Survival disparities in non-Hispanic Black and White cervical cancer patients vary by histology and are largely explained by modifiable factors.

PURPOSE: We investigated racial disparities in survival by histology in cervical cancer and examined the factors contributing to these disparities. METHODS: Non-Hispanic Black and non-Hispanic White (hereafter known as Black and White) patients with stage I-IV cervical carcinoma diagnosed between 2004 and 2017 in the National Cancer Database were studied. Survival differences were compared using Cox modeling to estimate hazard ratio (HR) or adjusted HR (AHR) and 95% confidence interval (CI). The contribution of demographic, socioeconomic and clinical factors to the Black vs White differences in survival was estimated after applying propensity score weighting in patients with squamous cell carcinoma (SCC) or adenocarcinoma (AC). RESULTS: This study included 10,111 Black and 43,252 White patients with cervical cancer. Black patients had worse survival than White cervical cancer patients (HR = 1.40, 95% CI = 1.35-1.45). Survival disparities between Black and White patients varied significantly by histology (HR = 1.20, 95% CI = 1.15-1.24 for SCC; HR = 2.32, 95% CI = 2.12-2.54 for AC, interaction p < 0.0001). After balancing the selected demographic, socioeconomic and clinical factors, survival in Black vs. White patients was no longer different in those with SCC (AHR = 1.01, 95% CI 0.97-1.06) or AC (AHR = 1.09, 95% CI = 0.96-1.24). In SCC, the largest contributors to survival disparities were neighborhood income and insurance. In AC, age was the most significant contributor followed by neighborhood income, insurance, and stage. Diagnosis of AC (but not SCC) at ≥65 years old was more common in Black vs. White patients (26% vs. 13%, respectively). CONCLUSIONS: Histology matters in survival disparities and diagnosis at ≥65 years old between Black and White cervical cancer patients. These disparities were largely explained by modifiable factors.

Racial, ethnic and country of origin disparities in aggressive endometrial cancer histologic subtypes.

OBJECTIVE: This study investigated the risk of an aggressive endometrial cancer (EC) diagnosis by race, ethnicity, and country of origin to further elucidate histologic disparities in non-Hispanic Black (NHB), Hispanic, Asian/Pacific Islander (API), American Indian/Alaskan Native (AIAN) vs. non-Hispanic White (NHW) patients, particularly in Hispanic or API subgroups. METHODS: Patient diagnosed between 2004 and 2020 with low grade (LG)-endometrioid endometrial cancer (ECC) or an aggressive EC including grade 3 EEC, serous carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or carcinosarcoma in the National Cancer Database were studied. The odds ratio (OR) and 95% confidence interval (CI) for diagnosis of an aggressive EC histology was estimated using logistic modeling. RESULTS: There were 343,868 NHW, 48,897 NHB, 30,013 Hispanic, 15,015 API and 1646 AIAN patients. The OR (95% CI) for an aggressive EC diagnosis was 3.07 (3.01-3.13) for NHB, 1.08 (1.06-1.11) for Hispanic, 1.17 (1.13-1.21) for API and 1.07 (0.96-1.19) for AIAN, relative to NHW patients. Subset analyses by country of origin illustrated the diversity in the OR for an aggressive EC diagnosis among Hispanic (1.18 for Mexican to 1.87 for Dominican), Asian (1.14 Asian Indian-Pakistani to 1.48 Korean) and Pacific Islander (1.00 for Hawaiian to 1.33 for Samoan) descendants. Hispanic, API and AIAN patients were diagnosed 5-years younger that NHW patients, and the risk for an aggressive EC histology were all significantly higher than NHW patients after correcting for age. Insurance status was another independent risk factor for aggressive histology. CONCLUSIONS: Risk of an aggressive EC diagnosis varied by race, ethnicity, and country of origin. NHB patients had the highest risk, followed by Dominican, South/Central American, Cuban, Korean, Thai, Vietnamese, and Filipino descendants.

Sequential Targeted Therapy for Advanced, Metastatic, and Recurrent Cervical Cancer: A Cost-Effectiveness Analysis of the Patient Journey.

