Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 28, Issue 11, 2010, Pages 1835-1842

  Scagliotti, Giorgio ^a   Novello, Silvia ^a   Von Pawel, Joachim ^a   Reck, Martin ^a   Pereira, José Rodrigues ^a   Thomas, Michael ^a   Miziara, José Elias Abrão ^a   Balint, Beatrix ^a   De Marinis, Filippo ^a   Keller, Alan ^a   Arén, Osvaldo ^a   Csollak, Maria ^a   Albert, Istvan ^a   Barrios, Carlos Henrique ^a   Grossi, Francesco ^a   Krzakowski, Maciej ^a   Cupit, Lisa ^a   Cihon, Frank ^a   DiMatteo, Sandra ^a   Hanna, Nasser ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; PACLITAXEL; PLACEBO; SORAFENIB; ANTINEOPLASTIC AGENT; BENZENESULFONIC ACID DERIVATIVE; PYRIDINE DERIVATIVE;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CANCER STAGING; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; DRY SKIN; EPISTAXIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HAND AND FOOT; HISTOPATHOLOGY; HUMAN; HYPERTENSION; LUNG HEMORRHAGE; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MYALGIA; NAUSEA; NEUTROPENIA; ORAL MUCOSITIS; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING; ADENOCARCINOMA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; LARGE CELL CARCINOMA; LUNG TUMOR; METASTASIS; MIDDLE AGED; PATHOLOGY; SQUAMOUS CELL CARCINOMA; SURVIVAL RATE; TREATMENT OUTCOME;

ADENOCARCINOMA; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARBOPLATIN; CARCINOMA, LARGE CELL; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SQUAMOUS CELL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PACLITAXEL; PLACEBOS; PYRIDINES; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 77951639655     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.26.1321     Document Type: Article

References (45)

1. Pfister DG, Johnson DH, Azzoli CG, et al: American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: Update 2003. J Clin Oncol 22:330-353, 2004
2. Schiller JH, Harrington D, Belani CP, et al: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346:92-98, 2002 (Pubitemid 34438899)
3. Scagliotti GV, De Marinis F, Rinaldi M, et al: Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. Italian Lung Cancer Project. J Clin Oncol 20:4285-4291, 2002 (Pubitemid 35266288)
4. Kelly K, Crowley J, Bunn PA Jr, et al: Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: A Southwest Oncology Group trial. J Clin Oncol 19:3210-3218, 2001 (Pubitemid 32591438)
5. Fossella F, Pereira JR, von Pawel J, et al: Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer: The TAX 326 study group. J Clin Oncol 21:3016-3024, 2003 (Pubitemid 46606280)
6. Delbaldo C, Michiels S, Rolland E, et al: Second or third additional chemotherapy drug for nonsmall cell lung cancer in patients with advanced disease. Cochrane Database Syst Rev 4:CD004569, 2007
7. Breathnach OS, Freidlin B, Conley B, et al: Twenty-two years of phase III trials for patients with advanced non-small-cell lung cancer: Sobering results. J Clin Oncol 19:1734-1742, 2001 (Pubitemid 32230875)
8. Sun S, Schiller JH, Spinola M, et al: New molecularly targeted therapies for lung cancer. J Clin Invest 117:2740-2750, 2007 (Pubitemid 47529602)
9. Sandler A, Gray R, Perry MC, et al: Paclitaxel-carboplatin alone or with bevacizumab for non-smallcell lung cancer. N Engl J Med 355:2542-2550, 2006 (Pubitemid 44917502)
10. Pirker R, Pereira JR, Szczesna A, et al: Cetuximab plus chemotherapy in patients with advanced non-smallcell lung cancer (FLEX): An open-label randomized phase III trial. Lancet 373:1525-1531, 2009
11. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353:123-132, 2005 (Pubitemid 41058344)
12. Wilhelm SM, Carter C, Tang L, et al: BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 64:7099-7109, 2004 (Pubitemid 39331023)
