GOG 244 - The Lymphedema and Gynecologic cancer (LeG) study: The impact of lower-extremity lymphedema on quality of life, psychological adjustment, physical disability, and function.

OBJECTIVE: To assess quality of life (QOL) in patients who developed lower-extremity lymphedema (LLE) after radical gynecologic cancer surgery on prospective clinical trial GOG 244. METHODS: The prospective, national, cooperative group trial GOG-0244 determined the incidence of LLE and risk factors for LLE development, as well as associated impacts on QOL, in newly diagnosed patients undergoing surgery for endometrial, cervical, or vulvar cancer from 6/4/2012-11/17/2014. Patient-reported outcome (PRO) measures of QOL (by the Functional Assessment of Cancer Therapy [FACT]), body image, sexual and vaginal function, limb function, and cancer distress were recorded at baseline (within 14 days before surgery), and at 6, 12, 18, and 24 months after surgery. Assessments of LLE symptoms and disability were completed at the time of lower limb volume measurement. A linear mixed model was applied to examine the association of PROs/QOL with a Gynecologic Cancer Lymphedema Questionnaire (GCLQ) total score incremental change ≥4 (indicative of increased LLE symptoms) from baseline, a formal diagnosis of LLE (per the GCLQ), and limb volume change (LVC) ≥10%. RESULTS: In 768 evaluable patients, those with a GCLQ score change ≥4 from baseline had significantly worse QOL (p < 0.001), body image (p < 0.001), sexual and vaginal function (p < 0.001), limb function (p < 0.001), and cancer distress (p < 0.001). There were no significant differences in sexual activity rates between those with and without LLE symptoms. CONCLUSIONS: LLE is significantly detrimental to QOL, daily function, and body image. Clinical intervention trials to prevent and manage this chronic condition after gynecologic cancer surgery are needed.

GOG 244-The lymphedema and gynecologic cancer (LEG) study: Incidence and risk factors in newly diagnosed patients.

OBJECTIVES: To evaluate the incidence and risk factors for lymphedema associated with surgery for gynecologic malignancies on GOG study 244. METHODS: Women undergoing a lymph node dissection for endometrial, cervical, or vulvar cancer were eligible for enrollment. Leg volume was calculated from measurements at 10-cm intervals starting 10 cm above the bottom of the heel to the inguinal crease. Measurements were obtained preoperatively and postoperatively at 4-6 weeks, and at 3-, 6-, 9-, 12-, 18-, and 24- months. Lymphedema was defined as a limb volume change (LVC) ≥10% from baseline and categorized as mild: 10-19% LVC; moderate: 20-40% LVC; or severe: >40% LVC. Risk factors associated with lymphedema were also analyzed. RESULTS: Of 1054 women enrolled on study, 140 were inevaluable due to inadequate measurements or eligibility criteria. This left 734 endometrial, 138 cervical, and 42 vulvar patients evaluable for LVC assessment. Median age was 61 years (range, 28-91) in the endometrial, 44 years (range, 25-83) in the cervical, and 58 years (range, 35-88) in the vulvar group. The incidence of LVC ≥10% was 34% (n = 247), 35% (n = 48), and 43% (n = 18), respectively. The peak incidence of lymphedema was at the 4-6 week assessment. Logistic regression analysis showed a decreased risk with advanced age (p = 0.0467). An exploratory analysis in the endometrial cohort showed an increased risk with a node count >8 (p = 0.033). CONCLUSIONS: For a gynecologic cancer, LVC decreased with age greater than 65, but increased with a lymph node count greater than 8 in the endometrial cohort. There was no association with radiation or other risk factors.

GOG 244 - The LymphEdema and Gynecologic cancer (LEG) study: The association between the gynecologic cancer lymphedema questionnaire (GCLQ) and lymphedema of the lower extremity (LLE).

