Splinter T A
Department of Medical Oncology, University Hospital Rotterdam Dijkzigt, The Netherlands.
Semin Oncol. 1996 Dec;23(6 Suppl 16):59-61.
In 1995, a randomized intergroup study of neoadjuvant chemotherapy followed by either surgery or radiotherapy in the treatment of non-small cell lung cancer was started under the auspices of the European Organization for Research and Treatment of Cancer (EORTC 08941). The objective of this study is to investigate whether surgery or radiotherapy represents superior locoregional treatment, in terms of survival and quality of life, for patients with stage IIIA(N2) non-small cell lung cancer who have achieved a response after three courses of neoadjuvant chemotherapy. A phase II side study will investigate the clinical and pathologic response rate (if applicable), as well as acute and late side effects during or after consecutive surgery and/or radiotherapy of combination paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin. It is planned that paclitaxel 175 mg/m2 will be given as a 3-hour infusion, followed by a 30-minute infusion of carboplatin at a dose based on a target area under the concentration-time curve of 6 mg x min/mL. This phase II study was started in October 1996. Depending on the response rate and early and late side effects observed in this well-defined, prognostically favorable group of patients, it will be decided whether and how to use the same combination chemotherapy in an ongoing randomized trial currently being conducted by the Dutch Lung Cancer Study Group (DLCSG 94-2). In the latter trial, patients with stage I and II non-small cell lung cancer are randomized to immediate surgery or two courses of neoadjuvant chemotherapy. Responding patients will receive another two courses of chemotherapy before surgery; nonresponders will go directly to surgery.
1995年，在欧洲癌症研究与治疗组织（EORTC 08941）的支持下，开展了一项关于新辅助化疗后行手术或放疗治疗非小细胞肺癌的随机组间研究。本研究的目的是调查对于IIIA期（N2）非小细胞肺癌患者，在接受三个疗程新辅助化疗后有反应者，手术或放疗在生存和生活质量方面是否代表更优的局部区域治疗。一项II期附带研究将调查临床和病理反应率（如适用），以及在连续手术和/或联合紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）和卡铂放疗期间或之后的急性和晚期副作用。计划给予紫杉醇175 mg/m²，静脉滴注3小时，随后以基于浓度-时间曲线下目标面积6 mg·min/mL的剂量静脉滴注卡铂30分钟。这项II期研究于1996年10月开始。根据在这一明确界定、预后良好的患者组中观察到的反应率以及早期和晚期副作用，将决定是否以及如何在荷兰肺癌研究组目前正在进行的一项正在进行的随机试验中使用相同的联合化疗方案（DLCSG 94 - 2）。在后者的试验中，I期和II期非小细胞肺癌患者被随机分为立即手术或两个疗程的新辅助化疗。有反应的患者将在手术前再接受两个疗程的化疗；无反应者将直接进行手术。
