Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: long-term survival outcomes in a matched cohort study

J.-H. Nam 0 J.-Y. Park 0 D.-Y. Kim 0 J.-H. Kim 0 Y.-M. Kim 0 Y.-T. Kim 0 0 Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center , Seoul , Korea Background: To compare the long-term survival outcomes between laparoscopic radical hysterectomy (LRH) and open radical hysterectomy (ORH). Method: We matched patients with stage IA2 to IIA cervical cancer with known risk factors for recurrence who underwent ORH and LRH. Results: Compared with ORH (n = 263), LRH (n = 263) did not have higher risks of recurrence [hazard ratio (HR) = 1.28; 95% confidence interval (CI) 0.62-2.64] or death (HR = 1.46; 95% CI 0.62-3.43). Even in patients with tumors >2 cm in diameter, the risks of recurrence (HR = 0.82; 95% CI 0.31-2.16) or death (HR = 1.01; 95% CI 0.35-2.95) were not higher for LRH than for ORH. The LRH and ORH group had 5-year recurrence-free survival rates of 92.8% and 94.4%, respectively (P = 0.499). LRH resulted in significantly lower estimated blood loss (379.6 versus 541.1 ml, P < 0.001) and shorter postoperative hospital stay (12.5 versus 20.3 days, P < 0.001). Intraoperative complication rates were similar in the two groups (6.8% versus 5.7%, P = 0.711), but postoperative complication rate was lower in the LRH than in the ORH group (9.2% versus 21%, P < 0.001). Conclusion: LRH is an oncologically safe alternative to ORH and was associated with fewer postoperative complication and earlier recovery. - introduction Cervical cancer is the second most common and the third leading cause of cancer fatalities among women worldwide [1]. In Korea, cervical cancer is the most common gynecologic cancer and the third most common cancer among women [2, 3]. The standard treatment of early-stage cervical cancer is open radical hysterectomy (ORH), resulting in 5-year survival rates of 75%90% [46]. Intermediate risk factors for recurrence after radical hysterectomy include tumor size, lymphovascular space invasion (LVSI), and depth of cervical stromal invasion [7, 8], and high risk factors include parametrial involvement, lymph node metastasis, and resection margin involvement [911]. Laparoscopic radical hysterectomy (LRH) is an alternative to ORH, but its acceptance has been slower than that of other laparoscopic oncological surgical techniques, with the use of LRH limited to patients with small tumors (<2 cm) because of technical difficulties. Since LRH was first described in the early 1990s [12, 13], only a few small retrospective studies have compared the outcomes of LRH and ORH [1420], and their long-term survival outcomes have never been compared to date in a large well-controlled study with sufficient follow-up. Using our 14-year, large-scale prospectively gathered database of patients with stage IA2 to IIA cervical cancer, we matched patients who underwent ORH and LRH for known risk factors for recurrence. The long-term survival outcomes and the immediate surgical outcomes in these two groups of patients were compared. materials and methods study population Using the cancer registry and computerized database of the Asan Medical Center (AMC; Seoul, Korea), we retrieved the records of all patients with early-stage cervical cancer who were treated and followed up between October 1997 and April 2008. With the approval of the Institutional Review Board of AMC, we retrospectively evaluated the demographic, clinicopathologic, and follow-up data of all patients. Patients were included if they had (i) previously untreated cervical cancer; (ii) International Federation of Gynecology and Obstetrics (FIGO) stage IA2 to IIA; (iii) squamous cell carcinoma, adenocarcinoma, or adenosquamous The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: carcinoma; (iv) had undergone LRH or ORH as primary treatment (v) had received adjuvant therapy after radical hysterectomy if they had intermediate or high risk factors; and (vi) were followed up for >2 years after radical hysterectomy. We excluded patients who received radiation or concurrent chemoradiation therapy as primary treatment, as well as those who received neoadjuvant chemotherapy, radiation, or concurrent chemoradiation therapy before radical hysterectomy. We found that 415 patients who underwent LRH and 721 who underwent ORH met the eligibility criteria and were included in the matching process (Figure 1). Each patient in the LRH group was matched to one patient in the ORH group using the following matching criteria: lymph node metastasis, parametrial involvement, tumor size (62 cm), depth of cervical stromal invasion (<1/2 versus >1/2), LVSI, and age (63 years). Since all variables were matched in equal significance, the two groups, each containing 263 patients, were completely matched for all intermediate and high risk factors for recurrence after radical hysterectomy. study treatment and follow-up We have described the surgical procedures for LRH in a previous report [16]. After LRH, a single Jackson-Pratt drain was inserted through the lateral trocar to ensure drainage, with the retroperitoneum remaining open. The Foley catheter was usually removed 7 days after surgery. Surgical procedures and the extent of resection of ORH were generally identical to those for LRH, except that, in ORH, a midline abdominal incision was made from the pubic symphysis to the supraumbilical area. If a positive pelvic or para-aortic lymph node was identified during surgery, our policy was to complete the radical hysterectomy, although it has not yet been determined whether the surgeon should complete the radical hysterectomy or stop the procedure and administer concurrent chemoradiation therapy. After surgery, patients with two or more intermediate risk factors (LVSI, tumor >4 cm, and/or deep cervical stromal invasion) were recommended to receive adjuvant radiation therapy, whereas patients with one or more high risk factors (resection margin involvement, parametrial involvement, or lymph node involvement) were recommended to receive adjuvant concurrent chemoradiation therapy. Some patients, however, received adjuvant chemotherapy depending on the preferences of the patient and physician. Following completion of treatment, patients were examined every 3 months for the first 2 years, every 6 months during the next 3 years and yearly thereafter. definitions Febrile morbidity after surgery was defined as the documentation of body temperature 38 C on two occasions at least 4 h apart during the postoperative period, excluding the first 24 h after surgery. Bladder dysfunction after surgery was defined as voiding difficulty requiring reindwelling of a Foley catheter or clean intermittent catheterization. Postoperative mortality was defined as death from any cause within 30 days after surgery. Intermediate risk factors for recurrence after surgery included tumor size, depth of cervical stromal invasion, (...truncated)