Breast cancer, a common cancer in women, is a disease in which cancer (malignant) cells are found in the tissues of the breast. Each breast has 15 to 20 sections called lobes, which have many smaller sections called lobules. The lobes and lobules are connected by thin tubes called ducts. The most common type of breast cancer is ductal cancer. It is found in the cells of the ducts. Cancer that begins in the lobes or lobules is called lobular cancer. Lobular cancer is more often found in both breasts than other types of breast cancer. Inflammatory breast cancer is an uncommon type of breast cancer. In this disease, the breast is warm, red, and swollen.

Hereditary breast cancer makes up approximately 5% to 10% of all breast cancer cases. The genes in cells carry the hereditary information that is received from a person's parents. Several genes have been found to be defective in some breast cancer patients. Relatives of breast cancer patients who carry these defective genes may be more likely to develop breast or ovarian cancer. Some defective genes are more common in certain ethnic groups. Tests are being developed to determine who has the genetic defect long before any cancer appears. (Refer to the PDQ summaries on Screening for Breast Cancer and Prevention of Breast Cancer for more information.)

Hormonal contraceptives may be another factor to consider. Research findings suggest a link between contraceptive use and a slightly increased risk of developing breast cancer.

A doctor should be seen if changes in the breasts are noticed. The doctor may suggest that you have a mammogram. A mammogram is a special x-ray of the breast that may find tumors that are too small to feel. If a lump in the breast is found, the doctor may need to cut out a small piece of the lump and look at it under the microscope to see if there are any cancer cells. This procedure is called a biopsy. Sometimes the biopsy is done by inserting a needle into the breast and drawing out some of the tissue. If the biopsy shows that there is cancer, it is important that certain tests (called estrogen and progesterone receptor tests) be done on the cancer cells.

Estrogen and progesterone receptor tests may tell whether hormones affect the way the cancer grows. They may also give information about the chances of the tumor coming back (recurring). The results help a doctor decide whether to use hormone therapy to stop the cancer from growing. Tissue from the tumor needs to be taken to the laboratory for estrogen and progesterone tests at the time of biopsy because it may be hard to get enough cancer cells later, although newer techniques can be used on tissue that is not fresh.

The chance of recovery (prognosis) and choice of treatment depend on the stage of the cancer (whether it is just in the breast or has spread to other places in the body), the type of breast cancer, certain characteristics of the cancer cells, and whether the cancer is found in the other breast. A woman's age, weight, menopausal status (whether or not a woman is still having menstrual periods), and general health can also affect the prognosis and choice of treatment.

If a patient is going to have a mastectomy, breast reconstruction (making a new breast mound) may be considered. It may be done at the time of the mastectomy or at some future time. The breast may be made with the patient's own (non-breast) tissue or by using implants. Different types of implants can be used. The Food and Drug Administration (FDA) has announced that breast implants filled with silicone gel may only be used in clinical trials. Saline-filled breast implants, which contain saltwater rather than silicone gel, may also be used. Before the decision to get an implant is made, patients can call the FDA's Center for Devices and Radiologic Health at 1-888-INFO-FDA (1-888-463- 6332) to obtain additional information. Additional questions can then be discussed with a doctor.

STAGE EXPLANATION

Stages of breast cancer

Once breast cancer has been found, more tests will be done to find out if the cancer has spread from the breast to other parts of the body. This is called staging. To plan treatment, a doctor needs to know the stage of the disease. The following stages are used for breast cancer.

Stage 0

Ductal carcinoma in situ (DCIS; also known as intraductal carcinoma) is a very early breast cancer that may develop into an invasive (cancer that has spread from the duct into surrounding tissues) type of breast cancer.

Lobular carcinoma in situ (LCIS) is not cancer, but rather a marker that identifies a woman at increased risk to develop invasive (cancer that has spread into surrounding tissues) breast cancer later in life.

Stage I

The cancer is no larger than 2 centimeters (about 1 inch) and has not spread outside the breast.

Stage II

Stage II is divided into stages IIA and IIB.

Stage IIA is defined by either of the following:

The cancer is no larger than 2 centimeters but has spread to the lymph nodes under the arm (the axillary lymph nodes).

The cancer is between 2 and 5 centimeters (from 1 to 2 inches), but has not spread to the lymph nodes under the arm.

Stage IIB is defined by either of the following:

The cancer is between 2 and 5 centimeters (from 1 to 2 inches), and has spread to the lymph nodes under the arm.

The cancer is larger than 5 centimeters (larger than 2 inches), but has not spread to the lymph nodes under the arm.

Stage III

Stage III is divided into stages IIIA and IIIB.

