Lassen U N, Osterlind K, Hirsch F R, Bergman B, Dombernowsky P, Hansen H H
Finsen Center, Department of Oncology, Rigshospitalet, National University Hospital, Copenhagen, Denmark.
Br J Cancer. 1999 Feb;79(3-4):515-9. doi: 10.1038/sj.bjc.6690080.
Based on an increased frequency of early death (death within the first treatment cycle) in our two latest randomized trials of combination chemotherapy in small-cell lung cancer (SCLC), we wanted to identify patients at risk of early non-toxic death (ENTD) and early toxic death (ETD). Data were stored in a database and logistic regression analyses were performed to identify predictive factors for early death. During the first cycle, 118 out of 937 patients (12.6%) died. In 38 patients (4%), the cause of death was sepsis. Significant risk factors were age, performance status (PS), lactate dehydrogenase (LDH) and treatment with epipodophyllotoxins and platinum in the first cycle (EP). Risk factors for ENTD were age, PS and LDH. Extensive stage had a hazard ratio of 1.9 (P = 0.07). Risk factors for ETD were EP, PS and LDH, whereas age and stage were not. For EP, the hazard ratio was as high as 6.7 (P = 0.0001). We introduced a simple prognostic algorithm including performance status, LDH and age. Using a prognostic algorithm to exclude poor-risk patients from trials, we could minimize early death, improve long-term survival and increase the survival differences between different regimens. We suggest that other groups evaluate our algorithm and exclude poor prognosis patients from trials of dose intensification.
基于我们最近两项小细胞肺癌（SCLC）联合化疗随机试验中早期死亡（在第一个治疗周期内死亡）频率的增加，我们希望识别有早期无毒死亡（ENTD）和早期毒性死亡（ETD）风险的患者。数据存储在数据库中，并进行逻辑回归分析以识别早期死亡的预测因素。在第一个周期中，937名患者中有118名（12.6%）死亡。在38名患者（4%）中，死亡原因是败血症。显著的风险因素包括年龄、体能状态（PS）、乳酸脱氢酶（LDH）以及在第一个周期接受表鬼臼毒素和铂类治疗（EP）。ENTD的风险因素是年龄、PS和LDH。广泛期的风险比为1.9（P = 0.07）。ETD的风险因素是EP、PS和LDH，而年龄和分期则不是。对于EP，风险比高达6.7（P = 0.0001）。我们引入了一种简单的预后算法，包括体能状态、LDH和年龄。使用预后算法将高风险患者排除在试验之外，我们可以将早期死亡降至最低，改善长期生存，并增加不同治疗方案之间的生存差异。我们建议其他研究小组评估我们的算法，并在剂量强化试验中排除预后不良的患者。
