A Multi-Center Trial to Evaluate the Safety and Toxicity of Nanoxel®-M in Breast Cancer Patients
3
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Purpose: Nanoxel®-M is a low-molecular-weight, non-toxic, biodegradable, docetaxel-loaded methoxy-poly (ethylene glycol)-block-poly (D,L-lactide) (mPEG-PDLLA) micellar formulation. We conducted a multicenter trial to evaluate the safety and toxicity of Nanoxel®-M and the quality of life (QoL) of Korean breast cancer patients treated with this formulation. Methods: Patients received adjuvant Nanoxel®-M with a schedule comprising four alternating cycles of doxorubicin with cyclophosphamide, followed by either Nanoxel®-M or Nanoxel®-M with cyclophosphamide after surgery for early breast cancer. We analyzed hematological and non-hematological toxicity profiles and alterations in patient QoL using the Korean version of the European organization for research and treatment of cancer core 30-item quality of life questionnaire. Fifty-five operable breast cancer patients with stage II or III disease were enrolled from four centers in Korea. Results: Regarding safety and toxicity profiles, grade 3/4 toxicity presented as anemia in 0.5%, neutropenia in 61.8%, febrile neutropenia in 4.5%, mucositis in 1.4%, and edema in 0.5% of patients during 220 total cycles. However, all-grade thrombocytopenia was not observed among hematological toxicities. No grade 3/4 nausea, vomiting, diarrhea, hand foot syndrome, dyspnea, allergic reaction, edema, or peripheral neuropathy were observed. Furthermore, no vehicle-related hypersensitivity reactions occurred when using Nanoxel®-M. Conclusion: Our findings indicate that Nanoxel®-M could be used to treat operable breast cancer patients, compare favorably with docetaxel in terms of hypersensitivity reactions and the incidence of taxane-induced peripheral neuropathy, and is associated with a similar incidence of febrile neutropenia.
Abstract
Purpose: Nanoxel®-M is a low-molecular-weight, non-toxic, biodegradable, docetaxel-loaded methoxy-poly (ethylene glycol)-block-poly (D,L-lactide) (mPEG-PDLLA) micellar formulation. We conducted a multicenter trial to evaluate the safety and toxicity of Nanoxel®-M and the quality of life (QoL) of Korean breast cancer patients treated with this formulation. Methods: Patients received adjuvant Nanoxel®-M with a schedule comprising four alternating cycles of doxorubicin with cyclophosphamide, followed by either Nanoxel®-M or Nanoxel®-M with cyclophosphamide after surgery for early breast cancer. We analyzed hematological and non-hematological toxicity profiles and alterations in patient QoL using the Korean version of the European organization for research and treatment of cancer core 30-item quality of life questionnaire. Fifty-five operable breast cancer patients with stage II or III disease were enrolled from four centers in Korea. Results: Regarding safety and toxicity profiles, grade 3/4 toxicity presented as anemia in 0.5%, neutropenia in 61.8%, febrile neutropenia in 4.5%, mucositis in 1.4%, and edema in 0.5% of patients during 220 total cycles. However, all-grade thrombocytopenia was not observed among hematological toxicities. No grade 3/4 nausea, vomiting, diarrhea, hand foot syndrome, dyspnea, allergic reaction, edema, or peripheral neuropathy were observed. Furthermore, no vehicle-related hypersensitivity reactions occurred when using Nanoxel®-M. Conclusion: Our findings indicate that Nanoxel®-M could be used to treat operable breast cancer patients, compare favorably with docetaxel in terms of hypersensitivity reactions and the incidence of taxane-induced peripheral neuropathy, and is associated with a similar incidence of febrile neutropenia.
