Shaw E G, Su J Q, Eagan R T, Jett J R, Maksymiuk A W, Deigert F A
Division of Radiation Oncology, Mayo Clinic, Rochester, MN 55905.
J Clin Oncol. 1994 Nov;12(11):2327-32. doi: 10.1200/JCO.1994.12.11.2327.
To determine whether prophylactic cranial irradiation (PCI) has an impact on brain failure and survival in patients with small-cell lung cancer (SCLC) who have achieved a complete response to chemotherapy with or without thoracic radiation therapy (TRT).
Between 1975 and 1990, the Mayo Clinic and North Central Cancer Treatment Group entered 1,617 patients on 15 phase II and III SCLC protocols of chemotherapy with or without TRT and PCI.
Of 772 patients with limited disease, 457 (59%) achieved a complete response, compared with 200 of 845 patients (24%) with extensive disease. With follow-up durations of 2 to 17 years (median, 4), the median survival time and 2-, 5-, and 10-year survival rates for the 457 completely responding limited-disease (LD-CR) patients were 19.6 months, 41%, 17%, and 5%, compared with 13.9 months, 26%, 8%, and 5%, respectively, for the 200 completely responding extensive disease (ED-CR) patients (P = .0001). Multiple prognostic factors, including whether the patient did or did not receive PCI (30 to 38 Gy in 2- to 3.6-Gy fractions) were analyzed. In both univariate and multivariate analyses, PCI was not associated with improved (or worsened) survival. The brain relapse rate was 37% for LD-CR patients who did not receive PCI versus 9% for those who did (P = .0001). In ED-CR patients, the brain relapse rate was 31% without PCI and 8% with (P = .009). Essentially all patients who developed brain relapse died within 2 years, with a median survival time of 3.7 months following relapse. Severe, life-threatening, or fatal CNS toxicity occurred in approximately 3% of patients who received PCI.
The use of PCI remains controversial outside the setting of a clinical trial.
确定预防性颅脑照射（PCI）对已接受化疗（联合或不联合胸部放疗（TRT））且达到完全缓解的小细胞肺癌（SCLC）患者的脑功能衰竭和生存情况是否有影响。
1975年至1990年间，梅奥诊所和北中部癌症治疗组将1617例患者纳入15项II期和III期SCLC化疗方案（联合或不联合TRT和PCI）。
772例局限性疾病患者中，457例（59%）达到完全缓解，而845例广泛性疾病患者中有200例（24%）达到完全缓解。随访时间为2至17年（中位时间为4年），457例完全缓解的局限性疾病（LD-CR）患者的中位生存时间以及2年、5年和10年生存率分别为19.6个月、41%、17%和5%，而200例完全缓解的广泛性疾病（ED-CR）患者分别为13.9个月、26%、8%和5%（P = 0.0001）。分析了多个预后因素，包括患者是否接受PCI（2至3.6 Gy分次给予30至38 Gy）。在单因素和多因素分析中，PCI均与生存率的改善（或恶化）无关。未接受PCI的LD-CR患者脑复发率为37%，接受PCI的患者为9%（P = 0.0001）。在ED-CR患者中，未接受PCI时脑复发率为31%；接受PCI时为8%（P = 0.009）。基本上所有发生脑复发的患者在2年内死亡，复发后的中位生存时间为3.7个月。接受PCI的患者中约3%发生严重、危及生命或致命的中枢神经系统毒性。
在临床试验之外，PCI的应用仍存在争议。
