Generic placeholder image

Current Pharmaceutical Design

Editor-in-Chief

ISSN (Print): 1381-6128
ISSN (Online): 1873-4286

Meta-Analysis

Comparison of Efficacy and Peripheral Neuropathy of Solvent-based Paclitaxel with Paclitaxel Poliglumex and NK105: A Systematic Review and Metaanalysis

Author(s): Azade Taheri*, Amirhossein Rad, Erfan Sadeghi and Jaleh Varshosaz

Volume 27, Issue 17, 2021

Published on: 17 September, 2020

Page: [2041 - 2055] Pages: 15

DOI: 10.2174/1381612826666200917145551

Price: $65

Abstract

Background and Introduction: Peripheral neuropathy is one of the most common dose-limiting side effects of solvent-based paclitaxel. Paclitaxel poliglumex (PPX) and NK105 were developed to overcome the paclitaxel induced peripheral neuropathy. However, the incidence of peripheral neuropathy induced by PPX and NK105 was reported higher than solvent-based paclitaxel, but evidence remains inconsistent.

Methods: The article was reported in accordance with PRISMA Guidelines (Registration number: CRD42021245313). We conducted a meta-analysis to compare the incidence and severity of peripheral neuropathy between solvent-based paclitaxel, PPX and NK105 mono-chemotherapy.

Results: Results revealed that no significant difference exists between the incidence of all grade peripheral neuropathy among the solvent-based paclitaxel, PPX and NK105 treated groups. While, the incidence of high grade peripheral neuropathy induced by NK105 was lower than two other groups. Moreover, the overall survival was not improved in PPX compared with other groups. However, NK105 demonstrated significant longer overall survival in patients with cancer.

Conclusion: Current evidence suggests more attention should be paid to the paclitaxel poliglumex re-formulation.

Keywords: Incidence, peripheral neuropathy, paclitaxel poliglumex, NK105, solvent-based paclitaxel, meta-analysis.

