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What Is Adjuvant Endocrine Therapy For Breast Cancer

Exploring Adjuvant Endocrine Therapy In The Breast Cancer Setting

Dr. Burstein on Adjuvant Endocrine Therapy for ER Breast Cancer

Terry P. Mamounas, MD, MPH, discusses the use of extended adjuvant therapy for patients with breast cancer and how the landscape is evolving.

Terry P. Mamounas, MD, MPH, medical director of the Comprehensive Breast Program at the University of Florida Health Cancer Center, discusses the use of extended adjuvant therapy for patients with breast cancer and how the landscape is evolving.

Mamounas says that physicians in this setting know that extended adjuvant therapy works for patients and the extent that it works when using tamoxifen after an aromatase inhibitor, which gives a significant benefit. There is less benefit when giving an aromatase inhibitor after the patient had already received an aromatase inhibitor for 5 years or so. Generally, studies of adjuvant therapy have shown a small absolute benefit and a 4% to 7% decrease in recurrence. For any agent where there is a 4% or 5% absolute reduction in recurrence, 95% of the patients do not need the intervention because they wont recur without it or they would recur even with it, Mamounas explains.

Aromatase Inhibitors In The Neoadjuvant Setting

Two large international trials have compared the efficacy of 3 months of neoadjuvant endocrine treatment with anastrozole or tamoxifen in receptor-positive women with early breast cancer. The primary endpoints in both trials were comparable with objective clinical response measured by calliper in one and objective clinical response measured by ultrasound in the other trial. Both trials also included a response evaluation with the respectively complementary assessment method and a surgical evaluation in terms of whether BCT was feasible subsequent to neoadjuvant therapy as secondary endpoints. The two trials, which were both conducted as doubleblind, double-dummy randomized international multicenter trials, differed, however, in the fact that PROACT allowed concurrent chemotherapy and was not restricted to operable breast cancer, whereas IMPACT did not. In the 202 postmenopausal women who received anastrozol in the PROACT trial, no significant improvement in the objective response rate could be observed when compared to the 201 patients who received tamoxifen, irrespective of whether ultrasound or clinical assessment was used. There was, however, a higher response rate in the anastrozole group within the group of patients in whom initially mastectomy had been recommended. This translated into an increased rate of BCT . Both treatments were well tolerated.

Cdk4/6 Inhibition In Early

The exciting results observed with CDK4/6 inhibitors in the treatment of advanced ER-positive, HER2-negative breast cancer have triggered the evaluation of these agents in the early-stage setting. For example, results of a neoadjuvant therapy setting were presented by Dowsett et al. from the PALLET study. In this study, palbociclib was given in addition to 3 months of the AI letrozole. It was shown that the antiproliferative effect of the AI is substantially increased by palbociclib. The percentage of tumors which underwent a complete cell cycle arrest in the form of a Ki-67 value < 2.7% during neoadjuvant therapy was able to be increased through the addition of palbociclib from 58.5 to 90.4%. In the adjuvant setting the PALLAS study has included 4,600 patients with stage II and III breast cancer and randomized between standard endocrine treatment +/ palbociclib. Comparable study concepts exist for abemaciclib and ribociclib .

The ADAPTcycle study follows a different approach: the comparison of ET plus ribociclib versus standard chemotherapy in intermediate-risk ER+/HER2 early breast cancer.

Results are eagerly awaited to establish new treatment options for early luminal B breast cancers.

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Efficacy Of Endocrine Therapy

In a phase II trial, 239 patients postmenopausal women with stage IIAIIIB HR+ BC were randomly assigned to receive neoadjuvant Anastrozole 1 mg/day or Exemestane 25 mg/day for 3 months or doxorubicin 60 mg/m2 with paclitaxel 200 mg/m2 . There was no statistically significant difference between AI and chemotherapy in terms of clinical response rate, time to response, or pathologic complete response . Endocrine treatment was well tolerated, and with slightly higher Rates of BCS . GEICAM/2006-03 randomised randomised 97 patients with IHC-defined luminal disease to receive neoadjuvant Exemestane for 24 weeks or chemotherapy , no statistically significant difference was found between the two arms in terms of clinical response rate , there was a trend for a worse outcome in the exemestane arm for premenopausal patients and those with high tumour Ki67 expression .

