CHICAGO (EGMN) – A study of 119 cancer patients with solid tumors suggests that the complexity of some oral chemotherapeutic regimens can interfere with adherence to treatment.

Only one-third to one-half of patients on various intermittent regimens was fully compliant with their dosing schedules, reported Barbara A. Given, Ph.D., at the annual Chicago Supportive Oncology Conference.

Patients on simple regimens were much less likely to miss doses of oral drugs or to take doses on off days, according to Dr. Given, a registered nurse and associate dean of research in the college of nursing at Michigan State University in East Lansing.

The study assessed the feasibility of using an automated voice response (AVR) system to remind patients about their dosing schedules, to monitor adherence and medication side effects, and to identify patients in need of additional nursing support.

Investigators randomized patients with solid tumors (primarily of the breast and lung) who were treated with nonhormonal oral biologics to the following three groups:

• Weekly AVR calls during weeks 1-8 for evaluation of adherence and 15 symptoms.

• Weekly AVR calls for adherence and symptom evaluation, as well as nurse follow-up calls during weeks 5-8 if any symptom was above threshold or adherence was 80% or less.

• Weekly AVR calls for adherence evaluation only, with nurse assistance during weeks 5-8 for 80% or less adherence.

Patients were primarily women (82%) with a mean age of 61 years. All participants received a tool kit containing frequently asked questions and symptom self-management strategies. They were interviewed at baseline and at 10 weeks regarding symptom severity, depression, beliefs about oral agents, and cost of therapy.

Initially, 119 patients were enrolled in the study. Through attrition, the number of participants fell to 91 at 10 weeks. Investigators interviewed these patients about their satisfaction with AVR.

Adherence did not differ significantly among patients in any of the three arms, and neither symptom severity nor depression at intake was related to adherence. Symptom severity decreased in all three arms at 10 weeks, although symptom severity among lung cancer patients did not improve. At 8 weeks, 33% of patients had experienced adherence problems, with regimen complexity the major contributor.

“We would like to know what would happen at 12, 15, and 20 weeks, since some of [these patients] are on drugs for a long time,” Dr. Given said.

Based on 100 patients assessed, the percentage who missed three or more doses was 12% among those on a consistent regimen (28 days on medication), but was 60%, 67%, and 38% among those on an intermittent regimen (14 days on, 7 days off; 7 days on, 7 days off; and other regimens, respectively).

Only 2% of patients on a consistent regimen overadhered to treatment (that is, took medication on an off day); however, 48%, 67%, and 13% of patients on the respective intermittent cycles overadhered. “Patients who overadhered by the end of the study really had worse symptoms, which then gave us another set of problems to deal with,” Dr. Given said, reporting that patients who overadhered had an average score of 19 on the Symptom Experience Inventory, whereas those who did not overadhere scored 13.

Patients with breast tumors had a mean SEI score of 18.9 on intake and 12.8 at 10 weeks, whereas lung cancer patients scored a mean of 18.1 on intake and 18.4 at 10 weeks. Patients with other tumors had a mean score of 19.1 on intake and 12.4 at 10 weeks.

Full adherence was found in 88% of patients on the consistent cycle, but in only 36%, 33%, and 50% of patients on the respective intermittent cycles.

More than half of participants reported that AVR helped them manage their symptoms. A Web-based AVR system to help patients with adherence and symptom management “adds value” for patients, practitioners, and payers, and it can improve outcomes by allowing patients to be followed over time, Dr. Given said.

Specialty pharmacies also could help to educate patients, she added.

The Oncology Nursing Society funded the study. Dr. Given had no conflicts of interest.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

芝加哥(EGMN)­——一项入选119例实体瘤患者的研究显示，复杂的口服治疗方案可影响治疗依从性。本研究旨在评价自动语音应答(AVR)系统是否可用于提醒患者服药、监测依从性和药物不良反应以及识别有额外护理需求的患者。

 

研究者将接受非激素类口服生物制剂治疗的实体瘤(主要为乳腺癌和肺癌)患者(主要为女性，82%；平均年龄为61岁)随机分成以下3组。第1组：1~8周期间，每周通过AVR呼叫来评估依从性和15种症状。第2组：每周通过AVR呼叫来评估依从性和症状，如症状高于阈值或依从率≤80%，则在5~8周由护士进行电话随访。第3组：每周通过AVR呼叫来评估依从性，如依从率≤80%，则在5~8周由护士给予协助。向所有患者发放包含常见问题和症状自我管理策略的工具包。在基线时和10周时对患者进行访谈，询问症状严重程度、抑郁、对口服药的看法、以及治疗费用等方面的信息。入组患者最初为119例，但由于减员，患者数量在10周时减至91例。研究者询问了这些患者对AVR的满意度。

 

结果显示，在3组间未观察到依从性存在显著差异。症状严重程度和服药时情绪低落均与依从性无关。10周时，所有3组患者的症状严重程度均降低，但肺癌患者的症状严重程度未见改善。8周时，33%的患者依从性较差，主要原因在于治疗方案复杂。基于所评价的100例患者，漏服次数≥3次的患者比例在连续用药(连服28天)患者中为12%，在间歇用药患者中则较高：在连服14天停服7天者中为60%，在连服7天停服7天者中为67%，在其他间歇用药者中为38%。在连续用药患者中，仅2%对治疗过度依从，意即在停药日也服药；但在上述间歇用药患者中，过度依从率分别为48%、67%和13%。研究结束时，过度依从者的症状更严重，症状体验问卷(Symptom Experience Inventory，SEI)评分平均为19分，而未过度依从者的评分为13分。乳腺癌患者的平均SEI评分在服药时为18.9分，在10周时为12.8分。肺癌患者的平均SEI评分在服药时为18.1分，在10周时为18.4分。其他癌症患者的平均SEI评分在服药时为19.1分，在10周时为12.4分。在连续用药的患者中，完全依从治疗的患者比例为88%，但在间歇用药的患者中，相应比例仅分别为36%、33%和50%。半数以上的患者表示，AVR有助于其管理症状。

 

本研究由肿瘤护理学会资助。研究者声明无经济利益冲突。

 

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