Harpole D H, Herndon J E, Young W G, Wolfe W G, Sabiston D C
Lung Cancer Research Laboratory, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
Cancer. 1995 Sep 1;76(5):787-96. doi: 10.1002/1097-0142(19950901)76:5<787::aid-cncr2820760512>3.0.co;2-q.
Nonsmall cell lung cancer (NSCLC) has become the leading cause of cancer-related deaths in women and men in the United States, with more than 157,000 estimated deaths in 1995. Surgical resection remains the mainstay of therapy in Stage I and II disease. However, local and distant recurrence account for the disappointing survival rates after resection. Appropriate selection of surgical procedures and effective use of adjuvant therapies will depend upon the elucidation of prognostic factors that predict for recurrence.
A detailed analysis was undertaken to evaluate surgical therapy and to define risk factors associated with recurrence and cancer death in 289 consecutive patients with NSCLC who were diagnosed, resected and followed at the Duke University Medical Center from January 1, 1980, until December 31, 1988. These patients had no evidence of metastases on head and chest/abdominal computed tomograms and radionuclide bone scans before resection. Resected specimens from these patients pathologic verification of Stage I disease. Follow-up was complete in all cases through 8/1/94 (median, 61 months). Variables analyzed included age, sex, smoking history, presenting signs and symptoms, operative procedure, histopathology, hospital course including complications, and the time and location of any recurrence or cancer death.
The 30-day mortality rate was 5 of 289 (1.7%), with minor and major morbidity rates of 17% and 9%, respectively. Statistical comparison of lobectomy (193) wedge resection (75) and pneumonectomy (21) revealed significantly (P < 0.04) smaller tumors (T1), more comorbidity, and fewer complications for wedge resection patients. A trend (P < 0.09) toward an increased rate of local/regional recurrence and no difference in survival was also observed for wedge resection. One hundred five patients died of cancer (13-month median time to recurrence) for an actual 5-year survival of 63%. Significant univariate predictors of early recurrence and decreased survival (P < 0.01) were: male sex, the presence of symptoms, hemoptysis, chest pain, type of cough, tumor size in cm and by T-classification, visceral pleural invasion, high mitotic index, and vascular invasion. Significant (P < 0.05) multivariate independent variables for early recurrence and cancer death were the presence of symptoms, vascular invasion, pleural invasion, high mitotic index, and tumor size greater than 3 cm.
Current surgical therapy for stage I NSCLC has an acceptable morbidity and mortality rate. The current data also stratify patients with Stage I NSCLC into high and low risk populations that can be used in future randomized trials of adjuvant therapy.
非小细胞肺癌（NSCLC）已成为美国男性和女性癌症相关死亡的主要原因，1995年估计死亡人数超过157,000。手术切除仍然是I期和II期疾病治疗的主要手段。然而，局部和远处复发导致切除术后生存率令人失望。合适的手术方式选择和辅助治疗的有效应用将取决于对预测复发的预后因素的阐明。
对1980年1月1日至1988年12月31日在杜克大学医学中心诊断、切除并随访的289例连续NSCLC患者进行了详细分析，以评估手术治疗并确定与复发和癌症死亡相关的危险因素。这些患者在切除术前头部及胸部/腹部计算机断层扫描和放射性核素骨扫描未发现转移证据。这些患者的切除标本经病理证实为I期疾病。所有病例随访至1994年8月1日（中位时间61个月）。分析的变量包括年龄、性别、吸烟史、出现的体征和症状、手术方式、组织病理学、住院过程包括并发症，以及任何复发或癌症死亡的时间和部位。
289例患者中30天死亡率为5例（1.7%），轻微和严重发病率分别为17%和9%。肺叶切除术（193例）、楔形切除术（75例）和全肺切除术（21例）的统计学比较显示，楔形切除术患者的肿瘤明显更小（T1期）、合并症更多、并发症更少（P < 0.04）。还观察到楔形切除术有局部/区域复发率增加的趋势（P < 0.09），生存率无差异。105例患者死于癌症（复发中位时间13个月），实际5年生存率为63%。早期复发和生存率降低的显著单因素预测因素（P < 0.01）为：男性、出现症状、咯血、胸痛、咳嗽类型、肿瘤大小（以厘米计及按T分类）、脏层胸膜侵犯、高有丝分裂指数和血管侵犯。早期复发和癌症死亡的显著多因素独立变量（P < 0.05）为出现症状、血管侵犯、胸膜侵犯、高有丝分裂指数和肿瘤大小大于3厘米。
目前I期NSCLC的手术治疗有可接受的发病率和死亡率。目前的数据也将I期NSCLC患者分为高风险和低风险人群，可用于未来辅助治疗的随机试验。
