Are Neoadjuvant And Adjuvant Therapies Used Together
Because they are administered at different phases of the treatment process, your doctor may suggest you get both neoadjuvant therapies and adjuvant therapies. Neoadjuvant therapies happen before the primary treatment, while adjuvant or maintenance therapies are used after addressing the original tumor with surgery or radiation.
Trastuzumab In The Adjuvant Setting
Findings from several trials testing the addition of trastuzumab in the adjuvant therapy of HER2/neu overexpressed breast cancer were presented in 2005.
NCCTG N9831 and NSABP B-31:
These trials randomized patients with HER2/neu overexpressed invasive breast cancer to receive doxorubicin and cyclophosphamide followed by paclitaxel with or without additional trastuzumab.75 Both trials also permitted the use of tamoxifen, and in 2003 also permitted the use of AIs for postmenopausal women. NSABP B-31 was limited to women with axillary lymph nodepositive breast cancer. N9831 was initially restricted to women with nodepositive breast cancer, but was amended in 2003 to include high-risk nodenegative disease . Patients with current or prior cardiac disease were excluded.
NSABP B-31 used trastuzumab begun concurrently with paclitaxel. The N9831 trial included an arm with trastuzumab begun concurrently with paclitaxel and an arm of sequential trastuzumab begun after paclitaxel. This makes N9831 trial the only trial to directly compare concurrent versus sequential trastuzumab.86 Analysis of the N9831 trial included a pair-wise comparison of the sequential and the concurrent arms compared with control and an additional comparison of the sequential versus the concurrent arms. The two control arms and the concurrent trastuzumab arms of the B-31 and N9831 were combined for a joint analysis.87,88
BIG 01-01 :
Sequential Versus Concurrent Therapy:
Determination of HER2/neu Status:
For Metastatic Breast Cancer
Chemo can be used as the main treatment for women whose cancer has spread outside the breast and underarm area to distant organs like the liver or lungs. Chemo can be given either when breast cancer is diagnosed or after initial treatments. The length of treatment depends on how well the chemo is working and how well you tolerate it.
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An Abbreviated History Of Adjuvant Systemic Therapy
The initial approach to therapy for breast cancer was based on the premise that the disease metastasized via locoregional spread in an orderly fashion, and thus could be cured with aggressive surgery. The radical mastectomy was thus the standard surgical procedure for breast cancer in the early 20th century . Randomized trials subsequently showed no benefit from radical mastectomy compared with less aggressive surgical procedures, and demonstrated that distant recurrence remained a major clinical problem irrespective of the primary surgical therapy .
Table 1 Systemic adjuvant therapy options for operable breast cancer
How Breast Cancer Is Treated
In cancer care, doctors specializing in different areas of cancer treatmentsuch as surgery, radiation oncology, and medical oncologywork together with radiologists and pathologists to create a patients overall treatment plan that combines different types of treatments. This is called a multidisciplinary team. Cancer care teams include a variety of other health care professionals, such as physician assistants, nurse practitioners, oncology nurses, social workers, pharmacists, counselors, nutritionists, and others. For people older than 65, a geriatric oncologist or geriatrician may also be involved in their care. Ask the members of your treatment team who is the primary contact for questions about scheduling and treatment, who is in charge during different parts of treatment, how they communicate across teams, and whether there is 1 contact who can help with communication across specialties, such as a nurse navigator. This can change over time as your health care needs change.
A treatment plan is a summary of your cancer and the planned cancer treatment. It is meant to give basic information about your medical history to any doctors who will care for you during your lifetime. Before treatment begins, ask your doctor for a copy of your treatment plan. You can also provide your doctor with a copy of the ASCO Treatment Plan form to fill out.
Learn more about making treatment decisions.
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Second Generation Chemotherapy Regimens
5-Flourouracil, epirubicin , and cyclophosphamide
After randomized trials demonstrated a doseresponse relationship for epirubicin in metastatic breast cancer , the FASG05 compared adjuvant fluorouracil and cyclophosphamide with epirubicin given at 50 mg/m2 or 100 mg/m2 every 21 days for six cycles . After 5 years of follow-up, FEC100 showed improved DFS and OS compared to FEC50 .
