Practice and progress in kidney cancer: Methodology for novel drug development

Journal of Urology

Volumn 171, Issue 6 I, 2004, Pages 2115-2121

  Rini, Brian I ^a   Weinberg, Vivian ^a   Small, Eric J ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Carcinoma, renal cell; Clinical trials, phase II; Clinical trials, phase III; Cytokines; Kidney

Indexed keywords

ALPHA INTERFERON; BEVACIZUMAB; CYTOKINE; INTERFERON; INTERLEUKIN 2; MEGESTROL ACETATE; RETINOIC ACID; VASCULOTROPIN; VINBLASTINE; YTTERBIUM;

ANTINEOPLASTIC ACTIVITY; BRAIN RADIATION; CENTRAL NERVOUS SYSTEM METASTASIS; CLINICAL MEDICINE; CLINICAL TRIAL; DRUG DESIGN; DRUG SCREENING; HISTOLOGY; HUMAN; KIDNEY CANCER; KIDNEY CARCINOMA; METASTASIS; NEPHRECTOMY; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; RADIOSURGERY; REVIEW; SIDE EFFECT; STEREOTAXIC SURGERY; SURVIVAL RATE; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TUMOR VOLUME;

EID: 2442455525     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1097/01.ju.0000113728.46439.02     Document Type: Review

References (43)

