BREAST CANCER SCREENING/RISK MANAGEMENT
Highlights from the 10th Annual Practical Women’s Health Issues, sponsored by Boston University School of Medicine
Educational Objectives
| The goals of this program are to improve screening for breast cancer, and to ensure that any screening for breast and
gynecologic cancers takes into account risk management issues. After hearing and assimilating this program, the clinician
will be able to:
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 | 1. Identify candidates for early breast cancer screening.
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| 2. Enumerate ways of minimizing false-negative mammography findings.
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| 3. Analyze the meaning of abnormal imaging findings and give patients a realistic idea of their risk for breast
cancer.
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| 4. Anticipate the issues that are most likely to arise in malpractice litigation involving failure to diagnose breast
or gynecologic cancers.
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| 5. Establish a standard cancer screening protocol.
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Faculty Disclosure
In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the
planning committee to disclose relevant financial relationships within the past 12 months that might create any personal
conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes
quality in health care and not a proprietary business or commercial interest. For this program, the faculty and planning
committee reported nothing to disclose.
Acknowledgements
This program was recorded at the 10th Annual Practical Women’s Health Issues, held October 27, 2007, in Dedham,
MA, and sponsored by the Boston University School of Medicine. The Audio-Digest Foundation thanks the speakers
and Boston University School of Medicine for their cooperation in the production of this program.
| UPDATE ON BREAST CANCER SCREENING —Priscilla J. Slanetz, MD, MPH, Associate Professor of Radiology,
and Director of Undergraduate Medical Education, Boston University School of Medicine, Boston, MA
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| Screening: 2 to 10 findings of cancer for every 1000 women screened; annual mammography recommended for
women at average risk starting at age 40 yr; reduces mortality by 30%; for women with first-degree premenopausal
relative with breast cancer, begin screening 10 yr before age of relative at diagnosis
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| Screening mammography: each breast compressed twice in 2 views (craniocaudad; mediolateral oblique); spiculated
mass and calcifications (especially if clustered or pleiomorphic) most common signs of malignancy ,
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| Breast Imaging Reporting and Data System (BI-RADS) mammography analysis: standardized method of describing
and communicating findings of imaging studies; consists of 7 assessment categories; malignancy potentially
still present if imaging findings negative but physical work-up yields palpable lump (refer to specialist)
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| Digital images: cancer detection rates equal to those achieved with film mammography; may be slightly better for
dense breasts
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| Mammography drawbacks: may miss 5% to 15% of cancers; patients often believe accuracy 100%
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| Techniques for minimizing false negatives: double reading—second radiologist examines every screening mammogram
for lesions missed by first reader; detects 5% to 15% of cancers missed initially; however, many centers
lack sufficient staff for double-reading program; digital equipment presents logistic work flow challenges; computer-aided
detection—images processed through software that looks specifically for features of malignancies;
increases cancer detection rate by 5% to 20%
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| Recall rates: currently ≈10%, up from 5% few years ago; urge patient to make all previous images available to
reading radiologist (≤50% reduction in risk for callback); after callback, 90% to 99% of patients return to routine
screening; of those called back, 1% to 2% undergo biopsy; 20% to 30% of those biopsies positive
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| Whole breast ultrasonography (US): performed in addition to mammography; as yet, no large prospective studies
to support use; technique difficult to standardize, so may not be appropriate for this application
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| Magnetic resonance imaging (MRI): currently used (especially in newly diagnosed patients) to assess extent of disease;
detects occult cancers in newly diagnosed and high-risk patients (ie, women with breast cancer susceptibility
gene); American Cancer Society recommends annual MRI screening in addition to mammography for women
with lifetime breast cancer risk >20% to 25% (do concurrently or alternately at 6-mo intervals)
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| New tools on horizon: digital tomosynthesis—specialized mammography machine; breast squeezed only once; machine
rotates over arc, generating 9 to 12 high-resolution images; reduces risk for false positives; positron emission
mammography—already approved by Food and Drug Administration; device resembles conventional
mammography machine (breast squeezed twice), but provides good views through dense tissue; patient injected
