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OBJECTIVE: The objective of the study was to compare adverse event rates between laparoscopic vs open surgery for endometrial cancer. STUDY DESIGN: This was a retrospective cohort study comparing 107 women who underwent laparoscopy with 269 age- and body mass index–matched women who underwent laparotomy for treatment of endometrial cancer. RESULTS: Adverse event rates were similar between cohorts (37% laparoscopy vs 43% laparotomy, P .248). Laparotomies had higher rates of cellulitis (16% vs 7%,P .018) and open wound infection (9% vs 2%,P .02), whereas laparoscopy had higher rates of sensory peripheral nerve deficit (5% vs 0%, P .008) and lymphedema (7% vs 1%,P .003). Laparoscopy was associated with longer mean operating room times but with shorter hospital stays and lower mean blood loss. CONCLUSION: Laparoscopy was associated with decreased rates of surgical site infections but had an increased risk of peripheral sensory nerve deficits and lymphedema when compared with laparotomy.

5084 Background: Although considerable progress has been made in the treatment of advanced ovarian cancer, complications of both disease and treatment limit long term survival. Further research is ...

Objective We sought to estimate mean costs of chemotherapy treatment for recurrent ovarian cancer with or without use of a chemoresponse assay. Study Design We estimated mean costs for 3 groups: (1) assay assisted: 75 women who received oncologist's choice of chemotherapy following chemoresponse testing (65% adherence to test results), (2) assay adherent: modeled group assuming 100% adherence to assay results, and (3) empiric: modeled from market share data on most frequently utilized chemotherapy regimens. Cost estimates were based on commercial claims database reimbursements. Results The most common chemotherapy regimens used were topotecan, doxorubicin, and carboplatin/paclitaxel. Mean chemotherapy costs for 6 cycles were $48,758 (empiric), $33,187 (assay assisted), and $23,986 (assay adherent). The cost savings related to the assay were associated with a shift from higher- to lower-cost chemotherapy regimens and lower use of supportive drugs such as hematopoiesis-stimulating agents. Conclusion Assay-assisted chemotherapy for recurrent ovarian cancer may result in reduced costs compared to empiric therapy.

5027 Background: A recent randomized trial (PORTEC 2) reported preliminary equivalence of adjuvant whole pelvic radiotherapy (WPRT) with vaginal brachytherapy (VB) in FIGO stage I endometrial cance...

Objective The objective of the study was to determine the cost-effectiveness of annual screening tests for endometrial cancer. Study Design Markov state transition model of the natural history of endometrial cancer used as the design for the study. Incidence was modeled for the general population and high risk groups (obese, body mass index [BMI] of ≥ 30 kg/m 2 ; tamoxifen users). Strategies evaluated were no screening, annual endometrial biopsy, annual endovaginal ultrasound, and annual serum screening. Serum screening was based on a recently described biomarker panel (sensitivity of 0.98, specificity of 0.98). Results In the general population model, no screening was least expensive, whereas annual serum screening age at 50-75 years had incremental cost-effectiveness ratio (ICER) of $60,363 per year of life saved (YLS) compared with no screening. In a high-risk population (obesity, BMI of ≥ 30 kg/m 2 ), annual serum screening at age 45-80 years had ICER of $41,226 per YLS compared with no screening. Annual endometrial biopsy and annual transvaginal ultrasound were dominated. Conclusion Annual serum screening for endometrial cancer has the potential to be cost effective when applied to high-risk populations.

