Introduction: This systematic review evaluated whether curative intent hypofractionated radiation therapy improved survival (primary endpoint) as compared to standard conventionally fractionated radiation therapy for stage III non-small cell lung cancer (NSCLC) patients. Toxicity was also examined as a secondary endpoint. Methods: Electronic bibliographic databases were searched from 1 January 1990 to 31 March 2024. Phase II and phase III trials were included to assess survival (primary outcome) and toxicity (secondary outcome) for newly diagnosed stage III NSCLC patients. Results: Eight phase II trials (n= 349 participants), 3 randomized phase II trials (n= 382 participants), and 5 randomized phase III trials (n= 811 participants), for a total of 1542 participants, were identified. The published trials were heterogeneous, with a wide variety of dose prescriptions. A wide range of survivals (median survival 13.6 months–42.5 months) and toxicities such as grade 3 or higher esophagitis (0–42%) and grade 3 or higher pneumonitis (0–18%) were reported. Conclusions: There is no level 1 evidence to date that suggests that any hypofractionated regimen (dose escalated or not) improves survival as compared to conventionally fractionated radiation. The published phase III trials have been powered for superiority (not equivalence) for the hypofractionated arm. Toxicity with hypofractionated regimens may be similar to conventionally fractionated regimens when normal tissue radiotherapy constraints are kept within tolerance limits. It is unclear how the use of systemic therapy may negatively affect radiation toxicity with hypofractionated radiation therapy.
引言：本系统综述旨在评估对于III期非小细胞肺癌（NSCLC）患者，相较于常规分割放疗，以根治为目的的大分割放疗是否能改善生存（主要终点）。毒性反应作为次要终点同时被考察。 方法：检索1990年1月1日至2024年3月31日期间的电子文献数据库。纳入II期和III期临床试验，以评估新诊断III期NSCLC患者的生存（主要结局）和毒性反应（次要结局）。 结果：共识别出8项II期试验（n=349名受试者）、3项随机II期试验（n=382名受试者）和5项随机III期试验（n=811名受试者），总计1542名受试者。已发表的试验存在异质性，剂量处方方案差异很大。报告了广泛的生存数据（中位生存期13.6个月至42.5个月）以及毒性反应，如3级或更高级别的食管炎（0–42%）和3级或更高级别的肺炎（0–18%）。 结论：迄今为止，尚无1级证据表明任何大分割方案（无论是否剂量递增）相较于常规分割放疗能改善生存。已发表的III期试验在设计上旨在证明大分割放疗组的优效性（而非等效性）。当正常组织的放疗限制剂量保持在耐受限度内时，大分割方案的毒性可能与常规分割方案相似。目前尚不清楚全身治疗的应用可能对大分割放疗的放射性毒性产生何种负面影响。
肿瘤(癌症)患者之家