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The study aim was to identify contemporary socioeconomic, racial, ethnic, and facility-related factors associated with stage at diagnosis, receipt of cancer treatment, and survival in women with endometrial cancer (EC).Women diagnosed with EC between 1998 and 2010 were identified from the National Cancer Database. Variables associated with the outcomes of interest were assessed using multivariable Cox proportional hazards and logistic regression.Among 228,511 women identified, the percentage of blacks with stage IIIC/IV disease at diagnosis was nearly twice that of non-Hispanic whites (17.8% vs 9.8%; P0.001). Patients with advanced disease who were insured with Medicare were less likely to receive standard-of-care postoperative radiotherapy and/or chemotherapy than those with private insurance (odds ratio: OR 0.80, P0.001), as were those residing in the South (reference) in comparison to the Northeast, Atlantic, Great Lakes, and Midwest regions (OR 1.3-1.7, all P0.001). Those residing in the Mountain region were even less likely to receive appropriate treatment (OR 0.7, P0.001). Five-year stage IIIC/IV survival was 42.8% for non-Hispanic whites vs 24.6% for blacks (hazard ratio 1.3, P0.001). Other factors associated with inferior 5-year survival included payer status (not insured, Medicaid, Medicare, vs private, ORs 1.2-1.3, all P0.01), and treatment at low-volume centers (5 vs ≥30cases/year, HR 1.3, P0.001).Socioeconomic, geographic and facility-related factors predict advanced endometrial cancer stage, failure to receive cancer care, and shorter survival. Black women had especially poor survival. Nationwide standardization and concentration of treatment at high-volume centers may improve outcomes.

Objective Clinical registries within medical societies have demonstrated the capacity to promote quality improvement. Opportunities for well-designed data repositories could yield reliable national standards for informing reimbursement, determining adherence to care guidelines, maintaining board certification, and developing bundled payment models. Looking to the future, we set out to develop a gynecologic cancer registry serving the members of the Society of Gynecologic Oncology (SGO). Methods The SGO Clinical Outcomes Registry (COR) initiated a web-based data entry platform as a foray into developing a functional registry, compiling data elements specific to gynecologic oncology. Endometrial and ovarian cancer patients began enrollment in early 2014. Within one year, 19 sites were participating with the addition of cervical cancer patients in January 2015. Results To date, >6500 patients are currently entered from 29 sites, and the COR is being queried to address topics of quality improvement, disparities, and cancer outcomes. Conclusions The SGO COR has proven the feasibility of developing a functional gynecologic cancer registry, with high uptake, rapid accrual, and ability to investigate topics of quality and outcome using the COR.

Objective Use of in vitro chemoresponse assays for informing effective treatment selection is a compelling clinical question and a topic of debate among oncologists. A prospective study was conducted evaluating the use of a chemoresponse assay in recurrent ovarian cancer patients. Methods Women with persistent or recurrent ovarian cancer were enrolled under an IRB-approved protocol, and fresh tissue samples were collected for chemoresponse testing. Patients were treated with one of 15 protocol-designated treatments empirically selected by the oncologist, blinded to the assay results. Each treatment was classified by the assay as: sensitive (S), intermediate (I), or resistant (R). Patients were prospectively monitored for progression-free survival (PFS) and overall survival (OS). Associations of assay response for the physician-selected treatment with PFS and OS were analyzed. Results A total of 262 evaluable patients were enrolled. Patients treated with an assay-sensitive regimen demonstrated significantly improved PFS and OS while there was no difference in clinical outcomes between I and R groups. Median PFS was 8.8months for S vs. 5.9months for I+R (hazard ratio [HR]=0.67, p=0.009). The association with assay response was consistent in both platinum-sensitive and platinum-resistant tumors (HR: 0.71 vs. 0.66) and was independent of other covariates in multivariate analysis (HR=0.66, p=0.020). A statistically significant14-month improvement in mean OS (37.5months for S vs. 23.9months for I+R, HR=0.61, p=0.010) was demonstrated. Conclusions This prospective study demonstrated improved PFS and OS for patients with either platinum-sensitive or platinum-resistant recurrent ovarian cancer treated with assay-sensitive agents.

