“CIGARETTE SMOKING… Rx for CHANGE

is the chief, single, avoidable cause of death in our society and the most important public health issue of our time.”

Clinician-Assisted Tobacco Cessation for Patients with Cancer

C. Everett Koop, M.D., former U.S. Surgeon General

2004 REPORT of the SURGEON GENERAL:

TRENDS in ADULT SMOKING, by SEX—U.S., 1955–2006

HEALTH CONSEQUENCES OF SMOKING

Trends in cigarette current smoking among persons aged 18 or older 60

20.8% of adults are current smokers

Male

50

Percent

40

FOUR MAJOR CONCLUSIONS: „

„

30

23.9%

Female

20

18.0%

Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general. Quitting smoking has immediate as well as long-term benefits, reducing risks for diseases caused by smoking and improving health in general.

10

„

0 1955

1959

1963

1967

1971

1975

1979

1983

1987

1991

1995

1999

2003

Year

70% want to quit

„

Smoking cigarettes with lower machine-measured yields of tar and nicotine provides no clear benefit to health. The list of diseases caused by smoking has been expanded.

Graph provided by the Centers for Disease Control and Prevention. 1955 Current Population Survey; 1965–2005 NHIS. Estimates since 1992 include some-day smoking.

U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General.

HEALTH CONSEQUENCES of SMOKING „

Cancers „ „ „ „ „ „ „ „ „

„

„

Acute myeloid leukemia Bladder and kidney Cervical Esophageal Gastric Laryngeal Lung Oral cavity and pharyngeal Pancreatic

„ „ „ „

„

„

Acute (e.g., pneumonia) Chronic (e.g., COPD)

„

„

„

Abdominal aortic aneurysm Coronary heart disease Cerebrovascular disease Peripheral arterial disease

Reproductive effects „

Pulmonary diseases „

Cardiovascular diseases

Reduced fertility in women Poor pregnancy outcomes (e.g., low birth weight, preterm delivery) Infant mortality

Other effects: cataract,

osteoporosis, periodontitis, poor surgical outcomes

U.S. Department of Health and Human Services. (2004). The Health Consequences of Smoking: A Report of the Surgeon General.

HEALTH CONSEQUENCES of SMOKELESS TOBACCO USE Periodontal effects

Gingival recession Bone attachment loss „ Dental caries „ „

Oral leukoplakia Cancer

Oral cancer „ Pharyngeal cancer „

Oral Leukoplakia Image courtesy of Dr. Sol Silverman University of California San Francisco

Use of alcohol in combination with moist snuff increases the risk of oral cancers.

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

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ANNUAL U.S. DEATHS ATTRIBUTABLE to SMOKING, 1997–2001

NICOTINE DISTRIBUTION

Percentage of all smokingattributable deaths*

137,979

Lung cancer

123,836

Respiratory diseases

101,454

Second-hand smoke*

38,112

Cancers other than lung

34,693

9% 8%

1,828

30 pack-years has been shown to be an independent prognostic factor for both short- and long-term survival rates

EFFECTS of SMOKING on QUALITY OF LIFE in PATIENTS WITH CANCER „

Smoking after diagnosis negatively impacts „ „

Tobacco mutagenicity may play a role in the growth and extension of certain cancers „

Presents further obstacles for survival

Quitting smoking before diagnosis and treatment can positively influence survival.

„

Overall quality of life (QOL) Risk for co-morbid diseases, which independently have a negative impact on QOL Symptom distress „

Higher in persistent smokers, compared to never smokers

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

5

HOW DOES SMOKING CESSATION IMPROVE CANCER PROGNOSIS? Quitting prior to diagnosis and treatment has a positive influence on prognosis and survival

„

WHAT FACTORS POSITIVELY INFLUENCE QUITTING in PATIENTS WITH CANCER? „

Examples

„

Head and neck cancer

„

„

Non-small cell lung cancer

„

„

„

Quitting 12 weeks and 1 yr prior to diagnosis reduces mortality by 40% and 70%, respectively „

Quitting at any point prior to lung operation is beneficial to prognosis and long-term survival

Patients with cancer tend to have: „ „ „ „ „ „

Higher levels of nicotine dependence Higher levels of psychiatric co-morbidity Higher need for treatment support High percentage of household smokers Poorer general health and physical functioning More stress and emotional distress

Cancer disease-related issues need to be taken into account in treatment decisions and patient monitoring

„

„

Impact of smoking on surgery, radiation, and chemotherapy

Systematic advice (from multiple providers), with steppedcare approach for patients experiencing difficulty with quitting