How Is Hormone Therapy Used To Treat Breast Cancer

breast cancer hormone therapy letrozole

There are three main ways that hormone therapy is used to treat hormone-sensitive breast cancer:

Adjuvant therapy for early-stage breast cancer:Tamoxifen is FDA approved for adjuvant hormone treatment of premenopausal and postmenopausal women with ER-positive early-stage breast cancer, and the aromatase inhibitorsanastrozole, letrozole, and exemestane are approved for this use in postmenopausal women.

Research has shown that women who receive at least 5 years of adjuvant therapy with tamoxifen after having surgery for early-stage ER-positive breast cancer have reduced risks of breast cancer recurrence, including a new breast cancer in the other breast, and reduced risk of death at 15 years .

Until recently, most women who received adjuvant hormone therapy to reduce the chance of a breast cancer recurrence took tamoxifen every day for 5 years. However, with the introduction of newer hormone therapies , some of which have been compared with tamoxifen in clinical trials, additional approaches to hormone therapy have become common .

Some premenopausal women with early-stage ER-positive breast cancer may have ovarian suppression plus an aromatase inhibitor, which was found to have higher rates of freedom from recurrence than ovarian suppression plus tamoxifen or tamoxifen alone .

Men with early-stage ER-positive breast cancer who receive adjuvant therapy are usually treated first with tamoxifen. Those treated with an aromatase inhibitor usually also take a GnRH agonist.

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Radiation Therapy Is Highly Localized

Radiation therapy can be either primary or secondary breast cancer treatment. Radiotherapy uses high-powered X-rays that focus on a very specific area of the body to kill breast cancer cells.

It is very common to use radiation therapy at the site of a breast cancer lumpectomy or mastectomy to kill any breast cancer cells that may remain undetected in the of the surgical site.

There are side effects to radiation therapy. Indeed radiation therapy is quite hard on the body. In fact, some side effects might only surface many years after treatment. However, breast cancer radiation therapy in combination with surgery is a tried and tested method of breast cancer treatment.

Adjuvant Endocrine Therapy In Her2

  • Oncology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, IsraelSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • Oncology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, IsraelSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • Oncology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, IsraelSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • Oncology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, IsraelSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • A. SonnenblickCorrespondenceCorrespondence to: Dr Amir Sonnenblick, Tel Aviv Sourasky Medical Center, 6 Weizmann Street, Tel Aviv 6423906, Israel. Tel: +972-3-6972061 Fax: +972-3-6974789Oncology Department, Tel Aviv Sourasky Medical Center, Tel Aviv, IsraelSackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

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Do I Still Need To Take My Anti

Nausea and vomiting can happen on the day you get chemotherapy or many days after getting chemotherapy. If the chemotherapy youre getting can cause nausea, your doctor will prescribe medication to reduce or prevent it. Always take your anti-nausea medication as instructed. Some medication works best if you take it before you become nauseous. If youre still nauseous while taking your medication as instructed, call your doctor or nurse.

Hair Loss Or Thinning

Exploring Extended Adjuvant Endocrine Therapy for HR Breast Cancer

Some chemotherapy medications cause hair loss. Hair loss usually starts about 2 to 4 weeks after your first chemotherapy treatment. If you do lose your hair, it will begin to grow back once youre no longer getting chemotherapy. Some hormonal therapies can thin your hair, as well.

Generally, hair loss is affected by:

  • The type, dose, and length of time you take the medication.
  • The amount of hair you have before treatment.
  • The amount of chemical processing the hair had before treatment.

What you can do:

What to avoid:

  • Bleaching or perming your hair.
  • Using hot curlers.

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Eye And Vision Changes

Some chemotherapy medications may cause you to have dry eyes or watery eyes . If this happens, you can use wetting drops or allergy eye drops. If you have blurry vision during your treatment, see your eye doctor. It may be because your eyes are dry or tearing.

