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接受化疗的高危乳腺癌患者的预处理生活质量、体能状态及其与治疗中断和治疗变更的关系:前瞻性随机ADEBAR试验的结果

Pretreatment quality of life, performance status and their relation to treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy: results from the prospective randomized ADEBAR trial.

作者信息

Eichler Martin, Singer Susanne, Janni Wolfgang, Harbeck Nadia, Rack Brigitte, Augustin Doris, Wischnik Arthur, Kiechle Marion, Ettl Johannes, Scholz Christoph, Fink Visnja, Schwentner Lukas

机构信息

Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.

Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.

出版信息

Breast Cancer. 2017 Mar;24(2):319-325. doi: 10.1007/s12282-016-0706-3. Epub 2016 Jun 4.

Abstract

BACKGROUND

Health-related quality of life (QoL) is a self-assessed construct indicating how people feel in regard to aspects of their health. Performance status (PS) is evaluated by the treating physician. We examined whether pretreatment QoL and PS are related to subsequent treatment discontinuation and treatment changes in high-risk breast cancer patients receiving chemotherapy.

METHODS

We conducted a prospective cohort study with data from a randomized phase III trial comparing FEC- and EC-DOC-chemotherapy in patients with primary breast cancer (ADEBAR). We examined the patient's request to discontinue the study, discontinuation due to toxicity, the prolongation of therapy, and dose reduction. Baseline QoL was assessed using the EORTC QLQ-C30. PS was evaluated using the Eastern Cooperative Oncology Group Scale (ECOG). Four QoL scales were selected prior to analysis as outcomes: global health, physical functioning, emotional functioning, and fatigue. Multivariate binary logistic regression analyses were used to test for differences within the independent variables.

MAIN RESULTS

1322 patients were included. 1094 (82.8 %) patients completed therapy according to protocol. 6.3 % stopped therapy due to toxicity and 4.4 % refused treatment. Global health was not related to any of the four QoL outcomes. Physical functioning had the strongest impact on QoL, when comparing the fittest group to the lowest quintile [OR 2.14 (95 % CI 1.00-4.60)]. ECOG 0 compared to worse than 1 was strongly correlated to therapy discontinuation due to toxicity [OR 20.15 (95 % CI 9.48-42.83)] and treatment refusal [OR 8.32 (95 % CI 3.81-18.14)].

CONCLUSIONS

Pretreatment QoL, especially physical functioning, is associated with subsequent therapy discontinuation due to toxicity and with changes of the treatment protocol. Pretreatment performance status is strongly associated with therapy discontinuation due to toxicity and with treatment refusal.

摘要

背景

健康相关生活质量(QoL)是一种自我评估的指标,反映人们对自身健康状况各方面的感受。体能状态(PS)由主治医生进行评估。我们研究了高危乳腺癌化疗患者治疗前的生活质量和体能状态是否与后续治疗中断及治疗方案变更有关。

方法

我们进行了一项前瞻性队列研究,数据来自一项比较原发性乳腺癌患者(ADEBAR)接受FEC和EC-DOC化疗的随机III期试验。我们研究了患者要求退出研究、因毒性反应而中断治疗、治疗延长以及剂量减少的情况。使用欧洲癌症研究与治疗组织生活质量核心问卷(EORTC QLQ-C30)评估基线生活质量。使用东部肿瘤协作组量表(ECOG)评估体能状态。在分析前选择了四个生活质量量表作为结果指标:总体健康、身体功能、情绪功能和疲劳。采用多变量二元逻辑回归分析来检验自变量之间的差异。

主要结果

共纳入1322例患者。1094例(82.8%)患者按方案完成治疗。6.3%因毒性反应停止治疗,4.4%拒绝治疗。总体健康与四个生活质量结果指标均无关。在将身体状况最佳组与最低五分位数组进行比较时,身体功能对生活质量的影响最大[比值比(OR)为2.14(95%置信区间为1.00 - 4.60)]。与ECOG 0相比,ECOG评分大于1与因毒性反应导致的治疗中断[OR为20.15(95%置信区间为9.48 - 42.83)]和治疗拒绝[OR为8.32(95%置信区间为3.81 - 18.14)]密切相关。

结论

治疗前的生活质量,尤其是身体功能,与后续因毒性反应导致的治疗中断以及治疗方案变更有关。治疗前的体能状态与因毒性反应导致的治疗中断和治疗拒绝密切相关。

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