[1]
Sinha R, Kim GJ, Nie S, Shin DM. Nanotechnology in cancer therapeutics: bioconjugated nanoparticles for drug delivery. Mol Cancer Ther 2006; 5(8): 1909-17.
[http://dx.doi.org/10.1158/1535-7163.MCT-06-0141] [PMID: 16928810]
[2]
Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy-induced peripheral neuropathy: A current review. Ann Neurol 2017; 81(6): 772-81.
[http://dx.doi.org/10.1002/ana.24951] [PMID: 28486769]
[3]
Scripture CD, Figg WD, Sparreboom A. Peripheral neuropathy induced by paclitaxel: recent insights and future perspectives. Curr Neuropharmacol 2006; 4(2): 165-72.
[http://dx.doi.org/10.2174/157015906776359568] [PMID: 18615126]
[4]
Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer 2015; 136(5): E359-86.
[http://dx.doi.org/10.1002/ijc.29210] [PMID: 25220842]
[5]
Campos FC, Victorino VJ, Martins-Pinge MC, Cecchini AL, Panis C, Cecchini R. Systemic toxicity induced by paclitaxel in vivo is associated with the solvent cremophor EL through oxidative stress-driven mechanisms. Food Chem Toxicol 2014; 68: 78-86.
[http://dx.doi.org/10.1016/j.fct.2014.03.013] [PMID: 24657178]
[6]
Sofias AM, Dunne M, Storm G, Allen C. The battle of “nano” paclitaxel. Adv Drug Deliv Rev 2017; 122: 20-30.
[http://dx.doi.org/10.1016/j.addr.2017.02.003] [PMID: 28257998]
[7]
Zang X, Lee JB, Deshpande K, Garbuzenko OB, Minko T, Kagan L. Prevention of paclitaxel-induced neuropathy by formulation approach. J Control Release 2019; 303: 109-16.
[http://dx.doi.org/10.1016/j.jconrel.2019.04.013] [PMID: 30981814]
[8]
Wang F, Porter M, Konstantopoulos A, Zhang P, Cui H. Preclinical development of drug delivery systems for paclitaxel-based cancer chemotherapy. J Control Release 2017; 267: 100-18.
[http://dx.doi.org/10.1016/j.jconrel.2017.09.026] [PMID: 28958854]
[9]
González-Aramundiz JV, Lozano MV, Sousa-Herves A, Fernandez-Megia E, Csaba N. Polypeptides and polyaminoacids in drug delivery. Expert Opin Drug Deliv 2012; 9(2): 183-201.
[http://dx.doi.org/10.1517/17425247.2012.647906] [PMID: 22243132]
[10]
Alexis F, Pridgen E, Molnar LK, Farokhzad OC. Factors affecting the clearance and biodistribution of polymeric nanoparticles. Mol Pharm 2008; 5(4): 505-15.
[http://dx.doi.org/10.1021/mp800051m] [PMID: 18672949]
[11]
Matsumura Y. Preclinical and clinical studies of NK012, an SN-38-incorporating polymeric micelles, which is designed based on EPR effect. Adv Drug Deliv Rev 2011; 63(3): 184-92.
[http://dx.doi.org/10.1016/j.addr.2010.05.008] [PMID: 20561951]
[12]
Matsumura Y, Hamaguchi T, Ura T, et al. Phase I clinical trial and pharmacokinetic evaluation of NK911, a micelle-encapsulated doxorubicin. Br J Cancer 2004; 91(10): 1775-81.
[http://dx.doi.org/10.1038/sj.bjc.6602204] [PMID: 15477860]
[13]
Hamaguchi T, Matsumura Y, Suzuki M, et al. NK105, a paclitaxel-incorporating micellar nanoparticle formulation, can extend in vivo antitumour activity and reduce the neurotoxicity of paclitaxel. Br J Cancer 2005; 92(7): 1240-6.
[http://dx.doi.org/10.1038/sj.bjc.6602479] [PMID: 15785749]
[14]
Koizumi F, Kitagawa M, Negishi T, et al. Novel SN-38-incorporating polymeric micelles, NK012, eradicate vascular endothelial growth factor-secreting bulky tumors. Cancer Res 2006; 66(20): 10048-56.
[http://dx.doi.org/10.1158/0008-5472.CAN-06-1605] [PMID: 17047068]
[15]
Singer JW. Paclitaxel poliglumex (XYOTAX, CT-2103): a macromolecular taxane. J Control Release 2005; 109(1-3): 120-6.
[http://dx.doi.org/10.1016/j.jconrel.2005.09.033] [PMID: 16297482]
[16]
Springett G, Takimoto C, McNamara M, Doroshow J, Syed S, Eastham E. Phase I study of CT-2106 (polyglutamate camptothecin) in patients with advanced malignancies. Journal of Clinical Oncology 2004; 22(14_suppl): 3127.
[17]
Kataoka K, Harada A, Nagasaki Y. Block copolymer micelles for drug delivery: design, characterization and biological significance. Adv Drug Deliv Rev 2012; 64: 37-48.
[http://dx.doi.org/10.1016/j.addr.2012.09.013] [PMID: 11251249]
[18]
