Bertsch L A, Donaldson G
Department of Cancer Therapy, Burroughs Wellcome Co, Research Triangle Park, NC, USA.
Semin Oncol. 1995 Apr;22(2 Suppl 5):45-53; discussion 53-4.
The effect of therapy on a patient's quality of life (QOL) is an important factor in choosing a treatment, especially when the primary intent of therapy is palliation of symptoms. An increasing recognition of the importance of QOL prompted inclusion of QOL assessments in a number of clinical trials of women with breast cancer. This report describes two clinical trials in which women with metastatic breast cancer were treated with intravenous (IV) vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Médicament, Paris, France). In a randomized trial, IV vinorelbine was compared with IV melphalan (Alkeran; Burroughs Wellcome Co) as second- or third-line treatment in patients with anthracycline-refractory breast cancer. In a second, nonrandomized study, vinorelbine was used as first- or second-line treatment in patients who had not received doxorubicin previously. Both studies assessed the QOL dimensions of physical functioning, symptom status, role functioning, and global QOL. In the randomized trial, analyses of linear time trends indicated that patients treated with vinorelbine compared with patients receiving IV melphalan had better physical functioning throughout most of the study. Differences between the two treatment groups in other QOL dimensions were not significant. In the nonrandomized study, patients who received vinorelbine as first-line therapy had worse role functioning and somewhat worse physical functioning than those who received the drug as second-line treatment. Overall, these studies suggest that patients who receive IV vinorelbine treatment maintain a reasonable QOL and that this agent is comparable to or better in some respects than IV melphalan.
治疗对患者生活质量（QOL）的影响是选择治疗方法时的一个重要因素，尤其是当治疗的主要目的是缓解症状时。对生活质量重要性的认识不断提高，促使在多项乳腺癌女性临床试验中纳入了生活质量评估。本报告描述了两项临床试验，其中转移性乳腺癌女性接受了静脉注射长春瑞滨（诺维本；百时美施贵宝公司，北卡罗来纳州三角研究园；法国巴黎皮尔法伯制药公司）治疗。在一项随机试验中，将静脉注射长春瑞滨与静脉注射美法仑（马法兰；百时美施贵宝公司）作为蒽环类难治性乳腺癌患者的二线或三线治疗进行了比较。在第二项非随机研究中，长春瑞滨被用作未接受过阿霉素治疗患者的一线或二线治疗。两项研究均评估了身体功能、症状状态、角色功能和总体生活质量等生活质量维度。在随机试验中，线性时间趋势分析表明，与接受静脉注射美法仑的患者相比，接受长春瑞滨治疗的患者在研究的大部分时间里身体功能更好。两个治疗组在其他生活质量维度上的差异不显著。在非随机研究中，接受长春瑞滨一线治疗的患者比接受二线治疗的患者角色功能更差，身体功能也稍差。总体而言，这些研究表明，接受静脉注射长春瑞滨治疗的患者维持了合理的生活质量，并且该药物在某些方面与静脉注射美法仑相当或更好。
