Bernhard J, Hürny C, Coates A S, Peterson H F, Castiglione-Gertsch M, Gelber R D, Goldhirsch A, Senn H J, Rudenstam C M
IBCSG Coordinating Center, Bern, Switzerland.
Ann Oncol. 1997 Sep;8(9):825-35. doi: 10.1023/a:1008269715091.
The International Breast Cancer Study Group (IBCSG) has developed and approach for assessing the impact of adjuvant therapy on quality of life (QL) within the framework of international, multilingual clinical trials. The major steps are summarized. Conceptual, methodological and practical issues are discussed with reference to results of two trials closed to accrual (IBCSG VI, VII) and one subsequent ongoing trial (IBCSG IX).
QL was assessed in pre- and post-menopausal patients with operable breast cancer. Various single-item linear analogue self-assessment (LASA) scales were used as indicators of components of QL, including global indicators of well-being, functioning and health perception, and specific indicators of symptoms of disease and treatment. In trials VI and VII, QL was assessed at baseline, during adjuvant treatment and follow-up, and at recurrence. Based on this experience, the QL form was revised for subsequent trials and further investigated in a subsample of patients randomized into trial IX.
In trials VI and VII, the QL indicators were responsive to the impact of biomedical factors at baseline, various adjuvant treatments, changes over the first 18 months, and recurrence. In trial IX, the revised QL form was well accepted by patients and staff. Completing this form did not exceed five minutes. QL differences between on and off cytotoxic treatment strengthen the claim that these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators.
Results from two trials closed to accrual and an ongoing trial confirm the feasibility, validity and clinical relevance of the IBCSG approach for studying the impact of adjuvant breast cancer therapy on QL in international clinical trials.
国际乳腺癌研究组（IBCSG）已制定了一种方法，用于在国际多语言临床试验框架内评估辅助治疗对生活质量（QL）的影响。现将主要步骤进行总结。结合两项已停止入组的试验（IBCSG VI、VII）以及一项后续正在进行的试验（IBCSG IX）的结果，对概念、方法和实际问题展开讨论。
对可手术乳腺癌的绝经前和绝经后患者的生活质量进行评估。使用各种单项线性模拟自评（LASA）量表作为生活质量各组成部分的指标，包括总体幸福感、功能和健康认知的综合指标，以及疾病和治疗症状的特定指标。在试验VI和VII中，于基线期、辅助治疗期间及随访期以及复发时对生活质量进行评估。基于这一经验，对生活质量表格进行了修订，用于后续试验，并在随机分组进入试验IX的患者亚组中进一步研究。
在试验VI和VII中，生活质量指标对基线期的生物医学因素影响、各种辅助治疗、最初18个月内的变化以及复发情况均有反应。在试验IX中，修订后的生活质量表格得到了患者和工作人员的良好接受。完成该表格不超过五分钟。细胞毒性治疗开启与关闭时的生活质量差异进一步证明了这些测量方法具有反应性。相关性和逻辑回归分析显示了各种综合指标和特定指标之间的预期关系。
两项已停止入组的试验和一项正在进行的试验结果证实了IBCSG方法在国际临床试验中研究辅助性乳腺癌治疗对生活质量影响方面的可行性、有效性和临床相关性。