OBJECTIVE: To explore whether patient-reported lymphedema-related symptoms, as measured by the Gynecologic Cancer Lymphedema Questionnaire (GCLQ), are associated with a patient-reported diagnosis of lymphedema of the lower extremity (LLE) and limb volume change (LVC) in patients who have undergone radical surgery, including lymphadenectomy, for endometrial, cervical, or vulvar cancer on Gynecologic Oncology Group (GOG) study 244. METHODS: Patients completed the baseline and at least one post-surgery GCLQ and LVC assessment. The 20-item GCLQ measures seven symptom clusters-aching, heaviness, infection-related, numbness, physical functioning, general swelling, and limb swelling. LLE was defined as a patient self-reported LLE diagnosis on the GCLQ. LVC was measured by volume calculations based on circumferential measurements. A linear mixed model was fitted for change in symptom cluster scores and GCLQ total score and adjusted for disease sites and assessment time. RESULTS: Of 987 eligible patients, 894 were evaluable (endometrial, 719; cervical, 136; vulvar, 39). Of these, 14% reported an LLE diagnosis (endometrial, 11%; cervical, 18%; vulvar, 38%). Significantly more patients diagnosed versus not diagnosed with LLE reported ≥4-point increase from baseline on the GCLQ total score (p < 0.001). Changes from baseline were significantly larger on all GCLQ symptom cluster scores in patients with LLE compared to those without LLE. An LVC increment of >10% was significantly associated with reported general swelling (p < 0.001), heaviness (p = 0.005), infection-related symptoms (p = 0.002), and physical function (p = 0.006). CONCLUSIONS: Patient-reported symptoms, as measured by the GCLQ, discerned those with and without a patient-reported LLE diagnosis and demonstrated predictive value. The GCLQ combined with LVC may enhance our ability to identify LLE.

Is Robotic-Assisted Surgery Safe in the Elderly Population? An Analysis of Gynecologic Procedures in Patients ≥ 65 Years Old.

BACKGROUND: The elderly population is expanding worldwide but is underrepresented in clinical trials. We sought to assess the safety of robotic gynecologic surgery in an elderly cohort and to identify factors associated with unfavorable outcomes. METHODS: All patients ≥ 65 years who underwent a robotically assisted procedure at a single institution between May 2007 to December 2016 were divided into three age groups: 65-74 (Group 1); 75-84 (Group 2); ≥ 85 (Group 3). Perioperative outcomes were recorded in patients who did not require conversion to laparotomy. We compared clinical variables among groups and performed multivariate logistic regression to detect variables associated with major complications (≥ Grade 3) or 90-day mortality. RESULTS: We retrospectively identified 982 cases: 685 in Group 1; 249 in Group 2; 48 in Group 3. Median age = 71 years. Median BMI = 28.9. Malignancy was documented in 72.8% of cases; the majority were endometrial cancer (61.8%). Thirty-four patients (3.5%) were readmitted within 30 days. Seventy-seven (7.8%) had a postoperative complication, and 23 (2.3%) had a major complication. Ninety-day mortality was 0.5%. There was significant difference between groups with respect to body mass index (P = 0.026), ECOG PS (P ≤ 0.001), > 5 comorbidities (P = 0.005), hospital stay (P < 0.001), major complications (P = 0.001), and 90-day mortality (P < 0.001). On multivariable logistic regression, age ≥ 85 years was associated with major complications. Body mass index, age ≥ 85 years, and major complications were significantly associated with 90-day mortality. CONCLUSIONS: Robotic-assisted surgery appears to be safe in an elderly cohort. The incidence of overall and major complications is consistent with those reported in the literature. Patients ≥ 85 years old appear to be at higher risk of unfavorable outcomes.

Trocar site hernia development in patients undergoing robotically assisted or standard laparoscopic staging surgery for endometrial cancer.

OBJECTIVES: To compare the incidence and potential risk factors of trocar site hernia formation in women undergoing robotically assisted versus standard laparoscopic staging (RBT vs. LSC, respectively) for endometrial cancer. METHODS: We retrospectively identified all patients who underwent MIS staging for endometrial cancer at our institution from 01/09-12/12. Data collection involved the review of all operative notes, postoperative follow-up visit notes, and postoperative imaging reports. Appropriate statistical tests were used. RESULTS: We identified 760 eligible patients (LSC, 193; RBT, 567). The overall median age was 61years (range, 33-90). The median BMI was 28.5kg/m2 for LSC (range, 16.6-67.6) and 29.5kg/m2 for RBT (range, 17.9-66) patients (p=0.8). A trocar site hernia developed in 16 patients (2.1%)-5 (2.6%) of 193 LSC and 11 (1.9%) of 567 RBT patients (p=0.6). Median time to hernia diagnosis was 13months (range, 5-20.5) and 18months (range, 3-49), respectively (p=0.5). All hernias in the LSC cohort developed at the camera trocar site. In the RBT cohort, 10 developed at the camera trocar site and 1 at a lateral trocar site. Only BMI was associated with the development of hernias. A hernia was diagnosed in 7 (6.9%) of 101 patients with a BMI ≥40kg/m2 compared with 9 (1.4%) of 659 with a BMI <40kg/m2 (p=0.001). CONCLUSION: MIS for endometrial cancer is associated with a low rate of trocar site hernia formation, with similar rates associated with RBT and standard LSC. Higher BMI is associated with the development of postoperative trocar site hernias.

