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ST. JOHN HEALTH

BREAST CARE PROGRAM

STANDARD4.3 PATIENT SURVEILLANCE Standard of Care:

Followingcompletionof breast cancertherapy,all patientsshouldbe monitoredin the following manner:

.

History and physical examination should be completed every 3-6 months for the first three years after primary therapy, every 6-12 months for years 4 and 5; then annually thereafter.

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Patients should be counseled to perform monthly breast self-examination.

.

First post-treatment mammogram should be completed withinl year of the initial mammogram that led to diagnosis but no earlier than 6 months after the definitive radiation therapy. Unless otherwise indicated, a yearly mammographic evaluation should be performed. For patients who have had a lumpectomy, a mammogram should be recommended every 6 months for the first 2-3 years.

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Regular gynecologic follow-up including a pelvic examination should be completed on an annual basis for women with intact uteri. If patients are receiving Tamoxifen, they should be advised to report any vaginal bleeding to their physician(s).

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Continuity of care should continue indefInitely by a physician experienced in the surveillance of cancer patients and in breast examination, including the

examination of irradiated breasts.

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Adjuvant endocrine therapy follow-up, to include patient adherence and

associated symptom management, should be managed by either a breast surgeon or a medical oncologist.

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Baseline levels of estradiol and gonadotropin followed by serial monitoring of these hormones should be performed if an aromatase inhibitor is initiated in women with amenorrhea following chemotherapy.

.

Bone health should be monitored and supplemental calcium and Vitamin D given to women who are at risk for osteopenia or osteoporosis (Le., premenopausal women who experience early ovarian failure secondary to adjuvant chemotherapy and postmenopausal women who are treated with an aromatase inhibitor).

.

Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling.

The following evaluations are not recommended in asymptomatic patients with no specific findings on clinical examination:

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Imaging studies (i.e., chest x-ray, bone scans, liver ultrasound, computed tomography scans);

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Tumor markers (i.e., CAI5-3, CA27-29 and CEA);

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FDG-PET scans ,for routine breast cancer surveillance;

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Breast MRI for routine breast cancer surveillance, however, this would be considered as an option for post-therapy surveillance and follow-up in women at high risk of bilateral disease (e.g., carriers ofBRCA 1 or 2 mutations, strong family history, dense breasts that might be difficult to interpret findings on a mammogram).

These recommendations are not intended to supplant physician judgment with respect to particular patients or special clinical situations and cannot be considered inclusive of all proper methods of care or exclusive of other treatments reasonably directed at obtaining the same result.

Standard of Practice:

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A follow-up care plan should be reviewed with each patient following the completion of their adjuvant therapy.

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The patient will be given a copy of the "St. John Health Breast Care Program Patient Guide for Follow-Up Care Following Breast Cancer Therapy" (see attached).

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The nurse navigator should make contact with patients at their 6, 12,24 and 60-month post-surgery to provide for follow-up and to evaluate patient status with respect to fatigue, pain, lymphedema symptoms, hospitalization, satisfaction with cosmesis, ongoing hormone therapy use, and disease recurrence.

Benefits of Procedure:

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Possible early detection of disease recurrence;

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Provide support for continuance of long-term therapy if applicable;

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Monitor possible disease and treatment sequelae and provide for appropriate intervention.

References:

The evidence supports regular history, physical examination, and mammography as the cornerstone of appropriate breast cancer follow-up. All patients should have a careful history and physical examination performed by a physician experienced in the

surveillance of cancer patients and in breast examination. Examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For those who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. Patients at high risk for familial breast cancer syndromes should be referred for genetic counseling. The use of CBCs, chemistry Ranels, bone scans, chest radiographs, liver ultrasounds, computed tomography scans, [ 8F] fluorodeoxyglucose-positron emission tomography scanning, magnetic resonance imaging, or tumor markers (carcinoembryonic antigen, CA 15-3, and

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CA 27-29) is not recommended for routine breast cancer follow-up in an otherwise asymptomatic patient with no specific fmdings on clinical examination. Careful history taking, physical examination, and regular mammography are recommended for

appropriate detection of breast cancer recurrence. (American Society of Clinical

Oncology 2006 Update of the Breast Cancer Follow-Up and Management Guidelines in the Adjuvant Setting)

Post-therapy follow-up is optimally performed by members of the treatment team and includes the performance of regular physical examinations and mammography. In

patients undergoing breast-conserving therapy, the first follow-up mammogram should be performed 6-12 months after the completion of breast-conserving radiation therapy. The routine performance of alkaline phosphatase and liver function tests are not included in the Guidelines. In addition, the Panel notes no evidence to support the use of "tumor markers" for breast cancer, and routine bone scans, CT scans, MRI scans, PET scans, or ultrasound examinations in the asymptomatic patient provide no advantage in survival or ability to palliate recurrent disease and are, therefore, not recommended.