Objective. To compare the tolerability, efficacy, and safety profiles of pegylated liposomal doxorubicin in combination with carboplatin (PLD–Carbo) with those of gemcitabine–carboplatin (Gem–Carbo) for the treatment of patients with platinum-sensitive recurrent ovarian cancer (PSROC) by reviewing the published literature. Methods. Using the PubMed database, a systematic review of peer-reviewed literature published between January 2000 and September 2009 was undertaken to identify studies related to the treatment of patients with PSROC with PLD–Carbo or Gem–Carbo. Studies reporting either response rate, progression-free survival (PFS), and/or overall survival (OS) were included. Treatment regimens, efficacy endpoints, and safety profiles were compared between the two combination therapies. Results. Ten studies evaluating 608 patients (PLD–Carbo: 5 studies, 278 patients; Gem–Carbo: 5 studies, 330 patients) were identified. The mean planned doses were: PLD, 34.8 mg/m2 and Gem, 993 mg/m2. The dose intensity reported in Gem trials was lower (75% of the planned dose) than the dose intensity reported in PLD trials (93.7% of the planned dose), suggesting better tolerability for the PLD–Carbo regimen. Among patients receiving PLD–Carbo, 60.2% achieved a response (complete, 27.0%; partial, 33.2%), versus 51.4% of patients treated with Gem–Carbo (complete, 19.2%; partial, 32.2%). The median PFS times were 10.6 months and 8.9 months in the PLD–Carbo and the Gem–Carbo populations, respectively. The median OS was longer for the PLD–Carbo regimen (27.1 months) than for the Gem–Carbo regimen (19.7 months). The hematological safety profiles were comparable in the two groups, although grade III or IV anemia (PLD–Carbo, 13.6%; Gem–Carbo, 24.5%) and neutropenia (PLD–Carbo, 45.5%; Gem–Carbo, 62.9%) were more common in patients receiving Gem–Carbo. Conclusion. Results from this systematic analysis of peer-reviewed literature suggest that PLD–Carbo therapy is a rational alternative to Gem–Carbo for the treatment of patients with PSROC.

Ureteroarterial fistulas (UAF) are a rare but potentially life-threatening complication of intra-abdominal malignancy, typically occurring after vascular or pelvic surgery. Patients with a history of radical pelvic surgery, chronic indwelling ureteral stents, and prior pelvic radiation appear to be at increased risk. The predisposing risk factors suggest that gynecological oncologists are the likely specialty to face this problem and should be familiar with the clinical presentation and etiology of UAF. We present two such cases to illustrate these salient points of clinical diagnosis and management.

Objective. To evaluate toxicity, response and progression-free survival of weekly topotecan chemotherapy in women with primary and secondary platinum-resistant epithelial ovarian cancer. Methods. A retrospective analysis of 69 patients who received weekly topotecan with a median dose of 3.75 on days 1, 8 and 15 of a 28-day cycle treated between November 2002 and May 2005. All patients had recurrent epithelial ovarian, primary peritoneal or tubal cancer with primary or secondary resistance to platinum. Disease response was evaluated by CA-125 levels, physical exam, and when appropriate, imaging studies. Toxicity was evaluated using the NCI Common Toxicity Criteria. Results. Response to topotecan therapy was noted in 14 of 69 patients (20.3%); (complete response 7.3%, and partial response 13%). Stable disease was noted in 23 patients (33.3%) and progression of disease occurred in 31 patients (44.9%). Two patients (2.8%) had significant side effects that warranted discontinuation of therapy. There was no significant difference in response to therapy between patients with primary or secondary platinum resistance. A total of 229 cycles was given with a median of 3 (range 1–12) cycles per patient. Grades 3 and 4 myelosuppression was rare: 1 cycle (0.4%) with grade 3 leukopenia, 16 cycles (7%) with grade 3 or 4 neutropenia, 1 cycle (0.4%) with grade 3 anemia, and 2 cycles (0.9%) with grade 3 thrombocytopenia. No patient was admitted with neutropenic fever. The median progression-free survival for responders was 5.7 months (2–16.75). Conclusions. Weekly topotecan is a well-tolerated and effective regimen for platinum-resistant ovarian cancer with considerable less hematological toxicity when compared with historical data for the 5-day regimen.

