Trends in Risk Reduction Practices for the Prevention of Lym

URGENT ADVOCATE ALERT: Trends in Risk Reduction Practices for the Prevention of Lymphedema * *
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Trends in Risk Reduction Practices for the Prevention of Lym

Postby patoco » Sat Mar 02, 2013 11:33 am

Trends in Risk Reduction Practices for the Prevention of Lymphedema in the first 12 months after Breast Cancer Surgery

Hi, all,

I've uploaded an article to the File section that was written by a surgeon at
Mayo in FL. She is asserting that LE risk information, since it has not been
adequately confirmed by research, should not be offered to cancer patients
because it creates anxiety for them. She would like surgeons to say less about
the risks and about any risk-reduction behaviors, because she believes these lay
an added burden on patients who may or may not ever develop LE.

For those of us who were never warned about the possibility of LE, or were told
we didn't need to worry about it because we "couldn't" get it with a sentinel
node biopsy (or because we were "too thin", or because "none of my patients ever
get LE" or whatever) this is NOT good news or good science. We were never given
the option of taking early action, because our risk was denied or ignored,
perhaps in an effort to "save" us from worry.

As Advocates for Lymphedema here, I just wanted to urge all of you, secondary
and primary alike, to read the article and, if you find it as alarming as I do,
to write to the journal editors and/or to the author. Their contact information
is below:

The journal editor:
Anne Wolfe, Managing Editor

The study author:
Dr. Sarah McLaughlin


Trends in Risk Reduction Practices for the Prevention of Lymphedema in the First 12 Months after Breast
Cancer Surgery

Sarah A McLaughlin, MD, FACS, Sanjay Bagaria, MD, Tammeza Gibson, PA-C, Michelle Arnold, BS,
Nancy Diehl, BS, Julia Crook, PhD, Alexander Parker, PhD, Justin Nguyen, MD, FACS

BACKGROUND: Lymphedema is a feared complication of breast cancer surgery. We evaluated the trends in
lymphedema development, patient worry, and risk reduction behaviors.

STUDY DESIGN: We prospectively enrolled 120 women undergoing sentinel node biopsy (SLNB) or axillary
node dissection (ALND) for breast cancer and assessed lymphedema by upper extremity
volume preoperatively and at 6 and 12 months postoperatively. We defined lymphedema
as a >10% volume change from baseline relative to the contralateral upper extremity. Patients
completed a validated instrument evaluating lymphedema worry and risk reducing behaviors.
Associations were determined by Fisher’s exact and signed rank tests.

RESULTS: At 6 months, lymphedema was similar between ALND and SLNB patients (p ¼ 0.22), but
was higher in ALND women at 12 months (19% vs 3%, p ¼ 0.005). A clear relationship
exists between relative change in upper extremity volume at 6 and 12 months (Kendall tau
coefficient 0.504, p < 0.001). Among the women with 0 to 9% volume change at 6 months,
22% had progressive swelling, and 18% resolved their volume changes at 12 months. Overall,
75% of ALND and 50% of SLNB patients had persistent worry about lymphedema at
follow-up, and no difference existed in the number of risk reducing behaviors practiced
among the 2 groups (p > 0.34).

CONCLUSIONS: Upper extremity volumes fluctuate, and there is a period of latency before development of
lymphedema. Despite the low risk of lymphedema after SLNB, most women worry about
lymphedema and practice risk reducing behaviors. Additional study into early upper
extremity volume changes is warranted to allay the fears of most women and better predict
which women will progress to lymphedema. (J Am Coll Surg 2013;216:380e389.
! 2013 by the American College of Surgeons)

Lymphedema is feared complication after axillary surgery
for breast cancer. The true incidence of lymphedema is
difficult to determine because it may take years to develop.
However, 90% of women who will develop lymphedema
do so within 3 years of breast cancer treatment.1,2 Although
some authors have argued a prodromal phase to lymphedema
exists, the current literature lacks data on progression
to lymphedema and assumes subtle increases in arm
volume remain stable or progress over time.