Cyclophosphamide, doxorubicin, and 5-fluorouracil
CAF is an acronym that is used to describe regimens in which cyclophosphamide is administered orally for 14 days and doxorubicin and 5-fluorouracil are given on days 1 and 8 every 28 days for six cycles, whereas FAC is an acronym used to describe a regimen in which all of these agents are given IV every 3 weeks for six cycles. The SWOG-8814/INT-0100 trial randomized postmenopausal women with hormone-receptor positive, node-positive breast cancer to CAF plus tamoxifen versus tamoxifen alone. DFS was superior for CAF plus tamoxifen , but OS was only marginally improved . The EBCTCG meta-analysis found that breast cancer mortality rates were reduced more with FAC for six cycles than AC for four cycles or CMF for six cycles , and that FAC or FEC combinations were more effective in reducing breast cancer mortality compared to CMF .
Sequential doxorubicin/cyclophosphamide followed by paclitaxel
Sequential epirubicin followed by CMF
Docetaxel plus cyclophosphamide
Who Shouldnt Do Adjuvant Chemotherapy
Adjuvant therapies are not recommended for every cancer patient. Some types of cancer do not have good evidence supporting the use of neoadjuvant, adjuvant, or maintenance chemotherapies. Your cancer stage and the likelihood of remission are also important. If youre not at high risk for cancer to come back, you may not be a good candidate for adjuvant therapies.
West HJ, Jin J. Neoadjuvant therapy. JAMA Oncol. 2015 1:550. doi:10.1001/jamaoncol.2015.1241
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How Is Adjuvant Therapy Given And For How Long
Adjuvant chemotherapy is given orally or by injection into a blood vessel. It is given in cycles, consisting of a treatment period followed by a recovery period. The number of cycles depends on the types of drugs used. Most patients do not have to stay in the hospital for chemotherapythey can be treated as an outpatient or at the doctors office. Adjuvant chemotherapy usually does not last for much more than 6 months.
Hormonal therapy is usually given orally, as a pill.
- Most women who undergo hormonal therapy take tamoxifen every day for 5 years.
- Some women may take an aromatase inhibitor every day for 5 years instead of tamoxifen.
- Some women may receive additional treatment with an aromatase inhibitor after 5 years of tamoxifen.
- Finally, some women may switch to taking an aromatase inhibitor after 2 or 3 years of tamoxifen, for a total of 5 or more years of hormonal therapy.
Trastuzumab is given by infusion into a blood vessel every 1 to 3 weeks for a year.
Radiation therapy given after mastectomy is divided into small doses given once a day over the course of several weeks. Radiation therapy may not be given at the same time as some types of chemotherapy or hormonal therapy.
Aromatase Inhibitors In Premenopausal Women
Aromatase inhibitors have not been well studied in premenopausal women with or without ovarian suppression or ablation and thus are only recommended for postmenopausal patients. The use of AIs in young women is associated with the occurrence of benign ovarian pathology. This raises the issue of determining menopausal status at the start of, during, and after therapy. For example, patients may become amenorrheic during adjuvant chemotherapy without permanent loss of ovarian hormone production. Thus, the distinction between a temporary versus a permanent menopause must be made. If menopausal status is uncertain after chemotherapy, tamoxifen should be used as the initial endocrine treatment. Incorrectly assuming that a patient is menopausal and treating with an AI deprives the patient of effective hormonal therapy with tamoxifen.
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Adjuvant Vs Extended Adjuvant Therapy In Hr+ Breast Cancer
Kristie Kahl: Welcome to CancerNetwork®s OncView program titled Individualizing Extended Adjuvant Therapy in HR+ Breast Cancer. Our discussion is going to focus on adjuvant therapy in hormone receptorpositive breast cancer. Welcome. Lets begin. Dr Gadi, whats the difference between adjuvant and extended adjuvant therapy in patients with early stage hormone receptorpositive breast cancer?
Vijayakrishna Gadi, MD, PhD: Before I start answering that question, I want to make 1 disclosure. Ive spent my career focused, to some degree, on diagnostics development. Im a founder of a company called SEngine Precision Medicine. I have intellectual property in a company called Chimerasite, I have received research funding from Agendia, and I served as a consultant speaker for Hologic.
