Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension (NDLS) versus Conventional Docetaxel as Neoadjuvant and Adjuvant Therapy for Primary Operable Breast Cancer

References

• Sarid D, Ron IG, Sperber F, et al. Neoadjuvant treatment with paclitaxel and epirubicin in invasive breast cancer: a phase II study. Clin Drug Investig. 2006;26(12):691–702. doi:10.2165/00044011-200626120-00003
   PubMed Web of Science ®Google Scholar
• Pennisi A, Kieber-Emmons T, Makhoul I, Hutchins L. Relevance of pathological complete response after neoadjuvant therapy for breast cancer. Breast Cancer. 2016;10:103–106. doi:10.4137/BCBCR.S33163
   PubMedGoogle Scholar
• Buzdar AU, Singletary SE, Theriault RL, et al. Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer. J Clin Oncol. 1999;17(11):3412–3417. doi:10.1200/JCO.1999.17.11.3412
   PubMed Web of Science ®Google Scholar
• Gradishar WJ. Docetaxel as neoadjuvant chemotherapy in patients with stage III breast cancer. Oncology. 1997;11(8 Suppl 8):15–18.
   PubMedGoogle Scholar
• Miller KD, McCaskill-Stevens W, Sisk J, et al. Combination versus sequential doxorubicin and docetaxel as primary chemotherapy for breast cancer: a randomized pilot trial of the Hoosier Oncology Group. J Clin Oncol. 1999;17(10):3033–3037. doi:10.1200/JCO.1999.17.10.3033
   PubMed Web of Science ®Google Scholar
• Rastogi P, Anderson SJ, Bear HD, et al. Preoperative chemotherapy: updates of national surgical adjuvant breast and bowel project protocols B-18 and B-27. J Clin Oncol. 2008;26(5):778–785. doi:10.1200/JCO.2007.15.0235
   PubMed Web of Science ®Google Scholar
• Sánchez-Moreno P, Boulaiz H, Ortega-Vinuesa JL, Peula-García JM, Aránega A. Novel drug delivery system based on docetaxel-loaded nanocapsules as a therapeutic strategy against breast cancer cells. Int J Mol Sci. 2012;13(4):4906–4919. doi:10.3390/ijms13044906
   PubMed Web of Science ®Google Scholar
• ten Tije AJ, Verweij J, Loos WJ, Sparreboom A. Pharmacological effects of formulation vehicles: implications for cancer chemotherapy. Clin Pharmacokinet. 2003;42(7):665–685. doi:10.2165/00003088-200342070-00005
   PubMed Web of Science ®Google Scholar
• van Zuylen L, Verweij J, Sparreboom A. Role of formulation vehicles in taxane pharmacology. Invest New Drugs. 2001;19(2):125–141. doi:10.1023/A:1010618632738
   PubMed Web of Science ®Google Scholar
• Engels FK, Mathot RA, Verweij J. Alternative drug formulations of docetaxel: a review. Anticancer Drugs. 2007;18(2):95–103. doi:10.1097/CAD.0b013e3280113338
   PubMed Web of Science ®Google Scholar
• Taxotere®. Prescribing_information. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020449s059lbl.pdf. Accessed March 24, 2023.
   Google Scholar
• Ahmad A, Sheikh S, Taran R, et al. Therapeutic efficacy of a novel nanosomal docetaxel lipid suspension compared with taxotere in locally advanced or metastatic breast cancer patients. Clin Breast Cancer. 2014;14(3):177–181. doi:10.1016/j.clbc.2013.09.011
   PubMed Web of Science ®Google Scholar
• Ahmad A, Sheikh S, Ali S, Ahmad M, Paithankar M. Development of aqueous based formulation of docetaxel: safety and pharmacokinetics in patients with advanced solid tumors. J Nanomed Nanotechnol. 2015;6:295.
   Google Scholar
• Mirza A, Mithal N. Alcohol intoxication with the new formulation of docetaxel. Clin Oncol. 2011;23(8):560–561. doi:10.1016/j.clon.2011.04.010
   Web of Science ®Google Scholar
• Estevez LG, Cuevas JM, Anton A, et al. Weekly docetaxel as neoadjuvant chemotherapy for stage II and III breast cancer: efficacy and correlation with biological markers in a Phase II, multicenter study. Clin Cancer Res. 2003;9(2):686–692.
   PubMed Web of Science ®Google Scholar
• McKeage K. Nanosomal docetaxel lipid suspension: a guide to its use in cancer. Clin Drug Investig. 2017;37(4):405–410. doi:10.1007/s40261-017-0510-7
   PubMed Web of Science ®Google Scholar
• Subramanian S, Prasanna R, Biswas G, et al. Nanosomal docetaxel lipid suspension-based chemotherapy in breast cancer: results from a multicenter retrospective study. Breast Cancer. 2020;12:77–85. doi:10.2147/BCTT.S236108
   PubMed Web of Science ®Google Scholar
• Amin MB, Greene FL, Edge SB, et al. The eighth edition AJCC cancer staging manual: continuing to build a bridge from a population-based to a more “personalized” approach to cancer staging. CA Cancer J Clin. 2017;67(2):93–99. doi:10.3322/caac.21388
   PubMed Web of Science ®Google Scholar
• Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice guideline focused update. J Clin Oncol. 2018;36(20):2105–2122. doi:10.1200/JCO.2018.77.8738
   PubMed Web of Science ®Google Scholar
• Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thürlimann B, Senn HJ. Strategies for subtypes--dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011;22(8):1736–1747. doi:10.1093/annonc/mdr304
   PubMed Web of Science ®Google Scholar
• Ogston KN, Miller ID, Payne S, et al. A new histological grading system to assess response of breast cancers to primary chemotherapy: prognostic significance and survival. Breast. 2003;12(5):320–327. doi:10.1016/S0960-9776(03)00106-1
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247. doi:10.1016/j.ejca.2008.10.026
   PubMed Web of Science ®Google Scholar
• National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf. Accessed April 21, 2020.
