Nagai Kanji, Tsuchiya Ryosuke, Mori Takashi, Tada Hiroto, Ichinose Yukito, Koike Teruaki, Kato Harubumi
Department of Thoracic Oncology, National Cancer Center Hospital East, Chiba, Japan.
J Thorac Cardiovasc Surg. 2003 Feb;125(2):254-60. doi: 10.1067/mtc.2003.15.
We performed a prospective randomized trial in patients with potentially resectable stage IIIA N2 non-small cell lung cancer to confirm the efficacy of induction chemotherapy before surgical resection.
Patients with stage IIIA N2 non-small cell lung cancer, all with histologically or cytologically confirmed metastases to the ipsilateral mediastinal lymph nodes, were randomly assigned to receive either three cycles of induction chemotherapy (cisplatin at 80 mg/m(2) on 1 day and vindesine at 3 mg/m(2) on 2 days) followed by surgery or surgery alone.
This trial was prematurely terminated because the accrual rate was too slow, which lowered the study's statistical power considerably. From June 1993 through April 1998, a total of 62 patients were enrolled, and 31 patients were assigned to each treatment group. The objective clinical response rate of induction chemotherapy was 28%. Complete resection was achieved in 20 patients in the induction chemotherapy group (65%) and 24 in the surgery alone group (77%). Median follow-up was 6.2 years. Median overall survivals were 17 months for the induction group and 16 months for the surgery alone group. The estimated 1-, 3-, and 5-year survivals, respectively, were 68% (95% confidence interval 51%-85%), 23% (95% confidence interval 8%-38%), and 10% (95% confidence interval 0%-20%) for the induction chemotherapy group and 65% (95% confidence interval 48%-82%), 26% (95% confidence interval 11%-41%), and 22% (95% confidence interval 7%-37%) for the surgery alone group. There was no statistically significant difference in survival between the groups (P =.5274). Treatment-related death was not observed in either group.
This randomized trial to compare induction chemotherapy (cisplatin and vindesine) followed by surgery with surgery alone for patients with stage IIIA N2 non-small cell lung cancer did not demonstrate a survival difference between the groups, although this may have been because the statistical power was limited.
我们对具有潜在可切除性的IIIA期N2非小细胞肺癌患者进行了一项前瞻性随机试验，以证实手术切除前诱导化疗的疗效。
IIIA期N2非小细胞肺癌患者，均经组织学或细胞学证实有同侧纵隔淋巴结转移，被随机分配接受三个周期的诱导化疗（第1天顺铂80mg/m²，第2天长春地辛3mg/m²），随后进行手术，或仅接受手术。
该试验因入组率过慢而提前终止，这大大降低了研究的统计效力。从1993年6月至1998年4月，共招募了62例患者，每个治疗组分配31例患者。诱导化疗的客观临床缓解率为28%。诱导化疗组20例患者（65%）实现了完全切除，单纯手术组24例患者（77%）实现了完全切除。中位随访时间为6.2年。诱导组的中位总生存期为17个月，单纯手术组为16个月。诱导化疗组的1年、3年和5年生存率估计分别为68%（95%置信区间51%-85%）、23%（95%置信区间8%-38%）和10%（95%置信区间0%-20%），单纯手术组分别为65%（95%置信区间48%-82%）、26%（95%置信区间11%-41%）和22%（95%置信区间7%-37%）。两组之间的生存率无统计学显著差异（P = 0.5274）。两组均未观察到与治疗相关的死亡。
这项随机试验比较了IIIA期N2非小细胞肺癌患者先进行诱导化疗（顺铂和长春地辛）然后手术与单纯手术的疗效，结果显示两组之间的生存率无差异，尽管这可能是因为统计效力有限。
