A phase-II study of combination of pegylated interferon alfa-2a and capecitabine in locally advanced or metastatic renal cell cancer

Cancer Chemotherapy and Pharmacology

Volumn 66, Issue 1, 2010, Pages 59-67

  Sunela, Kaisa Leea ^a   Koskinen, Sanna ^b   Kellokumpu Lehtinen, Pirkko Liisa ^a,b  

^a TAMPERE UNIVERSITY HOSPITAL   (Finland)

^b TAMPERE UNIVERSITY OF TECHNOLOGY   (Finland)

Author keywords

Capecitabine; Chemotherapy; Immunotherapy; Interferon; Pegylated; Renal cell carcinoma

Indexed keywords

CAPECITABINE; PEGINTERFERON ALPHA2A; ALPHA2A INTERFERON; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE; FLUOROURACIL; MACROGOL DERIVATIVE; PEGINTERFERON ALFA-2A;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; AGED; ALLERGIC DISEASE; ALOPECIA; ANEMIA; ARTICLE; BLOODY DIARRHEA; BLURRED VISION; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER GROWTH; CANCER REGRESSION; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONJUNCTIVITIS; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECREASED APPETITE; DIARRHEA; DOSE RESPONSE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG MONITORING; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FEVER; FOLLOW UP; GALLBLADDER HEMORRHAGE; HAND FOOT SYNDROME; HEART FAILURE; HUMAN; HYPERCALCEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; INFECTION; KIDNEY CARCINOMA; LEUKOPENIA; LOCAL METASTASIS; LUNG EMBOLISM; LUNG METASTASIS; MALE; METASTASIS; MULTIPLE CYCLE TREATMENT; MYALGIA; NAIL DISEASE; NAUSEA AND VOMITING; NEUROPATHY; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RASH; SIDE EFFECT; STOMATITIS; THROMBOCYTOPENIA; THROMBOPHLEBITIS; XEROSTOMIA; DISEASE FREE SURVIVAL; KAPLAN MEIER METHOD; KIDNEY TUMOR; MIDDLE AGED; MORTALITY; PATHOLOGY; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, RENAL CELL; DEOXYCYTIDINE; DISEASE-FREE SURVIVAL; FEMALE; FLUOROURACIL; HUMANS; INTERFERON ALFA-2A; KAPLAN-MEIERS ESTIMATE; KIDNEY NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM METASTASIS; POLYETHYLENE GLYCOLS; QUALITY OF LIFE; TREATMENT OUTCOME;

EID: 77951914543     PISSN: 03445704     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00280-009-1134-2     Document Type: Article

References (36)

