Nanoparticle albumin bound-paclitaxel for treatment of advanced non-small cell lung cancer: an evaluation of the clinical evidence

References

• Torre LA, Siegel RL, Jemal A. Lung cancer statistics. Adv Exp Med Biol. 2016;893:1–19.
   PubMed Web of Science ®Google Scholar
• Sacco PC, Gridelli C. An update on the developing mitotic inhibitors for the treatment of non-small cell carcinoma. Expert Opin Emerg Drugs. 2017 Sep;22(3):213–222.
   PubMed Web of Science ®Google Scholar
• Ettinger DS, Akerley W, Borghaei H, et al. Non-small cell lung cancer. J Natl Compr Canc Netw. 2012 Oct 1;10(10):1236–1271.
   PubMed Web of Science ®Google Scholar
• Non-Small Cell Lung Cancer Collaborative G. Chemotherapy and supportive care versus supportive care alone for advanced non-small cell lung cancer. Cochrane Database Syst Rev. 2010 May;12(5):CD007309.
   Google Scholar
• Reck M, Rodriguez-Abreu D, Robinson AG, et al. Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer. N Engl J Med. 2016 Nov 10;375(19):1823–1833.
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodriguez-Abreu D, Gadgeel S, et al. Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer. N Engl J Med. 2018 May 31;378(22):2078–2092.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Evans T, Gettinger S, et al. Treatment of stage IV non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American college of chest physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e341S–e368S.
   PubMedGoogle Scholar
• Hardin C, Shum E, Singh AP, et al. Emerging treatment using tubulin inhibitors in advanced non-small cell lung cancer. Expert Opin Pharmacother. 2017 May;18(7):701–716.
   PubMed Web of Science ®Google Scholar
• Derman BA, Mileham KF, Bonomi PD, et al. Treatment of advanced squamous cell carcinoma of the lung: a review. Transl Lung Cancer Res. 2015 Oct;4(5):524–532.
   PubMed Web of Science ®Google Scholar
• Ranson M, Davidson N, Nicolson M, et al. Randomized trial of paclitaxel plus supportive care versus supportive care for patients with advanced non-small-cell lung cancer. J Natl Cancer Inst. 2000 Jul 5;92(13):1074–1080.
   PubMed Web of Science ®Google Scholar
• Gelderblom H, Verweij J, Nooter K, et al. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer. 2001 Sep;37(13):1590–1598.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Bondarenko I, Karaseva NA, et al. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055–2062.
   PubMed Web of Science ®Google Scholar
• Ibrahim NK, Desai N, Legha S, et al. Phase I and pharmacokinetic study of ABI-007, a cremophor-free, protein-stabilized, nanoparticle formulation of paclitaxel. Clin Cancer Res. 2002 May;8(5):1038–1044.
   PubMed Web of Science ®Google Scholar
• Hidalgo M, Aylesworth C, Hammond LA, et al. Phase I and pharmacokinetic study of BMS-184476, a taxane with greater potency and solubility than paclitaxel. J Clin Oncol. 2001 May 1;19(9):2493–2503.
   PubMed Web of Science ®Google Scholar
• Szebeni J, Alving CR, Savay S, et al. Formation of complement-activating particles in aqueous solutions of Taxol: possible role in hypersensitivity reactions. Int Immunopharmacol. 2001 Apr;1(4):721–735.
   PubMed Web of Science ®Google Scholar
• U.S. Food and Drug Administration. Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) [package insert]. Summit (NJ): Abraxis Bioscience; 2005.
   Google Scholar
• Gardner ER, Dahut WL, Scripture CD, et al. Randomized crossover pharmacokinetic study of solvent-based paclitaxel and nab-paclitaxel. Clin Cancer Res. 2008 Jul 1;14(13):4200–4205.
   PubMed Web of Science ®Google Scholar
• Tiruppathi C, Song W, Bergenfeldt M, et al. Gp60 activation mediates albumin transcytosis in endothelial cells by tyrosine kinase-dependent pathway. J Biol Chem. 1997 Oct 10;272(41):25968–25975.