13. Wilhelm SM, Adnane L, Newell P, et al: Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Mol Cancer Ther 7:3129-3140, 2008
14. Moore M, Hirte HW, Siu L, et al: Phase I study to determine the safety and pharmacokinetics of the novel Raf kinase and VEGFR inhibitor BAY 43-9006, administered for 28 days on/7 days off in patients with advanced, refractory solid tumors. Ann Oncol 16:1688-1694, 2005 (Pubitemid 41510145)
15. Clark JW, Eder JP, Ryan D, et al: Safety and pharmacokinetics of the dual action Raf kinase and vascular endothelial growth factor receptor inhibitor, BAY 43-9006, in patients with advanced, refractory solid tumors. Clin Cancer Res 11:5472-5480, 2005 (Pubitemid 41060823)
16. Flaherty KT, Schiller J, Schuchter LM, et al: A phase I trial of the oral, multikinase inhibitor sorafenib in combination with carboplatin and paclitaxel. Clin Cancer Res 14:4836-4842, 2008
17. Strumberg D, Richly H, Hilger RA, et al: Phase I clinical and pharmacokinetic study of the novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 23:965-972, 2005 (Pubitemid 46202316)
18. Blumenschein GR Jr, Gatzemeier U, Fosella F, et al: Phase II multicenter uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory advanced non-small-cell lung cancer. J Clin Oncol 27:4274-4280, 2009
19. Schiller JH, Lee JW, Hanna N, et al: A randomized discontinuation phase II study of sorafenib versus placebo in patients with non-small-cell lung cancer who have failed at least two prior chemotherapy regimens: E2501. J Clin Oncol 26:427s, 2008 (suppl; abstr 8014)
20. Hauschild A, Agarwala SS, Trefzer U, et al: Results of a phase III, randomized, placebocontrolled study of sorafenib in combination with carboplatin and paclitaxel as second-line treatment in patients with unresectable stage III or stage IV melanoma. J Clin Oncol 27:2823-2830, 2009
21. Schiller JH, Flaherty KT, Redlinger M, et al: Sorafenib combined with carboplatin/paclitaxel for advanced non-small-cell lung cancer: A phase I subset analysis. J Clin Oncol 24:412s, 2006 (suppl; abstr 7194)
22. Okamoto I, Miyazaki M, Morinaga R, et al: Phase I clinical and pharmacokinetic study of sorafenib in combination with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer. Invest New Drugs 10.1007/s10637-009-9321-x [epub ahead of print on September 18, 2009]
23. National Cancer Institute: Common Terminology Criteria for Adverse Events v3.0 (CTCAE). http:// ctep.cancer.gov/protocolDevelopment/electronic- applications/ctc.htm
24. Therasse P, Arbuck SG, Eisenhauer EA, et al: 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 92:205-216, 2000
25. Robert C, Mateus C, Spatz A, et al: Dermatologic symptoms associated with the multikinase inhibitor sorafenib. J Am Acad Dermatol 60:299-305, 2009
26. Johnson DH, Fehrenbacher L, Novotny WF, et al: Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 22:2184-2191, 2004 (Pubitemid 41095154)
27. Reck M, von Pawel J, Zatloukal P, et al: Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAiL. J Clin Oncol 27:1227-1234, 2009
28. Amgen: Amgen press release: Amgen, Takeda and Millennium provide update on phase 3 trial of motesanib in patients with non-small cell lung cancer. 11-19-2008. http://www.amgen.com/ media/media-pr-detail.jsp?year =2008&releaseID=1228588
29. Scagliotti GV, Parikh P, von Pawel J, et al: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapynaive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26:3543-3551, 2008
30. Patnaik A, Wood D, Tolcher AW, et al: Phase I, pharmacokinetic, and biological study of erlotinib in combination with paclitaxel and carboplatin in patients with advanced solid tumors. Clin Cancer Res 12:7406-7413, 2006 (Pubitemid 46095415)
