A front-line window of opportunity phase 2 study of sorafenib in patients with advanced nonsmall cell lung cancer: North central cancer treatment group study N0326

Cancer

Volumn 116, Issue 24, 2010, Pages 5686-5693

  Dy, Grace K ^a   Hillman, Shauna L ^b   Rowland Jr , Kendrith M ^c   Molina, Julian R ^b   Steen, Preston D ^d   Wender, Donald B ^e   Nair, Suresh ^f   Mandrekar, Sumithra ^b   Schild, Steven E ^g   Adjei, Alex A ^a  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

^b MAYO CLINIC ROCHESTER   (United States)

^c Carle Cancer Center Community Clinical Oncology Program   (United States)

^d MeritCare Hospital   (United States)

^e Siouxland Hematology Oncology Associates   (United States)

^f LEHIGH VALLEY HOSPITAL   (United States)

^g MAYO CLINIC   (United States)

Author keywords

front line; lung cancer; nonsmall cell lung cancer; phase 2 trial; sorafenib

Indexed keywords

SORAFENIB;

ACNE; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANXIETY; ARTICLE; BONE PAIN; CANCER STAGING; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COUGHING; DEPRESSION; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG FEVER; DRUG RESPONSE; DYSPNEA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEMORRHOID; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOCALCEMIA; HYPONATREMIA; HYPOXIA; LEUKOPENIA; LUNG EMBOLISM; LUNG HEMORRHAGE; LUNG NON SMALL CELL CANCER; MALE; MOTOR NEUROPATHY; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PSYCHOSIS; RECTUM PAIN; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; SUPRAVENTRICULAR TACHYCARDIA; THORAX PAIN; THROMBOCYTOPENIA; WEIGHT REDUCTION;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BENZENESULFONATES; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PROGNOSIS; PYRIDINES;

EID: 78650084078     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.25448     Document Type: Article

References (39)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics 2008. CA Cancer J Clin. 2008; 58: 71-96.
2. Fossella FV, Lee JS, Hong WK,. Management strategies for recurrent non-small cell lung cancer. Semin Oncol. 1997; 24: 455-462.
3. Dy GK, Adjei AA,. Systemic cancer therapy: evolution over the last 60 years. Cancer. 2008; 113: 1857-1887.
4. Scagliotti GV, Masiero P, Pozzi E,. Biological prognostic factors in non-small cell lung cancer. Lung Cancer. 1995; 1 (suppl 12): S13-S25.
5. Folkman J,. Antiangiogenic gene therapy. Proc Natl Acad Sci U S A. 1997; 95: 9064-9066.
6. Ferrara N, Davis-Smyth T,. The biology of vascular endothelial growth factor. Endocr Rev. 1997; 18: 4-25.
7. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006; 355: 2542-2550.
8. Wilhelm SM, Carter C, Tang L, et al. BAY 43-9006 exhibits broad spectrum oral anti-tumor activity and targets the Raf/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res. 2004; 64: 7099-7109.
9. Carlomagno F, Anaganti S, Guida T, et al. BAY 43-9006 inhibition of oncogenic RET mutants. J Natl Cancer Inst. 2006; 98: 326-334.
10. Yu C, Bruzek LM, Meng XW, et al. The role of Mcl-1 downregulation in the proapoptotic activity of the multi kinase inhibitor BAY 43-9006. Oncogene. 2005; 24: 6861-6869.
11. 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. 2005; 16: 1688-1694.
12. Awada A, Hendlisz A, Gil T, et al. Phase I safety and pharmacokinetics of BAY 43-9006 administered for 21 days on/7 days off in patients with advanced, refractory solid tumors. Br J Cancer. 2005; 92: 1855-1861.
13. 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. 2005; 23: 965-972.
14. 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. 2005; 11: 5472-5480.
15. Escudier B, Lassau N, Angevin E, et al. Phase I trial of sorafenib in combination with IFN alpha-2a in patients with unresectable and/or metastatic renal cell carcinoma or malignant melanoma. Clin Cancer Res. 2007; 13: 1801-1809.
16. Flaherty KT, Brose M, Schuchter LM, et al. Sorafenib combined with carboplatin and paclitaxel for metastatic melanoma: PFS and response versus B-Raf status. Ann Oncol. 2006; 17: iii33.
17. Siu LL, Awada A, Takimoto CH, et al. Phase I/II trial of sorafenib and gemcitabine in advanced solid tumors and in advanced pancreatic cancer. Clin Cancer Res. 2006; 12: 144-151.
18. Kupsch P, Henning BF, Passarge K, et al. Results of a phase I trial of sorafenib (BAY 43-9006) in combination with oxaliplatin in patients with refractory solid tumors, including colorectal cancer. Clin Colorectal Cancer. 2005; 5: 188-196.
19. Ratain MJ, Eisen T, Satdler WM, et al. Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006; 24: 2505-2512. (Pubitemid 46630627)
20. Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007; 356: 125-134.
21. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008; 359: 378-390.
22. Cheng AL, Kang YK, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009; 10: 25-34.
23. Goldie JH, Coldman AJ,. The genetic origin of drug resistance in neoplasms: implications for systemic therapy. Cancer Res. 1984; 44: 3643-3653.
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. 2000; 92: 205-216.
25. Duffy D, Santner T,. Confidence intervals for a binomial parameter based on multistage tests. Biometrics. 1987; 43: 81-93.
26. Kaplan E, Meier P,. Nonparametric estimation for incomplete observations. J Am Stat Assoc. 1958; 53: 457-481.
27. Mandrekar S, Schild SE, Hillman S, et al. A prognostic model for advanced stage nonsmall cell lung cancer. Cancer. 2006; 107: 781-792.
28. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer. N Engl J Med. 2006; 355: 2542-2550. (Pubitemid 44917502)
29. Pirker R, Pereira JR, Szczesna A, et al. Cetuximab plus chemotherapy in patients with advanced non-small cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet. 2009; 373: 1525-1531.
30. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005; 353: 123-132.
31. Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet. 2005; 366: 1527-1537.
32. Rossi G, Cavazza A, Marchioni A, et al. Kit expression in small-cell carcinomas of the lung: effects of chemotherapy. Mod Pathol. 2003; 16: 1041-1047.
33. Fujita K, Miyamoto T, Okada Y, et al. Expression pattern of sonic hedgehog and effect of topical mitomycin C on its expression in human ocular surface neoplasms. Jpn J Ophthalmol. 2008; 52: 190-194.
34. Rasbridge SA, Gillett CE, Seymour AM, et al. The effects of chemotherapy on morphology, cellular proliferation, apoptosis and oncoprotein expression in primary breast carcinoma. Br J Cancer. 1994; 70: 335-341.
35. Blumenschein GR Jr, Gatzemeier U, Fossella 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. 2009; 27: 4274-4280.
36. Schiller JH, Lee JW, Hanna NH, 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 2 prior chemotherapy regimens: E2501 [abstract]. J Clin Oncol. 2008; 26 (15 suppl). Abstract 8014.
37. Socinski MA, Saleh MN, Trent DF, et al. A randomized phase II trial of 2 dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small cell lung cancer (NSCLC). Ann Oncol. 2009; 20: 1068-1073.
38. Scagliotti G, Novello S, von Pawel J, et al. Phase III trial study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small cell lung cancer. J Clin Oncol. 2010; 28: 1835-1842.
39. Goss GD, Arnold A, Shepherd FA, et al. Randomized, double-blind trial of carboplatin and paclitaxel with either daily oral cediranib or placebo in advanced non-small-cell lung cancer: NCIC clinical trials group BR24 study. J Clin Oncol. 2010; 28: 49-55.