Some chemotherapy medications may cause your eyelashes and eyebrows to fall out. If this happens, it wont last. They will grow back in after your chemotherapy treatment with that medication is over.

Biological Predictors Of Response

While in the early trials with tamoxifen patients were not selected for treatment based on their receptor status, it is now well known that only ER- and/or PR-positive tumors are likely to respond to any kind of endocrine treatment . In an elegant re-analysis of the P024 data, Ellis et al. found evidence for a direct correlation between the degree of ER expression and treatment response: By using the semi-quantitative Allred scoring system, they observed a tamoxifenassociated tumor response only in tumors that exhibited high ER expression , while letrozole already yielded tumor responses at scores of 3 and more . Although the absolute numbers are small, it is possible that the somewhat superior efficacy of AIs over tamox-ifen in the adjuvant setting might at least in part be due to increased AI efficacy in tumors expressing low and intermediate levels of ER.

Other important factors that predict outcome in neoadjuvant endocrine treatment include HER1 and HER2. In the P024 trial population, the same group found evidence for a lower response to tamoxifen in tumors that overexpress HER1 and/or HER2, with a response rate of only 14% as compared with 41% for HER1- and HER2-negative tumors .

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Data Supporting Adjuvant Therapy With Anthracyclines

The EBCTCG meets every five years to review data from global breast cancer trials. The 2011 EBCTCG meta-analysis included an analysis of the utility of adjuvant chemotherapy. One analysis compared no treatment to the combination of cyclophosphamide, methotrexate, and 5-fluoruracil compared to an anthracycline containing regimen. Compared to no treatment, the use of CMF in 5253 women resulted in a significant improvement in the risk of recurrence at 10 years , which translated into an absolute gain of 10.2 percent. There was also a significant reduction in breast cancer mortality , validating a complete benefit of 6.2 percent. Lastly, there was a significant reduction in overall mortality , thereby demonstrating an absolute gain of 4.7 percent. Comparatively the use of an anthracycline containing regimen compared to no treatment in 8575 women established a significant improvement in the risk of recurrence at 10 years , which resulted in a total gain of 8.0 percent. There was also a significant reduction in breast cancer mortality , ensuing an absolute improvement of 6.5 percent and a significant reduction in overall mortality , confirming an absolute benefit of 5.0 percent.

Evidence For Extended Endocrine Therapy

Use and Effectiveness of Adjuvant Endocrine Therapy for ...

The rationale for extended endocrine therapy beyond 5 years is due to hormone-positive breast cancer recurrence risk continuing indefinitely. Although detectable breast cancer can be removed surgically, there might be present undetectable microdeposits that after many years coulddevelop into clinically-apparent disease i.e. recurrence. This may in time lead to reduced OS in some cases .

The Role of Extended Tamoxifen Therapy.

Initial studies assessing the extended use of Tamoxifen were the ECOG , Scottish Trial , and NSABP B-14 . In total, 1,588 patients were included, but there was not observed any advantage of 10 years over the 5 years of Tamoxifen treatment period. According to this, it was suggested that the extended use if Tamoxifen increased the occurrence of side effects with no concomitant therapeutic advantage .

The NSABP B-14 was the first study to assess the benefit of continuing adjuvant Tamoxifen beyond 5 years. The study included 1152 ER-positive breast cancer patients, who, following completion of Tamoxifen, were randomised to a further 5-year vs. no further treatment. The trial however was closed prematurely in the first interim with no benefit noted from extended treatment. The DFS at 4 years was 92% compared to 86% in the 10 years arm and the reason was attributed to the agonistic action of Tamoxifen .

Recommendation 2: for postmenopausal women commencing adjuvant endocrine therapy.

