T1~T2期乳腺癌保乳术后化疗后程同步大分割放疗前瞻性Ⅰ期临床研究

A Prospective PhaseⅠClinical Study of Docetaxel with Concurrent Late-course Hyperfractionated Radiotherapy After Breast-conserving Surgery for Stage T1-T2 Breast Cancer

目的前瞻性评估T1~T2期乳腺癌保乳术后化疗后程大分割放疗的不良反应和耐受性,以及在缩短治疗时间、减轻患者经济负担等方面的价值。方法共入组20例T1~T2期乳腺癌保乳术后患者,所有患者于末次多西他赛化疗前开始大分割放疗。观察急性放射反应、治疗完成率及无病生存率、住院时间及住院费用等。结果治疗完成率100%。主要不良反应为血液学毒性(白细胞减少)及皮肤反应,患者均可耐受。中位随访时间为30.1个月,随访率100%。美容效果良好率100%。平均总治疗时间为4周,总住院治疗费用节省约1万元。21个月无病生存率为100%。结论T1~T2期乳腺癌保乳术后可耐受同步大分割放化疗,局部控制好,美容效果佳,且具有较高的卫生经济学价值。

Objective To evaluate prospectively the side effects and tolerance of docetaxel with concurrent late-course hyperfractionated radiotherapy after breast-conserving surgery for stage T1-T2 breast cancer,and to assess the value of this treatment in shortening the treatment time and reducing the economic burden among patients.Methods A total of 20 patients with T1-T2 breast cancer were recruited after they underwent breast-conserving surgery.The acute radiation response classification,treatment completion rate,disease-free survival,hospital stays,and treatment costs were observed.Radiotherapy for all patients was started before the last single-agent docetaxel chemotherapy.Results The completion rate of treatment and the good rate of cosmetic effect reached 100%.The main adverse reactions were hematological toxicity(leukopenia)and skin reactions,which were tolerated.The median follow-up time was 30.1 months,and the follow-up rate was 100%.The average total treatment time of this hyperfractionated radiotherapy with concurrent docetaxel was four weeks,and the total hospitalization cost savings was approximately 10,000 yuan.The 21-month disease-free survival rate was 100%.Conclusion Stage T1-T2 breast cancer can tolerate hyperfractionated radiotherapy with concurrent chemotherapy after a breast-conserving operation.The procedure results in good local control and satisfactory cosmetic effects,with high health and economic value.