Sexual health needs and educational intervention preferences for women with cancer.

PURPOSE: To assess sexual/vaginal health issues and educational intervention preferences in women with a history of breast or gynecologic cancer. METHODS: Patients/survivors completed a cross-sectional survey at their outpatient visits. Main outcome measures were sexual dysfunction prevalence, type of sexual/vaginal issues, awareness of treatments, and preferred intervention modalities. Descriptive frequencies were performed, and results were dichotomized by age, treatment status, and disease site. RESULTS: Of 218 eligible participants, 109 (50%) had a history of gynecologic and 109 (50%) a history of breast cancer. Median age was 49 years (range 21-75); 61% were married/cohabitating. Seventy percent (n = 153) were somewhat-to-very concerned about sexual function/vaginal health, 55% (n = 120) reported vaginal dryness, 39% (n = 84) vaginal pain, and 51% (n = 112) libido loss. Many had heard of vaginal lubricants, moisturizers, and pelvic floor exercises (97, 72, and 57%, respectively). Seventy-four percent (n = 161) had used lubricants, 28% moisturizers (n = 61), and 28% pelvic floor exercises (n = 60). Seventy percent (n = 152) preferred the topic to be raised by the medical team; 48% (n = 105) raised the topic themselves. Most preferred written educational material followed by expert discussion (66%, n = 144/218). Compared to women ≥50 years old (41%, n = 43/105), younger women (54%, n = 61/113) preferred to discuss their concerns face-to-face (p = 0.054). Older women were less interested in online interventions (52%, p < 0.001), despite 94% having computer access. CONCLUSION: Female cancer patients/survivors have unmet sexual/vaginal health needs. Preferences for receiving sexual health information vary by age. Improved physician-patient communication, awareness, and educational resources using proven sexual health promotion strategies can help women cope with treatment side effects.

Minimal access surgery compared to laparotomy for secondary surgical cytoreduction in patients with recurrent ovarian carcinoma: Perioperative and oncologic outcomes.

OBJECTIVES: To assess the perioperative outcomes of minimal access surgery (MAS) in secondary surgical cytoreduction (SSCR) for recurrent epithelial ovarian cancer (ROC); to compare oncologic outcomes with laparotomy (LAP). METHODS: Using an institutional database, we identified all patients with ROC undergoing SSCR from 1/5/09-6/14/14. Selection for MAS or LAP was based on surgeon preference. To minimize selection bias, preoperative imaging was reviewed for all LAP cases. In this manner, we identified potential MAS candidates, who were used in the comparison. Intent-to-treat analyses were undertaken using statistical testing. RESULTS: 170 cases were identified (131 LAP, 8 LSC, 31 RBT). 68/131 (52%) LAP cases were deemed potential candidates for MAS. Feasibility analyses included 68 LAP and 39 MAS cases. Six (15%) MAS cases were converted to LAP. Median age, BMI, operative time did not differ significantly between the groups. Complete gross resection was achieved in 37/39 (95%) MAS, 63/68 (93%) LAP (P=1.0). Median estimated blood loss was 50cm3 (range, 5-500) MAS, 150cm3 (range, 0-1500) LAP (P=0.001). Median length of stay was 1day (range, 0-23) MAS, 5days (range, 1-21) LAP (P<0.001). Complications occurred in 3/39 (8%) MAS, 15/68 (22%) LAP (P=0.06). The 2-year progression-free survival was 56.1% (SE 9%) MAS, 63.5% (SE 6%) LAP (P=1.0). The 2-year overall survival was 92.2% (SE 5.4%) MAS, 81.4% (SE 5.5%) LAP (P=0.7). CONCLUSIONS: MAS for SSCR is feasible in properly selected cases. MAS is associated with favorable perioperative outcomes and similar oncologic outcomes, compared to LAP.

Uterine Cancer After Risk-Reducing Salpingo-oophorectomy Without Hysterectomy in Women With BRCA Mutations.