OBJECTIVES: To evaluate outcomes and cost-effectiveness of targeted therapy sequencing for metastatic and recurrent cervical cancer. METHOD: Models were simulated based on phase II and III trials on bevacizumab (bev) from GOG-240, cemiplimab (cemi) from GOG 3016, pembrolizumab (pembro) from KEYNOTE-826, and tisotumab vedotin (tiso) from GOG 3023. Costs were based on IBM Micromedex RED BOOK™ and company listed costs. RESULTS: For [chemo + bev → chemo], total cost was $125,918.04, with median overall survival (mOS) of 21.8 months, and cost-effectiveness ratio (CER) of $119,835.79. For [chemo + bev → cemi], total cost was $187,562.99 with mOS of 28.5 months and CER of $162,039.16. For [chemo + bev + pembro → chemo], total cost was $319,963.78 with mOS 32.9 months and CER of $249,930.10. For [chemo + bev + pembro → tiso], total cost was $455,204.45, with mOS 36.5 months and CER of $320,072.99. CONCLUSION: The combination of immunotherapies and biologics have significantly increased overall survival, but with associated higher costs, primarily related to drug costs.

Racial disparities in high-risk uterine cancer histologic subtypes: A United States Cancer Statistics study.

OBJECTIVE: Black women with uterine cancer on average have worse survival outcomes compared to White women, in part due to higher rates of aggressive, non-endometrioid subtypes. However, analyses of incidence trends by specific high-risk subtypes are lacking, including those with hysterectomy and active pregnancy correction. The objective of our study was to evaluate racial disparities in age-adjusted incidence of non-endometrioid uterine cancer in 720,984 patients. METHODS: Data were obtained from United States Cancer Statistics using SEER*Stat. We used the Behavioral Risk Factor Surveillance System to correct for hysterectomy and active pregnancy. Age-adjusted, corrected incidence of uterine cancer from 2001 to 2016 and annual percent change (APC) were calculated using Joinpoint regression. RESULTS: Of 720,984 patients, 560,131 (77.7%) were White, 72,328 (10.0%) were Black, 56,239 (7.8%) were Hispanic, and 22,963 (3.2%) were Asian/Pacific Islander. Age-adjusted incidence of uterine cancer increased from 40.8 (per 100,000) in 2001 to 42.9 in 2016 (APC = 0.5, p < 0.001). Black women had the highest overall incidence at 49.5 (APC = 2.3, p < 0.001). The incidence of non-endometrioid subtypes was higher in Black compared to White women, with the most pronounced differences seen in serous carcinoma (9.1 vs. 3.0), carcinosarcoma (6.1 vs. 1.8), and leiomyosarcoma (1.3 vs. 0.6). In particular, Black women aged 70-74 with serous carcinoma had the highest incidence (61.3) and the highest APC (7.3, p < 0.001). CONCLUSIONS: Black women have a two to four-fold higher incidence of high-risk uterine cancer subtypes, particularly serous carcinoma, carcinosarcoma, and leiomyosarcoma, compared to White women after correcting for hysterectomy and active pregnancy.

Trends in the Utilization of Palliative Care in Patients With Gynecologic Cancer Who Subsequently Died During Hospitalization.

OBJECTIVE: To determine factors associated with the utilization of palliative care (PC) in patients with metastatic gynecologic cancer who died while hospitalized. METHODS: Data were abstracted from the National Inpatient Sample database for patients with cervical, uterine, and ovarian cancers from 2005 to 2011. Chi-squared and logistic regression models were used for statistical analyses. RESULTS: Of 4559 women (median age: 65 years; range: 19-102), 1066 (23.4%) utilized PC. Patients were 24.9% low socioeconomic status (SES), 23.9% low-middle, 23.7% middle-high, and 25.1% high SES. Medicare, Medicaid, and private insurance coverage were listed at 46.2%, 37.5%, 11.3% of patients; 36.2%, 21.1%, 18.1%, 24.6% were treated in the South, West, Midwest, and Northeast. Over the 7 year study period, the use of PC increased from 12% to 45%. Older age (odds ratio [OR]: 1.36; 95% CI: 1.11-1.68; P = .003), high SES (OR: 1.41; 95% CI: 1.12-1.78; P = .003), more recent treatment (OR: 9.22; 95% CI: 6.8-12.51; P < .0001), private insurance (OR: 1.81; 95% CI: 1.46-2.25; P < .001), and treatment at large-volume hospitals (OR: 1.36; 95% CI: 1.04-1.77; P = .02), Western (OR: 2.00; 95% CI: 1.61-2.49; P < .001) and Midwestern hospitals (OR: 1.35; 95% CI: 1.08-1.68; P = .001) were associated with higher utilization of PC. CONCLUSIONS: The use of inpatient PC for patients with gynecologic cancer increased over time. The lower utilization of PC for terminal illness was associated with younger age, lower SES, government-issued insurance coverage, and treatment in Southern and smaller volume hospitals, and warrants further attention.

