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Implementing New Data and Evolving Standards in Metastatic Triple-Negative Breast Cancer

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Implementing New Data and Evolving Standards in Metastatic Triple-Negative Breast Cancer

  1. 1. www.i3Health.com Clinical Tools and Resources for Self-Study and Patient Education TRIPLE-NEGATIVE BREAST CANCER REFERENCE GUIDE The clinical tools and resources contained herein are provided as educational adjuncts to the CME/CE-approved online activity Implementing New Data and Evolving Standards in Metastatic Triple-Negative Breast Cancer. To access the activity and earn CME/CE credit, visit: https://www.i3Health.com/tnbc CONTENTS I. General Staging of Breast Cancer......................................................................................................2 II. TNM Classifications of Breast Cancer ...............................................................................................4 III. Guidelines for Systemic Adjuvant Treatment: Triple-Negative Breast Cancer.................................6 IV. Chemotherapy for Recurrent or Metastatic Triple-Negative Breast Cancer ....................................7 V. Targeted Therapy and Immunotherapy for Metastatic Triple-Negative Breast Cancer....................8 VI. Patient Education: Side Effects of Treatment for Triple-Negative Breast Cancer..........................10
  2. 2. 090TNBC Reference Guide | Page 2 of 11 www.i3Health.com I. GENERAL STAGING OF BREAST CANCER Stage Description Stage 0 • Carcinoma in situ (DCIS) • Non-invasive: the cancer cells are still within a duct and have not invaded the surrounding fatty breast tissue • No spread to lymph nodes or distant sites Stage IA • Tumor is ≤2 cm across • No spread to lymph nodes or distant sites Stage IB • Tumor is ≤2 cm across (or is not found) • Micrometastases in 1-3 axillary lymph nodes (the cancer in the lymph nodes is >0.2 mm across and/or >200 cells but ≤2 mm across) • No spread to distant sites Stage IIA One of the following applies, and the cancer has not spread to distant sites: • Tumor is ≤2 cm across (or is not found); spread to 1-3 axillary lymph nodes, with the cancer in the lymph nodes >2 mm across • Tumor is ≤2 cm across (or is not found); tiny amounts of cancer are found in internal mammary lymph nodes on sentinel lymph node biopsy • Tumor is ≤2 cm across (or is not found); spread to 1-3 lymph nodes under the arm and to internal mammary lymph nodes (found on sentinel lymph node biopsy) • Tumor is >2 cm across and <5 cm; no spread to lymph nodes Stage IIB One of the following applies, and the cancer has not spread to distant sites: • Tumor is >2 cm and <5 cm across; spread to 1-3 axillary lymph nodes and/or tiny amounts of cancer found in internal mammary lymph nodes on sentinel lymph node biopsy • Tumor is >5 cm across but does not grow into the chest wall or skin; no spread to lymph nodes Stage IIIA One of the following applies, and the cancer has not spread to distant sites: • Tumor is ≤5 cm across (or cannot be found); spread to 4-9 axillary lymph nodes • Tumor is >5 cm across but does not grow into the chest wall or skin; spread to 1-9 axillary nodes or to internal mammary nodes Stage IIIB Tumor has grown into the chest wall or skin but has not spread to distant sites. One of the following applies: • No spread to lymph nodes • Spread to 1-3 axillary lymph nodes and/or tiny amounts of cancer found in internal mammary lymph nodes on sentinel lymph node biopsy • Spread to 4-9 axillary lymph nodes, or tumor has enlarged the internal mammary lymph nodes
  3. 3. 090TNBC Reference Guide | Page 3 of 11 www.i3Health.com Stage (cont.) Description (cont.) Stage IIIC The tumor is any size (or cannot be found) with no spread to distant sites. One of the following applies: • Spread to >10 axillary lymph nodes • Spread to the lymph nodes under the clavicle • Spread to the lymph nodes above the clavicle • Involvement of axillary lymph nodes • Spread to ≥4 axillary lymph nodes, with tiny amounts of cancer found in internal mammary lymph nodes on sentinel lymph node biopsy Stage IV • Tumor can be of any size • May or may not have spread to nearby lymph nodes • Spread to distant organs or to lymph nodes far from the breast • Most common sites of spread: bone, liver, brain, or lung National Cancer Institute (2019). Triple-negative breast cancer staging. Available at: https://www.pennmedicine.org/cancer/types-of- cancer/breast-cancer/types-of-breast-cancer/triplenegative-breast-cancer/triplenegative-breast-cancer-diagnosis/triplenegative- breast-cancer-staging
