Radiation therapy with or without weekly cisplatin for bulky stage 1B cervical carcinoma: follow-up of a Gynecologic Oncology Group trial.

OBJECTIVE: The objective of the study was to confirm that concurrent cisplatin (CT) with radiation therapy (RT) is associated with improved long-term progression-free survival (PFS) and overall survival (OS), compared with RT alone in stage IB bulky carcinoma of the cervix, when both groups' therapy is followed by hysterectomy. STUDY DESIGN: Three hundred seventy-four patients entered this trial. There were 369 evaluable patients; 186 were randomly allocated to receive RT alone and 183 to receive CT plus RT. Radiation dosage was 45 Gray (Gy) in 20 fractions followed by low dose-rate intracavitary application(s) of 30 Gy to point A. Chemotherapy consisted of intravenous cisplatin 40 mg/m2 every week for up to 6 weekly cycles. Total extrafascial hysterectomy followed the completion of RT by 6-8 weeks. RESULTS: Preliminary results have been published, at which time there were 292 censored observations, and median duration of follow-up was only 36 months. Patient and tumor characteristics were well balanced between the regimens. The median patient age was 41.5 years; 81% had squamous tumors; 59% were white. Median follow-up is now 101 months. The relative risk for progression was 0.61 favoring CT plus RT (95% confidence interval [CI] 0.43 to 0.85, P < .004). At 72 months, 71% of patients receiving CT plus RT were predicted to be alive and disease free when adjusting for age and tumor size, compared with 60% of those receiving RT alone. The adjusted death hazard ratio was 0.63 (95% CI 0.43 to 0.91, P < .015) favoring CT plus RT. At 72 months, 78% of CT plus RT patients were predicted to be alive, compared with 64% of RT patients. An increased rate of early hematologic and gastrointestinal toxicity was seen with CT plus RT. There was no detectable difference in the frequency of late adverse events. CONCLUSION: Concurrent weekly cisplatin with RT significantly improves long-term PFS and OS when compared with RT alone. Serious late effects were not increased. The inclusion of hysterectomy has been discontinued on the basis of another trial. Pending further trials, weekly cisplatin with radiation is the standard against which other regimens should be compared.

Outcomes of octogenarians and nonagenarians in elective major gynecologic surgery.

OBJECTIVE: The purpose of this study was to determine whether age is a risk factor for perioperative and postoperative complications. STUDY DESIGN: This was a retrospective case-control study of 120 women over age 79 (group 1) compared with 1,497 younger patients 50-79 (group 2) undergoing major elective gynecologic surgery. RESULTS: Mean length of stay was 4.8 days for group 1, compared with 3.8 for group 2 (P = .018). Patients hospitalized longer than 1 week was higher (P < .01) among group 1. There were statistically significant increases in UTI, psychiatric events, pulmonary edema, respiratory failure, sepsis, and hypovolemic shock. No significant difference in mortality rate was noted (group 1: 0.83%, n = 1 vs group 2: 0.47%, n = 7). CONCLUSION: Although length of stay for the elderly is slightly increased, mortality and complication rates are comparable to younger patients with few exceptions. We conclude that age need not be the sole determinant in the decision to undergo major elective gynecologic surgery.

Metastatic uterine serous carcinoma originating in an endometrial polyp: a report of 2 cases.

BACKGROUND: Endometrial carcinoma is the most common cancer of the female genital tract. Two histologic variants have been described: an estrogen-dependent form and a more aggressive, non-estrogen-dependent form, which includes uterine serous carcinoma. CASES: Two cases of uterine serous carcinoma were confined to an endometrial polyp without myometrial invasion and were widely metastatic. One patient presented with abdominal pain and constipation, while the other patient was asymptomatic. Both patients had elevated CA-125 levels. At the time of surgery, these patients were found to have extensive carcinomatosis and underwent surgical staging procedures that required bowel resections. Pathology showed metastatic disease originating in a small focus of serous adenocarcinoma at the tip of an endometrial polyp. Combination chemotherapy was planned; but 1 of the patients died prior to its initiation. CONCLUSION: These cases emphasize the aggressive nature of uterine serous carcinoma despite insignificant myometrial invasion.

Retroperitoneal liposarcoma weighing over one hundred pounds with review of the literature.

BACKGROUND: Rarely, excessively large, slow growing tumors are found to be malignant. One exception includes retroperitoneal tumors, which if considered a mass of pelvic origin, may be encountered by the gynecologic oncologist. CASE: A post-menopausal female was referred for evaluation of a huge mass thought to arise from the pelvis. The patient underwent exploratory laparotomy and had resected a 50x48x45 cm, 103.6 lb. liposarcoma arising from the right retroperitoneum. DISCUSSION: Rarely, large slow growing abdomino-pelvic masses may be malignant, and one should be prepared to perform an appropriate surgical resection. This case represents removal of the largest retroperitoneal liposarcoma reported.

