Paclitaxel-loaded polymeric micelle (230 mg/m2) and cisplatin (60 mg/m2) vs. paclitaxel (175 mg/m2) and cisplatin (60 mg/m2) in advanced non-small-cell lung cancer: A multicenter randomized phase IIB trial

Clinical Lung Cancer

Volumn 14, Issue 3, 2013, Pages 275-282

  Lee, Sung Yong ^a   Park, Hee Sun ^b   Lee, Kye Young ^c   Kim, Hee Joung ^c   Jeon, Young June ^d   Jang, Tae Won ^e   Lee, Kwan Ho ^f   Kim, Young Chul ^g   Kim, Kyu Sik ^g   Oh, In Jae ^g   Kim, Sun Young ^b  

^a Korea University College of Medicine   (South Korea)

^b Chungnam National University College of Medicine   (South Korea)

^c Konkuk University School of Medicine   (South Korea)

^d Keimyung University   (South Korea)

^e Kosin University   (South Korea)

^f Chonnam National University   (South Korea)

^g Yeungnam University College of Medicine   (South Korea)

Author keywords

Chemotherapy; Cisplatin; Non small cell lung cancer; Paclitaxel; Paclitaxel loaded polymeric micelle

Indexed keywords

CISPLATIN; DRUG CARRIER; PACLITAXEL; POLYMERIC MICELLE; UNCLASSIFIED DRUG;

ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTHRALGIA; ARTICLE; CANCER STAGING; CANCER SURVIVAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; FEBRILE NEUTROPENIA; FEMALE; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERSENSITIVITY; LARGE CELL CARCINOMA; LEUKOCYTE COUNT; LUNG ADENOCARCINOMA; LUNG NON SMALL CELL CANCER; LUNG SQUAMOUS CELL CARCINOMA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; NEUTROPHIL COUNT; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; THROMBOCYTE COUNT; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CISPLATIN; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MICELLES; MIDDLE AGED; PACLITAXEL; PROPORTIONAL HAZARDS MODELS;

EID: 84879979431     PISSN: 15257304     EISSN: 19380690     Source Type: Journal    
DOI: 10.1016/j.cllc.2012.11.005     Document Type: Article

References (26)

1. A. Jemal, F. Bray, M.M. Center Global cancer statistics CA Cancer J Clin 61 2011 69 90
2. Y. Ohe, Y. Ohashi, K. Kubota Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: four-arm cooperative study in Japan Ann Oncol 18 2007 317 323
3. H. Gelderblom, J. Verweij, K. Nooter Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation Eur J Cancer 37 2001 1590 1598
4. R.B. Weiss, R.C. Donehower, P.H. Wiernik Hypersensitivity reactions from Taxol J Clin Oncol 8 1990 1263 1268
5. M.G. Teneriello, P.C. Tseng, M. Crozier Phase II evaluation of nanoparticle albumin-bound paclitaxel in platinum-sensitive patients with recurrent ovarian, peritoneal, or fallopian tube cancer J Clin Oncol 27 2009 1426 1431
6. A.C. Mita, A.J. Olszanski, R.C. Walovitch Phase I and pharmacokinetic study of AI-850, a novel microparticle hydrophobic drug delivery system for paclitaxel Clin Cancer Res 13 2007 3293 3301
7. N.K. Ibrahim, B. Samuels, R. Page Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer J Clin Oncol 23 2005 6019 6026
8. T.Y. Kim, D.W. Kim, J.Y. Chung Phase I and pharmacokinetic study of Genexol-PM, a cremophor-free, polymeric micelle-formulated paclitaxel, in patients with advanced malignancies Clin Cancer Res 10 2004 3708 3716
9. D.W. Kim, S.Y. Kim, H.K. Kim Multicenter phase II trial of Genexol-PM, a novel Cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced non-small-cell lung cancer Ann Oncol 18 2007 2009 2014
10. P. Therasse, S.G. Arbuck, E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada J Natl Cancer Inst 92 2000 205 216
11. Q. Chu, M. Vincent, D. Logan Taxanes as first-line therapy for advanced non-small cell lung cancer: a systematic review and practice guideline Lung Cancer 50 2005 355 374
12. A.J. ten Tije, J. Verweij, W.J. Loos Pharmacological effects of formulation vehicles: implications for cancer chemotherapy Clin Pharmacokinet 42 2003 665 685
13. L. van Zuylen, M.O. Karlsson, J. Verweij Pharmacokinetic modeling of paclitaxel encapsulation in Cremophor EL micelles Cancer Chemother Pharmacol 47 2001 309 318
14. I. Okamoto, N. Yamamoto, K. Kubota Safety and pharmacokinetic study of nab-paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small cell lung cancer Invest New Drugs 30 2012 1132 1137
15. P. Bonomi, K. Kim, D. Fairclough Comparison of survival and quality of life in advanced non-small-cell lung cancer patients treated with two dose levels of paclitaxel combined with cisplatin versus etoposide with cisplatin: results of an Eastern Cooperative Oncology Group trial J Clin Oncol 18 2000 623 631
16. 2) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): a multicenter randomized trial Hellenic Cooperative Oncology Group (HeCOG) Ann Oncol 11 2000 799 805
17. J.D. Hainsworth, D.S. Thompson, F.A. Greco Paclitaxel by 1-hour infusion: an active drug in metastatic non-small-cell lung cancer J Clin Oncol 13 1995 1609 1614
18. M.T. Huizing, G. Giaccone, L.J. van Warmerdam Pharmacokinetics of paclitaxel and carboplatin in a dose-escalating and dose-sequencing study in patients with non-small-cell lung cancer The European Cancer Centre J Clin Oncol 15 1997 317 329
19. R. Pirker, G. Krajnik, S. Zöchbauer Paclitaxel/cisplatin in advanced non-small-cell lung cancer (NSCLC) Ann Oncol 6 1995 833 835
20. J.W. Hsu, J.Y. Hsu, C.D. Chiang Preliminary result of phase II study of paclitaxel and cisplatin chemotherapy for advanced non-small-cell lung cancer in Chinese patients Am J Clin Oncol 21 1998 487 490
21. M.A. Socinski, I. Bondarenko, N.A. Karaseva 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 30 2012 2055 2062
22. J. Treat, M.J. Edelman, C.P. Belani A retrospective analysis of outcomes across histological subgroups in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin for advanced non-small cell lung cancer Lung Cancer 70 2010 340 346
23. R. Rosell, U. Gatzemeier, D.C. Betticher Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial Ann Oncol 13 2002 1539 1549
24. G. Giaccone, T.A. Splinter, C. Debruyne Randomized study of paclitaxel-cisplatin versus cisplatin-teniposide in patients with advanced non-small-cell lung cancer The European Organization for Research and Treatment of Cancer lung cancer Cooperative Group J Clin Oncol 16 1998 2133 2141
25. A. Pircher, E. Ulsperger, R. Hack Basic clinical parameters predict gefitinib efficacy in non-small cell lung cancer Anticancer Res 31 2011 2949 2955
26. G. Metro, G. Finocchiaro, F. Cappuzzo Anti-cancer therapy with EGFR inhibitors: factors of prognostic and predictive significance Ann Oncol 17 suppl 2 2006 ii42 ii45