Stage IIIA is defined by either of the following:

The cancer is smaller than 5 centimeters and has spread to the lymph nodes under the arm, and the lymph nodes are attached to each other or to other structures.

The cancer is larger than 5 centimeters and has spread to the lymph nodes under the arm.

Stage IIIB is defined by either of the following:

The cancer has spread to tissues near the breast (skin or chest wall, including the ribs and the muscles in the chest).

The cancer has spread to lymph nodes inside the chest wall along the breast bone.

Stage IV

The cancer has spread to other organs of the body, most often the bones, lungs, liver, or brain. Or, tumor has spread locally to the skin and lymph nodes inside the neck, near the collarbone.

Inflammatory breast cancer

Inflammatory breast cancer is a special class of breast cancer that is rare. The breast looks as if it is inflamed because of its red appearance and warmth.

The skin may show signs of ridges and wheals or it may have a pitted appearance. Inflammatory breast cancer tends to spread quickly.

Recurrent

Recurrent disease means that the cancer has come back (recurred) after it has been treated. It may come back in the breast, in the soft tissues of the chest (the chest wall), or in another part of the body.

TREATMENT OPTION OVERVIEW

How breast cancer is treated

There are treatments for all patients with breast cancer. Four types of treatment are used:

• surgery (taking out the cancer in an operation)
• radiation therapy (using high-dose x-rays to kill cancer cells)
• chemotherapy (using drugs to kill cancer cells)
• hormone therapy (using drugs that change the way hormones work or taking out organs that make hormones, such as the ovaries)

Biological therapy (using the body's immune system to fight cancer), bone marrow transplantation, and peripheral blood stem cell transplantation are being tested in clinical trials.

Most patients with breast cancer have surgery to remove the cancer from the breast. Usually, some of the lymph nodes under the arm are also taken out and looked at under a microscope to see if there are any cancer cells. Different types of operations used: <> Surgery to conserve the breast:

Lumpectomy (sometimes called excisional biopsy or wide excision) is the removal of the lump in the breast and some of the tissue around it. It is usually followed by radiation therapy to the part of the breast that remains. Most doctors also take out some of the lymph nodes under the arm.

Partial or segmental mastectomy is the removal of the cancer as well as some of the breast tissue around the tumor and the lining over the chest muscles below the tumor. Usually some of the lymph nodes under the arm are taken out. In most cases, radiation therapy follows. Other types of surgery:

Total or simple mastectomy is the removal of the whole breast. Sometimes lymph nodes under the arm are also taken out.

Modified radical mastectomy is the removal of the breast, many of the lymph nodes under the arm, the lining over the chest muscles, and sometimes part of the chest wall muscles. This is the most common operation for breast cancer.

Radical mastectomy (also called the Halsted radical mastectomy) is the removal of the breast, chest muscles, and all of the lymph nodes under the arm. For many years, this was the operation most used, but it is used now only when the tumor has spread to the chest muscles.

Radiation therapy is the use of high-energy x-rays to kill cancer cells and shrink tumors. Radiation may come from a machine outside the body (external radiation therapy) or from putting materials that produce radiation (radioisotopes) through thin plastic tubes into the area where the cancer cells are found (internal radiation therapy).

Chemotherapy is the use of drugs to kill cancer cells. Chemotherapy may be taken by mouth or it may be put into the body by inserting a needle into a vein or muscle. Chemotherapy is called a systemic treatment because the drugs enter the bloodstream, travel through the body, and can kill cancer cells outside the breast area.

If tests show that the breast cancer cells have estrogen receptors and progesterone receptors, hormone therapy may be given. Hormone therapy is used to change the way hormones in the body help cancers grow. This may be done by using drugs that change the way hormones work or by surgery to take out organs that make hormones, such as the ovaries. Hormone therapy with tamoxifen is often given to patients with early stages of breast cancer. Hormone therapy with tamoxifen or estrogens can act on cells all over the body and may increase the chance of getting cancer of the uterus. A doctor should be seen for a pelvic examination every year. Any vaginal bleeding, other than menstrual bleeding, should be reported to a doctor as soon as possible.

Even if the doctor removes all the cancer that can be seen at the time of the operation, the patient may be given radiation therapy, chemotherapy, or hormone therapy after surgery to try to kill any cancer cells that may be left. Therapy given after an operation when there are no cancer cells that can be seen is called adjuvant therapy.

Biological therapy tries to get the body to fight cancer. It uses materials made by the body or made in a laboratory to boost, direct, or restore the body's natural defenses against disease. Biological therapy is sometimes called biological response modifier (BRM) therapy or immunotherapy. This treatment is currently only being given in clinical trials.

