A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence

Abstract

Objective: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet, few trials have tested FDA-approved tobacco use medications in this population. Extended use varenicline may represent an effective treatment for cancer patients who smoke given barriers to cessation including a prolonged time-line for relapse. Methods: A placebo-controlled randomized trial tested 12 weeks of varenicline plus 12 weeks of placebo (standard; ST) vs. 24 weeks of varenicline (extended; ET) with 7 counseling sessions for treatment-seeking cancer patients who smoke (N=207). Primary outcomes were 7-day, biochemically-confirmed abstinence at weeks 24 and 52. Treatment adherence and side effects, adverse and serious adverse events, and blood pressure were assessed. Results: Point prevalence and continuous abstinence quit rates at weeks 24 and 52 were not significantly different across treatment arms (p’s>0.05). Adherence (43% of sample) significantly interacted with treatment arm for week 24 point prevalence (OR=2.31, [95% CI:1.15–4.63, p=0.02) and continuous (OR=5.82, [95% CI:2.66–12.71], p<.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5%, 44.2%) vs. ST (44.7%, 27.7%), but differences in quit rates between arms were not significant for non-adherent participants (ET: 9.7%, 4.8%; ST: 12.7%, 10.9%). There were no significant differences between treatment arms on side effects, adverse and serious adverse events, and rates of high blood pressure (p’s>0.05). Conclusions: Compared to ST, ET varenicline does not increase patient risk and increases smoking cessation rates among patients who adhere to treatment. Studies are needed to identify effective methods to increase medication adherence to treat patient tobacco use effectively.

Design and Pilot Implementation of an Electronic Health Record-Based System to Automatically Refer Cancer Patients to Tobacco Use Treatment

“…This represented a substantial increase in the number of completed appointments compared with the 6 weeks before the pilot implementation period (25 completions vs. four completions), but represents an opportunity for improvement. Other studies also suggest that one of the major challenges to improving tobacco treatment among cancer patients has been the low rate of participation by the patients [6,[51][52][53][54].…”

Initiating Pharmacologic Treatment in Tobacco-Dependent Adults. An Official American Thoracic Society Clinical Practice Guideline

“…Controller pharmacotherapies treat tobacco dependence effectively when taken as prescribed, but relapse after pharmacologic discontinuation is common ( 171 ). Among the various strategies aimed at preventing relapse, an extended duration of treatment has been effective at modifying sustained abstinence rates in some contexts ( 172 ). The panel found guidance on treatment duration to be of critical importance, especially the comparison between extended-duration (i.e., >12 wk) and standard therapy (8–12 wk).…”

NewsCAP: New guidelines favor varenicline for smoking cessation.

“…Controller pharmacotherapies treat tobacco dependence effectively when taken as prescribed, but relapse after pharmacologic discontinuation is common (171). Among the various strategies aimed at preventing relapse, an extended duration of treatment has been effective at modifying sustained abstinence rates in some contexts (172). The panel found guidance on treatment duration to be of critical importance, especially the comparison between extended-duration (i.e., .12 wk) and standard therapy (8-12 wk).…”