de Haes H, Olschewski M, Kaufmann M, Schumacher M, Jonat W, Sauerbrei W
Academic Medical Center, University of Amsterdam, 1105 AZ Amsterdam, The Netherlands.
J Clin Oncol. 2003 Dec 15;21(24):4510-6. doi: 10.1200/JCO.2003.11.064. Epub 2003 Nov 10.
To compare quality of life (QoL) in premenopausal and perimenopausal patients with node-positive, early breast cancer treated with the endocrine agent goserelin (Zoladex; AstraZeneca Pharmaceuticals LP, Wilmington, DE) or cyclophosphamide + methotrexate + fluorouracil (CMF).
Patients from 86 centers worldwide were randomly assigned to receive either goserelin (3.6 mg every 28 days for 2 years; n = 514) or CMF (six 28-day cycles; n = 496), and were included in the QoL study. QoL was assessed using a self-administered patient questionnaire that consisted of 39 items from the Rotterdam Symptom Checklist, including dimensions evaluating physical and psychological symptom distress, activities of daily living, hormonal effects, and an assessment of overall QoL.
Early benefits were noted during months 3 to 6 of treatment, for goserelin compared with CMF. Significant differences were found for changes in overall QoL (eg, 6.96 +/- 0.88 v 0.69 +/- 0.92 at 6 months; P <.0001) and for physical symptom distress, activity levels, and "effort to cope with illness" dimensions. At 1, 2, and 3 years, there were no significant differences in overall QoL or specific QoL dimensions. Scores for hormonal symptoms were worse with goserelin during the 2-year goserelin treatment period; however, this trend was reversed at 3 years.
Goserelin offers improved overall QoL during the first 6 months of therapy compared with CMF chemotherapy in premenopausal and perimenopausal patients with early breast cancer. Coupled with equivalent efficacy in estrogen receptor-positive patients, these data support the use of goserelin as an alternative to CMF in premenopausal and perimenopausal patients with estrogen receptor-positive, node-positive early breast cancer.
比较戈舍瑞林（诺雷德；阿斯利康制药有限公司，特拉华州威尔明顿）或环磷酰胺+甲氨蝶呤+氟尿嘧啶（CMF）治疗的绝经前和围绝经期淋巴结阳性早期乳腺癌患者的生活质量（QoL）。
来自全球86个中心的患者被随机分配接受戈舍瑞林（每28天3.6毫克，共2年；n = 514）或CMF（六个28天周期；n = 496），并纳入生活质量研究。使用一份患者自行填写的问卷评估生活质量，该问卷由鹿特丹症状清单中的39个项目组成，包括评估身体和心理症状困扰、日常生活活动、激素影响以及总体生活质量的维度。
与CMF相比，戈舍瑞林在治疗的第3至6个月出现早期益处。在总体生活质量变化方面（例如，6个月时为6.96±0.88对0.69±0.92；P<.0001）以及身体症状困扰、活动水平和“应对疾病的努力”维度方面发现了显著差异。在1年、2年和3年时，总体生活质量或特定生活质量维度没有显著差异。在戈舍瑞林治疗的2年期间，戈舍瑞林组的激素症状评分更差；然而，这种趋势在3年时逆转。
与CMF化疗相比，戈舍瑞林在绝经前和围绝经期早期乳腺癌患者治疗的前6个月可改善总体生活质量。再加上在雌激素受体阳性患者中具有同等疗效，这些数据支持在绝经前和围绝经期雌激素受体阳性、淋巴结阳性早期乳腺癌患者中使用戈舍瑞林替代CMF。
