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在早期乳腺癌的当前临床实践中,化疗方案期间的患者报告毒性。

Patient-Reported Toxicities During Chemotherapy Regimens in Current Clinical Practice for Early Breast Cancer.

机构信息

School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA

Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

出版信息

Oncologist. 2019 Jun;24(6):762-771. doi: 10.1634/theoncologist.2018-0590. Epub 2018 Dec 14.

Abstract

BACKGROUND

This study explores the incidence of patient-reported major toxicity-symptoms rated "moderate," "severe," or "very severe"-for chemotherapy regimens commonly used in early breast cancer.

PATIENTS AND METHODS

Female patients aged 21 years or older completed a validated Patient-Reported Symptom Monitoring instrument and rated 17 symptoms throughout adjuvant or neoadjuvant chemotherapy. Fisher's exact tests compared differences in percentages in symptom ratings, and general linear regression was used to model the incidence of patient-reported major toxicity.

RESULTS

In 152 patients, the mean age was 54 years (range, 24-77), and 112 (74%) were white; 51% received an anthracycline-based regimen. The proportion of patients rating fatigue, constipation, myalgia, diarrhea, nausea, peripheral neuropathy, and swelling of arms or legs as a major toxicity at any time during chemotherapy varied significantly among four chemotherapy regimens ( < .05). The mean (SD) number of symptoms rated major toxicities was 6.3 (3.6) for anthracycline-based and 4.4 (3.5) for non-anthracycline-based regimens ( = .001; possible range, 0-17 symptoms). Baseline higher body mass index ( = .03), patient-reported Karnofsky performance status ≤80 ( = .0003), and anthracycline-based regimens ( = .0003) were associated with greater total number of symptoms rated major toxicities (alternative model: chemotherapy duration, < .0001). Twenty-six percent of dose reductions (26 of 40), 75% of hospitalizations (15 of 20), and 94% of treatment discontinuations (15 of 16) were in anthracycline-based regimens.

CONCLUSION

Capturing multiple toxicity outcomes throughout chemotherapy enables oncologists and patients to understand the range of side effects as they discuss treatment efficacies. Continuous symptom monitoring may aid in the timely development of interventions that minimize toxicity and improve outcomes IMPLICATIONS FOR PRACTICE: This study investigated patient-reported toxicities for 17 symptoms recorded prospectively during adjuvant and neoadjuvant chemotherapy regimens for early breast cancer. An analysis of four commonly used chemotherapy regimens identified significant differences among regimens in both individual symptoms and total number of symptoms rated moderate, severe, or very severe. Longer chemotherapy regimens, such as anthracycline-based regimens followed by paclitaxel, had higher proportions of symptoms rated major toxicities. The inclusion of patient perspectives on multiple toxicity outcomes at the same time at multiple time points during chemotherapy has the potential for improving patient-provider communication regarding symptom management, patient satisfaction, and long-term clinical outcomes.

摘要

背景

本研究探讨了在早期乳腺癌中常用的化疗方案中,患者报告的主要毒性症状(评为“中度”、“重度”或“非常严重”)的发生率。

方法

21 岁及以上的女性患者完成了经过验证的患者报告症状监测工具,并在辅助或新辅助化疗期间对 17 种症状进行了评分。Fisher 确切检验比较了症状评分百分比的差异,使用广义线性回归模型对患者报告的主要毒性发生率进行建模。

结果

在 152 名患者中,平均年龄为 54 岁(范围为 24-77 岁),112 名(74%)为白人;51%接受了基于蒽环类药物的方案。在化疗期间,四种化疗方案中疲劳、便秘、肌痛、腹泻、恶心、周围神经病和手臂或腿部肿胀被评为主要毒性的患者比例存在显著差异(<0.05)。基于蒽环类药物的方案和非蒽环类药物的方案中,被评为主要毒性的症状平均(SD)数量分别为 6.3(3.6)和 4.4(3.5)(=0.001;可能范围为 0-17 种症状)。基线较高的体重指数(=0.03)、患者报告的 Karnofsky 表现状态≤80(=0.0003)和基于蒽环类药物的方案(=0.0003)与被评为主要毒性的症状总数较多相关(替代模型:化疗持续时间,<0.0001)。26%的剂量减少(26/40)、75%的住院(15/20)和 94%的治疗中断(15/16)发生在基于蒽环类药物的方案中。

结论

在化疗过程中持续监测多种毒性结局,使肿瘤学家和患者能够了解治疗疗效的同时了解副作用的范围。连续的症状监测可能有助于及时制定干预措施,最大限度地减少毒性并改善结局。

实践意义

本研究前瞻性地调查了接受辅助和新辅助化疗方案治疗早期乳腺癌的患者报告的 17 种症状的毒性。对四种常用化疗方案的分析发现,方案之间在个体症状和评为中度、重度或非常严重的症状总数方面存在显著差异。例如,基于蒽环类药物的方案后加紫杉醇的化疗方案时间更长,被评为主要毒性的症状比例更高。在化疗期间的多个时间点同时纳入患者对多种毒性结局的看法,有可能改善患者与提供者之间关于症状管理、患者满意度和长期临床结局的沟通。

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