„

SUMMARY: REASONS TO QUIT for PATIENTS WITH CANCER „

Reduced risk for complications related to cancer therapy and surgery

„

Improved survival

„

Improved quality of life

„

Reduced risk of second primary tumor(s)

Patient concern about recurrent disease and the effects of smoking on treatment success Advice given in the context of medical care

RELAPSE in PATIENTS WITH CANCER

MORE INTENSIVE or TAILORED INTERVENTIONS MAY BE NEEDED „

Patient awareness of the link between smoking and their diagnosed smoking-related cancer

„

„

Up to one third or one half of patients will either continue to smoke after diagnosis or relapse after an initial quit attempt Relapse is often delayed in patients with cancer, compared to healthy patients „ Follow-up and monitoring is needed „ In relapsers: „

Encourage a subsequent quit attempt, to avoid additional post-diagnosis risk due to smoking

TREATING TOBACCO USE and DEPENDENCE: MEDICATIONS for QUITTING

TOBACCO CESSATION is an essential component of treatment for patients with cancer.

HANDOUT

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

6

PHARMACOLOGIC METHODS: FIRST-LINE THERAPIES

TOBACCO DEPENDENCE: A 2-PART PROBLEM Tobacco Dependence Physiological

Behavioral

The addiction to nicotine

The habit of using tobacco

Treatment

Three general classes of FDA-approved drugs for smoking cessation: ƒ Nicotine replacement therapy (NRT) ƒ Nicotine gum, patch, lozenge, nasal spray, inhaler

ƒ Psychotropics

Treatment

ƒ Sustained-release bupropion Medications for cessation

ƒ Partial nicotinic receptor agonist

Behavior change program

ƒ Varenicline

Treatment should address the physiological and the behavioral aspects of dependence.

PHARMACOTHERAPY: USE in PREGNANCY

PHARMACOTHERAPY “Clinicians should encourage all patients attempting to quit to use effective medications for tobacco dependence treatment, except where contraindicated or for specific populations* for which there is insufficient evidence of effectiveness.” * Includes pregnant women, smokeless tobacco users, light smokers, and adolescents.

Medications significantly improve success rates. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

„

The Clinical Practice Guideline makes no recommendation regarding use of medications in pregnant smokers „

Insufficient evidence of effectiveness

„

Category C: varenicline, bupropion SR

„

Category D: prescription formulations of NRT

“Because of the serious risks of smoking to the pregnant smoker and the fetus, whenever possible pregnant smokers should be offered person-to-person psychosocial interventions that exceed minimal advice to quit.” (p. 165) Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

PHARMACOTHERAPY: OTHER SPECIAL POPULATIONS

NRT: RATIONALE for USE

Pharmacotherapy is not recommended for: „

Smokeless tobacco users „

„

Individuals smoking fewer than 10 cigarettes per day

„

Adolescents „

„

„

No FDA indication for smokeless tobacco cessation

Nonprescription sales (patch, gum, lozenge) are restricted to adults ≥18 years of age NRT use in minors requires a prescription

„

„

Reduces physical withdrawal from nicotine Eliminates the immediate, reinforcing effects of nicotine that is rapidly absorbed via tobacco smoke Allows patient to focus on behavioral and psychological aspects of tobacco cessation

Recommended treatment is behavioral counseling. Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

NRT products approximately doubles quit rates.

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

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PLASMA NICOTINE CONCENTRATIONS for NICOTINE-CONTAINING PRODUCTS

NRT: PRODUCTS Polacrilex gum

„

Commit (OTC) Generic nicotine lozenge (OTC)

„ „

Nicotrol NS (Rx)

„

Nicotrol (Rx)

Transdermal patch

Moist snuff Nasal spray 15

Inhaler 10

„

Lozenge (2mg)

Gum (2mg) 5

NicoDerm CQ (OTC) Generic nicotine patches (OTC, Rx)

„

Patch 0 1/0/1900 0

1/10/1900 10

1/20/1900 20

2/19/1900 50

2/29/1900 60

Nicorette (GlaxoSmithKline); generics „

Resin complex „ „

Recent myocardial infarction (within past 2 weeks)

„

„

Serious arrhythmias

„

„

Serious or worsening angina

„

2/9/1900 40

NICOTINE GUM

NRT: PRECAUTIONS Patients with underlying cardiovascular disease

1/30/1900 30

Time (minutes)

Patients should stop using all forms of tobacco upon initiation of the NRT regimen.