The use of dedicated breast MRI may be considered as an option for post-therapy surveillance and follow-up in women at high risk of bilateral disease, such as carriers of BRCA 1 or 2 mutations. Rates of contralateral breast cancer following either breast-conserving therapy or mastectomy have been reported to be increased in women with BRCA 1 or 2 mutations when compared with patients with sporadic breast cancer. The Panel recommends that women with intact uteri who are taking tamoxifen should have yearly gynecologic assessments and rapid evaluation of any vaginal spotting that might occur because of the risk of tamoxifen-associated endometrial carcinoma in postmenopausal women. The performance of routine endometrial biopsy or

ultrasonography in the asymptomatic woman is not recommended. Neither test has demonstrated utility as a screening test in any population of women. The vast majority of women with tamoxifen-associated uterine carcinoma have early vaginal spotting.

Symptom management for women on adjuvant endocrine therapies often requires treatment of hot flashes and the treatment of concurrent depression. Venlafaxine has specifically been studied and is an effective intervention in decreasing hot flashes. Recent evidence has suggested that concomitant use of tamoxifen with certain selective serotonin reuptake inhibitors (SSRIs) (e.g., paroxetine and fluoxetine) may decrease plasma levels of endoxifen, an active metabolite of tamoxifen. These SSRIs may interfere with the enzymatic conversion of tamoxifen to endoxifen by inhibiting a particular isoform of cytochrome P-450 enzyme (CYP2D6) involved in the metabolism oftamoxifen. However, the SSRIs citalopram and venlafaxine appear to have only minimal effects on tamoxifen metabolism.

Premenopausal women who experience early ovarian failure secondary to adjuvant chemotherapy and postmenopausal women who are treated with an aromatase inhibitor are at increased risk for the development of osteopenia or osteoporosis with an associated increased risk of bone fracture. The guideline thus recommends monitoring of bone

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health during surveillance in these high risk women, and supplemental calcium and vitamin D. The use ofbisphosphonate is generally the preferred intervention to improve or maintain bone mineral density of women with breast cancer and osteopenia or

osteoporosis. A dental c;xaminationwith preventive dentistry prior to initiation of bisphophonate therapy is recommended.

A special situation arises in women who are premenopausal at diagnosis, who develop amenorrhea during or following treatment, and for whom the use of an aromatase inhibitor is considered. The continuation or return of ovarian function following chemotherapy with or without amenorrhea has been documented. If an aromatase

inhibitor is considered in women with amenorrhea following treatment, baseline levels of estradiol and gonadotropin followed by serial monitoring of these hormones should be performed if endocrine therapy with an aromatase inhibitor is initiated. Bilateral oophorectomy assures postmenopausal status in young women with therapy-induced amenorrhea and may be considered prior to initiating therapy with an aromatase inhibitor m a young woman.

Follow-up also includes assessment of patient adherence to ongoing medication regimens such as endocrine therapies. Predictors of poor adherence to medication include the presence of side effects associated with the medication, and incomplete understanding by the patient of the benefits associated with regular administration of the medication. The Panel recommends the implementation of simple strategies to enhance patient adherence to endocrine therapy, such as direct questioning of the patient during office visits, as well as brief, clear explanations on the value of taking the medication regularly and the

therapeutic importance oflonger durations of endocrine therapy. (National Comprehensive Cancer Network: Breast Cancer Practice Guidelines, 2009)

Attested that this standard was reviewed a,d al?proved by the St. John Health Breast Care Advisory Board on:

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Dated:

'Cheryl A. ~esen, MD, FACS

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ST. JOHN HEALTHBREAST CARE PROGRAM PATIENTGUIDE FOR

FOLLOW-UP

CARE

FOLLOWINGBREASTCANCERTHERAPY

As part of your ongoing care within the St. John Health System, the following recommendations are being provided to you as follow-up to the treatment you have received for your breast cancer. The intent of these recommendations is to assure for the close monitoring of your health care status, help you to cope with possible treatment-related side effects, and to help sustain your general overall health.

Follow-up Care Recommendation

*Physician visits You should schedule an appointment with your surgeon, medical oncologist or radiation oncologist (one of which will be your designated follow-up physician) every 3-6 months for the first 3 years after your breast cancer surgery. In years 4 and 5, this appointment should be scheduled every 6 months. Thereafter, your follow-up physician appointment should occur once a year.

H you are taking endocrine therapy (i.e., tamoxifen or an

aromatase inhibitor drug), your medical oncologist or surgeon wDl advise you on when to schedule physician appointments and other possible evaluations. You should also continue to take the hormone therapy as prescribed by your follow-uo ohvsician. Post-treatment One of your follow-up physicians will advise you as to the timing mammogram of your first mammogram which should be done within 6-12

months after your surgery. Thereafter, this evaluation should be scheduled yearly or as recommended by your follow-up

physician. Hyou had a lumpectomy, your physician may

recommend that you have a mammogram every 6 months for the first 2-3 years.

Breast self-examination You should continue to perform a monthly breast self-examination at the same time of the month.