e16503 Background: There is an absence of data in the literature on salvage rates for vaginal, pelvic, and extra-pelvic recurrences for early-stage UPSC patients (pts). The purpose of this study is to determine whether primary recurrences can be salvaged with chemotherapy or radiotherapy. Methods: A retrospective, multi-institution study of pts with stage I-II UPSC diagnosed from 1993–2006. All pts underwent comprehensive surgical staging. Postoperative treatment included either observation (OBS), radiotherapy (RT: brachytherapy, pelvic, abdominal or combo) or ≥ 3 cycles carboplatin/paclitaxel (CT) alone or with RT (CT+RT). Results: We identified 197 stage I-II pts; 44/197 (22.3%) experienced a primary recurrence during a median follow-up of 35 months. Patterns of recurrence analysis revealed that 17 (38.6%) were vaginal/pelvic (V/P) and 27 (61.4%) were extra-pelvic (EP). Multi-site relapses occurred in 13/44 (30%). Pts initially treated with adjuvant CT±RT (n = 108) had a significantly decreased risk of primary recurrence (9.9%) when compared to those patients treated with RT alone (n = 45; 37%) or OBS (n = 43; 35%; p < 0.001). There were no distinguishing risk factors for development of V/P versus EP recurrence. Median time to recurrence after diagnosis was 16 months. The majority of pts (86%) were not salvaged by second line therapy, with a median time from recurrence to death of 8.9 months. However, more pts with isolated vaginal recurrences (5/12 or 42%) were salvaged when compared to those with pelvic or EP recurrences (1/32 or 3.1%; p = 0.004). The 5 pts who are NED after vaginal relapse were treated with CT±RT (n = 3) or RT (n = 2); 80% had not received prior treatment and 20% had received prior CT. To date, more pts with EP recurrence are dead of disease (23/27) than with V/P recurrences (7/17; p = 0.003). Conclusions: Stage I-II USPC pts are more likely to experience an extra-pelvic than vaginal/pelvic primary recurrence, are unlikely to be salvaged and will have a short interval from recurrence to death. The exception is in those with isolated vaginal recurrence, who may be salvaged in select cases. The current best strategy to avoid primary recurrences in this setting is an initial staging surgery followed by adjuvant carboplatin/paclitaxel. No significant financial relationships to disclose.

5518 Background: There is currently no consensus regarding the management of advanced stage uterine MMT. In an effort to better define postoperative treatment modalities and their associated outcomes, we retrospectively reviewed factors that influence progression and survival. Methods: A retrospective, multi-institution study of women diagnosed from 1997–2007 was performed. Post-operative treatment included either observation (OBS), RT (brachytherapy, whole pelvic, or combination), chemotherapy (CT) alone or with RT (CT+RT). The majority of chemotherapy regimens included carboplatinum/paclitaxel, Ifosfamide/cisplatin, cisplatin/adriamycin, Data collected included time to recurrence, overall survival and sites of recurrence. Statistics included t-test, ANOVA and Kaplan Meier. Results: 119 patients were identified with late stage uterine MMT. 81 had stage III disease and 38 had stage IV disease. The median age at diagnosis was 67 years (range: 30–86). 70 (59%) were Caucasian and 48 (40%) were African-American. 116 (87%) were optimally debulked and their survival further analyzed. 18 (15%) were observed and 9 of these patients recurred. This group had the poorest median progression free survival (PFS) of 3.4 months. The majority (N = 50, 49%) of late stage patients underwent adjuvant CT with a median PFS of 13.3 months and median OS of 15.6 months. Of these patients 33 (66%) recurred. 18 (17 %) patients underwent RT alone with a median PFS of 12.4 months and OS of 14.9 months. 14 (78%) of these patients recurred. 20 patients (19%) underwent a combination of CT and RT and 11 (55%) experienced recurrences . The combination therapy group had the longest median PFS of 14.3 months and OS of 17.2 months (p = 0.27). Conclusions: Chemotherapy had become the standard therapy for advanced stage MMT however the addition of radiation has not been established. Patients diagnosed with advanced stage MMT can achieve long-term DFS in a minority of patients (33%) treated with chemotherapy. We showed that the addition of radiation to adjuvant chemotherapy showed a slight improvement over chemotherapy alone yet the optimal therapy has yet to be defined. This retrospective review highlights the need for prospective trials of new therapeutic agents and treatment regimens for women with advanced stage uterine MMT. No significant financial relationships to disclose.

5516 Background: The treatment of early stage uterine carcinosarcoma is controversial. We sought to retrospectively review factors that influence progression and survival. Methods: A retrospective, multi-institution study of women diagnosed from 1997–2007 was performed. Postoperative treatment included either observation (OBS), RT (brachytherapy, whole pelvic, or combination), chemotherapy (CT) alone or with RT (CT+RT). Data collected included time to recurrence, overall survival, and sites of recurrence. Statistics included ANOVA and Kaplan Meier. Results: One hundred and forty-six patients were diagnosed with early stage (stages 1 and 2) uterine carcinocarcoma. The median age at diagnosis was 68 years (range:40–91). The majority (62%) were Caucasian, 49 (34%) were African-American and the remainder were other ethnicities. One hundred and seventeen had stage 1 disease and 29 had stage 2. The majority of patients (N = 54, 37 %) were observed, 36 (25%) were treated with CT, 31 (21%) were treated with RT and 17 (12%) were treated with CT + RT. The median progression free survival (PFS) for patients diagnosed with early stage disease was 16.7 months for the OBS cohort and 38.2 months for the CT cohort (p < 0.01). Median overall survival was 23 months for the OBS cohort and 39.3 months for the CT cohort (p = 0.02). The cohorts that underwent RT or CT+RT had improved median progression free (29.9, 20 months) and overall survival (31.7, 20.8 months) as compared to the OBS cohort, however this was not a statistically significant difference. Conclusions: We report on the largest experience in the literature on early stage uterine carcinosarcoma and the first to show that women with early stage disease may benefit from adjuvant chemotherapy. The role of radiation therapy or combination chemotherapy and radiation could not be adequately assessed from this retrospective analysis, but a trend toward improved survival was present. Prospective trials evaluating the best treatment for patients with early stage carcinosarcoma of the uterus should be undertaken to better answer this question. No significant financial relationships to disclose.

