BACKGROUND: The role of neoadjuvant chemotherapy (NACT) for locoregionally advanced @entity189 ( @entity189 ) is unclear. We aimed to evaluate the feasibility and efficacy of NACT followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in locoregionally advanced @entity189 . METHODS: @entity1 with stage III-IVB (excluding T3N0-1) @entity189 were randomly assigned to receive NACT followed by CCRT (investigational arm) or CCRT alone (control arm). Both arms were treated with 80  mg/m(2) @entity900 every 3 weeks concurrently with radiotherapy. The investigational arm received @entity900 (80  mg/m(2) d1) and @entity1487 (800  mg/m(2) @entity4609 d1-5) every 3 weeks for two cycles before CCRT. The primary end-point was disease-free survival (DFS) and distant metastasis-free survival (DMFS). Secondary end-point was @entity1349 ( @entity1349 ). Survival curves for the time-to-event endpoints were analyzed by the Kaplan-Meier method and compared using the log-rank test. The P value was calculated using the 5-year endpoints. RESULTS: Four hundred seventy six @entity1 were randomly assigned to the investigational (n  =  238) and control arms (n  =  238). The investigational arm achieved higher 3-year DFS rate (82.0%, 95% CI  =  0.77-0.87) than the control arm (74.1%, 95% CI  =  0.68-0.80, P  =  0.028). The 3-year DMFS rate was 86.0% for the investigational arm versus 82.0% for the control arm, with marginal statistical significance (P  =  0.056). However, there were no statistically significant differences in @entity1349 or locoregional relapse-free survival (LRRFS) rates between two arms ( @entity1349 : 88.2% versus 88.5%, P  =  0.815; LRRFS: 94.3% versus 90.8%, P  =  0.430). The most common grade 3-4 @entity137 during NACT was @entity1398 (16.0%). During CCRT, the investigational arm experienced statistically significantly more grade 3-4 @entity137 (P  <  0.001). CONCLUSION: NACT improved @entity5 control compared with CCRT alone in locoregionally advanced @entity189 , particularly at distant sites. However, there was no early gain in @entity1349 . Longer follow-up is needed to determine the eventual therapeutic efficacy.

Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced XXXX : A phase III multicentre randomised controlled trial.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity', 'toxicities'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity900 :: ('MESH:D002945', 'Chemical') :: ['cisplatin'] @entity189 :: ('MESH:D002277', 'Disease') :: ['nasopharyngeal carcinoma', 'NPC'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival'] @entity4609 :: ('176652', 'Species') :: ['civ'] @entity1487 :: ('MESH:D005472', 'Chemical') :: ['fluorouracil']
@entity189 :: (MESH:D002277,Disease) :: ['nasopharyngeal carcinoma']