Objectives. The Gynecologic Oncology Group (GOG) compared methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) with topotecan and cisplatin (TC) or cisplatin alone (C) in advanced cervical cancer. The primary endpoint was overall survival (OS), with response rate, progression-free survival (PFS), and quality of life (QOL) as secondary objectives. Methods. Eligible patients were randomly allocated to receive either cisplatin 50 mg/m 2 q 3 weeks (C) or cisplatin 50 mg/m 2 day 1 and topotecan 0.75 mg/m 2 days 1–3 q 3 weeks (TC) or methotrexate 30 mg/m 2 days 1, 15, and 22, vinblastine 3 mg/m 2 days 2, 15, and 22, doxorubicin 30 mg/m 2 day 2, and cisplatin 70 mg/m 2 day 2 q 4 weeks (MVAC). QOL was assessed at four time points using the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx), Neurotoxicity Subscale (FACT/GOG-NTX subscale), and Brief Pain Inventory (BPI). Results. One hundred eighty-six patients (C = 60; TC = 63; MVAC = 63) were enrolled before MVAC was closed by the GOG Data Safety Monitoring Board after four treatment-related deaths occurred on that arm. MVAC produced a 22% overall response rate (95% CI: 0.13 to 0.34) and median PFS and OS of 4.4 months and 9.4 months, respectively. Compared with C and TC, there was more hematologic toxicity with MVAC. There were no appreciable differences in QOL scores after controlling for baseline scores. Conclusions. MVAC's clinical activity tended to be similar to that of TC but with an unacceptable risk of death from sepsis at this dose and schedule. Nevertheless, QOL, as measured by these instruments, was not substantially impaired by this regimen.

Objective: The aim of this study was to compare radical hysterectomy to extrafascial hysterectomy in the primary treatment of stage II carcinoma of the endometrium. Methods: We performed a retrospective review of women who underwent primary surgical therapy for stage II endometrial cancer at a single institution over a 15-year period. Results: Forty-seven women underwent radical (n = 16) or extrafascial (n = 31) hysterectomy and surgical staging at H. Lee Moffitt Cancer Center (Tampa, FL) from 1988 to 2003 for stage II endometrial carcinoma. There was no significant difference between the two groups for median age, body mass index (BMI), medical comorbities, length of hospitalization, return to regular diet, operative complications, or postoperative complications. The radical hysterectomy group demonstrated longer operative times by 30 minutes (p = 0.04), increased blood loss by 150 cc (p = 0.03), and longer duration of indwelling catheters (1 versus 17 days; p < 0.01). Prognostic tumor characteristics we...

Purpose On the basis of reported activity of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or topotecan plus cisplatin in advanced cervix cancer, we undertook a randomized trial comparing these combinations versus cisplatin alone, to determine whether survival is improved with either combination compared with cisplatin alone, and to compare toxicities and quality of life (QOL) among the regimens. Patients and Methods Eligible patients were randomly allocated to receive cisplatin 50 mg/m2 every 3 weeks (CPT); cisplatin 50 mg/m2 day 1 plus topotecan 0.75 mg/m2 days 1 to 3 every 3 weeks (CT); or methotrexate 30 mg/m2 days 1, 15, and 22, vinblastine 3 mg/m2 days 2, 15, and 22, doxorubicin 30 mg/m2 day 2, and cisplatin 70 mg/m2 day 2 every 4 weeks (MVAC). Survival was the primary end point; response rate and progression-free survival (PFS) were secondary end points. QOL data are reported separately. Results The MVAC arm was closed by the Data Safety Monitoring Board after four treatment-related deaths occurred among 63 patients, and is not included in this analysis. Two hundred ninety-four patients enrolled onto the remaining regimens: 146 to CPT and 147 to CT. Grade 3 to 4 hematologic toxicity was more common with CT. Patients receiving CT had statistically superior outcomes to those receiving CPT, with median overall survival of 9.4 and 6.5 months (P = .017), median PFS of 4.6 and 2.9 months (P = .014), and response rates of 27% and 13%, respectively. Conclusion This is the first randomized phase III trial to demonstrate a survival advantage for combination chemotherapy over cisplatin alone in advanced cervix cancer.