Kristie Kahl: What is the goal of each type of treatment?
Kristie Kahl: You just mentioned the endocrine therapies. What are the current treatment options for both treatment types?
Transcript edited for clarity.
Why Wasnt I Able To Get My Chemotherapy Treatment When It Was Scheduled
Chemotherapy works on both cancer cells and normal cells. Youre supposed to get your chemotherapy treatments on a set schedule so that your body has time to recover between treatments. This allows your normal cells to be replaced. Your body may need more time to reverse the effects of therapy .
Your doctor will decide if your chemotherapy should be rescheduled and they will discuss the reasons with you.
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Chemo Drugs For Breast Cancer That Has Spread
- Taxanes: Paclitaxel , docetaxel , and albumin-bound paclitaxel
- Antibody drug conjugates
Although drug combinations are often used to treat early breast cancer, advanced breast cancer often is treated with single chemo drugs. Still, some combinations, such as paclitaxel plus gemcitabine, are commonly used to treat metastatic breast cancer.
For cancers that are HER2-positive, one or more drugs that target HER2 may be used with chemo.
Other Extended Adjuvant Therapy Trials With Aromatase Inhibitors
Other trials have been conducted to investigate the role of extended adjuvant AI therapy . In the ABCSG Trial 6a, HR+ post-menopausal patients who were disease-free after 5 years of adjuvant tamoxifen were randomly assigned to 3 years of anastrozole or no further treatment . With 856 patients and a median follow-up of 62.3 months, anastrozole further reduced the risk of a BC event by 38% versus no further treatment . There was no statistically significant difference in OS between the two arms.
NSABP-B33 investigated extended adjuvant therapy with exemestane in post-menopausal women with clinical T1-3N1M0 BC who were disease-free after 5 years of adjuvant tamoxifen . This trial closed prematurely after the publication of the results of MA.17. At 30 months of median follow-up, ITT analysis showed a trend of improvement in 4-year DFS and a statistically significant improvement in 4-year recurrence-free survival .
The Adjuvant post-Tamoxifen Exemestane versus Nothing Applied trial compared exemestane versus observation after 5 years of previous tamoxifen . This trial was prematurely closed after recruiting only 448 patients.
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Planning Your Adjuvant Therapy
Your treatment plan is created for you based on many factors. Your doctor will review your full history, and do a physical exam. Then they will review your test results, pathology results, and imaging. They will use this information to design your treatment plan. Everyones treatment plan is different. Your doctor will review your treatment plan with you in detail. Ask your doctor or nurse any questions you may have.
Who Benefits From Adjuvant Treatment
To answer this, the prognosis of the patient without further treatment must be assessed. A prognostic factor is any measurement available at the time of diagnosis that is associated, either positively or negatively, with survival in the absence of additional therapy. Retrospective analyses have identified lymph node involvement, tumor size, histologic grade, and the presence of the estrogen receptor as independent prognostic factors in breast cancer.4,5 An increased risk of relapse and death is associated with greater lymph node involvement, larger tumor size, and more aggressive histologic features. ER-positive tumors, in contrast, are associated with a 10% lower risk of relapse at 5 years compared with ER-negative tumors.6 Prognosis is estimated for each patient over a period of time. For example, a woman with a 5-cm ER-negative high-grade breast cancer and 4 involved lymph nodes has a 10-year mortality of about 70%. In contrast, a woman with an ER-positive well-differentiated node-negative tumor smaller than 1 cm has a mortality of only 10% over 10 years.
In addition to prognostic factors, predictive factors, such as hormone-receptor status, identify patients who will respond to certain therapies such as endocrine therapy. Patient characteristics, including overall health, comorbidities, and personal preferences, must also be considered.
Ive Been Having Problems Urinating Is This Normal
Some chemotherapy can irritate your bladder. Side effects can be an urgency to urinate, burning when urinating, or blood in your urine. These may be signs of an infection or irritation. Call your doctor if you have any of these symptoms. They may want to collect some of your urine and test it to see if you have an infection.
