肿瘤患者的实际存活率低于临床试验结果
2012-06-04 00:04:04   来源： 丁香园   作者：  评论：0 点击：

1、CHICAGO -- Older patients with advanced cancers treated in the community had survival that fell short of that for patients who received the same regimens in clinical trials, analysis of a large government database showed.
在芝加哥，一项大型政府资料分析显示，在社区接受治疗的癌症晚期年长患者的生存期低于在临床试验中应用同样疗法的患者。
2、 Most of the differences were small in absolute terms, except for patients with stage IV colorectal cancer treated with the FOLFIRI chemotherapy regimen. Patients in the community had a median survival of 16.1 months, which was 30% lower than that of patients treated with the same regimen in a cooperative-group randomized clinical trial.
绝对的说，大部分的差异是不大的，除了接受FOLFIRI化疗的四期肠癌患者。社区治疗的患者中位生存期是16.1个月，这要比在医院接受相同治疗的随机对照组患者低30%。
3、 Moreover, survival among FOLFIRI-treated older patients was 4 months shorter than that of older patients treated with FOLFOX chemotherapy, Elizabeth B. Lamont, MD, reported here at the American Society of Clinical Oncology meeting.
此外，伊丽莎白B.拉蒙特博士在美国临床肿瘤协会会议上报道“接受FOLFIRI方案治疗的老年患者比接受FOLFOX化疗方案者生存期短4个月。
4、"The average survival for elderly Medicare patients with the advanced GI and lung cancers following aggressive, standard, first-line chemotherapy is shorter than that of study subjects on clinical trials," Lamont, of Harvard and Massachusetts General Hospital in Boston, told MedPage Today via email.
位于波士顿的哈佛及马萨诸塞州总医院的雷蒙特通过电子邮件告诉MedPage Today ，接受侵入性的、标准化的一线化疗药物治疗的患有晚期GI及肺癌的老年患者，其生存期低于临床试验的志愿者。
5、"This finding is important [because] results of clinical trials determine the 'standard of care' chemotherapy treatment regimens for community cancer patients, most of whom are elderly. If trial results systematically overestimate treatment-specific survival for elderly Medicare patients in the community, then this raises the possibility that what is considered the 'community standard' therapy may not actually be the best therapy for these patients."
“此项发现是重要的，因为临床试验的结果可用来确定在社区接受化疗的‘看护标准’， 这些患者大部分是老年人。如果试验结果显示（过去的）治疗方法估价过高-对于在社区接受老年医疗保健治疗的患者而言，那么这项试验结果就有可能说明过去遵 行的对老年患者进行治疗的‘社区标准’不是最好的。
6、Secondly, she continued, physicians in clinical practice often cite survival data from trials when discussing treatment decisions with patients.
其次，有临床经验的医师在与患者讨论治疗方案时常会引用试验治疗的生存期。
7、"Our results show that the survival estimates from trial patients are not generalizable to elderly Medicare patients treated in the community," said Lamont.
“我们的结果显示，来自试验治疗患者的生存期评估不能应用于在社区接受老年保健计划治疗的患者”。
8、 Historically, older patients have been underrepresented in oncology clinical trials that have determined current standards of therapy for advanced cancers. Consequently, relatively little information has accumulated to determine survival of such patients in real-world settings, Lamont and colleagues noted in their background information.
历史上，在肿瘤临床试验中，对晚期癌症患者的治疗标准，没有充分选择老年患者（进行评估）。在其背景资料中，雷蒙特及其同事标注到。
9、 In an effort to gain a better understanding of older patients' outcomes, investigators queried the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) database linked to Medicare claims records. They identified patients with advanced lung or GI cancers treated in usual-care settings within 6 months of diagnosis by oncologists who used standard chemotherapy regimens, as established in clinical trials.
