A RANDOMIZED TRIAL OF INDUCTION CHEMOTHERAPY PLUS HIGH-DOSE RADIATION VERSUS RADIATION ALONE IN STAGE-III NON-SMALL-CELL LUNG-CANCER
A RANDOMIZED TRIAL OF INDUCTION CHEMOTHERAPY PLUS HIGH-DOSE RADIATION VERSUS RADIATION ALONE IN STAGE-III NON-SMALL-CELL LUNG-CANCER
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DOI：
10.1056/nejm199010043231403
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发表时间：
1990-10-04
影响因子：
158.5
通讯作者：
GREEN, MR
中科院分区：
文献类型：
--
作者：
DILLMAN, RO;SEAGREN, SL;GREEN, MR
背景：对于局部或区域晚期非小细胞肺癌患者，放疗是标准治疗方法，但生存率仍然很低。因此，我们进行了一项随机试验，以确定放疗前诱导化疗是否能提高生存率。
方法：所有患者均经临床或手术分期确诊为Ⅲ期非小细胞肺癌。入选标准包括身体状况良好、体重减轻极少以及影像学检查可见病灶。随机分配到第1组的患者接受顺铂（体表面积每平方米100毫克，在第1天和第29天静脉注射）和长春碱（体表面积每平方米5毫克，在第1、8、15、22和29天静脉注射），然后在第50天开始放疗（6周内给予60戈瑞）。分配到第2组的患者接受相同的放疗，但立即开始，不接受化疗。
结果：第1组（n = 78）和第2组（n = 77）符合条件的患者在年龄（中位年龄60岁）、性别、身体状况、组织学特征、疾病分期以及放疗完成情况等方面具有可比性。第1组患者的中位生存期更长——13.8个月对比9.7个月（对数秩检验P = 0.0066）。第1组患者1年后的生存率为55%，2年后为26%，3年后为23%，而第2组分别为40%、13%和11%。第1组患者因严重感染需住院治疗的发生率较高（7%，第2组为3%），体重严重减轻的发生率也较高（14%对比6%），但没有治疗相关的死亡病例。
结论：在Ⅲ期非小细胞肺癌患者中，与单纯放疗相比，放疗前使用顺铂和长春碱进行诱导化疗可显著提高中位生存期（约4个月），并使长期生存者的数量翻倍。然而，由于四分之三的患者在3年内仍然死亡，因此需要进一步改进全身和局部治疗。
Background: For patients with locally or regionally advanced non-small-cell lung cancer radiation is the standard treatment, but survival remains poor. We therefore conducted a randomized trial to determine whether induction chemotherapy before irradiation improves survival. Methods: All the patients had documented non-small-cell cancer of the lung with Stage III disease established by clinical or surgical staging. Eligibility requirements included excellent performance status, minimal weight loss, and visible disease on radiography. Patients randomly assigned to group 1 received cisplatin (100 mg per square meter of body-surface area given intravenously on days 1 and 29) and vinblastine (5 mg per square meter given intravenously on days 1, 8, 15, 22, and 29) and then began radiation therapy on day 50 (60 Gy over a 6-week period). Patients assigned to group 2 received the same radiation therapy but began it immediately and received no chemotherapy. Results: The eligible patients in group 1 (n = 78) and group 2 (n = 77) were comparable in terms of age (median, 60 years), sex, performance status, histologic features, stage of disease, and completeness of radiation therapy. The median survival was greater for those in group 1 - 13.8 versus 9.7 months (P = 0.0066 by log-rank test). Rates of survival in group 1 were 55 percent after one year, 26 percent after two years, and 23 percent after three years, as compared with 40, 13, and 11 percent, respectively, in group 2. Those in group 1 had a higher incidence of serious infections requiring hospitalization (7 percent, vs. 3 percent in group 2) and severe weight loss (14 percent vs. 6 percent), but there was no treatment-related deaths. Conclusions: In patients with Stage III non-small-cell lung cancer, induction chemotherapy with cisplatin and vinblastine before radiation significantly improves median survival (by about four months) and doubles the number of long-term survivors, as compared with radiation therapy alone. Since three quarters of the patients still die within three years, however, further improvements in systemic and local therapy are needed.