Cabral H, Kataoka K. Progress of drug-loaded polymeric micelles into clinical studies. J Control Release 2014; 190: 465-76.
[http://dx.doi.org/10.1016/j.jconrel.2014.06.042] [PMID: 24993430]
[19]
Mukai H, Kato K, Esaki T, et al. Phase I study of NK105, a nanomicellar paclitaxel formulation, administered on a weekly schedule in patients with solid tumors. Invest New Drugs 2016; 34(6): 750-9.
[http://dx.doi.org/10.1007/s10637-016-0381-4] [PMID: 27595901]
[20]
Kato K, Chin K, Yoshikawa T, et al. Phase II study of NK105, a paclitaxel-incorporating micellar nanoparticle, for previously treated advanced or recurrent gastric cancer. Invest New Drugs 2012; 30(4): 1621-7.
[http://dx.doi.org/10.1007/s10637-011-9709-2] [PMID: 21728023]
[21]
Fujiwara Y, Mukai H, Saeki T, et al. A multi-national, randomised, open-label, parallel, phase III non-inferiority study comparing NK105 and paclitaxel in metastatic or recurrent breast cancer patients. Br J Cancer 2019; 120(5): 475-80.
[http://dx.doi.org/10.1038/s41416-019-0391-z] [PMID: 30745582]
[22]
Li C, Newman RA, Wu Q-P, et al. Biodistribution of paclitaxel and poly(L-glutamic acid)-paclitaxel conjugate in mice with ovarian OCa-1 tumor. Cancer Chemother Pharmacol 2000; 46(5): 416-22.
[http://dx.doi.org/10.1007/s002800000168] [PMID: 11127947]
[23]
Li C, Price JE, Milas L, et al. Antitumor activity of poly(L-glutamic acid)-paclitaxel on syngeneic and xenografted tumors. Clin Cancer Res 1999; 5(4): 891-7.
[PMID: 10213226]
[24]
NCT00108745. A randomized phase III trial of maintenance chemotherapy comparing 12, monthly cycles of single agent paclitaxel or CT- 2103 versus no treatment until documented relapse in women with advanced ovarian, primary peritoneal or fallopian tube cancer. Available from: https://clinicaltrialsgov/show/NCT00108745
[25]
Richards DA, Richards P, Bodkin D, Neubauer MA, Oldham F. Efficacy and safety of paclitaxel poliglumex as first-line chemotherapy in patients at high risk with advanced-stage non- small-cell lung cancer: results of a phase II study. Clin Lung Cancer 2005; 7(3): 215-20.
[http://dx.doi.org/10.3816/CLC.2005.n.039] [PMID: 16354318]
[26]
Sabbatini P, Aghajanian C, Dizon D, et al. Phase II study of CT-2103 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. J Clin Oncol 2004; 22(22): 4523-31.
[http://dx.doi.org/10.1200/JCO.2004.12.043] [PMID: 15542803]
[27]
Sabbatini P, Sill MW, O’Malley D, Adler L, Secord AA. A phase II trial of paclitaxel poliglumex in recurrent or persistent ovarian or primary peritoneal cancer (EOC): a Gynecologic Oncology Group Study. Gynecol Oncol 2008; 111(3): 455-60.
[http://dx.doi.org/10.1016/j.ygyno.2008.07.049] [PMID: 18829087]
[28]
Lin NU, Parker LM, Come SE, et al. Phase II study of CT-2103 as first- or second-line chemotherapy in patients with metastatic breast cancer: unexpected incidence of hypersensitivity reactions. Invest New Drugs 2007; 25(4): 369-75.
[http://dx.doi.org/10.1007/s10637-007-9034-y] [PMID: 17345004]
[29]
da Costa Santos CM, de Mattos Pimenta CA, Nobre MR. The PICO strategy for the research question construction and evidence search. Rev Lat Am Enfermagem 2007; 15(3): 508-11.
[http://dx.doi.org/10.1590/S0104-11692007000300023] [PMID: 17653438]
[30]
Eniu A, Palmieri FM, Perez EA. Weekly administration of docetaxel and paclitaxel in metastatic or advanced breast cancer. Oncologist 2005; 10(9): 665-85.
[http://dx.doi.org/10.1634/theoncologist.10-9-665] [PMID: 16249346]
[31]
Perroud HA, Alasino CM, Rico MJ, et al. Metastatic breast cancer patients treated with low-dose metronomic chemotherapy with cyclophosphamide and celecoxib: clinical outcomes and biomarkers of response. Cancer Chemother Pharmacol 2016; 77(2): 365-74.
[http://dx.doi.org/10.1007/s00280-015-2947-9] [PMID: 26721701]
[32]
Mielke S, Sparreboom A, Mross K. Peripheral neuropathy: a persisting challenge in paclitaxel-based regimes. Eur J Cancer 2006; 42(1): 24-30.
[http://dx.doi.org/10.1016/j.ejca.2005.06.030] [PMID: 16293411]
[33]
