Arriagada R, Kramar A, Le Chevalier T, De Cremoux H
Institut Gustave-Roussy, Villejuif, France.
J Clin Oncol. 1992 Mar;10(3):447-51. doi: 10.1200/JCO.1992.10.3.447.
We report results in terms of relapse-free survival (RFS), obtained in patients with limited small-cell lung carcinoma (SCLC) treated by four consecutive alternating protocols, using a competing risk approach with local recurrences, distant metastases, and death unrelated to cancer as competing events.
Two hundred two patients with limited SCLC were included in four consecutive protocols alternating radiotherapy and chemotherapy (CT). The alternating schedule consisted of six cycles of CT (doxorubicin, etoposide [VP16213], and cyclophosphamide [CAVP16], plus methotrexate in the first protocol; cisplatin replaced methotrexate in the other three protocols) and three courses of thoracic radiotherapy at a total dose of 45, 55, 65, and 61 Gy in the four consecutive protocols, respectively (accelerated hyperfractionation was used in the first course of the fourth protocol). A 1-week rest followed each CT cycle and each course of radiotherapy. Seventy-six percent of patients were in complete remission at the end of the induction treatment. RFS variables were determined according to a model assuming competing risks to define the first cause of failure (local disease, distant metastasis, or intercurrent death).
No significant differences were observed between the four treatment groups. Overall results showed a 2-year cumulative incidence rate of failure of 75%. When analyzed, the first cause of failure was local recurrence only, 33%; distant only, 25%; distant and local simultaneously, 9%; and intercurrent death, 8%.
The methodology of competing risks allowed an unequivocal description of first events in limited SCLC. The extent of the local problem has been relatively overshadowed by the use of conventional descriptive methods.
我们报告了采用四个连续交替方案治疗的局限期小细胞肺癌(SCLC)患者的无复发生存期(RFS)结果,使用竞争风险方法,将局部复发、远处转移和与癌症无关的死亡作为竞争事件。
202例局限期SCLC患者纳入四个连续的放疗与化疗(CT)交替方案。交替方案包括六个周期的CT(阿霉素、依托泊苷[VP16213]和环磷酰胺[CAVP16],第一个方案加用甲氨蝶呤;其他三个方案中顺铂替代甲氨蝶呤)以及四个连续方案中分别总剂量为45、55、65和61 Gy的三个疗程胸部放疗(第四个方案的第一个疗程采用加速超分割放疗)。每个CT周期和每个放疗疗程后休息1周。诱导治疗结束时76%的患者完全缓解。RFS变量根据一个假设竞争风险的模型来确定,以定义首次失败原因(局部疾病、远处转移或并发死亡)。
四个治疗组之间未观察到显著差异。总体结果显示2年累积失败发生率为75%。分析时,首次失败原因仅为局部复发的占33%;仅远处转移的占25%;远处和局部同时出现的占9%;并发死亡的占8%。
竞争风险方法能够明确描述局限期SCLC的首次事件。局部问题的程度在传统描述方法的使用中相对被掩盖了。