RANDOMIZED TRIAL OF NEOADJUVANT THERAPY FOR LUNG-CANCER - INTERIM ANALYSIS
RANDOMIZED TRIAL OF NEOADJUVANT THERAPY FOR LUNG-CANCER - INTERIM ANALYSIS
复制标题
DOI：
10.1016/0003-4975(92)90373-c
复制
发表时间：
1992-06-01
影响因子：
4.6
通讯作者：
MINNA, J
中科院分区：
文献类型：
--
作者：
PASS, HI;POGREBNIAK, HW;MINNA, J
新辅助化疗在Ⅲa期非小细胞肺癌中的作用尚不明确。自1987年以来，我院一项正在进行的前瞻性随机试验纳入了27例非小细胞肺癌患者，所有患者均经组织学证实有同侧纵隔淋巴结转移。13例患者被随机分配到术前依托泊苷 - 铂类（EP）化疗 - 手术 - 术后EP组，另外14例患者被随机分配到手术 - 术后纵隔放疗（SRT）组。两组在性别、年龄、体重减轻、肿瘤位置、术前肺功能、生理分级和肿瘤组织学方面相似。13例EP组患者中有8例有反应，表现为两个周期后影像学肿瘤缩小50%或更多。肿瘤和淋巴结完全切除率相似：EP组13例中有11例，SRT组14例中有12例。27例患者无手术死亡。EP组中位潜在随访时间为29.9个月，SRT组为34.9个月。初步结果显示，EP组（中位生存期28.7个月）相较于SRT组（中位生存期15.6个月）有生存期延长的趋势（p² = 0.095）。12例接受手术的SRT患者中有11例复发，而11例接受手术的EP患者中有8例复发。复发时间显示两组之间无显著差异，但EP组无病间期有延长的趋势（EP组12.7个月，SRT组5.8个月）。这项中期分析证明了此类试验的可行性；然而，尽管有这些趋势，明确的结论仍需进一步积累病例和研究成熟。
The role of neoadjuvant chemotherapy in stage IIIa non-small cell lung cancer remains undefined. Since 1987, 27 patients with non-small cell lung cancer, all with histologically confirmed metastases to the ipsilateral mediastinal lymph nodes, have been enrolled in an ongoing prospective, randomized trial at our institution. Thirteen patients have been randomized to preoperative etoposide-platinum (EP) chemotherapy-surgery-postoperative EP, and 14 other patients have been randomized to surgery-postoperative mediastinal irradiation (SRT). Both groups are similar in sex, age, weight loss, tumor location, preoperative pulmonary function, physiologic grade, and tumor histology. Eight of the 13 EP patients have responded as evidenced by a 50% or greater radiographic tumor shrinkage after two cycles. Complete tumor and nodal resection rates were similar: 11/13 EP patients versus 12/14 SRT patients. There was no operative mortality for the 27 patients. Median potential follow-up is 29.9 months for the EP group and 34.9 months for the SRT group. Preliminary results suggest a trend toward increased survival time for the EP group (median, 28.7 months) versus the SRT group (median, 15.6 months) (p2 = 0.095). Eleven of 12 resected SRT patients have had recurrence versus 8 of 11 resected EP patients. Time to recurrence reveals no significant differences between the two groups but a trend toward increased disease-free interval in the EP group (12.7 months versus 5.8 months, EP versus SRT). This interim analysis demonstrates the feasibility of such a trial; however, despite the trends, definitive conclusions await further accrual and study maturation.