VIEWPOINTS

Both Duration and Pack-Years of Tobacco Smoking Should Be Used

for Clinical Practice and Research
Roy A. Pleasants1,2, M. Patricia Rivera1, Stephen L. Tilley1, and Surya P. Bhatt3*
1
Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; 2North
Carolina Thoracic Society, Chapel Hill, North Carolina; and 3Division of Pulmonary, Allergy, and Critical Care Medicine, University of
Alabama at Birmingham, Birmingham, Alabama
ORCID ID: 0000-0002-9020-2487 (R.A.P.).

Tobacco smokers are more likely to develop
cardiac and pulmonary diseases than never-
smokers, and risk increases in a dose-
dependent manner. Pack-years, the product
of cigarettes per day in increments of packs
(one measure of intensity) and duration
(years smoked), is a cumulative exposure
indicator of smoking burden, routinely
used to estimate patients’ risk of
developing smoking-related diseases for
clinical practice, research, and healthcare
policies. The use of pack-years is based on
the assumption that both intensity and
duration are equally important. Research
suggests this is not the case; duration
should be considered more important
than intensity or the composite pack-years
in determining risk of developing
smoking-related diseases, such as lung
cancer (1–3) and coronary artery disease
(4), as well as affecting disease severity in
chronic obstructive pulmonary disease
(COPD) (5).
Evolution of Term Pack-Years
to Define Tobacco
Smoking History
In early clinical studies examining the dose–
response relationship in smoking-related
diseases, cigarettes per day and years
smoked were used to define tobacco
exposure. In a landmark study in 1950
examining the effect of tobacco smoking on
the occurrence of lung cancer, Doll and Hill
used smoking exposure metrics of cigarettes
smoked in lifetime, age of starting smoking,
and cigarettes per day (6). They arbitrarily
chose cigarettes per day categories ranging
from 1 to 4 cigarettes to .40 cigarettes/d
for their analysis. All tobacco smoking
measures were found to increase lung cancer
risk, including cumulative cigarettes smoked
in lifetime—a pack-years equivalent. About
95% of individuals diagnosed with lung
cancer had smoked for .20 years, and 79%
had initiated smoking at ,20 years of age,
indicating that exposure metrics that
consider duration are highly predictive of
disease risk (6). Pack-years were first
reported in the medical literature in the
mid-1950s, when Franklin and colleagues
found a strong relationship between pack-
years and lung function impairment in
patients with COPD (7). Among major
epidemiologic publications, it was not
until the 1971 U.S. Surgeon General’s
report on the health effects of smoking
that pack-years were first mentioned (8).
Numerous studies have since found a strong
relationship between pack-years and the
occurrence and severity of pulmonary and
cardiac diseases but often did not undertake
analyses comparing smoking duration with
intensity on outcomes.
Key Dose–Response Studies in
Lung Cancer
In one of the first studies to critically
evaluate the dose–response relationship
between tobacco smoking and the risk of
lung cancer, Doll and Peto found the risk to
be exponentially greater, between the
fourth and fifth power, for years smoked,
whereas cigarettes per day was to the
second power (1). Pack-years or other
cumulative exposure measures were not
reported in this study. Nearly 2 decades
later, Lubin and Caporaso reported
persons smoking at a lower intensity over a
long time period were more likely to
develop lung cancer than those smoking at
a higher intensity over a shorter time
period (2). At higher smoking intensity,
they found that the excess odds per
additional pack-years of smoking were
lower than for lower smoking intensities
(excess odds ratio per pack-years: 0.293,
0.315, 0.247, and 0.203 for smoking
intensities ,20, 20–29, 30–39, and >40
cigarettes per day, respectively) (2).
More recently, a case–control study

(Received in original form February 13, 2020; accepted in final form April 29, 2020 )
*S.P.B. is Associate Editor of AnnalsATS. His participation complies with American Thoracic Society requirements for recusal from review and decisions for
authored works.
Correspondence and requests for reprints should be addressed to Roy A. Pleasants, Pharm.D., Division of Pulmonary Diseases and Critical Care Medicine,
University of North Carolina at Chapel Hill, 7202 Marsico Hall, 125 Mason Farm Road, Chapel Hill, NC 27599. E-mail: roy.pleasants@unchealth.unc.edu.
Ann Am Thorac Soc Vol 17, No 7, pp 804–806, Jul 2020
Copyright © 2020 by the American Thoracic Society
DOI: 10.1513/AnnalsATS.202002-133VP
Internet address: www.atsjournals.org