Pelvic examination You should schedule an annual gynecologic visit with your

OB/GYN physician at which time you wDl have a PAP test. H you should experience any vaginal bleeding (especially if you are taking tamoxifen), you should report this event to both your OB/GYN and follow-up physician.

Bone Health You may be at an increased risk of bone loss if you are a

premenopausal woman who experienced early menopause while taking chemotherapy or if you are a postmenopausal woman who has been treated with an aromatase inhibitor drug. Your follow-up physician may recommend that you take sfollow-upplemental

calcium and vitamin D and have bone health assessments as determined necessary.

Colonoscopy Starting at the age of 50, it is recommended that you have a colonoscopy every ten years unless you have a history of polyps or family history of colon cancer. Your primary care physician may then recommend that you have a colonoscopy at more frequent intervals.

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Routine follow-up You should continue to be followed by your primary care physician if you have other medical conditions (e.g., high blood pressure, diabetes, arthritis, etc.) for which you are receiving treatment.

*Your follow-up visits and evaluations will be tailored to your specific needs. Blood tests and x-rays (other than mammograms) are not routinely needed for most patients. Tests that may be considered necessary for you will be ordered by your treating physician.

What to Look Out For

It is important to be aware of changes in your body in between physician visits. Immediately call your follow-up physician if you experience the following symptoms:

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New lumps or nodules in your breast or the skin around your surgery site.

.

Bone pain

.

Chest pain

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Abdominal pain or swelling

.

Shortness of breath or difficulty breathing

.

Persistent headaches

.

Persistent cough

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Nipple discharge

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New rectal or vaginal bleeding

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New fullness or redness in your breast or arm on the side of surgery

.

Back pain

Lifestvle Recommendations

Other lifestylefactors are important in maintaining health and are highly recommended for your well-being:

Ret!ular exercise: The American Cancer Society (ACS) recommends at least 30 minutes of moderate to vigorous activity on 5 or more days a week. Moderate activity means anything that makes you breathe as if you were walking briskly. Vigorous exercise causes the heart rate to increase, deep breathing and sweating.

Weight lifting, yoga and tai chi are beneficial for improving flexibility, balance and

strength. Exercise is also valuable to help prevent treatment-related fatigue, improve mood and sleep, and decrease stress.

The most important benefit of exercise is that you may reduce the risk of cancer recurrence by boosting the body's immune system.

Maintain a healthv weieht: Increased tummy fat is a predictor for several diseases including diabetes and cancer. Weight gain after menopause has been associated with a higher risk of breast cancer. It is important that you try to achieve your ideal body weight, which is based on your height and body frame.

Good nutrition: Good healthy eating habits are important for lowering the risks of many diseases including cancer. Incorporating 5-10 servings of fruits and vegetables per day should be the basis for your diet (a serving is % cup)- especially recommended are the dark green leafy and orange vegetables. Blueberries are high in antioxidants which support the healing processes and help to reduce the risk of cancer and infection. Studies suggest

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that a low-fat diet may be protective against cancer. It will certainly benefit your heart by reducing the fats in your diet.

Women need to make su~ they are getting enough calcium in their diet by way of dairy products or supplementation -'especially after menopause. The goal should be 1200 mg. per day. Vitamin D plays a very important role on how calcium is absorbed, and some studies show that Vitamin D levels may be low in patients with cancer. Please talk to your physician about a blood test for Vitamin D if you haven't had one already.

Smokint! Cessation: Smoking and second-hand smoke will delay your healing time and may have a negative impact on the effectiveness of both chemotherapy and radiation

therapy. It also increases your risk for developing cancer. Advise family and friends not to smoke around you or when they are in your home or car for your continued recovery and health.

Alcohol: Consuming 2 alcoholic drinks per day increases your risk of breast cancer by one-third so try to limit your intake to 4 ounces per day or less. While wine may have beneficial effects on the heart, you should also keep your intake to an occasional drink. Stress Manat!ement: It is normal to have feelings of anxiety, depression, and stress. Your emotions may trigger new physical problems of fatigue, poor sleep, headaches, body aches and other symptoms. Be sure to secure help and support as needed to handle these feelings and/or symptoms.

The mind-body connection should be part of your daily routine. Surrounding yourself with a community of caring family, friends, church or synagogue is part of the healing team. Joumaling, support groups, massage therapy, yoga, and music are good activities to relieve these feelings and can also help to heal your spirit. Make time for fun! Laughter, pets and children can reduce anxiety and improve mood. Laughter really is good medicine!

Please ask for a list of the many on-line resources available to aid you in your healing.

PLEASE DO NOT HESITATE TO MAKE CONTACT WITH

YOUR NURSE NA VIGATOR OR FOLLOW-UP PHYSICIAN IF YOU REQUIRE ADDITIONAL SUPPORT OR HAVE ANY QUESTIONS AND/OR CONCERNS

REGARDING YOUR ONGOING CARE WITHIN THE ST. JOHN HEALTH BREAST CARE PROGRAM

References

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