„

Moist snuff

20

Inhaler

Lozenge

Cigarette

Cigarette Plasma nicotine (mcg/l)

„

25

Nasal spray

Nicorette (OTC) Generic nicotine gum (OTC)

„

„

Nicotine Polacrilin

Sugar-free chewing gum base Contains buffering agents to enhance buccal absorption of nicotine Available: 2 mg, 4 mg; original, cinnamon, fruit, mint (various), and orange flavors

NRT products may be appropriate for these patients if they are under medical supervision.

NICOTINE GUM: DOSING Dosage based on current smoking patterns: If patient smokes

Recommended strength

≥25 cigarettes/day

4 mg

10 cigarettes/day Step 1 (21 mg x 4 weeks) Step 2 (14 mg x 2 weeks)

TRANSDERMAL NICOTINE PATCH: ADDITIONAL PATIENT EDUCATION „

„

„

„

Water will not harm the nicotine patch if it is applied correctly; patients may bathe, swim, shower, or exercise while wearing the patch Do not cut patches to adjust dose „

Nicotine may evaporate from cut edges

„

Patch may be less effective

Keep new and used patches out of the reach of children and pets Remove patch before MRI procedures

NICOTINE INHALER Nicotrol Inhaler (Pfizer) „

Each metered dose actuation delivers „ 50 mcL spray „ 0.5 mg nicotine ~100 doses/bottle

Step 2 (14 mg x 2 weeks)

Step 3 (7 mg x 2 weeks)

Nicotrol NS (Pfizer) Aqueous solution of nicotine in a 10-ml spray bottle

Step 1 (21 mg x 6 weeks)

Step 3 (7 mg x 2 weeks)

Step 3 (7 mg x 2 weeks)

NICOTINE NASAL SPRAY „

Step 2 (14 mg x 6 weeks)

(formerly Habitrol) Step 2 (14 mg x 6 weeks)

Apply patch to different area each day Do not use same area again for at least 1 week

Heavy Smoker >10 cigarettes/day

Step 3 (7 mg x 2 weeks) Generic

TRANSDERMAL NICOTINE PATCH: DIRECTIONS for USE „

Light Smoker ≤10 cigarettes/day

Nicotine inhalation system consists of: „ „

„

Mouthpiece Cartridge with porous plug containing 10 mg nicotine and 1 mg menthol

Delivers 4 mg nicotine vapor, absorbed across buccal mucosa

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

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BUPROPION: MECHANISM of ACTION

BUPROPION SR Zyban (GlaxoSmithKline); generic „

„

„

Nonnicotine cessation aid

„

Sustained-release antidepressant Oral formulation

„

Atypical antidepressant thought to affect levels of various brain neurotransmitters „

Dopamine

„

Norepinephrine

Clinical effects „

↓ craving for cigarettes

„

↓ symptoms of nicotine withdrawal

BUPROPION: CONTRAINDICATIONS „

Patients with a seizure disorder

„

Patients taking „ „

BUPROPION: WARNINGS and PRECAUTIONS Bupropion should be used with caution in the following populations:

Wellbutrin, Wellbutrin SR, Wellbutrin XL

„

Patients with a history of seizure

MAO inhibitors in preceding 14 days

„

Patients with a history of cranial trauma

„

„

„

Patients with a current or prior diagnosis of anorexia or bulimia nervosa Patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines)

„

Patients with severe hepatic cirrhosis

„

Patients with depressive or psychiatric disorders

VARENICLINE Chantix (Pfizer) „

„

„

Nonnicotine cessation aid Partial nicotinic receptor agonist Oral formulation

Patients taking medications that lower the seizure threshold (antipsychotics, antidepressants, theophylline, systemic steroids)

VARENICLINE: MECHANISM of ACTION „

„

Binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors „

Stimulates low-level agonist activity

„

Competitively inhibits binding of nicotine

Clinical effects „ „

↓ symptoms of nicotine withdrawal Blocks dopaminergic stimulation responsible for reinforcement & reward associated with smoking

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

11

VARENICLINE: WARNING In 2008, Pfizer added a warning label advising patients and caregivers:

„

Patients should stop taking varenicline and contact their healthcare provider immediately if agitation, depressed mood, or changes in behavior that are not typical for them are observed, or if the patient develops suicidal ideation or suicidal thoughts.

VARENICLINE: DOSING Patients should begin therapy 1 week PRIOR to their quit date. The dose is gradually increased to minimize treatment-related nausea and insomnia.

