Determination of quality of life-related health utilities for surgical complications in ovarian cancer.

OBJECTIVE: To assess the health state utilities of ovarian cancer patients, clinicians, and non-cancer controls regarding surgical complications in ovarian cancer. METHODS: Utilities for 14 surgical complications were assessed from patients with recently diagnosed or recurrent ovarian cancer, clinicians, and non-cancer controls using the visual analog scale (VAS) and time trade-off (TTO) methods. Health state utilities were converted to a 0-to-1 scale, where 0 represents the least favorable outcome and 1 represents the most favorable outcome. RESULTS: Fifty patients, 50 clinicians, and 50 controls participated. Median VAS scores were lower than TTO scores across all groups (p < 0.01). Patients viewed 'bleeding requiring transfusion' most favorably (VAS utility 0.75), followed in order by less favorable utility scores for hernia, thromboembolism, pleural effusion, abscess, ileus/bowel obstruction, wound infection, bowel obstruction requiring surgery, anastomotic leak requiring drain, temporary ostomy, anastomotic leak requiring surgery, genito-urinary fistula, permanent ostomy, and genito-intestinal fistula (VAS utility 0.2). Overall, clinicians perceived complications more favorably than patients by VAS (overall utility score 0.49 vs 0.43, p < 0.01), but not by the TTO. There were no differences in overall utility scores between patients and controls. Patients who had not experienced certain surgical complications had less favorable scores than patients who did (utility score for ostomy = 0.2 for patients without ostomy vs. 0.7 for patients with ostomy, p = 0.02). CONCLUSIONS: This study establishes health state utilities for surgical complications associated with ovarian cancer. These utilities can be used in future cost-effectiveness evaluations to determine quality-adjusted outcomes and may help in counseling patients during the shared decision-making process.

Peripheral nerve development in zebrafish requires muscle patterning by tcf15/paraxis.

The vertebrate peripheral nervous system (PNS) is an intricate network that conveys sensory and motor information throughout the body. During development, extracellular cues direct the migration of axons and glia through peripheral tissues. Currently, the suite of molecules that govern PNS axon-glial patterning is incompletely understood. To elucidate factors that are critical for peripheral nerve development, we characterized the novel zebrafish mutant, stl159, that exhibits abnormalities in PNS patterning. In these mutants, motor and sensory nerves that develop adjacent to axial muscle fail to extend normally, and neuromasts in the posterior lateral line system, as well as neural crest-derived melanocytes, are incorrectly positioned. The stl159 genetic lesion lies in the basic helix-loop-helix (bHLH) transcription factor tcf15, which has been previously implicated in proper development of axial muscles. We find that targeted loss of tcf15 via CRISPR-Cas9 genome editing results in the PNS patterning abnormalities observed in stl159 mutants. Because tcf15 is expressed in developing muscle prior to nerve extension, rather than in neurons or glia, we predict that tcf15 non-cell-autonomously promotes peripheral nerve patterning in zebrafish through regulation of extracellular patterning cues. Our work underscores the importance of muscle-derived factors in PNS development.

National trends in bowel and upper abdominal procedures in ovarian cancer surgery.

OBJECTIVES: In the United States, trends in the initial treatment approach for ovarian cancer reflect a shift in paradigm toward the increased use of neoadjuvant chemotherapy and interval cytoreductive surgery. The aim of this study was to evaluate the trends in surgical cytoreductive procedures in ovarian cancer patients who underwent either primary or interval cytoreductive surgery. METHODS: This retrospective, population-based study examined patients with stage III/IV ovarian cancer diagnosed between January 2000 and December 2013 identified using SEER-Medicare. Small or large bowel resection, ostomy creation, and upper abdominal procedures were identified using relevant billing codes and compared over time. A 1:1 primary and interval cytoreductive propensity matched cohort was created using demographic and clinical variables. 30-day complications and the use of acute care services were compared. RESULTS: A total of 5417 women were identified. 34% underwent bowel resections, 16% ostomy creation, and 8% upper abdominal procedures. There was an increase in bowel resections and upper abdominal procedures from 2000 to 2013 in patients who underwent primary cytoreductive surgery. Compared with patients who received primary cytoreduction, patients who underwent interval cytoreductive surgery were less likely to undergo bowel resection (OR=0.50; 95% CI [0.41, 0.61]) or ostomy creation (OR=0.48; 95% CI [0.42, 0.56]). Upper abdominal procedures did not differ between groups. For patients who underwent primary cytoreductive surgery, these procedures were associated with intensive care unit stay (4.6% vs <2%, P<0.01). In both primary and interval cytoreductive surgery patients, the receipt of bowel and upper abdominal procedures was associated with multiple 30-day postoperative complications and higher rates of readmission and emergency room visits. CONCLUSIONS: The performance of upper abdominal procedures in ovarian cancer patients increased from 2000 to 2013. Interval cytoreductive surgery was associated with decreased likelihood of bowel surgery. In matched primary and interval cytoreductive surgery cohorts, the receipt of these procedures were associated with the increased likelihood of postoperative complications and use of acute care services.

