Results of a phase II study of high-dose thoracic radiation therapy with concurrent cisplatin and etoposide in limited-stage small-cell lung cancer (NCCTG 95-20-53)
Results of a phase II study of high-dose thoracic radiation therapy with concurrent cisplatin and etoposide in limited-stage small-cell lung cancer (NCCTG 95-20-53)
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DOI：
10.1200/jco.2006.09.9606
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发表时间：
2007-07-20
影响因子：
45.3
通讯作者：
Adjei, Alex
中科院分区：
文献类型：
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作者：
Schild, Steven E.;Bonner, James A.;Adjei, Alex
PurposeTo评估有限期小细胞肺癌（L-SCLC）治疗与顺铂和足叶乙甙（PE），早期预防性颅照射（PCI），和高剂量每日两次胸部放疗（bid RT）的患者的结局。患者和方法共有76个评估的患者进行了治疗的第二阶段试验，其中包括6个周期的PE。PCI（25戈伊/10次）在第3周期输送到响应患者。周期4和5包括同步化疗和胸部RT（30戈伊/20 bid分数，2周的休息，和另外30戈伊/20 bid分数）。结果的76个可评估的患者，74例（97%）遭受3级或更高（3+）的毒性和61例（80%）有4级或更高（4+）的毒性。在这些不良事件中，72例患者（95%）发生了3级+血液学毒性，55例患者（72%）发生了3级+非血液学毒性。接受PCI的61例患者中只有1例（2%）发生了脑部治疗失败。76例可评估患者的5年生存率为24%（中位数，20个月）。接受胸部RT的64例患者的5年生存率为29%（中位数，22个月）。5年累计治疗失败率为34%。结论采用大剂量bid TRT方案，可提高5年生存率。局部失效仍然是一个需要进一步调查的问题。更新的技术应该允许更大剂量的RT的安全管理，这应该改善患者的结果。来自8项试验的数据被结合起来，以证明RT剂量分割和5年生存率之间的关系。
PurposeTo evaluate the outcome of patients with limited-stage small-cell lung cancer ( L-SCLC) treated with cisplatin and etoposide ( PE), early prophylactic cranial irradiation ( PCI), and high-dose twice-daily thoracic radiotherapy ( bid RT).Patients and MethodsA total of 76 assessable patients were treated on this phase II trial, which included six cycles of PE. PCI ( 25 Gy/10 fractions) was delivered during cycle 3 to responding patients. Cycles 4 and 5 included concurrent chemotherapy and thoracic RT ( 30 Gy/20 bid fractions, a 2-week break, and another 30 Gy/20 bid fractions).ResultsOf the 76 assessable patients, 74 patients ( 97%) suffered grade 3 or greater ( 3+) toxicity and 61 patients ( 80%) had grade 4 or greater ( 4+) toxicity. Of these adverse events, grade 3+ hematologic toxicity occurred in 72 patients ( 95%), and grade 3+ nonhematologic toxicity occurred in 55 patients ( 72%). Only one ( 2%) of the 61 patients who received PCI experienced treatment failure in the brain. The 5-year survival rate of the 76 assessable patients was 24% ( median, 20 months). The 5-year survival rate of the 64 patients who received thoracic RT was 29% ( median, 22 months). The 5-year cumulative incidence of in-field treatment failure was 34%.ConclusionThis regimen included a high total dose of bid TRT, which resulted in a favorable 5-year survival rate. Local failure remains a problem that will require additional investigation. Newer technology should allow the safe administration of greater doses of RT, which should improve patient outcome. Data from eight trials were combined to demonstrate a relationship between RT dose fractionation and 5-year survival.