Bone marrow transplantation is a type of treatment that is being studied in clinical trials. Sometimes breast cancer becomes resistant to treatment with radiation therapy or chemotherapy. Very high doses of chemotherapy may then be used to treat the cancer. Because the high doses of chemotherapy can destroy the bone marrow, marrow is taken from the bones before treatment. The marrow is then frozen and the patient is given high-dose chemotherapy with or without radiation therapy to treat the cancer. The marrow that was taken out is then thawed and given back to the patient through a needle inserted into a vein to replace the marrow that was destroyed. This type of transplant is called an autologous transplant. If the marrow that is given is taken from another person, the transplant is called an allogeneic transplant.

Another type of autologous transplant is called a peripheral blood stem cell transplant. The patient's blood is passed through a machine that removes the stem cells (immature cells from which all blood cells develop) and then returns the blood back to the patient. This procedure is called leukapheresis and usually takes 3 or 4 hours to complete. The stem cells are treated with drugs to kill any cancer cells and then frozen until they are transplanted back to the patient. This procedure may be done alone or with an autologous bone marrow transplant.

A greater chance for recovery occurs if the doctor chooses a hospital that does more than five bone marrow transplantations per year.

Treatment by stage

Treatment of breast cancer depends on the type and stage of the disease, and the patient's age, menopausal status, and overall health.

Standard treatment may be considered because of its effectiveness in patients in past studies, or participation in a clinical trial may be considered. Not all patients are cured with standard therapy and some standard treatments may have more side effects than are desired. For these reasons, clinical trials are designed to find better ways to treat cancer patients and are based on the most up-to-date information. Clinical trials are ongoing in most parts of the country for all stages of breast cancer. To learn more about clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237); TTY at 1-800-332-8615.

DUCTAL CARCINOMA IN SITU

If the patient has ductal carcinoma in situ (DCIS), treatment may be one of the following:

1. Breast-conserving surgery with radiation therapy, with or without hormone therapy.
2. Surgery to remove the whole breast (total mastectomy), with or without hormone therapy.
3. Clinical trials comparing breast-conserving surgery and hormone therapy with or without radiation therapy.

LOBULAR CARCINOMA IN SITU

If the patient has lobular carcinoma in situ (LCIS), treatment may be one of the following:

1. Biopsy to diagnose the LCIS followed by regular examinations and regular mammograms to find any changes as early as possible.
2. Hormone therapy to reduce the risk of developing breast cancer.
3. Clinical trials including a large clinical trial (Study of Tamoxifen and Raloxifene--STAR trial)comparing 2 types of hormone therapy to lower the risk of developing breast cancer and to compare the side effects of treatment. The Cancer Information Service can be called for more information (1-800-4-CANCER).
4. Surgery to remove all of both breasts (total bilateral mastectomy). This treatment choice is sometimes used in women who have a high risk of getting breast cancer. Most surgeons believe that this is a more aggressive treatment than is needed.

STAGE I, II, AND IIIA BREAST CANCER

Primary treatment may be one of the following:

If the cancer is confined to the breast and lymph nodes under the arm:

1. Breast-conserving surgery to remove only the cancer and some surrounding breast tissue (lumpectomy) followed by radiation therapy. Some of the lymph nodes under the arm are also removed.
2. Surgery to remove the whole breast and the lining over the chest muscles (modified radical mastectomy), as well as some of the lymph nodes under the arm with or without breast reconstruction surgery.
3. A clinical trial evaluating limited lymph node removal (sentinel lymph node biopsy).

Adjuvant therapy (given in addition to the treatments listed above) may include:

1. Radiation therapy to the lymph nodes under the arm following a modified radical mastectomy.
2. Systemic chemotherapy with or without hormone therapy.

STAGE IIIB, IV, RECURRENT, AND METASTATIC BREAST CANCER

Treatment for breast cancer that comes back (recurs) to the breast or chest wall may include:

1. Surgery (radical or modified radical mastectomy) and/or radiation therapy.
2. Systemic chemotherapy or hormone therapy.

Treatment for Stage IIIB cancer or inflammatory breast cancer may include one or more of the following:

1. Systemic chemotherapy.
2. Systemic chemotherapy followed by surgery (breast-conserving surgery or total mastectomy) with lymph node removal followed by radiation therapy. Additional systemic therapy (chemotherapy and/or hormone therapy) may be given).
3. Clinical trials testing new chemotherapy drugs, new drug combinations, and new ways of giving treatment.

