John B. Schlaerth

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.

Cost and quality-of-life analyses of surgery for early endometrial cancer: Laparotomy versus laparoscopy

OBJECTIVE The purpose of this study was to determine whether the cost or quality of life associated with surgical treatment of presumed early-stage endometrial cancer differed on the basis of the surgical approach. STUDY DESIGN A retrospective analysis was performed on a consecutive series of women with presumed early-stage endometrial cancer treated at the Womens Cancer Center of Northern California. The senior author was the surgeon, cosurgeon, or assistant on all cases. The women comprise two groups with different surgical approaches. The first group of 17 women underwent exploratory laparotomy, total abdominal hysterectomy, bilateral salpingo-oophorectomy, and pelvic and aortic lymphadenectomy. The second group of 13 women underwent the same surgery by laparoscopy. The two groups were compared with a two-tailed Student t test. Variables analyzed included age, height, weight, Quetelet index, and predisposing medical problems. Lymph node counts were compiled. Hospital costs were broken down into four cost categories: (1) operating room, (2) hospital bed, (3) pharmacy, and (4) anesthesia. A two-tailed Student t test was also used in this analysis. Issues examined regarding quality of life included (1) average hospital stay, (2) complications, and (3) time to return to normal activity. RESULTS The patient population differed significantly (p < 0.05) with regard to weight and Quetelet index. The laparotomy group required significantly longer hospitalization than the laparoscopy group (6.3 vs 2.4 days, p < 0.001), resulting in higher overall hospital costs (

The influence of surgical staging on the evaluation and treatment of patients with cervical carcinoma

19,158 vs

Laparoscopic bilateral pelvic and paraaortic lymph node sampoing: An evolving technique

13,988, p < 0.05). Similarly, patients undergoing laparotomy took longer to return to normal activity (5.3 weeks vs 2.4 weeks, p < 0.0001). CONCLUSION Laparoscopic management of endometrial cancer may result in significant cost savings and improved quality of life as demonstrated by shortened hospital stays and an earlier return to normal activity.

Extraperitoneal versus transperitoneal selective paraaortic lymphadenectomy in the pretreatment surgical staging of advanced cervical carcinoma (A Gynecologic Oncology Group study)

Abstract Ninety-six patients with cervical cancer underwent surgical staging prior to radiation therapy. An equal number of patients were explored by transperitoneal and extraperitoneal surgery. Three different extraperitoneal approaches were utilized. All patients had bilateral paraaortic lymphadenectomy and selective pelvic nodal sampling. Intraperitoneal cytology and selected biopsies were performed. A 52% correlation existed between clinical and surgical staging. Radiotherapeutic treatment decisions were subsequently based on findings at operative staging. Nine percent of patients undergoing transperitoneal staging experienced a small bowel injury after radiation requiring surgical correction. No patients undergoing extraperitoneal surgery experienced postradiation small bowel morbidity. Extended field radiation was administered to 17% of patients, and a 30% five-year disease-free survival rate was observed. Although prognostic stratification is enhanced with surgical staging, using current radiotherapy techniques, the majority of patients with paraaortic nodal metastases will fail treatment. Based on our experience, only 2.5% of patients in a Stage IIB-IVA category will benefit from radiotherapeutic treatment decisions made as a consequence of Staging laparotomy.

Resection of diaphragmatic peritoneum and muscle: Role in cytoreductive surgery for ovarian cancer

OBJECTIVE Reports describing laparoscopic lymph node sampling in patients with gynecologic malignancies have yet to describe a method to sample left-sided aortic lymph nodes that has been successful in a large series of patients. We submit our experience with evolving techniques that allow for excellent visualization and resection of both left and right aortic and pelvic lymph nodes. STUDY DESIGN Forty patients with gynecologic malignancies underwent laparoscopy for surgical staging. Thirty-five of the patients were completely staged laparoscopically with minimal blood loss. The average number of lymph nodes sampled was 27.7 (range 14 to 35). RESULTS Five patients required laparotomy, two to control bleeding, two to remove unsuspected intraabdominal disease, and one because of equipment failure. Four patients were rehospitalized within 30 days of surgery, two with small bowel obstructions resulting from herniation of the intestine through 12 mm trocar sites and two others with deep vein thromboses. CONCLUSION These preliminary results demonstrate an ability to complete surgical staging in patients with gynecologic malignancies by means of specific endoscopic techniques. However, there remains a need for continued evaluation of these techniques and the associated morbidities.