Racial disparities in uterine and ovarian carcinosarcoma: A population-based analysis of treatment and survival.

OBJECTIVE: To investigate racial disparities in uterine carcinosarcoma (UCS) and ovarian carcinosarcoma (OCS) in Commission on Cancer®-accredited facilities. METHODS: Non-Hispanic Black (NHB) and non-Hispanic White (NHW) women in the National Cancer Database diagnosed with stage I-IV UCS or OCS between 2004 and 2014 were eligible. Differences by disease site or race were compared using Chi-square test and multivariate Cox analysis. RESULTS: There were 2830 NHBs and 7366 NHWs with UCS, and 280 NHBs and 2586 NHWs with OCS. Diagnosis of UCS was more common in NHBs (11.5%) vs. NHWs (3.7%) and increased with age (P < .0001). OCS diagnosis remained <5% in both races and all ages. NHBs with UCS or OCS were more common in the South and more likely to have a comorbidity score ≥ 1, low neighborhood income and Medicaid or no insurance (P < .0001). Diagnosis at stage II-IV was more common in NHBs than NHWs with UCS but not OCS. NHBs with both UCS and OCS were less likely to undergo surgery and to achieve no gross residual disease with surgery (P = .002). Risk of death in NHB vs. NHW patients with UCS was 1.38 after adjustment for demographic factors and dropped after sequential adjustment for comorbidity score, neighborhood income, insurance status, stage and treatment by 4%, 16%, 7%, 19% and 10%, respectively, leaving 43.5% of the racial disparity in survival unexplained. In contrast, risk of death in NHBs vs. NHWs with OCS was 1.19 after adjustment for demographic factors and became insignificant after adjustment for comorbidity. Race was an independent prognostic factor in UCS but not in OCS. CONCLUSIONS: Racial disparities exist in characteristics, treatment and survival in UCS and OCS with distinctions that merit additional research.

Hospital-acquired conditions after surgery for gynecologic cancer - An analysis of 82,304 patients.

OBJECTIVE: To evaluate the hospital-acquired condition (HAC) following oophorectomy and/or hysterectomy for gynecologic cancer patients based on clinical outcomes and costs. MATERIALS AND METHODS: Data were obtained from the Nationwide Inpatient Sample from 2005 to 2011. Chi-squared and Wilcoxon rank sum two-sample tests and multivariate logistic regression model were used for statistical analysis. RESULTS: Of 82,304 women (median age: 60 years, range: 1-101), 49,386 (60.0%) had endometrial, 23,510 (28.6%) had ovarian, and 9408 (11.4%) had cervical cancers. Of 135 HAC events, these involved catheter-associated urinary tract infections (n = 47), vascular catheter-associated infection (n = 41), foreign object retained after surgery (n = 19), pressure ulcers (n = 16), manifestation of poor glycemic control (n = 10), and air embolism (n = 2). Older patients (≥60 years) experienced more HACs relative to younger (0.23% vs. 0.09%; OR = 2.13, 95% CI: 1.30-3.50; p = 0.003), and patients with Medicaid experienced more HACs compared to those with private insurance (0.35% vs. 0.10%; OR = 3.09, 95% CI: 1.70-5.62; p < 0.001). Laparoscopic surgeries were associated with less HACs compared to open surgeries (0.05% vs. 0.19%; OR = 0.41, 95% CI: 0.19-0.90; p = 0.03). Length of hospitalization and hospital charges were greater for those with HACs, (12 days vs. 3 days; p < 0.001; $89,324 vs. $31,107; p < 0.001), respectively. CONCLUSION: The odds of hospital-acquired conditions were higher in older patients, open surgery, Medicaid insured with higher associated hospital charges.

