UNASSIGNED: 249 Background: @entity900 -based NAC for @entity1 (pts) with invasive @entity150 is considered to provide a 5-8% @entity1349 ( @entity1349 ) advantage, although several studies failed to prove the survival benefit of NAC. METHODS: Eligibility criteria included histologically proven @entity189 , invasive (T2-4aN0M0) @entity150 within 8 weeks from TURBT, PS 0-1, age 20 to 75 years old. @entity1 were randomized to receive either 2 cycles of neoadjuvant MVAC followed by RC (NAC arm) or RC alone (RC arm). MVAC comprised M (30 mg/m(2)) on days 1, 15, and 22; V (3 mg/m(2)) on days 2, 15, and 22; A (30 mg/m(2)) on day 2; C (70 mg/m(2)) on day 2. The primary endpoint was @entity1349 . Secondary endpoints were progression-free survival (PFS), the surgery-related complication rate, adverse events during NAC, the rate of no @entity41 in the RC specimens (pT0), and quality of life. The sample size was 180 pts in each arm with a one-sided alpha of 5% and a power of 80% to detect a difference in 5-year @entity1349 from 45% in the RC arm to 57% in the NAC arm. RESULTS: From March 2003 to March 2009, 130 pts were randomized to the NAC arm (n=64) and RC arm (n=66). The @entity1 registration was terminated early because of slow accrual. At the second interim analysis conducted after the completion of @entity1 accrual, the @entity1349 of the NAC arm was better than that of the RC arm (median, 102 and 81 months, respectively), although the difference was not statistically significant (HR, 0.65; multiplicity adjusted 99.99%CI, 0.19 - 2.18; one-sided log-rank p = 0.07). Considering the current situation in which NAC with @entity136 and @entity900 (GC) is widely used in clinical practice, the Data and Safety Monitoring Committee recommended early publication of the results. The median PFS times in the RC arm and NAC arm were 78 and 99 months, respectively (p=0.04). No differences in perioperative complications, other than lymph leakage, were observed between the groups. pT0 in the NAC arm and RC arm was 34 % vs. 9 %, respectively (p<0.01). CONCLUSIONS: Although NAC with GC is widely used for invasive @entity150 , NAC with MVAC can still be considered promising. CLINICAL TRIAL INFORMATION: 000000093.

Randomized phase III trial of neoadjuvant chemotherapy (NAC) with methotrexate, doxorubicin, vinblastine, and @entity900 (MVAC) followed by radical cystectomy (RC) compared with RC alone for invasive XXXX ( @entity150 ): Japan Clinical Oncology Group Study, JCOG0209.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity41 :: ('MESH:D018365', 'Disease') :: ['residual tumor'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin', 'Cisplatin'] @entity189 :: ('MESH:D002277', 'Disease') :: ['urothelial carcinoma'] @entity150 :: ('MESH:D001749', 'Disease') :: ['BC', 'bladder cancer'] @entity136 :: ('MESH:C056507', 'Chemical') :: ['gemcitabine'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity150 :: (MESH:D001749,Disease) :: ['bladder cancer']