   Google Scholar
• Schneeweiss A, Marmé F, Ruiz A, et al. A randomized phase II trial of doxorubicin plus pemetrexed followed by docetaxel versus doxorubicin plus cyclophosphamide followed by docetaxel as neoadjuvant treatment of early breast cancer. Ann Oncol. 2011;22(3):609–617. doi:10.1093/annonc/mdq400
   PubMed Web of Science ®Google Scholar
• Bear HD, Anderson S, Brown A, et al. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003;21(22):4165–4174. doi:10.1200/JCO.2003.12.005
   PubMed Web of Science ®Google Scholar
• von Minckwitz G, Raab G, Caputo A, et al. Doxorubicin with cyclophosphamide followed by docetaxel every 21 days compared with doxorubicin and docetaxel every 14 days as preoperative treatment in operable breast cancer: the GEPARDUO study of the German Breast Group. J Clin Oncol. 2005;23(12):2676–2685. doi:10.1200/JCO.2005.05.078
   PubMed Web of Science ®Google Scholar
• Vriens B, Van de Vijver K, Boetes C, et al. Abstract P1-11-10: sequential versus upfront intensified neoadjuvant chemotherapy in patients with large resectable or locally advanced breast cancer (INTENS), first results from a phase III study of the Dutch Breast Cancer Trialists’ Group (BOOG). Cancer Res. 2010;70(24):P1–11–10. doi:10.1158/0008-5472.SABCS10-P1-11-10
   Google Scholar
• Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up†. Ann Oncol. 2019;30(8):1194–1220. doi:10.1093/annonc/mdz173
   PubMed Web of Science ®Google Scholar
• Thiery-Vuillemin A, Llombart-Cussac A, Chaigneau L, et al. Sequential taxane and anthracycline-containing neoadjuvant regimens: the sequential order impact. Breast. 2011;20(1):46–49. doi:10.1016/j.breast.2010.07.001
   PubMed Web of Science ®Google Scholar
• Zaheed M, Wilcken N, Willson ML, O’Connell DL, Goodwin A. Sequencing of anthracyclines and taxanes in neoadjuvant and adjuvant therapy for early breast cancer. Cochrane Database Syst Rev. 2019;2(2):CD012873–CD012873. doi:10.1002/14651858.CD012873.pub2
   PubMedGoogle Scholar
• Bear HD, Anderson S, Smith RE, et al. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer: nationalSurgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006;24(13):2019–2027. doi:10.1200/JCO.2005.04.1665
   PubMed Web of Science ®Google Scholar
• Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO international consensus guidelines for Advanced Breast Cancer (ABC 4)†. Ann Oncol. 2018;29(8):1634–1657. doi:10.1093/annonc/mdy192
   PubMed Web of Science ®Google Scholar
• Martin M. Docetaxel, Doxorubicin and Cyclophosphamide (the TAC regimen): an effective adjuvant treatment for operable breast cancer. Womens Health. 2006;2(4):527–537. doi:10.2217/17455057.2.4.527
   Google Scholar
• Fujii T, Le Du F, Xiao L, et al. Effectiveness of an adjuvant chemotherapy regimen for early-stage breast cancer: a systematic review and network meta-analysis. JAMA Oncol. 2015;1(9):1311–1318. doi:10.1001/jamaoncol.2015.3062
   PubMed Web of Science ®Google Scholar
• Eiermann W, Pienkowski T, Crown J, et al. Phase III study of doxorubicin/cyclophosphamide with concomitant versus sequential docetaxel as adjuvant treatment in patients with human epidermal growth factor receptor 2-normal, node-positive breast cancer: BCIRG-005 trial. J Clin Oncol. 2011;29(29):3877–3884. doi:10.1200/JCO.2010.28.5437
   PubMed Web of Science ®Google Scholar
• Livi L, Meattini I, de Luca Cardillo C, et al. Use of doxorubicin plus cyclophosphamide followed by docetaxel as adjuvant chemotherapy for breast cancer. J Chemother. 2011;23(1):36–39. doi:10.1179/joc.2011.23.1.36
   PubMed Web of Science ®Google Scholar
• Murali A, Gupta S, Pendharkar D. Efficacy and tolerability of nanoparticle docetaxel lipid suspension. J Clin Oncol. 2018;36(15_suppl):e14542–e14542. doi:10.1200/JCO.2018.36.15_suppl.e14542
   Web of Science ®Google Scholar
• Ho MY, Mackey JR. Presentation and management of docetaxel-related adverse effects in patients with breast cancer. Cancer Manag Res. 2014;6:253–259. doi:10.2147/CMAR.S40601
   PubMed Web of Science ®Google Scholar