Du X, Khan AR, Fu M, Ji J, Yu A, Zhai G. Current development in the formulations of non-injection administration of paclitaxel. Int J Pharm 2018; 542(1-2): 242-52.
[http://dx.doi.org/10.1016/j.ijpharm.2018.03.030] [PMID: 29555439]
[34]
Bernabeu E, Cagel M, Lagomarsino E, Moretton M, Chiappetta DA. Paclitaxel: What has been done and the challenges remain ahead. Int J Pharm 2017; 526(1-2): 474-95.
[http://dx.doi.org/10.1016/j.ijpharm.2017.05.016] [PMID: 28501439]
[35]
Boddy AV, Plummer ER, Todd R, et al. A phase I and pharmacokinetic study of paclitaxel poliglumex (XYOTAX), investigating both 3-weekly and 2-weekly schedules. Clin Cancer Res 2005; 11(21): 7834-40.
[http://dx.doi.org/10.1158/1078-0432.CCR-05-0803] [PMID: 16278406]
[36]
Nakamura I, Ichimura E, Goda R, et al. An in vivo mechanism for the reduced peripheral neurotoxicity of NK105: a paclitaxel-incorporating polymeric micellar nanoparticle formulation. Int J Nanomedicine 2017; 12: 1293-304.
[http://dx.doi.org/10.2147/IJN.S114356] [PMID: 28243090]
[37]
Van S, Das SK, Wang X, et al. Synthesis, characterization, and biological evaluation of poly(L-γ-glutamyl-glutamine)- paclitaxel nanoconjugate. Int J Nanomedicine 2010; 5: 825-37.
[http://dx.doi.org/10.2147/IJN.S13482] [PMID: 21042550]
[38]
Hultström D, Malmgren L, Gilstring D, Olsson Y. FITC-Dextrans as tracers for macromolecular movements in the nervous system. A freeze-drying method for dextrans of various molecular sizes injected into normal animals. Acta Neuropathol 1983; 59(1): 53-62.
[http://dx.doi.org/10.1007/BF00690317] [PMID: 6188315]
[39]
Liu Z, Wang Y, Zhang N. Micelle-like nanoassemblies based on polymer-drug conjugates as an emerging platform for drug delivery. Expert Opin Drug Deliv 2012; 9(7): 805-22.
[http://dx.doi.org/10.1517/17425247.2012.689284] [PMID: 22607499]
[40]
Hare JI, Lammers T, Ashford MB, Puri S, Storm G, Barry ST. Challenges and strategies in anti-cancer nanomedicine development: An industry perspective. Adv Drug Deliv Rev 2017; 108: 25-38.
[http://dx.doi.org/10.1016/j.addr.2016.04.025] [PMID: 27137110]
[41]
Paz-Ares L, Ross H, O’Brien M, et al. Phase III trial comparing paclitaxel poliglumex vs docetaxel in the second-line treatment of non-small-cell lung cancer. Br J Cancer 2008; 98(10): 1608-13.
[http://dx.doi.org/10.1038/sj.bjc.6604372] [PMID: 18475293]
[42]
O’Brien ME, Socinski MA, Popovich AY, et al. Randomized phase III trial comparing single-agent paclitaxel Poliglumex (CT-2103, PPX) with single-agent gemcitabine or vinorelbine for the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer. J Thorac Oncol 2008; 3(7): 728-34.
[http://dx.doi.org/10.1097/JTO.0b013e31817c6b68] [PMID: 18594318]
[43]
Mita M, Mita A, Sarantopoulos J, et al. Phase I study of paclitaxel poliglumex administered weekly for patients with advanced solid malignancies. Cancer Chemother Pharmacol 2009; 64(2): 287-95.
[http://dx.doi.org/10.1007/s00280-008-0869-5] [PMID: 19034451]
[44]
Akerley W, Herndon JE, Egorin MJ, et al. Weekly, high-dose paclitaxel in advanced lung carcinoma: a phase II study with pharmacokinetics by the Cancer and Leukemia Group B. Cancer 2003; 97(10): 2480-6.
[http://dx.doi.org/10.1002/cncr.11375] [PMID: 12733147]
[45]
Winer EP, Berry DA, Woolf S, et al. Failure of higher-dose paclitaxel to improve outcome in patients with metastatic breast cancer: cancer and leukemia group B trial 9342. J Clin Oncol 2004; 22(11): 2061-8.
[http://dx.doi.org/10.1200/JCO.2004.08.048] [PMID: 15169793]
[46]
Omura GA, Brady MF, Look KY, et al. Phase III trial of paclitaxel at two dose levels, the higher dose accompanied by filgrastim at two dose levels in platinum-pretreated epithelial ovarian cancer: an intergroup study. J Clin Oncol 2003; 21(15): 2843-8.
[http://dx.doi.org/10.1200/JCO.2003.10.082] [PMID: 12807937]
[47]
Horiguchi J, Rai Y, Tamura K, et al. Phase II study of weekly paclitaxel for advanced or metastatic breast cancer in Japan. Anticancer Res 2009; 29(2): 625-30.
[PMID: 19331212]
[48]
