Gelber R D, Bonetti M, Cole B F, Gelber S, Goldhirsch A
Department of Biostatistical Science, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
Recent Results Cancer Res. 1998;152:373-89. doi: 10.1007/978-3-642-45769-2_36.
In the breast cancer adjuvant therapy setting, the critical issue to consider in treatment decision-making is the tradeoff between quality and quantity of life. The toxicities of adjuvant therapies, both acute and late, must be balanced against the potential benefits of delayed recurrence and improved survival. The question should be addressed concerning when quality-of-life assessment is relevant in the adjuvant setting. Such assessments can inform patients about what to expect from their treatment, describe quality-of-life differences between treatments, provide an additional baseline measure with potential prognostic significance, inform clinicians about their patients' experiences with toxicities, indicate situations in which psychosocial interventions might be useful, and document patient adaptation to diagnosis and treatment. The relevance of quality-of-life assessment in the adjuvant setting can be illustrated by investigating one of the most controversial questions of today: When should chemotherapy be added to tamoxifen for postmenopausal patients? Data from the International Breast Cancer Study Group (IBCSG) Trial VII showed that adding 3 months of CMF (cyclophosphamide 100 mg/m2 orally days 1-14; methotrexate 40 mg/m2 i.v. days 1, 8; fluorouracil 600 mg/m2 i.v. days 1, 8; repeated every 28 days) to tamoxifen significantly improved disease-free survival compared with tamoxifen alone. The Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (QTWiST) method was used to compare the adjuvant therapies with respect to quality-adjusted survival. The analysis indicated that the decision to use adjuvant chemotherapy in this setting should be based on patient preferences concerning the relative importance of treatment toxicity versus disease recurrence.
在乳腺癌辅助治疗中，治疗决策时需要考虑的关键问题是生活质量与生命长度之间的权衡。辅助治疗的毒性，包括急性毒性和迟发性毒性，必须与延迟复发和提高生存率的潜在益处相平衡。应该解决在辅助治疗环境中生活质量评估何时相关的问题。此类评估可以让患者了解治疗的预期效果，描述不同治疗之间的生活质量差异，提供具有潜在预后意义的额外基线指标，让临床医生了解患者的毒性反应经历，指出心理社会干预可能有用的情况，并记录患者对诊断和治疗的适应情况。通过研究当今最具争议的问题之一，可以说明生活质量评估在辅助治疗环境中的相关性：绝经后患者何时应在他莫昔芬基础上加用化疗？国际乳腺癌研究组（IBCSG）试验VII的数据显示，与单独使用他莫昔芬相比，在他莫昔芬基础上加用3个月的CMF（环磷酰胺100mg/m²口服第1 - 14天；甲氨蝶呤40mg/m²静脉注射第1、8天；氟尿嘧啶600mg/m²静脉注射第1、8天；每28天重复一次）可显著提高无病生存率。采用无疾病症状或治疗毒性的质量调整时间（QTWiST）方法来比较辅助治疗的质量调整生存率。分析表明，在这种情况下使用辅助化疗的决定应基于患者对治疗毒性与疾病复发相对重要性的偏好。
