中医草药治疗转移性肺腺癌患者的预后改善是否因治疗延迟偏倚所致？

Is the improvement of prognosis of patients with metastatic pulmonary adenocarcinoma treated with TCM herbal medicine due to lag time to treatment bias?

机构信息

Longhua Hospital, Shanghai, China.

出版信息

Integr Cancer Ther. 2011 Sep;10(3):234-9. doi: 10.1177/1534735411418112. Epub 2011 Aug 23.

DOI:10.1177/1534735411418112

PMID:21862517

Abstract

UNLABELLED

BACKGROUND. Traditional Chinese herbal medicine was associated with improved prognosis in patients with performance score 0-1 at the time of diagnosis of stage IV pulmonary adenocarcinoma (PAC) treated with platinum-based chemotherapy (PBT). OBJECTIVE. The authors investigated the effect of 1- to 4-month lag time to traditional Chinese medicine (TCM) treatment on the median and 1-year survival of PBT-PAC patients.

METHODS

The median lag time to treatment was 3 months. In the first 3 months, about 35% of the patients died, but thereafter the survival curve flattened off and the death of the next 35% to 40% of patients took 9 months. Leaving out patients with lag time up to 3 months therefore would be a reasonable choice. To be on the safe side, the effects of leaving out patients up to 4 months were investigated. The Kaplan-Meier survival curves were used.

RESULTS

The median and 1-year survival of the PBT-PAC patients was 5.0 months and 27%, respectively. Leaving out patients with 0-1 month follow-up, 0-2, 0-3, and 0-4 months follow-up changed the median and 1-year survival, respectively, to 5.5 months and 32%, 6.5 months and 36%, 9.0 months and 43%, and 10.0 months and 52%. The median survival of PBT + TCM in PAC patients was 22.6 months and 78%. Median lag time to TCM treatment was 3.0 months. With up to 4 months lag time to treatment due to combined patients' and TCM doctor's waiting time, the improved survival of PBT + TCM performance score 0-1 (fully ambulant) patients at the time of diagnosis still is significant (P < .01, hazard ratio = 0.51). Moreover, the survival of patients treated by TCM doctors with little or more months lag time to treatment was not different (P = .79).

CONCLUSION

Increasing lag time to treatment up to 4 months improves the median and 1-year survival of PBT patients without TCM but is unlikely to explain the greatly improved prognosis of PBT + TCM treated patients with fully ambulant stage IV PAC.

摘要

背景

在接受铂类化疗（PBT）治疗的 IV 期肺腺癌（PAC）患者中，与诊断时表现评分为 0-1 的患者相比，传统中药（TCM）与预后改善相关。目的：作者研究了从接受 PBT 到开始 TCM 治疗的 1-4 个月的时间延迟对 PAC 患者的中位生存和 1 年生存的影响。方法：中位治疗延迟时间为 3 个月。在前 3 个月中，约有 35%的患者死亡，但此后生存曲线趋于平坦，接下来的 35%-40%的患者死亡需要 9 个月。因此，排除 3 个月内有治疗延迟的患者是合理的选择。为安全起见，还研究了排除 4 个月内有治疗延迟的患者的影响。使用 Kaplan-Meier 生存曲线。结果：PAC 患者的中位生存和 1 年生存率分别为 5.0 个月和 27%。排除随访时间为 0-1 个月、0-2 个月、0-3 个月和 0-4 个月的患者，中位生存和 1 年生存率分别为 5.5 个月和 32%、6.5 个月和 36%、9.0 个月和 43%以及 10.0 个月和 52%。PAC 患者接受 PBT+TCM 的中位生存为 22.6 个月和 78%。TCM 治疗的中位延迟时间为 3.0 个月。由于患者和 TCM 医生的等待时间，将治疗的延迟时间延长至 4 个月，仍可显著改善诊断时表现评分为 0-1（完全能走动）的 PAC 患者的 PBT+TCM 生存（P<.01，风险比=0.51）。此外，治疗延迟时间较少或较多的 TCM 医生治疗的患者的生存无差异（P=0.79）。结论：将治疗延迟时间延长至 4 个月可提高未接受 TCM 治疗的 PBT 患者的中位生存和 1 年生存，但不太可能解释接受 PBT+TCM 治疗的 IV 期 PAC 患者的预后显著改善。