Frequently cited lymphedema risk factors include the
type of axillary surgery, infection or injury to the ipsilateral
arm after surgery, increased weight or body mass index
(BMI), and radiation or adjuvant chemotherapy.3 Yet
studies disagree on which risk factors are significant and
they present contradictory data concerning the influence
of each risk factor on the future development of lymphedema.
3 Because risk factors are inconsistent, clinicians
educate all breast cancer survivors on precautionary behaviors
in an effort to reduce patient risk for lymphedema.
Common precautionary behaviors supported by the
National Lymphedema Network (NLN) include aggressive
skin care to avoid trauma or injury (avoidance of
needle punctures, blood draws, or intravenous sticks),
avoidance of limb constriction (blood pressure cuff inflation,
tight clothing), avoidance of extreme temperatures,
and frequent use of compression garments (especially for
air travel).4 However, the National Lymphedema Network
acknowledges the paucity of high quality evidence supporting
these practices and admits recommendations are
based on expert opinion and physiologic principles.
With this background, we reviewed our prospectively
maintained axillary surgery database to determine rates
of measured and perceived lymphedema, assess patient
uptake of precautionary practices, and evaluate for trends
in these practices over time, according to patient surgery
and treatment. We hypothesized that arm volume
changes are not static and that despite the lack of evidence
supporting precautionary behaviors to avoid lymphedema
development, the majority of women fear lymphedema
and, therefore, will follow risk reduction practices.



Between January 2009 and August 2010, we prospectively
enrolled 134 women into our registry. Significant travel
distance (3 patients), insurance change (7 patients), death
from other causes (1 patient), death from breast cancer
(1 patient), and withdraw of consent (2 patients) accounted
for those who did not complete 12-month follow-up. The
final study population consisted of 120 women, of whom
53 had an axillary node dissection (ALND) and 67 had
sentinel node biopsy (SLNB) with baseline, 6-month,
and 12-month follow-up. A single surgeon (SAM) performed
all surgical procedures. The prospective registry
records clinical and pathologic characteristics. All patients
consented to baseline and follow-up ipsilateral and contralateral
upper extremity measurements and completed questionnaires
regarding their risk reduction practices. All
patient weights were obtained using the same office digital
electronic scale by Scale-Tronix. Mayo Clinic Institutional
Review Board approved this study.

Education, patient interview, and measurements

At our institution, all patients with a new diagnosis of breast
cancer complete an intake process by a breast medicine
physician, which includes review of a PowerPoint presentation
and a printed Mayo Clinic breast handbook. These
discuss diagnosis, treatment (surgery and adjuvant therapies),
complications, and issues of survivorship including
lymphedema. As part of this handbook, postoperative
range-of-motion arm exercises and lymphedema identification
practices are reviewed and demonstrated with all
patients. Patients then proceed to the breast surgery clinic
on a subsequent day. Once roomed, patients complete
a Disability Arm Shoulder Hand (DASH) and Functional
Assessment Cancer Treatment-Breast (FACT-B) questionnaire
before the consultation. A single surgeon (SAM) then
interviewed all patients, reviewed lymphedema risk,
concerns, prevention, and activity before and after surgery.
Measurements were then obtained preoperatively with the
same nonelastic tape measure.

Two clinicians (SAM and TG) performed all arm
measurements to limit inter-rater variability at 4-cm
increments, from the nail bed base of the middle finger
to the axillary fold using the same nonelastic tape
measure. To limit intra-rater variability, measurements
differing by more than 1 cm from the contralateral arm
were repeated twice to verify the difference, and the
average of these measures was used to calculate the
volume of a frustrum.

