Bernhard J, Hürny C, Maibach R, Herrmann R, Laffer U
SIAK Coordinating Center, Bern, Switzerland.
Ann Oncol. 1999 Jul;10(7):775-82. doi: 10.1023/a:1008311918967.
We examined whether patients with colon cancer undergoing surgery with or without adjuvant chemotherapy change the internal standards on which they base their quality-of-life (QL) estimation, and, if they do so, whether this reframing alters interpretation of QL findings. These questions were addressed within a randomized clinical trial of the Swiss Group for Clinical Cancer Research (SAKK 40/93).
After radical resection of adenocarcinoma of the colon (pT1-4pN > 0M0 and pT3-4pN0M0) and perioperative chemotherapy, patients were randomized to three treatment arms: observation only (A), 5-FU 450 mg/m2 plus Levamisol (B), or 5-FU 600 mg/m2 (C). QL was measured by linear analogue self-assessment indicators. Patients estimated their pre-surgery QL both before surgery and retrospectively thereafter, and their pre-adjuvant QL both at the beginning of randomly assigned chemotherapy or observation and retrospectively about two months later. Thereafter, current QL was assessed. Paired t-tests were used to test the hypotheses of no change.
Overall, 187 patients with at least one pair of corresponding questionnaires were analyzed. Patients estimated their pre-surgery QL after surgery significantly lower than before and their pre-adjuvant QL under treatment or observation also lower than at the beginning. In the adjuvant phase, in contradiction to our hypothesis, chemotherapy had almost no impact on these changes attributed to reframing. Conventionally assessed changes indicated an improvement in QL. Patients with treatment C reported less improvement in functional performance than those with B or those under observation (P = 0.04). Patients with treatment B indicated a greater worsening in nausea/vomiting than those with C, whereas patients with observation only showed an improvement (P = 0.0009). After adjustment of current QL scores under treatment or observation to patients' retrospective estimation, the treatment effects were diluted but the overall improvement was substantially amplified in most QL indicators.
Patients with colon cancer substantially reframe their perception in estimating QL both under radical resection and under adjuvant chemotherapy or observation. This effect is an integral part of patients' adaptation to disease and treatment. An understanding of this phenomenon is of particular relevance for patient care. Its role in evaluating QL endpoints in clinical trials needs further investigation.
我们研究了接受手术且无论有无辅助化疗的结肠癌患者是否会改变其用于评估生活质量（QL）的内部标准，以及如果他们这样做了，这种重新构建是否会改变对QL结果的解读。这些问题在瑞士临床癌症研究组（SAKK 40/93）的一项随机临床试验中进行了探讨。
在结肠癌腺癌（pT1 - 4pN＞0M0和pT3 - 4pN0M0）根治性切除及围手术期化疗后，患者被随机分为三个治疗组：仅观察（A组）、5-氟尿嘧啶450mg/m²加左旋咪唑（B组）或5-氟尿嘧啶600mg/m²（C组）。QL通过线性模拟自评指标进行测量。患者在手术前及术后回顾性地评估其术前QL，在随机分配的化疗或观察开始时及约两个月后回顾性地评估其辅助化疗前QL。此后，评估当前QL。采用配对t检验来检验无变化的假设。
总体上，对187例至少有一对相应问卷的患者进行了分析。患者术后评估的术前QL显著低于术前，且在治疗或观察期间评估的辅助化疗前QL也低于开始时。在辅助治疗阶段，与我们的假设相反，化疗对这些因重新构建而产生的变化几乎没有影响。传统评估的变化表明QL有所改善。C组患者在功能表现方面的改善程度低于B组患者或观察组患者（P = 0.04）。B组患者在恶心/呕吐方面的恶化程度大于C组患者，而仅观察组患者有所改善（P = 0.0009）。在将治疗或观察期间的当前QL评分调整为患者的回顾性评估后，治疗效果被稀释，但大多数QL指标的总体改善幅度显著增大。
结肠癌患者在根治性切除以及辅助化疗或观察期间评估QL时会大幅重新构建其认知。这种效应是患者适应疾病和治疗的一个组成部分。理解这一现象对患者护理尤为重要。其在临床试验中评估QL终点方面的作用需要进一步研究。