1. Quesada JR, Swanson DA, Trindade A, Gutterman JU (1983) Renal cell carcinoma: antitumor effects of leukocyte interferon. Cancer Res Z 43(2):940-947
2. Tagliaferri P, Caraglia M, Budillon A et al (2005) New pharmacokinetic and pharmacodynamic tools for interferon-alpha (IFN-alpha) treatment of human cancer. Cancer Immunol Immunother 54:1-10
3. Motzer RJ, Rakhit A, Ginsberg M et al (2001) Phase I trial of 40-kd branched pegylated interferon alfa-2a for patients with advanced renal cell carcinoma. J Clin Oncol 19(5):1312-1319
4. Talpaz M, O'Brien S, Rose E et al (2001) Phase 1 study of polyethylene glycol formulation of interferon-alfa-2B (Schering 54031) in Philadelphia chromosome-positive chronic myelogenous leukemia. Blood 98(6):1708-1713
5. Motzer RJ, Rakhit A, Thompson J et al (2002) Phase II trial of branched peginterferon-alfa 2a (40 kd) for patients with advanced renal cell carcinoma. Ann Oncol 13:1799-1805
6. Bukowski R, Ernstoff MS, Gore ME et al (2002) Pegylated interferon Alfa-2b treatment for patients with solid tumors: a phase I/II study. J Clin Oncol 20(18):3841-3849
7. Bex A, Mallo H, Kerst M, Haanen J, Horenblas S, de Gast GC (2005) A phase-II study of pegylated interferon alfa-2b for patients with metastatic renal cell carcinoma and removal of the primary tumor. Cancer Immunol Immunother 54:713-719
8. Motzer RJ, Russo P (2000) Systemic therapy for renal cell carcinoma. J Urol 163:408-417
9. Kish JA, Wolf M, Crawford ED et al (1994) Evaluation of low dose continuous infusion 5-fluorouracil in patients with advanced and recurrent renal cell carcinoma. A Southwest Oncology Group Study. Cancer 74(3):916-919
10. Miwa M, Ura M, Nishida M et al (1998) Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 34(8):1274-1281
11. Pagliaro LC, Perez CA, Tu SM, Daliani DD (2006) Phase II study of capecitabine single-agent therapy in patients with metastatic renal cell carcinoma. Urol Oncol 24:487-491
12. Petrioli R, Paolelli L, Francini E et al (2007) Capecitabine as third-line treatment in patients with metastatic renal cell carcinoma after failing immunotherapy. Anticancer Drugs 18(7):817-820
13. Eda H, Fujimoto K, Watanabe S et al (1993) Cytokines induce thymidine phosphorylase expression in tumor cells and make them more susceptible to 5'-deoxy-5-fluorouridine. Cancer Chemother Pharmacol 32:333-338 (Pubitemid 23207988)
14. Morita T, Tokue A (1999) Biomodulation of 5-fluorouracil by interferon-alfa in human renal carcinoma cells: relationship to the expression of thymidine phosphorylase. Cancer Chemother Pharmacol 44:91-96
15. Gebrosky NP, Koukol S, Nseyo UO, Carpenter C, Lamm DL (1997) Treatment of renal cell carcinoma with 5-fluorouracil and alfa-interferon. Urology 50(6):863-868
16. Negrier S, Caty A, Lesimple T et al (2000) Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. J Clin Oncol 18(24):4009-4015
17. Chang DZ, Olencki T, Budd GT et al (2001) Phase I trial of capecitabine in combination with interferon alpha in patients with metastatic renal cancer: toxicity and pharmacokinetics. Cancer Chemother Pharmacol 48:493-498
18. Padrik P, Leppik K, Arak A (2004) Combination therapy with capecitabine and interferon alfa-2A in patients with advanced renal cell carcinoma: a phase II study. Urol Oncol 22:387-392
19. Segota E, Mekhail T, Olencki T et al (2007) Phase II trial of capecitabine and rHU-interferon-alfa-2a in patients with metastatic renal cell carcinoma, limited efficacy, and moderate toxicity. Urol Oncol 25:46-52
20. Wenzel C, Locker GJ, Bartsch R et al (2003) Capecitabine monotherapy and in combination with immunotherapy in the treatment of metastatic renal cell carcinoma. Anticancer Drugs 14(10):779-784
21. Wenzel C, Locker GJ, Schmidinger M et al (2002) Capecitabine in the treatment of metastatic renal cell carcinoma failing immunotherapy. Am J Kidney Dis 39(1):48-54
22. Amato RJ, Rawat A (2006) Interferon-alfa plus capecitabine and thalidomide in patients with metastatic renal cell carcinoma: a pilot study. Invest New Drugs 24:171-175
23. Oovermann K, Buer J, Hoffman R et al (2000) Capecitabine in the treatment of metastatic renal cell carcinoma. Br J Cancer 83(5):583-587
24. Recchia F, Saggio G, Amiconi G et al (2007) Multicenter phase II study of chemo-immunotherapy in the treatment of metastatic renal cell carcinoma. J Immunother 30(4):448-454
25. Therasse P, Arbuck SG, Eisenhauer EA et al (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92(3):205-216 (Pubitemid 30099779)
26. Cancer Therapy Evaluation Program. NCI-CTCAE, available in http://ctep. cancer.gov/protocolDevelopment/electronic-applications /docs/ctcaev3.pdf
27. Aaronson NK, Ahmedzai S, Bergman B et al (1993) The European Organisation for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376
28. Rini BI, Weinberg V, Small EJ (2005) A phase I trial of fixed dose rate gemcitabine and capecitabine in metastatic renal cell carcinoma. Cancer 103(3):553-558
29. Waters JS, Moss C, Pyle L et al (2004) Phase II clinical trial of capecitabine and gemcitabine chemotherapy in patients with metastatic renal carcinoma. Br J Cancer 91:1763-1768
30. Clark JI, Mehrabi J, Sosman JA et al (2007) Phase I/II trial of outpatient PEG-interferon with interleukin-2 in advanced renal cell carcinoma: a Cytokine Working Group Study. J Immunother 30(8):839-846
31. George S, Hutson TE, Mekhail T et al (2008) Phase I trial of PEG-interferon and recombinant IL-2 in patients with metastatic renal cell carcinoma. Cancer Chemother Pharmacol 62:347-354
32. Motzer RS, Figlin RA, Olencki T et al. NCCN Kidney Cancer Panel members. NCCN clinical practice guidelines in oncology. Kidney Cancer V. I.2010. Available in htpp://www.nccn.org
33. 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 370:2103-2111
34. Motzer RJ, Hutson TE, Tomczak P et al (2007) Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. NEJM 356(2):115-124
35. Motzer RJ, Hutson TE, Tomczak P et al (2009) Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 27(22):3584-3590
36. Hudes G, Carducci M, Tomczak P et al (2007) Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. NEJM 356(22):2271-2281 (Pubitemid 46849157)