Niehoff Peter, Polgár Csaba, Ostertag Horst, Major Tibor, Sulyok Zoltán, Kimmig Bernhard, Kovács György
Klinik für Strahlentherapie (Radioonkologie), University Hospital S-H, Kiel, Germany.
Radiother Oncol. 2006 Jun;79(3):316-20. doi: 10.1016/j.radonc.2006.05.010. Epub 2006 Jun 14.
In a prospective multi-center phase II trial, we investigated the MammoSite Radiation Therapy System, a new device for delivering intracavitary brachytherapy following breast conserving surgery. The MammoSite is a dual lumen, closed ended catheter with a small, spherical inflatable balloon and a port for connecting a remote afterloader to the central lumen. We analyzed the surgical procedure and placement of the MammoSite, treatment planning and radiation delivery complications and cosmesis, as well the comfort for the patients.
Between 2002 and 2004 a total of 32 patients (pts) were implanted using the MammoSite. The reference isodose was defined 1cm from the balloon surface. We analyzed the post-implant anatomic position of the applicator and the geometric form of the balloon via ultrasound, CT and X-ray, related side effects, cosmetic outcome and patient quality of life.
Twenty-three out of 32 patients (72%) were eligible for MammoSite intracavitary brachytherapy. Twenty-eight percentage had to be excluded because of different reasons. Eleven patients were treated with primary brachytherapy with a total dose of 34 Gy (2 x 3.4 Gy) and 12 had a boost with a mean dose of 13.3 Gy (range: 7.5-15 Gy; 2 x 2.5 Gy) combined with EBRT and doses ranged between 46 and 50 Gy. In three cases a balloon rupture occurred. We observed two abscesses within 3 months of implantation and serious seroma development in 10 patients (39%). Skin related side effects were erythema in 21 patients (91%), hyperpigmentation in 13 patients (56%) and teleangiectasia in six patients (26%) after mean follow-up 20 months.
The MammoSite Radiation Therapy System is a feasible treatment modality for intracavitary brachytherapy of breast cancer after breast conserving surgery. The advantage of the system is only one applicator is necessary for the delivery of a fractionated radiotherapy. In addition, patient tolerance of the procedure is high. Critical issues concern possible overdosages at the skin reflected by a high rate of late skin damage after only 20 months of follow-up time. The method could serve as an alternative to conventional multi-catheter brachytherapy for a selected group of patients.
在一项前瞻性多中心II期试验中，我们研究了MammoSite放射治疗系统，这是一种用于保乳手术后腔内近距离放疗的新设备。MammoSite是一种双腔、封闭端导管，带有一个小的球形可充气气球以及一个用于将远程后装治疗机连接到中心腔的端口。我们分析了MammoSite的手术操作及放置、治疗计划、放射治疗并发症与美容效果，以及患者的舒适度。
2002年至2004年间，共有32例患者植入了MammoSite。参考等剂量线定义为距气球表面1厘米处。我们通过超声、CT和X射线分析了植入后施源器的解剖位置及气球的几何形状、相关副作用、美容效果和患者生活质量。
32例患者中有23例（72%）适合进行MammoSite腔内近距离放疗。28%的患者因不同原因被排除。11例患者接受了单纯近距离放疗，总剂量为34 Gy（2×3.4 Gy），12例患者接受了推量放疗，平均剂量为13.3 Gy（范围：7.5 - 15 Gy；2×2.5 Gy），联合体外放疗，剂量范围在46至50 Gy之间。有3例发生了气球破裂。我们观察到植入后3个月内出现2例脓肿，10例患者（39%）出现严重血清肿。平均随访20个月后，与皮肤相关的副作用包括21例患者（91%）出现红斑，13例患者（56%）出现色素沉着，6例患者（26%）出现毛细血管扩张。
MammoSite放射治疗系统是保乳手术后乳腺癌腔内近距离放疗的一种可行治疗方式。该系统的优点是进行分次放疗仅需一个施源器。此外，患者对该操作的耐受性较高。关键问题在于仅随访20个月后就出现了较高的晚期皮肤损伤发生率，这反映出皮肤可能存在剂量过量的情况。对于特定患者群体，该方法可作为传统多导管近距离放疗的替代方法。
