Pioneer: A phase III randomized trial of paclitaxel poliglumex versus paclitaxel in chemotherapy-naive women with advanced-stage non-small-cell lung cancer and performance status of 2

Clinical Lung Cancer

Volumn 7, Issue 6, 2006, Pages 417-419

  Albain, Kathy S ^a   Belani, Chandra P ^b   Bonomi, Philip ^c   O'Byrne, Kenneth J ^d   Schiller, Joan H ^e   Socinski, Mark ^f  

^a LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^c RUSH UNIVERSITY MEDICAL CENTER   (United States)

^d ST JAMES S HOSPITAL   (Ireland)

^e UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^f UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

Author keywords

Cathepsin B; Estradiol; Estrogen; Lysosomal proteases; Macromolecular drug conjugate

Indexed keywords

CARBOPLATIN; GEMCITABINE; GROWTH FACTOR; NAVELBINE; OPIATE; PACLITAXEL; PACLITAXEL POLIGLUMEX; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AREA UNDER THE CURVE; ARTICLE; CANCER STAGING; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG CLEARANCE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG STABILITY; DRUG TOLERABILITY; DRUG USE; FEMALE; HOSPITALIZATION; HUMAN; HUMAN CELL; HUMAN TISSUE; LUNG NON SMALL CELL CANCER; MULTICENTER STUDY; OPEN STUDY; OUTCOMES RESEARCH; PHASE 2 CLINICAL TRIAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; TISSUE DISTRIBUTION;

EID: 33745886796     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2006.n.027     Document Type: Article

References (28)

1. Fu JB, Kau TY, Severson RK, et al. Lung cancer in women: analysis of the national Surveillance, Epidemiology, and End Results database. Chest 2005; 127:768-777.
2. Jemal A, Murray T, Ward E, et al. Cancer statistics, 2005 [published erratum in CA Cancer J Clin 2005; 55:259]. CA Cancer J Clin 2005; 55:10-30.
3. Moore R, Doherty D, Chamberlain R, et al. Sex differences in survival in non-small cell lung cancer patients 1974-1998. Acta Oncol 2004; 43:57-64.
4. Smith LE, Denissenko MF, Bennett WP, et al. Targeting of lung cancer mutational hotspots by polycyclic aromatic hydrocarbons. J Natl Cancer Inst 2000; 92:803-811.
5. Mollerup S, Ryberg D, Hewer A, et al. Sex differences in lung CYP1A1 expression and DNA adduct levels among lung cancer patients. Cancer Res 1999; 59:3317-3320.
6. Siegfried JM, Han YH, DeMichele MA, et al. Production of gastrin-releasing peptide by a non-small cell lung carcinoma cell line adapted to serum-free and growth factor-free conditions. J Biol Chem 1994; 269:8596-8603.
7. Shriver SP, Bourdeau HA, Gubish CT, et al. Sex-specific expression of gastrin-releasing peptide receptor: relationship to smoking history and risk of lung cancer. J Natl Cancer Inst 2000; 92:24-33.
8. Bell DW, Lynch TJ, Haserlat SM, et al. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol 2005; 23:8091-8092.
9. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004; 350:2129-2139.
10. Massaro D, Massaro GD. Estrogen regulates pulmonary alveolar formation, loss, and regeneration in mice. Am J Physiol Lung Cell Mol Physiol 2004; 287:L1154-L1159.
11. Massaro D, Massaro GD. Estrogen receptor regulation of pulmonary alveolar dimensions: alveolar sexual dimorphism in mice. Am J Physiol Lung Cell Mol Physiol 2006; 290:L866-L870.
12. Wu CT, Chang YL, Shin JY, et al. The significance of estrogen receptor beta in 301 surgically treated non-small cell lung cancers. J Thorac Cardiovasc Surg 2005; 130:979-986.
13. Stabile LP, Davis AL, Gubish CT, et al. Human non-small cell lung tumors and cells derived from normal lung express both estrogen receptor alpha and beta and show biological responses to estrogen. Cancer Res 2002; 62:2141-2150.
14. Bunone G, Briand PA, Miksicek RJ, et al. Activation of the unliganded estrogen receptor by EGF involves the MAP kinase pathway and direct phosphorylation. Embo J 1996; 15:2174-2183.
15. Razandi M, Pedram A, Park ST, et al. Proximal events in signaling by plasma membrane estrogen receptors. J Biol Chem 2003; 278:2701-2712.
16. Stabile LP, Lyker JS, Gubish CT, et al. Combined targeting of the estrogen receptor and the epidermal growth factor receptor in non-small cell lung cancer shows enhanced antiproliferative effects. Cancer Res 2005; 65:1459-1470.
17. Liu Y, Inoue M, Sobue T, et al. Reproductive factors, hormone use and the risk of lung cancer among middle-aged never-smoking Japanese women: a large-scale population-based cohort study. Int J Cancer 2005; 117:662-666.
18. Albain KS, Crowley JJ, LeBlanc M, et al. Survival determinants in extensive-stage non-small-cell lung cancer: the Southwest Oncology Group experience. J Clin Oncol 1991; 9:1618-1626.
19. Singer JW, Shaffer S, Baker B, et al. Paclitaxel poliglumex (Xyotax; CT-2103): an intracellularly targeted taxane. Anticancer Drugs 2005; 16:243-254.
20. Greish K, Fang J, Inutsuka T, et al. Macromolecular therapeutics: advantages and prospects with special emphasis on solid tumour targeting. Clin Pharmacokinet 2003; 42:1089-1105.
21. Matsumura Y, Maeda H. A new concept for macromolecular therapeutics in cancer chemotherapy: mechanism of tumoritropic accumulation of proteins and the antitumor agent smancs. Cancer Res 1986; 46:6387-6392.
22. Roshy S, Sloane BF, Moin K. Pericellular cathepsin B and malignant progression. Cancer Metastasis Rev 2003; 22:271-286.
23. Yan S, Sloane BF. Molecular regulation of human cathepsin B: implication in pathologies. Biol Chem 2003; 384:845-854.
24. Kremer M, Judd J, Rifkin B, et al. Estrogen modulation of osteoclast lysosomal enzyme secretion. J Cell Biochem 1995; 57:271-279.
25. Balan KV, Hollis VW, Eckberg WR, et al. Cathepsin B and complement C3 are major comigrants in the estrogen-induced peroxidase fraction of rat uterine fluid. J Submicrosc Cytol Pathol 2001; 33:221-230.
26. Waters KM, Safe S, Gaido KW. Differential gene expression in response to methoxychlor and estradiol through ERalpha, ERbeta, and AR in reproductive tissues of female mice. Toxicol Sci 2001; 63:47-56.
27. Langer CJ, Socinski MA, O'Byrne KJ, et al. Paclitaxel poliglumex (PPX)/ carboplatin vs paclitaxel/carboplatin for the treatment of PS2 patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC): a phase III study. J Clin Oncol 2005; 23(16 suppl):623s (Abstract #LBA7011).
28. O'Brien M, Oldham F. Paclitaxel poliglumex vs. gemcitabine or vinorelbine for the treatment of performance status (PS) 2 patients with chemotherapy-naive advanced non-small cell lung cancer (NSCLC): the STELLAR 4 phase III study. Eur J Cancer Suppl 2005; 3:324.