IMPORTANCE: The link between BRCA mutations and uterine cancer is unclear. Therefore, although risk-reducing salpingo-oophorectomy (RRSO) is standard treatment among women with BRCA mutations (BRCA+ women), the role of concomitant hysterectomy is controversial. OBJECTIVE: To determine the risk for uterine cancer and distribution of specific histologic subtypes in BRCA+ women after RRSO without hysterectomy. DESIGN, SETTING, AND PARTICIPANTS: This multicenter prospective cohort study included 1083 women with a deleterious BRCA1 or BRCA2 mutation identified from January 1, 1995, to December 31, 2011, at 9 academic medical centers in the United States and the United Kingdom who underwent RRSO without a prior or concomitant hysterectomy. Of these, 627 participants were BRCA1+; 453, BRCA2+; and 3, both. Participants were prospectively followed up for a median 5.1 (interquartile range [IQR], 3.0-8.4) years after ascertainment, BRCA testing, or RRSO (whichever occurred last). Follow up data available through October 14, 2014, were included in the analyses. Censoring occurred at uterine cancer diagnosis, hysterectomy, last follow-up, or death. New cancers were categorized by histologic subtype, and available tumors were analyzed for loss of the wild-type BRCA gene and/or protein expression. MAIN OUTCOMES AND MEASURES: Incidence of uterine corpus cancer in BRCA+ women who underwent RRSO without hysterectomy compared with rates expected from the Surveillance, Epidemiology, and End Results database. RESULTS: Among the 1083 women women who underwent RRSO without hysterectomy at a median age 45.6 (IQR: 40.9 - 52.5), 8 incident uterine cancers were observed (4.3 expected; observed to expected [O:E] ratio, 1.9; 95% CI, 0.8-3.7; P = .09). No increased risk for endometrioid endometrial carcinoma or sarcoma was found after stratifying by subtype. Five serous and/or serous-like (serous/serous-like) endometrial carcinomas were observed (4 BRCA1+ and 1 BRCA2+) 7.2 to 12.9 years after RRSO (BRCA1: 0.18 expected [O:E ratio, 22.2; 95% CI, 6.1-56.9; P < .001]; BRCA2: 0.16 expected [O:E ratio, 6.4; 95% CI, 0.2-35.5; P = .15]). Tumor analyses confirmed loss of the wild-type BRCA1 gene and/or protein expression in all 3 available serous/serous-like BRCA1+ tumors. CONCLUSIONS AND RELEVANCE: Although the overall risk for uterine cancer after RRSO was not increased, the risk for serous/serous-like endometrial carcinoma was increased in BRCA1+ women. This risk should be considered when discussing the advantages and risks of hysterectomy at the time of RRSO in BRCA1+ women.

Sister Society Meeting on Global Education Development and Collaboration: Meeting Report.

OBJECTIVES: To identify common barriers to teaching and training and to identify strategies that would be useful in developing future training programs in gynecologic oncology in low- and middle- income countries. METHODS: There is a lack of overall strategy to meet the needs of education and training in gynecologic oncology in low- and middle- income countries, the leaderships of sister societies and global health volunteers met at the European Society of Gynecologic Oncology in October 23, 2015. The challenges of the training programs supported by gynecologic oncology societies, major universities and individual efforts were presented and discussed. Strategies to improve education and training were identified. RESULTS: Major challenges include language barriers, limited surgical equipment, inadequate internet access, lack of local support for sustainability in training programs, inadequate pathology and radiation oncology, finance and a global deficiency in identifying sites and personnel in partnering or developing training programs. The leaderships identified various key components including consultation with the local Ministry of Health, local educational institutions; inclusion of the program into existing local programs, a needs assessment, and the development of curriculum and regional centers of excellence. CONCLUSIONS: Proper preparation of training sites and trainers, the development of global curriculum, the establishment of centers of excellence, and the ability to measure outcomes are important to improve education and training in gynecologic oncology in low- and middle- income countries.

Impact of Obesity on Sentinel Lymph Node Mapping in Patients with Newly Diagnosed Uterine Cancer Undergoing Robotic Surgery.