Treatment for Stage IV cancer or metastatic breast cancer may include one or more of the following:

1. Hormone therapy and/or chemotherapy with or without trastruzumab (Herceptin).
2. Radiation therapy and/or surgery to relieve the pain caused by the cancer.
3. Clinical trials testing new chemotherapy and/or hormone therapy. Clinical trials are also studying new combinations of trastruzumab (Herceptin) with chemotherapy drugs.
4. Clinical trials evaluating other approaches, including high-dose chemotherapy with bone marrow or peripheral stem cell transplantation.

Source: www.laurushealth.com

Complementary and Alternative Therapies for breast cancer:

A comprehensive treatment plan for breast cancer may include a range of complementary and alternative therapies. Psychotherapy and support groups may help improve quality of life and survival.

Nutrition

Nutritional tips include the following.

• Eliminate non-organic poultry, dairy, red meat, sugar, white flour and refined foods, coffee, tea, chocolate, and colas.
• Eat cruciferous vegetables (broccoli, cabbage, cauliflower).
• Eat only organically raised foods.
• Include liver foods such as beets, carrots, yams, garlic, dark leafy greens, lemons, and apples.
• Follow a high-fiber diet.
• Use soy.

Potentially beneficial nutrient supplements include the following.

1. Coenzyme Q10 (120 mg three times a day)
2. Calcium d-glucarate (500 to 1,000 mg three times a day)
3. Vitamin A (25,000 IU a day), vitamin E (800 IU a day), and vitamin C (250 to 500 mg twice per day) to decrease side effects of chemotherapy and radiation
4. Selenium (200 to 400 mcg a day) to decrease side effects of chemotherapy and radiation
5. Bromelain (500 mg two times a day between meals)
6. Melatonin (10 to 50 mg a day)

Herbs

The use of certain herbal remedies may offer relief from symptoms. Try the following: a combination of black cohosh (Cimicifuga racemosa), red clover (Trifolium pratense), and alfalfa (Medicago sativa) as a base (1 to 3 g); add two to three of the following in equal parts, 30 to 60 drops two to three times daily:

• With anxiety: passionflower (Passiflora incarnata), kava kava (Piper methysticum)
• With lymph node involvement: poke root (Phytolacca americana), red root (Ceanothus americanus); maximum dose of poke root is 0.4 ml a day.
• With nausea: ginger root (Zingiber officinale), fennel seed (Foeniculum vulgare)
• With exhaustion: oatstraw (Avena sativa), skullcap (Scutellaria lateriflora)

Herbs are generally available as dried extracts (pills, capsules, or tablets), teas, or tinctures (alcohol extraction, unless otherwise noted). Dose for teas is 1 heaping tsp./cup water steeped for 10 minutes (roots need 20 minutes).

Homeopathy

An experienced homeopath considers both your symptoms and constitutional type in order to create an individualized treatment regimen. Some of the most common homeopathic remedies that may helpful in treating symptoms associated with breast cancer are listed below.

• Arsenicum for anxiety and nausea, with restlessness and burning pains
• Ipecac for nausea unrelieved by vomiting
• Nux vomica for sharp abdominal pains with anger and collapse

Acute dose is three to five pellets of 12X to 30C every one to four hours until symptoms are relieved.

Acupuncture

While acupuncture is not used as a treatment for cancer itself, evidence suggests it can be a valuable therapy for symptoms associated with cancer and the side effects of chemotherapy. In a study of 104 women with breast cancer and nausea from chemotherapy (all of whom were taking anti-nausea medication), women treated with acupuncture experienced fewer attacks of nausea than women who received the medication alone. There have also been studies indicating that acupuncture may help eliminate pain and hot flashes caused by tamoxifen (a breast cancer medication). One study found that acupuncture markedly improved breathlessness in women with late stages of breast cancer. Acupressure (pressing on rather than needling acupuncture points) has also proved useful in controlling breathlessness; this is a technique that individuals can learn and then use to treat themselves.

Some acupuncturists prefer to work with breast cancer patients only after they have completed conventional medical cancer therapy. Others will provide acupuncture and/or herbal therapy during active chemotherapy or radiation. Acupuncturists treat breast cancer patients based on an individualized assessment of the excesses and deficiencies of qi located in various meridians. In many cases of cancer-related symptoms, a qi deficiency is usually detected in the spleen or kidney meridians

Source: www.mdconsult.com

Medical Details

The Quality of Early-Stage Breast Cancer Care

Annals of Surgery

Volume 232 • Number 2 • AUGUST 2000

Nina A. Bickell MD, MPH, Arthur H. Aufses Jr. MD, Mark R. Chassin MD, MPP, MPH

From the Departments of Health Policy and Surgery, Mount Sinai School of Medicine, New York, New York

Correspondence: Nina Bickell, MD, MPH, Dept. of Health Policy, Box 1077, Mount Sinai School of Medicine, 1 Gustave L. Levy Pl., New York, NY 10029

Objective To assess whether recent practice has improved, the authors created detailed, evidence-based guidelines and assessed the quality of early-stage breast cancer care at four hospitals in the metropolitan New York area.