Either SAM or TG saw all patients postoperatively at
1 month, 6 months, and 12 months. At these postoperative
visits, patients first completed the Disability Arm
Shoulder Hand and the Functional Assessment Cancer
Treatment-Breast questionnaires, a modified version of
the Lymphedema and Breast Cancer Questionnaire,5
and a standardized questionnaire asking about the practice
of precautionary behaviors to reduce the risk of lymphedema,
and to assess individual fear and worry about lymphedema
risk. The clinician then specifically asked if the
patient had any current swelling in the operated arm
and then obtained the arm measurements. We compared
follow-up and baseline measures for each side and
compared the differences between the ipsilateral and
contralateral arms according to the following formula:

LE ¼ (Ipsilateral Fvolf=u=Ipsilateral FvolB) / (Contralateral Fvolf=u=Contralateral FvolB)

where LE is lymphedema, F is frustrum, vol is volume,
f/u is follow-up, and B is baseline. Lymphedema was
defined as a ratios greater than or equal to 1.10 (10%
increase in the ipsilateral arm when compared with the
changes in the contralateral arm).

All patients were then re-educated on the risk of lymphedema;
patients deemed to be at highest risk, especially
those having ALND or axillary radiation, or any symptomatic
patients (perceived but not measured lymphedema),
those with volume changes >5%, or those with range-ofmotion
difficulties, were referred for evaluation by a single
lymphedema specialty trained physical therapist. This evaluation
consisted of a 1-time educational visit that included
discussion regarding the role of compression sleeves and
range-of-motion exercises. Sleeves were given at patient
request or if deemed necessary by the physical therapist.
No formal decongestive therapy or massage was performed
or taught. The physical therapist counseled all patients to
wear the sleeve if experiencing symptoms but did not
recommend prophylactic use.

At all preoperative and postoperative visits, patients
were counseled (by SAM) to maintain their normal
activity, acknowledge their symptoms, and to return to
their presurgery activity in a gradual fashion. In addition,
they were told, in accordance with recently published
data, that exercise and weight lifting in a controlled
fashion starting with low weight and few repetitions
may potentially be beneficial in lymphedema prevention6-
8 and may offer psychological benefit and improved
range of motion, without hastening the development of

Data analysis

Patient objective measurements, interview data, and questionnaire
responses were summarized and compared by
axillary surgery group and other patient characteristics.
Differences between groups and associations between
lymphedema, worry, and precautionary behaviors were
assessed using Fisher’s exact test for categorical variables
and the Wilcoxon rank sum test or signed rank test for
continuous variables. Evaluation was performed using
the SAS 9.2 operating system and a p value of less than
0.05 was considered statistically significant.


Study population characteristics according to surgery type
are listed in Table 1. Women completing SLNB were
similar in age and BMI to those undergoing ALND,
but had smaller tumors and were less likely to receive
adjuvant chemotherapy or radiation. Operations were
performed on the side ipsilateral to the dominant hand
in 56 of 120 (47%) and on the side of the nondominant
hand in 61 of 120 (51%). All patients completed 6-
month and 12-month follow-up.

Measurement data

Measurement data demonstrated no difference in the
presence of lymphedema among SLNB patients at 6
and 12 months (2% vs 3%, p ¼ 0.56), but found an
increase in lymphedema between 6 and 12 months
among ALND patients (6% vs 19%, p ¼ 0.008). No
difference in lymphedema existed at 6 months among
women having ALND or SLNB (3 of 53 [6%] vs 1 of
67 [2%], p ¼ 0.22). However, at 12 months, significantly
more ALND women developed lymphedema compared
with SLNB (ALND, 10 of 53 [19%] vs SLNB, 2 of 67
[3%], p ¼ 0.005) (Table 2). Although we demonstrated
a relationship between the relative change in upper
extremity volumes at 6 and 12 months, Kendall’s tau
coefficient 0.504, p < 0.001 (Table 3), arm measurements
did not remain static. Of the 114 women whose
relative volume change ranged between 0 and 9% at 6
months, 25 of 114 (22%) had worsening of their
swelling, and 9 of these 25 (36%) progressed to lymphedema
by 12 months (Table 3). Conversely, 19 of 114
(18%) women had a decrease in their relative volume
change at 12 months compared with the 6-month
measurement, with 17 returning to <0% change
compared with baseline.

