PDF(Pubmed)
Abstract：
BACKGROUND: Prophylactic cranial irradiation (PCI) is part of standard care in limited-stage small cell lung cancer (SCLC) at present. As evidence from retrospective studies increases, the benefits of PCI for limited-stage SCLC are being challenged.
METHODS: A multicenter, prospective, randomized controlled study was designed. The key inclusion criteria were: histologically or cytologically confirmed small cell carcinoma, age ≥ 18 years, KPS ≥ 80, limited-stage is defined as tumor confined to one side of the chest including ipsilateral hilar, bilateral mediastinum and supraclavicular lymph nodes, patients have received definitive thoracic radiotherapy (regardless of the dose-fractionation of radiotherapy used) and chemotherapy, evaluated as complete remission (CR) of tumor 4-6 weeks after the completion of chemo-radiotherapy. Eligible patients will be randomly assigned to two arms: (1) PCI and brain MRI surveillance arm, receiving PCI (2.5 Gy qd to a total dose of 25 Gy in two weeks) followed by brain MRI surveillance once every three months for two years; (2) brain MRI surveillance alone arm, undergoing brain MRI surveillance once every three months for two years. The primary objective is to compare the 2-year brain metastasis-free survival (BMFS) rates between the two arms. Secondary objectives include 2-year overall survival (OS) rates, intra-cranial failure patterns, 2-year progression-free survival rates and neurotoxicity. In case of brain metastasis (BM) detect during follow-up, stereotactic radiosurgery (SRS) will be recommended if patients meet the eligibility criteria.
CONCLUSIONS: Based on our post-hoc analysis of a prospective study, we hypothesize that in limited-stage SCLC patients with CR after definitive chemoradiotherapy, and ruling out of BM by MRI, it would be feasible to use brain MRI surveillance and omit PCI in these patients. If BM is detected during follow-up, treatment with SRS or whole brain radiotherapy does not appear to have a detrimental effect on OS. Additionally, this approach may reduce potential neurotoxicity associated with PCI.
METHODS: A multicenter, prospective, randomized controlled study was designed. The key inclusion criteria were: histologically or cytologically confirmed small cell carcinoma, age ≥ 18 years, KPS ≥ 80, limited-stage is defined as tumor confined to one side of the chest including ipsilateral hilar, bilateral mediastinum and supraclavicular lymph nodes, patients have received definitive thoracic radiotherapy (regardless of the dose-fractionation of radiotherapy used) and chemotherapy, evaluated as complete remission (CR) of tumor 4-6 weeks after the completion of chemo-radiotherapy. Eligible patients will be randomly assigned to two arms: (1) PCI and brain MRI surveillance arm, receiving PCI (2.5 Gy qd to a total dose of 25 Gy in two weeks) followed by brain MRI surveillance once every three months for two years; (2) brain MRI surveillance alone arm, undergoing brain MRI surveillance once every three months for two years. The primary objective is to compare the 2-year brain metastasis-free survival (BMFS) rates between the two arms. Secondary objectives include 2-year overall survival (OS) rates, intra-cranial failure patterns, 2-year progression-free survival rates and neurotoxicity. In case of brain metastasis (BM) detect during follow-up, stereotactic radiosurgery (SRS) will be recommended if patients meet the eligibility criteria.
CONCLUSIONS: Based on our post-hoc analysis of a prospective study, we hypothesize that in limited-stage SCLC patients with CR after definitive chemoradiotherapy, and ruling out of BM by MRI, it would be feasible to use brain MRI surveillance and omit PCI in these patients. If BM is detected during follow-up, treatment with SRS or whole brain radiotherapy does not appear to have a detrimental effect on OS. Additionally, this approach may reduce potential neurotoxicity associated with PCI.
摘要：
背景：目前，预防性颅骨照射（PCI）是局限期小细胞肺癌（SCLC）标准治疗的一部分。随着回顾性研究证据的增加，PCI对有限阶段SCLC的益处受到挑战.
方法：多中心，prospective,设计了随机对照研究。关键的纳入标准是：组织学或细胞学证实的小细胞癌，年龄≥18岁，KPS≥80，局限期定义为肿瘤局限于胸部一侧，包括同侧肺门，双侧纵隔和锁骨上淋巴结，患者接受了明确的胸部放疗（无论使用的放疗的剂量分割）和化疗，化疗完成后4-6周评估为肿瘤完全缓解（CR）。符合条件的患者将被随机分配到两个组：（1）PCI和脑MRI监测组，接受PCI（2.5Gyqd至总剂量为25Gy在两周内），然后每三个月进行一次脑MRI监测，为期两年；（2）仅进行脑MRI监测，每三个月接受一次脑部MRI监测，为期两年。主要目的是比较两组之间的2年无脑转移生存率（BMFS）。次要目标包括2年总生存率（OS），颅内衰竭模式，2年无进展生存率和神经毒性。如果在随访期间检测到脑转移（BM），如果患者符合入选标准,则推荐使用立体定向放射外科(SRS).
结论：根据我们对一项前瞻性研究的事后分析，我们假设在确定性放化疗后出现CR的局限期SCLC患者中，并通过MRI排除BM，在这些患者中使用脑MRI监测和省略PCI是可行的.如果在随访期间检测到BM，SRS或全脑放射治疗似乎对OS没有不利影响。此外,这种方法可以减少与PCI相关的潜在神经毒性.
方法：多中心，prospective,设计了随机对照研究。关键的纳入标准是：组织学或细胞学证实的小细胞癌，年龄≥18岁，KPS≥80，局限期定义为肿瘤局限于胸部一侧，包括同侧肺门，双侧纵隔和锁骨上淋巴结，患者接受了明确的胸部放疗（无论使用的放疗的剂量分割）和化疗，化疗完成后4-6周评估为肿瘤完全缓解（CR）。符合条件的患者将被随机分配到两个组：（1）PCI和脑MRI监测组，接受PCI（2.5Gyqd至总剂量为25Gy在两周内），然后每三个月进行一次脑MRI监测，为期两年；（2）仅进行脑MRI监测，每三个月接受一次脑部MRI监测，为期两年。主要目的是比较两组之间的2年无脑转移生存率（BMFS）。次要目标包括2年总生存率（OS），颅内衰竭模式，2年无进展生存率和神经毒性。如果在随访期间检测到脑转移（BM），如果患者符合入选标准,则推荐使用立体定向放射外科(SRS).
结论：根据我们对一项前瞻性研究的事后分析，我们假设在确定性放化疗后出现CR的局限期SCLC患者中，并通过MRI排除BM，在这些患者中使用脑MRI监测和省略PCI是可行的.如果在随访期间检测到BM，SRS或全脑放射治疗似乎对OS没有不利影响。此外,这种方法可以减少与PCI相关的潜在神经毒性.
