Date of Award

2018

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

Objective: The objective of this systematic review is to determine whether or not Epidermal Growth Factor Vaccine also known as CimaVax-EGF is more effective at improving survival than best supportive care or other therapies in patients with non-small cell lung cancer.

Study Design: Systematic review of two randomized control trials (RCTs) and one observational/before and after study published after the year 2007.

Data Sources: All articles were published in English in peer reviewed journals and were searched for personally by me, the author, via PubMed and Embase. Articles selected were only those that were published after 2007, were relevant to my clinical question and addressed patient oriented outcomes that mattered.

Outcomes Measured: Primary outcome measured was overall survival as estimated in months or measured in years. Secondary outcome measured was safety as estimated by percent of patients experiencing any adverse effects and/or specific adverse reactions.

Results: Both Rodriguez et al and Vinageras et al claim that Epidermal Growth Factor vaccine improves overall survival in patients with stage IIIB/IV NSCLC based on the results of their RCTs (Rodriguez et al 343 patients total assessed for efficacy, p = 0.036, 5 year survival in vaccinated 16.62% vs control 6.2% NNT = 10, Vinageras et al 74 patients total assessed for efficacy, p = 0.0124, 1 year survival in vaccinated 67% vs. control 33% NNT = 3). Kananathan made no claims about efficacy but claimed survival rates indicated the need for a randomized control trial to determine efficacy (23 patients assessed for efficacy, 1 year survival = 91% 5 year survival = 9%). All three studies found the vaccine to be safe and well tolerated.

Conclusions: Although both RCTs claim the EGF vaccine improves survival in Stage IIIB/IV NSCLC patients, risk of bias in study design (not blinded, use of other therapies) and quality of data reported (not reporting some censored patients, overlap of CIs) limit efficacy claims as does the number of studies reviewed. Large double blinded studies are needed to study efficacy.

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