Overall, 56 of 114 (49%) women with volume changes
(progression or regression) had been evaluated by physical
therapy for the symptoms or because they had an ALND.
In all cases, however, garment use was not standardized
and patients were urged to wear compression garments
when they had symptoms, but not for prophylactic use.
With this method, 7 women progressed to lymphedema
(>10% at 12 months), 9 women regressed from 0 to
5% at 6 months to <0% by 12 months, and 38 remained
unchanged. The remaining 58 of 114 (51%) did not have
any garment use.

Interview data

More ALND than SLNB patients perceived arm swelling
at 6 and 12 months. Interview data identified a similar
number of ALND patients perceiving swelling at both
6 and 12 months (25% vs 31%, p ¼ 0.80) (Table 2).
The perception of swelling in SLNB patients was also
similar at 6 and 12 months (11% vs 6%, p ¼ 0.76),
but was consistently less than that seen in patients having
ALND. Interestingly, at all time points and regardless of
the type of axillary surgery, more patients perceived
swelling than had measured lymphedema. Data from
the validated instrument paralleled patient perceptions:
19% and 25% ALND (p ¼ 0.65) and 5% and 6% of
SLNB patients (p ¼ 1.0) reported an increase in arm
size at 6 and 12 months, respectively. Overall, 83% of
patients had agreement in their measurement and perceptions
of lymphedema; the remaining 17% disagreed with
12% perceiving lymphedema without measurement and
5% having measured lymphedema without the perception,
but this discordance was not statistically significant

Risk factors

At 12 months, we found extent of axillary surgery to be
the only significant risk for developing lymphedema
(p ¼ 0.005). Patient age, BMI at baseline and follow-up,
type of breast surgery (breast conserving surgery or mastectomy),
and receipt of breast or chest wall radiation were
not associated with increased lymphedema (all p > 0.49)
(Table 5). Although 11 women reported infection or
injury in the ipsilateral arm 12 months postsurgery, only
1 perceived swelling in her arm, and none demonstrated
measured lymphedema. Finally, patients with measured
lymphedema at 6 and 12 months were more likely to
have had surgery on the side of their nondominant arm:
75% and 67%, respectively. Similarly, more patients
perceiving lymphedema also had surgery on the side of
their nondominant arm: 65% and 60%, respectively.

Overall, patients with lymphedema practiced a similar
number of precautionary behaviors to those without

Patient worry and risk reduction practices
The majority of patients demonstrated worry about developing
lymphedema. At 6 months, 75% of ALND and
52% of SLNB patients reported worry about getting lymphedema.
Interestingly, patient worry remained consistent
at 12 months, with 76% of ALND and 49% of SLNB
patients reporting worry (both p > 0.45) (Table 2). To
reduce future risk of lymphedema, ALND patients practiced
a median of 5 risk reducing behaviors at 6 and 12
months, and SLNB women followed 4 at both time
periods (p each > 0.34). Of the 10 precautionary behaviors
assessed, avoidance of IVs, blood pressure cuff inflation,
and blood draws were the most commonly
practiced (Table 6). Although at least 96%, 88%, and
94% of ALND women practiced these behaviors, respectively,
at both time points, fewer, but still the majority,
of all SLNB patients followed the same practices (87%,
69%, and 76%, respectively). No difference existed in
the frequency of these practices in either group or between
6 and 12 months (all p > 0.62). Of the remaining precautionary
behaviors surveyed, ALND women were more
likely to adopt wearing a compression sleeve by 12 months
than at 6 (35% vs 15%, respectively, p ¼ 0.003). Otherwise,
no difference existed in the adoption or practice of
any precautionary behavior at 12 months when compared
with 6 months.