Primary vaginal melanoma: Thirteen-year disease-free survival after wide local excision and review of recent literature

Abstract Two-hundred and eighty-eight patients with predominately stage IIB or IIIB cervical carcinoma underwent pretreatment surgical staging including selective paraaortic lymphadenectomy (SPAL), followed by pelvic irradiation with or without paraaortic irradiation (RT). Four patients were excluded from analysis (two received no RT and two were insufficiently documented). Of the remaining 284 patients, 128 underwent extraperitoneal (EP) SPAL and 156 transperitoneal (TP) SPAL procedures. Age, race, and stage (clinical and surgical), cell type, paraaortic nodal status, and peritoneal cytology findings were similar in both groups. Complications presumed to arise from operative staging were infection, which was similar for both groups, and vascular injury, which was higher in the TP group, although not statistically significant. Complications subsequent to RT fell into two categories: local—pelvic necrosis, vesicovaginal and rectovaginal fistulas, proctitis, etc., and regional—enterovaginal fistula, bowel obstruction, enteritis, bowel perforation, etc. The frequency of local complications was similar for both EP and TP patients. Utilizing univariant analysis, among regional complications, both bowel obstruction and nonobstructive enteric injuries were observed significantly more often in TP patients than in EP patients (11.5% vs 3.9%, P = 0.03, for both types). Multivariant analysis confirmed these observations. This report supports the conclusions that in advanced cervical carcinoma (1) EP- and TP-SPAL are of similar sensitivity in detecting nodal spread, (2) no significant differences in the frequency of surgical complications could be detected between EP- and TP-SPAL groups, and (3) TP-SPAL is associated with a higher frequency of certain postirradiation regional enteric complications.

Hormonal contraception and trophoblastic sequelae after hydatidiform mole (A Gynecologic Oncology Group study)

Abstract Fourteen patients undergoing primary cytoreductive surgery for stage III ovarian malignancies had diaphragmatic peritoneum, muscle, or both resected in an attempt to remove all metastatic disease greater than 0.5 cm in diameter. Resection was completed in 13 of 14 patients (93%), all obtaining optimal cytoreduction. Size of resected specimens varied from 12 × 7 to 17 × 11 cm. The mediastinum was entered in two patients. Four patients had resection of diaphragmatic muscle. All defects were closed primarily and a thoracostomy tube was placed. One patient who did not have muscle resection had a 30% pneumothorax that spontaneously resolved. No subdiaphragmatic hematomas or abscesses occurred. Time (mean 65 min, range 40–150 min) and blood loss (mean 175 ml, range 100–1500 ml) for the surgery depended upon extent of disease. One procedure was terminated due to bleeding from a lacerated liver capsule. We conclude that diaphragmatic peritoneum/muscle resection can be completed successfully with acceptable morbidity.

Embryonal rhabdomyosarcoma of the uterine corpus and cervix

OBJECTIVES We present a case report of a woman who has survived 13 years after conservative treatment with wide excision for vaginal melanoma and review and evaluate the literature on this disease since the last metaanalysis in 1989. STUDY DESIGN A database literature search along with cross referencing from related articles uncovered 66 patients who were reported to have vaginal melanoma since 1989 with adequate information for our analysis. We add to this one original case reported by us. Where information was available, we analyzed outcomes on these cases on the basis of patient age, tumor thickness, tumor size, and treatment. RESULTS The patient we describe is only the eighteenth reported patient to survive vaginal melanoma 5 years and only the third to survive for 10 years. Of the 67 patients in our overall review, mean age at the time of diagnosis was 62 years. Patients with tumor size < 3 cm had a mean survival of 41 months compared with 12 months for those with tumor size > or = 3 cm (p < 0.0024). Tumor thickness did not significantly affect patient survival at any of the depths analyzed, although there was a tendency toward significance at depths > 8 mm (p < 0.0778). There also was no significant difference in patient outcome among five treatment groups: (1) wide excision, (2) radical surgery, (3) radiation therapy, (4) wide excision plus radiation therapy, and (5) other. CONCLUSION Tumor size appears to affect survival in patients with vaginal melanoma. Tumor thickness, at least at the levels at which vaginal melanomas are currently being diagnosed, does not seem to affect survival. Because no single treatment is clearly preferable, we suggest conservative resection where possible. We find it difficult to support radical surgery as primary treatment for vaginal melanoma unless necessary to achieve clear tumor margins. Radiation therapy appears to offer results comparable to those of surgery.

The influence of oral contraceptives on the postmolar human chorionic gonadotropin regression curve.

A prospective randomized study was undertaken to determine whether the administration of oral contraceptives after the evacuation of a hydatidiform mole affects the human chorionic gonadotropin serum level in a way that leads to an increased frequency in the diagnosis of postmolar trophoblastic disease. Between 1981 and 1988, 266 patients were randomly assigned to either oral contraceptives or barrier contraception after evacuation of a hydatidiform mole. Patients were followed up until serum levels of human chorionic gonadotropin were normal or until specific criteria for the diagnosis of postmolar trophoblastic disease were met. Twenty-three percent of patients receiving oral contraceptives had postmolar trophoblastic disease, whereas those using a barrier method had a rate of 33%. The median time to spontaneous regression in the oral contraceptives group was 9 weeks, whereas the median time to regression in the barrier group was 10 weeks. Twice as many patients in the barrier group became pregnant in the immediate follow-up period. We conclude that oral contraceptives are the preferred method of contraception after evacuation of a hydatidiform mole.