White J E, Chen T, McCracken J, Kennedy P, Seydel H G, Hartman G, Mira J, Khan M, Durrance F Y, Skinner O
Cancer. 1982 Sep 15;50(6):1084-90. doi: 10.1002/1097-0142(19820915)50:6<1084::aid-cncr2820500611>3.0.co;2-w.
Two hundred and ninety-eight patients with limited (confined to chest and supraclavicular area, encompassable by a single radiation portal) small cell carcinoma of the lung were entered on Southwest Oncology Group Protocol 7628. Patients were treated with multi-agent chemotherapy and radiation therapy with or without BCG. Radiation therapy quality control analysis, including dosimetric reconstruction and port film review was introduced after the protocol was activated and was retrospectively applied. Patients who were considered major protocol variations had statistically worse survival (40 weeks versus 60 weeks; P = .002), a lesser improvement in response rate after induction chemotherapy (27 versus 48%; P = .05) and a higher chest failure rate (77 versus 55%; P = .047) than evaluable patients. Five patients relapsed in the brain, all associated with chest failure. Quality control is essential in cooperative group studies.
298例局限期(局限于胸部和锁骨上区域,可由单个放射野覆盖)肺小细胞癌患者进入西南肿瘤协作组7628方案。患者接受了多药化疗和放疗,部分患者接受或未接受卡介苗治疗。该方案启动后引入了放射治疗质量控制分析,包括剂量重建和射野片复查,并进行回顾性应用。被视为主要方案变异的患者与可评估患者相比,生存统计上更差(40周对60周;P = 0.002),诱导化疗后缓解率改善较小(27%对48%;P = 0.05),胸部失败率更高(77%对55%;P = 0.047)。5例患者出现脑转移复发,均与胸部失败相关。质量控制在协作组研究中至关重要。