JAMA. 1994 May 25;271(20):1587-92. doi: 10.1001/jama.1994.03510440047031.
To assess prospectively the impact on survival and health-related quality of life of two follow-up protocols in patients with early breast cancer.
Randomized controlled clinical trial.
Multicenter study involving 26 general hospitals in Italy.
A consecutive sample of 1320 women younger than 70 years with stage I, II, and III unilateral primary breast cancer.
Patients were randomly assigned to an intensive surveillance, which included physician visits and performance of bone scan, liver echography, chest roentgenography, and laboratory tests at predefined intervals (n = 655), or to a control regimen (n = 665), in which patients were seen by their physicians at the same frequency but only clinically indicated tests were performed. Both groups received a yearly mammogram aimed at detecting contralateral breast cancer.
Primary end points were overall survival and health-related quality of life.
Compliance to the two follow-up protocols was more than 80%. At a median follow-up of 71 months, no difference was apparent in overall survival with 132 deaths (20%) in the intensive group and 122 deaths (18%) in the control group. No significant differences were apparent in time to detection of recurrence between the two groups. Measurements of health-related quality of life (ie, overall health and quality-of-life perception, emotional well-being, body image, social functioning, symptoms, and satisfaction with care) at 6, 12, 24, and 60 months of follow-up did not show differences by type of care received.
Results of this trial support the view that a protocol of frequent laboratory tests and roentgenography after primary treatment for breast cancer does not improve survival or influence health-related quality of life. Routine use of these tests should be discouraged.
前瞻性评估两种随访方案对早期乳腺癌患者生存及健康相关生活质量的影响。
随机对照临床试验。
意大利26家综合医院参与的多中心研究。
连续选取1320名年龄小于70岁、患有I期、II期和III期单侧原发性乳腺癌的女性。
患者被随机分配至强化监测组（n = 655），该组包括医生问诊，并按预定间隔进行骨扫描、肝脏超声检查、胸部X线检查及实验室检测；或对照组（n = 665），对照组患者由医生以相同频率问诊，但仅进行临床指征性检查。两组均接受每年一次旨在检测对侧乳腺癌的乳房X线检查。
主要终点为总生存期及健康相关生活质量。
两种随访方案的依从率均超过80%。中位随访71个月时，强化组132例死亡（20%），对照组122例死亡（18%），总生存期无明显差异。两组间复发检测时间无显著差异。随访6、12、24和60个月时，健康相关生活质量测量（即总体健康和生活质量感知、情绪健康、身体形象、社会功能、症状及对治疗的满意度）未显示因接受的治疗类型不同而存在差异。
本试验结果支持以下观点，即乳腺癌初次治疗后频繁进行实验室检测和X线检查的方案并不能提高生存率或影响健康相关生活质量。应不鼓励常规使用这些检测。
