Harper P
Department of Oncology, Guys Hospital, London, UK.
Semin Oncol. 1997 Aug;24(4 Suppl 14):S14-30-S14-32.
Neoadjuvant therapy in the treatment of stage IIIa/b non-small cell lung cancer (NSCLC) has the potential to reduce tumor size in patients whose tumors were previously inoperable. This report describes the design and status of an ongoing randomized, phase III study of docetaxel (Taxotere; Rhône-Poulenc Rorer, Antony, France) as neoadjuvant treatment in patients with stage IIIa/b NSCLC, as well as of two phase II studies of combination neoadjuvant therapies. A phase III, multicenter, international, randomized trial is in progress which compares docetaxel with no neoadjuvant chemotherapy in patients with histologically confirmed, previously untreated NSCLC with stage IIIa N2(T0-3) or T3 (N0-1) disease or stage IIIb disease that can be treated radically. Patients are assigned to receive three cycles of docetaxel or no neoadjuvant therapy. Definitive therapy is administered immediately or within 6 weeks of the third cycle of docetaxel. The primary objective of the study is median survival. Secondary end points include response rate, tumor resectability, survival after surgery and after curative-intent radiation, time to disease progression, and quality of life. To date, 110 of the planned 292 patients have been randomized. It is anticipated that the study will be completed in 1998. A phase I/II dose escalation study of the combination of docetaxel and cisplatin as neoadjuvant treatment of patients with stage IIIa T1-T3 NSCLC with N2 disease on mediastinoscopy is ongoing. The objectives of the study are to determine the clinical response to chemotherapy, the pathologic response after surgery, and survival. A phase II, multicenter, nonrandomized trial of the combination of docetaxel and carboplatin as neoadjuvant therapy in patients with stage IIIa N2 NSCLC is in progress. The primary objective of the study is to determine the response rate after chemotherapy. The results of both studies should be available by late 1997. The ultimate hope is that there is potential for neoadjuvant chemotherapy to provide a significant benefit for patients with advanced NSCLC.
新辅助治疗用于Ⅲa/b期非小细胞肺癌（NSCLC）的治疗，对于那些肿瘤先前无法手术切除的患者，有缩小肿瘤大小的潜力。本报告描述了一项正在进行的多西他赛（泰索帝；法国罗纳普朗克·乐安公司，安东尼）作为Ⅲa/b期NSCLC患者新辅助治疗的随机Ⅲ期研究，以及两项新辅助联合治疗的Ⅱ期研究的设计和进展情况。一项Ⅲ期、多中心、国际性随机试验正在进行，该试验比较多西他赛与不进行新辅助化疗，用于组织学确诊、先前未接受治疗的Ⅲa期N2（T0 - 3）或T3（N0 - 1）疾病或可根治性治疗的Ⅲb期NSCLC患者。患者被分配接受三个周期的多西他赛治疗或不进行新辅助治疗。确定性治疗在第三个多西他赛周期后立即或6周内进行。该研究的主要目标是中位生存期。次要终点包括缓解率、肿瘤可切除性、手术后及根治性放疗后的生存期、疾病进展时间和生活质量。到目前为止，计划入组的292例患者中有110例已被随机分组。预计该研究将于1998年完成。一项多西他赛和顺铂联合作为新辅助治疗纵隔镜检查为N2疾病的Ⅲa期T1 - T3 NSCLC患者的Ⅰ/Ⅱ期剂量递增研究正在进行。该研究的目的是确定化疗的临床反应、手术后的病理反应和生存期。一项多西他赛和卡铂联合作为Ⅲa期N2 NSCLC患者新辅助治疗的Ⅱ期、多中心、非随机试验正在进行。该研究的主要目标是确定化疗后的缓解率。两项研究的结果预计在1997年末可得。最终的希望是新辅助化疗有可能为晚期NSCLC患者带来显著益处。