PURPOSE: The aim of this study was to determine the impact of obesity on the rate of successful sentinel lymph node (SLN) mapping in patients with uterine cancer undergoing robotic surgery, and compare SLN detection rates using indocyanine green (ICG) versus blue dye. METHODS: We reviewed robotic cases undergoing SLN mapping with a cervical injection from January 2011 to December 2013 using either blue dye or ICG with near-infrared (NIR) fluorescence imaging. Data were stratified by body mass index (BMI) and the dye used. Appropriate statistical tests were applied. RESULTS: Overall, 472 cases were identified. Bilateral mapping was successful in 352 cases (75 %), and unilateral mapping was successful in 73 cases (15 %). Bilateral mapping was achieved in 266 (85 %) of 312 ICG cases compared with 86 (54 %) of 160 blue-dye cases (p < 0.001). Cases with successful bilateral mapping had a median BMI of 29.8 kg/m(2) (range 16.3-65.3 kg/m(2)); cases with no mapping had a median BMI of 34.7 kg/m(2) (range 21.4-60.4 kg/m(2)) (p = 0.001). With increasing BMI, there was a significant decrease in successful bilateral mapping rates for both the ICG (p < 0.001) and blue-dye groups (p = 0.041); however, the use of ICG resulted in better bilateral (p = 0.002) and overall (p = 0.011) mapping rates compared with the use of blue dye in all BMI groups. CONCLUSIONS: ICG results in a higher overall and bilateral SLN detection than blue dye in women with uterine cancer. Successful mapping decreases with increasing BMI irrespective of the dye used; however, it is significantly improved with the use of ICG and NIR fluorescence imaging compared with blue dye.

Herniation formation in women undergoing robotically assisted laparoscopy or laparotomy for endometrial cancer.

OBJECTIVE: To compare the incidence of trocar site hernia in women who underwent robotically assisted laparoscopic surgery (RBT) for endometrial cancer staging with the incidence of ventral hernia formation in patients who underwent laparotomy (LAP) for the same indication. To analyze risk factors for hernia formation in women undergoing RBT for endometrial cancer. METHODS: We retrospectively identified all patients who underwent surgical staging for endometrial cancer via RBT or LAP from 2009-2012. Clinicopathologic data were analyzed. Appropriate statistical tests were used. RESULTS: 738 patients were staged via RBT (n=567) or LAP (n=171). Overall median age was 61 years (RBT range, 33-90; LAP range,28-86; p=0.4). Median BMI was 29.5 kg/m(2) (range, 17.9-66) and 30.3 kg/m(2) (range, 16.8-67.2), respectively (p=1.0). Eleven (1.9%) of 567 patients in the RBT cohort developed a trocar site hernia compared with 11 (6.4%) of 171 LAP patients who developed a ventral hernia (p=0.002). Median time to diagnosis was 18 months (range, 3-49) and 17 months (range, 7-30), respectively (p=0.7). Of the 11 RBT patients who developed a trocar site hernia, 10 (91%) were midline defects and 1 (9%) was a lateral defect of a prior inferior epigastric port site. No hernias required emergent operative intervention. Four (0.7%) of 567 RBT patients compared with 2 (1.2%) of 171 LAP patients required surgical hernia repair (p=0.4). CONCLUSIONS: Trocar site herniation after RBT staging for endometrial cancer is uncommon and less likely to occur than ventral hernia formation with LAP staging. Furthermore, surgical revision rates are low.

Impact of Robotic Platforms on Surgical Approach and Costs in the Management of Morbidly Obese Patients with Newly Diagnosed Uterine Cancer.

BACKGROUND: Minimally invasive surgery (MIS) is associated with decreased complication rates, length of hospital stay, and cost compared with laparotomy. Robotic-assisted surgery-a method of laparoscopy-addresses many of the limitations of standard laparoscopic instrumentation, thus leading to increased rates of MIS. We sought to assess the impact of robotics on the rates and costs of surgical approaches in morbidly obese patients with uterine cancer. METHODS: Patients who underwent primary surgery at our institution for uterine cancer from 1993 to 2012 with a BMI ≥40 mg/m(2) were identified. Surgical approaches were categorized as laparotomy (planned or converted), laparoscopic, robotic, or vaginal. We identified two time periods based on the evolving use of MIS at our institution: laparoscopic (1993-2007) and robotic (2008-2012). Direct costs were analyzed for cases performed from 2009 to 2012. RESULTS: We identified 426 eligible cases; 299 performed via laparotomy, 125 via MIS, and 2 via a vaginal approach. The rates of MIS for the laparoscopic and robotic time periods were 6 % and 57 %, respectively. The rate of MIS was 78 % in this morbidly obese cohort in 2012; 69 % were completed robotically. The median length of hospital stay was 5 days (range 2-37) for laparotomy cases and 1 day (range 0-7) for MIS cases (P < 0.001). The complication rate was 36 and 15 %, respectively (P < 0.001). The rate of wound-related complications was 27 and 6 %, respectively (P < 0.001). Laparotomy was associated with the highest cost. CONCLUSIONS: The robotic platform provides significant health and cost benefits by increasing MIS rates in this patient population.