with radioactive glucose, which is taken up by metabolically active tissue (ie, tumor); particularly promising for
women at high risk or with dense breasts
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| Algorithm for patient with BI-RADS 0 image: category denotes incomplete assessment or abnormal screen; order
diagnostic mammography (plus US in some cases; rely on radiologist for guidance); few patients require more
imaging or biopsy
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| The problem patient: presents with lump, diffuse or focal pain, nipple discharge; evaluate patient’s clinical history
and risk factors; conduct thorough physical examination, looking for masses, thickening, discharge, skin
changes, or axillary lymphadenopathy; diagnostic mammography and US also indicated for patients older than 30
yr; US alone sufficient for younger patients; show patient where you feel abnormality (if different from her observation);
use diagram if possible
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| Diagnostic mammography: many centers do not have radiologist on site to read screening studies; radiologist
does read diagnostic images; technologist has patient mark area of concern on skin, then takes additional spot
compression or magnification views for close-up examination; US targeted specifically to area of concern; 1%
to 3% of patients have malignancy, so follow-up necessary within 1 to 6 mo, with referral for biopsy if concerns
persist
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| When and how to biopsy: if mass solid and appears benign—6-mo follow-up “reasonable,” but few patients
comfortable with that (prefer needle biopsy to confirm benign status); options include fine needle aspiration
(FNA), core biopsy, or excisional biopsy
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| Core needle biopsy: less invasive than surgical biopsy, with equivalent accuracy; unlike FNA, can distinguish
between invasive and in-situ cancer; receptors on tissue can help guide future chemotherapy, if necessary;
>90% of biopsies today performed with US guidance; other guidance modalities include stereotaxis and
MRI; risk for sampling error key drawback; always match pathology results with imaging findings; discrepancy
usually indication for surgical excision; other benign diagnoses that indicate excision—atypia; radical
scar; atypical papillary lesion; even these usually benign
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| Stereotactic needle biopsy: reserved for calcifications or masses not visible on US; vacuum-assisted device often
guides needle; radiographs taken of tissue samples
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| Magnetic resonance (MR)-guided core biopsy: especially helpful in determining extent of disease in newly diagnosed
patient, finding primary tumor in patient with positive axillary lymph node, and screening high-risk patients;
highly sensitive; patient lies prone, with breasts hanging into device; requires only local anesthesia (as
with all needle biopsies); possible complications include local bruising, bleeding, and infection
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| FNA: usually reserved for lumps in axillary lymph node; involves insertion of 22-gauge spinal needle into lesion
and acquiring cells for cytology
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| Preoperative needle localization: identifies nonpalpable lesion for surgery; ≥1 wires placed to help guide surgeon;
needle localization usually performed under mammography or US; performed under local anesthesia,
but patient must be fasting because surgery follows procedure
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| Key points: according to current screening recommendations, initiate annual mammography at age 40 yr (earlier if
risk factors present); ensure all previous studies from outside facilities available (can reduce recall rate by ≤50%);
use BI-RADS assessment codes to ensure appropriate follow-up; recall rate ≈10%, but majority of women return to
routine screening; if patient symptomatic, not pregnant, and >30 yr of age, order diagnostic mammography (plus
US if lesion palpable); outcome of those studies determines next course of action; start with US if patient pregnant
or <30 yr of age and symptomatic; benign disease best managed in office
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| LIABILITY RISKS AND PITFALLS IN BREAST AND GYNECOLOGIC CANCER MANAGEMENT —
Maureen Mondor, Vice-President, ProMutual Group, Boston
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| Study conducted by ProMutual Group: between 2002 and 2004; included internal medicine, family practice,
radiology, obstetrics/gynecology, general surgery, and orthopedics; most common allegation failure to diagnose
(39% of 452 cases); total payout $71 million; of that, $37.8 million indemnity paid for failure to diagnose cancer;
largest number of cancer cases for breast cancer; of 62 cases closed during study period, 26 paid out, with
aggregate indemnity payment of $13225,000; litigation related to colorectal cancer growing; often involves patients
in their early twenties who have indeterminate gastrointestinal symptoms; claims involving other gynecologic
cancers—of 28 cases involving cervical cancer, 12 closed with total payment of $3555,000; of 6 cases of
uterine cancer, 2 closed with total payment of $475,000; overall, fewer lawsuits related to breast cancer (and
with lower payouts) today than in previous years; most likely due to better care