National patterns of care and fertility outcomes for reproductive-aged women with endometrial cancer or atypical hyperplasia.

BACKGROUND: Although it is uncommon, the incidence of endometrial cancer and atypical hyperplasia among reproductive-aged women is increasing. The fertility outcomes in this population are not well described. OBJECTIVE: We aim to describe the patterns of care and fertility outcomes of reproductive-aged women with endometrial cancer or atypical hyperplasia. MATERIALS AND METHODS: A cohort of women aged ≤45 years with endometrial cancer or atypical hyperplasia diagnosed in 2000 to 2014 were identified in Truven Marketscan, an insurance claims database of commercially insured patients in the United States. Treatment information, including use of progestin therapy, hysterectomy, and assisted fertility services, was identified and collected using a combination of Common Procedural Terminology codes, International Statistical Classification of Diseases and Related Health Problems codes, and National Drug Codes. Pregnancy events were identified from claims data using a similar technique. Patients were categorized as receiving progestin therapy alone, progestin therapy followed by hysterectomy, or standard surgical management with hysterectomy alone. Multivariable logistic regression was performed to assess factors associated with receiving fertility-sparing treatment. RESULTS: A total of 4007 reproductive-aged patients diagnosed with endometrial cancer or atypical hyperplasia were identified. The majority of these patients (n = 3189; 79.6%) received standard surgical management. Of the 818 patients treated initially with progestins, 397 (48.5%) subsequently underwent hysterectomy, whereas 421 (51.5%) did not. Patients treated with progestin therapy had a lower median age than those who received standard surgical management (median age, 36 vs 41 years; P < .001). The proportion of patients receiving progestin therapy increased significantly over the observation period, with 24.9% treated at least initially with progestin therapy in 2014 (P < .001). Multivariable analysis shows that younger age, a diagnosis of atypical hyperplasia diagnosis rather than endometrial cancer, and diagnosis later in the study period were all associated with a greater likelihood of receiving progestin therapy (P < .0001). Among the 421 patients who received progestin therapy alone, 92 patients (21.8%; 92/421) had 131 pregnancies, including 49 live births for a live birth rate of 11.6%. Among the 397 patients treated with progestin therapy followed by hysterectomy, 25 patients (6.3%; 25/397) had 34 pregnancies with 13 live births. The median age of patients who experienced a live birth following diagnosis during the study period was 36 years (interquartile range, 33-38). The use of some form of assisted fertility services was observed in 15.5% patients who were treated with progestin therapy. Among patients who experienced any pregnancy event following diagnosis, 54% of patients used some form of fertility treatment. For patients who experienced a live birth following diagnosis, 50% of patients received fertility treatment. Median time to live birth following diagnosis was 756 days (interquartile range, 525-1077). Patients treated with progestin therapy were more likely to experience a live birth if they had used assisted fertility services (odds ratio, 5.9; 95% confidence interval, 3.4-10.1; P < .0001). CONCLUSION: The number of patients who received fertility-sparing treatment for endometrial cancer or atypical hyperplasia increased over time. However, the proportion of women who experience a live birth following these diagnoses is relatively small.

Total and out-of-pocket costs of different primary management strategies in ovarian cancer.

