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Chemotherapy for Metastatic Breast Cancer (MBC)

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Chemotherapy for Metastatic Breast Cancer (MBC) Clinical Conversations Between an Oncology Nurse and Oncology Pharmacist During the Treatment of Patients With Breast Cancer: A Focus on Oral Chemotherapeutic Formulations © 2020. All rights reserved. No part of this report may be reproduced or distributed without the expressed written permission of PTCE. Faculty Information Chair Danielle Roman, PharmD, BCOP Manager, Clinical Pharmacy Services Allegheny Health Network Pittsburgh, Pennsylvania Allison Butts, PharmD, BCOP Kandra Horne, DNP, APRN, WHNP-BC Clinical Coordinator, Oncology Pharmacy Women’s Health Care Nurse Practitioner UK HealthCare Breast and GYN Oncology: Medical Oncology Assistant Adjunct Professor Winship Cancer Institute: Emory Healthcare UK College of Pharmacy Atlanta, Georgia Lexington, Kentucky This activity is supported by an educational grant from Athenex. Educational Objectives At the completion of this activity, participants will be able to: • Distinguish optimized treatment approaches for breast cancer based on disease- and patient-specific factors and potential places in therapy for oral formulations • Analyze the results of recent clinical trials with recently approved and emerging treatment options to inform the appropriate management of adverse effects and adherence for patients with breast cancer • Examine the benefits of multidisciplinary care across multiple practice environments for patients with breast cancer to optimize patient outcomes Evolving Oral Chemotherapeutic Opportunities in Breast Cancer Care Danielle Roman, PharmD, BCOP Manager, Clinical Pharmacy Services Allegheny Health Network Pittsburgh, Pennsylvania Pharmacologic Therapy for Breast Cancer Hormonal Therapies Other Targeted Therapies CDK 4/6 inhibitors Tamoxifen mTOR inhibitors Aromatase inhibitors (AIs) PD-1/PD-L1 inhibitors Fulvestrant PARP inhibitors LHRH agonists PI3K inhibitor HER2-Targeted Therapies Trastuzumab Pertuzumab Ado-trastuzumab emtansine Cytotoxic Chemotherapy Fam-trastuzumab deruxtecan Neratinib Lapatinib NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.3.2020 © National Comprehensive Cancer Network, Inc 2020. Accessed 3/23/20. Chemotherapy for Metastatic Breast Cancer (MBC) NCCN-preferred regimens Select NCCN “other recommended regimens” Other agents Doxorubicin/liposomal Cyclophosphamide Etoposide doxorubicin Paclitaxel Docetaxel Topotecan Capecitabine Albumin-bound paclitaxel Gemcitabine Epirubicin Vinorelbine Ixabepilone Eribulin Doxorubicin/cyclophosphamide (AC) Carboplatin or cisplatin Epirubicin/cyclophosphamide (EC) Cyclophosphamide/methotrexate/ 5-fluorouracil (CMF) Green = commercially available oral agent Docetaxel/capecitabine Blue = oral agent in development NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.3.2020. © National Comprehensive Cancer Network, Inc. 2020. Accessed 3/23/20. Advantages of Oral Route of Administration • Patient convenience • Home treatment • Minimize clinic/infusion visits • Removes the need for IV access and related complications (eg, infections) • Eliminates the risk of infusion-related hypersensitivity reactions related to formulation (eg, polyethoxylated castor oil [Cremophor]) • Removes need for hypersensitivity premedications (eg, corticosteroids) Dai MS, et al. J Clin Oncol. 2019;37:no.15_suppl_abstr 1084. Ciruelos EM, et al. Eur J Cancer Care. 2019;28:e13164. Changes in Roles and Responsibilities • Patient and/or caregiver • Health care providers • Must initiate therapy at the correct time • Establish a mechanism to track patients of day and at the correct dose on oral chemotherapy • Need to alert health care provider of • Longitudinal monitoring for AEs adverse effects (AEs) in a timely manner • Ensuring appropriate follow-up and labs • Increased responsibility for adherence throughout the course of treatment • May need to facilitate acquisition through a specialty pharmacy • Monitoring adherence with the regimen • Identify potential barriers to oral therapy (such as cost and access to medications) Select Oral Cytotoxic Agents in Breast Cancer Capecitabine Cyclophosphamide Vinorelbine Dosing BID on days 1–14 every 21 Daily on days 1–21 or days 1–14 Daily once weekly days every 28 days Administration - Swallow whole -Swallow whole Prophylactic antiemetic - Take with water and -Prophylactic antiemetic for doses within 30 minutes after a ≥100 mg/m2/day meal -Increase oral hydration -Morning administration preferred Place in Monotherapy (adjuvant; Monotherapy (metastatic) Not in current guidelines therapy metastatic) Combination (neoadjuvant, Monotherapy (metastatic) Combination (metastatic) adjuvant, or metastatic) Combination (metastatic) FDA approved Yes Yes No for breast cancer? NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer V.3.2020. © National Comprehensive Cancer Network, Inc. 2020. Accessed 3/23/20; Capecitabine. Lexicomp. Wolters Kluwer, Inc. Accessed 3/23/20. online.lexi.com; Cyclophosphamide. Lexicomp. Wolters Kluwer, Inc. Accessed 3/23/20. online.lexi.com; Steger GG, et al. Clin Breast Cancer. 