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| Risk issues: failure to have or adhere to cancer screening protocol—utilizing protocol strongly recommended; determine
when to send patient for mammography or US; if patient does not follow through, document that recommendation
made but not heeded; failure to include cancer in differential diagnosis—think “worst to least” and
work backward from there; inadequate follow-up another common mistake; physician-to-physician
communication—establish who is in charge of following patient and ensuring follow-up visit; some primary
care physicians now employ nurse practitioners to perform breast and pelvic examinations; physicians uncomfortable
with performing these examinations in office should make sure patients directed to professional facilities
elsewhere; do not rely solely on patient’s answers; determine which tests to order, and whether mammography
should be screening or diagnostic
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| Clinical breast examination: done properly, may take 15 to 20 min; perform annually and document; medical
history—commonly missed; always ask about family history of breast cancer (common issue in malpractice
cases); also ask about and follow up on any breast complaints, especially those involving breast self-examination
(BSE; 87% of plaintiffs in ProMutual study discovered their own lumps but were inadequately followed); ask
whether another clinician performing patient’s breast examinations, and if so, obtain copy of that report; follow
up on previous complaints; pay immediate attention to pregnant patients with breast complaints; first postpartum
breast examination critical
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| Screening mammography: be aware of false negatives; establish protocols for performing or referring; identify at-
risk patients in your practice (ask about family history, as well as personal history of breast complaints); compare
films if patient has them (lost or misidentified films always danger when patient entrusted to carry them from one
office to another; save copy of patient’s driver’s license when she picks up her films); assume cancer until it is
ruled out; have patient point out lump or abnormal area
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| Tissue diagnosis: perform or refer; biopsies or FNA best performed by someone who does them frequently; share
results with other practitioners (ensure patient does not fall out of “circle of care”); consider options
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| Communication: identify person responsible for coordinating clinical team; if patient does not keep follow-up appointments,
send letter emphasizing seriousness of matter; call ≥3 times; document all efforts to reach patient; explain
benefits and limits of treatment as part of informed consent; answer all of patient’s questions; if patient has
written list of questions, put copy in her chart, noting when they were discussed; most important action to develop
and implement system for tracking and following up on results; develop and implement system for patient
notification
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| Documentation: record every step, including plan; document breast characteristics, including contour, texture, discharge,
masses, symmetry, and tenderness; draw pictures; follow up and refer when indicated
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| Gynecologic risk issues: similar to those for breast cancer; develop and adhere to cancer screening protocols; always
“think cancer”; it “knows no age limits”; follow-up and tracking important
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| Papanicolaou (Pap) tests: ascertain where and to whom they go, and their standards for returning results; learn what
quality assurance systems pathologist has in place
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| Communication: educate patient, make her your partner, listen to her; familiarize yourself with patient education
Web sites and recommend some; remain open to what patient has to say
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Suggested Reading
Barron MA, Fishel RS: Talk to your patients about breast disease. Nurse Pract 32:22, 2007; Berg WA et al: Combined
screening with ultrasound and mammography vs mammography alone in women at elevated risk of breast cancer.
JAMA 299:2151, 2008; Koh JM et al: Prospective assessment of computer-aided detection in interpretation of screening
mammography. Am J Roentgenol 187:1483, 2006; Levy AG et al: Making sense of cancer risk calculators on the
web. J Gen Intern Med 23:229, 2008; Mendel JB, Long M, Slanetz PJ: CT-guided core needle biopsy of breast lesions
visible only on MRI. Am J Roentgenol 189:152, 2007; Miller D et al: Interventions for relieving the pain and discomfort
of screening mammography. Cochrane Database Syst Rev Jan 23:CD002942, 2008; Pineault P: Breast cancer
screening: women’s experiences of waiting for further testing. Oncol Nurse Forum 34:847, 2007; Potter MB: Counseling
women about mammography: benefits vs. harms. Am Fam Physician 76:652, 2007; Singh H et al: Errors in
cancer diagnosis: current understanding and future directions. J Clin Oncol 25:5009, 2007; Strunk AL, Kenyon
S: Medicolegal considerations in the diagnosis of breast cancer. Obstet Gynecol Clin North Am 29:43, 2002; Zylstra
S et al: Defense of breast cancer malpractice claims. Breast J 7:76, 2001.
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