Frasci G, Conforti S, Zullo F, Mastrantonio P, Comella G, Comella P, Persico G, Iaffaioli R V
VII Division of General Surgery, University Frederico II, Naples, Italy.
Cancer. 1996 Mar 15;77(6):1122-30.
We evaluated the incorporation of CA 125 normalization times into a prognostic model based on pretreatment variables in patients with ovarian carcinoma to determine if they could render second-look laparotomy (SLL) redundant.
A total of 54 consecutive patients with ovarian carcinoma who underwent SLL between 1985 and 1990 were included in this analysis. At diagnosis, all of the patients had abnormal CA-125 serum levels, which fell to within the normal range during chemotherapy. Cox's model was used to select pretreatment variables relevant for prognosis. The influence of the time to normalization of CA 125 (< or = vs. > 1 months) and the capability of SLL results to modify prognostic prediction, were also evaluated.
The size of the residual tumor at the beginning of therapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) were independently predictive of survival. The time to normalization of CA 125 serum levels (analyzed either as -a continuous or as a two-category variable) also had an independent prognostic role when included in the model. When we examined the inclusion of both CA 125 parameter and SLL into the model together, we found that only CA 125 continued to have an independent prognostic relevance. On the basis of the two pretreatment parameters (PS and tumor size) and of this response parameter (time to normalization of CA 125 values) we selected six subgroups of patients having different outcomes (log rank test of equality over-strata < 0.001). Patients with good prognostic pretreatment variables, and those with intermediate prognosis at the beginning of therapy who showed a quick normalization of CA 125, had an 80% 5-year survival, compared with 16% 5-year survival in the remaining patients. (P < 0.0001).
Our data suggest that the survival of patients with advanced ovarian carcinoma could be accurately predicted by considering some pretreatment variables and time to CA 125 normalization together, without performing SLL. Our risk model, however, needs to be validated by larger prospective trials, to draw any definitive conclusions about the abandonment of surgically defined response.
我们评估了将CA 125正常化时间纳入基于卵巢癌患者治疗前变量的预后模型，以确定其是否能使二次探查剖腹术（SLL）变得多余。
本分析纳入了1985年至1990年间连续接受SLL的54例卵巢癌患者。诊断时，所有患者的CA - 125血清水平均异常，化疗期间降至正常范围。采用Cox模型选择与预后相关的治疗前变量。还评估了CA 125正常化时间（≤1个月与＞1个月）的影响以及SLL结果对预后预测的修正能力。
治疗开始时残余肿瘤的大小以及东部肿瘤协作组（ECOG）的体能状态（PS）可独立预测生存。当将CA 125血清水平正常化时间（作为连续变量或两类变量分析）纳入模型时，它也具有独立的预后作用。当我们同时将CA 125参数和SLL纳入模型时，发现只有CA 125继续具有独立的预后相关性。基于两个治疗前参数（PS和肿瘤大小）以及这个反应参数（CA 125值正常化时间），我们选择了六个预后不同的患者亚组（各层间相等性的对数秩检验＜0.001）。具有良好预后治疗前变量的患者，以及治疗开始时预后中等但CA 125迅速正常化的患者，5年生存率为80%，而其余患者的5年生存率为16%。（P＜0.0001）。
我们的数据表明，综合考虑一些治疗前变量和CA 125正常化时间，无需进行SLL即可准确预测晚期卵巢癌患者的生存。然而，我们的风险模型需要通过更大规模的前瞻性试验进行验证，才能就放弃手术定义的反应得出任何明确结论。
