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χ² 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),χ²=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 specific 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 χ² 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 conventional dosage 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;0(0/50)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=-1.494,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, 0.673, 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), χ² =4.141, P= 0.042].

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.