A multicenter phase II study of erlotinib and sorafenib in chemotherapy-naïve patients with advanced non-small cell lung cancer

Clinical Cancer Research

Volumn 16, Issue 11, 2010, Pages 3078-3087

  Lind, Joline S W ^a   Dingemans, Anne Marie C ^b   Groen, Harry J M ^c   Thunnissen, Frederik B ^a   Bekers, Otto ^b   Heideman, Daniëlle A M ^a   Honeywell, Richard J ^a   Giovannetti, Elisa ^a   Peters, Godefridus J ^a   Postmus, Pieter E ^a   Van Suylen, Robert Jan ^b   Smit, Egbert F ^a  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450; CYTOCHROME P450 3A4; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; K RAS PROTEIN; PROTEIN TYROSINE KINASE INHIBITOR; SORAFENIB; VASCULOTROPIN RECEPTOR;

ACNE; ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANOREXIA; ARTICLE; CANCER GROWTH; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; COUGHING; DIARRHEA; DNA POLYMORPHISM; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DRY EYE; DRY SKIN; DYSGEUSIA; DYSPNEA; EPISTAXIS; FATIGUE; FEMALE; FEVER; GENE MUTATION; HEADACHE; HEMOPTYSIS; HOARSENESS; HUMAN; HYPERTENSION; HYPOPHOSPHATEMIA; HYPOTHYROIDISM; LUNG HEMORRHAGE; LUNG NON SMALL CELL CANCER; MALE; MUCOSA INFLAMMATION; MULTICENTER STUDY; NAUSEA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RASH; SIDE EFFECT; SKIN MANIFESTATION; STOMATITIS; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; MUTATION; PROTEIN KINASE INHIBITORS; PROTO-ONCOGENE PROTEINS; PYRIDINES; QUINAZOLINES; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; VASCULAR ENDOTHELIAL GROWTH FACTORS;

EID: 77953114837     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-09-3033     Document Type: Article

References (40)

