Mariani L, Salvadori B, Marubini E, Conti A R, Rovini D, Cusumano F, Rosolin T, Andreola S, Zucali R, Rilke F, Veronesi U
Istituto Nazionale per lo Studio e la Cura dei Tumori (INT), Milan, Italy.
Eur J Cancer. 1998 Jul;34(8):1156-62. doi: 10.1016/s0959-8049(98)00137-3.
We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P < 0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR occurrence was relatively high, when compared with the rate of IBTR occurrence as first event. In summary, the results of this trial show that a better local control of the disease can be obtained with the more extensive surgical resection, i.e. QUART.
我们报告了一项随机临床试验的10年结果，该试验比较了患有小的、非转移性原发性乳腺癌的女性的两种不同保乳治疗策略：象限切除术、腋窝淋巴结清扫术和放疗（QUART）与肿瘤切除术、腋窝淋巴结清扫术，随后进行外照射放疗并用192Ir植入进行瘤床加量放疗（TART）。手术切缘阳性的女性未接受二次手术。腋窝淋巴结阳性的女性接受辅助药物治疗。从1985年至1987年，该试验纳入了705例患者，QUART组360例，TART组345例。计算了两个治疗组中作为首要事件的乳腺内肿瘤复发（IBTR）和转移的粗累积发病率曲线以及死亡率曲线。还计算了作为次要事件（在已经发生局部复发的女性中）的IBTR的粗累积发病率曲线。通过使用Cox回归模型比较两组发生IBTR、转移或死亡的风险，模型均对患者年龄、肿瘤大小、腋窝转移淋巴结数量和组织学进行了调整和未调整。还研究了上述预后因素与手术类型之间可能的相互作用。两组在基线患者和肿瘤特征方面匹配良好，唯一的例外是手术切缘，TART组手术切缘阳性的情况更常见。在Cox模型中，两组在IBTR方面存在显著差异（P < 0.0001），但在远处转移和总生存方面无显著差异。特别是QUART组IBTR的5年和10年粗累积发病率估计分别为4.7%和7.4%，TART组分别为11.6%和18.6%。该差异未受患者或疾病特征的实质性影响。同样，接受TART治疗的女性的手术切缘状态对IBTR发生风险没有显著影响。最后，与作为首要事件的IBTR发生率相比，第二次IBTR的发生率相对较高。总之，该试验结果表明，通过更广泛的手术切除，即QUART，可以更好地实现对疾病的局部控制。