BACKGROUND: Communicating healthcare costs to patients is an important component of delivering high-quality value-based care, yet cost data are lacking. This is especially relevant for ovarian cancer, where no clinical consensus on optimal first-line treatment exists. OBJECTIVE: The objective of this study was to generate cost estimates of different primary management strategies in ovarian cancer. STUDY DESIGN: All women who underwent treatment for ovarian cancer from 2006-2015 were identified from the MarketScan database (n=12,761) in this observational cohort study. Total and out-of-pocket costs were calculated with the use of all claims within 8 months from initial treatment and normalized to 2017 US dollars. The generalized linear model method was used to assess cost by strategy. RESULTS: Among patients who underwent neoadjuvant chemotherapy and those who underwent primary debulking, mean adjusted total costs were $113,660 and $107,153 (P<.001) and mean out-of-pocket costs were $2519 and $2977 (P<.001), respectively. Total costs for patients who had intravenous standard, intravenous dose-dense, and intraperitoneal/intravenous chemotherapy were $105,047, $115,099, and $121,761 (P<.001); and out-of-pocket costs were $2838, $3405, and $2888 (P<.001), respectively. Total costs for regimens that included bevacizumab were higher than those without it ($171,468 vs $104,482; P<.001); out-of-pocket costs were $3127 vs $2898 (P<.001). Among patients who did not receive bevacizumab, 25% paid ≥$3875, and 10% paid ≥$6265. For patients who received bevacizumab, 25% paid ≥$4480, and 10% paid ≥$6635. Among patients enrolled in high-deductible health plans, median out-of-pocket costs were $4196, with 25% paying ≥$6680 and 10% paying ≥$9751. CONCLUSION: Costs vary across different treatment strategies, and patients bear a significant out-of-pocket burden, especially those enrolled in high-deductible health plans.

National trends, outcomes, and costs of radiation therapy in the management of low- and high-intermediate risk endometrial cancer.

OBJECTIVE: To assess treatment patterns, outcomes, and costs for women with low-(LIR) and high-intermediate risk endometrial cancer (HIR) who are treated with and without adjuvant radiotherapy. METHODS: All patients with stage I endometrioid endometrial cancer who underwent surgery from 2000 to 2011 were identified from the SEER-Medicare database. LIR was defined as G1-2 tumors with <50% myometrial invasion or G3 with no invasion. HIR was defined as G1-2 tumors with ≥50% or G3 with <50% invasion. Patients were categorized according to whether they received adjuvant radiotherapy (vaginal brachytherapy [VBT], external beam radiotherapy [EBRT], or both) or no radiotherapy. Outcomes were analyzed and compared (primary outcome was overall survival). RESULTS: 10,842 patients met inclusion criteria. In the LIR group (n = 7609), there was no difference in 10-year overall survival between patients who received radiotherapy and those who did not (67% vs 65%, adjusted HR 0.95, 95% CI 0.81-1.11). In the HIR group (n = 3233), patients who underwent radiotherapy had a significant increase in survival (60% vs 47%, aHR 0.75, 95% CI 0.67-0.85). Radiotherapy was associated with increased costs compared to surgery alone ($26,585 vs $16,712, p < .001). Costs for patients receiving VBT, EBRT, and concurrent VBT/EBRT were $24,044, $27,512, and $31,564, respectively (p < .001). Radiotherapy was associated with an increased risk of gastrointestinal (7 vs 4%), genitourinary (2 vs 1%), and hematologic (16 vs 12%) complications (p < .001). CONCLUSIONS: Radiotherapy was associated with improved survival in women with HIR, but not in LIR. It also had increased costs and a higher morbidity risk. Consideration of observation without radiotherapy in LIR may be reasonable.

Neoadjuvant chemotherapy in elderly women with ovarian cancer: Rates of use and effectiveness.

BACKGROUND: Neoadjuvant chemotherapy (NACT) may reduce perioperative morbidity in women undergoing primary treatment for ovarian cancer. We evaluated patterns of use and outcomes in a population-based cohort of elderly women with ovarian cancer (OC). METHODS: A cohort of patients ≥66 years old diagnosed between 2000 and 2013 with stage III-IV epithelial OC who received surgery and platinum/taxane chemotherapy for primary treatment was identified from the SEER-Medicare database. Propensity-score matching methods were used to examine differences in outcomes. Kaplan-Meier analysis was performed to compare overall survival (OS) in the matched cohort. RESULTS: From 2000 to 2013, 22.5% of older women received NACT. The use of NACT increased over time from 16% in 2000 to 35.4% in 2013 (p < .0001). Among women who received PCS, the rate of ostomy creation was higher compared with NACT (23.3% vs. 10.8%, p < .0001). Infectious and other surgical complications were higher among those who had PCS, regardless of stage. Median OS of women III ovarian cancer who underwent PCS was longer compared with NACT (38.8 vs. 28 months, p ≤ .0001). There were no survival differences between NACT and PCS in women with stage IV disease (29.4 vs. 29.8 months, p = .61) or for women aged >80. CONCLUSION: Careful consideration should be given to older patients prior to undergoing PCS. Survival outcomes were similar for patients with stage IV disease, although NACT was associated with decreased perioperative morbidity compared with PCS. Among women with stage III disease, PCS was associated with improved overall survival, but higher rates of perioperative morbidity and acute care.