The purpose of this study was to determine whether pelvic examination identifies factors that suggest the need for radiotherapy after radical hysterectomy for cervical cancer.This was an observational study that was conducted from July 1, 2000 through December 31, 2002 that comprised 67 patients with stage 1B-2A cervical cancer who underwent primary surgical treatment. Assessments that were made on pelvic examination were compared with pathologic findings. Data were analyzed with the use of descriptive statistics, calculation of sensitivities, specificities, positive and negative predictive values, and determination of odds ratios.The overall spectrum of small to large tumors (1-8 cm) and cervices (2.5-8 cm) correlated well with examination (r=0.77-0.88). The accuracy of examination was approximately 50% for tumor diameter (+/-25%), 85% for cervical diameter (+/-25%), 80% for outer-third invasion, 80% for endophytic growth, and 90% for vaginal involvement. The likelihood for adjuvant radiotherapy had a significant association with the number of at-risk examination variables that were present.For women who undergo radical hysterectomy for stage 1B to 2A cervical cancer, the presence of multiple high-risk factors that are found on pelvic examination is associated significantly with indications for adjuvant postoperative radiotherapy.

OBJECTIVE: This study was undertaken to determine the incidence of catheter-associated infection after radical hysterectomy and to evaluate the role of prophylactic antibiotics in these patients. STUDY DESIGN: A 4-year retrospective review of 102 women undergoing radical hysterectomy for cervical or endometrial cancer was performed. Clinical data were abstracted and analyzed with χ2 and t tests. RESULTS: Catheter-associated infection was observed in 11% (12 of 102) and was not altered by the administration of prophylactic antibiotics (11.1% vs 11.8%, P = .95). Of the 12 women who had infection, 11 were treated as outpatients, and 1 patient required admission for pyelonephritis. Patient age, comorbid medical conditions, class of radical hysterectomy, perioperative complications, operative time, blood loss, catheter type, duration of catheterization, and length of hospitalization had no effect on the development of catheter-associated infection. CONCLUSION: The incidence of catheter-associated infection in women requiring prolonged catheterization after radical hysterectomy is relatively low. Withholding prophylactic antibiotics from these patients is a reasonable clinical option.

Few data are available to help predict which older cancer patient is at risk of developing chemotherapy-related toxicity. This study was a pilot for a project designing a predictive risk score. Chemotherapy patients aged 70 years and older were prospectively enrolled. Chemotherapies were adjusted for their published toxicity. 60 patients were enrolled, 59 were evaluable. Mean dose-intensity was 90.3%, range 33.3-129.0%. 47% of the patients experienced grade 4 haematological and/or grade 3-4 non-haematological toxicity. Published toxicity (MAX2), diastolic blood pressure, marrow invasion and lactate dehydrogenase (LDH) were all associated with toxicity (P

Objective. Our objective was to review our experience with carcinoma of Bartholin's gland relative to treatment and oncologic outcome. Methods. Patient names were collected from our vulvar cancer database for the period September 1985 to September 2000. The medical records were retrospectively reviewed, and data were abstracted relative to demographics, presenting symptoms, treatment, and oncologic outcome. Results. We treated 12 women with Bartholin's gland carcinoma, and 11 patients are reported. Seven women presented with a painless vulvar mass, and 8 of 11 had initially been treated for an infectious process before referral to our institution. Squamous histology was most common, and the right gland was more frequently involved. Ten patients were treated with primary surgery, followed by adjuvant radiation in 7 for inadequate resection margins or lymphatic metastases. One patient was treated with primary chemoradiation. Stage I, II, III, IVA, and IVB disease was present in 3, 1, 4, 2, and 1 patient, respectively. Recurrence was suffered by 54.5% during a mean follow-up time of 73.5 months (median, 60; range, 8–180 months). Overall survival is 58.3% to date. Conclusions. Conventional therapy for Bartholin's gland carcinoma yielded a 67% 5-year survival. Seventy-one percent of women receiving adjuvant radiotherapy recurred despite this precaution. Work is needed to identify an effective systemic therapy and to better determine which patients may benefit from pelvic radiotherapy.

Use of artificial technologies is increasing within the United States. Unfortunately, data describing the possible effects of 'superovulation' and potential risk of subsequent ovarian carcinoma are not well defined. This discussion focuses on current data regarding the potential for increased risk for ovarian carcinoma in patients who have undergone infertility evaluation and subsequent treatments.

Gynecologic malignancies account for 15% of all cancer diagnosis in women. Primary lymphatic spread is well recognized in vulvar, cervical, uterine, and ovarian carcinomas. Vulvar carcinoma spreads locally to the inguinofemoral lymph nodes in a relatively predictable fashion similar to the local spread of breast carcinoma. Lymphatic mapping using radioactive colloid should provide adequate means to sample these nodal basins while attempting to reduce postoperative morbidity. Methods of vulvar lymphoscintigraphy are described.

