Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer "unfit" for cisplatin-based chemotherapy: Phase II - Results of EORTC study 30986

Journal of Clinical Oncology

Volumn 27, Issue 33, 2009, Pages 5634-5639

  De Santis, Maria ^a   Bellmunt, Joaquim ^a   Mead, Graham ^a   Kerst, Martijn J ^a   Leahy, Michael ^a   Maroto, Pablo ^a   Skoneczna, Iwona ^a   Marreaud, Sandrine ^a   De Wit, Ronald ^a   Sylvester, Richard ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; GEMCITABINE; METHOTREXATE; VINBLASTINE; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE;

ADULT; AGED; ARTICLE; BLEEDING; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; FEBRILE NEUTROPENIA; FEMALE; GLOMERULUS FILTRATION RATE; HUMAN; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEPHROTOXICITY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TRANSITIONAL CELL CARCINOMA; URINARY TRACT CARCINOMA; CANCER INVASION; CANCER STAGING; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; DRUG EFFECT; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; PATHOLOGY; PHASE 3 CLINICAL TRIAL; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME; URINARY TRACT CANCER; UROTHELIUM;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; CARCINOMA, TRANSITIONAL CELL; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; METHOTREXATE; MIDDLE AGED; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PROGNOSIS; SURVIVAL ANALYSIS; TREATMENT OUTCOME; UROLOGIC NEOPLASMS; UROTHELIUM; VINBLASTINE;

EID: 73949120020     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.21.4924     Document Type: Article

References (55)