804 AnnalsATS Volume 17 Number 7 | July 2020

 VIEWPOINTS

found the odds ratio for lung cancer
was greater with pack-years or duration
than cigarettes per day (3). The odds
of lung cancer increased more with every
10-U increase in exposure for duration
(odds ranging from 1.23–28.94 for 20 to
.50 yr of exposure) than for intensity
(3.18–11.87 for 20 to .40 cigarettes per
day) (3). Lung cancer mortality also
appears to be more strongly affected by
years smoked than smoking intensity.
Among 746,485 smokers enrolled in
the American Cancer Prevention Study II,
the association between duration and
lung cancer mortality (risk ratio for
log-transformed years ranging from 3.5
to 16) was exponentially greater than
for cigarettes per day (risk ratio for
log transformed intensity ranging
from 1.4 to 2.6) across strata of age and
sex (9).
Key Dose–Response Study in
Obstructive Lung Diseases
Obstructive lung disease also appears
to be affected to a greater extent by
smoking duration than intensity. In the
COPDGene cohort of smokers (>10 pack-
year history), Bhatt and colleagues
compared the dose–effect relationships of
cigarettes per day, pack-years, and
smoking duration with disease severity
measures (5). There was a linear decrease
in adjusted mean forced expiratory
volume in 1 second/forced vital capacity
with years smoked over all ranges of
smoking intensity (b = 20.041 6 0.004;
P , 0.001) but a relatively flat slope for
cigarettes per day across all ranges of
smoking duration (b = 20.009 6 0.009;
P = 0.34). Computed tomography (CT)
measures of emphysema and gas
trapping were similarly more strongly
associated with smoking duration than
intensity (5).
Going beyond Using
Pack-Years for COPD and
Lung Cancer
First and foremost, patients and healthcare
providers should recognize that it is the
number of years smoked, and not how much
tobacco one smokes daily, that is the most
important measure associated with risk of
adverse health outcomes in COPD and
lung cancer. In other words, even small
amounts of daily tobacco smoking over an
extended time period have significant health
risks.
Although there is sufficient evidence to
show that COPD severity on the basis of
clinical and radiographic measures is more
dependent on years smoked than pack-years
or cigarettes per day (5), it is unclear which
smoking metric provides the best estimate
for the risk of developing COPD. The
implications of relying on pack-year history
alone while not considering duration of
smoking are substantial for lung cancer, in
particular regarding population screening with
low-dose CT. In the United States, the National
Lung Screening Trial established the criteria for
use of low-dose CT among current or former
(quit within 15 yr) smokers, aged 55 to 74 years
with at least a 30 pack-year smoking history
(10), but no specific rationale was provided for
this amount of tobacco smoking or cessation
interval. In the NELSON study in Europe
investigating lung cancer screening in the
general population, inclusion criteria for
smoking were based on a combination of years
smoked and pack-years (11). High-risk
subjects were defined as those between the
age of 50 and 74 years, who had smoked at
least 15 cigarettes/d for >25 years or 10
cigarettes/d for >30 years. Omission of
low-intensity, long-term smokers from
screening leads to disparities, particularly
in black and Hispanic individuals who
typically smoke a half-pack or less daily
but often with longer durations (12).
Compared with white individuals, black
adults are more likely to be diagnosed with
lung cancer and have the worst outcomes
(hazard ratio for all-cause mortality, 1.35)
but accrue greater survival benefit from
lung cancer screening (hazard ratio for
mortality, 0.61 vs. 0.86) (13).
There are some pragmatic issues also in
support of reporting smoking duration: 1)
patient recall is more reliable for years
smoked than pack-years because use is
variable over time, 2) widely used electronic
medical record systems for patient care
contain a field to document years of use, 3)
tobacco years is a simplified approach to
define exposure to smoking pipes, cigars, or
hookah that are harder to quantify than
cigarettes, and 4) duration provides a
practical measure for population health
surveys of tobacco use.
Conclusions
On the basis of current evidence, we believe
it is time for a paradigm change in assessing
and reporting patients’ smoking history to
include both the composite of pack-years
and the duration of smoking—whether it be
for patient care or research. Low-intensity
smokers and those who have decreased their
daily consumption because “it is safer”
should be informed that a few cigarettes
each day can be as damaging to the lungs as
a pack or more a day. Methodologic research
is needed in epidemiologic and clinical
studies of COPD and lung cancer to
determine how to simultaneously
incorporate measures of duration and
intensity. In particular, further investigation
is needed to determine if reliance on pack-
years is appropriate to guide healthcare
policy or for enrollment in clinical trials of
COPD, or for other uses, all of which
typically rely on a minimum of a 10 pack-
year history. n
Author disclosures are available with the text
of this article at www.atsjournals.org.

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AnnalsATS Volume 17 Number 7 | July 2020