참고문헌 (29)
- Bissery MC, "Preclinical pharmacology of docetaxel", Eur J Cancer, 31, pp.S1~6 (1995)
- Shtil AA, "Differential regulation of mitogen-activated protein kinases by microtubule-binding agents in human breast cancer cells", Oncogene, 18, pp.377~384 (1999)
- Schiff PB, "Promotion of microtubule assembly in vitro by taxol", Nature, 277, pp.665~667 (1979)
- Schiff PB, "Taxol assembles tubulin in the absence of exogenous guanosine 5’-triphosphate or microtubule-associated proteins", Biochemistry, 20, pp.3247~3252 (1981)
- Chevallier B, "Docetaxel is a major cytotoxic drug for the treatment of advanced breast cancer : a phase II trial of the Clinical Screening Cooperative Group of the European Organization for Research and Treatment of Cancer", J Clin Oncol, 13, pp.314~322 (1995)
- van Oosterom AT, "Docetaxel(taxotere), a review of preclinical and clinical experience. Part II : clinical experience", Anticancer Drugs, 6, pp.356~368 (1995)
- Piccart MJ, "Docetaxel : an active new drug for treatment of advanced epithelial ovarian cancer", J Natl Cancer Inst, 87, pp.676~681 (1995)
- Gelderblom H, "The drawbacks and advantages of vehicle selection for drug formulation", Eur J Cancer, 37, pp.1590~1598 (2001)
- Adams JD, "Taxol : a history of pharmaceutical development and current pharmaceutical concerns", J Natl Cancer Inst Monogr, 15, pp.141~147 (1993)
- Weiszhar Z, "Complement activation by polyethoxylated pharmaceutical surfactants : Cremophor-EL, Tween-80 and Tween-20", Eur J Pharm Sci, 45, pp.492~498 (2012)
- Ojima I, "Taxane anticancer agents : a patent perspective", Expert Opin Ther Pat, 26, pp.1~20 (2016)
- Yared JA, "Update on taxane development : new analogs and new formulations", Drug Des Devel Ther, 6, pp.371~384 (2012)
- Feng L, "A critical review of lipid-based nanoparticles for taxane delivery", Cancer Lett, 334, pp.157~175 (2013)
- Yun YH, "Validation of the Korean version of the EORTC QLQ-C30", Qual Life Res, 13, pp.863~868 (2004)
- Aaronson NK, "The European Organization for Research and Treatment of Cancer QLQ-C30 : a quality-of-life instrument for use in international clinical trials in oncology", J Natl Cancer Inst, 85, pp.365~376 (1993)
- ten Bokkel Huinink WW, "A phase II trial with docetaxel(Taxotere)in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trials Group", Ann Oncol, 5, pp.527~532 (1994)
- von Minckwitz G, "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, 23, pp.2676~2685 (2005)
- Bear HD, "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, 21, pp.4165~4174 (2003)
- Jones S, "Docetaxel with cyclophosphamide is associated with an overall survival benefit compared with doxorubicin and cyclophosphamide : 7-Year follow-up of US Oncology Research Trial 9735", J Clin Oncol, 27, pp.1177~1183 (2009)
- Han HS, "Racial differences in acute toxicities of neoadjuvant or adjuvant chemotherapy in patients with early-stage breast cancer", Eur J Cancer, 47, pp.2537~2545 (2011)
- Chow LWC, "Toxicity profile differences of adjuvant docetaxel", cyclophosphamide(TC)between Asian and Caucasian breast cancer patients, 2017, pp.13, 372~378
- Jones SE, "Phase III trial comparing doxorubicin plus cyclophosphamide with docetaxel plus cyclophosphamide as adjuvant therapy for operable breast cancer", J Clin Oncol, 24, pp.5381~5387 (2006)
- Syrigou E, "Acute hypersensitivity reactions to chemotherapy agents : an overview", Inflamm Allergy Drug Targets, 9, pp.206~213 (2010)
- Markman M, "Paclitaxel-associated hypersensitivity reactions : experience of the gynecologic oncology program of the Cleveland Clinic Cancer Center", J Clin Oncol, 18, pp.102~105 (2000)
- Rowinsky EK, "Paclitaxel(taxol)", N Engl J Med, 332, pp.1004~1014 (1995)
- Argyriou AA, "Peripheral nerve damage associated with administration of taxanes in patients with cancer", Crit Rev Oncol Hematol, 66, pp.218~228 (2008)
- Winer EP, "Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer : cancer and leukemia group B trial 9342", J Clin Oncol, 22, pp.2061~2068 (2004)
- Song SJ, "Incidence of taxane-induced peripheral neuropathy receiving treatment and prescription patterns in patients with breast cancer", Support Care Cancer, 25, pp.2241~2248 (2017)
- Fayers PM, "Interpreting quality of life data : population-based reference data for the EORTC QLQ-C30", Eur J Cancer, 37, pp.1331~1334 (2001)