Three Lymphadenectomy Strategies in Low-Risk Endometrial Carcinoma: A Cost-Effectiveness Analysis.

OBJECTIVE: To evaluate the cost-utility of three lymphadenectomy strategies in the management of low-risk endometrial carcinoma. METHODS: A decision analysis model compared three lymphadenectomy strategies in women undergoing minimally invasive surgery for low-risk endometrial carcinoma: 1) routine lymphadenectomy in all patients, 2) selective lymphadenectomy based on intraoperative frozen section criteria, and 3) sentinel lymph node mapping. Costs and outcomes were obtained from published literature and Medicare reimbursement rates. Costs categories consisted of hospital, physician, operating room, pathology, and lymphedema treatment. Effectiveness was defined as 3-year disease-specific survival adjusted for the effect of lymphedema (utility=0.8) on quality of life. A cost-utility analysis was performed comparing the different strategies. Multiple deterministic sensitivity analyses were done. RESULTS: In the base-case scenario, routine lymphadenectomy had a cost of $18,041 and an effectiveness of 2.79 quality-adjusted life-years (QALYs). Selective lymphadenectomy had a cost of $17,036 and an effectiveness of 2.81 QALYs, whereas sentinel lymph node mapping had a cost of $16,401 and an effectiveness of 2.87 QALYs. With a difference of $1,005 and 0.02 QALYs, selective lymphadenectomy was both less costly and more effective than routine lymphadenectomy, dominating it. However, with the lowest cost and highest effectiveness, sentinel lymph node mapping dominated the other modalities and was the most cost-effective strategy. These findings were robust to multiple sensitivity analyses varying the rates of lymphedema and lymphadenectomy, surgical approach (open or minimally invasive surgery), lymphedema utility, and costs. For the estimated 40,000 women undergoing surgery for low-risk endometrial carcinoma each year in the United States, the annual cost of routine lymphadenectomy, selective lymphadenectomy, and sentinel lymph node mapping would be $722 million, $681 million, and $656 million, respectively. CONCLUSION: Compared with routine and selective lymphadenectomy, sentinel lymph node mapping had the lowest costs and highest quality-adjusted survival, making it the most cost-effective strategy in the management of low-risk endometrial carcinoma.

Treatment Patterns, Outcomes, and Costs for Bowel Obstruction in Ovarian Cancer.

OBJECTIVE: The aim of this study was to assess treatment patterns, outcomes, and costs for bowel obstruction in ovarian cancer. METHODS/MATERIALS: All patients with stage II to IV ovarian cancer who were admitted for bowel obstruction greater than or equal to 6 months after cancer diagnosis from 2000 to 2011 were identified from the Surveillance, Epidemiology, and End Results registry-Medicare database. Management strategies and outcomes of bowel obstruction were compared. RESULTS: Among 1397 women with bowel obstruction, 562 (40%) underwent surgery, and 154 (11%) had a gastrostomy or jejunostomy (G/J) tube placed. Thirty-four percent of patients who underwent surgery subsequently received chemotherapy, compared with 8% of those managed with a G/J tube (odds ratio, 4.8; 95% confidence interval [CI], 2.7-8.8). Thirty-day complications were higher for patients in the surgery group compared with those in the tube group (69% vs 46%; odds ratio, 2.5; 95% CI, 1.8-3.7), as were mean adjusted 30-day total costs ($28,872 vs $18,528, P < 0.001). Median survival was greater for women who underwent surgery compared with those who had a G/J tube (5.3 vs 1.2 months; adjusted hazard ratio, 0.31; 95% CI, 0.25-0.38). The median survival of patients in whom surgical correction failed and required G/J tube placement during the same inpatient admission was 2.6 months. Women who received postintervention chemotherapy had improved survival compared with those who did not in both the surgery (17.0 vs 2.8 months, P < 0.001) and G/J tube (5.7 vs 1.0 months, P < 0.001) groups. CONCLUSIONS: In women with ovarian cancer who develop bowel obstruction, surgery may benefit a subset of patients, likely related to the ability to receive subsequent chemotherapy. Efforts to identify those who derive no benefit may reduce unnecessary laparotomy, along with its associated complications and costs. Given this population's limited survival, patient preferences should be evaluated in future studies assessing the management of bowel obstruction.