1. Camp ER, Summy J, Bauer TW, Liu W, Gallick GE, Ellis LM. Molecular mechanisms of resistance to therapies targeting the epidermal growth factor receptor. Clin Cancer Res 2005;11:397-405. (Pubitemid 40075820)
2. Groen HJ, Smit EF, Dingemans A. A phase II study of erlotinib (E) and bevacizumab (B) in patients (pts) with previously untreated stage IIIB/IV non-small cell lung cancer (NSCLC). J Clin Oncol (Meeting Abstracts) 2007;25:7625.
3. Herbst RS, O'neill VJ, Fehrenbacher L, et al. Phase II study of efficacy and safety of bevacizumab in combination with chemotherapy or erlotinib compared with chemotherapy alone for treatment of recurrent or refractory non-small-cell lung cancer. J Clin Oncol 2007; 25:4743-4750
4. Hainsworth J, Lin M, O'Connor P, et al. A phase III, multicenter, placebo-controlled, double-blind, randomized, clinical trial to evaluate the efficacy of bevacizumab (Avastin) in combination with erlotinib (Tarceva) compared with erlotinib alone for treatment of advanced non-small cell lung cancer (NSCLC) after failure of standard first line chemotherapy (BETA), IASLC Meeting, November 11-13, 2008, Chicago, IL.
5. 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 2004;64:7099-7109 (Pubitemid 39331023)
6. 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;27:4277-4280
7. Liu B, Barrett T, Choyke P, et al. A phase II study of BAY 43-9006 (Sorafenib) in patients with relapsed non-small cell lung cancer (NSCLC). J Clin Oncol (Meeting Abstracts) 2006;24:17119.
8. Schiller JH, Lee JW, Hanna NH, Traynor AM, Carbone DP. 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 (Meeting Abstracts) 2008;26:8014.
9. Duran I, Hotte SJ, Hirte H, et al. Phase I targeted combination trial of sorafenib and erlotinib in patients with advanced solid tumors. Clin Cancer Res 2007;13:4849-4857 (Pubitemid 47294792)
10. Giovannetti E, Danesi R, Smit EF, et al. Inhibition of multiple signalling pathways by sorafenib synergizes with erlotinib in non-small lung cancer (NSCLC) cells sensitive and resistant to EGFR-inhibitors. AACR 100th Annual Meeting, San Diego. 2009.
11. 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
12. Lara PN, Jr., Redman MW, Kelly K, et al. Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol 2008;26:463-467 (Pubitemid 351171700)
13. Heideman DA, Thunnissen FB, Doeleman M, Kramer D. A panel of high resolution melting (HRM) technology-based assays with direct sequencing possibility for effective mutation screening of EGFR and K-ras genes. Cell Oncol 2009;31:329-333
14. Kramer D, Thunnissen FB, Gallegos-Ruiz MI, et al. A fast, sensitive and accurate high resolution melting (HRM) technology-based assay to screen for common K-ras mutations. Cell Oncol 2009;31:161-167
15. Honeywell R, Yarzadah K, Giovannetti E, et al. Simple and selective method for the determination of tyrosine kinase inhibitors used in the clinical setting by liquid chromatography tandem mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci, Epub 2010 Mar 15.
16. Cheung CY, Op den Buijsch RA, Wong KM, et al. Influence of different allelic variants of the CYP3A and ABCB1 genes on the tacrolimus pharmacokinetic profile of Chinese renal transplant recipients. Pharmacogenomics 2006;7:563-574
17. Wijnen PA, Drent M, Nelemans PJ, et al. Role of cytochrome P450 polymorphisms in the development of pulmonary drug toxicity: a case-control study in the Netherlands. Drug Saf 2008;31:1125-1134
18. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. (Pubitemid 19099520)
19. Giaccone G, Ruiz MG, Le Chevalier T, et al. Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. Clin Cancer Res 2006;12:6049-6055 (Pubitemid 44703768)
20. Crabb SJ, Patsios D, Sauerbrei E, et al. Tumor cavitation: impact on objective response evaluation in trials of angiogenesis inhibitors in non-small-cell lung cancer. J Clin Oncol 2008;27:404-410
21. Minami H, Kawada K, Ebi H, et al. Phase I and pharmacokinetic study of sorafenib, an oral multikinase inhibitor, in Japanese patients with advanced refractory solid tumors. Cancer Sci 2008;99:1492-1498 (Pubitemid 351761743)
22. 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 (Pubitemid 46202316)
23. Marom EM, Martinez CH, Truong MT, et al. Tumor cavitation during therapy with antiangiogenesis agents in patients with lung cancer. J Thorac Oncol 2008;3:351-357 (Pubitemid 351489474)
24. Scagliotti G, von Pawel J, Reck M, et al. Phase III trial comparing carboplatin and paclitaxel with or without sorafenib in chemonaive patients with stage IIIB (with effusion) or IV non-small cell lung cancer. First IASLC-ESMO European Lung Cancer Conference 2008, Geneva. 2008.
25. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361:947-957
26. Spigel D, Greco AF, Burris HA III, et al. A randomized double-blind placebo-controlled phase II trial of sorafenib and erlotinib or erlotinib alone in previously treated advanced non-small-cell lung cancer. IASLC Meeting 31 July-4 Aug 2009, San Francisco. 2010.
27. Hidalgo M, Siu LL, Nemunaitis J, et al. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 2001;19:3267-3279 (Pubitemid 32591445)
28. Adjei AA, Molina JR, Mandrekar SJ, et al. Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent non-small cell lung cancer. Clin Cancer Res 2007;13:2684-2691 (Pubitemid 46788036)
29. Kuhn JG, Gilbert MR, Wen P, et al. Interaction between sorafenib and erlotinib. J Clin Oncol (Meeting Abstracts) 2009;27:2500.
30. Schirmer M, Toliat MR, Haberl M, et al. Genetic signature consistent with selection against the CYP3A4*1B allele in non-African populations. Pharmacogenet Genomics 2006;16:59-71. (Pubitemid 41803878)
31. Li J, Karlsson MO, Brahmer J, et al. CYP3A phenotyping approach to predict systemic exposure to EGFR tyrosine kinase inhibitors. J Natl Cancer Inst 2006;98:1714-1723 (Pubitemid 44942709)
32. Carey KD, Garton AJ, Romero MS, et al. Kinetic analysis of epidermal growth factor receptor somatic mutant proteins shows increased sensitivity to the epidermal growth factor receptor tyrosine kinase inhibitor, erlotinib. Cancer Res 2006;66:8163-8171
33. Yun CH, Mengwasser KE, Toms AV, et al. The T790M mutation in EGFR kinase causes drug resistance by increasing the affinity for ATP. Proc Natl Acad Sci U S A 2008;105:2070-2075
34. Yun CH, Boggon TJ, Li Y, et al. Structures of lung cancer-derived EGFR mutants and inhibitor complexes: mechanism of activation and insights into differential inhibitor sensitivity. Cancer Cell 2007; 11:217-227 (Pubitemid 46349842)
35. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353:123-132 (Pubitemid 41058344)
36. Lind JS, Postmus PE, Heideman DA, Thunnissen EB, Bekers O, Smit EF. Dramatic response to low-dose erlotinib of epidermal growth factor receptor mutation-positive recurrent non-small cell lung cancer after severe cutaneous toxicity. J Thorac Oncol 2009;4:1585-1586
37. Azad NS, Ragon-Ching JB, Dahut WL, et al. Hand-foot skin reaction increases with cumulative sorafenib dose and with combination antivascular endothelial growth factor therapy. Clin Cancer Res 2009;15: 1411-1416
38. Chu D, Lacouture ME, Fillos T, Wu S. Risk of hand-foot skin reaction with sorafenib: a systematic review and meta-analysis. Acta Oncol 2008;47:176-186
39. Rudin CM, Liu W, Desai A, et al. Pharmacogenomic and pharmacokinetic determinants of erlotinib toxicity. J Clin Oncol 2008;26: 1119-1127
40. Strumberg D, Awada A, Hirte H, et al. Pooled safety analysis of BAY 43-9006 (sorafenib) monotherapy in patients with advanced solid tumours: is rash associated with treatment outcome? Eur J Cancer 2006;42:548-556