为了对老年患者的治疗结果进行更好的评估，调查者质询了国家癌症研究会监督委员会、流行病学会以及与医疗保险索赔记录有联系的最终结果数据库。他们选择那些经过基于临床试验的标准化化疗方案进行治疗的晚期肺癌或GI癌的患者，这些患者都在确诊癌症6个月内。
10、 Of 108,386 Medicare patients with the cancers and stages of interest, 39% (42,570) received some type of chemotherapy. Of the patients treated with chemotherapy, 32% (13,689) received one of the standard regimens prespecified by Lamont and colleagues.
有108386例老年癌症患者在这个选择范围内，39%（42570例）患者接受了化疗。接受化疗的患者中，有32%（13689例）的患者符合雷蒙特及其同事制定的标准之一。
11、 The study population consisted of 728 patients with stage IV colorectal cancer, 3,815 patients with advanced pancreatic cancer, 8,040 patients with stage IV non-small cell lung cancer (NSCLC), and 1,104 patients with extensive-stage small-cell lung cancer (SCLC).
研究对象由728例4期肠癌患者、3815例晚期胰腺癌患者，8040例4期非小细胞肺癌患者以及1104例小细胞肺癌患者组成。
12、 The patients with stage IV colorectal cancer included 598 treated with FOLFOX chemotherapy. They had a median overall survival of 19.4 months, comparable to the median survival of 19.7 months in the PRIME randomized clinical trial (J Clin Oncol 2010; 28: 4697-4705).
4期肠癌患者中，598例接受了FOLFOX化疗方案，其中位生存期为19.4个月。与之相比，相同方案的随机化临床试验治疗的中位生存期是19.7月。
13、 The remaining 130 patients with stage IV colorectal cancer received FOLFIRI chemotherapy. Their median survival differed substantially from the 23.1-month median observed with FOLFIRI-treated patients in BICC-C Trial.
剩余的130例4期肠癌患者接受的是FOLFIRI化疗方案。他们的中位生存期大大低于临床试验中的23.1个月。
14、 The Medicare patients with pancreatic cancer had a median survival of 4.3 months with standard gemcitabine therapy, as compared with a 5.8-month median survival among patients treated in the Cancer and Leukemia Group B (CALGB) 80303 study of gemicitabine.
患有胰腺癌的老年保健制患者，接受标准化gemcitabine化疗后中位生存期为4.3个月，而CALGB对80303例患者采用相同方法治疗后，其中位生存期为5.8个月。
15、 Among the Medicare patients with stage IV NSCLC, carboplatin-paclitaxel chemotherapy was associated with a median survival of 7.0 months, comparable to the 7.8-month median observed in the Eastern Cooperative Oncology Group 1594 trial with the same chemotherapy regimen.
4期非小细胞肺癌的老年保健制患者，carboplatin-paclitaxel 化疗后，中位生存期为7个月，而东部联合组采用相同方法治疗的患者是7.8个月。
16、 Finally, Medicare patients with advanced SCLC had a median survival of 8.5 months with cisplatin and VP16, whereas patients in the CALGB 9732 trial had a median survival of 10.0 months when treated with the same regimen.
最后，晚期小细胞肺癌的老年保障制患者，接受顺铂及VP16化疗后的中位生存期是8.5个月，而CALGB治疗的9732例是10个月。
17、"By providing treating oncologists with more accurate cancer site, stage, and treatment-specific survival distributions for elderly Medicare patients with advanced GI and lung cancers, we hope to improve patient-physician treatment decision-making for elderly Medicare patients who are diagnosed with these terminal illnesses," said Lamont.
雷蒙特说“鉴于肿瘤治疗更精确的部位、时期以及治疗方法，晚期GI及肺癌老年保健制度患者生存期的特殊性，我们希望优化医患间对治疗方案的制定，特别是对于已经确诊患有这种不治之症的老年保健医疗制的患者。
18、 Whether the results apply to other types of cancer remains unclear, she added. Findings related to the cancers included in this study should not be extrapolated to other cancer sites, stages, or chemotherapy regimens.
她补充道，这对于其他类型的癌症是否有意义尚不清楚。目前发现的这种关联性对其他癌症的部位、时期及化疗方案没有可推断性。