1. Atkins, M. B.: A randomized phase III trial of high-dose IL-2 versus subcutaneous IL-2 in patients with metastatic renal cell carcinoma. Presented at Chiron Investigator's Meeting, Phoenix, Arizona, March 6, 2003
2. Yang, J. C., Sherry, R. M., Steinberg, S. M., Topalian, S. L., Schwartzentruber, A. J., Hwu, P. et al: Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol, 21: 3127, 2003
3. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Medical Research Council Renal Cancer Collaborators. Lancet, 353: 14, 1999
4. Pyrhonen, S., Salminen, E., Ruutu, M., Lehtonen, T., Nurmi, M., Tammela, T. et al: Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol, 17: 2859, 1999
5. Negrier, S., Escudier, B., Lasset, C., Douillard, J.-Y., Savary, J., Chevreau, C. et al: 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: 1272, 1998
6. Motzer, R. J., Bacik, J., Murphy, B. A., Russo, P. and Mazumdar, M.: Interferon-alfa as a comparative treatment for clinical trials of new therapies against advanced renal cell carcinoma. J Clin Oncol, 20: 289, 2002
7. Abou-Jawde, R. M., Mekhail, T., Bou Merhi, G. F., Malhi, S., Wood, L., Olencki, T. et al: Prognostic factors (PF) for survival in previously untreated metastatic renal cell cancer (RCC): a comprehensive evaluation and validation of established risk groups. Progr Proc Am Soc Clin Oncol, 22: 385, abstract 1545, 2003
8. Negrier, S., Escudier, B., Gomez, F., Douillard, J.-Y., Ravaud, A., Chevreau, C. et al: Prognostic factors of survival and rapid progression in 782 patients with metastatic renal carcinomas treated by cytokines: a report from the Groupe Francais d'Immunotherapie. Ann Oncol, 13: 1460, 2002
9. Zisman, A., Pantuck, A. J., Wieder, J. Chao, D. H., Dorey, F., Said, J. W. et al: Risk group assessment and clinical outcome algorithm to predict the natural history of patients with surgically resected renal cell carcinoma. J Clin Oncol, 20: 4559, 2002
10. Kovacs, G., Akhtar, M., Beckwith, B. J., Bugert, P., Cooper, C. S., Delahunt, B. et al: The Heidelberg classification of renal cell tumours. J Pathol, 183: 131, 1997
11. Storkel, S., Eble, J. N., Adlakha, K., Amin, M., Blute, M. L., Bostwick, D. G. et al: Classification of renal cell carcinoma: Workgroup No. 1 Union Internationale Contre le Cancer (UICC) and the American Joint Committee on Cancer (AJCC). Cancer, 80: 987, 1997
12. Gnarra, J. R., Lerman, M. I., Zbar, B. and Linehan, M.: Genetics of renal-cell carcinoma and evidence for a critical role for von Hippel-Lindau in renal tumorigenesis. Semin Oncol, 22: 3, 1995
13. Ma, X., Yang, K., Lindblad, P., Egevad, L. and Hemminki, K.: VHL gene alterations in renal cell carcinoma patients: novel hotspot or founder mutations and linkage disequilibrium. Oncogene, 20: 5393, 2001
14. Brieger, J., Weidt, E. J., Schirmacher, P., Storkel, S., Huber, C. and Decker, H. J.: Inverse regulation of vascular endothelial growth factor and VHL tumor suppressor gene in sporadic renal cell carcinomas is correlated with vascular growth: an in vivo study on 29 tumors. J Mol Med, 77: 505, 1999
15. Iliopoulos, O., Levy, A. P., Jiang, C., Kaelin, W. G., Jr. and Goldberg, M. A.: Negative regulation of hypoxia-inducible genes by the von Hippel-Lindau protein. Proc Natl Acad Sci USA, 93: 10595, 1996
16. Schmidt, L., Duh, F. M., Chen, F., Kishida, T., Glenn, G., Choyke, P. et al: Germline and somatic mutations in the tyrosine kinase domain of the MET proto-oncogene in papillary renal carcinomas. Nat Genet, 16: 68, 1997
17. Sweeney, P., El-Naggar, A. K., Lin, S. H. and Pisters, L. L.: Biological significance of c-met over expression in papillary renal cell carcinoma. J Urol, 168: 51, 2002
18. Mian, B. M., Bhadkamkar, N., Slaton, J. W., Pisters, P. W., Daliani, D., Swanson, D. A. et al: Prognostic factors and survival of patients with sarcomatoid renal cell carcinoma. J Urol, 167: 65, 2002
19. Cangiano, T., Liao, J., Naitoh, J., Dorey, F., Figlin, R. and Belldegrun, A.: Sarcomatoid renal cell carcinoma: biologic behavior, prognosis, and response to combined surgical resection and immunotherapy. J Clin Oncol, 17: 523, 1999
20. Oda, H., Nakatsuru, Y. and Ishikawa, T.: Mutations of the p53 gene and p53 protein overexpression are associated with sarcomatoid transformation in renal cell carcinomas. Cancer Res, 55: 658, 1995
21. Contractor, H., Zariwala, M., Bugert, P., Zeisler, J. and Kovacs, G.: Mutation of the p53 tumour suppressor gene occurs preferentially in the chromophobe type of renal cell tumour. J Pathol, 181: 136, 1997