Background Data Adjuvant treatments for early-stage breast cancer have been shown to improve health and longevity. However, reports from the 1980s showed marked underuse of these therapies.

Methods:

All 723 women with early-stage breast cancer who had a definitive surgical procedure at four participating hospitals in the Mount Sinai-NYU Health System between April 1994 and August 1996 were included. Inpatient and outpatient records were abstracted.

Results Fifty-nine percent of women underwent breast-conserving surgery, of whom 81% received radiation therapy. Hospital-specific radiation therapy rates varied from 69% to 87%. Seventy-eight percent of women with stage 1B or greater cancer received systemic treatment, with hospital-specific rates varying from 71% to 86%. Between 18% and 33% of women who could have benefited from local or systemic adjuvant treatments did not receive them. The risk of not getting a beneficial adjuvant treatment varied more than twofold by the hospital where the breast cancer surgery was performed.

Conclusions

The hospital where breast cancer surgery is performed is associated with the likelihood that women receive effective local and systemic adjuvant treatments. Surgeons and members of hospital quality improvement programs should encourage multidisciplinary approaches to breast cancer care.

Introduction:

In the 1990s, meta-analyses summarized the results of randomized clinic trials that enrolled 30,000 women to assess the efficacy of tamoxifen, 26,000 to evaluate chemotherapy, and 28,000 to study radiation therapy. These analyses showed that for patients with early-stage disease, adjuvant hormone therapy reduces the annual death rate by 17%, chemotherapy reduces the annual death rate by 16%, ^[1] and radiation therapy after breast-conserving surgery reduces local recurrence rates by two thirds. ^[2] Research in the 1980s documented marked underuse of these adjuvant therapies. ^{[3] [4] [5] [6] [7] [8]} In one study, 48% of patients undergoing breast-conserving surgery did not receive radiation, and 44% of women with stage II breast cancer did not receive systemic treatment. ^[3] It is unknown how the quality of early-stage breast cancer care has changed since publication of the large meta-analyses of the efficacy of adjuvant systemic and radiation therapies. A recent Institute of Medicine report assessing the quality of cancer care notes that serious underuse of treatments may be due to older practice patterns from the 1980s, as well as to questionable reliability of data in cancer registries. ^[9] They call for reports of current, reliable data on key processes and outcomes to assess breast cancer care. We undertook a study to determine the current quality of breast cancer care at a sample of hospitals in our health system.

Methods:

We recruited four teaching hospitals in the New York metropolitan area to participate in an early-stage breast cancer quality improvement project. All hospitals performed at least 100 breast cancer surgeries per year. The hospitals were a 493-bed community teaching hospital, a 420-bed community teaching hospital, a 705-bed tertiary care teaching hospital, and a 1,171-bed tertiary care teaching hospital. We assembled a steering committee of breast cancer experts from the four participating hospitals and created evidence-based guidelines (Table 1) . Guidelines were created based on studies from the mid-1980s through the mid-1990s and represented standard practice in breast cancer care. Guidelines were mailed to all physicians with an accompanying letter from the chairman of the surgery department encouraging support of and participation in the project. ^[10]

Table 1. GUIDELINES FOR CARE OF PATIENTS WITH BREAST CANCER

I. All women with early-stage breast cancer should be offered the alternative of breast-conserving surgery with radiation therapy.
Exceptions: Mammogram with multicentric disease

II. All women with early-stage breast cancer who receive breast-conserving surgery should receive a course of radiation therapy.
Exceptions: Women with poor prognosis resulting from conditions other than breast cancer undergoing palliative breast-conserving surgery

III. Women with early breast cancer choosing mastectomy should not receive radical mastectomy (surgery including removal of pectoralis major muscle).

IV. All women with early-stage breast cancer should undergo level I or level I/II axillary node dissection.
Exceptions: Women with poor prognostic comorbidities undergoing breast-conserving surgery

V. All women with early-stage breast cancer should have hormone receptor assay testing performed on the tumor.

VI. All women with early-stage breast cancer should receive adjuvant therapy with tamoxifen and/or a multidrug regimen.
Exceptions: Women with T1 tumors (<1 cm) who are node-negative and who have no poor prognostic factors histologically

Using tumor registries, hospital discharge and ambulatory surgery databases, and pathology databases and files, we identified a study population consisting of all women who received their initial definitive surgical procedure for primary stage 1 or 2 breast cancer at each participating hospital during the study period (March 1994 through August 1996). We assessed care provided during a period before the development and dissemination of our guidelines to describe baseline performance before planned interventions for improvement.

