Castelli J, Figl A, Raoust I, Lallement M, Flipo B, Ettore F, Chapelier C, Ferrero J-M, Courdi A, Hannoun-Lévi J-M
Département de Radiothérapie Oncologique, Centre Antoine-Lacassagne, 33 Avenue de Valombrose, 06189 Nice cedex, France.
Cancer Radiother. 2011 Apr;15(2):130-5. doi: 10.1016/j.canrad.2010.07.638. Epub 2010 Dec 14.
Currently, radical mastectomy represents the gold standard for ipsilateral breast cancer recurrence. However, we already showed that a second conservative treatment was feasible combining lumpectomy plus low-dose rate interstitial brachytherapy. In this study, we reported the preliminary results of a second conservative treatment using a high-dose rate brachytherapy.
From June 2005 to July 2009, 42 patients presenting with an ipsilateral breast cancer recurrence underwent a second conservative treatment. Plastic tubes were implanted intra-operatively at the time of the lumpectomy. After a post-implant CT scan, a total dose of 34 Gy in 10 fractions over 5 consecutive days was delivered through an ambulatory procedure. The toxicity evaluation used the Common Terminology Criteria for Adverse Events v3.0.
The median follow-up was 21 months (6-50 months), median age at the time of the local recurrence was 65 years (30-85 years). The median delay between the primary and the recurrence was 11 years (1-35 years). The location of the recurrence was in the tumor bed for 22 patients (52.4%), in the same quadrant for 14 patients (33.3%) and unknown for six patients (14.3%). The median tumor size of the recurrence was 12 mm (2-30 mm). The median number of plastic tubes and plans were nine (5-12) and two (1-3) respectively. The median CTV was 68 cm(3) (31.2-146 cm(3)). The rate of second local control was 97%. Twenty-two patients (60%) experienced complications. The most frequent side effect consisted in cutaneous and sub-cutaneous fibrosis (72% of all the observed complications).
A second conservative treatment for ipsilateral breast cancer recurrence using high-dose rate brachytherapy appears feasible leading to encouraging results in terms of second local control with an acceptable toxicity. Considering that a non-inferiority randomized trial comparing mastectomy versus second conservative treatment could be difficult to perform, what proof level will be necessary to achieve in order to change the medical procedures?
目前,根治性乳房切除术是同侧乳腺癌复发的金标准。然而,我们已经表明,保乳手术联合低剂量率组织间近距离放射治疗的二次保守治疗是可行的。在本研究中,我们报告了使用高剂量率近距离放射治疗进行二次保守治疗的初步结果。
2005年6月至2009年7月,42例同侧乳腺癌复发患者接受了二次保守治疗。在保乳手术时术中植入塑料导管。植入后CT扫描后,通过门诊程序在连续5天内分10次给予总剂量34 Gy。毒性评估采用《不良事件通用术语标准》第3.0版。
中位随访时间为21个月(6 - 50个月),局部复发时的中位年龄为65岁(30 - 85岁)。初次发病与复发之间的中位间隔时间为11年(1 - 35年)。复发部位在瘤床的有22例患者(52.4%),在同一象限的有14例患者(33.3%),6例患者(14.3%)复发部位不明。复发肿瘤的中位大小为12 mm(2 - 30 mm)。塑料导管和计划的中位数量分别为9根(5 - 12根)和2个(1 - 3个)。中位临床靶体积为68 cm³(31.2 - 146 cm³)。二次局部控制率为97%。22例患者(60%)出现并发症。最常见的副作用是皮肤和皮下纤维化(占所有观察到的并发症中的72%)。
使用高剂量率近距离放射治疗对同侧乳腺癌复发进行二次保守治疗似乎是可行的,在二次局部控制方面取得了令人鼓舞的结果,且毒性可接受。考虑到比较乳房切除术与二次保守治疗的非劣效性随机试验可能难以开展,为了改变医疗程序需要达到何种证据水平?