Fowble B, Fein D A, Hanlon A L, Eisenberg B L, Hoffman J P, Sigurdson E R, Daly M B, Goldstein L J
Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Int J Radiat Oncol Biol Phys. 1996 Jul 1;35(4):669-77. doi: 10.1016/0360-3016(96)00185-x.
To evaluate the impact of tamoxifen on breast recurrence, cosmesis, complications, overall and cause-specific survival in women with Stage I-II breast cancer and estrogen receptor positive tumors undergoing conservative surgery and radiation.
From 1982 to 1991, 491 women with estrogen receptor positive Stage I-II breast cancer underwent excisional biopsy, axillary dissection, and radiation. The median age of patient population was 60 years with 21% < 50 years of age. The median follow-up was 5.3 years (range 0.1 to 12.8). Sixty-nine percent had T1 tumors and 83% had histologically negative axillary nodes. Re-excision was performed in 49% and the final margin of resection was negative in 64%. One hundred fifty-four patients received tamoxifen and 337 patients received no adjuvant therapy. None of the patients received adjuvant chemotherapy.
There were no significant differences between the two groups for age, race, clinical tumor size, histology, the use of re-excision, or median total dose to the primary. Patients who received tamoxifen were more often axillary node positive (44% tamoxifen vs. 5% no tamoxifen), and, therefore, a greater percentage received treatment to the breast and regional nodes. The tamoxifen patients less often had unknown margins of resection (9% tamoxifen vs. 22% no tamoxifen). The 5-year actuarial breast recurrence rate was 4% for the tamoxifen patients compared to 7% for patients not receiving tamoxifen (p = 0.21). Tamoxifen resulted in a modest decrease in the 5-year actuarial risk of a breast recurrence in axillary node-negative patients, in those with unknown or close margins of resection, and in those who underwent a single excision. Axillary node-positive patients had a clinically significant decrease in the 5-year actuarial breast recurrence rate (21 vs. 4%; p = 0.08). The 5-year actuarial rate of distant metastasis was not significantly decreased by the addition of adjuvant tamoxifen in all patients or pathologic node-negative patients. Pathologically node-positive patients had a significant decrease in distant metastasis (35 vs. 11%; p = 0.02). There were no significant differences in cause-specific survival for patients receiving tamoxifen when compared to observation (95% no tamoxifen vs. 89% tamoxifen; p = 0.24). Similar findings were noted for pathologically node-negative patients. However, axillary node-positive patients receiving tamoxifen had an improvement in 5-year actuarial cause-specific survival (90% tamoxifen vs. 70% no tamoxifen; p = 0.10). Cosmesis (physician assessment) was good to excellent in 85% of the tamoxifen patients compared to 88% of the patients who did not receive tamoxifen.
The addition of tamoxifen to conservative surgery and radiation in women with Stage I-II breast cancer and estrogen receptor positive tumors resulted in a modest but not statistically significant decrease in the 5-year actuarial risk of a breast recurrence. Tamoxifen significantly decreased the 5-year actuarial risk of distant metastasis in axillary node-positive patients and there was a trend towards improvement in cause-specific survival that was not statistically significant. Tamoxifen did not decrease the 5-year actuarial rate of distant metastasis in axillary node negative, patients and in this group, there was no improvement in cause-specific survival. Tamoxifen did not have an adverse effect on cosmesis or complications.
评估他莫昔芬对接受保乳手术及放疗的Ⅰ-Ⅱ期乳腺癌且雌激素受体阳性肿瘤患者的乳腺复发、美容效果、并发症、总生存率及特定病因生存率的影响。
1982年至1991年，491例雌激素受体阳性的Ⅰ-Ⅱ期乳腺癌患者接受了切除活检、腋窝清扫及放疗。患者人群的中位年龄为60岁，21%的患者年龄小于50岁。中位随访时间为5.3年（范围0.1至12.8年）。69%的患者为T1肿瘤，83%的患者腋窝淋巴结组织学检查为阴性。49%的患者进行了再次切除，64%的患者最终切除切缘为阴性。154例患者接受了他莫昔芬治疗，337例患者未接受辅助治疗。所有患者均未接受辅助化疗。
两组在年龄、种族、临床肿瘤大小、组织学类型、再次切除的使用情况或原发灶的中位总剂量方面无显著差异。接受他莫昔芬治疗的患者腋窝淋巴结阳性更为常见（他莫昔芬组为44%，未接受他莫昔芬组为5%），因此，接受乳房及区域淋巴结治疗的比例更高。接受他莫昔芬治疗的患者切除切缘不明的情况较少见（他莫昔芬组为9%，未接受他莫昔芬组为22%）。他莫昔芬治疗组患者的5年精算乳腺复发率为4%，未接受他莫昔芬治疗的患者为7%（p = 0.21）。他莫昔芬使腋窝淋巴结阴性患者、切缘不明或切缘接近的患者以及仅接受一次切除的患者的5年精算乳腺复发风险略有降低。腋窝淋巴结阳性患者的5年精算乳腺复发率有临床显著降低（21%对4%；p = 0.08）。在所有患者或病理淋巴结阴性患者中，加用辅助性他莫昔芬并未显著降低5年远处转移精算率。病理淋巴结阳性患者的远处转移显著降低（35%对11%；p = 0.02）。与观察相比，接受他莫昔芬治疗的患者特定病因生存率无显著差异（未接受他莫昔芬组为95%，他莫昔芬组为89%；p = 0.24）。病理淋巴结阴性患者也有类似发现。然而，接受他莫昔芬治疗的腋窝淋巴结阳性患者的5年精算特定病因生存率有所改善（他莫昔芬组为90%，未接受他莫昔芬组为70%；p = 0.10）。他莫昔芬组85%的患者美容效果（医生评估）为良好至优秀，未接受他莫昔芬治疗的患者为88%。
对于Ⅰ-Ⅱ期乳腺癌且雌激素受体阳性肿瘤的女性患者，在保乳手术及放疗基础上加用他莫昔芬可使5年精算乳腺复发风险略有降低，但无统计学意义。他莫昔芬显著降低了腋窝淋巴结阳性患者的5年精算远处转移风险，且特定病因生存率有改善趋势，但无统计学意义。他莫昔芬未降低腋窝淋巴结阴性患者的5年精算远处转移率，且该组患者的特定病因生存率无改善。他莫昔芬对美容效果或并发症无不良影响。
