Ambrogi Federico, Trevisi Letizia, Martelli Gabriele, Boracchi Patrizia
Tumori. 2014 Jul-Aug;100(4):406-14. doi: 10.1700/1636.17896.
The problem of the search for a proportion of cured patients of breast cancer and the relative time to cure breast cancer has been known since the 1950s. The literature on this topic has developed during the last decades thanks to the availability of studies with long follow-up times, which was required by the type of disease in question. The aim of this study is to estimate, if it exists, the proportion of cured breast cancer patients with a parametric method accounting for competing causes of death.
In this work we used data from a two-group randomized controlled trial. From 1973 to 1980, 701 women were recruited with breast cancer measuring no more than 2 cm in diameter. They were randomly assigned to radical mastectomy (349 patients) or breast-conserving surgery followed by radiotherapy to the ipsilateral mammary tissue (352 patients). Thanks to a reliable classification of the causes of death, it was possible to analyze data using cause-specific mortality.
The parametric crude cumulative incidence estimates by the Gompertz distribution accorded closely with the non-parametric estimates. The analysis was also performed for subsets of patients based on menopausal status and number of positive lymph nodes. Statistical evidence for the existence of a cure fraction ranging from 0.48 to 0.71, depending on the subset, was found. However, the estimated proportion of cured patients has not been reached after 30 years' follow-up for most of the subsets.
Although statistical evidence has been found for the presence of a cure fraction, in practical terms it seems that 30 years after a breast cancer diagnosis cure cannot yet be claimed.
自20世纪50年代以来,寻找乳腺癌治愈患者的比例以及乳腺癌治愈的相对时间这一问题就已为人所知。由于该疾病类型需要长期随访研究,关于这一主题的文献在过去几十年中得到了发展。本研究的目的是,若存在的话,用一种考虑了竞争性死亡原因的参数方法来估计乳腺癌治愈患者的比例。
在这项研究中,我们使用了两组随机对照试验的数据。1973年至1980年,招募了701名直径不超过2厘米的乳腺癌女性患者。她们被随机分配至根治性乳房切除术组(349例患者)或保乳手术联合同侧乳腺组织放疗组(352例患者)。由于对死亡原因进行了可靠分类,因此可以使用特定病因死亡率来分析数据。
通过Gompertz分布得出的参数化粗累积发病率估计值与非参数估计值非常接近。还根据绝经状态和阳性淋巴结数量对患者亚组进行了分析。发现存在治愈比例的统计学证据,该比例在0.48至0.71之间,具体取决于亚组。然而,对于大多数亚组,在30年的随访后仍未达到估计的治愈患者比例。
尽管已发现存在治愈比例的统计学证据,但实际上,在乳腺癌诊断30年后似乎仍不能宣称已治愈。