   PubMed Web of Science ®Google Scholar
• Desai N, Trieu V, Yao Z, et al. Increased antitumor activity, intratumor paclitaxel concentrations, and endothelial cell transport of cremophor-free, albumin-bound paclitaxel, ABI-007, compared with cremophor-based paclitaxel. Clin Cancer Res. 2006 Feb 15;12(4):1317–1324.
   PubMed Web of Science ®Google Scholar
• Tiruppathi C, Finnegan A, Malik AB. Isolation and characterization of a cell surface albumin-binding protein from vascular endothelial cells. Proc Natl Acad Sci U S A. 1996 Jan 9;93(1):250–254.
   PubMed Web of Science ®Google Scholar
• Porter PL, Sage EH, Lane TF, et al. Distribution of SPARC in normal and neoplastic human tissue. J Histochem Cytochem. 1995 Aug;43(8):791–800.
   PubMed Web of Science ®Google Scholar
• Thomas R, True LD, Bassuk JA, et al. Differential expression of osteonectin/SPARC during human prostate cancer progression. Clin Cancer Res. 2000 Mar;6(3):1140–1149.
   PubMed Web of Science ®Google Scholar
• Chen N, Li Y, Ye Y, et al. Pharmacokinetics and pharmacodynamics of nab-paclitaxel in patients with solid tumors: disposition kinetics and pharmacology distinct from solvent-based paclitaxel. J Clin Pharmacol. 2014 Oct;54(10):1097–1107.
   PubMed Web of Science ®Google Scholar
• Joerger M. Metabolism of the taxanes including nab-paclitaxel. Expert Opin Drug Metab Toxicol. 2015 May;11(5):691–702.
   PubMed Web of Science ®Google Scholar
• Lai XS, Yang LP, Li XT, et al. Human CYP2C8: structure, substrate specificity, inhibitor selectivity, inducers and polymorphisms. Curr Drug Metab. 2009 Nov;10(9):1009–1047.
   PubMed Web of Science ®Google Scholar
• Nyman DW, Campbell KJ, Hersh E, et al. Phase I and pharmacokinetics trial of ABI-007, a novel nanoparticle formulation of paclitaxel in patients with advanced nonhematologic malignancies. J Clin Oncol. 2005 Nov 1;23(31):7785–7793.
   PubMed Web of Science ®Google Scholar
• Rizvi NA, Riely GJ, Azzoli CG, et al. Phase I/II trial of weekly intravenous 130-nm albumin-bound paclitaxel as initial chemotherapy in patients with stage IV non-small-cell lung cancer. J Clin Oncol. 2008 Feb 1;26(4):639–643.
   PubMed Web of Science ®Google Scholar
• Green MR, Manikhas GM, Orlov S, et al. Abraxane, a novel Cremophor-free, albumin-bound particle form of paclitaxel for the treatment of advanced non-small-cell lung cancer. Ann Oncol. 2006 Aug;17(8):1263–1268.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Manikhas GM, Stroyakovsky DL, et al. A dose finding study of weekly and every-3-week nab-Paclitaxel followed by carboplatin as first-line therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):852–861.
   PubMed Web of Science ®Google Scholar
• Bertino EM, Williams TM, Nana-Sinkam SP, et al. Stromal caveolin-1 is associated with response and survival in a phase ii trial of nab-paclitaxel with carboplatin for advanced NSCLC patients. Clin Lung Cancer. 2015 Nov;16(6):466–474.
   PubMed Web of Science ®Google Scholar
• Reynolds C, Barrera D, Jotte R, et al. Phase II trial of nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab in first-line patients with advanced nonsquamous non-small cell lung cancer. J Thorac Oncol. 2009 Dec;4(12):1537–1543.
   PubMed Web of Science ®Google Scholar
• Gandara DR, Kawaguchi T, Crowley J, et al. Japanese-US common-arm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009 Jul 20;27(21):3540–3546.