A pelvic mass in pregnancy is a relatively common entity, especially considering the increased use of ultrasound or early fetal evaluation. These masses can derive from multiple gynecologic and nongynecologic origin, and fortunately the majority will resolve with observation into the second trimester. Masses persisting into the second trimester should be surgically evaluated given the decreased risk to both mother and fetus at this time. For masses persisting into the third trimester, a 2% to 5% risk of malignancy is to be expected. Documentation of disease (FIGO stage) is critically important in defining need for adjuvant cytotoxic chemotherapy. Above all, potentially lifesaving therapy should not be withheld from patients because they are pregnant, especially considering that chemotherapy is apparently safe in the second and third trimesters.

A case of preoperative spontaneous internal jugular/subclavian vein thrombosis documented with magnetic resonance imaging associated with a synchronous stage II ovarian/stage I endometrial malignancy is presented. This unusual deep venous thrombosis site is classically associated with trauma, infection, head and neck malignancies, or central venous catheterization and is rarely associated with distant malignancies. Neck pain and swelling in a gynecologic oncology patient should prompt consideration of this diagnosis.

OBJECTIVES: Our purpose was to determine the relationship between human papillomavirus genotypes contained in primary early stage cervical cancers and those contained in the respective recurrences. STUDY DESIGN: Six early-stage cervical cancers that were considered cured by surgical extirpation subsequently recurred within 21 months of the original surgery. The primary tumors and the recurrences underwent PolYmerase chain reaction for human PaPillomavirus typing with confirmation of types performed by means of diagnostic restriction fragments. RESULTS: All primary tumors and recurrences contained human papillomavirus, with all primary tumors positive for multiple types. The concordance rate between the primary tumors and recurrences for specific types was 73% 11/15. Among the highly onco9enic types 16 and 18 there was 100% concordance between primary and recurrent tumors. CONCLUSIONS: Highly oncogenic types of human PaPillomavirus are preserved between primary tumors and their recurrences in cervical cancers. This further supports the role of oncogenic types in the maintenance of the malignant state and supports the clono9enic nature of cervical cancer recurrence.

We report the second case in the literature of a recurrent Stage III papillary serous carcinoma of the ovary that presented as a choroidal metastasis.

Objective This study was undertaken to determine the most appropriate management of the subcutaneous tissue of midline vertical incisions with 3 cm or more of subcutaneous fat. Study design Patients undergoing surgery within the Division of Gynecologic Oncology at University of South Florida and East Tennessee State University with 3 cm or more of subcutaneous fat were randomly assigned to 1 of 3 groups: suture approximation of Camper's fascia, closed suction drainage of the subcutaneous space, or no intervention as a control group. Participants were evaluated daily during postoperative hospitalization and at 2 and 6 weeks postoperatively as an outpatient. Demographic information, perioperative data, and wound complications were recorded and then analyzed with χ 2 , t test, analysis of variance, and logistic regression where appropriate. Results Two hundred twenty-five patients were enrolled with 222 eligible for evaluation. Wound complications were observed in 34 (15.3%) patients, and 25 of these women also had wound disruption. Overall wound complication and wound disruption rates were not significantly different between groups: suture (12.8%, 7.7%), drain (17.9%, 14.9%), control (15.6%, 11.7%); P = .70 and P = .39, respectively. Conclusion Suture approximation or drainage of the subcutaneous tissues of women with 3 cm or more subcutaneous fat measured in midline vertical incisions resulted in no significant change in the incidence of overall wound complications or superficial wound disruption.

Objective. A phase II study was conducted to determine the efficacy of single agent flavopiridol therapy in patients with recurrent or persistent endometrial adenocarcinoma refractory to established treatments. Methods. Eligible patients with measurable disease who failed primary therapy including one cytotoxic regimen were eligible for the trial. They were treated with single agent flavopiridol (50 mg/m 2 /day, IV bolus days 1, 2, 3). Treatment was repeated every 21 days with dose adjustments made for toxicity. Patients were treated until progression of disease or adverse side effects precluded further therapy. Results. A total of 26 patients were enrolled in the study of whom, 23 patients were eligible. There were no objective responses. Five patients had stable disease (22%), 15 (65%) had increasing disease, and response could not be assessed in 3 (13%). The most frequent side effects included anemia, neutropenia, and diarrhea, all of which appeared manageable. Conclusion. Flavopiridol as a single agent in the above dosing schedule appears to have minimal activity as second-line chemotherapy of endometrial adenocarcinoma.