Reproducibility of the diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study.

BACKGROUND: Most gynecologists determine therapy based on current International Society of Gynecologic Pathologists (ISGP)/World Health Organization classification of endometrial hyperplasia, the reproducibility of which has been questioned. The Gynecologic Oncology Group (GOG) initiated a protocol to assess the efficacy of hormonal therapy of atypical endometrial hyperplasia (AEH). Primary goals of the first phase (Part A) were to prospectively determine reproducibility of referring institution's pathologist's diagnosis of AEH by a panel of 3 gynecologic pathologists and to determine reproducibility of diagnoses by panel members. METHODS: Three hundred six women were entered on this protocol with a referring institution's pathologist diagnosis of AEH based on biopsy or curettage. Available slides were assessed independently and interpreted by each of a panel of 3 gynecologic pathologists who used International Society of Gynecologic Pathologists (ISGP)/World Health Organization criteria. The majority diagnosis was based on diagnostic concordance by at least 2 of the 3 panelists. RESULTS: The referring institution's pathologist's diagnosis of AEH was supported by the majority of the panel in only 38% of cases. Overall kappa value for the panel diagnosis of AEH was 0.28. The majority diagnosis was adenocarcinoma in 29%, cycling endometrium in 7%, and nonatypical hyperplasia in 18% of cases. Unanimous agreement for any diagnosis was reached among all 3 of the panel in 40% of cases. For the panel, paired kappa values for any diagnosis ranged 0.34-0.43, with an overall kappa value of 0.40. CONCLUSION: Reproducibility of referring institution's pathologists' diagnosis of AEH by a panel of gynecologic pathologists is poor. Both underestimation and overestimation of the severity of the lesion are very common. The level of reproducibility among subspecialist panel members for diagnosis of AEH in these specimens also is poor. Better criteria and better sampling are needed to improve reproducibility of this diagnosis, particularly if it is to be used for clinical decisions.

Recurrent colorectal carcinoma detected by routine cervicovaginal papanicolaou smear testing.

BACKGROUND: We present a case of recurrent colon cancer detected by routine, annual Papanicolaou screening. CASE: A 59-year-old African American woman who had been treated for T2N0M0 (stage II, Dukes A) colon cancer 2 years before to presentation had a Pap smear showing a high-grade squamous intraepithelial lesion with a normal cervical biopsy result. Because of this discrepancy, a loop electrosurgical excision procedure and endocervical curettage were performed and showed atypical glandular cells suspicious for adenocarcinoma. Subsequent colonoscopy showed recurrent adenocarcinoma of the colon. The patient underwent an en-block total abdominal hysterectomy and anterior-perineal resection showing invasion of recurrent colon cancer into the uterus and cervix. CONCLUSION: In patients with a history of extrauterine adenocarcinoma, abnormal Pap screening may indicate recurrent or metastatic carcinoma.

Gynecological surgery in octogenarians and nonagenarians.

OBJECTIVE: The study analyzed morbidity and mortality rates among octogenarian and nonagenarian patients who underwent operations for gynecologic indications. STUDY DESIGN: A retrospective chart review was performed for patients, aged >or=80 years, who underwent gynecologic procedures between January 1, 1995, and September 30, 2000. Information obtained included a complete medical history, type of surgical procedure, length of hospital stay, and discharge disposition. Simple demographic statistics were used. RESULTS: Sixty-two patients (mean age, 83.6 years) were identified. Seventy-seven operative procedures, 49 major and 28 minor, were performed. All patients were discharged home, except 2, who were discharged to nursing homes. Sixteen patients, who underwent minor procedures, were discharged the same day, and 6 patients were admitted for "23" hour stays. There were 11 perioperative complications and no perioperative deaths. CONCLUSION: Successful gynecologic surgical outcomes with minimal morbidity are achievable in octogenarian patients and nonagenarian patients with optimization of co-medical conditions and careful perioperative treatment. Age should not be the sole determinant in the decision-making process.

Evaluation of paclitaxel in previously treated leiomyosarcoma of the uterus: a gynecologic oncology group study.

OBJECTIVE: The purpose of this phase II trial was to evaluate the efficacy of intravenous paclitaxel in patients with recurrent or advanced leiomyosarcoma of the uterus. METHODS: To be eligible, patients with recurrent or persistent leiomyosarcoma of the uterus were to have measurable disease not previously treated with paclitaxel and adequate hematologic (WBC >or=3000/microl, platelet count >or=100000/microl), renal (serum creatinine

Completion hysterectomy after radiation therapy for bulky cervical cancer stages IB, IIA, and IIB: complications and survival rates.

