Phse III study of preoperative concurrent chemoradiotherapy compared with preoperative radiotherapy alone in the treatment of locally advanced head and neck squamons cell carcinona

Abstract

Objective To investigate the role of chemoradiotherapy in the preoperative radiotherapy for locally advanced head and neck squamous cell carcinoma. Methods From Sep. 2002 to Dec. 2008,totally 157 locally advanced head and neck squamous cell carcinoma (HNSCC) patients was assigned to preoperative concurrent chemoradiotherapy group ( n =81 ) or preoperative radiotherapy alone group ( n =76 ) randomly. The chemotherapy regimen was consisted of cisplatin 30 mg/m2, weekly. The radiotherapy in both groups was identical. The primary lesion will continue concurrent chemoradiotherapy or radiotherapy for those the tumor response was or nearly complete remission (CR) and those who refused surgery when evaluated at DT50 Gy, the others will receive surgery 1 month later if the tumor response was less than CR.For N3 patients, the planed neck dissection will be done. Results The follow up rate was 98. 1％, 91patients followed up more than 5 years, there were 46 in concurrent chemoradiotherapy group and 45 in radiotherapy alone group. The rate of 5-year local control, overall survival, disease free survival and distant metastasis-free survival for preoperative concurrent chemoradiotherapy group and preoperative radiotherapy alone group were 63％ and 50％ ( x2 =0. 40,P =0. 528), 46％ and 38％ ( x2 =0. 48,P =0. 490) ,41％ and 35 ( x2 =0. 29, P =0. 593 ) ,76％ and 65％ ( x2 =3.38, P =0. 066 ) respectively. Subgroup analysis showed that the 2-years distant metastasis-free survival of preoperative concurrent chemoradiotherapy group and preoperative radiotherapy alone group were 88％ and 60％ ( x2 =5.99,P =0. 014). Conclusions Preoper -ative concurrent chemoraidotherapy with the regimen of cisplatin 30 mg/m2 weekly did not improve the overall survival for locally advanced HNSCC when compared with preoperative radiotherapy alone.Preoperative concurrent chemoradiotherapy improved the distant metastasis-free survival of locally advanced hypopharyngeal and laryngeal carcinoma. Key words: Head and neck squamous cell carcinoma, locally advanced; Radiotherapy,preoperative; Concurrent chemoradiotherapy,preoperative; Surgery; Prognosis