Primary debulking surgery in advanced stage ovarian cancer is associated with improved survival

Abstracts / Gynecologic Oncology 136 (2015) 394–411

BMI. The median overall survival (OS) was 42.6 months (CI 26.8– 58.3) in women with a BMI N30 and 51.8 months (CI 42.6–60.9) in women with a BMI b30 (P = 0.203). Conclusions: There was no difference in histopathologic features or degree of optimal cytoreduction based on BMI. There was no difference in cycles of IP chemotherapy completed or IP therapy related complications in respect to BMI. This translated into no significant difference in OS between groups. This data suggests that IP chemotherapy is feasible in obese patients without incurring increased morbidity. doi:10.1016/j.ygyno.2014.11.046

Session V: Ovarian Cancer Delay in chemotherapy administration adversely affects overall survival in elderly ovarian cancer patients Naima Joseph, Rachel Clark, Malinda Lee, Don S. Dizon, Whitfield B. Growdon. Massachusetts General Hospital, Harvard University, USA Objectives: Elderly patients with ovarian cancer represent a vulnerable population that frequently demonstrates poor outcomes. In this study, we sought to evaluate the impact of treatment modification (dose delays and reduction) on overall survival in the elderly as well as to characterize treatment patterns in this population and how they relate to overall survival (OS). Methods: In this retrospective cohort study, we identified all patients N65 years with Stage II–IV epithelial ovarian cancer who underwent cytoreduction and chemotherapy at our institution between 2003 and 2011. Clinical variables related to co-morbidities, disease status, chemotherapy administration and complications were extracted. Statistical analyses were performed using logistic regression, Kaplan–Meier curves, and multivariable Cox proportional hazard models. Results: A total of 184 patients were included in the analysis. The average age was 73 years and median ASA class was 2. Seventy-eight percent of the cohort underwent primary cytoreduction and 70% of patients received platinum doublet adjuvant chemotherapy. Forty-seven percent of patients underwent an initial dose reduction, 46% required at least one transfusion, and 39% experienced at least one dose delay. OS was 2.6 years (range, 1.3–6.8 years) in the entire cohort. When modeled as both continuous and binary variables, the need for chemotherapy delay and transfusion was significantly associated with a worsened OS (p = 0.02 and p = 0.05, respectively); further for each chemotherapy cycle delayed, there was worsened overall survival. The most common indication for dose delay was blood transfusion. After adjusting for variables such as age, ASA class, and disease stage, any delay in chemotherapy remained significantly associated with decreased median overall survival (p = 0.029). Conclusions: In this study, elderly patients with ovarian cancer who underwent cytoreduction frequently required both delays in chemotherapy administration and transfusions. Number of dose delays was independently associated with decreased OS. doi:10.1016/j.ygyno.2014.11.047

Session V: Ovarian Cancer Clinical characteristics and outcomes of patients with stage I epithelial ovarian cancer compared to fallopian tube cancer J. Alejandro Rauh-Haina, Olivia W. Foleya, Dina Winograda, Carolina Andradea, Rachel M. Clarka, Roberto J. Vargasa,b, Emily M. Hinchcliffa, b , Katherine M. Esselenb, Neil S. Horowitzb, Marcela G. del Carmena. a Massachusetts General Hospital, Harvard University, USA, bBrigham Women's Hospital, Harvard University, USA

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Objectives: The aim of this study is to compare clinical characteristics and survival between patients with stage I epithelial ovarian cancer (EOC) and stage I fallopian tube cancer (FTC). Methods: We identified all women with stage I EOC and FTC that underwent treatment between 2000 and 2010 at the participant institutions. Correlation between categorical variables was assessed with chi square test. The Kaplan–Meier survival analysis was used to generate overall survival data (OS). Factors predictive of outcome were compared using the log-rank test and Cox proportional hazards model. Results: The final study group consisted of 385 women with EOC and 43 with FTC. Patients with FTC had a higher rate of stage IA disease (65% vs. 48%; P = 0.02) and grade 3 tumors (60.4% vs. 30.9%; P b 0.001) compared to women with EOC. Women with FTC had a higher rate of serous carcinoma and a lower frequency of endometrioid, mucinous, and clear cell carcinomas. Patients with FTC had a significantly higher rate of breast cancer (25.6% vs. 5.7%; P b 0.001). Women with FTC had complete staging (51.2% vs. 29.6%; P = 0.004) and also underwent a restaging procedure more frequently (41.8% vs. 15.8%; P b 0.001). There was no difference in the rates of platinum-based and paclitaxel chemotherapy between the groups. However, women with FTC received six or more cycles of chemotherapy more frequently (58.1% vs. 44.1%; P = 0.02). The 5-year disease-free survival (DFS) rates were 100% in women with FTC and 93% in patients with EOC (P = 0.04). The 5-year OS rates were 100% and 95% for patients with FTC and EOC, respectively (P = 0.7). Conclusion: In this comparison of early-stage FTC and EOC, we found a higher rate of stage IA, grade 3, and serous carcinoma in FTC patients. Women with FTC had a higher rate of breast cancer. There was no difference in OS between the groups. doi:10.1016/j.ygyno.2014.11.048

