Schumacher K, Schneider B, Reich G, Stiefel T, Stoll G, Bock P R, Hanisch J, Beuth J
Institut fuer Biometrie, Medizinische Hochschule Hannover, Konstanty-Gutschow-Str. 8, 30625 Hannover, Germany.
Anticancer Res. 2003 Nov-Dec;23(6D):5081-7.
This epidemiological study was performed to evaluate the influence of postoperative complementary treatment with lectin-standardized mistletoe extract (sME) on breast cancer patients. The design (retrolective cohort analysis with parallel groups) and conduct of the study were in agreement with current standards for prospectively randomized clinical trials. A cohort of 1,248 breast cancer patients on postoperative chemo-, radio-, hormone-therapy were studied in 27 randomized centers. Patients with complementary medications other than sME were excluded from the evaluation and the final analysis was performed on data of 689 patients. From this cohort 219 patients received a complementary treatment exclusively with sME (therapy group), while 470 patients were without complementary treatment (control group). The median follow-up time was 284 days (therapy group) and 285 days (control group). The primary end-point of the study was to determine the impact of complementary sME treatment on disease- or therapy-induced adverse reactions in breast cancer patients. Imbalances for causal effects (covariates) were adjusted by propensity scores. Final evaluation was performed by estimating the linear regression between change in symptom score and propensity score with all data and using the regression line to calculate the change in symptom score expected for each patient. Tumor-associated events were evaluated by number and time until event. The safety of sME treatment was analysed in terms of number, severity, duration and outcome of adverse reactions. As compared to breast cancer patients without complementary treatment (control group), the administration of sME (therapy group) resulted in a significant reduction of adverse reactions induced by the tumor-destructive therapies (e.g. nausea, gastro-intestinal tract symptoms, depression, fatigue, mental symptoms) and prolonged relapse-free intervals, most pronounced for UICC stages IIa and IIb. The rate of sME-associated adverse reactions was 12.8%. All side-effects were mild to moderate, predominantly local skin reactions and self-limiting without therapeutic intervention. Complementary treatment of breast cancer patients with lectin-standardized mistletoe extract (sME) proved to be a well tolerated optimization of standard tumor-destructive therapies, mainly improving quality of life and relapse-free intervals in defined UICC stages.
本流行病学研究旨在评估术后使用凝集素标准化槲寄生提取物（sME）进行辅助治疗对乳腺癌患者的影响。该研究的设计（平行组回顾性队列分析）和实施符合前瞻性随机临床试验的现行标准。在27个随机中心对1248例接受术后化疗、放疗、激素治疗的乳腺癌患者进行了研究。除sME外使用其他辅助药物的患者被排除在评估之外，最终对689例患者的数据进行了分析。在该队列中，219例患者仅接受sME辅助治疗（治疗组），而470例患者未接受辅助治疗（对照组）。中位随访时间为284天（治疗组）和285天（对照组）。该研究的主要终点是确定辅助sME治疗对乳腺癌患者疾病或治疗引起的不良反应的影响。通过倾向得分调整因果效应（协变量）的不平衡。通过估计所有数据的症状评分变化与倾向得分之间的线性回归并使用回归线计算每个患者预期的症状评分变化来进行最终评估。通过事件数量和直至事件发生的时间评估肿瘤相关事件。根据不良反应的数量、严重程度、持续时间和结果分析sME治疗的安全性。与未接受辅助治疗的乳腺癌患者（对照组）相比，sME给药（治疗组）导致肿瘤破坏性治疗引起的不良反应显著减少（如恶心、胃肠道症状、抑郁、疲劳、精神症状），并延长了无复发生存期，在国际抗癌联盟（UICC）IIa期和IIb期最为明显。sME相关不良反应的发生率为12.8%。所有副作用均为轻度至中度，主要为局部皮肤反应且无需治疗干预可自行缓解。事实证明，用凝集素标准化槲寄生提取物（sME）对乳腺癌患者进行辅助治疗是对标准肿瘤破坏性治疗的一种耐受性良好的优化，主要改善了特定UICC分期患者的生活质量和无复发生存期。
