Journal of Clinical Oncology, Vol 17, Issue 10
(October), 1999: 3173-3181
© 1999 American Society for Clinical Oncology
Long-Term Survival in Metastatic Transitional-Cell Carcinoma and Prognostic Factors Predicting Outcome of Therapy
Dean F. Bajorin,
Paul M. Dodd,
Madhu Mazumdar,
Melissa Fazzari,
John A. McCaffrey,
Howard I. Scher,
Harry Herr,
Geralyn Higgins,
Mary G. Boyle
From the Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Division of Urology, Department of Surgery, and Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, and Department of Medicine, Cornell University Medical College, New York, NY.
Address reprint requests to Dean F. Bajorin, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021.
PURPOSE: The variation in reported survival of patients with metastatic transitional-cell carcinoma (TCC) treated with systemic chemotherapy may be a consequence of pretreatment patient characteristics. We hypothesized that a prognostic factorbased model of survival among patients treated with methotrexate, vinblastine, doxorubicin, and cisplatin chemotherapy could account for such differences and help guide clinical trial design and interpretation.
PATIENTS AND METHODS: A database of 203 patients with unresectable or metastatic TCC was retrospectively subjected to a multivariate regression analysis to determine which patient characteristics had independent prognostic significance for survival. Patients were assigned to three risk categories depending on the number of unfavorable characteristics. Patient selection in phase II studies was addressed by developing a table of expected median survival for patient cohorts that had varying proportions of patients from the three risk categories.
RESULTS: Two factors had independent prognosis: Karnofsky performance status (KPS) less than 80% and visceral (lung, liver, or bone) metastasis. Median survival times for patients who had zero, one, or two risk factors were 33, 13.4, and 9.3 months, respectively (P = .0001). The median survival time of patient cohorts could vary from 9 to 26 months simply by altering the proportion of patients from different risk categories.
CONCLUSION: The presence of baseline KPS less than 80% or visceral metastasis has an impact on survival. Reporting the proportion of patients with zero, one, and two risk factors will facilitate understanding of the relevance of the median survival in phase II trials. Phase III trials should stratify patients according to the number of risk factors to avoid imbalance in treatment arms.

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18(8):
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|
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|
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|
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25(16):
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|
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 |
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|
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|
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|
 |
|

|
 |

|
 |
 
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|
 |
|

|
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|
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|
 |
|

|
 |

|
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23(21):
4602 - 4608.
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[PDF]
|
 |
|

|
 |

|
 |
 
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February 20, 2005;
23(6):
1185 - 1191.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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The outcome of elderly patients with advanced urothelial carcinoma after platinum-based combination chemotherapy
Ann. Onc.,
February 1, 2005;
16(2):
307 - 313.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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June 1, 2004;
22(11):
2150 - 2154.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
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Docetaxel and Cisplatin With Granulocyte Colony-Stimulating Factor (G-CSF) Versus MVAC With G-CSF in Advanced Urothelial Carcinoma: A Multicenter, Randomized, Phase III Study From the Hellenic Cooperative Oncology Group
J. Clin. Oncol.,
January 15, 2004;
22(2):
220 - 228.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. Bajorin
The Phase III Candidate: Can We Improve the Science of Selection?
J. Clin. Oncol.,
January 15, 2004;
22(2):
211 - 213.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D.F. Roychowdhury, A. Hayden, and A.M. Liepa
Health-Related Quality-of-Life Parameters as Independent Prognostic Factors in Advanced or Metastatic Bladder Cancer
J. Clin. Oncol.,
February 15, 2003;
21(4):
673 - 678.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
L. C. Pagliaro, R. E. Millikan, S.-M. Tu, D. Williams, D. Daliani, C. N. Papandreou, and C. J. Logothetis
Cisplatin, Gemcitabine, and Ifosfamide As Weekly Therapy: A Feasibility and Phase II Study of Salvage Treatment for Advanced Transitional-Cell Carcinoma
J. Clin. Oncol.,
July 1, 2002;
20(13):
2965 - 2970.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. O. Siefker-Radtke, R. E. Millikan, S.-M. Tu, D. F. Moore Jr, T. L. Smith, D. Williams, and C. J. Logothetis
Phase III Trial of Fluorouracil, Interferon Alfa-2b, and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Metastatic or Unresectable Urothelial Cancer
J. Clin. Oncol.,
March 1, 2002;
20(5):
1361 - 1367.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
D. J. Vaughn, C. M. Broome, M. Hussain, J. C. Gutheil, and A. B. Markowitz
Phase II Trial of Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
J. Clin. Oncol.,
February 15, 2002;
20(4):
937 - 940.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. N. Sternberg, P. H.M. de Mulder, J. H. Schornagel, C. Theodore, S. D. Fossa, A. T. van Oosterom, F. Witjes, M. Spina, C. J. van Groeningen, C. de Balincourt, et al.
Randomized Phase III Trial of High-Dose-Intensity Methotrexate, Vinblastine, Doxorubicin, and Cisplatin (MVAC) Chemotherapy and Recombinant Human Granulocyte Colony-Stimulating Factor Versus Classic MVAC in Advanced Urothelial Tract Tumors: European Organization for Research and Treatment of Cancer Protocol No. 30924
J. Clin. Oncol.,
May 15, 2001;
19(10):
2638 - 2646.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Hussain, U. Vaishampayan, W. Du, B. Redman, and D. C. Smith
Combination Paclitaxel, Carboplatin, and Gemcitabine Is an Active Treatment for Advanced Urothelial Cancer
J. Clin. Oncol.,
May 1, 2001;
19(9):
2527 - 2533.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
J. Bellmunt, V. Guillem, L. Paz-Ares, J. L. Gonzalez-Larriba, J. Carles, E. Batiste-Alentorn, A. Saenz, M. Lopez-Brea, A. Font, M. Nogue, et al.
Phase I-II Study of Paclitaxel, Cisplatin, and Gemcitabine in Advanced Transitional-Cell Carcinoma of the Urothelium
J. Clin. Oncol.,
September 18, 2000;
18(18):
3247 - 3255.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
H. von der Maase, S.W. Hansen, J.T. Roberts, L. Dogliotti, T. Oliver, M.J. Moore, I. Bodrogi, P. Albers, A. Knuth, C.M. Lippert, 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.,
September 17, 2000;
18(17):
3068 - 3077.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
R. Dreicer, J. Manola, B. J. Roth, M. B. Cohen, A. K. Hatfield, and G. Wilding
Phase II Study of Cisplatin and Paclitaxel in Advanced Carcinoma of the Urothelium: An Eastern Cooperative Oncology Group Study
J. Clin. Oncol.,
March 1, 2000;
18(5):
1058 - 1058.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|