OBJECTIVE: The purpose of this study was to assess survival and morbidity when completion hysterectomy follows radiation for bulky cervical cancer. STUDY DESIGN: This was a retrospective observational descriptive review that assessed the survival and morbidity of patients with bulky cervical cancer that was treated with radiation followed by completion hysterectomy between 1993 and 2002. Chemotherapy, external beam radiation, and brachytherapy data were collected. RESULTS: Fifty-five cases were reviewed. Fifty-three patients received brachytherapy. Twenty-nine patients underwent sensitizing chemotherapy. All patients had hysterectomies. There were 12 early postoperative complications (21.8%) and 10 late complications (19.6%). Eleven patients are dead of disease (21.6%); 3 patients are alive with disease (5.9%), and 37 patients are free of disease (72.5%). Four patients were lost to follow-up. Seven patients who are free of disease had residual cancer in the specimen at hysterectomy. CONCLUSION: Complications of combined therapy were comparable to radiation or radical hysterectomy alone. In cases in which an incomplete response to radiation and chemotherapy leaves potential residual carcinoma, adjuvant hysterectomy may be a reasonable treatment option.

Necrotizing fasciitis in gynecologic and obstetric patients: a surgical emergency.

OBJECTIVE: We reviewed the cases of 23 patients who were admitted to the hospital with a primary diagnosis of histopathologically confirmed necrotizing fasciitis in the lower abdomen or pelvis. Rapid demise of a healthy postpartum women piqued our interest in trying to identify the early signs and symptoms that may lead to earlier diagnosis and treatment of this often fatal disease. STUDY DESIGN: A retrospective analysis of charts of all patients who were admitted to the gynecology and obstetrics services of our hospital systems with a diagnosis of necrotizing fasciitis for the past 14 years was performed. Age, comorbid factors, precipitating events, weight, symptoms and signs, microbiologic factors, radiographs, surgical therapy, and morbidity were correlated. RESULTS: Definitive operation was accomplished within 48 hours of the diagnosis of necrotizing fasciitis in all but 3 patients. Of the 17 patients who were not puerperal, 88% of the women were obese; 65% of the women were hypertensive, and 47% of the women were diabetic. Of the total 23 patients, 70% of the women complained of severe pain, and 35% of the women had radiographic diagnostics for necrotizing fasciitis ("gas"). Four patients had diverting colostomies, and 39% of the patients had flaps or synthetic grafts. Three patients died (mortality rate, 13%). One patient who was puerperal died of a severe rapid septicemia; the 2 late deaths were the result of systemic candidiasis. CONCLUSION: Necrotizing fasciitis is a rapidly progressive, often lethal, infectious disease process that requires early aggressive debridement. Any patient with inordinate pain and unilateral edema in the pelvis, especially in the puerperium, should be suspected of having this disease. Radiographic studies are often diagnostic of this condition. The triad of pelvic pain, edema, and any sign of septicemia carries an extremely grave prognosis and mandates immediate surgical intervention.

Radiation therapy with and without extrafascial hysterectomy for bulky stage IB cervical carcinoma: a randomized trial of the Gynecologic Oncology Group.

OBJECTIVE: To evaluate, in a randomized clinical trial, the role of adjuvant hysterectomy after standardized radiation in improving progression-free survival and survival for patients with "bulky" stage IB cervical cancer. METHODS: A total of 256 eligible patients with exophytic or "barrel" shaped tumors measuring > or = 4 cm were randomized to either external and intracavitary irradiation (RT, N = 124) or attenuated irradiation followed by extrafascial hysterectomy (RT + HYST, N = 132). Twenty-five percent of patients had tumors with a maximum diameter of > or =7 cm. RESULT: Tumor size was the most pronounced prognostic factor followed by performance status 2 and age at diagnosis. Hysterectomy did not increase the frequency of reported grade 3 and 4 adverse effects (both groups, 10%). The majority of these adverse effects were from the gastrointestinal or genitourinary tracts exclusively. There was a lower cumulative incidence of local relapse in the RT + HYST group (at 5 years, 27% vs. 14%). There were no statistical differences in outcomes between regimens except for the adjusted comparison of progression-free survival, although all indicated a lower risk in the adjuvant hysterectomy regimen (unadjusted relative risk [URR] of progression, 0.77, P = 0.07; URR of death, P = 0.26, both one tail). CONCLUSION: Overall, there was no clinically important benefit with the use of extrafascial hysterectomy. However, there is good evidence to suggest that patients with 4-, 5-, and 6-cm tumors may have benefitted from extrafascial hysterectomy (URR of progression; 0.58; URR of death, 0.60).