1. Dash A, Galsky MD, Vickers AJ, et al: Impact of renal impairment on eligibility for adjuvant cisplatin-based chemotherapy in patients with urothelial carcinoma of the bladder. Cancer 107:506-513, 2006
2. Balducci L: Evidence-based management of cancer in the elderly. Cancer Control 7:368-376, 2000
3. Balducci L, Extermann M: Management of cancer in the older person: A practical approach. Oncologist 5:224-237, 2000
4. Balducci L, Yates J: General guidelines for the management of older patients with cancer. Oncology (Williston Park) 14:221-227, 2000
5. De Santis M, Bachner M: New developments in first- and second-line chemotherapy for transitional cell, squamous cell and adenocarcinoma of the bladder. Curr Opin Urol 17:363-368, 2007
6. Petrioli R, Frediani B, Manganelli A, et al: Comparison between a cisplatin-containing regimen and a carboplatin-containing regimen for recurrent or metastatic bladder cancer patients. A randomized phase II study. Cancer 77:344-351, 1996
7. Dogliotti L, Carteni G, Siena S, et al: Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: Results of a randomized phase 2 trial. Eur Urol 52:134-141, 2007
8. Dreicer R, Manola J, Roth BJ, et al: Phase III trial of methotrexate, vinblastine, doxorubicin, and cisplatin versus carboplatin and paclitaxel in patients with advanced carcinoma of the urothelium. Cancer 100:1639-1645, 2004
9. Bellmunt J, Ribas A, Eres N, et al: Carboplatin-based versus cisplatin-based chemotherapy in the treatment of surgically incurable advanced bladder carcinoma. Cancer 80:1966-1972, 1997
10. de Wit R, Tesselaar M, Kok TC, et al: Randomised phase II trial of carboplatin and iproplatin in advanced urothelial cancer. Eur J Cancer 27:1383-1385, 1991
11. Mottet-Auselo N, Bons-Rosset F, Costa P, et al: Carboplatin and urothelial tumors. Oncology 50: 28-36, 1993
12. Bellmunt J, Albanell J, Gallego OS, et al: Carboplatin, methotrexate, and vinblastine in patients with bladder cancer who were ineligible for cisplatin-based chemotherapy. Cancer 70:1974-1979, 1992
13. Klocker J, Pont J, Schumer J, et al: Carboplatin, methotrexate and vinblastin (Carbo-MV) for advanced urothelial cancer. A phase II trial. Am J Clin Oncol 14:328-330, 1991
14. Small EJ, Fippin LJ, Ernest ML, et al: A carboplatin-based regimen for the treatment of patients with advanced transitional cell carcinoma of the urothelium. Cancer 78:1775-1780, 1996
15. Lorusso V, Pollera CF, Antimi M, et al: A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Italian Co-operative Group on Bladder Cancer. Eur J Cancer 34:1208-1212, 1998
16. Pollera CF, Ceribelli A, Crecco M, et al: Weekly gemcitabine in advanced bladder cancer: A preliminary report from a phase I study. Ann Oncol 5:182-184, 1994
17. Stadler WM, Kuzel T, Roth B, et al: Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer. J Clin Oncol 15:3394-3398, 1997
18. Moore MJ, Tannock IF, Ernst DS, et al: Gemcitabine: A promising new agent in the treatment of advanced urothelial cancer. J Clin Oncol 15:3441-3445, 1997
19. Albers P, Siener R, Härtlein M, et al: Gemcitabine monotherapy as second-line treatment in cisplatin-refractory transitional cell carcinoma - prognostic factors for response and improvement of quality of life. Onkologie 25:47-52, 2002
20. von der Maase H: Gemcitabine in transitional cell carcinoma of the urothelium. Expert Rev Anticancer Ther 3:11-19, 2003
21. de Wit R: Overview of bladder cancer trials in the European Organization for Research and Treatment. Cancer 97:2120-2126, 2003
22. Bellmunt J, de Wit R, Albanell J, et al: A feasibility study of carboplatin with fixed dose of gemcitabine in "unfit" patients with advanced bladder cancer. Eur J Cancer 37:2212-2215, 2001
23. 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 92:205-216, 2000
24. Cockcroft DW, Gault MH: Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41, 1976
25. Bryant J, Day R: Incorporating toxicity considerations into the design of two-stage phase II clinical trials. Biometrics 51:1372-1383, 1995
26. Bajorin DF, Dodd PM, Mazumdar M, et al: Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy. J Clin Oncol 17:3173-3181, 1999
27. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341: 2061-2067, 1999
28. Lewis JH, Kilgore ML, Goldman DP, et al: Participation of patients 65 years of age or older in cancer clinical trials. J Clin Oncol 21:1383-1389, 2003
29. Kemeny MM, Peterson BL, Kornblith AB, et al: Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 21:2268-2275, 2003
30. Extermann M, Albrand G, Chen H, et al: Are older French patients as willing as older American patients to undertake chemotherapy? J Clin Oncol 21:3214-3219, 2003
31. Ries LAG, Melbert D, Krapcho M, et al: SEER Cancer Statistics Review, 1975-2005, National Cancer Institute. Bethesda, MD, 2008
32. Yee KW, Pater JL, Pho L, et al: Enrollment of older patients in cancer treatment trials in Canada: Why is age a barrier? J Clin Oncol 21:1618-1623, 2003