Breast cancer survivors have long feared lymphedema given
its associated physical and emotional impairments and
associated negative impact on overall quality of life. To
reduce the incidence of lymphedema, surgeons have proactively
tried to limit axillary surgery. The adoption of SLNB
as the standard of care for axillary staging attests to this
movement. More recently, practice patterns have demonstrated
a decline in ALND after positive SLNB for micrometastatic
or isolated tumor cells, suggesting clinicians feel
axillary evaluation is more a diagnostic than a therapeutic
procedure.9 Publication of the American College of
Surgeons Oncology Group (ACOSOG) Z0011 trial now
confirms the lack of a survival benefit for completion
ALND in women with 1 or 2 positive nodes completing
breast conserving surgery, adjuvant systemic therapy, and
whole breast radiation.10 In spite of these efforts to minimize
axillary surgery, the risk of lymphedema remains
because there is clearly a small but definite risk of lymphedema
after SLNB11-15 and a clear but less well documented
risk of lymphedema after axillary radiation.16
The etiology and progression of arm symptoms and
measurements to lymphedema are unclear. Norman and
colleagues1 demonstrated that women with mild lymphedema
are more prone to progress to severe lymphedema.
However, few data document change in arm volumes in
the prodromal or prelymphedema phase that may signal
future risk for the development of lymphedema. We found
that although a clear relationship exists between arm
volume measurements at 6 months and 12 months, not
all patients with an increase in their arm volume from baseline
progress to lymphedema. We demonstrated that 30%
(19 of 63 patients) of women with some degree of measurement
change from 0 to 9% at 6 months actually resolved
their volume increase by 12 months, with little to no
compression garment usage in the majority of patients. This
is important because it further demonstrates our inability to
predict who will progress to lymphedema and underscores
the need for baseline ipsilateral and contralateral arm
measurements. In addition, this regression without intervention
highlights the natural fluctuations in arm volumes
and underscores the need for consistent long-term, consecutive
follow-up measurements to confirm lymphedema.
Importantly and in contrast, those women demonstrating
lymphedema at 6 months did not resolve their lymphedema
or decrease their arm measurements at 1 year.
Clinicians frequently counsel patients regarding lymphedema
risk based on the presence of previously reported
risk factors like injury, infection, BMI, age, and
surgery. Lymphedema prediction based solely on these
factors is unreliable, as evidenced by the multiple studies
presenting conflicting data on each risk factor and on the
magnitude of influence each risk factor carries.2,3,17
Furthermore, individual recall of these events can be
subject to significant bias as demonstrated in our data,
10 women reported infection in the arm at 6 months
postsurgery, but only 5 reported infection since surgery
at 1 year. Clearly, clinician reliance on patient acknowledgement
of risk factors may not successfully result in
accurate prediction and stratification of lymphedema risk.
Perceived lymphedema remains higher than measured
lymphedema at all time points. Although we found
a high degree of concordance between perceptions and
measurements, we suggest that a perception of lymphedema
is more likely to influence the adoption of lymphedema
risk reducing behaviors than is an unrecognized
measurement change. This is consistent with the findings
of other investigators, who have demonstrated that symptomatic
women with lymphedema or those with symptoms
or the perception of lymphedema have an overall
poorer quality of life.18-20 Although debate exists on the
standardization of lymphedema evaluation methods,
perhaps in reality, from the patient’s perspective it is
only the perception of lymphedema that matters clinically
and it is this perception that influences quality of life
more than a measurement change.
Just as patients appear to overestimate their long-term
risk of contralateral breast cancer,21 we found that at 12
months they also worry in excess of their true risk for
developing lymphedema (75% of ALND patients and
50% of SLNB patients). Although worry of lymphedema
after ALND may be more understandable, excess worry
after SLNB may be unfounded, given the sustained low
risk of developing lymphedema after SLNB. It is possible
that patient knowledge that lymphedema is unpredictable,
devastating, and a permanent complication influences
the fear and worry of developing lymphedema
many women feel years after surgery. Although the
etiology of this worry remains unclear, some suggest it
may be attributed to patient symptoms, treatment regimens,
education level, earlier experiences, or even education
and counsel on risk reducing practices.22,23
Regardless of its etiology, clinicians must recognize that
patient worry about the future development of lymphedema
is significant. Clinicians struggle in counseling
patients because the development of lymphedema is
multifactorial and the ability to control all risk factors
and patient exposures across studies is merely impossible.
Bevilacqua and associates24 developed a nomogram to help
predict development of lymphedema. Internal validation
suggests reasonable concordance when used preoperatively,
with a concordance index of 0.706. Although no
nomogram can dictate patient care it may help stratify
at risk patients, allowing individualization of risk
reduction strategies. Specific implementation strategies
and algorithm development, as opposed to widespread
application of all practices, will be critical to determining
the real value of risk reducing behaviors. Further, this
strategy will allow early intervention in high risk patients
with physical therapy and intense preventative practices
(garments, exercise, and perhaps early decongestive
therapy). Beyond this, it is our opinion that patients
who understand their individual risk and are knowledgeable
about symptoms, arm function, and exercise will
ultimately incorporate only high yield changes to their
lifestyle. However, this patient understanding can be
achieved only with better clinician education.
Physicians and allied health staffmust recognize that data
supporting risk reducing behaviors are sparse, and what few
data are available are contradictory and of poor quality.25-30
Despite these flaws, patients adopt these practices vigilantly
and almost uniformly. Furthermore, to our knowledge, our
data are the first to demonstrate that the practices are adopted
almost immediately after surgery.This is ironic given the
current evidence-based focus on breast cancer care and the
lack of proven benefits associated with these practices, but
understandable given that within 12 months most patients
are just completing adjuvant treatments. Unfortunately,
the risk of lymphedema will not be eliminated by simply
limiting axillary surgery. Although practice patterns demonstrate
and support a move away from axillary dissection,
especially after breast conserving surgery,6 the breast cancer
community has witnessed an increase in the use of axillary
radiation to help maintain local control. Recent data by
Caudle and coworkers31 found axillary radiation tangents
to be adjusted higher in up to 43% of patients in the
post-Z0011 era. Although no debate exists on the importance
of multimodality care, there has been little focus on
the potential side effects from these other treatments

