Mineo T C, Ambrogi V, Corsaro V, Roselli M
Department of Thoracic Surgery, Tor Vergata University, Rome, Italy.
Eur J Cardiothorac Surg. 2001 Aug;20(2):378-84. doi: 10.1016/s1010-7940(01)00779-5.
Although surgical resection alone is considered adequate treatment in stage IB non-small-cell lung cancer (NSCLC), long-term survival is not satisfactory and the recurrence rate is quite high. The validity of postoperative chemotherapy at stage IB in terms of disease-free and overall survival was assessed in a randomised trial.
The trial was designed as a randomised, two-group study with postoperative adjuvant chemotherapy versus surgery alone as control group. All patients had stage IB disease (pT2N0) assessed after a radical surgical procedure. Chemotherapy consisted of treatment with cisplatin (100 mg/m(2) on day 1) and etoposide (120 mg/m(2) on days 1--3) for a total of six cycles.
Between January 1988 and December 1994, 66 patients were included in the study. Thirty-three belonged to the adjuvant chemotherapy group and 33 to the control group. Groups were homogeneous for conventional risk factors. There was no clinical significant morbidity associated to chemotherapy. Patients were followed for a minimum period of 5 years. The rates of locoregional recurrence and distant metastases were 18 and 30%, respectively, in the adjuvant chemotherapy group and 24 and 43%, respectively, in the control group. The 5-year disease-free survival rates were 59% in the adjuvant group and 30% in the control group (P = 0.02). The difference in the Kaplan--Meier survival between the groups was significant as assessed using the log-rank test (P = 0.04).
Our results suggest that adjuvant chemotherapy may reduce recurrences and prolong overall survival in patients at stage IB NSCLC deemed radically operated. Despite being difficult to accept, the use of adjuvant chemotherapy might have better long-term results.
尽管单纯手术切除被认为是ⅠB期非小细胞肺癌（NSCLC）的充分治疗方法，但长期生存率并不理想，复发率相当高。在一项随机试验中评估了ⅠB期术后化疗在无病生存和总生存方面的有效性。
该试验设计为随机两组研究，术后辅助化疗组与单纯手术对照组。所有患者在根治性手术后被评估为ⅠB期疾病（pT2N0）。化疗包括顺铂（第1天100mg/m²）和依托泊苷（第1 - 3天120mg/m²）治疗，共六个周期。
1988年1月至1994年12月，66例患者纳入研究。33例属于辅助化疗组，33例属于对照组。两组在传统危险因素方面具有同质性。化疗未产生临床显著的并发症。患者至少随访5年。辅助化疗组的局部区域复发率和远处转移率分别为18%和30%，对照组分别为24%和43%。辅助组的5年无病生存率为59%，对照组为30%（P = 0.02）。使用对数秩检验评估，两组之间的Kaplan - Meier生存率差异具有显著性（P = 0.04）。
我们的结果表明，辅助化疗可能会减少ⅠB期NSCLC根治性手术后患者的复发并延长总生存期。尽管难以接受，但使用辅助化疗可能会有更好的长期效果。
