Phase III randomized trial of preoperative concurrent chemoradiotherapy versus preoperative radiotherapy for patients with locally advanced head and neck squamous cell carcinoma.
OBJECTIVE
To determine the role of preoperative concurrent chemoradiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma (HNSCC).


METHODS
A total of 222 patients with stage III/IVA-B HNSCC were randomly assigned to receive preoperative concurrent chemoradiotherapy (Pre-S CRT, weekly cisplatin 30mg/m2) or preoperative radiotherapy alone (Pre-S RT). Survival analysis was estimated by the Kaplan-Meier method and compared by the log-rank test.


RESULTS
With a medial follow-up of 59 month, the 5-year overall survival (OS), progression-free survival (PFS), distant metastasis-free survival (DMFS) of Pre-S CRT v Pre-S RT group were 53.8% v 39.0% (hazard ratio [HR], 0.74, 95% CI, 0.50 to 1.10, P = 0.13), 53.2% v 38.7%, (HR, 0.69, 95% CI, 0.47 to 1.01, P =0.06), and 80.4% v 68.1% (HR, 0.53, 95% CI, 0.28 to 0.98, P = 0.04), respectively. In patients with larynx-hypopharynx primaries, the 5-year OS, PFS and DMFS of Pre-S CRT v Pre-S RT were 62.7% v 38.8% (HR, 0.59, 95% CI 0.35 to 1.02, P = 0.054), 63.1% v 39.9% (HR, 0.52; 95% CI 0.30 to 0.89, P = 0.03) and 86.2% v 63.3% (HR, 0.35, 95% CI 0.15 to 0.82, P = 0.01), respectively.


CONCLUSIONS
The addition of weekly cisplatin concurrent to preoperative RT does not improve OS, but improve DMFS in locally advanced HNSCC. However, in a subset of patients with the larynx-hypopharynx primaries, preoperative chemoradiotherapy has significantly improved PFS and DMFS, and has also provided a borderline benefit in OS in comparison with preoperative radiotherapy alone.
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Junlin
J
Yi
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Xiaodong
X
Huang
Department of Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Zhengang
Z
Xu
Department of Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Shaoyan
S
Liu
Department of Surgery, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Xiaolei
X
Wang
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Xiaohui
X
He
Department of Diagnostic Radiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Dehong
D
Luo
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Jingwei
J
Luo
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Jianping
J
Xiao
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Shiping
S
Zhang
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Kai
K
Wang
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Yuan
Y
Qu
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Yuan
Y
Tang
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Weixin
W
Liu
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Guozhen
G
Xu
Department of Radiation Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Li
L
Gao
Department of Radiation Oncology, Rush University Medical Center, Chicago, USA.
Dian
D
Wang
D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D059248:Chemoradiotherapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011300:Preoperative Care / Q000379:methods; D016016:Proportional Hazards Models; D018714:Radiotherapy, Adjuvant; D017211:Treatment Failure; D016896:Treatment Outcome
concurrent chemoradiotherapy; head and neck squamous cell carcinoma; multimodality treatment; organ function preservation; preoperative radiotherapy