Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study.

PURPOSE: The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of uterine cancer. PATIENTS AND METHODS: Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. RESULTS: With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence rates were substantially lower than anticipated, resulting in an estimated 3-year recurrence rate of 11.4% with laparoscopy and 10.2% with laparotomy, or a difference of 1.14% (90% lower bound, -1.28; 95% upper bound, 4.0). The estimated 5-year overall survival was almost identical in both arms at 89.8%. CONCLUSION: This study previously reported that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay end points. The potential for increased risk of cancer recurrence with laparoscopy versus laparotomy was quantified and found to be small, providing accurate information for decision making for women with uterine cancer.

Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2.

PURPOSE: The objective was to compare laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer. PATIENTS AND METHODS: Patients with clinical stage I to IIA uterine cancer were randomly assigned to laparoscopy (n = 1,696) or open laparotomy (n = 920), including hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The main study end points were 6-week morbidity and mortality, hospital length of stay, conversion from laparoscopy to laparotomy, recurrence-free survival, site of recurrence, and patient-reported quality-of-life outcomes. RESULTS: Laparoscopy was initiated in 1,682 patients and completed without conversion in 1,248 patients (74.2%). Conversion from laparoscopy to laparotomy was secondary to poor visibility in 246 patients (14.6%), metastatic cancer in 69 patients (4.1%), bleeding in 49 patients (2.9%), and other cause in 70 patients (4.2%). Laparoscopy had fewer moderate to severe postoperative adverse events than laparotomy (14% v 21%, respectively; P < .0001) but similar rates of intraoperative complications, despite having a significantly longer operative time (median, 204 v 130 minutes, respectively; P < .001). Hospitalization of more than 2 days was significantly lower in laparoscopy versus laparotomy patients (52% v 94%, respectively; P < .0001). Pelvic and para-aortic nodes were not removed in 8% of laparoscopy patients and 4% of laparotomy patients (P < .0001). No difference in overall detection of advanced stage (stage IIIA, IIIC, or IVB) was seen (17% of laparoscopy patients v 17% of laparotomy patients; P = .841). CONCLUSION: Laparoscopic surgical staging for uterine cancer is feasible and safe in terms of short-term outcomes and results in fewer complications and shorter hospital stay. Follow-up of these patients will determine whether surgical technique impacts pattern of recurrence or disease-free survival.

Laparoscopic staging in patients with incompletely staged cancers of the uterus, ovary, fallopian tube, and primary peritoneum: a Gynecologic Oncology Group (GOG) study.

OBJECTIVE: The purpose of this study was to determine the feasibility of laparoscopically staging patients with incompletely staged cancers of the uterus, ovary, fallopian tube, and primary peritoneum, and to evaluate related effects. STUDY DESIGN: Patients without evidence of metastatic disease had laparoscopic bilateral para-aortic and pelvic lymph node dissection. Other procedures were individualized based on extent of the primary surgery; laparotomy was undertaken for identified resectable disease. RESULTS: Ninety-five eligible patients were entered on 2 Gynecologic Oncology Group (GOG) protocols. Eleven were excluded. Fifty-eight patients (69%) underwent complete endoscopic staging with photographic documentation. Nine others (10%) were incompletely staged. Seventeen patients (20%) had laparotomy. In patients undergoing laparoscopy, 6% had bowel complications; 11% were found to have more advanced disease. Hospital stay was significantly shorter with laparoscopy alone (3 vs 6 days, P = .04). CONCLUSION: Interval laparoscopic staging of gynecologic malignancies can be successfully undertaken in selected patients, but laparotomy for adhesions or metastatic disease and risk of visceral injury may be anticipated.

Radical trachelectomy and pelvic lymphadenectomy with uterine preservation in the treatment of cervical cancer.

OBJECTIVE: The purpose of this study was to determine whether radical trachelectomy, combined with pelvic lymphadenectomy, can be a feasible method for the treatment of early-stage cervical carcinoma in women who want to preserve their fertility. STUDY DESIGN: From January 1, 1995, through December 31, 1999, 12 women with stage I carcinoma of the cervix were scheduled to undergo radical trachelectomy and pelvic lymphadenectomy of the intact uterus as treatment. The procedure was abandoned in 2 women because of endometrial extension of the cancer. Surgical margins were clear in all other women. No lymph node metastases were encountered. The proximal cervical remnant was reinforced in 10 women. RESULTS: Hospitalization ranged from 2 to 8 days (mean, 3.2 days). Estimated blood loss averaged 203 mL (range, 50-600 mL). Complications included 2 intraoperative cystotomies and 1 pelvic hematoma. Four pregnancies have occurred, with 2 third-trimester deliveries and 2 preterm losses at 24 and 26 weeks of gestation, respectively. The follow-up period has ranged from 28 to 84 months (mean, 47.6 months). CONCLUSION: Radical trachelectomy, combined with pelvic lymphadenectomy, can be a feasible method of treatment for early-stage cervical carcinoma in women who want to preserve their fertility.