A total of 1,258 potentially eligible women were identified. Of these, 400 were excluded: 183 received their definitive surgery at other hospitals, 93 had recurrent cancers, 53 had late-stage cancer, 49 were not treated during the study period, 21 did not have breast cancer, and 1 was a man. An additional 135 women were stage 0 (ductal carcinoma in situ) and were not included in these analyses.

Because most adjuvant treatments are provided in the outpatient setting, records were abstracted from both inpatient and outpatient sources. All physicians agreed to participate. Two hundred eighty physician offices provided access to data about their patients for this study. The median number of different information sources required to complete data abstraction on each patient was two (range 1-6).

Insurance was categorized by primary outpatient payor. All patients with Medicaid were categorized as Medicaid; patients with Medicare only or Medicare and commercial insurance were categorized as Medicare. Patients with commercial insurance only were categorized as commercial. Analyses included chi-square tests for categorical and t tests for continuous bivariate comparisons and logistic regression for multivariable modeling. Interaction terms for age, hospital, and insurance were not statistically significant and are not included in the final models. The final model and model fit were assessed using the log likelihood and the Hosmer Lemeshow goodness-of-fit test, respectively. Logistic models calculate odds ratios that may overestimate the relative risk of outcomes of interest if the incidence of that outcome is 10% or greater. We corrected our logistic models' odds ratios using a method to approximate a risk ratio from the adjusted odds ratio for common outcomes.

RESULTS

The final study population consisted of 723 women receiving definitive surgical treatment of primary stage 1 or 2 breast cancer: 146 patients at hospital 1, 148 at hospital 2, 154 at hospital 3, and 275 at hospital 4. Patient and surgeon characteristics are listed in Table 2. The mean age at each of the hospitals was 65 years. One of the hospitals had a slightly older patient population with a median age of 69 years, compared with age 65 at the other three facilities. Between 5% and 12% of patients were black. Between 4% and 23% had Medicaid, and 1% to 7% did not have insurance. The number of surgeons performing breast cancer surgery at each institution varied from 15 to 27. The proportion of surgeons at each hospital whose status was full-time salaried varied from 0% to 43%. Individual surgeon volume at the participating hospital ranged from 1 to 59 cases, with median values between 2 and 4.

Table 2. PATIENT AND SURGEON CHARACTERISTICS Characteristic	Hospital
	1 (n = 146)	2 (n = 148)	3 (n = 154)	4 (n = 275)
Median age, years (range)	65 (33-103)	65 (31-93)	69 (27-91)	65 (33-103)
Black (%)	12	10	5	10
Medicaid (%)	10	4	23	9
No insurance (%)	7	7	1	1
Stage 1A (%)	12	13	15	26
Stage 1B (%)	45	41	44	39
Stage 2A (%)	34	31	31	23
Stage 2B (%)	8	16	10	12
Surgeons performing breast cancer surgery (no.)	23	15	20	27
Full-time, salaried (%)	0	0	52	30
Median no. of cases/surgeon (range)	2 (1-50)	3 (1-35)	4 (1-46)	2 (1-59)

Rates of performance on the quality measures for each hospital are listed in Table 3. No woman underwent a radical mastectomy. The rate of axillary dissection for the whole population was 87%, with hospital rates varying from 79% to 92%. Sentinel node biopsy was performed at one of the participating institutions in the context of a study trial; all 10 women who underwent the procedure also underwent axillary dissection. Eighty-five percent of all women had their tumors assayed for hormone receptors. Three of the four hospitals performed the assays frequently; in one hospital, only 56% of tumors were tested for hormone receptors.

Table 3. QUALITY OF EARLY-STAGE BREAST CANCER CARE Quality Measures and Care Processes	Hospital
	1	2	3	4
Radical mastectomy	0	0	0	0
Evidence of surgical options discussion	100	100	100	65
Axillary node dissection (%)	92	89	79	88
Hormone receptor assay (%)	82	97	56	99
BCS (%)	49	50	60	69
RT after BCS (%)	79	82	69	87
Referral to oncologist* (%)	56	81	50	66
Adjuvant systemic Rx * (%)	74	71	75	86
<50 years (%)	66	82	59	87
50 years (%)	77	65	80	85
Missing one or both adjuvant Rxs TFN3-2-0078 TFN3-2-0078(%)	29	33	33	18

BCS, breast-conserving surgery; RT, radiation therapy.
* Rates calculated for women with stage 1B.

Includes women with breast-conserving surgery and women with stage 1B.