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Uterine Protection With Tamoxifen Use

Tamoxifen is commonly used as adjuvant endocrine therapy in the treatment of estrogen receptorpositive breast cancer in premenopausal women and in selected postmenopausal women. In postmenopausal women, tamoxifen appears to increase the risk of endometrial polyps, hyperplasia, and cancer. A systematic review of the LNG-IUS in the prevention of endometrial pathology in tamoxifen users concluded that Mirena reduced the risk of endometrial polyps in tamoxifen users, but no data demonstrate that it reduces the risk of endometrial hyperplasia or cancer. Mirena users had a higher incidence of unscheduled bleeding, which may increase the need for diagnostic intervention in this high-risk group.111

Richard J. Santen, in, 2009

Body Changes And Sexual Intimacy

Breast cancer and breast cancer treatment may change how you look. This may be because of a tumor, radiation, surgery, or a combination of these. Changes in your body from cancer treatment may affect:

  • How you feel about yourself.
  • Your comfort with showing your body to another person.
  • Your desire for sex. Both men and women may notice a decrease in their sexual desire during chemotherapy.
  • How your body responds sexually.
  • Your ability to get pregnant and have children.

What you can do:

  • Talk with your partner. Its important to share with each other how youre both feeling. You may find that theyre worried about causing you pain or discomfort during sex.
  • Talk with a member of your healthcare team about ways to improve your sexual health.
  • Read the resource Sexual Health and Intimacy for more information.

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My Chemotherapy Treatment Was Delayed Because My Anc Was Low What Is An Anc

An ANC is an absolute neutrophil count. A neutrophil is a white blood cell that helps fight infections. The ANC count usually falls 7 to 14 days after getting chemotherapy. If your ANC is low, your doctor may delay your treatment until its back to normal. This is a precaution to prevent you from getting an infection.

Low White Blood Cell Count

Adjuvant Endocrine Therapy and Risk of Contralateral Breast Cancer

Your white blood cells help your body fight off infections. Having a low white blood cell count can raise your risk of getting an infection. You may start having low white blood cell counts 7 to 14 days after each treatment. There are medications that may be used to raise your white blood cell count or prevent it from falling. These medications come in the form of injections or devices that you wear on your arm.

What you can do if you have a low white blood cell count:

  • Take your temperature by mouth every 4 hours if you think you have a fever, body aches, or chills, or notice an increased temperature of your skin. This is very important. If you have a fever after hours, you should call your doctors office and ask to talk to the doctor on call.
  • Ask your nurse or doctor if you can take acetaminophen .
  • Always wash your hands after using the toilet and before eating.
  • Protect your hands from cuts and burns:
  • Dont cut your cuticles. Push them back instead.
  • Wear gloves when you wash the dishes, cook, or garden.
  • Keep your skin moisturized to avoid skin cracking.
  • If you have a cut, wash it with soap and water right away. You can also use an antibacterial ointment or spray on the cut. Watch for any signs of infection such as redness, swelling, or pus. If you notice any of these signs, call your doctor.
  • What to avoid if you have a low white blood cell count:

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    Endocrine Therapy As Adjuvant Or Neoadjuvant Therapy For Breast Cancer: Selecting The Best Agents The Timing And Duration Of Treatment

    Department of Breast Surgery, Fudan University Shanghai Cancer Center, and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, China

    Contributions: Conception and design: ZM Shao Administrative support: All authors Provision of study materials or patients: JJ Li Collection and assembly of data: All authors Data analysis and interpretation: All authors Manuscript writing: All authors Final approval of manuscript: All authors.

    Correspondence to:

    Keywords: Breast cancer endocrine therapy adjuvant neoadjuvant

    Submitted Mar 22, 2016. Accepted for publication Mar 28, 2016.

    doi: 10.21037/cco.2016.03.24

    Early Stage Her2 Positive Tumors

    It has been hypothesized that a specific population of patients who may benefit from the use of anthracycline is that of patients with HER2 positive tumors. The National Surgical – Breast and Bowel Project 31 trial included women with HER2 positive, node positive breast cancer. Patients were assigned to treatment with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab therapy. In conjunction with this trial was the North Central Cancer Treatment Group intergroup trial N9831 which enrolled women with HER2 positive node positive or high-risk node negative breast cancer. The women were treated with AC and T followed by no treatment, AC and T followed by sequential H or AC followed by concurrent T and H. From these two trials at a median follow up of 3.9 years, chemotherapy plus adjuvant trastuzumab compared to treatment without trastuzumab resulted in significantly superior DFS and OS .

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