5092 Background: Combination paclitaxel and platinum-based chemotherapy has been shown to improve survival in patients with recurrent platinum-sensitive ovarian cancer. However, the incidence of neurotoxicity was significantly greater with combination therapy than with other platinum-based regimens. The aim of this study was to compare the efficacy and adverse event profile of combination versus sequential weekly docetaxel and carboplatin therapy in patients with recurrent platinum-sensitive ovarian cancer. Methods: Patients with recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer were randomized to either weekly docetaxel 30 mg/m2/days 1 and 8 and carboplatin AUC 6/day 1 q 3 weeks (regimen A) or docetaxel 30 mg/m2/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks (regimen B) for 6 cycles or until disease progression. The primary endpoint was time to progression (TTP). Results: At the time of this analysis, 51 patients, with a median age of 65.1 years, had been enrolled. There were 25 randomized to regimen A and 26 to regimen B from January 2004 to April 2005. There were no differences between the groups with respect to age, performance status, prior consolidation therapy, or anatomic site of cancer. The study is still open to accrual and thus far the overall response rate was 51% (2 CR, 24 PR) with stable disease in 26%. Median TTP was 12.6 months. The incidence of grade 2 or 3 neurotoxicity and grade 3 or 4 neutropenia was higher with regimen A compared to regimen B (15% vs. 3%; 44% vs. 10%), respectively. Conclusions: Combination and sequential weekly docetaxel and carboplatin have significant activity in recurrent platinum-sensitive ovarian cancer. Both regimens have a low incidence of moderate to severe neurotoxicity relative to that observed in other studies that employed paclitaxel. [Table: see text]

5152 Background: Topotecan (T) and vinorelbine (V) have shown efficacy in recurrent ovarian and cervical cancer. The purpose of this trial was to determine the recommended dose of combination T and V and to assess its efficacy in patients with refractory gynecologic cancer. Methods: Sixteen patients with measurable disease and advanced gynecologic malignancies were enrolled. The phase I study evaluated the toxicity of combining T (0.75–1.25 mg/m2) administered as a 30 minute infusion on days 1,2, and 3 and V (20–22.5 mg/m2) IVP on days 1 and 8 of a 21 day cycle. The phase II study evaluated 8 patients treated with T (0.75 mg/m2) on days 1,2, and 3 followed by V(20 mg/m2) IVP on days 1 and 8. Results: Five DLTs appeared during the first 8 cycles in levels 1 and 2. The MTD was reached and the recommended dose for this combination schedule was T: 0.75 mg/m2 on days #1, 2, and 3 combined with V: 22.5 mg/m2 on days # 1 and 8. Phase II: 8 patients have been enrolled at the recommended dose (median age 60 [35–74...

5089 Background: A phase I/II study of liposomal doxorubicin combined with whole abdominal hyperthermia was conducted in patients with refractory ovarian cancer. Liposomal doxorubicin combined with hyperthermia has been shown to increase liposomal extravasation into tumor xenografts resulting in enhanced cytotoxic effects. Methods: Thirty patients with either recurrent or persistent epithelial ovarian cancer were enrolled. All patients had either measurable or assessable disease. Patients received intravenous (IV) liposomal doxorubicin 40 mg/m2 as a 1-hour infusion followed by whole abdominal hyperthermia. Quality of life (QOL) was performed at baseline, prior to each cycle, and every 3 months following treatment. Results: All 30 patients were either paclitaxel and/or platinum resistant initially or developed resistant disease. The median number of prior chemotherapeutic regimens was three (range 2–8) and 6 patients had been previously treated with liposomal doxorubicin. There were 3 partial responses for...