A multicenter assessment of the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease at primary debulking for advanced epithelial ovarian cancer.

OBJECTIVE: To assess the ability of preoperative computed tomography scan and CA-125 to predict gross residual disease (RD) at primary cytoreduction in advanced ovarian cancer. METHODS: A prospective, non-randomized, multicenter trial of patients who underwent primary debulking for stage III-IV epithelial ovarian cancer previously identified 9 criteria associated with suboptimal (>1cm residual) cytoreduction. This is a secondary post-hoc analysis looking at the ability to predict any RD. Four clinical and 18 radiologic criteria were assessed, and a multivariate model predictive of RD was developed. RESULTS: From 7/2001-12/2012, 350 patients met eligibility criteria. The complete gross resection rate was 33%. On multivariate analysis, 3 clinical and 8 radiologic criteria were significantly associated with the presence of any RD: age≥60years (OR=1.5); CA-125≥600U/mL (OR=1.3); ASA 3-4 (OR=1.6); lesions in the root of the superior mesenteric artery (OR=4.1), splenic hilum/ligaments (OR=1.4), lesser sac >1cm (OR=2.2), gastrohepatic ligament/porta hepatis (OR=1.4), gallbladder fossa/intersegmental fissure (OR=2); suprarenal retroperitoneal lymph nodes (OR=1.3); small bowel adhesions/thickening (OR=1.1); and moderate-severe ascites (OR=2.2). All ORs were significant with p<0.01. A 'predictive score' was assigned to each criterion based on its multivariate OR, and the rate of having any RD for patients who had a total score of 0-2, 3-5, 6-8, and ≥9 was 45%, 68%, 87%, and 96%, respectively. CONCLUSIONS: We identified 11 criteria associated with RD, and developed a predictive model in which the rate of having any RD was directly proportional to a predictive score. This model may be helpful in treatment planning.

Impact of body mass index and operative approach on surgical morbidity and costs in women with endometrial carcinoma and hyperplasia.

OBJECTIVE: To assess the impact of body mass index (BMI) and operative approach on surgical morbidity and costs in patients with endometrial carcinoma (EC) and hyperplasia (EH). METHODS: All women with BMI data who underwent surgery for EC or EH from 2008 to 2014 were identified from MarketScan, a healthcare claims database. Differences in 30-day complications and costs were compared between BMI groups and stratified by surgical modality. RESULTS: Of 1112 patients, 35%, 36%, and 29% had a BMI of ≤29, 30-39, and ≥40kg/m2, respectively. Compared to patients with a BMI of 30-39 and ≤29, women with a BMI ≥40 had higher rates of venous thromboembolism (3% vs 0.2% vs 0.3%, p<0.01) and wound infection (7% vs 3% vs 3%, p=0.02). This increase was driven by the subset of patients who had laparotomy and was not seen in those undergoing minimally invasive surgery (MIS). Median total costs for women with a BMI ≥40, 30-39, and ≤29 were U.S. $17.3k, $16.8k, and $16.6k respectively (p=0.53). Costs were higher for patients who had laparotomy than those who had MIS across all BMI groups, with the cost difference being highest in morbidly obese women (≥40: $21.6k vs $14.9k, p<0.01; 30-39: $18.9k vs $16.1k, p=0.01; ≤29: $19.3k vs $15k, p<0.01). Patients who had complications had higher costs compared to those who did not, with a higher cost difference in the laparotomy group ($27.7k vs $16.4k, p<0.01) compared to the MIS group ($19.9k vs $15k, p<0.01). CONCLUSIONS: MIS may increase the value of care by minimizing complications and decreasing costs. This may be most pronounced in morbidly obese women.

Electronic patient-reported outcomes from home in patients recovering from major gynecologic cancer surgery: A prospective study measuring symptoms and health-related quality of life.

