Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.
Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.
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DOI：
10.1038/s41523-017-0033-7
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发表时间：
2017
影响因子：
5.9
通讯作者：
Ben-Baruch N
中科院分区：
文献类型：
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作者：
Stemmer SM;Steiner M;Rizel S;Geffen DB;Nisenbaum B;Peretz T;Soussan-Gutman L;Bareket-Samish A;Isaacs K;Rosengarten O;Fried G;McCullough D;Svedman C;Shak S;Liebermann N;Ben-Baruch N
复发评分越来越多地用于淋巴结阳性ER+ HER 2阴性乳腺癌。这项前瞻性设计登记研究的回顾性分析评价了2006年1月至2011年12月通过Clalit Health Services进行复发评分测试的淋巴结阳性乳腺癌患者的治疗/结局（N = 709）。审查医疗记录以验证治疗/复发/生存。中位随访时间为5.9年，中位年龄为62岁，53.9%为2级，69.8%肿瘤≤ 2 cm，84.5%为浸润性导管癌，42.0%为N1 mi，37.2%/15.5%/5.2%有1/2/3个阳性淋巴结; 53.4%复发评分< 18，36.4%复发评分18-30，10.2%复发评分≥ 31。总体而言，26.9%的患者接受了辅助化疗：复发评分< 18、18-30和≥ 31组分别为7.1%、39.5%和86.1%。各组的5年Kaplan-Meier远处复发估计值分别为3.2%、6.3%和16.9%，相应的5年乳腺癌死亡估计值分别为0.5%、3.4%和5.7%。复发评分< 18分的患者中，N1 mi/1个阳性淋巴结/2-3个阳性淋巴结的5年远处复发率分别为1.2%、4.4%、5.4%。由于患者未被随机分配接受治疗，并且治疗决策受到复发评分的严重影响，因此根据化疗使用情况对5年远处复发进行的分析是探索性的，应谨慎解释：复发评分< 18时，化疗治疗患者（n = 27）的复发率为7.7%，化疗未治疗患者（n = 352）的复发率为2.9%; P = 0.245。在复发评分18-30中，化疗患者（n = 102）的复发率显著低于未治疗患者（n = 156）（1.0% vs. 9.7%，P = 0.019）;复发评分≤ 25（RxPONDER研究截止值），化疗治疗患者（n = 89）和化疗未治疗患者（n = 488）的复发率分别为2.3%和4.4%; P = 0.521。总之，我们的研究结果支持在微转移/1-3个阳性淋巴结和复发评分< 18的ER+ HER 2阴性乳腺癌患者中单独使用内分泌治疗。如果患有乳腺癌的女性在OncotypeDX上的得分低于18分，那么已经扩散到淋巴结的乳腺癌患者在抗激素治疗中表现良好。来自以色列Petah Tikvah的Rabin医学中心的Salomon Stemmer及其同事对一项大型前瞻性设计的注册表进行了首次分析，其中腋下淋巴结中有乳腺癌细胞的患者进行了称为OncotypeDX的21基因表达分析，以指导他们的治疗。在709名淋巴结阳性、ER阳性、HER阴性疾病的女性中，测试分数低于18的患者在接受抗激素治疗的同时接受化疗或不接受化疗，其复发率也一样好，而那些分数为18至30的患者如果接受两种治疗，复发率显著降低。研究结果表明，只有OncotypeDX评分低于18的女性才能安全地放弃化疗。
The Recurrence Score® is increasingly used in node-positive ER+ HER2-negative breast cancer. This retrospective analysis of a prospectively designed registry evaluated treatments/outcomes in node-positive breast cancer patients who were Recurrence Score-tested through Clalit Health Services from 1/2006 through 12/2011 (N = 709). Medical records were reviewed to verify treatments/recurrences/survival. Median follow-up, 5.9 years; median age, 62 years; 53.9% grade 2; 69.8% tumors ≤ 2 cm; 84.5% invasive ductal carcinoma; 42.0% N1mi, and 37.2%/15.5%/5.2% with 1/2/3 positive nodes; 53.4% Recurrence Score < 18, 36.4% Recurrence Score 18–30, and 10.2% Recurrence Score ≥ 31. Overall, 26.9% received adjuvant chemotherapy: 7.1%, 39.5%, and 86.1% in the Recurrence Score < 18, 18–30, and ≥ 31 group, respectively. The 5-year Kaplan–Meier estimates for distant recurrence were 3.2%, 6.3%, and 16.9% for these respective groups and the corresponding 5-year breast cancer death estimates were 0.5%, 3.4%, and 5.7%. In Recurrence Score < 18 patients, 5-year distant-recurrence rates for N1mi/1 positive node/2–3 positive nodes were 1.2%/4.4%/5.4%. As patients were not randomized to treatment