Phase 2 study of sorafenib in malignant mesothelioma previously treated with platinum-containing chemotherapy

Journal of Thoracic Oncology

Volumn 8, Issue 6, 2013, Pages 783-787

  Papa, Sophie ^a,e   Popat, Sanjay ^b,c   Shah, Riyaz ^d   Prevost, A Toby ^e   Lal, Rohit ^a   McLennan, Blair ^a   Cane, Paul ^a   Lang Lazdunski, Loic ^a,e   Viney, Zaid ^a   Dunn, Joel T ^a   Barrington, Sally ^a,e   Landau, David ^a,e   Spicer, James ^a,e  

^a GUY'S AND ST THOMAS' NHS FOUNDATION TRUST   (United Kingdom)

^b ROYAL MARSDEN HOSPITAL   (United Kingdom)

^c NATIONAL HEART AND LUNG INSTITUTE   (United Kingdom)

^d Kent Cancer Centre   (United Kingdom)

^e KING'S COLLEGE LONDON   (United Kingdom)

Author keywords

Mesothelioma; Sorafenib

Indexed keywords

CISPLATIN; FLUORODEOXYGLUCOSE; PEMETREXED; SORAFENIB;

ADULT; AGED; ALOPECIA; ANOREXIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CONSTIPATION; DIARRHEA; DRUG EFFICACY; DRUG TOLERABILITY; DRY SKIN; DYSPHONIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART INFARCTION; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MALE; MALIGNANT MESOTHELIOMA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA AND VOMITING; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; RASH; REFERENCE VALUE; TREATMENT DURATION;

EID: 84879501497     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e31828c2b26     Document Type: Article

References (38)

