A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients

Efficacy, safety, and adherence

Robert Schnoll*, Frank Leone, Anna Veluz-Wilkins, Andrew Miele, Anita Hole, Nancy C. Jao, E. Paul Wileyto, Allison J. Carroll, Ravi Kalhan, Jyoti Patel, Corey Langer, Su Fen Lubitz, Brian L Hitsman

*Corresponding author for this work

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (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 seven 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 (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95% CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5% and 44.2%) vs ST (44.7% and 27.7%), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7% and 4.8%; ST: 12.7% and 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 with 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.

Original languageEnglish (US)
Pages (from-to)561-569
Number of pages9
JournalPsycho-oncology
Volume28
Issue number3
DOIs
StatePublished - Mar 1 2019

Fingerprint

Tobacco Use
Patient Safety
Patient Compliance
Randomized Controlled Trials
Smoke
Neoplasms
Therapeutics
Odds Ratio
Placebos
Confidence Intervals
Medication Adherence
Smoking Cessation
United States Food and Drug Administration
Varenicline
Counseling
Blood Pressure
Recurrence
Population

Keywords

  • adherence
  • cancer
  • extended treatment
  • safety
  • smoking cessation
  • varenicline

ASJC Scopus subject areas

  • Experimental and Cognitive Psychology
  • Oncology
  • Psychiatry and Mental health

Cite this

Schnoll, Robert ; Leone, Frank ; Veluz-Wilkins, Anna ; Miele, Andrew ; Hole, Anita ; Jao, Nancy C. ; Paul Wileyto, E. ; Carroll, Allison J. ; Kalhan, Ravi ; Patel, Jyoti ; Langer, Corey ; Lubitz, Su Fen ; Hitsman, Brian L. / A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients : Efficacy, safety, and adherence. In: Psycho-oncology. 2019 ; Vol. 28, No. 3. pp. 561-569.
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abstract = "Objective: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (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 seven 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 (odds ratio [OR] = 2.31; 95{\%} confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95{\%} CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5{\%} and 44.2{\%}) vs ST (44.7{\%} and 27.7{\%}), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7{\%} and 4.8{\%}; ST: 12.7{\%} and 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 with 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.",
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author = "Robert Schnoll and Frank Leone and Anna Veluz-Wilkins and Andrew Miele and Anita Hole and Jao, {Nancy C.} and {Paul Wileyto}, E. and Carroll, {Allison J.} and Ravi Kalhan and Jyoti Patel and Corey Langer and Lubitz, {Su Fen} and Hitsman, {Brian L}",
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Schnoll, R, Leone, F, Veluz-Wilkins, A, Miele, A, Hole, A, Jao, NC, Paul Wileyto, E, Carroll, AJ, Kalhan, R, Patel, J, Langer, C, Lubitz, SF & Hitsman, BL 2019, 'A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients: Efficacy, safety, and adherence', Psycho-oncology, vol. 28, no. 3, pp. 561-569. https://doi.org/10.1002/pon.4978

A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients : Efficacy, safety, and adherence. / Schnoll, Robert; Leone, Frank; Veluz-Wilkins, Anna; Miele, Andrew; Hole, Anita; Jao, Nancy C.; Paul Wileyto, E.; Carroll, Allison J.; Kalhan, Ravi; Patel, Jyoti; Langer, Corey; Lubitz, Su Fen; Hitsman, Brian L.

In: Psycho-oncology, Vol. 28, No. 3, 01.03.2019, p. 561-569.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized controlled trial of 24 weeks of varenicline for tobacco use among cancer patients

T2 - Efficacy, safety, and adherence

AU - Schnoll, Robert

AU - Leone, Frank

AU - Veluz-Wilkins, Anna

AU - Miele, Andrew

AU - Hole, Anita

AU - Jao, Nancy C.

AU - Paul Wileyto, E.

AU - Carroll, Allison J.

AU - Kalhan, Ravi

AU - Patel, Jyoti

AU - Langer, Corey

AU - Lubitz, Su Fen

AU - Hitsman, Brian L

PY - 2019/3/1

Y1 - 2019/3/1

N2 - Objective: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (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 seven 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 (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95% CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5% and 44.2%) vs ST (44.7% and 27.7%), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7% and 4.8%; ST: 12.7% and 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 with 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.

AB - Objective: Continuing to smoke after a cancer diagnosis undermines prognosis. Yet few trials have tested Food and Drug Administration (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 seven 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 (odds ratio [OR] = 2.31; 95% confidence interval [CI], 1.15-4.63; P = 0.02) and continuous (OR = 5.82; 95% CI, 2.66-12.71; P < 0.001) abstinence. For both outcomes, adherent participants who received ET reported higher abstinence (60.5% and 44.2%) vs ST (44.7% and 27.7%), but differences in quit rates between arms were not significant for nonadherent participants (ET: 9.7% and 4.8%; ST: 12.7% and 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 with 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.

KW - adherence

KW - cancer

KW - extended treatment

KW - safety

KW - smoking cessation

KW - varenicline

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