Improved survival in stage III non-small-cell lung cancer: Seven-year follow-up of cancer and leukemia group B (CALGB) 8433 trial
Improved survival in stage III non-small-cell lung cancer: Seven-year follow-up of cancer and leukemia group B (CALGB) 8433 trial
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DOI：
10.1093/jnci/88.17.1210
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发表时间：
1996-09-04
期刊：
影响因子：
--
通讯作者：
Green, MR
中科院分区：
文献类型：
--
作者：
Dillman, RO;Herndon, J;Green, MR
背景资料：多年来，高剂量放射治疗是局部或区域性晚期非小细胞肺癌（NSCLC）患者的标准治疗，尽管这种治疗后的5年生存率仅为3%-10%。从1984年5月到1987年5月，癌症和白血病组B（CALGB）进行了一项随机试验，结果表明，在放疗前进行诱导化疗可提高前3年随访的生存率。目的：本报告提供了CALGB试验入组患者的7年随访数据。研究方法：患者人群包括临床或手术III期、组织学记录的NSCLC患者; CALGB体能状态为0-1;诊断前3个月内体重减轻小于5%;放射学可见疾病。患者被随机分配接受1）顺铂（第1天和第29天静脉注射100 mg/m2体表面积）和长春碱（5 mg/m2体表面积，每周静脉注射，第1、8、15、22天，和29），随后从第50天开始以6000 cGy分30次给予放射治疗（CT-RT组）或2）从第1天开始的单独6000 cGy放射治疗（RT组），最长持续时间为6-7周。如果患者有可测量或可评估的疾病，则评估其肿瘤消退，并监测毒性作用、疾病进展和死亡日期。结果：有78名合格患者随机分配到CT-PT组，77名随机分配到RT组。两组在性别、年龄、组织学细胞类型、体能状态、疾病亚期以及分期是否为临床或手术方面相似。在随机分配至治疗组时，所有患者均具有可测量或可评价的疾病。两组接受了相似数量和质量的放射治疗。如前所述，CT-PT组和RT组的肿瘤缓解率分别为56%和43%（P = 0.092）。在超过7次Sears随访后，通过对数秩检验（双侧）确定，CT-RT组的中位生存期（13.7个月）仍然高于RT组（9.6个月）（P = 0.012）。CT-RT组1年至7年后存活的患者百分比分别为54、26、24、19、17、13和13，RT组为40、13、10、7、6、6和6。结论：长期随访证实，在放疗前接受5周顺铂和长春碱化疗的III期NSCLC患者中位生存期延长4.1个月。与单纯放疗相比，序贯化疗-放疗可使5年生存率增加2.8倍。然而，多达80%-85%的此类患者仍然在5年内死亡，并且因为在接受顺序化疗-放疗或单独放疗的患者中，治疗失败发生在照射野和远处部位，所以仍然需要进一步改进该疾病的局部和全身治疗。
Background: For many years, high-dose radiation therapy was the standard treatment for patients with locally or regionally advanced non-small-cell lung cancer (NSCLC), despite a 5-year survival rate of only 3%-10% following such therapy. From May 1984 through May 1987, the Cancer and Leukemia Group B (CALGB) conducted a randomized trial that showed that induction chemotherapy before radiation therapy improved survival during the first 3 years of follow-up. Purpose: This report provides data for 7 years of follow-up of patients enrolled in the CALGB trial. Methods: The patient population consisted of individuals who had clinical or surgical stage III, histologically documented NSCLC; a CALGB performance status of 0-1; less than 5% loss of body weight in the 3 months preceding diagnosis; and radiographically visible disease. Patients were randomly assigned to receive either 1) cisplatin (100 mg/m(2) body surface area intravenously on days 1 and 29) and vinblastine (5 mg/m(2) body surface area intravenously weekly on days 1, 8, 15, 22, and 29) followed by radiation therapy with 6000 cGy given in 30 fractions beginning on day 50 (CT-RT group) or 2) radiation therapy with 6000 cGy alone beginning on day 1 (RT group) for a maximum duration of 6-7 weeks. Patients were evaluated for tumor regression if they had measurable or evaluable disease and were monitored for toxic effects, disease progression, and date of death. Results: There were 78 eligible patients randomly assigned to the CT-PT group and 77 randomly assigned to the RT group. Both groups were similar in terms of sex, age, histologic cell type, performance status, substage of disease, and whether staging had been clinical or surgical. All patients had measurable or evaluable disease at the time of random assignment to treatment groups. Both groups received a similar quantity and quality of radiation therapy. As previously reported, the rate of tumor response, as determined radiographically, was 56% for the CT-PT group and 43% for the RT group (P = .092). After more than 7 Sears of follow-up, the median survival remains greater for the CT-RT group (13.7 months) than for the RT group (9.6 months) (P = .012) as ascertained by the logrank test (two-sided). The percentages of patients surviving after years 1 through 7 were 54, 26, 24, 19, 17, 13, and 13 for the CT-RT group and 40, 13, 10, 7, 6, 6, and 6 for the RT group. Conclusions: Long-term follow-up confirms that patients with stage III NSCLC who receive 5 weeks of chemotherapy with cisplatin and vinblastine before radiation therapy have a 4.1-month increase in median survival. The use of sequential chemotherapy-radiotherapy increases the projected proportion of 5-year survivors by a factor of 2.8 compared with that of radiotherapy alone. However, inas-much as 80%-85% of such patients still die within 5 years and because treatment failure occurs both in the irradiated field and at distant sites in patients receiving either sequential chemotherapy-radiotherapy or radiotherapy alone, the need for further improvements in both the local and systemic treatment of this disease persists.