Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer.
OBJECTIVE
To define the role of pretreatment surgical staging for locally advanced cervical carcinoma.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Lai
Chyong-Huey
CH
Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan, Taiwan. sh6erry@ms6.hinet.net
Huang
Kuan-Gen
KG
Hong
Ji-Hong
JH
Lee
Chyi-Long
CL
Chou
Hung-Hsueh
HH
Chang
Ting-Chang
TC
Hsueh
Swei
S
Huang
Huei-Jean
HJ
Ng
Koon-Kwan
KK
Tsai
Chieh-Sheng
CS
D000328:Adult; D000368:Aged; D001706:Biopsy / Q000379:methods; D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging / Q000379:methods*; D011446:Prospective Studies; D016019:Survival Analysis; D014057:Tomography, X-Ray Computed; D002583:Uterine Cervical Neoplasms / Q000473:pathology* / Q000601:surgery