Staging Lymphadenectomy in Patients With Clear Cell Carcinoma of the Ovary.

OBJECTIVE: The purpose of this study was to assess the rate of lymph node (LN) metastasis in comprehensively staged ovarian clear cell carcinoma (OCCC) clinically confined to the ovary and determine factors associated with LN metastasis. METHODS: We identified all cases of OCCC treated at 4 institutions from January 1994 through December 2011. We included cases with disease grossly confined to the ovary that had surgical staging performed, including at least 10 LNs sampled. Clinical and pathologic data were abstracted from electronic medical records, and a deidentified data set was compiled and processed at a single institution. Factors potentially associated with LN metastasis were tested. Appropriate statistical tests were performed. RESULTS: We identified 145 eligible cases that met the criteria for this analysis. Median age was 52.9 years (range, 30-81 years), and median total LN count was 19 (range, 10-74). Seven (4.8%) of 145 comprehensively staged cases had LN metastasis; 6 of these cases (4.1%) were isolated metastasis. Cytologic washings, peritoneal, omental, and fallopian tube involvement were not associated with nodal metastasis. Cases with ovarian surface involvement and positive cytology had a 37.5% incidence of LN positivity, which was statistically meaningful when compared with all other cases (P = 0.003). CONCLUSIONS: Women who underwent comprehensive staging for clinical stage I OCCC had an LN metastasis rate of 4.8%. The subgroup of cases with both ovarian surface involvement and positive cytology had the highest incidence of LN metastasis. This may influence clinical decision making on whether to perform lymphadenectomy in patients with incidental OCCC found after salpingo-oophorectomy.

Prognostic significance of the number of postoperative intraperitoneal chemotherapy cycles for patients with advanced epithelial ovarian cancer.

OBJECTIVE: Phase 3 trials have demonstrated a survival advantage for patients with optimally debulked epithelial ovarian cancer who received intravenous (IV) and intraperitoneal (IP) chemotherapy compared with IV therapy alone. This was despite a significant proportion of patients in the IV/IP arms not completing all 6 planned cycles. Our objective was to evaluate the prognostic significance of the number of IV/IP cycles administered. METHODS/MATERIALS: Data were analyzed for all patients with stage III to IV epithelial ovarian cancer who underwent optimal primary cytoreduction followed by 1 or more cycles of IV/IP chemotherapy from January 2005 to July 2011 at our institution. A landmark analysis was performed to associate progression-free survival (PFS) and overall survival (OS) with the number of IV/IP cycles given. RESULTS: We identified 201 patients; 26 (13%) received 1 to 2 cycles of IV/IP chemotherapy, 41 (20%) received 3 to 4 cycles, and 134 (67%) received 5 to 6 cycles. The 5-year PFS for patients who received 1 to 2, 3 to 4, and 5 to 6 cycles was 18%, 29%, and 17%, respectively. The 5-year OS for patients who received 1 to 2, 3 to 4, and 5 to 6 cycles was 44%, 54%, and 57%, respectively. There was no significant difference in PFS (P = 0.31) or OS (P = 0.14) between the 3 groups. The most common reason for discontinuing IV/IP therapy was treatment-related toxicity (77%). Postoperative complications were the most common reason for not initiating IV/IP therapy (42%) in patients who subsequently transitioned to it. CONCLUSIONS: We did not detect a significant survival difference between patients who received 1 to 2, 3 to 4, or 5 to 6 IV/IP chemotherapy cycles. Women may still derive a survival benefit if they receive fewer than 6 IV/IP cycles.

A comparison of primary intraperitoneal chemotherapy to consolidation intraperitoneal chemotherapy in optimally resected advanced ovarian cancer.