PURPOSE: We previously reported on the feasibility of a Web-based system to capture patient-reported outcomes (PROs) in the immediate postoperative period. The purpose of this study was to update the experience of these patients and assess patient and provider satisfaction and feedback regarding the system. METHODS: This is a prospective cohort study of patients scheduled to undergo laparotomy for presumed gynecologic malignancy. Patients completed a Web-based Symptom Tracking and Reporting (STAR) questionnaire preoperatively and weekly during a 6-week postoperative period. Email alerts were sent to study nurses when concerning patient responses were entered. The patient and the nurse assessments of STAR's usefulness were measured via an exit survey. RESULTS: The study enrolled 96 eligible patients. Of these, 71 patients (74%) completed at least four of seven total sessions. Of the patients who completed the exit satisfaction survey, 98% found STAR easy to use; 84% found it useful; and 82% would recommend it to other patients. Despite positive feedback from patients, clinical personnel found that the STAR system increased their current workload without enhancing patient care. CONCLUSIONS: Application of an electronic program for PROs in those recovering from major gynecologic cancer surgery is feasible, and acceptable to most patients. While most clinicians did not find STAR clinically helpful, the majority of patients reported a positive experience with the system and would recommend its use. The program helped many patients feel more empowered in their postoperative recovery.

Diverting ileostomy during primary debulking surgery for ovarian cancer: Associated factors and postoperative outcomes.

OBJECTIVE: To examine the use, as well as postoperative and long-term oncologic outcomes of diverting loop ileostomy (DI) during primary debulking surgery (PDS) for ovarian cancer. METHODS: Patients with stage II-IV ovarian, fallopian tube, or primary peritoneal carcinoma who underwent colon resection during PDS from 1/2005-1/2014 were identified. Demographic and clinical data were analyzed. RESULTS: Of 331 patients, 320 (97%) had stage III/IV disease and 278 (84%) had disease of high-grade serous histology. Forty-four (13%) underwent a DI. There were no significant differences in age, comorbidity index, smoking status, serum albumin, or attending surgeon between the DI and non-DI groups. Operative time (OR=1.21; 95% CI, 1.03-1.42; p=0.02) and length of rectosigmoid resection (OR=1.04; 95% CI, 1.01-1.08; p=0.02) were predictors of DI on multivariable analysis. The overall anastomotic leak rate was 6%. A comparison of groups (DI vs non-DI) showed no significant differences in major complications (30% vs 23%; p=0.41), anastomotic leak rate (5% vs 7%; p=0.60), hospital length of stay (10 vs 9days; p=0.25), readmission rate (23% vs 17%; p=0.33), or interval to postoperative chemotherapy (41 vs 40days; p=0.20), respectively. Ileostomy reversal was successful in 89% of patients. Median follow-up was 52.6months. There were no differences in median progression-free (17.9 vs 18.6months; p=0.88) and overall survival (48.7 vs 63.8months; p=0.25) between the groups. CONCLUSIONS: In patients undergoing PDS, those with longer operative time and greater length of rectosigmoid resection more commonly underwent DI. DI does not appear to compromise postoperative outcomes or long-term survival.

Predictive value of the Age-Adjusted Charlson Comorbidity Index on perioperative complications and survival in patients undergoing primary debulking surgery for advanced epithelial ovarian cancer.

OBJECTIVE: To assess the ability of the Age-Adjusted Charlson Comorbidity Index (ACCI) to predict perioperative complications and survival in patients undergoing primary debulking for advanced epithelial ovarian cancer (EOC). METHODS: Data were analyzed for all patients with stage IIIB-IV EOC who underwent primary cytoreduction from 1/2001-1/2010 at our institution. Patients were divided into 3 groups based on an ACCI of 0-1, 2-3, and ≥4. Clinical and survival outcomes were assessed and compared. RESULTS: We identified 567 patients; 199 (35%) had an ACCI of 0-1, 271 (48%) had an ACCI of 2-3, and 97 (17%) had an ACCI of ≥4. The ACCI was significantly associated with the rate of complete gross resection (0-1=44%, 2-3=32%, and ≥4=32%; p=0.02), but was not associated with the rate of minor (47% vs 47% vs 43%, p=0.84) or major (18% vs 19% vs 16%, p=0.8) complications. The ACCI was also significantly associated with progression-free (PFS) and overall survival (OS). Median PFS for patients with an ACCI of 0-1, 2-3, and ≥4 was 20.3, 16, and 15.4 months, respectively (p=0.02). Median OS for patients with an ACCI of 0-1, 2-3, and ≥4 was 65.3, 49.9, and 42.3 months, respectively (p<0.001). On multivariate analysis, the ACCI remained a significant prognostic factor for both PFS (p=0.02) and OS (p<0.001). CONCLUSIONS: The ACCI was not associated with perioperative complications in patients undergoing primary cytoreduction for advanced EOC, but was a significant predictor of PFS and OS. Prospective clinical trials in ovarian cancer should consider stratifying for an age-comorbidity covariate.