33. von der Maase H, Hansen SW, Roberts JT, et al: Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol 18:3068-3077, 2000
34. Bellmunt J, von der Maase H, Mead GM, et al: Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy; EORTC30987/Intergroup Study. J Clin Oncol 25:242s, 2007 (suppl; abstr LBA5030)
35. Brenner BM, Meyer TW, Hostetter TH: Dietary protein intake and the progressive nature of kidney disease: The role of hemodynamically mediated glomerular injury in the pathogenesis of progressive glomerular sclerosis in aging, renal ablation, and intrinsic renal disease. N Engl J Med 307:652-659, 1982
36. Nogué -Aliguer M, Carles J, Arrivi A, et al: Gemcitabine and carboplatin in advanced transitional cell carcinoma of the urinary tract: An alternative therapy. Cancer 97:2180-2186, 2003
37. Launay-Vacher V, Izzedine H, Rey JB, et al: Incidence of renal insufficiency in cancer patients and evaluation of information available on the use of anticancer drugs in renally impaired patients. Med Sci Monit 10:CR209-212, 2004
38. Lichtman SM, Wildiers H, Launay-Vacher V, et al: International Society of Geriatric Oncology (SIOG) recommendations for the adjustment of dosing in elderly cancer patients with renal insufficiency. Eur J Cancer 43:14-34, 2007
39. Repetto L: Greater risks of chemotherapy toxicity in elderly patients with cancer. J Support Oncol 1:18-24, 2003
40. Wedding U, Honecker F, Bokemeyer C, et al: Tolerance to chemotherapy in elderly patients with cancer. Cancer Control 14:44-56, 2007
41. Dimopoulos MA, Anagnostopoulos A, Pantazopoulos D, et al: Primary treatment of muscleinvasive bladder cancer in elderly patients and in patients with impaired heart or lung function with gemcitabine and docetaxel. Proc Am Soc Clin Oncol 18, 1999 (abstr 1297)
42. Linardou H, Aravantinos G, Efstathiou E, et al: Gemcitabine and carboplatin combination as first-line treatment in elderly patients and those unfit for cisplatin-based chemotherapy with advanced bladder carcinoma: Phase II study of the Hellenic Co-operative Oncology Group. Urology 64:479-484, 2004
43. Constenla M, Lorenzo I, Carrete N, et al: Docetaxel (TXT) monotherapy & G-CSF for advanced breast cancer (ABC) in elderly patients (EP). Proc Am Soc Clin Oncol 19, 2000 (abstr 425)
44. Tirelli U, Balzarotti M, Uziel L, et al: Comprehensive geriatric assessment (CGA)-adapted chemotherapy (CT) in 100 elderly patients (pts) (> 70 years) with diffuse large B-cell non-Hodgkin's lymphoma (DLBCL). J Clin Oncol, 25:708s, 2007 (suppl; abstr 19515)
45. Argiris A, Li Y, Murphy BA, et al: Outcome of elderly patients with recurrent or metastatic head and neck cancer treated with cisplatin-based chemotherapy. J Clin Oncol 22:262-268, 2004
46. Macpherson N, O'Reilly SE, Connors JM, et al: ODBEP chemotherapy for elderly patients with advanced stage Hodgkin's disease. Proc Am Soc Clin Oncol 15, 1996 (abstr 1323)
47. Souglakos J, Pallis A, Kakolyris S, et al: Combination of irinotecan (CPT-11) plus 5-fluorouracil and leucovorin (FOLFIRI regimen) as first line treatment for elderly patients with metastatic colorectal cancer: A phase II trial. Oncology 69:384-390, 2005
48. Gómez H, Hidalgo M, Casanova L, et al: Risk factors for treatment-related death in elderly patients with aggressive non-Hodgkin's lymphoma: Results of a multivariate analysis. J Clin Oncol 16:2065-2069, 1998
49. Tirelli U, Zagonel V, Serraino D, et al: Non-Hodgkin's lymphomas in 137 patients aged 70 years or older: A retrospective European Organization for Research and Treatment of Cancer Lymphoma Group Study. J Clin Oncol 6:1708-1713, 1988
50. Buffoni L, Dongiovanni D, Barone C, et al: Fractionated dose of cisplatin (CDDP) and vinorelbine (VNB) chemotherapy for elderly patients with advanced non-small cell lung cancer: Phase II trial. Lung Cancer 54:353-357, 2006
51. Italiano A, Ortholan C, Oudard S, et al: Firstline docetaxel-based chemotherapy in elderly patients (age 75 and older) with castration-refractory prostate cancer: A French national study. Eur Urol 55:1368-1376, 2008
52. Kasahara K, Shibata K, Shirasaki H, et al: A phase II trial of carboplatin, oral etoposide, and vincristine in elderly or unfit patients with small cell lung cancer (SCLC). Proc Am Soc Clin Oncol 21: 332a, 2002 (abstr 1326)
53. Fosså SD, Sternberg C, Scher HI, et al: Survival of patients with advanced urothelial cancer treated with cisplatin-based chemotherapy. Br J Cancer 74:1655-1659, 1996
54. Castagneto B, Zai S, Marenco D, et al: Single-agent gemcitabine in previously untreated elderly patients with advanced bladder carcinoma: Response to treatment and correlation with the comprehensive geriatric assessment. Oncology 67:27-32, 2004
55. Chester JD, Hall GD, Forster M, et al: Systemic chemotherapy for patients with bladder cancer-current controversies and future directions. Cancer Treat Rev 30:343-358, 2004