Toledano Alain, Garaud Pascal, Serin Daniel, Fourquet Alain, Bosset Jean-Francois, Breteau Noel, Body Gilles, Azria David, Le Floch Olivier, Calais Gilles
Department of Radiotherapy, Hospital Tenon AP-HP, Paris, France.
Int J Radiat Oncol Biol Phys. 2006 Jun 1;65(2):324-32. doi: 10.1016/j.ijrobp.2005.12.020. Epub 2006 Mar 20.
In 1996, a multicenter randomized study was initiated that compared sequential vs. concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) after breast-conserving surgery (ARCOSEIN study). After a median follow-up of 6.7 years (range, 4.3-9 years), we decided to prospectively evaluate the late effects of these 2 strategies.
A total of 297 patients from the 5 larger participating institutions were asked to report for a follow-up examination. Seventy-two percent (214 patients) were eligible for evaluation of late toxicity. After breast-conserving surgery, patients were treated either with sequential treatment with CT first followed by RT (Arm A) or CT administered concurrently with RT (Arm B). In all patients, CT regimen consisted of mitoxantrone (12 mg/m2), 5-FU (500 mg/m2), and cyclophosphamide (500 mg/m2), 6 cycles (Day 1 to Day 21). Conventional RT was delivered to the whole breast by administration of a 2 Gy per fraction protocol to a total dose of 50 Gy (+/- boost to the primary tumor bed). The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist, according to the LENT/SOMA scale. Skin pigmentation was also evaluated according to a personal 5-points scoring system (excellent, good, moderate, poor, very poor).
Among the 214 evaluable patients, 107 were treated in each arm. The 2 populations were homogeneous for patient, tumor, and treatment characteristics. Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in Arm B. No statistical difference was observed between the 2 arms of the study concerning Grade 2 or higher pain, breast edema, or lymphedema. No deaths were caused by late toxicity.
After breast-conserving surgery, the concurrent use of CT with RT is significantly associated with an increase incidence of Grade 2 or greater late side effects.
1996年启动了一项多中心随机研究，比较保乳手术后序贯辅助化疗（CT）与同步辅助化疗（CT）联合放射治疗（RT）的效果（ARCOSEIN研究）。中位随访6.7年（范围4.3 - 9年）后，我们决定前瞻性评估这两种治疗策略的晚期效应。
来自5家较大参与机构的297例患者被要求前来进行随访检查。72%（214例患者）符合晚期毒性评估标准。保乳手术后，患者接受先序贯CT后RT的治疗（A组）或CT与RT同步进行的治疗（B组）。所有患者的CT方案均为米托蒽醌（12 mg/m²）、5-氟尿嘧啶（500 mg/m²）和环磷酰胺（500 mg/m²），共6个周期（第1天至第21天）。常规RT通过每次2 Gy的方案对全乳进行照射，总剂量为50 Gy（±对原发肿瘤床的加量照射）。毒性评估对治疗情况设盲，由放射肿瘤学家根据LENT/SOMA量表进行分级。皮肤色素沉着也根据个人5分评分系统（优秀、良好、中等、差、非常差）进行评估。
在214例可评估患者中，每组各有107例接受治疗。两组在患者、肿瘤和治疗特征方面具有同质性。B组的皮下纤维化（SF）、毛细血管扩张（T）、皮肤色素沉着（SP）和乳腺萎缩（BA）显著增加。在2级或更高级别的疼痛、乳腺水肿或淋巴水肿方面，两组之间未观察到统计学差异。晚期毒性未导致死亡。
保乳手术后，CT与RT同步使用与2级或更严重晚期副作用的发生率增加显著相关。
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