31. Gatzemeier U, Pluzanska A, Szczesna A, et al: Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-smallcell lung cancer: The Tarceva Lung Cancer Investigation Trial. J Clin Oncol 25:1545-1552, 2007 (Pubitemid 46733081)
32. Herbst RS, Prager D, Hermann R, et al: TRIBUTE: A phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol 23:5892-5899, 2005
33. Miller VA, Johnson DH, Krug LM, et al: Pilot trial of the epidermal growth factor receptor tyrosine kinase inhibitor gefitinib plus carboplatin and paclitaxel in patients with stage IIIb or IV non-small-cell lung cancer. J Clin Oncol 21:2094-2100, 2003 (Pubitemid 46606357)
34. Giaccone G, Herbst RS, Manegold C, et al: Gefitinib in combination with gemcitabine and cisplatin in non-small-cell lung cancer: A phase III trial - INTACT 1. J Clin Oncol 22:777-784, 2004 (Pubitemid 41103588)
35. Herbst RS, Giaccone G, Schiller JH, et al: Gefitinib in combination with paclitaxel carboplatin in a non-small-cell lung cancer: A phase III trial - INTACT 2. J Clin Oncol 22:785-794, 2004 (Pubitemid 41103589)
36. Laurie SA, Gauthier I, Arnold A, et al: Phase I and pharmacokinetic study of daily oral AZD2171, an inhibitor of vascular endothelial growth factor tyrosine kinases, in combination with carboplatin and paclitaxel in patients with advanced non-small-cell lung cancer: The National Cancer Institute of Canada clinical trials group. J Clin Oncol 26:1871-1878, 2008
37. Laurie SA, Arnold A, Shepherd FA, et al: National Cancer Institute of Canada clinical trials group study BR.24, a randomized placebo controlled phase II trial of cediranib (ced) plus carboplatin + paclitaxel (C+P) in advanced non-small cell lung cancer of any histology: Further analyses. J Thor Oncol 3:S304, 2008 (suppl)
38. Kim ES, Kies MS, Fossella FV, et al: Phase II study of the farnesyltransferase inhibitor lonafarnib with paclitaxel in patients with taxane-refractory/ resistant non small cell lung carcinoma. Cancer 104:561-569, 2005 (Pubitemid 41022814)
39. Blumenschein G, Ludwig C, Thomas G, et al: A randomized phase III trial comparing lonafarnib/ carboplatin/paclitaxel versus carboplatin/paclitaxel (CP) in chemotherapy-naive patients with advanced or metastatic non-small cell lung cancer (NSCLC). Lung Cancer 49:S30, 2005 (suppl 2; abstr O-082)
40. Khuri FR, Rigas JR, Figlin RA, et al: Multi-institutional phase I/II trial of oral bexarotene in combination with cisplatin and vinorelbine in previously untreated patients with advanced non-smallcell lung cancer. J Clin Oncol 19:2626-2637, 2001 (Pubitemid 32441367)
41. Blumenschein GR Jr, Khuri FR, von Pawel J, et al: Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naïve patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. J Clin Oncol 26:1879-1885, 2008
42. Dowlati A, Gray R, Sandler AB, et al: Cell adhesion molecules, vascular endothelial growth factor, and basic fibroblast growth factor in patients with non-small cell lung cancer treated with chemotherapy with or without bevacizumab: An Eastern Cooperative Oncology Group study. Clin Cancer Res 14:1407-1412, 2008 (Pubitemid 351413922)
43. Fontanini G, Boldrini L, Chinè S, et al: Expression of vascular endothelial growth factor mRNA in non-small-cell lung carcinomas. Br J Cancer 79:363-369, 1999 (Pubitemid 29002309)
44. Bonnesen B, Pappot H, Holmstav J, et al: Vascular endothelial growth factor A and vascular endothelial growth factor receptor 2 expression in non-small cell lung cancer patients: Relation to prognosis. Lung Cancer 66:314-318, 2009
45. Davidoff AM, Ng CY, Zhang Y, et al: Careful decoy receptor titering is required to inhibit tumor angiogenesis while avoiding adversely altering VEGF bioavailability. Mol Ther 11:300-310, 2005