Cutuli Bruno, Cohen-Solal-le Nir Christine, de Lafontan Brigitte, Mignotte Hervé, Fichet Virginie, Fay Renaud, Servent Véronique, Giard Sylvia, Charra-Brunaud Claire, Lemanski Claire, Auvray Hugues, Jacquot Stéphane, Charpentier Jean-Christophe
Department of Radiation Oncology, Paul Strauss Center Strasbourg and Polyclinique de Courlancy, Reims, France.
Int J Radiat Oncol Biol Phys. 2002 Jul 15;53(4):868-79. doi: 10.1016/s0360-3016(02)02834-1.
To assess the long-term outcome for women with ductal carcinoma in situ of the breast treated in current clinical practice by conservative surgery with or without definitive breast irradiation.
We analyzed 705 cases of ductal carcinoma in situ treated between 1985 and 1995 in nine French regional cancer centers; 515 underwent conservative surgery and radiotherapy (CS+RT) and 190 CS alone. The median follow-up was 7 years.
The 7-year crude local recurrence (LR) rate was 12.6% (95% confidence interval [CI] 9.4-15.8) and 32.4% (95% CI 25-39.7) for the CS+RT and CS groups, respectively (p <0.0001). The respective 10-year results were 18.2% (95% CI 13.3-23) and 43.8% (95% CI 30-57.7). A total of 125 LRs occurred, 66 and 59 in the CS+RT and CS groups, respectively. Invasive or microinvasive LRs occurred in 60.6% and 52% of the cases in the same respective groups. The median time to LR development was 55 and 41 months. Nine (1.7%) and 6 (3.1%) nodal recurrences occurred in the CS+RT and CS groups, respectively. Distant metastases occurred in 1.4% and 3% of the respective groups. Patient age and excision quality (final margin status) were both significantly associated with LR risk in the CS+RT group: the LR rate was 29%, 13%, and 8% among women aged < or =40, 41-60, and > or =61 years (p <0.001). Even in the case of complete excision, we observed a 24% rate of LR (6 of 25) in women <40 years. Patients with negative, positive, or uncertain margins had a 7-year crude LR rate of 9.7%, 25.2%, and 12.2%, respectively (p = 0.008). RT reduced the LR rate in all subgroups, especially in those with comedocarcinoma (17% vs. 59% in the CS+RT and CS groups, respectively, p <0.0001) and mixed cribriform/papillary tumors (9% vs. 31%, p <0.0001). In the multivariate Cox regression model, young age and positive margins remained significant in the CS+RT group (p = 0.00012 and p = 0.016). Finally, the relative LR risk in the CS+RT group compared with the CS group was 0.35 (95% CI 0.25-0.51, p = 0.0001). Subsequent contralateral breast cancer occurred in 7.1% and 7.5% of the patients in the CS+RT and CS groups, respectively.
Despite the absence of randomization, our results are extremely consistent with the updated National Surgical Adjuvant Breast Project B17 and European Organization for Research and Treatment of Cancer 10853 trials. We also noted that the LR risk was very high in women <40 years and/or in the case of incomplete excision.
评估在当前临床实践中，接受保乳手术加或不加术后放疗的乳腺导管原位癌女性患者的长期预后。
我们分析了1985年至1995年间在法国9个地区癌症中心接受治疗的705例导管原位癌患者；515例行保乳手术加放疗（CS+RT），190例仅行保乳手术（CS）。中位随访时间为7年。
CS+RT组和CS组的7年局部复发（LR）粗发生率分别为12.6%（95%置信区间[CI]9.4-15.8）和32.4%（95%CI 25-39.7）（p<0.0001）。10年结果分别为18.2%（95%CI 13.3-23）和43.8%（95%CI 30-57.7）。共发生125例局部复发，CS+RT组和CS组分别为66例和59例。侵袭性或微侵袭性局部复发在相应两组中的发生率分别为60.6%和52%。局部复发发生的中位时间分别为55个月和41个月。CS+RT组和CS组分别有9例（1.7%）和6例（3.1%）发生区域复发。远处转移在相应两组中的发生率分别为1.4%和3%。患者年龄和切除质量（切缘最终状态）在CS+RT组中均与局部复发风险显著相关：年龄≤40岁、41-60岁和≥61岁的女性局部复发率分别为29%、13%和8%（p<0.001）。即使在完全切除的情况下，我们观察到年龄<40岁的女性局部复发率为24%（25例中有6例）。切缘阴性、阳性或不确定的患者7年局部复发粗发生率分别为9.7%、25.2%和12.2%（p=0.008）。放疗降低了所有亚组的局部复发率，尤其是粉刺癌亚组（CS+RT组和CS组分别为17%和59%，p<0.0001）以及筛状/乳头状混合瘤亚组（9%和31%，p<0.0001）。在多因素Cox回归模型中，年轻和切缘阳性在CS+RT组中仍具有显著性（p=0.00012和p=0.016）。最后，CS+RT组与CS组相比，局部复发的相对风险为0.35（95%CI 0.25-0.51，p=0.0001）。CS+RT组和CS组分别有7.1%和7.5%的患者随后发生对侧乳腺癌。
尽管缺乏随机分组，但我们的结果与更新后的美国国立外科辅助乳腺和肠道项目B17试验以及欧洲癌症研究与治疗组织10853试验极为一致。我们还注意到，年龄<40岁和/或切除不完全的女性局部复发风险非常高。