OBJECTIVE: To compare survival outcomes for patients with advanced epithelial ovarian cancer (EOC) who received primary intravenous/intraperitoneal (IV/IP) chemotherapy to those who received IV followed by consolidation (treatment given to patients in remission) IP chemotherapy. METHODS: Data were analyzed and compared for all patients with stage III-IV EOC who underwent optimal primary cytoreduction (residual disease ≤ 1 cm) followed by cisplatin-based consolidation IP chemotherapy (1/2001-12/2005) or primary IV/IP chemotherapy (1/2005-7/2011). RESULTS: We identified 224 patients; 62 (28%) received IV followed by consolidation IP chemotherapy and 162 (72%) received primary IV/IP chemotherapy. The primary IP group had significantly more patients with serous tumors. The consolidation IP group had a significantly greater median preoperative platelet count, CA-125, and amount of ascites. There were no differences in residual disease at the end of cytoreduction between both groups. The median progression-free survival (PFS) was greater for the primary IP group; however, this did not reach statistical significance (23.7 months vs 19.7 months; HR 0.78; 95% CI, 0.57-1.06; p=0.11). The median overall survival (OS) was significantly greater for the primary IP group (78.8 months vs 57.5 months; HR 0.56; 95% CI, 0.38-0.83; p=0.004). On multivariate analysis, after adjusting for confounders, the difference in PFS was not significant (HR 0.78; 95% CI, 0.56-1.11; p=0.17), while the difference in OS remained significant (HR 0.59; 95% CI, 0.39-0.89; p=0.01). CONCLUSIONS: In our study, primary IV/IP chemotherapy was associated with improved OS compared to IV followed by consolidation IP chemotherapy in patients with optimally cytoreduced advanced EOC.

Cost-effectiveness analysis of robotically assisted laparoscopy for newly diagnosed uterine cancers.

OBJECTIVE: To assess the direct costs of three surgical approaches in uterine cancer and the cost-effectiveness of incorporating robot-assisted surgery. METHODS: A cost system that allocates the actual cost of resources used to treat each patient, as opposed to borrowing cost data from a billing system, was used to determine direct costs for patients who underwent surgery for uterine cancer from 2009 to 2010. These costs included all aspects of surgical care up to 6 months after discharge. Total amortized direct costs included the capital cost of three dual-console robotic platforms with 5 years of service contracts. Nonamortized costs were also calculated (excluded capital costs). Modeling was performed to estimate the mean cost of surgical care for patients presenting with endometrial cancer from 2007 to 2010. RESULTS: Of 436 cases (132 laparoscopic, 262 robotic, 42 laparotomy), total mean amortized direct costs per case were $20,489 (laparoscopy), $23,646 (robot), and $24,642 (laparotomy) (P<.05 [robot compared with laparoscopy]; P=.6 [robot compared with laparotomy]). Total nonamortized costs per case were $20,289, $20,467, and $24,433, respectively (P=.9 [robot compared with laparoscopy]; P=.03 [robot compared with laparotomy]). The planned surgical approach in 2007 was laparoscopy, 68%; robot, 8%; and laparotomy, 24% compared with 26%, 64%, and 9%, respectively, in 2010 (P<.001). The modeled mean amortized direct costs per case were $21,738 in 2007 and $22,678 in 2010 (+$940). Nonamortized costs were $21,298 in 2007 and $20,573 in 2010 (-$725). CONCLUSION: Laparoscopy is least expensive when including capital acquisition costs. Laparoscopy and robotic surgery are comparable if upfront costs are excluded. There is cost neutralization with the robot when it helps decrease laparotomy rates.

Quantifying the risk of recurrence and death in stage III (FIGO 2009) endometrial cancer.

OBJECTIVE: Advanced endometrial cancer patients comprise a heterogeneous group. This study assessed the association of clinicopathological factors with relapse and death from endometrial cancer. METHODS: Eligible patients were treated for stage III (FIGO 2009) endometrial adenocarcinoma, had peritoneal cytology performed, and had no gross residual disease post-operatively. RESULTS: Of 192 patients, 59% were ≥60 years old, 48% had ≥50% myometrial invasion, 71% lymphovascular invasion, 25% cervical stromal invasion, 37% adnexal involvement, and 23% positive peritoneal cytology. High-grade histology (serous, clear cell, undifferentiated, or grade 3 endometrioid) was present in 45%. Pelvic lymphadenectomy was performed in 93% and para-aortic lymphadenectomy in 73%. Adjuvant chemotherapy and/or radiation therapy was administered to 93%. At a median follow-up of 42 months, the 5-year rate of relapse was 37% and of death from endometrial cancer was 30%. On multivariate analysis, both outcomes were associated with high-grade histology, positive peritoneal cytology, and deep myometrial invasion (p≤0.04). The cohort was divided into subgroups of patients with 0 (n=46), 1 (n=83), or ≥2 (n=63) of these high-risk characteristics. The 5-year relapse rate for patients with 0 risk factors was 13%, 1 risk factor was 27%, and ≥2 risk factors was 62% (p<0.001). The corresponding 5-year rates of death from endometrial cancer were 11%, 20%, and 56%, respectively (p<0.001). CONCLUSIONS: Stratification of stage III endometrial cancer according to high-grade histology, positive peritoneal cytology, and deep myometrial invasion is useful for prognostication and may grant insight into the optimal treatment for specific subgroups of patients.

