Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial
Accelerated Partial-Breast Irradiation Compared With Whole-Breast Irradiation for Early Breast Cancer: Long-Term Results of the Randomized Phase III APBI-IMRT-Florence Trial
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DOI：
10.1200/jco.20.00650
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发表时间：
2020-12-10
影响因子：
45.3
通讯作者：
Livi, Lorenzo
中科院分区：
文献类型：
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作者：
Meattini, Icro;Marrazzo, Livia;Livi, Lorenzo
目的报告体外加速部分乳腺照射（APBI）调强放射治疗（IMRT）佛罗伦萨III期试验的长期结果，比较早期乳腺癌的全乳腺照射（WBI）和APBI。患者和方法主要终点是确定保乳手术后，30戈伊分5次每日一次（APBI组）和50戈伊分25次并加瘤床增强（WBI组）同侧乳腺肿瘤复发（IBTR）的5年差异。结果：2005年至2013年期间，随机分配了520例患者（WBI，n = 260; APBI，n = 260），其中90%以上具有低复发风险相关特征。中位随访时间为10.7年。WBI组IBTR的10年累积发生率为2.5%（n = 6），APBI组为3.7%（n = 9）（风险比[HR]，1.56; 95%CI，0.55至4.37; P = 0.40）。两组的10年总生存率均为91.9%（HR，0.95; 95% CI，0.50 - 1.79; P = 0.86）。WBI组和APBI组的10年乳腺癌特异性生存率分别为96.7%和97.8%（HR，0.65; 95%CI，0.21 - 1.99; P = 0.45）。APBI组的急性毒性（P = 0.0001）和晚期毒性（P = 0.0001）显著降低，医生（P = 0.0001）和患者（P = 0.0001）评价的美容效果改善。结论采用IMRT技术的体外APBI治疗早期乳腺癌10年累积IBTR发生率较低，与WBI治疗后无差异。急性和晚期治疗相关毒性和美容结局明显有利于APBI。
PURPOSE To report the long-term results of external-beam accelerated partial-breast irradiation (APBI) intensity-modulated radiation therapy (IMRT) Florence phase III trial comparing whole-breast irradiation (WBI) to APBI in early-stage breast cancer. PATIENTS AND METHODS The primary end point was to determine the 5-year difference in ipsilateral breast tumor recurrence (IBTR) between 30 Gy in 5 once-daily fractions (APBI arm) and 50 Gy in 25 fractions with a tumor bed boost (WBI arm) after breast-conserving surgery. RESULTS Five hundred twenty patients, more than 90% of whom had characteristics associated with low recurrence risk, were randomly assigned (WBI, n = 260; APBI, n = 260) between 2005 and 2013. Median follow-up was 10.7 years. The 10-year cumulative incidence of IBTR was 2.5% (n = 6) in the WBI and 3.7% (n = 9) in the APBI arm (hazard ratio [HR], 1.56; 95% CI, 0.55 to 4.37; P = .40). Overall survival at 10 years was 91.9% in both arms (HR, 0.95; 95% CI, 0.50 to 1.79; P = .86). Breast cancer-specific survival at 10 years was 96.7% in the WBI and 97.8% in the APBI arm (HR, 0.65; 95% CI, 0.21 to 1.99; P = .45). The APBI arm showed significantly less acute toxicity (P = .0001) and late toxicity (P = .0001) and improved cosmetic outcome as evaluated by both physician (P = .0001) and patient (P = .0001). CONCLUSION The 10-year cumulative IBTR incidence in early breast cancer treated with external APBI using IMRT technique in 5 once-daily fractions is low and not different from that after WBI. Acute and late treatment-related toxicity and cosmesis outcomes were significantly in favor of APBI.