Seidman A D, Portenoy R, Yao T J, Lepore J, Mont E K, Kortmansky J, Onetto N, Ren L, Grechko J, Beltangady M
Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA.
J Natl Cancer Inst. 1995 Sep 6;87(17):1316-22. doi: 10.1093/jnci/87.17.1316.
Despite the clinical benefit that may be associated with reduction of tumor volume, chemotherapy may produce physical or psychological distress that could compromise a patient's quality of life. Although palliation may be as relevant as tumor response in patients with metastatic breast cancer, quality of life is not commonly evaluated in phase II clinical trials of new therapeutic agents.
We evaluated the utility of quality-of-life assessment in two phase II clinical trials of patients receiving paclitaxel (Taxol) and recombinant human granulocyte colony-stimulating factor (rhG-CSF) as salvage therapy for metastatic breast cancer.
A battery of instruments (i.e., Memorial Symptom Assessment Scale [MSAS], Functional Living Index-Cancer [FLIC], Rand Mental Health Inventory [MHI], Brief Pain Inventory [BPI], and Memorial Pain Assessment Card [MPAC]) designed to capture information about social, psychological, and functional aspects of quality of life, as well as symptom prevalence and distress, was completed prior to treatment; serial assessments were obtained at regular intervals during the treatment period. Univariate and multivariate analyses were performed evaluating base-line quality-of-life parameters and standard prognostic factors in relation to outcome measures of survival, tumor response, and toxicity. For 30 consecutive patients with extensive prior chemotherapy for metastatic disease, longitudinal data were analyzed associating tumor response to changes in quality-of-life scores throughout the course of treatment with paclitaxel.
Base-line scores of two validated quality-of-life instruments, the MSAS and the FLIC, independently predicted the overall survival (P < .01 for each). In this model, however, neither standard prognostic factors nor quality of life instruments predicted the likelihood of tumor response or the probability of encountering grade 3 or grade 4 nonhematologic toxicity. With serial assessments of quality of life, the majority of patients who achieved partial tumor response or stable disease reported improved or unchanged quality-of-life scores, while those patients with progressive disease experienced rapid deterioration in quality of life.
Base-line quality-of-life assessment may provide prognostic information distinct from that obtained through standard prognostic indicators alone. The combination of two factors--extent of disease and a base-line quality-of-life assessment--predicted survival more accurately than either used separately. Evaluation of quality-of-life outcomes in relation to tumor response may illuminate previously unmeasured palliative effects of chemotherapy, such as pain relief, as well as the burdens it imposes.
Information obtained from quality-of-life assessment in conjunction with phase II testing of new chemotherapeutic agents for metastatic breast cancer can guide quality-of-life evaluation planned in large, randomized future studies.
尽管肿瘤体积缩小可能带来临床益处，但化疗可能会产生身体或心理上的痛苦，进而影响患者的生活质量。在转移性乳腺癌患者中，姑息治疗可能与肿瘤反应同样重要，但在新治疗药物的II期临床试验中，生活质量通常未得到评估。
我们在两项II期临床试验中评估了生活质量评估的效用，这两项试验的患者接受紫杉醇（泰素）和重组人粒细胞集落刺激因子（rhG-CSF）作为转移性乳腺癌的挽救治疗。
在治疗前完成一组旨在获取有关生活质量的社会、心理和功能方面信息以及症状发生率和痛苦程度的工具（即纪念症状评估量表[MSAS]、癌症功能生活指数[FLIC]、兰德心理健康量表[MHI]、简明疼痛量表[BPI]和纪念疼痛评估卡[MPAC]）；在治疗期间定期进行系列评估。进行单变量和多变量分析，评估基线生活质量参数和标准预后因素与生存、肿瘤反应和毒性的结局指标之间的关系。对于30例先前因转移性疾病接受过广泛化疗的连续患者，分析纵向数据，将肿瘤反应与使用紫杉醇治疗全过程中生活质量评分的变化相关联。
两种经过验证的生活质量工具MSAS和FLIC的基线评分独立预测了总生存期（每种工具的P <.01）。然而，在该模型中，标准预后因素和生活质量工具均未预测肿瘤反应的可能性或发生3级或4级非血液学毒性的概率。通过对生活质量的系列评估，大多数实现部分肿瘤反应或疾病稳定的患者报告生活质量评分改善或未改变，而疾病进展的患者生活质量迅速恶化。
基线生活质量评估可能提供不同于仅通过标准预后指标获得的预后信息。疾病范围和基线生活质量评估这两个因素的组合比单独使用任何一个因素更准确地预测生存。评估与肿瘤反应相关的生活质量结局可能会揭示化疗以前未被测量的姑息作用，如疼痛缓解，以及化疗带来的负担。
从生活质量评估中获得的信息以及转移性乳腺癌新化疗药物的II期试验可以指导未来大型随机研究中计划的生活质量评估。
