[Objective]To investigate the rate of. local and regional control, disease-free survival, overall survival, local and regional recurrence, and distant metastasis and adverse effects of postoperative concurrent chemoradiotherapy in advanced squamous cell carcinoma of head and neck.To evaluate advantage and disadvantage of postoperative concurrent chemoradiotherapy. To estimate the patients' improvement of quality of life after therapy.[Methods] Between July, 2003, and May, 2005, 146 patients with advanced squamous cell carcinoma of head and neck were enrolled in Tumor Research and Treatment Center , Shandong Provincial Hospital, including oropharynx, larynx, and hypopharynx carcinoma. After undergoing total resection ,146 patients are randomly divided into two groups: 73 patients in treatment group recieved concurrent chemoradiotherapy ,while the other 73 patients in control group received radiotherapy only. There were no obviously clinical differences in two groups. All patients were treated by conventional fractionated radiotherapy during the whole course with 50Gy in 25 fractions. The treatment group took cisplatin 15mg/m~2 once a week from the first day of radiotherapy,every week as one cycle to totally 5 cycles. No patient received other therapy after radiotherapy and chemotherapy. All patients were followed-up until three years after therapy.By clinical observation, local and regional control rate, disease-free survival rate, overall survival rate, local and regional recurrence rate, distant metastasis rate,adverse effects and quality of life were abtained and compared between two groups.[Results] In treatment group, 23 patients received five cycles chemotherapy, 26 patients received four cycles chemotherapy, 17 patients received three cycles chemotherapy, 6 patients received two cycles chemotherapy, and 1 patients received one cycle chemotherapy. All patients completed radiotherapy. The followed-up rate is 89.0 percent (130/146) . The 2-year local and regional control rate of treatment group and control group was 79% (58/73) and 64%(47/73) respectively with statistically significant difference (P=0.042), The 3-year disease-free survival rate of treatment group and control group was 49% (36/73) and 33%(24/73) respectively with statistically significant difference (P=0.043).The 3-year overall survival rate of treatment group and control group was 61%(45/73) and 49%(36/73) respectively with no statistically significant difference (P=0.134). The 3-year local and regional recurrence rate of treatment group and control group was 21% (15/73) and 35%(26/73) respectively with statistically significant difference(P=0.042) .The 3-year distant metastasis rate of treatment group and control group was 23 percent(17/73) and 27 percent(20/73)respectively with no statistically significant difference (P=0.568) .The survival curve showed a trend towards improving the long-term survival. The rate of grade 3 and grade 4 bone marrow depression was 38 percent(28/73) in treatment group and 15 percent(11/73) in control group with statistically significant difference (P<0.001). The rate of grade 3 and grade 4 mucous membrane reaction was 55 percent(40/73) in observation group and 29 percent(21/73) in control group with statistically significant difference(P<0.001). There was no statistical difference between two groups assessed by KPS. The score of nausea-vomit,appetite and constipation in treatment group was higher than control group with statistically significant difference. As for others such as body function, society function, role function, emotion function, cognition function, hurt, dyspnea, languor, insomnia, diarrhoea, financial straits,population health,there was no statistically significant difference between two groups. As for late radiation injury such as esophagus, trachea, spinal cord and skin. There was no statistical significant difference between two groups.[Conclusion] Postoperative concurrent chemoradiotherapy can improve tow-year rate of local and regional control, three-year disease-free survival, three-year rate of local and regional recurrence and had a trend towards improving the long-term survival, but can't improve three-year rate of overall survival and distant metastasis. This combined therapy also improve the quality of life.Its acute adverse effects were stastistically different from radiotherapy only.The value of Postoperative concurrent chemoradiotherapy in long-term results need further study in clinic.
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