1. Wagner JC, Sleggs CA, Marchand P. Diffuse pleural mesothelioma and asbestos exposure in the North Western Cape Province. Br J Ind Med 1960;17:260-271.
2. Hodgson JT, McElvenny DM, Darnton AJ, Price MJ, Peto J. The expected burden of mesothelioma mortality in Great Britain from 2002 to 2050. Br J Cancer 2005;92:587-593. (Pubitemid 40395543)
3. Vogelzang NJ, Rusthoven JJ, Symanowski J, et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003;21:2636-2644. (Pubitemid 46606305)
4. van Meerbeeck JP, Gaafar R, Manegold C, et al.; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol 2005;23:6881-6889.
5. König J, Tolnay E, Wiethege T, Müller K. Co-expression of vascular endothelial growth factor and its receptor flt-1 in malignant pleural mesothelioma. Respiration 2000;67:36-40. (Pubitemid 30114163)
6. Kumar-Singh S, Weyler J, Martin MJ, Vermeulen PB, Van Marck E. Angiogenic cytokines in mesothelioma: a study of VEGF, FGF-1 and -2, and TGF beta expression. J Pathol 1999;189:72-78. (Pubitemid 29406822)
7. Ohta Y, Shridhar V, Bright RK, et al. VEGF and VEGF type C play an important role in angiogenesis and lymphangiogenesis in human malignant mesothelioma tumours. Br J Cancer 1999;81:54-61. (Pubitemid 29415491)
8. Strizzi L, Catalano A, Vianale G, et al. Vascular endothelial growth factor is an autocrine growth factor in human malignant mesothelioma. J Pathol 2001;193:468-475. (Pubitemid 32266815)
9. Masood R, Kundra A, Zhu S, et al. Malignant mesothelioma growth inhibition by agents that target the VEGF and VEGF-C autocrine loops. Int J Cancer 2003;104:603-610. (Pubitemid 36337260)
10. Demirag F, Unsal E, Yilmaz A, Caglar A. Prognostic significance of vascular endothelial growth factor, tumor necrosis, and mitotic activity index in malignant pleural mesothelioma. Chest 2005;128:3382-3387. (Pubitemid 41698667)
11. Kindler HL, Karrison TG, Gandara DR, et al. Multicenter, double-blind, placebo-controlled, randomized phase II trial of gemcitabine/cisplatin plus bevacizumab or placebo in patients with malignant mesothelioma. J Clin Oncol 2012;30:2509-2515.
12. Lowinger TB, Riedl B, Dumas J, Smith RA. Design and discovery of small molecules targeting raf-1 kinase. Curr Pharm Des 2002;8:2269-2278. (Pubitemid 35189900)
13. 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)
14. Chang YS, Adnane J, Trail PA, et al. Sorafenib (BAY 43-9006) inhibits tumor growth and vascularization and induces tumor apoptosis and hypoxia in RCC xenograft models. Cancer Chemother Pharmacol 2007;59:561-574. (Pubitemid 46295136)
15. Liu L, Cao Y, Chen C, et al. Sorafenib blocks the RAF/MEK/ERK pathway, inhibits tumor angiogenesis, and induces tumor cell apoptosis in hepatocellular carcinoma model PLC/PRF/5. Cancer Res 2006;66:11851-11858. (Pubitemid 46094197)
16. Panka DJ, Wang W, Atkins MB, Mier JW. The Raf inhibitor BAY 43-9006 (Sorafenib) induces caspase-independent apoptosis in melanoma cells. Cancer Res 2006;66:1611-1619. (Pubitemid 43259945)
17. Rahmani M, Davis EM, Bauer C, Dent P, Grant S. Apoptosis induced by the kinase inhibitor BAY 43-9006 in human leukemia cells involves down-regulation of Mcl-1 through inhibition of translation. J Biol Chem 2005;280:35217-35227. (Pubitemid 41532709)
18. Yu C, Bruzek LM, Meng XW, et al. The role of Mcl-1 downregulation in the proapoptotic activity of the multikinase inhibitor BAY 43-9006. Oncogene 2005;24:6861-6869. (Pubitemid 41509409)
19. Sun W, Powell M, O'Dwyer PJ, Catalano P, Ansari RH, Benson AB 3rd. Phase II study of sorafenib in combination with docetaxel and cisplatin in the treatment of metastatic or advanced gastric and gastroesophageal junction adenocarcinoma: ECOG 5203. J Clin Oncol 2010;28:2947-2951.
20. Gupta-Abramson V, Troxel AB, Nellore A, et al. Phase II trial of sorafenib in advanced thyroid cancer. J Clin Oncol 2008;26:4714-4719.
21. Dahut WL, Scripture C, Posadas E, et al. A phase II clinical trial of sorafenib in androgen-independent prostate cancer. Clin Cancer Res 2008;14:209-214. (Pubitemid 351377997)
22. Moreno-Aspitia A, Morton RF, Hillman DW, et al. Phase II trial of sorafenib in patients with metastatic breast cancer previously exposed to anthracyclines or taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336. J Clin Oncol 2009;27:11-15.
23. Kelly RJ, Rajan A, Force J, et al. Evaluation of KRAS mutations, angiogenic biomarkers, and DCE-MRI in patients with advanced nonsmall- cell lung cancer receiving sorafenib. Clin Cancer Res 2011; 17:1190-1199.
24. 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.
25. Escudier B, Eisen T, Stadler WM, et al.; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125-134. (Pubitemid 46089673)
26. Llovet JM, Ricci S, Mazzaferro V, et al.; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med 2008;359:378-390.
27. Byrne MJ, Nowak AK. Modified RECIST criteria for assessment of response in malignant pleural mesothelioma. Ann Oncol 2004;15:257-260. (Pubitemid 38262625)
28. Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma-The EORTC Lung Cancer Group. J Clin Oncol 2006;24:3007-3012. (Pubitemid 46638933)
29. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. (Pubitemid 19099520)
30. Sleijfer S, Wagner AJ. The challenge of choosing appropriate end points in single-arm phase II studies of rare diseases. J Clin Oncol 2012;30:896-898.
31. Dubey S, Jänne PA, Krug L, et al. A phase II study of sorafenib in malignant mesothelioma: results of Cancer and Leukemia Group B 30307. J Thorac Oncol 2010;5:1655-1661.
32. Garland LL, Chansky K, Wozniak AJ, et al. Phase II study of cediranib in patients with malignant pleural mesothelioma: SWOG S0509. J Thorac Oncol 2011;6:1938-1945.
33. Jahan T, Gu L, Kratzke R, et al. Vatalanib in malignant mesothelioma: a phase II trial by the Cancer and Leukemia Group B (CALGB 30107). Lung Cancer 2012;76:393-396.
34. Nowak AK, Millward MJ, Creaney J, et al. A phase II study of intermittent sunitinib malate as second-line therapy in progressive malignant pleural mesothelioma. J Thorac Oncol 2012;7:1449-1456.
35. Laurie SA, Gupta A, Chu Q, et al. Brief report: a phase II study of sunitinib in malignant pleural mesothelioma. the NCIC Clinical Trials Group. J Thorac Oncol 2011;6:1950-1954.
36. Ratain MJ. Bar the windows but open the door to randomization. J Clin Oncol 2010;28:3104-3106.
37. Muers MF, Stephens RJ, Fisher P, et al.; MS01 Trial Management Group. Active symptom control with or without chemotherapy in the treatment of patients with malignant pleural mesothelioma (MS01): a multicentre randomized trial. Lancet 2008;371:1685-1694. (Pubitemid 351671885)
38. Freidlin B, Simon R. Evaluation of randomized discontinuation design. J Clin Oncol 2005;23:5094-5098. (Pubitemid 46224017)