Ovarian vein thrombosis after debulking surgery for ovarian cancer: epidemiology and clinical significance.

OBJECTIVE: Ovarian vein thrombosis is associated with pregnancy and pelvic surgery. Postpartum ovarian vein thrombosis is associated with infection and a high morbidity rate and is treated with anticoagulant and intravenous antibiotic therapy. The natural history of such thrombotic events after debulking surgery for ovarian cancer has not been well described. Our objective was to characterize the presentation and outcomes for patients with this condition at our institution. STUDY DESIGN: We conducted a retrospective study of patients who underwent surgical debulking for ovarian cancer at Memorial Sloan Kettering Cancer Center between the years 2001 and 2010. Patients were included if contrast computed tomography scans of both the abdomen and pelvis were performed within 12 weeks before and 12 weeks after the surgery. The images were reviewed to assess for the presence and extent of a new postoperative ovarian vein thrombosis. When available, subsequent studies were assessed for thrombus progression. Medical records were reviewed to determine whether anticoagulation was used for treatment of the thrombotic episode and to record the occurrence of any new significant venous thromboembolic event in the next year. RESULTS: One hundred fifty-nine patients had satisfactory imaging. New ovarian vein thrombosis was a common complication of debulking surgery, as found in 41 of patients (25.8%). Only 5 women with ovarian vein thrombosis were started on anticoagulation, of which 2 individuals had an independent venous thromboembolic event as indication for treatment. Only 2 of the ovarian vein thromboses (4.9%) progressed to the inferior vena cava or left renal vein on subsequent scan. The estimated cumulative incidence of venous thromboembolism 1 year after the first postoperative scan was 17.1% for patients in the new ovarian vein thrombosis group vs 15.3% of individuals for the group without a postoperative ovarian vein thrombosis (P = .78). CONCLUSION: Ovarian vein thrombosis is commonly encountered after debulking surgery for ovarian cancer. Anticoagulation is usually not indicated, and clinically meaningful thrombus progression rarely occurs.

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.

Primary debulking surgery for metastatic cervical adenocarcinoma: A case report.

•The case presented is that of a primary debulking surgery for presumed ovarian cancer.•Final pathology revealed diffusely metastatic endocervical adenocarcinoma.•After primary chemotherapy, the patient has remained disease-free 30 months after surgery.

Labor outcomes of obese patients undergoing induction of labor with misoprostol compared to dinoprostone.

OBJECTIVE: The aim of the article is to evaluate and compare labor outcomes in obese patients undergoing induction of labor (IOL) with misoprostol and dinoprostone. STUDY DESIGN: This was a retrospective review of patients who delivered from February 1, 2008, to July 1, 2013 at our institution. All obese women who underwent IOL were identified. The rates of successful cervical ripening and cesarean delivery (CD) for patients who underwent IOL with misoprostol and dinoprostone were calculated and compared. RESULTS: A total of 564 women met inclusion criteria; 297 (52.7%) were induced with misoprostol, and 267 (47.3%) were induced with dinoprostone. The misoprostol group had a higher successful cervical ripening rate (78.1 vs. 66.7%; odds ratio [OR], 1.79; 95% confidence interval [CI], 1.23-2.6; p = 0.002) and a lower CD rate (39.1 vs. 51.3%; OR, 0.61; 95% CI, 0.44-0.85; p = 0.003) than the dinoprostone group. This significance persisted in a multivariate model adjusting for parity, gestational age, birth weight, and indication for IOL. The rates of tachysystole, terbutaline use, postpartum hemorrhage, and infectious morbidity were comparable in both groups, as were Apgar scores, rates of neonatal intensive care unit admission, and meconium passage. CONCLUSION: In obese women undergoing IOL, misoprostol leads to a higher successful cervical ripening rate and a lower CD rate than dinoprostone, with a similar rate of peripartum complications and neonatal outcomes.

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.