Feasibility and perioperative outcomes of robotic-assisted surgery in the management of recurrent ovarian cancer: a multi-institutional study.

OBJECTIVES: Minimally invasive surgery for recurrent ovarian cancer is generally not performed. The aim of this study was to assess the feasibility and surgical outcomes of robotic-assisted surgery in the management of recurrent ovarian cancer. METHODS: Eligible patients included those with confirmed recurrent ovarian cancer amenable to surgical resection and in which a complete resection was thought to be feasible with the use of the robotic platform. Patients with evidence of carcinomatosis were not considered for a robotic approach. Clinical and pathologic data were abstracted from the medical records. Appropriate statistical tests were performed using SPSS statistical software program (SPSS 20.0 Inc., Chicago, IL). RESULTS: A total of 48 patients were identified. Thirty-six (75%) patients had a recurrent mass or masses isolated to one anatomic region (pelvis or abdomen). Conversion to laparotomy was necessary in 4 (8.3%) cases. In cases not requiring conversion to laparotomy, the median operative time, EBL, and length of stay were 179.5 min, 50 cc, and 1 day, respectively. An optimal debulking was achieved in 36 (82%) cases. Complications occurred in 6 (13.6%) cases. The median operative time, EBL, length of stay, and complications were all statistically significantly lower in the cases not converted to laparotomy compared to those that were (p<0.001). CONCLUSIONS: This study suggests that select patients with recurrent ovarian cancer in the absence of carcinomatosis may be candidates for secondary surgical cytoreduction via a robotic approach. Surgical and postoperative outcomes appear to be favorable compared to reports of laparotomy in recurrent ovarian cancer.

The feasibility and safety of same-day discharge after robotic-assisted hysterectomy alone or with other procedures for benign and malignant indications.

OBJECTIVE: This study aimed to report the feasibility and safety of same-day discharge after robotic-assisted hysterectomy. METHODS: Same-day discharge after robotic-assisted hysterectomy was initiated 07/2010. All cases from then through 12/2012 were captured for quality assessment monitoring. The distance from the hospital to patients' homes was determined using http://maps.google.com. Procedures were categorized as simple (TLH+/-BSO) or complex (TLH+/-BSO with sentinel node mapping, pelvic and/or aortic nodal dissection, appendectomy, or omentectomy). Urgent care center (UCC) visits and readmissions within 30days of surgery were captured, and time to the visit was determined from the initial surgical date. RESULTS: Same-day discharge was planned in 200 cases. Median age was 52years (range, 30-78), BMI was 26.8kg/m(2) (range, 17.4-56.8), and ASA was class 2 (range, 1-3). Median distance traveled was 31.5miles (range, 0.2-149). Procedures were simple in 109 (55%) and complex in 91 (45%) cases. The indication for surgery was: endometrial cancer (n=82; 41%), ovarian cancer (n=5; 2.5%), cervical cancer (n=8; 4%), and non-gynecologic cancer/benign (n=105; 53%). One hundred fifty-seven (78%) had successful same-day discharge. Median time for discharge for these cases was 4.8h (range, 2.4-10.3). Operative time, case ending before 6pm, and use of intraoperative ketorolac were associated with successful same-day discharge. UCC visits occurred in 8/157 (5.1%) same-day discharge cases compared to 5/43 (11.6%) requiring admission (P=.08). Readmission was necessary in 4/157 (2.5%) same-day discharge cases compared to 3/43 (7.0%) requiring admission (P=.02). CONCLUSIONS: Same-day discharge after robotic-assisted hysterectomy for benign and malignant conditions is feasible and safe.