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2
How rapidly do oncologists respond to clinical trial data?肿瘤学家对临床试验数据的反应有多迅速?
Oncologist. 2005 Jan;10(1):15-21. doi: 10.1634/theoncologist.10-1-15.
3
Postoperative radiotherapy in non-small-cell lung cancer: update of an individual patient data meta-analysis.非小细胞肺癌术后放疗:个体患者数据荟萃分析的更新
Lung Cancer. 2005 Jan;47(1):81-3. doi: 10.1016/j.lungcan.2004.09.010.
4
Clinical overview: adjuvant therapy of gastrointestinal cancer.临床概述:胃肠道癌的辅助治疗
Cancer Chemother Pharmacol. 2004 Sep;54 Suppl 1:S4-11. doi: 10.1007/s00280-004-0880-4.
5
A randomized trial of adjuvant chemotherapy with uracil-tegafur for adenocarcinoma of the lung.一项关于尿嘧啶替加氟辅助化疗治疗肺腺癌的随机试验。
N Engl J Med. 2004 Apr 22;350(17):1713-21. doi: 10.1056/NEJMoa032792.
6
Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer.完全切除的非小细胞肺癌患者的顺铂辅助化疗。
N Engl J Med. 2004 Jan 22;350(4):351-60. doi: 10.1056/NEJMoa031644.
7
Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell Lung cancer.完全切除的Ⅰ期、Ⅱ期或ⅢA期非小细胞肺癌辅助化疗的随机研究
J Natl Cancer Inst. 2003 Oct 1;95(19):1453-61. doi: 10.1093/jnci/djg059.
8
Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial.一项在晚期非小细胞肺癌患者中比较紫杉醇/卡铂与紫杉醇/顺铂的III期随机试验:一项多国合作试验。
Ann Oncol. 2002 Oct;13(10):1539-49. doi: 10.1093/annonc/mdf332.
9
A new method of segmental resection for primary lung cancer: intermediate results.一种原发性肺癌节段性切除的新方法:中期结果。
Eur J Cardiothorac Surg. 2002 May;21(5):894-9; discussion 900. doi: 10.1016/s1010-7940(02)00122-7.
10
A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIA non-small-cell lung cancer. Eastern Cooperative Oncology Group.完全切除的II期或IIIA期非小细胞肺癌患者术后辅助治疗的随机试验。东部肿瘤协作组。
N Engl J Med. 2000 Oct 26;343(17):1217-22. doi: 10.1056/NEJM200010263431703.

辅助治疗选择在非小细胞肺癌切除患者:医生治疗计划和相关的 III 期试验数据的相关性。

Adjuvant Therapy Choices in Patients With Resected Non-Small-Cell Lung Cancer: Correlation of Doctors' Treatment Plans and Relevant Phase III Trial Data.

机构信息

Network for Medical Communications and Research, Atlanta, GA.

出版信息

J Oncol Pract. 2005 Jul;1(2):37-42. doi: 10.1200/JOP.2005.1.2.37.

DOI:10.1200/JOP.2005.1.2.37
PMID:20871677
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2793579/
Abstract

PURPOSE

To evaluate case-based choices selected from among preselected options for adjuvant therapy management in patients with completely resected non-small-cell lung cancer (NSCLC).

METHODS

In a series of meetings in which US oncologists participated in case-based discussions, market research data were acquired using audience response keypad technology. Participant's anonymous responses to specific case-based questions were recorded electronically and tabulated.

RESULTS

Core behaviors among the majority of physician participants are driven by emerging level 1 evidence. However, a "more aggressive than literature-supported treatment posture" is frequently selected. For the scenario involving a patient with completely resected pT1N0 disease, approximately 60% recommended observation but one third of respondents indicated they would propose three to four cycles of platinum-based adjuvant chemotherapy. Twenty-three percent would recommend adjuvant radiation following adjuvant chemotherapy for a patient with completely resected pT2N1 (stage IIB) disease. In the stage IIB setting, when cisplatin or carboplatin chemotherapy choices were specified, carboplatin-based combinations were selected by 43.6% compared with 30% for cisplatin regimens. Eight respondents (3.5%) favored observation for the stage IIB setting. This is consistent with the preponderance of level 1 evidence for adjuvant management. Carboplatin combinations are also recommended despite the availability of only abstract data and a meeting report for a single phase III trial showing a survival benefit for carboplatin based management in stage IB disease. The use of radiation as an element in adjuvant therapy in the settings assessed in this research is not supported by prospective data.

CONCLUSIONS

Treatment plans that include adjuvant platinum-based chemotherapy have been widely adopted by US oncologists for a large fraction of patients with completely resected NSCLC. Recommendations for adjuvant chemotherapy for the patient described here with stage IA disease, or for adjuvant radiation alone or after adjuvant chemotherapy, for the stage IIB disease patient presented are overly aggressive, not evidence based, and carry potential harm. In settings in which level 1 evidence for a survival benefit from adjuvant chemotherapy does exist, some of the specific adjuvant chemotherapy regimens selected, while widely used in NSCLC patients with more advanced disease, have not yet been demonstrated to provide improved disease-free or overall survival as adjuvant treatment. Individualized adjuvant treatment recommendations not specifically grounded in level 1 evidence appear to be widely recommended by US medical oncologists for patients with completely resected NSCLC.

摘要

目的

评估在完全切除的非小细胞肺癌(NSCLC)患者中选择辅助治疗管理的预选项中基于案例的选择。

方法

在美国肿瘤学家参加基于案例的讨论的一系列会议中,使用观众响应键盘技术获取市场研究数据。参与者对特定基于案例问题的匿名回答被电子记录并制表。

结果

大多数医生参与者的核心行为是由新兴的 1 级证据驱动的。然而,经常选择“比文献支持的治疗立场更激进”。对于涉及完全切除的 pT1N0 疾病患者的情况,大约 60%的人建议观察,但三分之一的受访者表示他们将提出三到四个周期的铂类辅助化疗。对于完全切除的 pT2N1(IIB 期)疾病患者,三分之一的人会建议在辅助化疗后进行辅助放疗。在 IIB 期,当指定顺铂或卡铂化疗选择时,基于卡铂的联合治疗被 43.6%的人选择,而顺铂方案为 30%。8 名(3.5%)受访者主张观察 IIB 期。这与辅助治疗管理的大量 1 级证据一致。尽管只有一项 III 期试验的摘要数据和会议报告显示卡铂治疗在 IB 期疾病中有生存获益,但仍推荐使用卡铂联合治疗。在本研究评估的环境中,作为辅助治疗一部分的放疗并没有前瞻性数据支持。

结论

包括辅助铂类化疗在内的治疗方案已被美国肿瘤学家广泛应用于很大一部分完全切除的 NSCLC 患者。对于这里描述的 IA 期疾病患者或单独辅助放疗或辅助化疗后的 IIB 期疾病患者的辅助化疗建议过于激进,没有循证依据,并且可能带来潜在危害。在存在辅助化疗生存获益的 1 级证据的环境中,一些在更晚期 NSCLC 患者中广泛使用的特定辅助化疗方案尚未被证明可作为辅助治疗提供改善的无病或总生存。美国肿瘤学家似乎广泛推荐针对完全切除的 NSCLC 患者的基于案例的辅助治疗建议,而这些建议并未明确基于 1 级证据。