  4. 4. 090TNBC Reference Guide | Page 4 of 11 www.i3Health.com II. TNM CLASSIFICATIONS OF BREAST CANCER Tumor Tx Primary tumor cannot be assessed T0 No evidence of primary tumor Tis (DCIS) Ductal carcinoma in situ Tis (Paget) Paget disease of the nipple NOT associated with invasive carcinoma and/or carcinoma in situ (DCIS) in the underlying breast parenchyma (tissue) T1 Tumor £20 mm in greatest dimension T1mi Tumor £1 mm in greatest dimension T1a Tumor >1 mm but £5 mm in greatest dimension T1b Tumor >5 mm but £10 mm in greatest dimension T1c Tumor >10 mm but £20 mm in greatest dimension T2 Tumor >20 mm but £50 mm in greatest dimension T3 Tumor >50 mm in greatest dimension T4 Tumor of any size with direct extension to the chest wall and/or skin (ulceration or macroscopic nodules) T4a Extension to the chest wall T4b Ulceration and/or ipsilateral macroscopic satellite nodules and/or edema of the skin that does not meet the criteria for inflammatory carcinoma T4c Both T4a and T4b are present T4d Inflammatory carcinoma Node pNX Regional lymph nodes cannot be assessed pN0 No regional lymph node metastasis identified; alternately, isolated tumor cells (ITCs) only pN0(i+) ITCs only: malignant cell clusters ≤0.2 mm) in regional lymph node(s) pN0(mol+) Positive molecular findings by reverse transcriptase polymerase chain reaction (RT-PCR); no ITCs detected pN1 Micrometastases, metastases in 1-3 axillary (armpit) lymph nodes, and/or clinically negative internal mammary nodes with micrometastases or macrometastases by sentinel lymph node biopsy pN1mi Micrometastases (approximately 200 cells, >0.2 mm and <2.0 mm in size) pN1a Metastases in 1-3 axillary lymph nodes, with at least one metastasis >2.0 mm pN1b Metastases in ipsilateral internal mammary sentinel nodes, excluding ITCs pN1c pN1a and pN1b combined
  5. 5. 090TNBC Reference Guide | Page 5 of 11 www.i3Health.com Node (cont.) pN2 Metastases in 4-9 axillary lymph nodes or positive ipsilateral internal mammary lymph nodes by imaging in the absence of axillary lymph node metastases pN2a Metastases in 4-9 axillary lymph nodes (at least one tumor deposit >2.0 mm) pN2b Metastases in clinically detected internal mammary lymph nodes with or without microscopic confirmation; pathologically negative axillary nodes pN3 Metastases that satisfy any of the following conditions: • Present in ≥10 axillary lymph nodes • Present in infraclavicular (below the clavicle, or collar bone) (Level III axillary) lymph nodes • Positive ipsilateral internal mammary lymph nodes by imaging in the presence of one or more positive Level I or II axillary lymph nodes • Present in >3 axillary lymph nodes, as well as micrometastases or macrometastases by sentinel lymph node biopsy in clinically negative ipsilateral internal mammary lymph nodes • Present in ipsilateral supraclavicular lymph nodes (lymph nodes above the clavicle) pN3a Metastases in ≥10 axillary lymph nodes (at least one tumor deposit >2.0 mm) pN3b Either pN1a or pN2a in the presence of cN2b (positive internal mammary nodes by imaging) or pN2a in the presence of pN1b pN3c Metastases in ipsilateral supraclavicular lymph nodes Metastasis M0 No clinical or radiographic evidence of distant metastases cM0(i+) No clinical or radiographic evidence of distant metastases in the presence of tumor cells; alternately, deposits ≤0.2 mm detected microscopically or by molecular techniques in circulating blood, bone marrow, or other nonregional nodal tissue in a patient without symptoms or signs of metastases cM1 Distant metastases detected by clinical and radiographic means pM1 Any histologically proven metastases in distant organs, or if in non-regional nodes, metastases >0.2 mm Amin MB, Edge S, Green F, et al (2017). AJCC Cancer Staging Manual. 8th ed. New York, NY: Springer.