Initial dose titration

Treatment Day

Dose

Day 1 to day 3

0.5 mg qd

Day 4 to day 7

0.5 mg bid

Day 8 to end of treatment*

1 mg bid * Up to 12 weeks

VARENICLINE: ADVERSE EFFECTS 30

Common (≥5% and 2-fold higher than placebo) „ „ „ „ „

Nausea Sleep disturbances (insomnia, abnormal dreams) Constipation Flatulence Vomiting

Active drug Placebo

25

Percent quit

„

LONG-TERM (≥6 month) QUIT RATES for AVAILABLE CESSATION MEDICATIONS

20

23.9 20.2

19.0

18.0

17.1

16.1

15.8

15 11.8

11.3

10

9.9

8.1

Nicotine patch

Nicotine lozenge

11.2

10.3

9.1

5 0 Nicotine gum

Nicotine nasal spray

Nicotine inhaler

Bupropion

Varenicline

Data adapted from Cahill et al. (2008). Cochrane Database Syst Rev; Stead et al. (2008). Cochrane Database Syst Rev; Hughes et al. (2007). Cochrane Database Syst Rev

COMPLIANCE IS KEY to QUITTING

COMBINATION PHARMACOTHERAPY Regimens with enough evidence to be ‘recommended’ first-line „

Combination NRT

„

„

Long-acting formulation (patch) „

Produces relatively constant levels of nicotine

PLUS Short-acting formulation (gum, inhaler, nasal spray) „

„

Allows for acute dose titration as needed for nicotine withdrawal symptoms

Promote compliance with prescribed regimens. Under-dosing of NRT is common and can contribute to relapse

„

Use according to dosing schedule, NOT as needed.

„

Consider telling the patient: „

“When you use this medication, it’s important to read all the directions thoroughly. The products work best in alleviating withdrawal symptoms when used correctly, and according to the recommended dosing schedule.”

Bupropion SR + Nicotine Patch

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

12

COMPLIANCE IS KEY to QUITTING

„

„

Promote compliance with prescribed regimens.

Average $/pack of cigarettes, $4.32 $8 $7

Use according to dosing schedule, NOT as needed. Consider telling the patient: „

$6 $5

$/day

„

COMPARATIVE DAILY COSTS of PHARMACOTHERAPY

“When you use a cessation product it is important to read all the directions thoroughly before using the product. The products work best in alleviating withdrawal symptoms when used correctly, and according to the recommended dosing schedule.”

$4 $3 $2 $1 $0 Gum

Lozenge

Patch

Inhaler

Nasal spray

Bupropion SR

Varenicline

Trade

$6.58

$5.26

$3.89

$5.29

$3.72

$7.40

$4.75

Generic

$3.28

$3.66

$1.90

-

-

$3.62

-

TOBACCO DEPENDENCE: A 2-PART PROBLEM

ASSISTING PATIENTS with QUITTING

Tobacco Dependence Physiological

Behavioral

The addiction to nicotine

The habit of using tobacco

Treatment

Medications for cessation

Treatment

Behavior change program

Treatment should address the physiological and the behavioral aspects of dependence.

HANDOUT

CLINICIANS CAN MAKE a DIFFERENCE

TOBACCO CESSATION REQUIRES BEHAVIOR CHANGE

„

„

„

Fewer than 5% of people who quit without assistance are successful in quitting for more than a year. Many patients under-estimate the impact that counseling can have on their ability to quit Few patients adequately PREPARE and PLAN for their quit attempt. Many patients assume they can just “make themselves quit” when they are ready to do so. Behavioral counseling is a key component of treatment for tobacco use and dependence.

With help from a clinician, the odds of quitting approximately doubles. Estimated abstinence at 5+ months

„

30

n = 29 studies

Compared to patients who receive no assistance from a clinician, patients who receive assistance are 1.7–2.2 times as likely to quit successfully for 5 or more months.

20

10

1.7 1.0

1.1

No clinician

Self-help material

2.2

0 Nonphysician clinician

Physician clinician

Type of Clinician Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

13

Estimated abstinence rate at 5+ months

The NUMBER of CLINICIANS CAN MAKE a DIFFERENCE, too 30

n = 37 studies

Compared to smokers who receive assistance from no clinicians, smokers who receive assistance from two or more clinicians are 2.4– 2.5 times as likely to quit successfully for 5 or more months.

2.5

20

1.8 10

2.4

(1.9,3.4)

(2.1,3.4)

Two

Three or more

CANCER DIAGNOSIS: A TEACHABLE MOMENT „

„

„

(1.5,2.2)

1.0

0 None

One

Number of Clinician Types Fiore et al. (2008). Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: USDHHS, PHS, May 2008.