The economic impact of surgical care for morbidly obese endometrial cancer patients: a nationwide study.

BACKGROUND: Obesity significantly impacts the cost of cancer treatment, yet the impact of morbid obesity on inpatient hospital charges related to endometrial cancer treatment is not well-defined. OBJECTIVES: The purpose of this study was to determine the charges that are associated with inpatient surgery, hospitalization, and postoperative care of morbidly obese patients with endometrial cancer. STUDY DESIGN: Data were obtained from the National Inpatient Sample from 2010. Chi-square test, t-test, and linear regression were used for statistical analyses. RESULTS: Six thousand five hundred sixty patients who underwent hysterectomy for endometrial cancer were identified. Mean age was 62 years (range, 22-99 years). The majority were white (78%), and the remainder were black (10%), Hispanic, (8%), Asian (3%), and Native American (1%). Insurance types were private (45%), Medicare (45%), Medicaid (5%), and uninsured (7%). One thousand eighty-eight of these patients (17%) were coded as morbidly obese. The mean postoperative stay for the morbidly obese was 4.0 days (range, 0-46 days) compared with 3.5 days (range, 0-81 days) for the non-morbidly obese patients (P < .01). Morbidly obese patients required more intensive care with mechanical ventilation (5.5% vs 1.6%; P < .01). The median hospital charges were higher for morbidly obese patients compared with their counterparts ($46,654 vs $41,164; P < .01). After adjustment for charges that were associated with insurance type, hospital type, and the surgery that was performed, the incremental increase in hospital charges that were associated with treating the morbidly obese patient was $5096 per patient (95% confidence interval, $2593-$7598; P < .01). CONCLUSION: In this economic analysis, the health care charges that were associated with inpatient endometrial cancer treatment in the morbidly obese patient was significantly higher compared the non-morbidly obese patient. Resources are needed to support the needs of this population, and programs to encourage weight loss and optimize general health should be encouraged.

Robotic versus laparoscopic versus open surgery in morbidly obese endometrial cancer patients - a comparative analysis of total charges and complication rates.

OBJECTIVE: To compare the complications and charges of robotic vs. laparoscopic vs. open surgeries in morbidly obese patients treated for endometrial cancer. METHODS: Data were obtained from the Nationwide Inpatient Sample from 2011. Chi-squared, Wilcoxon rank sum two-sample tests, and multivariate analyses were used for statistical analyses. RESULTS: Of 1087 morbidly obese (BMI ≥40kg/m(2)) endometrial cancer patients (median age: 59years, range: 22 to 89), 567 (52%) had open surgery (OS), 98 (9%) laparoscopic (LS), and 422 (39%) robotic surgery (RS). 23% of OS, 13% of LS, and 8% of RS patients experienced an intraoperative or postoperative complication including: blood transfusions, mechanical ventilation, urinary tract injury, gastrointestinal injury, wound debridement, infection, venous thromboembolism, and lymphedema (p<0.0001). RS and LS patients were less likely to receive blood transfusions compared to OS (5% and 6% vs. 14%, respectively; p<0.0001). The median lengths of hospitalization for OS, LS, and RS patients were 4, 1, and 1days, respectively (p<0.0001). Median total charges associated with OS, LS, and RS were $39,281, $40,997, and $45,030 (p=0.037), respectively. CONCLUSIONS: In morbidly obese endometrial cancer patients, minimally invasive robotic or laparoscopic surgeries were associated with fewer complications and less days of hospitalization relative to open surgery. Compared to laparoscopic approach, robotic surgeries had comparable rates of complications but higher charges.

The centralization of robotic surgery in high-volume centers for endometrial cancer patients--a study of 6560 cases in the U.S.