   PubMed Web of Science ®Google Scholar
• Paz-Ares LG, Luft A, Gumus ATM, et al. Phase 3 study of carboplatin-paclitaxel/nab-paclitaxel (Chemo) with or without pembrolizumab (Pembro) for patients (Pts) with metastatic squamous (Sq) non-small cell lung cancer (NSCLC). J Clin Oncol. 2018;36(15_suppl):105.
   Google Scholar
• Jotte RM, Cappuzzo F, Vynnychenko I, et al. IMpower131: primary PFS and safety analysis of a randomized phase III study of atezolizumab + carboplatin + paclitaxel or nab-paclitaxel vs carboplatin + nab-paclitaxel as 1L therapy in advanced squamous NSCLC. J Clin Oncol. 2018;36(18_suppl):LBA9000-LBA9000.
   Web of Science ®Google Scholar
• Chen Y, Li J, Chen S, et al. Nab-paclitaxel in combination with cisplatin versus docetaxel plus cisplatin as first-line therapy in non-small cell lung cancer. Sci Rep. 2017 Sep 7;7(1):10760.
   PubMedGoogle Scholar
• Higuchi M, Takagi H, Owada Y, et al. Efficacy and tolerability of nanoparticle albumin-bound paclitaxel in combination with carboplatin as a late-phase chemotherapy for recurrent and advanced non-small-cell lung cancer: a multi-center study of the Fukushima lung cancer association group of surgeons. Onco l Lett. 2017 Jun;13(6):4315–4321.
   PubMed Web of Science ®Google Scholar
• Wu Y, Feng J, Hu W, et al. A randomized placebo-controlled clinical study of nab-paclitaxel as second-line chemotherapy for patients with advanced non-small cell lung cancer in China. Biosci Rep. 2017 Aug 31;37(4):BSR20170020.
   Google Scholar
• Sakata S, Saeki S, Okamoto I, et al. Phase II trial of weekly nab-paclitaxel for previously treated advanced non-small cell lung cancer: kumamoto thoracic oncology study group (KTOSG) trial 1301. Lung Cancer. 2016 Sep;99:41–45.
   PubMed Web of Science ®Google Scholar
• Tanaka H, Taima K, Morimoto T, et al. A single-arm phase II study of nab-paclitaxel for patients with chemorefractory non-small cell lung cancer. BMC Cancer. 2017 Oct 16;17(1):683.
   PubMedGoogle Scholar
• Jin F, Zhu H, Shi F, et al. A retrospective analysis of safety and efficacy of weekly nab-paclitaxel as second-line chemotherapy in elderly patients with advanced squamous non-small-cell lung carcinoma. Clin Interv Aging. 2016;11:167–173.
   PubMed Web of Science ®Google Scholar
• Nakaya A, Kurata T, Yokoi T, et al. Retrospective analysis of single-agent nab-paclitaxel in patients with platinum-resistant non-small cell lung cancer. Mol Clin Oncol. 2017 Nov;7(5):803–807.
   PubMedGoogle Scholar
• Gong W, Sun P, Mu Z, et al. Efficacy and safety of nab-paclitaxel as second-line chemotherapy for locally advanced and metastatic non-small cell lung cancer. Anticancer Res. 2017 Aug;37(8):4687–4691.
   PubMed Web of Science ®Google Scholar
• Saxena A, Schneider BJ, Christos PJ, et al. Treatment of recurrent and platinum-refractory stage IV non-small cell lung cancer with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as a single agent. Med Oncol. 2016 Feb;33(2):13.
   PubMed Web of Science ®Google Scholar
• Duan J, Hao Y, Wan R, et al. Efficacy and safety of weekly intravenous nanoparticle albumin-bound paclitaxel for non-small cell lung cancer patients who have failed at least two prior systemic treatments. Thorac Cancer. 2017 May;8(3):138–146.
   PubMed Web of Science ®Google Scholar
• Yasuda Y, Nomizo T, Ozasa H, et al. Retrospective analysis of acute exacerbation of interstitial lung diseases with nanoparticle albumin-bound paclitaxel in patients with advanced lung cancer with preexisting interstitial lung disease. Mol Clin Oncol. 2017 Oct;7(4):677–680.