Session V: Ovarian Cancer Primary debulking surgery in advanced stage ovarian cancer is associated with improved survival Rachel M. Clark, Joel T. Clemmer, Alexander Melamed, Jose A. RauhHain, David Boruta, Marcela del Carmen, Anne Kathryn Goodman, Whitfield B. Growdon, Tracilyn Hall, John O. Schorge. Massachusetts General Hospital, Harvard University, USA Objectives: The timing of surgical cytoreduction for advanced epithelial ovarian cancer (EOC) is controversial. At our institution, we advocate an aggressive posture favoring primary debulking surgery (PDS). The purpose of this study was to determine the clinical outcomes of this approach in patients with advanced EOC. Methods: We identified all patients with stage IIIC or IV EOC who underwent debulking at our institution between 2000 and 2009. The decision to perform PDS versus neoadjuvant chemotherapy/interval debulking surgery (IDS) was based on physician discretion. Residual disease was stratified into three categories: suboptimal (N1 cm), optimal (≤1 cm) and no residual disease (NRD). Chemotherapy was platinum based and reflected standard protocols. A retrospective chart review was performed and clinical variables were extracted. Appropriate statistics were performed. Results: A total of 492 women were included. Eighty percent of patients (n = 393) underwent PDS; the remaining 20% (n = 99) had IDS. Of patients undergoing PDS, 79.4% were optimally cytoreduced and 32.1% were debulked to NRD. In the IDS cohort, 89.9% were optimally cytoreduced with 51.5% of patients debulked to NRD (p = 0.002). Patients who underwent PDS had higher surgical radicality scores than those undergoing IDS (p b 0.001), but a similar number of perioperative complications (p = 0.33). Regardless of group, cytoreduction to NRD decreased risk for death (HR 0.56, 0.41–0.77) in reference to suboptimal debulking. Median overall survival was significantly better for patients

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Abstracts / Gynecologic Oncology 136 (2015) 394–411

that had PDS compared to IDS and were cytoreduced to NRD (69.6 months vs 35.4 months, p b 0.0001). Even when controlling for age, stage, and other covariates, PDS demonstrated a survival advantage over IDS with a HR of 0.69 (0.51–0.91). Conclusions: In a high volume center, PDS for advanced EOC is feasible and safe for the majority of patients. Patients who are resected to NRD have a lower risk of dying from their cancer. Furthermore, patients who are NRD after PDS have almost double the median survival of those undergoing NACT/IDS, even when controlling for age and stage. doi:10.1016/j.ygyno.2014.11.049

Session V: Ovarian Cancer Predictive factors for the presence of malignant transformation of pelvic endometriosis Y. Kadan, S. Fiascone, C. McCourt, C. Raker, C.O. Granai, M. Steinhoff, R.G. Moore. Program in Women's Oncology, Women and Infants Hospital, Brown University, USA Objectives: Endometriomas pose a diagnostic and management dilemma for asymptomatic patients. While the majority of endometriomas never undergo malignant transformation, the elevated risk of ovarian cancer is well established. However, universal resection of endometriomas may unnecessarily expose women to operative risks. A recent study identified tumor size N9 cm, postmenopausal status, and age N45 years as independent risk factors for the presence of ovarian cancer. The development of a risk stratification system for malignant transformation of endometriomas may help clinicians in deciding which patients to operate on or refer to a gynecologic oncologist. The objective of our study was to use clinical, laboratory, and radiologic findings to determine predictors for the malignant transformation of endometriomas. Methods: Case–control analysis comparing 42 women with ovarian cancer in the background of endometriosis to 96 women with benign endometriomas. All women had a preoperative diagnosis of adnexal mass and no other findings concerning for malignancy. Preoperative data included patient symptoms, CA 125 levels and radiologic findings. Specific data were collected for women who underwent observation before surgery. Results: Women with ovarian cancer were older than women with endometriosis alone (mean 54 vs 39 years, P b 0.0001). Women with cancer were more likely to have weight change and constipation (12% vs 1%; 10% vs 1%). Patients with cancer had higher CA 125 (203 vs 67, P = 0.2) and larger cyst size (12 vs 7 cm, P b 0.0001). 66% of malignant lesions had a solid component compared to 16% of endometriomas (P b 0.0001). Women observed preoperatively had an average increase in tumor size of 3.3 cm in cases vs 1.1 cm in controls (P = 0.02). On multiple logistic regression, every 5 year increase in age had an adjusted OR of 2.4 (P = 0.001). Age N48 had 80% sensitivity and specificity for malignancy, and solid components on imaging had an adjusted OR of 10.4 (P = 0.003). Conclusions: Age N48 and solid components are strong predictors for malignant transformation of endometriomas. These data, in combination with CA 125 level and cyst size, may help with decision-making regarding safety of conservative management, referral to a gynecologic oncologist, and information for patients. doi:10.1016/j.ygyno.2014.11.050

