ABSTRACT
PURPOSE: This prospective, randomized phase III intergroup trial of the Gynecologic Oncology Group and National Cancer Institute of Canada Clinical Trials Group was designed to test the effectiveness and safety of adding the hypoxic cell sensitizer tirapazamine (TPZ) to standard cisplatin (CIS) chemoradiotherapy in locally advanced cervix cancer. PATIENTS AND METHODS: Patients with locally advanced cervix cancer were randomly assigned to CIS chemoradiotherapy versus CIS/TPZ chemoradiotherapy. Primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS) and tolerability. RESULTS: PFS was evaluable in 387 of 402 patients randomly assigned over 36 months, with enrollment ending in September 2009. Because of the lack of TPZ supply, the study did not reach its original target accrual goal. At median follow-up of 28.3 months, PFS and OS were similar in both arms. Three-year PFS for the TPZ/CIS/RT and CIS/RT arms were 63.0% and 64.4%, respectively (log-rank P = .7869). Three-year OS for the TPZ/CIS/RT and CIS/RT arms were 70.5% and 70.6%, respectively (log-rank P = .8333). A scheduled interim safety analysis led to a reduction in the starting dose for the TPZ/CIS arm, with resulting tolerance in both treatment arms. CONCLUSION: TPZ/CIS chemoradiotherapy was not superior to CIS chemoradiotherapy in either PFS or OS, although definitive commentary was limited by an inadequate number of events (progression or death). TPZ/CIS chemoradiotherapy was tolerable at a modified starting dose.
Subject(s)
Adenocarcinoma/therapy , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Adenosquamous/therapy , Carcinoma, Squamous Cell/therapy , Chemoradiotherapy , Uterine Cervical Neoplasms/therapy , Adenocarcinoma/mortality , Adenocarcinoma/pathology , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Canada , Carcinoma, Adenosquamous/mortality , Carcinoma, Adenosquamous/pathology , Carcinoma, Squamous Cell/mortality , Carcinoma, Squamous Cell/pathology , Chemoradiotherapy/adverse effects , Chemoradiotherapy/mortality , Chi-Square Distribution , Cisplatin/administration & dosage , Disease Progression , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Middle Aged , Neoplasm Staging , Proportional Hazards Models , Prospective Studies , Time Factors , Tirapazamine , Treatment Outcome , Triazines/administration & dosage , United States , Uterine Cervical Neoplasms/mortality , Uterine Cervical Neoplasms/pathologySubject(s)
Endometrial Neoplasms/surgery , Hysterectomy , Intestinal Obstruction/etiology , Intestinal Obstruction/surgery , Intestine, Small , Intussusception/etiology , Intussusception/surgery , Postoperative Complications/etiology , Postoperative Complications/surgery , Adult , Female , Humans , Intestinal Obstruction/diagnosis , Intussusception/diagnosis , Postoperative Complications/diagnosisABSTRACT
OBJECTIVE: To evaluate preoperative levels of CA-125 for the prediction of advanced stages of uterine cancer. STUDY DESIGN: Retrospective chart review of 141 women with endometrial cancer who were treated by a single gynecologic oncologist at a community teaching hospital in North Carolina between November 1994 and September 2002. RESULTS: Ninety-three of 106 patients (87.7%) with surgical stage I or II endometrial cancer had normal preoperative CA-125 levels. Ten of 11 (91%) women with stage IV endometrial cancer had elevated preoperative CA-125 levels. High CA-125 levels and positive lymph vascular space invasion correlated most strongly with advanced stage (p < 0.01). Similar trends in correlation of CA-125 levels were seen with the highest grade and the deepest myometrial invasion. The sensitivity and specificity of a CA-125 cutoff level of 35 U/mL were 63% and 88%, respectively, with a positive predictive value of 61% and negative predictive value of 89%. CONCLUSION: Measurement of preoperative CA-125 is a clinically useful test in endometrial cancer patients. CA-125 appears to be a significant independent predictor of the extrauterine spread of disease and is a better predictor of disease than depth of invasion or grade. This evidence complements a growing body of literature that supports the strong relationship between CA-125 level and stage of disease. A CA-125 level should be included as part of the preoperative workup for all patients with endometrial cancer.
Subject(s)
Biomarkers, Tumor/blood , CA-125 Antigen/blood , Endometrial Neoplasms/pathology , Adult , Aged , Aged, 80 and over , Endometrial Neoplasms/blood , Endometrial Neoplasms/surgery , Female , Humans , Logistic Models , Lymph Nodes/pathology , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Predictive Value of Tests , Preoperative Care , Prognosis , ROC Curve , Retrospective Studies , Sensitivity and SpecificityABSTRACT
BACKGROUND: Sarcoidosis is a multisystem disease and can be confused with benign or malignant tumors. In patients with recurrent gynecologic cancer, liver and intrathoracic lesions should undergo a biopsy to rule in metastatic malignancy, as clinical findings and CAT scan results may represent other disease processes. CASE: A 67 year old woman had a total abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic and periaortic lymphadenectomy, and peritoneal cytology in 2001 for Stage I B grade 1 adenocarcinoma of the endometrium. She developed a vaginal recurrence in 2005. A CT scan of lungs, abdomen, and pelvis revealed extensive mediastinal adenopathy and multiple space occupying hepatic lesions worrisome for metastatic disease. A needle biopsy of the largest liver lesion revealed sarcoidosis. CONCLUSION: Sarcoid lesions may mimic metastatic disease in patients with malignancy, potentially leading to delayed and/or inappropriate therapy.
