Cummings F J, Gray R, Tormey D C, Davis T E, Volk H, Harris J, Falkson G, Bennett J M
Brown University, Providence, RI.
J Clin Oncol. 1993 Jan;11(1):29-35. doi: 10.1200/JCO.1993.11.1.29.
This study analyzes the long-term results and causes of death in elderly women with node-positive breast cancer who participated in a double-blind adjuvant trial that compared tamoxifen with placebo to determine the benefit of 2 years of treatment.
One hundred eighty-one women 65 to 84 years old were given 20 mg of tamoxifen or placebo daily for 2 years after stratification by estrogen receptor status, tumor size, and degree of lymph node involvement. Approximately 30% of patients were older than 70 years and 20% were older than 75 years. Eighty-five percent were estrogen receptor-positive. Median follow-up was 10 years.
Among the 168 eligible patients, there have been 98 recurrences (59 placebo v 39 tamoxifen), with reduced distant and bone-only first sites in patients treated with tamoxifen. Median time to failure was 4.4 years for placebo versus 7.4 years for tamoxifen (log-rank P = .001). A similar number of new nonbreast cancers occurred in each arm (seven placebo v six tamoxifen), but a reduced number of opposite-breast cancers (five placebo v one tamoxifen) was noted. Overall, there were 102 deaths (57 placebo v 45 tamoxifen). Median survivals were 8.0 years with placebo and 8.5 years with tamoxifen (log-rank P = .063); 50% of the tamoxifen patients and 33% of the placebo patients are still alive. Sixty-one percent of the deaths were reported to have been caused by breast cancer recurrence, 4% by other cancers, and 22% by the sequelae of non-cancer-related illness, with equal distributions for cardiovascular and cerebrovascular disease. There was no increase in the number of endometrial or other types of cancer, or thrombotic or orthopedic complications in this older group.
Tamoxifen currently is the treatment of choice for elderly women with breast cancer. It extends the time to treatment failure by 3 years and reduces the number of recurrences, deaths, distant and bone-only first recurrences, and second breast cancers.
本研究分析了参加一项双盲辅助试验的老年淋巴结阳性乳腺癌女性患者的长期结果和死亡原因，该试验比较了他莫昔芬与安慰剂，以确定2年治疗的益处。
181名年龄在65至84岁之间的女性在根据雌激素受体状态、肿瘤大小和淋巴结受累程度分层后，每天服用20毫克他莫昔芬或安慰剂，持续2年。约30%的患者年龄超过70岁，20%的患者年龄超过75岁。85%为雌激素受体阳性。中位随访时间为10年。
在168名符合条件的患者中，有98例复发（安慰剂组59例，他莫昔芬组39例），他莫昔芬治疗的患者远处和仅骨转移的首发部位减少。安慰剂组的中位失败时间为4.4年，他莫昔芬组为7.4年（对数秩检验P = .001）。每组发生的新发非乳腺癌数量相似（安慰剂组7例，他莫昔芬组6例），但对侧乳腺癌数量减少（安慰剂组5例，他莫昔芬组1例）。总体而言，有102例死亡（安慰剂组57例，他莫昔芬组45例）。安慰剂组的中位生存期为8.0年，他莫昔芬组为8.5年（对数秩检验P = .063）；50%的他莫昔芬组患者和33%的安慰剂组患者仍然存活。据报告，61%的死亡是由乳腺癌复发引起的，4%是由其他癌症引起的，22%是由非癌症相关疾病后遗症引起的，心血管疾病和脑血管疾病分布相等。在这个老年组中，子宫内膜癌或其他类型癌症的数量、血栓形成或骨科并发症均未增加。
他莫昔芬目前是老年乳腺癌女性的首选治疗药物。它将治疗失败时间延长了3年，并减少了复发、死亡、远处和仅骨转移的首次复发以及对侧乳腺癌的数量。
