Cox J D, Azarnia N, Byhardt R W, Shin K H, Emami B, Pajak T F
University of Texas MD Anderson Cancer Center, Houston 77030.
J Clin Oncol. 1990 Sep;8(9):1543-55. doi: 10.1200/JCO.1990.8.9.1543.
A phase Ilate/II trial of hyperfractionated (HFX) radiation therapy for non-small-cell carcinoma of the lung (NSCCL) was conducted by the Radiation Therapy Oncology Group (RTOG) between 1983 and 1987. Fractions of 1.2 Gy were administered twice daily with greater than or equal to 4 hours between fractions. Patients were randomized to receive minimum total doses of 60.0, 64.8, and 69.6 Gy. After acceptable risks of acute and late effects were found, 74.4 Gy and 79.2 Gy arms were added, and the lowest total dose arms were closed. No significant differences in the risks of acute or late effects in normal tissues were found among the 848 patients analyzed in the five arms; risks of severe or life-threatening pneumonitis were 2.6% for 60.0 to 64.8 Gy, 5.7% for 69.6 to 74.4 Gy, and 8.1% for 79.2 Gy. Among 350 patients who had the same criteria as Cancer and Leukemia Group B (CALGB) protocol 84-33 (American Joint Committee on Cancer Staging [AJCCS], 1984, stage III; Karnofsky performance status [KPS] 70 to 100; less than 6% weight loss), there was a dose response for survival: survival with 69.6 Gy (median, 13.0 months; 2 years, 29%) was significantly (P = .02) better than the lower total doses. There were no differences in survival among the three highest total-dose arms. Comparisons with results in similar patients treated with 60 Gy in 30 fractions of 2.0 Gy 5 days per week for 6 weeks suggest benefit from HFX radiation therapy with 69.6 Gy. Improvement in survival with HFX radiation therapy at 69.6 Gy total dose without increase in normal tissue effects, justifies phase III comparison with standard fractionation alone and combined with systemic chemotherapy in this common presentation of NSCCL.
放射治疗肿瘤学组（RTOG）于1983年至1987年开展了一项针对非小细胞肺癌（NSCCL）的超分割（HFX）放射治疗的II期后期/III期试验。每次1.2 Gy，每天给予两次，两次照射之间间隔大于或等于4小时。患者被随机分配接受最低总剂量为60.0、64.8和69.6 Gy的治疗。在发现急性和晚期效应的可接受风险后，增加了74.4 Gy和79.2 Gy剂量组，最低总剂量组关闭。在五个剂量组分析的848例患者中，正常组织急性或晚期效应的风险没有显著差异；60.0至64.8 Gy组严重或危及生命的肺炎风险为2.6%，69.6至74.4 Gy组为5.7%，79.2 Gy组为8.1%。在350例符合癌症与白血病B组（CALGB）方案84 - 33标准（美国癌症联合委员会分期[AJCCS]，1984年，III期；卡诺夫斯基功能状态[KPS]70至100；体重减轻小于6%）的患者中，生存存在剂量反应：69.6 Gy组的生存率（中位数，13.0个月；2年生存率，29%）显著（P = 0.02）优于较低总剂量组。三个最高总剂量组之间的生存率没有差异。与每周5天、每次2.0 Gy、共30次、6周给予60 Gy治疗的类似患者的结果比较表明，69.6 Gy的HFX放射治疗有益。在不增加正常组织效应的情况下，69.6 Gy总剂量的HFX放射治疗改善了生存率，证明在这种常见的NSCCL表现中，有必要与单纯标准分割以及与全身化疗联合进行III期比较。
