Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less
Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less
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DOI：
10.1200/jco.2002.11.101
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发表时间：
2002-10-15
影响因子：
45.3
通讯作者：
Wolmark, N
中科院分区：
文献类型：
--
作者：
Fisher, B;Bryant, J;Wolmark, N
目的：这项试验是由不确定性的需要乳房照射后肿块切除术的淋巴结阴性妇女浸润性乳腺癌：5 - 1厘米，推测他莫昔芬（TAM）可能是或更有效的比放射治疗（XRT）在减少同侧乳腺肿瘤复发率（IBTR）在这些妇女，和论文，这两种方式可能是更有效的比任何一个单独的。乳房肿瘤切除术后，1,009名妇女被随机分配到TAM组（n = 336），XRT和安慰剂组（n = 336），或XRT和TAM组（n = 337）。IBTR、远处复发和对侧乳腺癌（CBC）的发生率是分析的终点。计算IBTR和CBC的累积发生率，考虑竞争风险。双侧P值为0.05或更低的结果具有统计学意义。结果：XRT和安慰剂导致IBTR的风险率比TAM单独低49%，XRT和TAM导致IBTR的风险率比XRT和安慰剂低63%。当与单独的TAM相比时，XRT加TAM导致lBTR的危险率降低81%。TAM组8年内IBTR的累积发生率为16.5%，XRT和安慰剂组为9.3%，XRT和TAM组为2.8%。无论雌激素受体（ER）状态如何，XRT均可将IBTR降低至低于单独使用TAM达到的水平。远程治疗失败不常见，组间无显著差异（P =.28）。当TAM治疗的妇女与接受XRT和安慰剂的妇女相比，CBC显著降低（风险比，0.45; 95%置信区间，0.21至0.95; P = 0.039）。三组的生存率分别为93%、94%和93%（P = 0.93）。结论：在肿瘤小于或等于1 cm的女性中，在肿瘤切除术后IBTR发生的频率足以证明考虑XRT（无论肿瘤ER状态如何）和TAM加XRT（当肿瘤ER阳性时）是合理的。
Purpose : This trial was prompted by uncertainty about the need for breast irradiation after lumpectomy in node-negative women with invasive breast cancers of :5 1 cm, by speculation that tamoxifen (TAM) might be as or more effective than radiation therapy (XRT) in reducing the rate of ipsilateral breast tumor recurrence (IBTR) in such women, and by the thesis that both modalities might be more effective than either alone.Patients and Methods: After lumpectomy, 1,009 women were randomly assigned to TAM (n = 336), XRT and placebo (n = 336), or XRT and TAM (n = 337). Rates of IBTR, distant recurrence, and contralateral breast cancer (CBC) were among the end points for analysis. Cumulative incidence of IBTR and of CBC was computed accounting for competing risks. Results with two-sided P values of .05 or less were statistically significant.Results: XRT and placebo resulted in a 49% lower hazard rate of IBTR than did TAM alone, XRT and TAM resulted in a 63% lower rate than did XRT and placebo. When compared with TAM alone, XRT plus TAM resulted in an 81% reduction in hazard rate of lBTR. Cumulative incidence of IBTR through 8 years was 16.5% with TAM, 9.3% with XRT and placebo, and 2.8% with XRT and TAM. XRT reduced IBTR below the level achieved with TAM alone, regardless of estrogen receptor (ER) status. Distant treatment failures were infrequent and not significantly different among the groups (P =.28). When TAM-treated women were compared with those who received XRT and placebo, there was a significant reduction in CBC (hazard ratio, 0.45; 95% confidence interval, 0.21 to 0.95; P =.039). Survival in the three groups was 93%, 94%, and 93%, respectively (P =.93).Conclusion: In women with tumors less than or equal to 1 cm, IBTR occurs with enough frequency after lumpectomy to justify considering XRT, regardless of tumor ER status, and TAM plus XRT when tumors are ER positive.