Its important to drink 8 to 10 glasses of liquids each day and urinate often.
Can I Have Dental Work
Dont have any procedure that can cause bleeding, such as dental work. This may allow bacteria to enter your bloodstream, which could cause an infection. If your blood counts are low, youre also at a higher risk for a serious infection. Check with your doctor before you schedule any dental work, including cleanings or surgery.
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Aromatase Inhibitors In Postmenopausal Women
Randomized trials using the selective AIs as adjuvant endocrine therapy of postmenopausal women have been reported that have used the selective AIs as either initial therapy versus tamoxifen, sequentially following 2 to 3 years of tamoxifen, or as extended therapy after approximately 5 years of tamoxifen.
Initial Therapy With Aromatase Inhibitor Versus Tamoxifen:
The ATAC trial recruited 9,366 postmenopausal women with early breast cancer of any estrogen or progesterone receptor status from 1996 to 2000. Results of the trial are now available, with a median follow-up of 68 months.55 After initial treatment with surgery with or without additional radiation therapy or chemotherapy, patients were randomized to receive tamoxifen versus anastrozole versus tamoxifen plus anastrozole for 5 years. No difference in outcome has been seen between tamoxifen alone and tamoxifen in combination with anastrozole. At 6 years follow up, a 3.3% absolute difference was seen in DFS in patients with hormone receptorpositive disease favoring anastrozole compared with tamoxifen and recurrence-free survival The reduction in recurrences is related to the prevention of ipsilateral recurrences, new contralateral breast primaries, and distant recurrences. No difference in overall survival has been seen to date.
Time-to-recurrence in hormone-receptorpositive patients. Reprinted from Howell et al.55 with permission.
Part of Sequential Therapy After 2 or 3 Years of Tamoxifen:
I Havent Lost My Hair Yet And My Counts Havent Dropped Does This Mean That The Chemotherapy Isnt Working
Not having side effects such as hair loss, lowered blood counts, or nausea doesnt mean that the chemotherapy isnt working. Different therapies cause different side effects. Different people also have different reactions to the same treatment. Your doctor and nurse will monitor your progress and response to treatment.
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Increased Risk Of Leukemia
Very rarely, certain chemo drugs, such as doxorubicin , can cause diseases of the bone marrow, such as myelodysplastic syndromes or even acute myeloid leukemia, a cancer of white blood cells. If this happens, it is usually within 10 years after treatment. For most women, the benefits of chemo in helping prevent breast cancer from coming back or in extending life are far likely to exceed the risk of this rare but serious complication.
Side Effects Experienced By Women
Menstrual cycle changes
Some treatments may cause your periods to change , become irregular, or stop. Your treatment plan may also include medication or surgery that will stop your periods.
- If you still have ovaries and a uterus, you can still be ovulating and can get pregnant, even if your periods stop. If you have ovaries and a uterus, you must use a non-hormonal form of birth control such as a condom, diaphragm, or non-hormonal IUD during your treatment.
- Read the resource Sex and Your Cancer Treatment for more information.
Many women have vaginal dryness after menopause or from hormonal treatments. This can make penetrative sex painful or difficult. It can also make it easier to get urinary tract infections .
What you can do to help with vaginal dryness:
- Use vaginal moisturizers regularly, such as Replens®, K-Y®, Silk-E®, or Vitamin E gel caps.
- Use lubricants during sexual activity to reduce discomfort.
- Use water-based lubricants, such as Astroglide®, K-Y® Jelly, or Liquid Silk.
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Possible Side Effects Of Chemo For Breast Cancer
Chemo drugs can cause side effects, depending on the type and dose of drugs given, and the length of treatment. Some of the most common possible side effects include:
- Hot flashes and/or vaginal dryness from menopause caused by chemo
Chemo can also affect the blood-forming cells of the bone marrow, which can lead to:
- Increased chance of infections
- Easy bruising or bleeding
These side effects usually go away after treatment is finished. There are often ways to lessen these side effects. For example, drugs can be given to help prevent or reduce nausea and vomiting.
Other side effects are also possible. Some of these are more common with certain chemo drugs. Ask your cancer care team about the possible side effects of the specific drugs you are getting.