Background Standard adjuvant chemotherapy for epithelial ovarian carcinoma most commonly consists of a combination of carboplatin with a taxane derivative. However, treatment-related side effects such as peripheral neuropathy and neutropenia can be debilitating and in certain patient populations alterations may need to be considered. Case We describe a case of a patient with epithelial ovarian carcinoma who had pre-existing peripheral neuropathy secondary to Charcot–Marie–Tooth Disease (CMT). She developed a distal sensory and motor neuropathy after her first treatment with carboplatin and paclitaxel and was unable to walk, write, or drive. Upon transfer of care to our center, we changed her taxane to docetaxel and her symptoms improved dramatically. We discuss the outcome of her treatment and the effects of paclitaxel on her underlying peripheral neuropathy. Conclusion Patients with Charcot–Marie–Tooth Disease who require chemotherapy may not be able to tolerate the neurotoxic side effects of paclitaxel-based chemotherapy. Consideration of alternative, less neurotoxic treatment regimens containing docetaxel may be considered.

Objective The purpose of this study was to 1) report on the distribution of bowel segments resected in a population of patients who underwent primary optimal cytoreductive surgery for epithelial ovarian cancer, and 2) discuss implications for surgical management regarding resection of these bowel segments. Study design This was a retrospective study from 1995 to 2003 of 144 ovarian cancer patients who underwent primary optimal cytoreductive operations that included bowel resection. Results Bowel segments removed and major complications are presented in tabulated form. Eighty-one out of 144 resections were rectosigmoid only. Thirty-six percent had extensive involvement of colon segments separate from the rectosigmoid. Excluding hemorrhage, 9 patients (6%) experienced a major complication. Conclusion The present study does suggest the necessity for a highly individualized approach to the surgical management of epithelial ovarian cancer patients who can be optimally cytoreduced by resection of multifocal colonic involvement. Further study is needed to better assess the complications, function, and oncologic outcome of the different surgical approaches to these patients.

The aim of this study was to examine the relationship of changes in hemoglobin levels to changes in fatigue and cognitive functioning in cancer patients undergoing chemotherapy treatment. Seventy-seven (77) patients completed a self-administered measure of fatigue and a battery of psychometrician-administered measures of cognitive performance before the start of chemotherapy and again before the start of the fourth treatment cycle. Hemoglobin levels were measured at corresponding timepoints. Findings partially supported the hypothesis that greater declines in hemoglobin over the course of repeated chemotherapy administrations would be accompanied by greater increases in fatigue and greater declines in cognitive performance over the same interval. Among the subset of 49 patients who demonstrated a decline in hemoglobin to a final valueor =12 g/dL, greater declines in hemoglobin were significantly (P0.05) related to greater increases in fatigue duration and disruptiveness and more negative changes in performance on three cognitive tasks. These findings suggest that, in addition to previously reported relationships with fatigue, declines in hemoglobin levels during chemotherapy treatment are associated with adverse changes in cognitive functioning.

Objective. Cisplatin is a standard treatment in advanced, recurrent cervical cancer. Because topotecan is an established treatment in gynecologic malignancies such as ovarian cancer and exhibits nonoverlapping toxicity with cisplatin, a phase II trial was conducted to evaluate the tolerability and antitumor activity of a cisplatin/topotecan doublet in persistent or recurrent cervical cancer patients. Methods. Patients with bidimensionally measurable persistent or recurrent squamous cell and non squamous cell cervical cancer and adequate bone marrow were enrolled. Patients received 50 mg/m 2 of cisplatin intravenously over 1 h on Day 1 and 0.75 mg/m 2 of topotecan intravenously over 30 min on Days 1, 2, and 3 of 21-day cycles for six cycles or until disease progression. Tumor response and regimen toxicity were assessed using established Gynecologic Oncology Group criteria. Results. Thirty-two of 35 enrolled patients were evaluable for toxicity and tumor response. All but 2 evaluable patients had received previous radiotherapy. No patient received prior chemotherapy. The cisplatin/topotecan doublet was well tolerated, with 77 and 78% of courses given without interruption or delay and at full doses, respectively. As anticipated, the most common toxicity was hematologic, with grade 3/4 neutropenia and thrombocytopenia reported in 30 and 10% of cycles, respectively. The overall response rate was 28% (9/32), with 3 complete and 6 partial responses. The antitumor response in nonirradiated fields (30%) was similar to the response observed in previously irradiated fields (33%), suggesting good drug penetration. Median duration of response was 5 months (range, 2 to 15+ months). An additional 9 (28%) patients achieved stable disease. Median survival was 10 months, with 3 patients in lasting remission. Conclusions. These results demonstrate that the cisplatin/topotecan combination is safe, well tolerated, and active in persistent or recurrent cervical cancer patients. A phase III, multicenter trial is under way (cisplatin/topotecan versus cisplatin) based on these favorable results to confirm the safety and efficacy profile in this patient population.

