乳腺癌保乳术后大分割放疗与常规分割放疗的疗效及其安全性比较

Comparison of efficacy and safety between hypofractionated radiotherapy and conventional radiotherapy after breast-conserving surgery

目的比较早期乳腺癌保乳术后大分割放疗(HyRt)与常规分割放疗的疗效及其安全性。方法本研究为单中心、前瞻性、随机对照研究,纳入2017年5月-2019年5月唐山市人民医院收治的83例pTis-T2N0M0乳腺癌患者,接受保乳术+前哨淋巴结活检(SLNB),术后采用逆向调强放射治疗(IMRT)技术,采用随机数字表法分为大分割放疗组(n=41)与常规分割放疗组(n=42)。分析两组危及器官受量、治疗疗效、治疗失败模式及放疗相关不良反应。根据NCI CTC AE 3.0标准评估放疗相关不良反应,包括放射性皮炎、放射性肺炎、乳腺/皮肤纤维化、肺纤维化等。结果最终纳入83例乳腺癌患者,中位年龄44(26~67)岁。两组患者的年龄(P=0.443)、TNM分期(P=0.335)、分子分型(P=0.333)、分化程度(P=0.617)、病理类型(P=0.127)等临床参数比较,差异无统计学意义。与常规分割放疗组比较,大分割放疗组患者的患侧肺V5(25.6%vs.33.8%,P=0.015)、患侧肺V20(13.3%vs.17.2%,P=0.042)及患侧肺平均照射剂量(MLD;7.4 Gy vs.10.4 Gy,P=0.020)均明显降低。本组仅3例患者出现远处转移,未观察到区域淋巴结转移及局部复发。大分割放疗组与常规分割放疗组2年无进展生存(PFS)率无明显差异(94.4%vs.85.2%,P=0.818)。与常规分割放疗组比较,大分割放疗组≥Ⅱ级放射性皮炎发生率明显降低(2.4%vs.21.4%,P=0.015);大分割放疗组与常规分割放疗组Ⅰ级乳腺/皮肤纤维化发生率无明显差异(19.5%vs.14.3%,P=0.570),两组均未观察到≥Ⅲ级放疗相关不良反应。结论相较全乳常规放疗同期瘤床加量照射,早期乳腺癌保乳术后患者行HyRt耐受性好,不良反应发生率低,可作为首选的放射治疗模式。

Objective To compare the efficacy and safety between hypofractionated radiotherapy(HyRt)and conventional radiotherapy after breast-conserving surgery.Methods This study was a single-center,prospective,randomized controlled study.Eighty-three patients with pTis-T2N0M0 breast cancer admitted to Tangshan People's Hospital from May 2017 to May 2019 were included.The patients received breast-conserving surgery+sentinel lymph node biopsy(SLNB).After surgery,they were treated with intensity modulated radiation therapy(IMRT).According to random table method,patients were divided into HyRt group(n=41)and conventional radiotherapy group(n=42).The dose of organs at risk,treatment efficacy,treatment failure modes,and radiotherapy related adverse reactions were analyzed in the two groups.The radiotherapy-related adverse reactions were evaluated according to NCI CTC AE Version 3.0,including radiation dermatitis,radiation pneumonia,breast/skin fibrosis,pulmonary fibrosis,etc.Results Eighty-three patients with breast cancer were included,with a median age of 44(26-67)years.There was no statistically significant difference in clinical parameters such as age(P=0.443),TNM stage(P=0.335),molecular typing(P=0.333),degree of differentiation(P=0.617),and pathological type(P=0.127)between the two groups of patients.Compared with conventional radiotherapy group,the V5(25.6%vs.33.8%,P=0.015),V20(13.3%vs.17.2%,P=0.042),and the mean radiation dose(MLD;7.4 Gy vs.10.4 Gy,P=0.020)of the affected lung of HyRt group significantly decreased.Only 3 patients in this study experienced distant metastasis,and no regional lymph node metastasis or local recurrence was observed.There was no significant difference in PFS rate at 2 years between HyRt group and conventional radiotherapy group(94.4%vs.85.2%,P=0.818).Compared with conventional radiotherapy group,the incidence of≥gradeⅡirradiation dermatitis in HyRt group was significantly reduced(2.4%vs.21.4%,P=0.015).There was no difference in the incidence of gradeⅠbreast/skin fibrosis(19.5%vs.14.3%,P=0.570)between the two groups,and no gradeⅢradiotherapy-related side effects were observed in the two groups.Conclusions Compared with conventional radiotherapy with simultaneously integrated boosting-intensity modulated radiotherapy,the patients who received HyRt after breast-conserving surgery for early-stage breast cancer have good tolerance and low incidence of adverse reactions.HyRt can be used as the first option of radiation therapy.