  6. 6. 090TNBC Reference Guide | Page 6 of 11 www.i3Health.com III. GUIDELINES FOR SYSTEMIC ADJUVANT TREATMENT: TRIPLE- NEGATIVE BREAST CANCER National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: breast cancer. Version 1.2019. Available at: http://www.nccn.org
  7. 7. 090TNBC Reference Guide | Page 7 of 11 www.i3Health.com IV. CHEMOTHERAPY FOR RECURRENT OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER Chemotherapy Options Preferred single agents • Doxorubicin (Adriamycin®, Rubex®) • Paclitaxel (Abraxane®, Taxol®) • Gemcitabine (Gemzar®) • Eribulin (Halaven®) • Liposomal doxorubicin (Doxil®) • Capecitabine (Xeloda®) • Vinorelbine (Navelbine®) Other single agents • Cyclophosphamide (Cytoxan®, Neosar®) • Docetaxel (Taxotere®) • Cisplatin (Platinol®) • Ixabepilone (Ixempra®) • Carboplatin (Paraplatin®) • Albumin-bound paclitaxel (Abraxane®) • Epirubicin (Ellence®) Combination regimens • Doxorubicin/cyclophosphamide • Epirubicin/cyclophosphamide • Cyclophosphamide/methotrexate/fluoroucacil (Trexall®, Rasuvo®, Otrexup®)/(Efudex®, Fluoroplex®, Carac®) • Docetaxel/capecitabine • Gemcitabine/paclitaxel • Gemcitabine/carboplatin • Paclitaxel/bevacizumab (Avastin®) National Comprehensive Cancer Network (2019). Clinical Practice Guidelines in Oncology: breast cancer. Version 1.2019. Available at: http://www.nccn.org
  8. 8. 090TNBC Reference Guide | Page 8 of 11 www.i3Health.com V. TARGETED THERAPY AND IMMUNOTHERAPY FOR METASTATIC TRIPLE- NEGATIVE BREAST CANCER Class Agents Adverse Events PARP Inhibitors • The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells • Research has shown that medicines that interfere with or inhibit the PARP enzyme make it harder for cancer cells with a BRCA1 or BRCA2 mutation to fix DNA damage • This makes it harder for the cancer cells to survive Olaparib (Lynparza®) Talazoparib (Talzenna®) Bone marrow problems: myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Symptoms: • Weakness • Weight loss • Fever • Frequent infections • Blood in urine or stool • Shortness of breath • Feeling very tired • Bruising or bleeding more easily Common side effects: • Nausea or vomiting • Low red or white blood cell count • Tiredness or weakness • Sore throat or runny nose • Diarrhea • Joint, muscle, and back pain • Headache • Constipation • Changes in the way food tastes • Loss of appetite • Mouth sores • Respiratory infections • Changes in kidney function blood test • Indigestion or heartburn • Low platelet count • Hair loss Breastcancer.org (2018). Triple-negative breast cancer. Available at: https://www.breastcancer.org/symptoms/diagnosis/trip_neg Lynparza® (olaparib) prescribing information (2018). AstraZeneca. Available at: https://www.lynparza.com/breast-cancer/breast- cancer-treatment-side-effects.html Talzenna® (talazoparib) prescribing information (2018). Pfizer. Available at: https://www.talzenna.com
  9. 9. 090TNBC Reference Guide | Page 9 of 11 www.i3Health.com Class (cont.) Agents (cont.) Adverse Events (cont.) Monoclonal Antibodies • Molecules produced in laboratories to substitute antibodies that can restore, enhance or mimic the immune system’s attack on cancer cells • Bind to antigens that are usually more present on cancer cell surfaces than healthy cell surfaces Atezolizumab (Tecentriq®) Severe side effects: • Lung problems (pneumonitis): new or worsening cough, shortness of breath, and chest pain • Liver problems (hepatitis): yellowing of skin/whites of eyes, severe nausea or vomiting, pain on right side of stomach, drowsiness, dark urine (tea-colored), easy bleeding or bruising, reduced hunger • Intestinal problems (colitis): diarrhea or increase in bowel movements; blood or mucus in stools or dark, tarry, sticky stools; severe abdominal pain or tenderness • Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary): headaches, extreme tiredness, weight gain or loss, dizziness or fainting, increased hunger or thirst, hair loss, changes in mood or behavior (such as decreased libido, irritability, or forgetfulness), chills, constipation, deepening of the voice, frequent urination, nausea or vomiting, abdominal pain • Problems in other organs: severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, swelling of ankles • Severe infections: fever, cough, flu-like symptoms, frequent or painful urination, back pain • Severe infusion reactions: chills, shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of face or lips, dizziness, fever, feelings of faintness, back or neck pain Common side effects: • Fatigue • Nausea • Constipation • Cough • Shortness of breath • Decreased appetite Tecentriq® (atezolizumab) prescribing information (2019). Genentech. Available at: https://www.tecentriq.com