Radical surgery has resulted in impressive cure rates in women with locally advanced vulvar carcinoma. Unfortunately, morbidity mostly related to inguinofemoral lymphadenectomy, is common. The present review discusses innovations in the management of vulvar disease with attempts to reduce attendant morbidity.

Objective: Two decades of research have resulted in modest gains in progression-free and overall survival for ovarian cancer patients. Peer reviewed studies randomizing these patients to various standard chemotherapies consistently demonstrate remarkably similar survival, highlighting the therapeutic equivalence and ambiguity that exists with empiric treatment. Chemoresponse assays were developed to determine an individual's in vitro tumor response to various chemotherapy agents, providing sensitivity and resistance information to guide patient treatment. Utilizing a two arm clinical trial design approach, the objective of this study was to conduct a comparative analysis of the impact that a chemoresponse assay (ChemoFx®, Precision Therapeutics, Inc.) has on overall survival (OS) as compared to patients treated by non-assay informed empiric choice from previously accrued drug trials from 4 large cooperative group studies. Methods: Patient characteristics from 4 cooperative group studies (duBios JNCI 2003; Pfisterer JNCI 2006; duBois JCO 2006; Bookman 2009 JCO) totaling >7,000 patients were used as the empiric control arm and compared to a 192 patient cohort from a chemoresponse assay study (Herzog 2010 AJOG). These arms were compared to confirm that the assay-informed arm was representative of large trial patient populations in advanced ovarian cancer. In addition, annual rates for OS were compared among all 5 patient cohorts. An additional analysis was conducted comparing patient outcomes from the assay-informed arm with one of the cohorts from the empirically-treated arm (Bookman 2009 JCO). Patients from the assay-informed arm were categorized by in vitro response as sensitive (S), intermediate (I), or resistant (R) to the drug administered, and Kaplan Meier survival curves were created for each response category. These survival curves were compared to the Kaplan Meier curves from the selected empirically-treated cohort. Results: Patient characteristics were very similar between the empirically-treated and the assay-informed arms, though 11-16% more patients were optimally debulked in each of the 4 empirically-treated cohorts. Additionally, with the exception of one of the cohorts (Bookman 2009 JCO), patient stage was lower for the empirically-treated arm as compared to the assay-informed arm, with approximately 10% of patients earlier staged. The assay-informed arm experienced a 10% improvement in median OS (48 vs. 44 months). At the time of completion of the assay-informed study (6 years), the difference in OS rates between the 2 arms was 10%, with 39% OS for the assay-informed vs. 29% in the empirically-treated arm. The largest cohort from the empirically treated arm (Bookman 2009 JCO) included 4,312 patients and a stage distribution similar to the assay-informed arm. It was chosen for further analysis to see survival differences when patients in the assay-informed arm were separated by response category. Median OS by response category for the assay-informed was 72.5, 48.6, and 28.2 months, for S (n=20), I (n=133), and R (n=39), respectively (P=0.03; hazard ratio, 0.70; 95% CI, 0.50-0.97), as compared to 44 months for the patient subset from the empirically-treated arm. Conclusion: Realizing study design limitations and despite a generally worse prognosis, patients from the assay-informed arm experienced increased median OS when compared to the empirically-treated arm. This difference was further augmented when the assay informed arm was compared directly to one of the cohorts from the empirically treated population. These results support the use of chemoresponse assays as predictors of clinical response and OS in epithelial ovarian cancer as well as for choosing between equivalent treatments in clinical practice. Citation Format: Thomas J. Herzog, James Fiorica, James W. Orr, Jr., Robert Holloway, Mike Gabrin, Edward C. Grendys, Jr.. A comparison of patient outcomes in advanced ovarian cancer: Assay-informed vs. empirically treated. [abstract]. In: Proceedings of the AACR Special Conference on Advances in Ovarian Cancer Research: From Concept to Clinic; Sep 18-21, 2013; Miami, FL. Philadelphia (PA): AACR; Clin Cancer Res 2013;19(19 Suppl):Abstract nr A85.

