Park Jong Ho, Lee Choon-Taek, Lee Hae Won, Baek Hee Jong, Zo Jae Ill, Shim Young Mog
Department of Thoracic Surgery, Korea Cancer Center Hospital, Nowon-Ku Gongneung-Dong 215-4, Seoul 139-706, South Korea.
Eur J Cardiothorac Surg. 2005 Jun;27(6):1086-91. doi: 10.1016/j.ejcts.2005.01.039. Epub 2005 Mar 2.
Surgery constitutes the mainstay of treatment in stage I non-small cell lung cancer (NSCLC). However, a significant fraction of patients after surgical resection die mainly due to systemic relapse. Nonetheless, the best adjuvant treatment to improve survival and decrease relapse rate remains as an ever controversial issue. Therefore, we conducted a randomized trial to determine whether postoperative adjuvant chemotherapy is beneficial in prolonging survival and decreasing recurrence in patients with completely resected stage I NSCLC.
It was designed as a randomized, prospective two-armed study with surgery only (control group, 59 patients) versus surgery plus adjuvant MVP (mitomycin C, vinblastin and cisplatin) chemotherapy (study group, 59 patients).
Data for all the patients were complete. Twenty-four patients in the control group and nine patients in the study group experienced tumor recurrence during the follow-up. Neither histological type nor surgical extent correlated with recurrence. However, the addition of adjuvant MVP chemotherapy could decrease the rate of recurrence and the incidence of cancer-related death after surgery in the patients of stage I NSCLC (P<0.05). We followed up at least 5 years, and the duration of mean follow-up was 7.3 years. The rates of the loco-regional and distant metastases were 3.4 and 40.7% in the control group, and 3.4 and 11.9% in the study group, respectively. The 5- and 10-year survival rates were 74.6 and 56.3% in the control group, and 81.4 and 65.0% in the study group, respectively (P=0.19, log-rank test). The 5- and 10-year disease-free survival rates were 64.8 and 54.8% in the control group, and 88.8 and 76.8% in the study group, respectively (P=0.002, log-rank test).
Our results suggest that the addition of adjuvant MVP chemotherapy may reduce the incidence of distant metastasis and prolong the disease-free survival of the patients with stage I NSCLC after surgery.
手术是Ⅰ期非小细胞肺癌(NSCLC)治疗的主要手段。然而,相当一部分手术切除后的患者主要因全身复发而死亡。尽管如此,改善生存和降低复发率的最佳辅助治疗仍是一个一直存在争议的问题。因此,我们进行了一项随机试验,以确定术后辅助化疗对完全切除的Ⅰ期NSCLC患者延长生存期和降低复发率是否有益。
本研究设计为一项随机、前瞻性双臂研究,一组仅接受手术(对照组,59例患者),另一组接受手术加辅助MVP(丝裂霉素C、长春花碱和顺铂)化疗(研究组,59例患者)。
所有患者的数据完整。对照组24例患者和研究组9例患者在随访期间出现肿瘤复发。组织学类型和手术范围均与复发无关。然而,辅助MVP化疗可降低Ⅰ期NSCLC患者术后的复发率和癌症相关死亡率(P<0.05)。我们至少随访了5年,平均随访时间为7.3年。对照组的局部区域转移率和远处转移率分别为3.4%和40.7%,研究组分别为3.4%和11.9%。对照组的5年和10年生存率分别为74.6%和56.3%,研究组分别为81.4%和65.0%(P=0.19,对数秩检验)。对照组的5年和10年无病生存率分别为64.8%和54.8%,研究组分别为88.8%和76.8%(P=0.002,对数秩检验)。
我们的结果表明,辅助MVP化疗可能降低Ⅰ期NSCLC患者术后远处转移的发生率,并延长其无病生存期。