study Type: Observational
• Enrollment (Actual): 436

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Health plan enrollees whose data are reflected in the Truven Health MarketScan Commercial and Medicare Supplemental database. This database captures clinical utilization, expenditures and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations

Description

Inclusion Criteria:

• Patients with a pharmacy claim for IFN between 1/1/2007 and 12/31/2011. The date of the first observed claim will be defined as the index date
• Patients with a melanoma diagnosis based on two medical claims prior to the index date
• Patients with a procedure code for melanoma-related lymph node dissection before the index date
• Patients ≥ 18 years of age on or before the index date
• Patients with continuous benefit enrollment for at least 180 days before and after the index date

Exclusion Criteria:

• Patients with diagnosis of any other (primary) cancer during the 180-day pre-index period (excepting skin cancers and hematologic malignancies)
• Patients with diagnosis of a secondary cancer during the 180-day pre-index period or on the index date (excepting lymph node metastasis to a site common for melanoma or an improbable site for any other primary cancer)
• Patients who received systemic chemotherapy during the pre- or post-index period

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

IFN Treatment; Adult (age ≥ 18 years) patients identified as having stage III melanoma and no other primary or secondary cancer who initiated treatment with IFN between 1/1/2007 and 12/31/2011. Patients are required to have continuous pharmaceutical benefit enrollment for 180 days before (pre-index) and after (post-index) IFN initiation and no evidence of treatment with systemic chemotherapy during the pre- or post-index period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of depression in patients with stage III melanoma before initiation of Interferon alfa-2b (IFN) therapy	180 days prior to the index date
Prevalence of depression in patients with stage III melanoma after initiation of IFN therapy	180 days after the index date
Prevalence of fatigue in patients with stage III melanoma before initiation of IFN therapy	180 days prior to the index date
Prevalence of fatigue in patients with stage III melanoma after initiation of IFN therapy	180 days after the index date
Prevalence of myalgia in patients with stage III melanoma before initiation of IFN therapy	180 days prior to the index date
Prevalence of myalgia in patients with stage III melanoma after initiation of IFN therapy	180 days after the index date

Secondary Outcome Measures

Outcome Measure	Time Frame
Pre-IFN treatment period Health care costs related to depression	180 days prior to the index date
Post-IFN treatment period Health care costs related to depression	180 days after the index date
Pre-IFN treatment period Health care costs related to fatigue	180 days prior to the index date
Post-IFN treatment period Health care costs related to fatigue	180 days after the index date
Pre-IFN treatment period Health care costs related to myalgia	180 days prior to the index date
Post-IFN treatment period Health care costs related to myalgia	180 days after the index date

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CA184-404