Special Focus Session 2: Surgical Techniques Evaluation of reliability and the predictive value of ICG directed SLN dissection in women with endometrial and cervical cancer Anze Urh, Katina Robison, Christina Raker, Margaret Steinhoff, Paul DiSilvestro, Carolyn McCourt, Cara Mathews, Ashley Stuckey, C.O.

Granai, Richard G. Moore. Women and Infants Hospital, Brown University, USA Objectives: Determining which endometrial cancer patients will benefit from nodal staging is controversial. SLN biopsy can be useful as an adjunct to lymphadenectomy in high risk patients, but more importantly employed as an alternative method of nodal evaluation for patients with low risk tumors. Recently the NCCN guidelines included SLN biopsy as an option for nodal evaluation in women with endometrial cancer. The objective of this study was to evaluate the surgical learning curve and to examine the performance characteristics of SLN dissections. Method: This was an IRB approved observational study examining women who had an isolated ICG SLN dissection or an ICG SLN dissection with a complete lymph node dissection (CND). Women who underwent an ICG SLN dissection from June 1, 2013 to May 14, 2014 were analyzed. Results: A total of 75 patients (70 endometrial and 5 cervical cancer) were identified. The mean age was 63.9 years with 74.6%, (56/75) of the tumors being endometrioid, 5.3% (4/75) serous, 2.7% (2/75) clear cell, other endometrial tumors compromised 10.7% (8/75), and 7.8% (5/75) were SCC of the cervix. There were 61 stage I, 1 stage II, 7 stage III and 1 stage IV patients with endometrial cancer. Detection of bilateral SLN was influenced by a learning curve. In the first 10 cases bilateral SLN was detected in 53.3% (23/43) of cases. For surgeons with N10 cases bilateral SLN was detected in 84.4% (27/32) (p = 0.006). In 27 patients both a SLN and a CND were performed. SLN biopsy achieved a sensitivity of 100% with a false negative rate of 0%. SLN was the only positive nodes in 62.5% (5/8) of the patients whereas both SLN and non-SLN were positive in 25% (2/8). One patient failed to map a SLN and a CND was performed identifying metastatic disease. On the contralateral side a SLN was detected and was negative consistent with the non-SLN from that nodal basin. Isolated microscopic metastasis in the SLN was detected in 37.5% (3/8) of patients. Conclusion: Bilateral SLN detection rate significantly improves after the surgeons' first 10 cases. SLN evaluation accurately reflects the nodal basin status for metastatic disease and can identify micrometastasis that may not have been detected with standard nodal evaluation. SLN dissection should be considered as a part of the nodal evaluation in patients with endometrial and cervical cancer. doi:10.1016/j.ygyno.2014.11.051

Special Focus Session 2: Surgical Techniques Sentinel lymph node mapping predicts metastasis in endometrial cancer Elizabeth M. Emberley, Heidi Godoy, Patrick F. TimminsIII. Albany Medical Center, USA Objectives: Metastatic disease to lymph nodes continues to be the most important factor impacting survival, however there is significant morbidity associated with complete lymphadenectomy. Sentinel lymph node biopsy has been raised as a possible alternative to complete lymphadenectomy, but there is concern that SLN mapping may not identify node positive lymph nodes, thereby causing under-treatment of disease. The aim of our study was to determine the safety of replacing lymphadenectomy with sentinel lymph node biopsy in selected women with apparent uterine-limited endometrial cancer. Methods: This retrospective cohort reviewed the records of 64 women who were diagnosed with uterine-limited endometrial cancer from January 2011 to March 2014 and underwent sentinel lymph node mapping and biopsy, pelvic lymphadenectomy, peritoneal cytology, hysterectomy and bilateral salpingo-oophorectomy and analyzed the