Sadeghi A, Payne D, Rubinstein L, Lad T
LCSG Operations Office, Information Management Services, Inc., Rockville, MD 20852.
Int J Radiat Oncol Biol Phys. 1988 Jul;15(1):89-97. doi: 10.1016/0360-3016(88)90351-3.
The purpose of this study was to compare the effect of post-operative thoracic radiation with or without systemic chemotherapy on survival and recurrence patterns in patients subjected to thoracotomy with curative intent, but subsequently found to have residual tumor in the resected margin or metastasis in the highest paratracheal lymph node. All patients were treated with postoperative mediastinal irradiation and randomized to receive or not receive combination chemotherapy (cytoxan, adriamycin, and platinum) for 6 months beginning concurrently with radiation. Of the 172 patients randomized, 164 were eligible for analysis. The mean time since randomization for the eligible patients is 4.2 years. Radiation therapy was administered to all patients by split course regimen [20 Gy in 5 fractions over 5 days]. Two such courses were given with a 3-week interval. The initial recurrence rates for both in-field recurrence and distant relapse were reduced in the combined postoperative radiation therapy and chemotherapy group, although only the latter difference achieved statistical significance (p = 0.01). Also, local recurrence overall (not restricted to initial recurrences) is examined as a function of histology, extent of residual disease after resection, and T and N status. The treatment effect achieves statistical significance only for patients with macroscopic residual (p = .023) or T3 tumor (p = .010). The combined therapy group of patients have a significantly longer recurrence-free survival [p = 0.006 by the two-sided Mantel-Haenszel logrank test] which fails, however, to translate to a significant difference in overall survival (p = 0.146). Median survival of the entire group is 14.5 months with 34% alive 2 years after resection. Most of the initial recurrences (82%) have been systemic, with brain being the most common site. Distant failure, therefore, remains an important problem even in the favorable prognosis subset of patients with advanced NSCLC, but combined modality approaches can produce improved recurrence-free survival.
本研究的目的是比较术后胸部放疗联合或不联合全身化疗对接受根治性开胸手术但随后发现切缘有残留肿瘤或最高气管旁淋巴结转移患者的生存及复发模式的影响。所有患者均接受术后纵隔照射,并随机分为接受或不接受联合化疗(环磷酰胺、阿霉素和铂)6个月,化疗与放疗同时开始。在172例随机分组的患者中,164例符合分析条件。符合条件患者自随机分组后的平均时间为4.2年。所有患者均采用分割疗程方案进行放射治疗[5天内分5次给予20 Gy]。给予两个这样的疗程,间隔3周。术后放疗联合化疗组的野内复发和远处复发的初始复发率均降低,尽管只有后者的差异具有统计学意义(p = 0.01)。此外,还根据组织学、切除后残留疾病的范围以及T和N状态来检查总体局部复发情况(不限于初始复发)。仅对于有肉眼残留(p = 0.023)或T3肿瘤(p = 0.010)的患者,治疗效果具有统计学意义。联合治疗组患者的无复发生存期明显更长[双侧Mantel-Haenszel对数秩检验p = 0.006],然而,这并未转化为总生存期的显著差异(p = 0.146)。整个组的中位生存期为14.5个月,切除后2年有34%的患者存活。大多数初始复发(82%)为全身性复发,脑是最常见的部位。因此,即使在晚期非小细胞肺癌预后良好的亚组患者中,远处转移仍然是一个重要问题,但综合治疗方法可以提高无复发生存期。