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

Bamias, Aristotelis; Aravantinos, G.; Deliveliotis, Ch.; Bafaloukos, Dimitrios; Kalofonos, C.; Xiros, Nikolaos I.; Zervas, Anastasios; Mitropoulos, Dionysios; Samantas, E.; Pectasides, Dimitrios; Papakostas, Pavlos; Gika, D; Kourousis, C.; Koutras, A.; Papadimitriou, Christos; Bamias, C; Kosmidis, P.; Dimopoulos, Meletios Α.

doi:10.1200/jco.2004.02.152

Cited by 174 publications

(84 citation statements)

References 25 publications

(8 reference statements)

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“…The validation cohort included 2 regimens, one of which resulted in inferior survival in the original randomized trial. 15 Nevertheless, the nomogram performed similarly in the validation cohort compared with the development cohort. The degree to which the differences in treatment regimens may have contributed to the moderate discrimination achieved with the current nomogram is not entirely clear.…”

Section: Discussionmentioning

confidence: 97%

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Nomogram for predicting survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin‐based chemotherapy

Galsky

Moshier

Krege³

et al. 2013

Cancer

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BACKGROUND:The current study was conducted to develop a pretreatment prognostic model for patients with unresectable and/or metastatic urothelial cancer who were treated with first-line, cisplatin-based chemotherapy. METHODS: Individual data were pooled from 399 patients who were enrolled on 8 phase 2 and 3 trials evaluating cisplatin-based, first-line chemotherapy in patients with metastatic urothelial carcinoma. Variables selected for inclusion in the model were combined in a Cox proportional hazards model to produce a points-based nomogram with which to predict the median, 1-year, 2-year, and 5-year survival. The nomogram was validated externally using data from a randomized trial of the combination of methotrexate, vinblastine, doxorubicin plus cisplatin versus docetaxel plus cisplatin. RESULTS: The median survival of the development cohort was 13.8 months (95% confidence interval, 12.1 months-16.0 months); 68.2% of the patients had died at the time of last follow-up. On multivariable analysis, the number of visceral metastatic sites, Eastern Cooperative Oncology Group performance status, and leukocyte count were each found to be associated with overall survival (P <.05), whereas the site of the primary tumor and the presence of lymph node metastases were not. All 5 variables were included in the nomogram. When subjected to internal validation, the nomogram achieved a bootstrap-corrected concordance index of 0.626. When applied to the external validation cohort, the nomogram achieved a concordance index of 0.634. Calibration plots suggested that the nomogram was well calibrated for all predictions. CONCLUSIONS: Based on routinely measured pretreatment variables, a nomogram was constructed that predicts survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin-based chemotherapy. This model may be useful in patient counseling and clinical trial design. Cancer 2013;119:3012-9. V C 2013 American Cancer Society.KEYWORDS: urothelial cancer; bladder cancer; prognosis; metastatic; chemotherapy; cisplatin. INTRODUCTIONContemporary cisplatin-based combination chemotherapy regimens achieve objective responses in approximately 50&percnt to 60% of patients with metastatic urothelial cancer.1,2 Although response durations are generally short, and the median overall survival of patients with unresectable and/or metastatic urothelial cancer is only approximately 14 months, significant heterogeneity exists with regard to patient outcomes.2 Long-term follow-up of clinical trials has demonstrated that approximately 10% to 20% of patients are alive at 5 years.1,3 The ability to predict individual patient outcomes has clear implications with regard to both patient counseling and patient stratification on clinical trials.Prognostic models have previously been developed for chemotherapy-naive patients with unresectable and/or metastatic urothelial cancer. In 1998, Bajorin et al identified Karnofsky performance status and the presence of visceral metastases as independent predictors ...

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Section: Discussionmentioning

confidence: 97%

“…The details of each trial are provided in Table 1 and have been presented or published previously. [9][10][11][12][13][14][15][16] Each study was approved by the Institutional Review Board at the participating institutions and informed consent was obtained before treatment.…”

Section: Inclusion Criteriamentioning

confidence: 99%

Nomogram for predicting survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin‐based chemotherapy

Galsky

Moshier

Krege³

et al. 2013

Cancer

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“…204 A phase 3 study comparing docetaxel and cisplatin (DC) with G-CSF versus MVAC with G-CSF found MVAC to be more effective than DC for metastatic cancer; MVAC demonstrated both a superior median time to progression (9.4 vs 6.1 months; P ϭ .003) and median survival time (14.2 vs 9.3 months; P ϭ .026). 224 A phase 2 study of bevacizumab in combination with cisplatin and gemcitabine in metastatic or locally advanced bladder cancer involving 36 patients showed a complete response in 6 (17%), and a partial response in 18 (50%); this combination is now being studied in a phase 3 trial. 123,225 Another phase 2 study involving trastuzumab (Herceptin), which is an antibody to HER-2, has been evaluated in metastatic or locally advanced bladder cancer patients with HER-2 expression in combination with chemotherapy; responses were seen in 70% of patients (5 complete and 26 partial responses).…”

Section: Metastatic Diseasementioning

confidence: 99%

Bladder Cancer in 2010: How Far have We Come?

Jacobs¹,

Lee

Montie

2010

CA: A Cancer Journal for Clinicians

295

269

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Bladder cancer is the fourth most common cancer and ranks eighth as a cause of death from cancer among men in the United States. Although guidelines assist in treatment, the art of managing bladder cancer, such as the decision to use neoadjuvant chemotherapy and the timing of cystectomy, is still variable. Bladder cancer has a propensity to recur, and with recurrence, a significant number of cases progress, which makes the early detection of high-risk patients imperative. Advances in detection, surveillance, and treatment of bladder cancer are reviewed in this article.

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“…A phase III randomized trial comparing DC with MVAC has been reported by the Hellenic Cooperative Oncology Group [13]. Patients randomized to DC received docetaxel 75 mg/m 2 and cisplatin 75 mg/m 2 repeated every 3 weeks.…”

Section: Docetaxel Plus Cisplatinmentioning

confidence: 99%

The Role of Taxanes in the Management of Bladder Cancer

Galsky

2005

The Oncologist

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Learning ObjectivesAfter completing this course, the reader will be able to:1. List the prognostic factors that are the best predictors of outcome for patients with metastatic bladder cancer.2. Interpret the results of the completed phase III trials comparing MVAC with taxane-based regimens in patients with metastatic bladder cancer.3. Describe the ongoing multinational phase III trial using taxane-based therapy in patients with metastatic bladder cancer.

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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

Abstract: MVAC is more effective than DC in advanced urothelial cancer. G-CSF-supported MVAC is well tolerated and could be used instead of classic MVAC as first-line treatment in advanced urothelial carcinoma.

Cited by 174 publications

References 25 publications

Nomogram for predicting survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin‐based chemotherapy

Nomogram for predicting survival in patients with unresectable and/or metastatic urothelial cancer who are treated with cisplatin‐based chemotherapy

Bladder Cancer in 2010: How Far have We Come?

The Role of Taxanes in the Management of Bladder Cancer

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