Interest and motivation to quit is increased after cancer diagnosis Particularly for cancers closely related to smoking, such as lung and head & neck cancer

Health-care providers should routinely address smoking with patients and family members during this window of opportunity

“The window of opportunity remains open throughout treatment and into the period of cancer survivorship.” -- Ellen R. Gritz, PhD The University of Texas MD Anderson Cancer Center

WHY SHOULD CLINICIANS ADDRESS TOBACCO? „

„

The 5 A’s

Tobacco users expect to be encouraged to quit by health professionals.

ASK

Screening for tobacco use and providing tobacco cessation counseling are positively associated with patient satisfaction (Barzilai et al., 2001).

about tobacco USE

ADVISE

tobacco users to QUIT

ASSESS

READINESS to make a quit attempt

ASSIST

with the QUIT ATTEMPT

ARRANGE

Failure to address tobacco use tacitly implies that quitting is not important.

FOLLOW-UP care

HANDOUT

Barzilai et al. (2001). Prev Med 33:595–599.

STEP 1: ASK „

ASK about tobacco use Ask „

“Do you, or does anyone in your household, ever smoke or use any type of tobacco?”

STEP 2: ADVISE „

ADVISE tobacco users to quit „

“Quitting is an important component of your treatment for cancer.” „

„

“We ask all of our patients about tobacco use, because it can negatively impact your [surgery, radiation, chemotherapy] treatment.”

„

„

„

“Smoking slows the healing process after surgery.” “Patients who smoke during radiation therapy have reduced treatment efficacy and lower survival than non-smokers.” “Smoking interacts with many of the chemotherapy medications, and can reduce its effects.”

“It will be important for your family and close friends to either quit with you or to be supportive of your quitting.”

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

14

STEP 3: ASSESS

STEP 4: ASSIST ƒ ASSIST tobacco users with a quit plan

ASSESS readiness to quit

„

„ „

„

Ask every tobacco user if s/he is willing to quit at this time.

ƒ Discuss reasons for quitting and benefits of quitting

If willing to quit, provide resources and assistance „ See STEP 4, ASSIST

ƒ Review past quit attempts -- what helped, what led to relapse

If NOT willing to quit at this time, provide resources and enhance motivation. Ask three questions:

ƒ Set a quit date -- within 2 weeks

„ „ „

ƒ Discuss support from family, friends, and coworkers

“Do you ever plan to quit?” [If yes, continue with…] “How will it benefit you to quit later, as opposed to now?” “What is the worst thing that could happen if you were to quit tomorrow?”

ƒ Encourage use of pharmacotherapy when not contraindicated ƒ Anticipate challenges, particularly during the first few weeks ƒ Nicotine withdrawal, stress-related smoking, etc.

IN THE ABSENCE OF TIME OR EXPERTISE: REFER

STEP 5: ARRANGE ARRANGE follow-up care

„ „

„ „

„

Ask about support from friends, family, co-workers Identify ongoing temptations and triggers for relapse (stress, negative affect, smokers, eating, alcohol, cravings)

„

Referral options: „

„

Has the patient used tobacco at all -- even a puff?

Medication compliance, plans for termination „

REFER patients to other resources

„

Slips and relapse „

„

„

Status of attempt

Is the regimen being followed? Are withdrawal symptoms being alleviated?

A doctor, nurse, pharmacist, or other clinician, for additional counseling A local group program The support program provided free with each smoking cessation medication

„

Websites like www.quitnet.org

„

The toll-free telephone quit line: 1-800-QUIT-NOW

PROVIDE ASSISTANCE THROUGHOUT THE QUIT ATTEMPT

REFERRAL to a TOLL-FREE TELEPHONE QUIT LINE „

Referring patients to a toll-free quit line is simple and easily integrated into routine patient care. „

„ „

Quit line callers receive one-on-one coaching from trained counselors Follow-up counseling is provided Quit lines are effective and are provided at no cost to the caller

THE CANCER CARE TEAM’s RESPONSIBILITY The cancer care team has a professional obligation to address tobacco use and can have an important role in helping patients with cancer, and their family members, plan for their quit attempts.

Sample cards, for distribution to patients.

1-800-QUIT-NOW

TOBACCO CESSATION is an essential component of CANCER TREATMENT for ALL PATIENTS who use tobacco.

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

15

DR. GRO HARLEM BRUNTLAND,

FORMER DIRECTOR-GENERAL of the WHO:

“If we do not act decisively, a hundred years from now our grandchildren and their children will look back and seriously question how people claiming to be committed to public health and social justice allowed the tobacco epidemic to unfold unchecked.”

USDHHS. (2001). Women and Smoking: A Report of the Surgeon General. Washington, DC: PHS.

Copyright © 1999-2009 The Regents of the University of California, University of Southern California, and Western University of Health Sciences. All rights reserved. Updated October 2008.

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