A phase II trial of gefitinib and pegylated IFNα in previously treated renal cell carcinoma

International Journal of Clinical Oncology

Volumn 16, Issue 5, 2011, Pages 494-499

  Shek, Derek ^a   Longmate, Jeff ^b   Quinn, David I ^d   Margolin, Kim A ^e   Twardowski, Przemyslaw ^c   Gandara, David R ^a   Frankel, Paul ^c   Pan, Chong Xian ^a,b   Lara Jr , Primo N ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c CITY OF HOPE NATIONAL MEDICAL CENTER   (United States)

^d UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^e UNIVERSITY OF WASHINGTON   (United States)

Author keywords

Cytokine therapy; Epidermal growth factor receptor (EGFR) inhibitor; Renal cell cancer

Indexed keywords

ALPHA INTERFERON; BEVACIZUMAB; BORTEZOMIB; CEDIRANIB; GEFITINIB; INTERLEUKIN 2; OBLIMERSEN; PEGINTERFERON ALPHA; SORAFENIB; SUNITINIB; ANTINEOPLASTIC AGENT; MACROGOL DERIVATIVE; PEGINTERFERON ALPHA2A; QUINAZOLINE DERIVATIVE; RECOMBINANT PROTEIN;

ACNE; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BONE MARROW SUPPRESSION; CANCER GROWTH; CLINICAL ARTICLE; DEHYDRATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; FEMALE; HEART ATRIUM FIBRILLATION; HUMAN; HYPERGLYCEMIA; HYPOALBUMINEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; INTERNATIONAL NORMALIZED RATIO; KIDNEY CARCINOMA; KIDNEY FAILURE; LEUKOPENIA; LYMPHOCYTOPENIA; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHRECTOMY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; SYSTEMIC THERAPY; CANCER STAGING; CLINICAL TRIAL; DISEASE FREE SURVIVAL; KIDNEY TUMOR; MIDDLE AGED; PATHOLOGY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; INTERFERON-ALPHA; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; POLYETHYLENE GLYCOLS; QUINAZOLINES; RECOMBINANT PROTEINS;

EID: 84857076257     PISSN: 13419625     EISSN: 14377772     Source Type: Journal    
DOI: 10.1007/s10147-011-0212-8     Document Type: Article

References (36)