and treatment decision is heavily influenced by Recurrence Score, analysis of 5-year distant recurrence by chemotherapy use was exploratory and should be interpreted cautiously: In Recurrence Score < 18, recurrence rate was 7.7% in chemotherapy-treated (n = 27) and 2.9% in chemotherapy-untreated patients (n = 352); P = 0.245. In Recurrence Score 18–30, recurrence rate in chemotherapy-treated patients (n = 102) was significantly lower than in untreated patients (n = 156) (1.0% vs. 9.7% P = 0.019); in Recurrence Score ≤ 25 (the RxPONDER study cutoff), recurrence rate was 2.3% in chemotherapy-treated (n = 89) and 4.4% in chemotherapy-untreated patients (n = 488); P = 0.521. In conclusion, our findings support using endocrine therapy alone in ER+ HER2-negative breast cancer patients with micrometastases/1–3 positive nodes and Recurrence Score < 18. Women with breast cancer that has spread to the lymph nodes do well on anti-hormone treatment alone if they score under 18 on OncotypeDX. Salomon Stemmer from Rabin Medical Center in Petah Tikvah, Israel, and colleagues conducted the first analysis of a large prospectively designed registry in which patients with breast cancer cells in the underarm lymph nodes have taken the 21-gene expression analysis known as OncotypeDX to guide their treatment. Among the 709 women with node-positive, ER-positive, HER-negative disease, patients with test scores under 18 did just as well if they received chemotherapy or not in addition to anti-hormone treatment, whereas those with scores of 18 to 30 had significantly lower recurrence rates if they received both therapies. The findings suggest that only women with OncotypeDX scores under 18 can safely forgo chemotherapy.
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DOI：
10.1056/nejmoa1510764
发表时间：
2015-11-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Sparano JA;Gray RJ;Makower DF;Pritchard KI;Albain KS;Hayes DF;Geyer CE Jr;Dees EC;Perez EA;Olson JA Jr;Zujewski J;Lively T;Badve SS;Saphner TJ;Wagner LI;Whelan TJ;Ellis MJ;Paik S;Wood WC;Ravdin P;Keane MM;Gomez Moreno HL;Reddy PS;Goggins TF;Mayer IA;Brufsky AM;Toppmeyer DL;Kaklamani VG;Atkins JN;Berenberg JL;Sledge GW
通讯作者：
Sledge GW
DOI：
10.1093/annonc/mds512
发表时间：
2013-03
期刊：
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子：
--
作者：
Eiermann W;Rezai M;Kümmel S;Kühn T;Warm M;Friedrichs K;Schneeweiss A;Markmann S;Eggemann H;Hilfrich J;Jackisch C;Witzel I;Eidtmann H;Bachinger A;Hell S;Blohmer J
通讯作者：
Blohmer J
影响因子：
158.5
作者：
Cardoso, F.;van't Veer, L. J.;Piccart, M.
通讯作者：
Piccart, M.
影响因子：
5.9
作者：
Petkov VI;Miller DP;Howlader N;Gliner N;Howe W;Schussler N;Cronin K;Baehner FL;Cress R;Deapen D;Glaser SL;Hernandez BY;Lynch CF;Mueller L;Schwartz AG;Schwartz SM;Stroup A;Sweeney C;Tucker TC;Ward KC;Wiggins C;Wu XC;Penberthy L;Shak S
通讯作者：
Shak S
影响因子：
--
作者：
Fried G;Moskovitz M
通讯作者：
Moskovitz M