Laparoscopic radical hysterectomy (type III) with aortic and pelvic lymphadenectomy in patients with stage I cervical cancer: surgical morbidity and intermediate follow-up.

OBJECTIVE: The purpose of this study was to determine the risk of recurrence and to quantify morbidity and mortality rates in patients with cervical cancer who consented to undergo laparoscopic radical hysterectomy (type III) and retroperitoneal lymphadenectomy. STUDY DESIGN: Seventy-eight consecutive patients with stage IA(2) and IB cervical cancer with at least 3 years of follow-up consented to undergo this surgical procedure with argon beam coagulation and endoscopic staplers. All patients had a Quetelet index of <35. The average age was 41.5 years (range, 26-62 years). Sixty-eight patients had squamous cell carcinomas; 8 patients had adenocarcinomas, and 2 patients had adenosquamous carcinomas of the cervix. RESULTS: All but 5 surgical procedures were completed laparoscopically. The average operative time was 205 minutes (range, 150-430 minutes). The average blood loss was 225 mL (range, 50-700 mL). One patient (1.3%) had transfusion. Operative cystotomies occurred for 3 patients: 2 cystotomies were repaired laparoscopically, and 1 cystotomy required laparotomy. One patient underwent laparotomy because of equipment failure, and another patient underwent laparotomy to pass a ureteral stent. Two other patients underwent laparotomy to control bleeding sites. The average lymph node count was 34 (range, 19-68). Nine patients (11.5%) had positive lymph nodes. All surgical margins were macroscopically negative, but 3 patients had microscopically positive and/or close surgical margins. One patient had a ureterovaginal fistula after the operation that required reoperation. Follow-up has been provided every 3 months. There have been 4 documented recurrences (5.1%), with a minimum of 3 years of follow-up. CONCLUSION: Laparoscopic radical hysterectomy (type III) can be successfully completed in patients with early-stage cervical cancer with acceptable morbidity. Intermediate-term follow-up validates the adequacy of this procedure.

Laparoscopic retroperitoneal lymphadenectomy followed by immediate laparotomy in women with cervical cancer: a gynecologic oncology group study.

OBJECTIVES: From May 1993 until June 1997, the Gynecologic Oncology Group undertook a study of women with cancer of the cervix (Stage IA, IB, and IIA) who were about to undergo radical abdominal hysterectomy, pelvic lymphadenectomy, and aortic lymph node sampling. Immediately before this surgery, laparoscopy was performed and removal of the lymph nodes was attempted. There were two objectives: (1) to obtain information on the adverse effects and difficulties associated with laparoscopic lymph node removal and (2) to determine the adequacy of the lymph node removal. METHODS: Four methods determined the adequacy of the lymph node removal: (1) the surgeon's opinion during laparoscopy, (2) a photographic record reviewed by two independent observers, (3) inspection of the surgical sites at laparotomy, and (4) lymph node count. RESULTS: Seventy-three women were entered onto the study. Four patients were judged ineligible; 2 did not undergo laparoscopy and 17 women did not complete laparoscopic surgery because of metastatic lymph nodes judged unresectable or complications. Ten women were inevaluable. The remaining 40 women were completely evaluable for protocol objectives. All cases of bilateral laparoscopic aortic lymph node sampling were judged adequate by all four methods of evaluation. For laparoscopic pelvic lymphadenectomy 6 were judged incomplete at laparotomy, 3 of which were judged incomplete by independent reviewers. The mean number of right pelvic nodes removed was 16.6; left pelvic nodes 15.5; right aortic nodes 6.2; and left aortic nodes 5.9. CONCLUSIONS: Laparoscopic bilateral aortic lymph node sampling appeared to be reasonably safe and feasible. Laparoscopic therapeutic bilateral pelvic lymphadenectomy, although having a reasonable complication rate, demonstrated problems regarding adequacy, which are probably correctable.