OBJECTIVE: To evaluate the hospital and patient factors associated with robotic surgery for endometrial cancer in the United States. METHODS: Data was obtained from the Nationwide Inpatient Sample from the year 2010. Chi-squared and multivariate analyses were used for statistical analysis. RESULTS: Of the 6560 endometrial cancer patients who underwent surgery, the median age was 62 (range: 22 to 99). 1647 (25%) underwent robotic surgery, 820 (13%) laparoscopic, and 4093 (62%) had open surgery. The majority was White (65%). Hospitals with 76 or more hysterectomy cases for endometrial cancer patients per year (4% of hospitals in the study) performed 31% of all hysterectomies and 40% of all robotic hysterectomies (p<0.01). 29% of Whites had robotic surgery compared to 15% of Hispanics, 12% of Blacks, and 11% of Asians (p<0.01). Patients with upper-middle and high incomes underwent robotic surgery more than patients with low or middle incomes (p<0.01). 27% of Medicare patients and 26% of patients with private insurance had robotic surgery compared to only 14% of Medicaid patients and 12% of uninsured patients (p<0.01). CONCLUSIONS: The majority of robotic surgeries for endometrial cancer were performed at a small number of high-volume hospitals in the United States. Socioeconomic status, insurance type, and race were also important predictors for the use of RS. Further studies are warranted to better understand the barriers to receiving minimally invasive surgery.

A Markov model to evaluate cost-effectiveness of antiangiogenesis therapy using bevacizumab in advanced cervical cancer.

OBJECTIVE: To evaluate the cost-effectiveness of bevacizumab in recurrent/persistent and metastatic cervical cancer using recently reported updated survival and toxicology data. METHODS: A Markov decision tree based on the Gynecologic Oncology Group 240 randomized trial was created. The 2013 MediCare Services Drug Payment Table and Physician Fee Schedule provided costs. In the 5-year model subjects transitioned through the following states: response, progression, minor complications, severe complications, and death. Patients experiencing a health utility per month according to treatment effectiveness were calculated. Because cervical cancer survival is measured in months rather than years, results were reported in both quality adjusted cervical cancer life months and years (QALmonth, QALY), adjusted from a baseline of having advanced cervical cancer during a month. RESULTS: The estimated total cost of therapy with bevacizumab is approximately 13.2 times that for chemotherapy alone, adding $73,791 per 3.5months (0.29year) of life gained, resulting in an incremental cost-effectiveness ratio (ICER) of $21.083 per month of added life. The ICER increased to $5775 per month of added life and $24,597/QALmonth ($295,164/QALY) due to the smaller difference in QALmonths. With 75% bevacizumab cost reduction, the ICER is $6737/QALmonth ($80,844/QALY), which translates to $23,580 for the 3.5month (0.29year) gain in OS. CONCLUSIONS: Increased costs are primarily related to the cost of drug and not the management of bevacizumab-induced complications. Cost reductions in bevacizumab result in dramatic declines in the ICER, suggesting that cost reconciliation in advanced cervical cancer may be possible through the availability of biosimilars, and/or less expensive, equally efficacious anti-angiogenesis agents.

A cost-effectiveness analysis of a chemoresponse assay for treatment of patients with recurrent epithelial ovarian cancer.

OBJECTIVE: Clinical validation of a chemoresponse assay was recently published, demonstrating a significant increase in overall survival in recurrent ovarian cancer patients treated with therapies to which their tumor was sensitive in the assay. The current study investigates the cost effectiveness of using the assay at the time of ovarian cancer recurrence from the payer's perspective. METHODS: Using a Markov state transition model, patient characteristics and survival data from the recent clinical study, the cumulative costs over the study horizon (71 months) for both the baseline (no assay) and intervention (assay consistent, hypothetical) cohorts were evaluated. RESULTS: The assay consistent cohort had an incremental cost effectiveness ratio (ICER) of $6206 per life year saved (LYS), as compared to the baseline cohort. Cost-effectiveness was further demonstrated in platinum-sensitive and platinum-resistant populations treated with assay-sensitive therapies, with ICERs of $2773 per LYS and $2736 per LYS, respectively. CONCLUSIONS: The use of a chemoresponse assay to inform treatment decisions in recurrent ovarian cancer patients has the potential to be cost-effective in both platinum-sensitive and platinum-resistant patients.

