Common use of Introduction/Background Clause in Contracts

Introduction/Background. Endometrial cancer is the most common gynecologic malignancy diagnosed in the United States and is second to ovarian cancer in annual mortality for gynecologic cancers, with 10,170 deaths [1]. With the decline in hormone replacement therapy utilization, there was a corresponding decline in the incidence of endometrial cancer. However, more recently this trend has reversed as obesity rates have increased [2]. The majority of new endometrial cancers will be International Federation of Gynecology and Obstetrics (FIGO) stage I-II disease, at approximately 85% of new cases [3]. Recurrence rates of early endometrial cancers vary within a specific stage and thus treatment options differ across the early endometrial cancers [4,5]. Endometrial cancer is less likely to lead to death than other medical comorbidities [6-8]. A Surveillance, Epidemiology, and End Results (SEER) study of early-stage, low-grade endometrial carcinoma showed that 7% of patients diagnosed died of malignancy, whereas 42% died of cardiovascular disease [9]. The most common presenting symptom of uterine carcinoma is vaginal bleeding, typically after menopause. Workup of a suspected endometrial cancer includes history and physical examination with an endometrial biopsy. A false-negative result can occur in 10% of cases, so a negative biopsy is typically followed by dilation and curettage [10]. Once a histopathologic diagnosis is established and uterine-confined disease is suspected, blood counts, routine biochemistry, and chest radiographs are recommended to complete workup [11]. Surgery consists of total hysterectomy and bilateral salpingo-oophorectomy with or without lymph node dissection. Visual inspection of the peritoneal, serosal, and diaphragmatic surfaces with biopsy of suspicious lesions is required to evaluate for extrauterine disease. FIGO recommends obtaining peritoneal washings even though a positive finding was removed from the most recent staging system. The recommendations for adjuvant radiation therapy in early-stage endometrial cancer depend on the presence or absence of several risk factors, such as older age, deep myometrial invasion, high grade, large tumor size, and lymphovascular space invasion (LVSI) [12-14]. Classification into low-risk, intermediate-risk, and high-risk early-stage uterine cancer is based on a combination of these risk factors, but investigators and studies often differ in their definitions. In early-stage endometrial cancer, the most common site of recurrence in the absence of adjuvant radiation therapy is the vaginal cuff. Vaginal brachytherapy reduces the risk of a vaginal recurrence and has a low side-effect profile. Sorbe et al [15] published a randomized trial comparing adjuvant vaginal brachytherapy to observation in grade 1 or 2, stage IA endometrioid carcinoma in 645 patients. After a median follow-up of 68 months, there was no difference in vaginal recurrence rates (1.2% in the brachytherapy group versus 3.1% in the observation group (P=0.114). The impact of adjuvant brachytherapy appears to be limited in low-risk patients. The toxicity of vaginal brachytherapy is mild and limited to urinary (2.8% brachytherapy group versus 0.6% observation group (P=0.063), and vaginal side effects (8.8% brachytherapy group versus 1.5% observation group, P<0.01) [15].