Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

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Transitional Cell Carcinoma

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Doxorubicin

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4 cycles of neoadjuvant chemotherapy using dose dense MVAC with G-CSF

Methotrexate, 30 mg/m2 IV bolus, Day 1 Vinblastine, 3 mg/m2 IV bolus, Day2 Doxorubicin, 30 mg/m2 IV bolus, Day2 Cisplatin, 70 mg/m2 IV over 1hr, Day2 Pegylated G-CSF, 6mg SC, Day 3 every 2 weeks

dose dense MVAC with pegylated GCSF

Kwonoh Park, MD, PhD

Bora Kim

The objective is to investigate the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with MIBC and locally advanced UC

* Currently, most treatment guidelines including NCCN recommend a neoadjuvant chemotherapy (NAC) as a standard of care in muscle invasive bladder cancer (MIBC).
* Although standard NAC regimen is controversial due to rare of head to head study between each regimens, cisplatin based multidrug combination regimens such as MVAC, GP, and dose dense MVAC (ddMVAC) with G-CSF supports are regarded as a backbone treatment on the basis of the results from previous studies.
* Application of NAC is still relatively slow adoption in real practice. These slow adoption result from intuitive concerns such as significant toxicity of multidrug combination chemotherapy represented by MVAC and delayed application of radical surgical treatment in non-responder
* The ddMVAC with G-CSF support regimen showed an improved efficacy compared with GP regimen, and tolerable compared with standard MVAC using application of routine G-CSF support and high intensity of cisplatin.
* In case of clinically lymph node evolvement (cN+) is not for strict NAC, but patient with cN+ UC have been treated induction chemotherapy of similar NAC regimens and surgical treatment. So, this study included MIBC plus cN+ UC as locally advanced UC.
* In Korea, there is a low adoption of NAC, additionally rare of ddMVAC with G-CFS in locally advanced UC. It is supposed concerns related with toxicity of ddMVAC. Although the concern is likely not true considering the previous result of the Western, there has not been studied ddMVAC as NAC in Asian including Korean.
* The objective of this trial is to assess the efficacy and safety of four cycles of ddMVAC with G-CSF support in patients with locally advanced UC.

Prospective, Single institution, Open-label, Phase 2

Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma

Efficacy and Safety of Neoadjuvant Chemotherapy With Dose Dense MVAC Followed by Radical Surgery in Patients With MIBC and Locally Advanced Urothelial Carcinoma of Bladder: Phase II, Single-arm Study

No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen

No residual tumor (ypT0N0) in surgical specimen

Time from enrollment until death from any cause

Time from enrollment until the earliest occurrence of disease progression in inoperablity, locoregional recurrence, distant metastasis, or death from any cause

Adverse events related with ddMVAC using CTCAE 4.0

Spots Global Cancer Trial Database for dose dense mvac with pegylated gcsf