Overall, 59% of women underwent breast-conserving surgery. At the two community hospitals, the breast-conserving surgery rate was approximately 50%; the rates were higher at the tertiary care hospitals. Eighty-one percent of women who underwent breast-conserving surgery received radiation therapy afterward, with rates varying from 69% to 87%. The radiation therapy rate among women 65 years and older was 75%. Seventy-eight percent of women with stage 1B or stage 2 tumors received adjuvant systemic treatment, with rates varying from 71% to 86%. We found that 64% of women with stage 1B or stage 2 breast cancer were referred to a medical oncologist. Referral to an oncologist was associated with receipt of systemic therapy. Of women with stage 1B or stage 2 cancer, 91% of women referred to an oncologist received systemic therapy compared with 53% of women who were not referred (P < .0001). Overall, 18% to 33% of women treated at these hospitals who could have benefited from an adjuvant treatment did not receive either radiation after breast-conserving surgery or adjuvant systemic treatment, or both.

Risk factors for omission of adjuvant radiation and systemic therapies are listed in Table 4. Adjusting for important clinical and demographic factors, we found that age is a significant independent predictor of receipt of radiation therapy. Women age 75 and older were 2.4 times more likely than younger women to have radiation therapy omitted after breast-conserving surgery. Insurance is also associated with receipt of radiation therapy. Compared with women who had commercial insurance, uninsured women had a fourfold increased risk of not receiving radiation therapy. The hospital where a woman had her breast cancer surgery performed was associated with receipt of radiation therapy. Women who underwent breast-conserving surgery at hospital 3 had a 2.2 greater risk of not receiving radiation therapy as women whose surgery was at hospital 4.

BREAST CANCER Characteristic			Corrected RR TFN4-3-0078 TFN4-3-0078	P
Missing Radiation Therapy;*
Age 75+	192	3.0 (1.6, 5.5)	2.4	<.0001
Stage	424	1.0 (0.7, 1.4)	1.0	NS
Tumor size 1 cm+	424	0.6 (0.2, 1.6)		NS
Race (black)	40	0.5 (0.1, 1.4)	0.5	NS
Medicare	181	2.2 (1.1, 4.4)	2.0	.02
Medicaid	46	2.1 (0.9, 4.9)	2.0	NS
Self-pay	10	6.9 (1.6, 29.8)	4.3	0.01
Commercial	204	1.0	1.0	Referent group
Hospital 1	71	1.6 (0.7, 3.2)	1.4	NS
Hospital 2	74	1.1 (0.5, 2.5)	1.1	NS
Hospital 3	91	2.7 (1.4, 5.4)	2.2	<.0001
Hospital 4	188	1.0	1.0	Referent group
Missing Systemic TherapyTFN4-2-0078 TFN4-2-0078
Age 75+	162	0.9 (0.5, 1.5)	1.0	NS
Tumor size	587	1.1 (0.9, 1.5)		NS
Stage 2A	204	0.5 (0.3, 0.9)	0.6	.01
Stage 2B	85	0.2 (0.1, 0.5)	0.2	.001
Race (black)	64	1.7 (0.9, 3.1)	1.5	NS
Medicare	238	1.7 (1.1, 3.8)	2.0	NS
Medicaid	71	2.4 (1.2, 4.5)	1.9	<.01
Self-pay	21	1.9 (0.7, 5.6)	1.7	NS
Commercial	291	1.0	1.0	Referent group
Hospital 1	128	1.9 (1.1, 3.5)	1.7	<.05
Hospital 2	129	2.4 (1.3, 4.3)	2.0	<.01
Hospital 3	131	1.8 (1.0, 3.1)	1.6	.05
Hospital 4	204	1.0	1.0	Referent group

Statistical significance considered at P < .05 level.
* Breast-conserving surgery patients only.

Stage 1b or 2.

Corrected RR = OR/[(1 - P₀ ) + (P₀ × OR)].

Receipt of adjuvant systemic treatment was found to be related to stage, insurance, and the hospital where the breast cancer surgery was performed. Age did not affect the likelihood of receiving systemic treatment. The more advanced the stage, the more likely women were to receive systemic treatment. Women with stage 2B were 80% more likely than those with stage 1B to receive systemic treatment. Women with stage 1B or higher breast cancer who had Medicaid insurance appeared to be at double the risk of not receiving systemic treatment. Women whose surgery was performed at hospitals 1 or 2 had a significantly increased risk of not receiving systemic therapy compared with women who had their surgery at hospital 4.