  10. 10. 090TNBC Reference Guide | Page 10 of 11 www.i3Health.com VI. PATIENT EDUCATION: SIDE EFFECTS OF TREATMENT FOR TRIPLE- NEGATIVE BREAST CANCER TNBC Treatment Side Effects Adverse Event Description Management Cognitive dysfunction (“Chemo brain”) A constellation of cognitive symptoms resulting from chemotherapy: • Trouble remembering words or directions • Difficulty concentrating • Memory lapses in the middle of tasks • Feeling of being in a mental fog • Use a planner or calendar to keep track of “to do” lists and events • Focus on the task at hand (it’s ok not to multitask!) • Organize your home and work spaces; keep important items such as keys in a specific place • Tell your friends and family that you’re having trouble so they can help you remember important information • Keep a record of the problems you have and report them to a healthcare provider Fatigue • One of the most common side effects of cancer and its treatment • Often described as “paralyzing” • Comes on suddenly, does not result from activity or exertion, and is not relieved by sleep • May persist throughout treatment and even for a few months afterward • Accept help from others who want to lighten your load • Engage in regular moderate exercise, especially walking. This decreases fatigue • Nap when you can, but limit naps to 30 minutes • Get 8 hours of sleep per night • Set a routine for sleeping and waking • Conserve energy by setting priorities and planning to do the most important things when you have the most energy Hair loss (alopecia) • Patient may lose eyebrows, eyelashes, and other body hair in addition to the hair on their head • Radiation therapy may cause loss of hair in the treated area • If you choose to have a wig, buy it before treatment begins to help match it to your own hair. Also consider turbans, scarves, and hats • Your health insurance may cover wigs. If so, ask your doctor to write “cranial prosthesis” on the prescription rather than “wig” • Use a mild shampoo and a soft brush or wide-toothed comb • Avoid using elastic hair bands, which can cause breakage • Sleep on a satin pillowcase • Ask your doctor if using a cooling cap during treatment would be appropriate for you
  11. 11. 090TNBC Reference Guide | Page 11 of 11 www.i3Health.com TNBC Treatment Side Effects (cont.) Adverse Event Description Management Lymphedema • The lymphatic system carries white blood cells throughout the body to help fight infections • Lymph node removal during treatment can cause a buildup of lymphatic fluid, resulting in swelling in the area where the lymph nodes were removed, most often in an arm or leg • Lymphedema typically occurs immediately after surgery or radiation therapy, but it can also become an issue months or even years after treatment ends • Use a compression garment or tight bandages to apply pressure to the area • Elevate the swollen limb to encourage drainage of the lymphatic system • Talk to your doctor about manual lymphatic drainage (MLD), a gentle skin massage that helps drain lymphatic fluid into the bloodstream, reducing swelling • Also ask about complete decongestive therapy (CDT), which combines manual massage with skin care, exercise, and compression Nausea and vomiting • Most often caused by chemotherapy treatments • Eat smaller, more frequent meals throughout the day • Eat at the times of the day when you feel best • Avoid spicy and fatty foods and avoid foods with citric acid (such as citrus fruits). Bland foods, such as bananas and crackers, are easier to digest • Foods and drinks that include ginger can be soothing • Peppermint can relieve nausea • Drink plenty of fluids Neuropathy • Pain or discomfort caused by damage to the nerves that control movement and feeling in the arms and legs • Symptoms: numbness, pain, burning, tingling, or loss of feeling in the hands or feet • If you have these symptoms, keep a journal of when they happen, what they are, how long they last, and how intense they are. Share this information with your health care team • Avoid tight-fitting clothes • Wear comfortable shoes • Keep your hands and feet warm • Avoid standing or walking for extended periods Patient Resource (2019). Triple negative breast cancer. Available at: https://www.patientresource.com/TNBC_Side_Effects.aspx

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