Survival differences of Asian and Caucasian epithelial ovarian cancer patients in the United States.

OBJECTIVE: To compare the racial differences in treatment and survival of Asian-Americans and White patients with epithelial ovarian cancer. METHODS: Data were obtained from the Surveillance, Epidemiology, and End Results Program between 1988 and 2009 and analyzed using Chi-squared tests, Kaplan-Meier methods, and Cox regression analysis. RESULTS: Of the 52,260 women, 3932 (7.5%) were coded as Asian, and 48,328 (92.5%) were White. The median age of Asians at diagnosis was 56 vs. 64 years for the Whites (p<0.001). Asians were more likely to undergo primary surgery, have an earlier stage of disease, have a diagnosis of a non-serous histology, and have lower grade tumors. The 5-year disease-specific survival (DSS) of Asians was higher compared to Whites (59.1% vs. 47.3%, p<0.001). On a subset analysis, Vietnamese, Filipino, Chinese, Korean, Japanese, and Asian Indian/Pakistani ethnicities had 5-year DSS of 62.1%, 61.5%, 61.0%, 59.0%, 54.6%, and 48.2%, respectively (p=0.015). On multivariate analysis, age at diagnosis, year of diagnosis, race, surgery, stage, and tumor grade were all independent prognostic factors for survival. Asians were further stratified to U.S. born versus those who were born in Asia and immigrated. Asian immigrants presented at a younger age compared to U.S. born Asians. Immigrants were found to have an improved 5-year DSS when compared to U.S. born Asians and Whites of 55%, 52%, and 48%, respectively (p<0.001). CONCLUSION: Asians were more likely to be younger, undergo primary surgery, have an earlier stage of disease, non-serous histology, lower grade tumors, and higher survival.

Bevacizumab in treatment of high-risk ovarian cancer--a cost-effectiveness analysis.

The objective of this study was to evaluate a cost-effectiveness strategy of bevacizumab in a subset of high-risk advanced ovarian cancer patients with survival benefit. Methods. A subset analysis of the International Collaboration on Ovarian Neoplasms 7 trial showed that additions of bevacizumab (B) and maintenance bevacizumab (mB) to paclitaxel (P) and carboplatin (C) improved the overall survival (OS) of high-risk advanced cancer patients. Actual and estimated costs of treatment were determined from Medicare payment. Incremental cost-effectiveness ratio per life-year saved was established. Results. The estimated cost of PC is $535 per cycle; PCB + mB (7.5 mg/kg) is $3,760 per cycle for the first 6 cycles and then $3,225 per cycle for 12 mB cycles. Of 465 high-risk stage IIIC (>1 cm residual) or stage IV patients, the previously reported OS after PC was 28.8 months versus 36.6 months in those who underwent PCB + mB. With an estimated 8-month improvement in OS, the incremental cost-effectiveness ratio of B was $167,771 per life-year saved. Conclusion. In this clinically relevant subset of women with high-risk advanced ovarian cancer with overall survival benefit after bevacizumab, our economic model suggests that the incremental cost of bevacizumab was approximately $170,000.

Utilization of and charges for robotic versus laparoscopic versus open surgery for endometrial cancer.

BACKGROUND AND OBJECTIVES: To analyze the utilization and hospital charges associated with robotic (RS) versus laparoscopic (LS) versus open surgery (OS) in endometrial cancer patients. METHODS: Hospital discharge data were extracted from Florida Agency for Health Care Administration between October 2008 and December 2009. RESULTS: Of 2,247 patients (median age: 64 years), 29% had RS, 10% had LS, and 61% had OS. The mean length of hospital stay was 1.6, 1.8, and 3.9 days for RS, LS, and OS, respectively (P < 0.001). The median hospital charge was $51,569, $37,202, and $36,492, for RS, LS, and OS (P < 0.001), with operating room charges ($22,600, $13,684, and $11,272) accounting for the major difference. Robotic surgery utilization increased by 11% (23-34%) over time. CONCLUSIONS: In this statewide analysis of endometrial cancer patients, the utilization of robotic surgery increased and is associated with higher hospital charges compared to laparoscopic and open procedures.