   PubMedGoogle Scholar
• Niwa H, Nakahara Y, Yokoba M, et al. Safety and efficacy of carboplatin plus nab-paclitaxel for treating advanced non-small-cell lung cancer with interstitial lung disease. Mol Clin Oncol. 2017 Oct;7(4):604–608.
   PubMedGoogle Scholar
• Weiss J, Force RW, Pugmire BA, et al. Comparative effectiveness and resource usage in patients receiving first-line taxane-based chemotherapy for stage IV non-small-cell lung cancer in a US community oncology setting. Clin Lung Cancer. 2017 Jul;18(4):372–380.e1.
   PubMed Web of Science ®Google Scholar
• Gradishar WJ. Albumin-bound paclitaxel: a next-generation taxane. Expert Opin Pharmacother. 2006 Jun;7(8):1041–1053.
   PubMed Web of Science ®Google Scholar
• Davidoff AJ, Tang M, Seal B, et al. Chemotherapy and survival benefit in elderly patients with advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2191–2197.
   PubMed Web of Science ®Google Scholar
• Langer CJ. Clinical evidence on the undertreatment of older and poor performance patients who have advanced non-small-cell lung cancer: is there a role for targeted therapy in these cohorts? Clin Lung Cancer. 2011 Sep;12(5):272–279.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Langer CJ, Okamoto I, et al. Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Feb;24(2):314–321.
   PubMed Web of Science ®Google Scholar
• Langer CJ, Hirsh V, Okamoto I, et al. Survival, quality-adjusted survival, and other clinical end points in older advanced non-small-cell lung cancer patients treated with albumin-bound paclitaxel. Br J Cancer. 2015 Jun 30;113(1):20–29.
   PubMed Web of Science ®Google Scholar
• Shiroyama T, Tamiya M, Minami S, et al. Carboplatin plus weekly nanoparticle albumin-bound paclitaxel in elderly patients with previously untreated advanced squamous non-small-cell lung cancer selected based on mini nutritional assessment short-form scores: a multicenter phase 2 study. Cancer Chemother Pharmacol. 2017 Sep;80(3):461–467.
   PubMed Web of Science ®Google Scholar
• Miyauchi E, Inoue A, Usui K, et al. Phase II study of modified carboplatin plus weekly nab-paclitaxel in elderly patients with non-small cell lung cancer: North Japan lung cancer study group trial 1301. Oncologist. 2017 Jun;22(6):640–e59.
   PubMed Web of Science ®Google Scholar
• Okuma Y, Hosomi Y, Takahashi S, et al. A phase II study of nanoparticle albumin-bound paclitaxel plus carboplatin as the first-line therapy in elderly patients with previously untreated advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2016 Aug;78(2):383–388.
   PubMed Web of Science ®Google Scholar
• Socinski MA, Okamoto I, Hon JK, et al. Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer. Ann Oncol. 2013 Sep;24(9):2390–2396.
   PubMed Web of Science ®Google Scholar
• Thomas M, Spigel DR, Jotte RM, et al. nab-paclitaxel/carboplatin induction in squamous NSCLC: longitudinal quality of life while on chemotherapy. Lung Cancer (Auckl). 2017;8:207–216.
   PubMedGoogle Scholar
• Mudad R, Patel MB, Margunato-Debay S, et al. Comparative effectiveness and safety of nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin in first-line treatment of advanced squamous cell non-small cell lung cancer in a US community oncology setting. Lung Cancer (Auckl). 2017;8:179–190.
   PubMed Web of Science ®Google Scholar
• de Marinis F, Pereira JR, Fossella F, et al. Lung Cancer Symptom Scale outcomes in relation to standard efficacy measures: an analysis of the phase III study of pemetrexed versus docetaxel in advanced non-small cell lung cancer. J Thorac Oncol. 2008 Jan;3(1):30–36.
   PubMed Web of Science ®Google Scholar
• Bezjak A, Tu D, Seymour L, et al. Symptom improvement in lung cancer patients treated with erlotinib: quality of life analysis of the national cancer institute of Canada clinical trials group study BR.21. J Clin Oncol. 2006 Aug 20;24(24):3831–3837.