Discussions:
pWe found that the quality of early-stage breast cancer care has improved since reports published in the 1980s. The rates of performance we found were substantially higher than those previously published; however, there continues to be a substantial percentage of women who could benefit from adjuvant treatments who do not receive them. Between 18% and 33% of women did not receive guideline-recommended adjuvant therapy known to improve health outcomes. We found that receipt of adjuvant therapies was affected by clinical factors including age and stage, and the hospital where the woman had her definitive breast cancer surgery performed.

We found a high rate of receipt of radiation therapy in the total population, comparable to the highest rates previously documented. Studies from the late 1980s and early 1990s documented rates of radiation therapy after breast-conserving surgery of 46% to 87%. ^{[12] [13] [14] [15]} In particular, our 75% rate of radiation therapy among older women with breast-conserving surgery was markedly higher than found in previous work. However, age remains a significant factor in omission of radiation therapy: the older old are less likely to receive radiation therapy. A study of Medicare beneficiaries from 1985 to 1989 reported a 46% rate of radiation therapy among women undergoing breast-conserving surgery. ^[13>] Our rate of systemic treatment was high compared with the 44% to 83% rates reported in the late 1980s and early 1990s. ^{[12] [13] [14] [15]} Past studies of older women reported that 59% to 63% of node-positive, estrogen receptor-positive postmenopausal women received adjuvant systemic treatment. ^[14] Our higher rates of systemic treatment among older women may indicate that higher proportions of older women are now receiving systemic therapy, but may also result from the intense efforts we used to find treatment data from outpatient sources.

Women with Medicaid or no insurance have lower rates of cancer screening, are diagnosed with breast cancer at later stages, and have a lower 5-year survival rate from early-stage breast cancer than women with other forms of insurance. ^{[16] [17] [18]} Our finding of an increased risk of not receiving efficacious radiation and systemic treatments among women with Medicaid or no insurance provides a possible explanation for their lower survival rates. Although suggestive, this result must be interpreted with caution because there were only 82 women with Medicaid and 24 with no insurance. Our finding of a significant relation between Medicare and omission of radiation therapy is probably due to the high correlation of older age and Medicare status.

The three hospitals in our study in which almost one third of newly diagnosed breast cancer patients did not receive a beneficial adjuvant treatment were hospitals with a moderate volume of breast cancer cases (50-150 cases per year). The hospital in which 18% of newly diagnosed breast cancer patients did not receive a beneficial adjuvant treatment was a high-volume facility (>150 cases per year). The variation we found in receipt of adjuvant treatments by hospital suggests a possible explanation for the relation between hospital volume of breast cancer surgery and 5-year survival rates described by Roohan et al. ^[19] Demonstrating a direct relation between the volume of breast cancer operations and receipt of adjuvant treatments across the full range of hospital volume, including very low (<10 cases per year) and low (10-49 cases), would provide confirming evidence.

Our study has several limitations. We assessed care at only four hospitals. All the hospitals in this study were teaching hospitals in the metropolitan New York area and had relatively high volumes of breast cancer cases. Previous studies have shown higher rates of performance of breast cancer adjuvant treatment and better quality of care in general at teaching hospitals and larger hospitals. ^{[7] [20]} It may be impossible to generalize our findings to other types of settings. The guidelines we created were based on literature from the mid-1980s and early 1990s and should have had adequate time to disseminate and affect usual practice in the absence of a specific intervention to improve practice. The present study was designed to assess current practice and to inform the design of subsequent specific interventions to improve the quality of breast cancer care; it was not designed to evaluate an effort to increase compliance with a guideline. Some patients refused treatments; we documented 13 such refusals, 0 at hospital 1, 4 at hospital 2, 3 at hospital 3, and 6 at hospital 4. This may be an underestimate of patient refusal of treatment. If a patient chose not to follow through on treatment recommendations and never returned, we considered this to be a failure to receive treatment but did not attribute it to patient refusal.

Treatment of breast cancer frequently requires multispecialty care. We found that after controlling for age, stage, tumor size, insurance status, and race, the hospital where a woman undergoes breast cancer surgery affects the likelihood of her receiving beneficial adjuvant local and systemic treatments. The variability in rates of performance by hospital emphasizes the critical role hospitals may be able to play in improving the care of patients whose treatments frequently extend beyond the inpatient stay and continue in the outpatient setting. For example, our finding of substantially higher rates of adjuvant systemic therapy among patients referred to medical oncologists suggests that a system intervention, such as automatic referral of stage 1B or 2 patients from surgeon to oncologist, may increase the rate of appropriate systemic treatment. Surgeons and members of hospital-based quality improvement activities should encourage multidisciplinary approaches to breast cancer care to ensure that women with early-stage breast cancer receive beneficial adjuvant therapies.

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