Characteristics of success in mentoring and research productivity - a case-control study of academic centers.

OBJECTIVES: While mentoring has been associated with research productivity, the specific characteristics of successful mentoring have not been well studied. Thus, we performed a case-control study to identify characteristics of successful mentoring programs. METHODS: Institutions were divided based on number of plenary research presentations at an annual society meeting over 6years. Case institutions (Group A) had more presentations vs. controls (Group B). A survey of professors and research fellows assessed characteristics of their mentoring program. Chi-square and logistic regression analyses were performed. RESULTS: Of 159 surveyed, response rates were 46% for professors and 51% for fellows. Compared to Group B, Group A was more likely to have: an additional year of protected fellowship research training (62% vs. 24%; p=0.003), an established program to connect a mentor and mentee with similar research interests (52% vs. 27%; p=0.049), methods to provide feedback to mentors (62% vs. 29%; p=0.01), require mentee research progress reports (45% vs. 21%; p=0.047), and report ease of identifying a mentor (90% vs. 69%; p=0.046). On multivariate analyses, the additional year of research training (OR=7.53, 95% CI: 2.10-27.09; p=0.002) and ease at identifying a research mentor (OR=7.45, 95% CI: 1.44-38.6; p=0.017) remained as independent factors associated with higher research productivity. CONCLUSIONS: Our data suggest that programs can enhance research productivity with the incorporation of accountability features including formalized reports of progress and mentorship feedback in fellowship training. Facilitating the identification of a mentor and providing an additional year of research may be independent factors associated with research productivity.

An economic analysis of dose dense weekly paclitaxel plus carboplatin versus every-3-week paclitaxel plus carboplatin in the treatment of advanced ovarian cancer.

OBJECTIVE: Compared with every-3-week paclitaxel (q3T) plus carboplatin, dose-dense weekly paclitaxel (ddT) plus carboplatin improved the survival of ovarian cancer patients. We performed a cost analysis comparing these two regimens. METHODS: Using a Markov decision model, an acceptable incremental cost-effectiveness ratio (ICER) per progression-free life-year saved (PFLYS) was estimated. Cost of drugs, growth colony-stimulating factors, and transfusions were derived from Medicare reimbursement data. Survival and rates of complications were estimated based on the clinical trial. RESULTS: Using a body weight and surface area of an average woman age 63, the estimated cost per cycle of ddT was $107 vs. $80 for q3T. The costs per cycle of combination chemotherapy including treatment administration were $873 for ddT and $535 for q3T. With a median progression-free survival (PFS) of 28 months with ddT vs. 17.2 months with q3T, the ICER was $5809 per PFLYS for ddT compared with q3T arm. Using a maximum ICER of $100,000 per LYS as cost-effective threshold, the ddT regimen was cost-effective. The ICER was most sensitive to the hazard rate for difference in PFS between the two regimens. A 4-month difference in PFS resulted in a $1200 change of ICER per PFLYS. The ICER was also sensitive to overall survival difference, rate of hematological toxicity, and rate of discontinuation. CONCLUSIONS: In this economic model, dose-dense weekly paclitaxel is a cost-effective treatment option for advanced ovarian cancer.

An economic analysis of robotic versus laparoscopic surgery for endometrial cancer: costs, charges and reimbursements to hospitals and professionals.