   PubMed Web of Science ®Google Scholar
• Hirsh V, Okamoto I, Hon JK, et al. Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Jan;9(1):83–90.
   PubMed Web of Science ®Google Scholar
• Sparreboom A, Scripture CD, Trieu V, et al. Comparative preclinical and clinical pharmacokinetics of a cremophor-free, nanoparticle albumin-bound paclitaxel (ABI-007) and paclitaxel formulated in cremophor (Taxol). Clin Cancer Res. 2005 Jun 1;11(11):4136–4143.
   PubMed Web of Science ®Google Scholar
• Hirsh V, Ko A, Pilot R, et al. Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: analysis of safety and efficacy in patients with diabetes. Clin Lung Cancer. 2016 Sep;17(5):367–374.
   PubMed Web of Science ®Google Scholar
• Langer CJ, Hirsh V, Ko A, et al. Weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: analysis of safety and efficacy in patients with renal impairment. Clin Lung Cancer. 2015 Mar;16(2):112–120.
   PubMed Web of Science ®Google Scholar
• Schubert W, Frank PG, Razani B, et al. Caveolae-deficient endothelial cells show defects in the uptake and transport of albumin in vivo. J Biol Chem. 2001 Dec 28;276(52):48619–48622.
   PubMed Web of Science ®Google Scholar
• Chatterjee M, Ben-Josef E, Robb R, et al. Caveolae-mediated endocytosis is critical for albumin cellular uptake and response to albumin-bound chemotherapy. Cancer Res. 2017 Nov 1;77(21):5925–5937.
   PubMed Web of Science ®Google Scholar
• Merlot AM, Kalinowski DS, Richardson DR. Unraveling the mysteries of serum albumin-more than just a serum protein. Front Physiol. 2014;5:299.
   PubMed Web of Science ®Google Scholar
• Huang Y, Zhang J, Zhao YY, et al. SPARC expression and prognostic value in non-small cell lung cancer. Chin J Cancer. 2012 Nov;31(11):541–548.
   PubMedGoogle Scholar
• Komiya K, Nakamura T, Nakashima C, et al. SPARC is a possible predictive marker for albumin-bound paclitaxel in non-small-cell lung cancer. Onco Targets Ther. 2016;9:6663–6668.
   PubMed Web of Science ®Google Scholar
• Shao H, Tang H, Salavaggione OE, et al. Improved response to nab-paclitaxel compared with cremophor-solubilized paclitaxel is independent of secreted protein acidic and rich in cysteine expression in non-small cell lung cancer. J Thorac Oncol. 2011 6;Jun(6):998–1005.
   Google Scholar
• Socinski MA, Ivanova A, Bakri K, et al. A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer. Ann Oncol. 2006 Jan;17(1):104–109.
   PubMed Web of Science ®Google Scholar
• Belani CP, Ramalingam S, Perry MC, et al. Randomized, phase III study of weekly paclitaxel in combination with carboplatin versus standard every-3-weeks administration of carboplatin and paclitaxel for patients with previously untreated advanced non-small-cell lung cancer. J Clin Oncol. 2008 Jan 20;26(3):468–473.
   PubMed Web of Science ®Google Scholar
• Levine MN, Juergens R. Method to our madness or madness in our methods? Pitfalls in trial methodology. J Clin Oncol. 2012 Jun 10;30(17):2025–2027.
   PubMed Web of Science ®Google Scholar
• Kaira K, Tomizawa Y, Imai H, et al. Phase I study of nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in patients with locally advanced non-small cell lung cancer. Cancer Chemother Pharmacol. 2017 Jan;79(1):165–171.
   PubMed Web of Science ®Google Scholar
• Saji H, Marushima H, Miyazawa T, et al. Feasibility study of adjuvant chemotherapy with modified weekly nab-paclitaxel and carboplatin for completely resected non-small-cell lung cancer: FAST-nab. Anticancer Drugs. 2017 Aug;28(7):795–800.
   PubMed Web of Science ®Google Scholar