Our study is limited due to small numbers and short
follow-up. We continue to actively enroll patients in the
registry and are actively following patients annually.
Unfortunately, our small numbers make it difficult to
determine the effectiveness of the individual precautionary
behaviors, but the study was not designed to show intervention
differences, only practice patterns. We opted for
circumferential tape measurements at 4 cm increments,
then conversion of the circumferential measurements into
volume calculations as our measurement technique, despite
knowing traditional water displacement is the gold standard
for limb volume assessment. Practical limitations in
volume displacement prohibited implementation into our
daily surgical practice. We limited those performing the
measurements to minimize variability in technique and
found this the cheapest and easiest way to standardize
our practice. Consistent circumferential measurements
are an accepted measurement assessment tool for lymphedema.
Finally, intervention by physical therapy was not
standardized in patients with volume changes <10%.
Although 49% of these women had a formal physical
therapy evaluation, only 10% had volume changes >5%
at 6 months. Garment use was inconsistent but all patients
were encouraged to exercise and use their arm normally.
Individualization in surgery and radiation therapies
may help further minimize the risk of measured or
perceived lymphedema. Regardless of risk, however,
patients demonstrate worry about developing lymphedema.
Unless we can better predict lymphedema, persisting
patient and clinician confusion will reinforce the
general application of precautionary behaviors to all
breast cancer survivors without regard to individual
patient risk or documented benefit. Improved risk stratification
of patients and further study into the value of the
precautionary behaviors may help to allay the fears of the
majority of SLNB women who are unlikely to ever
develop lymphedema.
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