Department of Radiotherapy, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
Medical Oncology, Amsterdam University Medical Centre, Amsterdam, The Netherlands.
Acta Oncol. 2022 Apr;61(4):441-448. doi: 10.1080/0284186X.2022.2033315. Epub 2022 Feb 9.
In patients with inoperable local regional recurrences of breast cancer in previously irradiated areas, local control is difficult to maintain and treatment options are limited. The Dutch standard treatment for such recurrences is reirradiation combined with hyperthermia. Apart from enhancing the effect of reirradiation, hyperthermia is also known to improve local effects of chemotherapy like cisplatin. This randomized phase-II trial compares reirradiation and hyperthermia versus the same treatment combined with cisplatin.
From December 2010 up to January 2019, 49 patients were randomized, 27 in the standard arm and 22 in the combined arm. A total of 32 Gy was given in eight fractions of 4 Gy in 4 weeks, at two fractions per week. After January 2015, the radiation schedule was changed to 46 Gy in 23 fractions of 2 Gy, at five fractions per week. Hyperthermia was added once a week after radiotherapy. The combined arm was treated with four cycles of weekly cisplatin 40 mg/m.
Complete response rate was 60.9% in the standard arm and 61.1% in the combined arm ( = 0.87). Partial response rate was 30.4% in the standard arm and 33.3% in the combined arm ( = 0.79). One-year overall survival was 63.4% in the standard arm and 57.4% in the combined arm. One-year local progression-free interval was 81.5% in the standard arm and 88.1% in the combined arm ( = 0.95). Twenty-five percentage of patients in the standard arm experienced grade 3 or 4 acute toxicity and 29% of patients in the combined arm ( = 0.79).
No potential benefit could be detected of adding cisplatin to reirradiation and hyperthermia in patients with recurrent breast cancer in a previously irradiated area. With or without cisplatin, most patients had subsequent local control until last follow-up or death.
对于既往放疗区域内不可手术的局部区域性复发性乳腺癌患者，局部控制较难维持，治疗选择有限。荷兰对这类复发患者的标准治疗是再次放疗联合热疗。除了增强放疗效果外，热疗还可以提高顺铂等化疗的局部效果。本随机 II 期试验比较了再次放疗和热疗与相同治疗联合顺铂的效果。
从 2010 年 12 月至 2019 年 1 月，共 49 名患者被随机分为标准组（n=27）和联合组（n=22）。在 4 周内，每周进行 2 次共 8 次，每次 4Gy，总剂量为 32Gy。2015 年 1 月后，放疗方案改为每周 5 次，每次 2Gy，共 23 次，总剂量为 46Gy。放疗后每周加用 1 次热疗。联合组每周接受 4 个周期的顺铂（40mg/m）。
标准组完全缓解率为 60.9%，联合组为 61.1%（ = 0.87）。标准组部分缓解率为 30.4%，联合组为 33.3%（ = 0.79）。标准组和联合组的 1 年总生存率分别为 63.4%和 57.4%。标准组和联合组的 1 年局部无进展间隔分别为 81.5%和 88.1%（ = 0.95）。标准组有 25%的患者出现 3 或 4 级急性毒性，联合组有 29%的患者（ = 0.79）。
在既往放疗区域内复发性乳腺癌患者中，添加顺铂并未发现再次放疗和热疗有潜在获益。无论是否使用顺铂，大多数患者在末次随访或死亡前均有局部控制。