2018;18:e41-e47; Aapro M, Finek J. Cancer Treat Rev. 2012;38:120-126. Oral Etoposide in MBC • Retrospective review of 110 patients with previously treated MBC • Median number of previous chemotherapy lines = 5 • Received oral etoposide 50 mg/day x 20 days in 28-day cycles • Results Response or Median stable disease duration on Median survival Tumor response = 6.4% lasting >6 therapy = 4 = 10.6 months months: 18.2% months • Well-tolerated with only 2 patients discontinuing treatment due to toxicity Giannone G, et al. Breast. 2018;38:160-164. Barriers to the Development of Oral Chemotherapy Formulations • Active excretion of drug by efflux transporters • P-glycoprotein (P-gp) in the intestinal cells • Breast cancer-resistant protein (BCRP) • Limited aqueous solubility • Acid hydrolysis in the stomach • Susceptibility to cytochrome P450 • Poor permeability across the gastrointestinal (GI) tract Mazzaferro S, et al. Drug Discovery Today. 2013;18:25-34. Mazzaferro S, et al. Drug Discovery Today. 2013;18:93-98. Mazzaferro S, et al. Drug Discovery Today. 2013;18:99-104. Circumventing the Barriers • Drug delivery systems • Addition of micelles, liposomes, micro- and nanocapsules, dendrimers, emulsions, microemulsions, nano-emulsions, and cyclodextrins • Use of mucoadhesive drug delivery system • Coadministration with CYP450 inhibitors • Coadministration with P-gp inhibitors • Prodrugs Mazzaferro S, et al. Drug Discovery Today. 2013;18:25-34. Mazzaferro S, et al. Drug Discovery Today. 2013;18:93-98. Mazzaferro S, et al. Drug Discovery Today. 2013;18:99-104. P-gp Inhibitors • Enable the oral absorption of anticancer drugs that are substrates of P-gp • Ideal agent has minimal oral absorption, which allows for localized activity in the GI tract • Examples of first-generation inhibitors include verapamil, cyclosporine A, ketoconazole, and erythromycin • Encequidar (HM30181A) is being studied in ongoing clinical trials with several chemotherapy agents Phase 1 Preparing for phase 2 Phase 3 • Eribulin • Docetaxel • Paclitaxel • Topotecan • Irinotecan Mazzaferro S, et al. Drug Discovery Today. 2013;18:99-104. Orascovery platform. Accessed 3/21/20. athenex.com/pipeline/orascovery-platform Prodrugs • Inactive compounds that are converted in vivo to active cytotoxic compounds • Benefits of the prodrug design • Improve solubility and chemical stability • Increase oral or local absorption and brain permeability • Modify presystemic metabolism • Reduce toxicity • Capecitabine is a third-generation fluoropyrimidine • Rapidly and almost completely absorbed from the intestine • Converted into fluorouracil in a 3-stage mechanism • Higher levels of fluorouracil produced in tumors with minimal exposure of healthy tissue Mazzaferro S, et al. Drug Discovery Today. 2013;18:93-98. Delahousse J, et al. Cancer Chemother Pharmacol. 2019;84:937-958. Questions for Panel Discussion • In your experience, what is the patient’s perspective on the use of oral chemotherapy compared with IV agents? • What is the biggest challenge that you have faced with the increasing use of oral chemotherapy in patients with breast cancer? • Historically, novel oral formulations of cytotoxic agents have not played a big role in the treatment of breast cancer. Why do you think we aren’t seeing more of these agents used in practice? Evolving Treatment Options in Breast Cancer: Optimizing Outcomes in the Clinic Allison Butts, PharmD, BCOP Clinical Coordinator, Oncology Pharmacy UK HealthCare Assistant Adjunct Professor UK College of Pharmacy Lexington, Kentucky Commonly Used Oral Agents in Breast Cancer ER/PR+ HER2+ ER/PR/HER2- CDK4/6 inhibitors Capecitabine^ PI3K inhibitor Tyrosine kinase inhibitors mTOR inhibitor PARP inhibitors* PARP inhibitors* *BRCA mutation. ^Can also be used in ER/PR+ or HER2+ disease. Identifying Patients Likely to Achieve Clinical Benefit • Extent and site of disease • Pathology and targetable mutations • Comorbidities • Performance status • Response to prior treatments • Tolerability of prior treatments • Demonstrated adherence Anticipated Benefit Based on Site of Disease Example: Tucatinib Total population (+) Brain metastases N = 320 N = 148 TUCATINIB PLACEBO TUCATINIB PLACEBO 1-year PFS 33.1% 12.3% 24.9% 0% Median PFS 7.8 months 5.6 months 7.6 months 5.4 months Median OS 21.9 months 17.4 months • Bottom Line • Tucatinib was FDA approved in 2020 for patients with unresectable or metastatic HER2+ breast cancer, including brain metastases, who
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