GOG9402 previously described the feasibility of laparoscopic staging of gynecologic cancers.1
That study led to GOG LAP2, the first multi-center randomized trial of laparoscopy to be conducted in gynecologic cancer (). This study addressed the important question of the equivalency of conventional surgery with total abdominal hysterectomy, bilateral salpingo-oophorectomy, and pelvic and periaortic lymph node dissection versus laparoscopic pelvic and periaortic lymph node dissection, bilateral salpingo-oophorectomy, and vaginal hysterectomy for clinical stage I and IIa endometrial carcinoma. The parameters that were evaluated include adequacy of the specimen, operative time, operative and postoperative morbidity, length of hospital stays, progression-free interval, and survival. Additionally, 600 patients were evaluated for quality of life objectives. The study was amended to enroll an additional 1,900 patients to monitor subcutaneous abdominal wall recurrences and recurrence rates during the first 5 years following surgery. Laparoscopy patients had similar rates of intraoperative injuries as laparotomy patients (9% vs. 8%, p=0.11), fewer adverse events (27% vs. 37%, p<0.001), fewer moderate to severe (>CTC grade 2) complications (14% vs. 21%, p<0.001), and had shorter length of hospital stay (median 3 days vs. 4 days, p<0.001). Eight (0.5%) deaths within six weeks occurred in laparoscopy arm and six (0.7%) in the laparotomy arm (p=0.579). This study showed that laparoscopic staging is feasible with longer operative times, comparable complications, shorter hospital stay, and better quality of life at six weeks than laparotomy. Of note, GOG LAP2 did not assess cost, which may be significantly higher for laparoscopy. Data reflecting survival analysis is not yet mature. At this time, therefore, laparoscopy cannot be considered standard of care, although it should be considered a feasible alternative for appropriate patients.2,3
Fig. 1 A phase III randomized clinical trial of laparoscopic pelvic and para-aortic node sampling with vaginal hysterectomy and BSO versus open laparotomy with pelvic and para-aortic node sampling and abdominal hysterectomy and BSO in endometrial adenocarcinoma (more ...)
The current staging protocol is GOG0210 "A Molecular Staging study of Endometrial Carcinoma." This is a molecular and Surgico-pathological staging study of endometrial carcinoma. The overall goal of this pilot protocol is to improve outcome and/or quality of life for patients with endometrial cancer. This fundamental goal will be accomplished through the development of more accurate models of risk, identification of candidate targets for therapeutic intervention and utilization of individualized treatments based on molecular characteristics identified in tumor tissue, normal tissue and/or in readily accessible biological fluids, like serum and urine. Specifically, a repository of clinical specimens (tissue, urine, and serum) with detailed clinical and epidemiologic data from patients with surgically staged endometrial carcinoma has been established. It will utilize genomic, proteomic and immunoassay results from these specimens for the purpose of class prediction and class discovery to identify and validate molecular characteristics associated with risk of endometrial cancer recurrence, clinical and histological characteristics, and epidemiologic factors. The study will seek to improve the accuracy and resolution of the risk assessment models for predicting endometrial cancer recurrence using informative genomic, proteomic and immunoassay results in combination with clinical, pathological, and epidemiologic factors. Mining the genomic, proteomic and immunoassay results along with the clinical, histological and epidemiologic data obtained for this research study should identify candidate characteristics to target or exploit that would help prevent and/or treat endometrial carcinoma, and to expand the current understanding of the biology, progression, metastasis and responsiveness of endometrial carcinoma. As technology advances, other laboratory and translational proposals are being sought to fulfill the aims of GOG0210.