Decker T, Overkamp F, Rösel S, et al. A randomized phase II study of paclitaxel alone versus paclitaxel plus sorafenib in second- and third-line treatment of patients with HER2-negative metastatic breast cancer (PASO). BMC Cancer 2017; 17(1): 499.
[http://dx.doi.org/10.1186/s12885-017-3492-1] [PMID: 28743247]
[49]
Forastiere AA, Shank D, Neuberg D, Taylor SG IV, DeConti RC, Adams G. Final report of a phase II evaluation of paclitaxel in patients with advanced squamous cell carcinoma of the head and neck: an Eastern Cooperative Oncology Group trial (PA390). Cancer 1998; 82(11): 2270-4.
[http://dx.doi.org/10.1002/(SICI)1097-0142(19980601)82:11<2270::AID-CNCR24>3.0.CO;2-Q] [PMID: 9610709]
[50]
Juan O, Albert A, Campos JM, Caranyana V, Muñoz J, Alberola V. Measurement and impact of co-morbidity in elderly patients with advanced non-small cell lung cancer treated with chemotherapy. A phase II study of weekly paclitaxel. Acta Oncol 2007; 46(3): 367-73.
[http://dx.doi.org/10.1080/02841860600833178] [PMID: 17450473]
[51]
Koizumi W, Akiya T, Sato A, et al. Second-line chemotherapy with biweekly paclitaxel after failure of fluoropyrimidine-based treatment in patients with advanced or recurrent gastric cancer: a report from the gastrointestinal oncology group of the Tokyo cooperative oncology group, TCOG GC-0501 trial. Jpn J Clin Oncol 2009; 39(11): 713-9.
[http://dx.doi.org/10.1093/jjco/hyp099] [PMID: 19812061]
[52]
Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol 1994; 12(12): 2654-66.
[http://dx.doi.org/10.1200/JCO.1994.12.12.2654] [PMID: 7989941]
[53]
Yamaguchi K, Tada M, Horikoshi N, et al. Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer. Gastric Cancer 2002; 5(2): 90-5.
[http://dx.doi.org/10.1007/s101200200015] [PMID: 12111584]
[54]
Perez EA, Vogel CL, Irwin DH, Kirshner JJ, Patel R. Weekly paclitaxel in women age 65 and above with metastatic breast cancer. Breast Cancer Res Treat 2002; 73(1): 85-8.
[http://dx.doi.org/10.1023/A:1015230212550] [PMID: 12083634]
[55]
Sato K, Inoue K, Saito T, et al. Multicenter phase II trial of weekly paclitaxel for advanced or metastatic breast cancer: the Saitama Breast Cancer Clinical Study Group (SBCCSG-01). Jpn J Clin Oncol 2003; 33(8): 371-6.
[http://dx.doi.org/10.1093/jjco/hyg075] [PMID: 14523055]
[56]
Fidias P, Supko JG, Martins R, et al. A phase II study of weekly paclitaxel in elderly patients with advanced non-small cell lung cancer. Clin Cancer Res 2001; 7(12): 3942-9.
[PMID: 11751486]
[57]
Ishikawa H, Nakanishi T, Nawa A, Suzuki Y, Kuzuya K. 3-hour infusion of single-agent paclitaxel for recurrent ovarian cancer. Int J Clin Oncol 2001; 6(3): 128-31.
[http://dx.doi.org/10.1007/PL00012094] [PMID: 11706781]
[58]
Curtin JP, Blessing JA, Soper JT, DeGeest K. Paclitaxel in the treatment of carcinosarcoma of the uterus: a gynecologic oncology group study. Gynecol Oncol 2001; 83(2): 268-70.
[http://dx.doi.org/10.1006/gyno.2001.6256] [PMID: 11606082]
[59]
Lilenbaum RC, Herndon JE II, List MA, et al. Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B (study 9730). J Clin Oncol 2005; 23(1): 190-6.
[http://dx.doi.org/10.1200/JCO.2005.07.172] [PMID: 15625373]
[60]
Hirai Y, Hasumi K, Onose R, et al. Phase II trial of 3-h infusion of paclitaxel in patients with adenocarcinoma of endometrium: Japanese Multicenter Study Group. Gynecol Oncol 2004; 94(2): 471-6.
[http://dx.doi.org/10.1016/j.ygyno.2004.05.042] [PMID: 15297190]
[61]
Im CK, Rha SY, Jeung H-C, et al. A phase II feasibility study of weekly paclitaxel in heavily pretreated advanced gastric cancer patients with poor performance status. Oncology 2009; 77(6): 349-57.
[http://dx.doi.org/10.1159/000265941] [PMID: 20016228]
[62]
Nishimura R, Ogawa T, Kato M, et al. Weekly paclitaxel in the treatment of advanced or metastatic breast cancer previously treated or not treated with docetaxel: a phase II study. Chemotherapy 2005; 51(2-3): 126-31.
[http://dx.doi.org/10.1159/000085620] [PMID: 15886472]

Rights & Permissions Print Export Cite as
© 2024 Bentham Science Publishers | Privacy Policy