In other Gynecologic Oncology Group (GOG) studies, ifosfamide demonstrated antineoplastic activity against ovarian epithelial tumors, squamous carcinomas of the cervix, uterine sarcomas, and trophoblastic disease. Responses were also observed in 15% of patients with endometrial adenocarcinoma previously exposed to chemotherapy. This is a phase II trial of ifosfamide in patients with chemotherapy-naive advanced or recurrent endometrial adenocarcinoma. Thirty-seven patients with advanced adenocarcinoma of the endometrium recurrent after surgery and/or radiotherapy were treated with ifosfamide 1.2 g/m 2 intravenously daily for 5 days every 4 weeks and mesna 300 mg/m 2 intravenously every 4 hr for 3 doses daily for 5 days with each course. Three patients were ineligible—one due to a second primary, one did not have an endometrial primary, and the other because of wrong cell type. One patient was inevaluable for response; thus, 33 were evaluable for response. All patients had undergone hysterectomy and 24 had received radiotherapy before entering the trial. Eleven had GOG performance status of 0, 18 had a status of 1, and 4 had performance status of 2. Median age was 68 years (range, 41–86 years). Grade 3 or 4 neutropenia occurred in eight patients each and grade 3 thrombocytopenia was observed in one patient. One patient had a grade 4 neurotoxicity. Complete responses were observed in two patients (6.1%) and partial responses in six (18.2%) for an overall response rate of 24.3%. Ifosfamide in this dose and schedule is an active drug in the treatment of patients with advanced or recurrent adenocarcinoma of the endometrium.

The clinical, surgical, and histopathologic data from 202 patients with endometrial adenocarcinoma with cervical involvement are presented. One hundred fifty-one (75%) had histopathologically confirmed cervical involvement at the time of their definitive surgery, while in 51 (25%) no cervical involvement was conclusively identified. The 5-year actuarial survival for patients with true surgical stage II endometrial carcinoma (N = 24) was 76%. Extrauterine disease was documented in 32% (27/84) of patients in which the primary treatment modality was surgical. The 5-year actuarial survival was 65% for all patients with clinical surgical stage II disease. There appeared to be a survival advantage for patients treated by radical surgery as compared with more conventional treatments, especially in patients with numerous high-risk factors. The subgroup of patients (N = 53) having tumor grossly involving the cervix had a 5-year survival of 48%. In this subgroup of patients, radical hysterectomy offered improved 5-year survival over more traditional forms of treatment, particularly compared with simple hysterectomy or combined treatment with radiation and surgery. Multivariate analysis positively correlated myometrial invasion, grade, uterine serosal involvement, lower uterine segment involvement, adnexal metastasis, pelvic metastasis, aortic node metastasis, and peritoneal cytology, with disease-free survival. Clinical and surgical findings correlated poorly; therefore, primary surgical evaluation is recommended when possible.

This issue of Current Opinion in Obstetrics and Gynecology focuses on the rapidly changing field of gynecologic oncology. Initially regarded as pure radical pelvic and abdominal surgery, the subspeciality has evolved into a field of significant scientific discovery ranging from research in evolving surgical technology on a macroscopic level to DNA sequencing and gene therapy on a submicroscopic scale. The following reviews focus on some of these recent efforts to study, diagnose and treat gynecologic malignancies.

Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the country's fourth most common cause of cancer mortality in women. In the year 2004, there will be an estimated 25,580 new diagnoses and an estimated 16,090 deaths from this neoplasm. The incidence increases with age and is most prevalent in the eighth decade of life, with an incidence rate of 57/100,000 women. The median age at the time of diagnosis is 63 years, and 70% of patients present with advanced disease. For the most recent version of the guidelines, please visit NCCN.org