1. Jemal A, Siegel R, Xu J et al (2010) Cancer statistics 2010. CA Cancer J Clin 60:277-300
2. Yang JC, Sherry RM, Steinberg SM et al (2003) Randomized study of high dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol 21:3127-3132 (Pubitemid 46606294)
3. Langner C, Ratschek M, Rehak P et al (2004) Are heterogenous results of EGFR immunoreactivity in RCC related to non-standardized criteria for staining evaluation? J Clin Pathol 57(7):773-775 (Pubitemid 38901498)
4. Sirotnak F, Zakowski M, Miller VA et al (2000) Efficacy of cytotoxic agents against human tumor xenografts is markedly enhanced by coadministration of ZD1839 (Iressa), an inhibitor of EGFR tyrosine kinase. Clin Cancer Res 6:4885-4892 (Pubitemid 32110433)
5. Roskoski R (2004) The ErbB/HER receptor protein-tyrosine kinases and cancer. Biochem Biophys Res Commun 319:1-11
6. Asakuma J, Sumitomo M, Asano T et al (2004) Modulation of tumor growth and tumor induced angiogenesis after epidermal growth factor receptor inhibition by gefitinib in RCC. J Urol 171:897-902 (Pubitemid 38090529)
7. Byrne R, Leung H, Neal DE (1996) Peptide growth factors in the prostate as mediators of stromal epithelial interactions. Br J Urol 77:627-633 (Pubitemid 27402266)
8. Uhlman DL, Nguyen P, Manivel JC et al (1995) Epidermal growth factor receptor and transforming growth factor alpha expression in papillary and nonpapillary RCC: correlation with metastatic behavior and prognosis. Clin Cancer Res 1:913-920
9. Sargent ER, Gomella LG, Belldegrun A et al (1989) Epidermal growth factor receptor gene expression in normal human kidney and RCC. J Urol 142:1364-1368 (Pubitemid 19277993)
10. Stumm G, Eberwein S, Rostock-Wolf S et al (1996) Concomitant overexpression of the EGFR and erbB-2 genes in RCC (RCC) is correlated with dedifferentiation and metastasis. Int J Cancer 69:17-22 (Pubitemid 26083265)
11. Eisenkraft BL, Nanus DM, Albino AP et al (1991) Alpha-IFN down-regulates epidermal growth factor receptors on renal carcinoma cells: relation to cellular responsiveness to the antiproliferative action of alpha-IFN. Cancer Res 51:5881-5887
12. Heise H, Depenbrock H, Rastetter JW et al (1995) Characterization and mutual ligand-induced modulation of epidermal growth factor and IFN-alpha receptors on renal carcinoma cells in vitro. Anticancer Drugs 6:686-692
13. Martyre MC, Grimaux M, Beaupain R (1990) Increase of epidermal growth factor expression associated with a lack of antiproliferative effect of IFN-beta in human lung cancer nodules in organotypic culture. Tumour Biol 11:202-209 (Pubitemid 20292241)
14. Negrier S, Escudier B, Lasset C et al (1998) Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais d'Immunotherapie. N Engl J Med 338(18):1272-1278 (Pubitemid 28216581)
15. Amato R (1999) Modest effect of interferon alfa on metastatic renal-cell carcinoma. Lancet 353(9146):6-7 (Pubitemid 29037692)
16. Drucker B, Bacik J, Ginsberg M et al (2003) Phase II trial of gefitinib (IRESSA) in patients with advanced RCC. Invest New Drugs 21:341-345 (Pubitemid 37486334)
17. Amato RJ, Jac J, Hernandez-McClain J (2008) IFN-alpha in combination with either imatinib (Gleevec) or gefitinib (Iressa) in metastatic RCC: a phase II trial. Anti Cancer Drugs 19:527-533 (Pubitemid 351556404)
18. Hainsworth JD, Sosman JA, Spigel DR et al (2005) Treatment of metastatic renal cell carcinoma with a combination of bevacizumab and erlotinib. J Clin Oncol 23(31):7889-7896 (Pubitemid 46657387)
19. Bukowski RM, Kabbinavar FF, Figlin RA et al (2007) Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol 25(29):4536-4541 (Pubitemid 350035309)
20. Linday KL, Trepo C, Heintges T et al (2001) A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic hepatitis C. Hepatology 34:395-403 (Pubitemid 32702353)
21. Feldman DR, Kondagunta GV, Schwartz L et al (2008) Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer 6(1):25-30 (Pubitemid 351656240)
22. Guilhot F, Roy L, Saulnier PJ et al (2009) Interferon in chronic myeloid leukaemia: past and future. Best Pract Res Clin Haematol 22:315-329
23. Green SJ, Dahlberg S (1992) Planned versus attained design in phase II clinical trials. Stat Med 11(7):853-862
24. Escudier B, Pluzanska A, Koralewski P et al (2007) Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: A randomised, double-blind phase III trial. Lancet 370(9605):2103-2111 (Pubitemid 350296300)
25. Rini BI, Halabi S, Rosenberg JE et al (2008) Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol 26(33):5422-5428
26. Amato RJ, Jac J, Hernandez-McClain J (2008) Interferon-alpha in combination with either imatinib (Gleevec) or gefitinib (Iressa) in metastatic renal cell carcinoma: a phase II trial. Anticancer Drugs 19(5):527-533 (Pubitemid 351556404)
27. Jermann M, Stahel RA, Salzberg M et al (2006) A phase II, openlabel study of gefitinib (IRESSA) in patients with locally advanced, metastatic, or relapsed renal-cell carcinoma. Cancer Chemother Pharmacol 57:533-539 (Pubitemid 43087597)
28. Escudier B, Eisen T, Stadler WM et al (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356(2): 125-134 (Pubitemid 46089673)
29. Atkins MB, Hidalgo M, Stadler WM et al (2004) Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinoma. J Clin Oncol 22(5): 909-918 (Pubitemid 41103603)
30. Ravaud A, Hawkins R, Gardner JP et al (2008) Lapatinib versus hormone therapy in patients with advanced RCC: a randomized phase III clinical trial. J Clin Oncol 26:2285-2291
31. Motzer RJ, Amato R, Todd M et al (2003) Phase II trial of antiepidermal growth factor receptor antibody C225 in patients with advanced RCC. Invest New Drugs 21:99-101 (Pubitemid 36628489)
32. Rowinsky EK, Schwartz GH, Gollob JA et al (2004) Safety, pharmacokinetics, and activity of ABX-EGF, a fully human antiepidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol 22:3003-3015 (Pubitemid 41103711)
33. Bukowski RM, Kabbinavar FF, Figlin RA et al (2007) Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol 25:4536
34. Gordon M, Hussey M, Nagle R et al (2009) Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol 27(34): 5788-5793
35. Kuroda K, Horiguchi A, Sumitomo M et al (2009) Activated Akt prevents antitumor activity of gefitinib in renal cancer cells. Urology 74(1):209-215
36. Ito N, Eto M, Nakamura E et al (2007) STAT3 polymorphism predicts interferon-alfa response to patients with metastatic renal cell carcinoma. J Clin Oncol 25(19):2785-2791 (Pubitemid 47123187)