低分割放射治疗对早期乳腺癌保留乳房手术后患者的疗效和安全性评价

Efficacy and safety of hypofractionation radiotherapy in patients with early breast cancer after breast-conserving surgery

目的评价低分割放射治疗对早期乳腺癌保留乳房(简称保乳)手术后患者的疗效和安全性。方法选择2010年2月至2011年1月海南省第三人民医院收治的120例早期乳腺癌保乳手术后患者进行前瞻性研究。根据患者意愿将其分为常规剂量(50.0 Gy,分为25次)和低分割(41.6 Gy,分为16次)全乳放射治疗组,每组60例,治疗后随访5年,观察并比较2组患者的5年局部复发率、5年区域复发率、远处转移率、非乳腺癌特异性病死率、放射治疗不良反应发生率、美容效果和生活质量,其中,2组之间率的比较采用χ~2检验或Fisher确切概率法,美容效果比较采用Mann-Whitney U检验,SF-36生活质量评分比较采用t检验。结果患者失访率为14.2%(17/120)。实际纳入分析的患者共103例,其中,常规剂量组50例,低分割组53例。常规剂量组与低分割组患者相比,5年局部复发率、5年区域复发率、远处转移率和非乳腺癌特异性病死率差异均无统计学意义[6.0%(3/50)比3.8%(2/53),P=0.676;0(0/50)比1.9%(1/53),P=1.000;2.0%(1/50)比3.8%(2/53),P=1.000;0(0/50)比1.9%(1/53),P=1.000],并且,2组患者间美容效果(Z=-1.494,P=0.135)和SF-36生活质量各维度(躯体健康、社会功能、躯体角色、躯体疼痛、心理健康、情绪角色、精力和总体健康)评分比较,差异也均无统计学意义(t=0.629、1.748、0.673、0.894、1.649、1.276、1.300、0.887,P均>0.050),但是,低分割组患者放射治疗不良反应发生率低于常规剂量组[64.2%(34/53)比82.0%(41/50),χ~2=4.141,P=0.042]。结论与常规剂量相比,低分割放射治疗虽未提高早期乳腺癌保乳手术后患者的疗效,但其放射治疗不良反应相对较低,因而更加安全。

Objective To evaluate the efficacy and safety of hypofractionation radiotherapy in patients with early breast cancer after breast-conserving surgery. Methods A prospective study was conducted in 120 patients with early breast cancer after breast-conserving surgery in the Third People＇s Hospital of Hainan Province from February 2010 to January 2011. Based on their own wishes, the patients were divided into two groups ： conventional dosage group （ 50. 0 Gy, 25 times, n = 60 ） and hypofractionation whole-breast radiotherapy group（41.6 Gy, 16 times, n=60）. The patients were followed up for 5 years. The 5-year local recurrence rate, 5-year regional recurrence rate, distant metastasis rate, non-breast cancer speeifie mortality, incidence of adverse events in radiotherapy, cosmetic outcome and quality of life were compared between two groups. The rates between two groups were compared using X2 test or Fisher exact test, cosmetic outcome using Mann-Whitney U test, SF-36 scores on quality of life using t test. Results The 14. 2% of patients were missed in follow-up （17/120）. Totally 103 patients were enrolled in this study, including 50 patients in conventionaldosage group and 53 patients in hypofractionation group. There was no significant difference in 5-year local recurrence rate, 5-year regional recurrence rate, distant metastasis rate and non-breast cancer specific mortality between conventional dosage group and hypofractionation group [ 6.0% （3/50） vs 3.8% （2/53） , P = 0. 676; O（O/50）vs 1.9% （ 1/53 ）, P= 1. 000 ;2. 0% （1/50） vs 3.8% （2/53） ,P= 1. 000;0（0/50）vs 1.9% （ 1/53 ）, P= 1. 000]. There was no significant difference in cosmetic outcome （Z=-I. 494 ,P=0. 135 ） and each aspect of SF-36 scores on quality of life including physical health, social function, physical role, physical pain, psychological health, emotional role, energy and overall health （t = 0. 629, 1. 748, O. 673, 0. 894, 1. 649, 1. 276, 1. 300, 0. 887; all P〉0. 050）. However, the incidence of adverse events in hypofractionation group was significantly lower than that in conventional dosage group [ 64. 2% （34/53） vs 82. 0% （41/50） , X2 = 4. 141, P= O. 042 ]. Conclusion Compared with conventional dosage, hypofractionation radiotherapy has a lower incidence of adverse events and higher safety, without increasing the efficacy in early breast cancer after breast-conserving surgery.