OBJECTIVE: To determine the actual costs, charges, and reimbursements associated with robotic vs. laparoscopic surgery for endometrial cancer. METHODS: Data were collected from hospital billing records, MD professional group billing records, tumor registry, and medical records on operations performed by a single surgeon from one institution between 2008 and 2010. For comparison, surgical groups were matched based on age, histology, and stage of disease over the same time period. RESULTS: Of 54 patients, 27 underwent robotic surgery (RS) and 27 had laparoscopic surgery (LS). The median age was 57 years. There were no statistically significant differences between the groups based on age, stage, and histology. The hospital charges for RS were higher at $64,266 vs. $55,130 for LS (p=0.036). However, the reimbursement to the hospital was not statistically different at $13,003 for RS and $10,245 for LS (p=0.29). Operating suite, room and board, anesthesia, post anesthesia care unit, and pathology accounted for over 90% of hospital charges. The surgeon charges for RS and LS were $6824 and $6327, respectively (p=0.033) and the anesthesiologist charges were $4049 and $2985, respectively (p=0.001). However, there were no differences in reimbursement to the surgeon (p=0.74) and anesthesiologist (p=0.84) between the two operative approaches. CONCLUSIONS: Our data showed that the direct costs and charges associated with robotic surgery were higher compared to laparoscopic surgery. However, actual reimbursements to the hospital, surgeon, and anesthesiologist were not significantly different between the two surgical approaches.

Cost effectiveness of a test to detect metastases for endometrial cancer.

OBJECTIVE: To estimate the potential cost-effectiveness of a hypothetical test to screen for lymph node metastases in women with newly diagnosed, apparent early stage endometrial cancer. METHODS: A decision model was constructed to inform a choice between the following strategies: (1) Usual care, in which the probability of undergoing full surgical staging (29%) is based on literature review; (2) Non-invasive diagnostic testing for metastasis (Testing), in which patients with abnormal test results undergo full surgical staging; (3) 100% referral, in which all patients are referred for full surgical staging. Survival was modeled using Surveillance Epidemiology and End Results (SEER) database. Base case diagnostic test characteristic estimates (sensitivity 0.90, specificity 0.90) were varied for sensitivity analysis. Cost of the diagnostic test was set at $500 and varied; costs of treatment for endometrial cancer (surgery, adjuvant therapies, diagnosis of recurrence, salvage therapies and palliative care) were incorporated. RESULTS: Usual care was the least expensive strategy, while Testing was more expensive and more effective, with an incremental cost-effectiveness ratio (ICER) of $18,785 per year of life saved (YLS) compared to Usual care. 100% referral was the most expensive and most effective strategy, with an ICER of $35,358 per YLS compared to Testing. Results are relatively sensitive to variation in test characteristics and the cost of the diagnostic test but insensitive to cost of treatment and probability of adjuvant therapies. Testing remains cost-effective compared to Usual care unless the usual rate of referral to a Gynecologic Oncologist for full staging exceeds 90%. CONCLUSIONS: Given the current low rates of full surgical staging and/or referral to a Gynecologic Oncologist, a diagnostic test to detect nodal metastasis for endometrial cancer has potential to be cost-effective when compared to usual care. Testing is also potentially cost-effective compared to 100% referral at very high test sensitivities and at the lower range of test costs.

Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success?

PURPOSE: To identify the characteristics of phase II studies that predict for subsequent "positive" phase III trials (those that reached the proposed primary end points of study or those wherein the study drug was superior to the standard regimen investigating targeted agents in advanced tumors. METHODS: We identified all phase III clinical trials of targeted therapies against advanced cancers published from 1985 to 2005. Characteristics of the preceding phase II studies were reviewed to identify predictive factors for success of the subsequent phase III trial. Data were analyzed using the chi(2) test and logistic regression models. RESULTS: Of 351 phase II studies, 167 (47.6%) subsequent phase III trials were positive and 184 (52.4%) negative. Phase II studies from multiple rather than single institutions were more likely to precede a successful trial (60.4% v 39.4%; P < .001). Positive phase II results were more likely to lead to a successful phase III trial (50.8% v 22.5%; P = .003). The percentage of successful trials from pharmaceutical companies was significantly higher compared with academic, cooperative groups, and research institutes (89.5% v 44.2%, 45.2%, and 46.3%, respectively; P = .002). On multivariate analysis, these factors and shorter time interval between publication of phase II results and III study publication were independent predictive factors for a positive phase III trial. CONCLUSION: In phase II studies of targeted agents, multiple- versus single-institution participation, positive phase II trial, pharmaceutical company-based trials, and shorter time period between publication of phase II to phase III trial were independent predictive factors of success in a phase III trial. Investigators should be cognizant of these factors in phase II studies before designing phase III trials.