Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer.
To define the role of pretreatment surgical staging for locally advanced cervical carcinoma.
                A two-step randomized trial was conducted to compare clinical staging (arm A) versus surgical staging (arm B) and to compare the laparoscopic (LAP) with the extraperitoneal (EXP) approach in previously untreated locally advanced cervical carcinoma. After the first randomization, those in arm B were randomly allocated to either LAP or EXP. An interim analysis was planned to evaluate the feasibility of LAP versus EXP, which led to the current report.
                A total of 61 patients were eligible (arm A, 29; arm B, 32). The operation time, blood loss, and lymph node yield of LAP and EXP were not significantly different. Serious acute and late toxicity was not different between arm A and arm B, or LAP versus EXP. Para-aortic node metastasis was documented in 25% (95% confidence interval, 10% to 40%) of patients on arm B. An interim analysis was performed in January 2000. Patients on arm B had significantly worse progression-free survival than those on arm A. Hazard ratios of relapse/persistent or death were 3.13 (P = 0.005) and 1.76 (P = 0.150), respectively. Patient accrual was terminated according to the early stopping rules. With further follow-up till December 2001, the difference in progression-free survival remained significant (P = 0.003), and the difference in overall survival became significant (P = 0.024) as the data matured.
                The benefit of pretreatment surgical staging for cervical carcinoma remained unproven. The detrimental effects of surgical staging observed in this study must be considered in the design of clinical guidelines or future trials.
Since the last version of this review no new studies were found.
From the one available RCT we found insufficient evidence that pre-treatment surgical para-aortic lymph node assessment for locally advanced cervical cancer is beneficial, and it may actually have an adverse effect on survival. However, this conclusion is based on analysis of a small single trial and therefore definitive guidance or recommendations for clinical practice cannot be made.
Therefore, the decision to offer surgical pre-treatment assessment of para-aortic lymph nodes in locally advanced cervical cancer needs to be individualised. The uncertainty regarding any impact on survival from pre-treatment para-aortic lymph node assessment should be discussed openly with the women.