22. Flanigan, R. C., Salmon, S. E., Blumenstein, B. A., Bearman, S. I., Roy, V., McGrath, P. C. et al: Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med, 345: 1655, 2001
23. Mickisch, G. H., Garin, A., van Poppel, H., de Prijck, L., Sylvester, R. and European Organization for the Research and Treatment of Cancer (EORTC) Genitourinary Group: Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet, 358: 966, 2001
24. Schwartz, L. H., Mazumdar, M., Wang, L., Smith, A., Marion, S., Panicek, D. et al: Effect of response criteria on outcome assessment for patients with advanced renal carcinoma. Progr Proc Am Soc Clin Oncol, 22: 385, abstract 1546, 2003
25. Decker, D. A., Decker, V. L., Herskovic, A. and Cummings, G. D.: Brain metastases in patients with renal cell carcinoma: prognosis and treatment. J Clin Oncol, 2: 169, 1984
26. Culine, S., Bekradda, M., Kramar, A., Rey, A., Escudier, B. and Droz, J. P.: Prognostic factors for survival in patients with brain metastases from renal cell carcinoma. Cancer, 83: 2548, 1998
27. Schoggl, A., Kitz, K., Ertl, A., Dieckmann, K., Saringer, W. and Koos, W. T.: Gamma-knife radiosurgery for brain metastases of renal cell carcinoma: results in 23 patients. Acta Neurochir, 140: 549, 1998
28. Goyal, L. K., Suh, J. H., Reddy, C. A. and Barnett, G. H.: The role of whole brain radiotherapy and stereotactic radiosurgery on brain metastases from renal cell carcinoma. Int J Radiat Oncol Biol Phys, 47: 1007, 2000
29. Hernandez, L., Zamorano, L., Sloan, A., Fontanesi, J., Lo, S., Levin, K. et al: Gamma knife radiosurgery for renal cell carcinoma brain metastases. J Neurosurg, 97: 489, 2002
30. Miller, A. B., Hoogstraten, B., Staquet, M. and Winkler, A.: Reporting results of cancer treatment. Cancer, 47: 207, 1981
31. Therasse, P., Arbuck, S. G., Eisenhauer, E. A., Wanders, J., Kaplan, R. S., Rubinstein, L. 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, 2000
32. Yagoda, A., Petrylak, D. and Thompson, S.: Cytotoxic chemoi therapy for advanced renal cell carcinoma. Urol Clin North Am, 20: 303, 1993
33. Figlin, R. A., Pierce, W. C., Kaboo, R., Tso, C. L., Moldawer, N., Gitlitz, B. et al: Treatment of metastatic renal cell carcinoma with nephrectomy, interleukin-2 and cytokine-primed or CD8(+) selected tumor infiltrating lymphocytes from primary tumor. J Urol, 158: 740, 1997
34. Figlin, R. A., Thompson, J. A., Bukowski, R. M., Vogelzang, N. J., Novick, A. C., Lange, P. et al: Multicenter, randomized, phase III trial of CD8(+) tumor-infiltrating lymphocytes in combination with recombinant interleukin-2 in metastatic renal cell carcinoma. J Clin Oncol, 17: 2521, 1999
35. Motzer, R. J., Schwartz, L., Law, T. M., Murphy, B. A., Hoffman, A. D., Albino, A. P. et al: Interferon alfa-2a and 13-cis-retinoic acid in renal cell carcinoma: antitumor activity in a phase II trial and interactions in vitro. J Clin Oncol, 13: 1950, 1995
36. Motzer, R. J., Murphy, B. A., Bacik, J., Schwartz, L. H., Nanus, D. M., Mariani, T. et al: Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma. J Clin Oncol, 18: 2972, 2000
37. De Mulder, P. H., Oosterhof, G., Bouffioux, C., van Oosterom, A. T., Vermeylen, K. and Sylvester, R.: EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma. The EORTC Genitourinary Group. Br J Cancer, 71: 371, 1995
38. Fossa, S. D., Martinelli, G., Otto, U., Schneider, G., Wander, H., Oberling, F. et al: Recombinant interferon alfa-2a with or without vinblastine in metastatic renal cell carcinoma: results of a European multi-center phase III study. Ann Oncol, 3: 301, 1992
39. Law, T. M., Motzer, R. J., Mazumdar, M., Sell, K. W., Walther, P. J., O'Connell, M. et al: Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma. Cancer, 76: 824, 1995
40. Yang, J. C., Haworth, L., Sherry, R. M., Hwu, P., Schwartzentruber, D. J., Topalian, S. L. et al: A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Eng J Med, 349: 427, 2003
41. Kopec, J. A., Abrahamowicz, M. and Esdaile, J. M.: Randomized discontinuation trials: utility and efficiency. J Clin Epidemiol, 46: 959, 1993
42. Rosner, G. L., Stadler, W. and Ratain, M. J.: Randomized discontinuation design: application to cytostatic antineoplastic agents. J Clin Oncol, 20: 4478, 2002
43. Tchekmedyian, S., Rosen, L. S., Gordon, D., Hirsh, V., Yanagihara, R., Coleman, R. E. et al: Long-term efficacy and safety of zoledronic acid in reducing skeletal complications in patients with bone metastases from solid tumors. Proc Am Soc Clin Oncol, 22: 630, abstract 2532, 2003