Pergolizzi S, Settineri N, Russi E G, Maisano R, Adamo V, Santacáterina A, Raffaele L, Marchetti G, Mesiti M
Satellite Unit of Biomedical Technology (Radiobiomedical Area), IST-Genova, Italy.
Anticancer Res. 1997 May-Jun;17(3C):2303-8.
Supraclavicular lymph node metastases (SLM) as the only site of metastatic disease from breast cancer is a rare and a poor prognostic event. In order to evaluate the role of Radiotherapy (RT) with "radical dose" to the supraclavicular fossa, we carried out a non randomized clinical trial comparing systemic therapy alone to integrated and aggressive treatment (systemic therapy plus radiotherapy). The primary end-point was time to progression (TTP). The second end-point was the overall survival (OS).
From 1/1/1989 to 31/12/1994 37 patients (with or without the presence of locoregional disease) were enrolled into two arms, of the study, but were allowed, when giving their consent, to change the arm of the study which they had been originally allotted to. Arm A, 18 patients, 15 evaluable: chemo +/- hormonotherapy for 6 courses; after the second course, if local progression disease was present, the pts. were submitted to RT and removed from the study (3 patients). Arm B, 19 patients all evaluable: chemo +/- hormonotherapy for 3 courses followed by RT with "radical" dose. Results were analyzed on 30/11/1995 and no interim analysis was performed. The potential median follow up for all patients was 56.5 months (range 11-83 months): for Arm A 61 months (range: 12-82); for Arm B 53 months (range: 11-83). The two groups were homogeneous and balanced, without statistical differences.
Median TTP was 12.5 months in Arm A and 19.5 months in Arm B (p = 0.064). Median overall survival (OS) was 27.5 months in Arm A and 48 months in Arm B. T-status to the time of the diagnosis was found to be independent prognostic factor for TTP (p = 0.0029). Disease-free interval from diagnosis to recurrence was found to be a significant prognostic factor for OS (p = 0.009).
The results in Arm B demonstrated the opportunity of a long term control in this subset of patients. Therefore we suggest the start of a wider multicenter study in order to define the biological significance of SLM, its importance in staging breast cancer and to consider the optimum treatment.
锁骨上淋巴结转移（SLM）作为乳腺癌转移疾病的唯一部位是一种罕见且预后不良的事件。为了评估对锁骨上窝采用“根治性剂量”放疗（RT）的作用，我们开展了一项非随机临床试验，比较单纯全身治疗与综合积极治疗（全身治疗加放疗）。主要终点是疾病进展时间（TTP）。次要终点是总生存期（OS）。
从1989年1月1日至1994年12月31日，37例患者（有或无局部区域疾病）被纳入研究的两个组，但在获得他们同意后，允许他们改变最初分配的研究组。A组，18例患者，15例可评估：进行6个疗程的化疗±激素治疗；在第二个疗程后，如果出现局部进展性疾病，患者接受放疗并退出研究（3例患者）。B组，19例患者均可评估：进行3个疗程的化疗±激素治疗，随后采用“根治性”剂量放疗。1995年11月30日对结果进行分析，未进行中期分析。所有患者的潜在中位随访时间为56.5个月（范围11 - 83个月）：A组61个月（范围：12 - 82）；B组53个月（范围：11 - 83）。两组同质且均衡，无统计学差异。
A组的中位TTP为12.5个月，B组为19.5个月（p = 0.064）。A组的中位总生存期（OS）为27.5个月，B组为48个月。诊断时的T分期被发现是TTP的独立预后因素（p = 0.0029）。从诊断到复发的无病间期被发现是OS的显著预后因素（p = 0.009）。
B组的结果表明在这部分患者中实现长期控制的可能性。因此，我们建议开展更广泛的多中心研究，以明确SLM的生物学意义、其在乳腺癌分期中的重要性，并考虑最佳治疗方案。
