FIRST ISOLATED LOCOREGIONAL RECURRENCE FOLLOWING MASTECTOMY FOR BREAST-CANCER - RESULTS OF A PHASE-III MULTICENTER STUDY COMPARING SYSTEMIC TREATMENT WITH OBSERVATION AFTER EXCISION AND RADIATION
FIRST ISOLATED LOCOREGIONAL RECURRENCE FOLLOWING MASTECTOMY FOR BREAST-CANCER - RESULTS OF A PHASE-III MULTICENTER STUDY COMPARING SYSTEMIC TREATMENT WITH OBSERVATION AFTER EXCISION AND RADIATION
复制标题
DOI：
10.1200/jco.1994.12.10.2071
复制
发表时间：
1994-10-01
影响因子：
45.3
通讯作者：
BRUNNER, K
中科院分区：
文献类型：
--
作者：
BORNER, M;BACCHI, M;BRUNNER, K
目的：我们进行了一项随机III期多中心研究，比较乳腺癌患者完全切除和放疗后孤立首次局部复发的全身治疗与不治疗。167例雌激素受体（ER+）阳性复发或受体状态未知的良好风险患者，将大于12个月的无病间隔（DFI）和小于或等于3个复发肿瘤结节（每个直径小于或等于3cm）输入研究。他们被随机分配到局部治疗后观察或接受他莫昔芬（TAM），直到疾病进展。79%的患者绝经后。结果：整个研究人群的中位观察期为6.3年。观察组的中位无病生存期（DFS）为26个月，TAM组为82个月（P = 0.007）。这主要是由于进一步的局部复发减少，而早期远处转移的发生被延迟。多变量分析确定DFI和TAM治疗是DFS的重要预后因素。5年总生存率（OS）分别为76%和74%（P = .77）。DFI也是一个预后因素远OS。结论：TAM孤立局部复发的乳腺癌后的系统治疗显着增加5年DFS率从36%至59%，与单独观察和延长中位DFS超过4.5年的ER+肿瘤患者或在不明ER状态的情况下，DFI大于12个月，肿瘤负荷最小。目前TAM治疗对OS无显著影响，但尚未达到研究人群的中位生存期。
Purpose: We performed a randomized phase III multicenter study to compare systemic treatment versus no treatment after complete excision and radiotherapy for isolated first locoregional recurrence in patients with breast cancer.Patients and Methods: One hundred sixty-seven good-risk patients with an estrogen receptor (ER+) positive recurrence or, in case of unknown receptor status, a disease-free interval (DFI) of greater than 12 months and less than or equal to three recurrent tumor nodules each less than or equal to 3 cm in diameter were entered onto the study. They were randomized to observation subsequent to local treatment or to receive tamoxifen (TAM) until disease progression. Seventy-nine percent of the patients were postmenopausal.Results: The median observation period far the entire study population was 6.3 years. The median disease-free survival (DFS) duration was 26 months for observation and 82 months for TAM patients (P = .007). This was mainly due to the reduction of further local recurrences, whereas the occurrence of early distant metastases was delayed. A multivariate analysis identified DFI and treatment with TAM as significant prognostic factors for DFS. The 5-year overall survival (OS) rates were 76% and 74%, respectively (P = .77). DFI was also a prognostic factor far OS.Conclusion: Systemic therapy with TAM after isolated locoregional recurrence of breast cancer significantly increased 5-year DFS rates from 36% to 59% compared with observation alone and prolonged median DFS by more than 4.5 years in patients with ER+ tumors or in the case of unknown ER status with a DFI of greater than 12 months and minimal tumor burden. Treatment with TAM currently has no significant impact on OS, but the median survival duration of the study population has not yet been reached.