Kathryn A. Maurer

Impact of age on 30-day mortality and morbidity in patients undergoing surgery for endometrial cancer☆

OBJECTIVES To investigate the impact of age on postoperative mortality and morbidity for women undergoing surgery for endometrial cancer. METHODS Patients with endometrial cancer who had a hysterectomy were identified in the 2005-2011 National Surgical Quality Improvement Program database. Patient characteristics and outcomes were compared between age groups. Multivariable logistic regression models were used. RESULTS 4000 patients met inclusion criteria. Octogenarians (n=328) were less likely to undergo laparoscopic surgery (p<0.001) but there was no difference in surgical complexity among age groups (p=0.54). In multivariate analysis, ages 60-69 (OR 0.9, 95% CI 0.3-2.8, p=0.82), 70-79 (OR 1.4, 95% CI 0.4-4.3, p=0.60) and ≥80 years (OR 2.4, 95% CI 0.7-8.1, p=0.17) were not associated with increased mortality compared to age<60 years. Significant predictors of mortality were respiratory or renal disease, dependent functional status, and hypoalbuminemia. Octogenarians were more likely to have non-surgical complications (8% vs. 3-5%, p=0.001) but there was no difference in surgical complications (p=0.89). In multivariate analysis, ages 60-69 (OR 1.2, 95% CI 1.0-1.6, p=0.09), 70-79 (OR 1.3, 95% CI 1.0-1.8, p=0.05) and ≥80 years (OR 1.3, 95% CI 0.9-2.5, p=0.14) were not associated with increased complications compared to age<60 years. Significant predictors of complications were higher ASA class, anemia, and thrombocytosis. CONCLUSIONS Older patients should not be denied surgery for endometrial cancer based on age alone as they do not have higher rates of 30-day morbidity or mortality after adjusting for other factors. An increased effort should be made to perform minimally invasive surgery in octogenarians.

Same-day cervical preparation with misoprostol prior to second-trimester D&E: a case series

BACKGROUND Traditionally, overnight cervical preparation with osmotic dilators has been used for second trimester dilation and evacuation (D&E) procedures. Misoprostol offers an alternative treatment that could shorten cervical preparation time. STUDY DESIGN This study reports on a case series of patients who received only buccal or vaginal misoprostol for cervical preparation on the same day as the D&E procedure. Data were collected from charts of women undergoing second trimester D&E at an outpatient womens health clinic. Eligible cases included procedures performed between January 2001 and December 2010 at 17 0/7 to 23 0/7 weeks of gestation. RESULTS Chart review identified 1177 cases of D&E during the study period. After deletion of 96 multiple-day cases using laminaria, 1081 misoprostol-only cases remained for analysis. Two of the cases were not able to be completed in the same day (0.2%). Ninety-eight percent of cases were 17-20 weeks of gestation. The average time from either vaginal or buccal placement of the first misoprostol dose to procedure completion was 4.9 h (SD±1.7 h). The average procedure length was 13.0 min (SD±10.2 min). Complications were reported in 21 of 1079 same-day procedures (2%) and included resuction (n=4), hemorrhage (n=5), cervical laceration (n=4), endometritis (n=5), pulmonary embolus (n=1), disseminated intravascular coagulation (n=1) and perforation (n=1). CONCLUSION Same-day cervical preparation with misoprostol for second trimester D&E is both safe and effective. With the continuing shortage of D&E providers, the resulting increase in travel distance to obtain the procedure, mandatory waiting periods and the capability of having the procedure completed in a single day may increase patient access, reduce cost and improve patient satisfaction.

The Impact of Percent Reduction in CA-125 Levels on Prediction of the Extent of Interval Cytoreduction and Outcome in Patients With Advanced-Stage Cancer of Müllerian Origin Treated With Neoadjuvant Chemotherapy.

Objective To investigate the role of CA-125 percent reduction after neoadjuvant chemotherapy in predicting the extent of the interval debulking surgery (IDS) and outcomes in patients with advanced-stage müllerian carcinoma. Methods Patients who received neoadjuvant chemotherapy for advanced-stage müllerian carcinoma from 2000 to 2013 were identified. Percent reduction in CA-125 was categorized into 2 groups: ≥90% (CA ≥ 90%) and <90% (CA < 90%) reduction from prechemotherapy to preoperative CA-125. Results Of the 115 patients identified, 73% had CA ≥ 90% and 27% had CA < 90%. Optimal and complete IDS were achieved in 87% and 38%, respectively. Compared with the CA < 90% group, the CA ≥ 90% group was more likely to have complete IDS (P = 0.035), less likely to have a bowel resection (P < 0.001), and more likely to have no viable tumor/microscopic disease with treatment effect (P < 0.001). No difference in overall survival (OS; P = 0.81) and progression-free survival (PFS; P = 0.60) was noted between the groups. In multivariable analysis, CA ≥ 90% was not a predictor of PFS (hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.65–1.79; P = 0.77) or OS (HR, 1.45; 95% CI, 0.73–2.9; P = 0.29). Patients with preoperative CA-125 < 20 had significantly longer OS (P = 0.05) and PFS (P = 0.005) than did those with preoperative CA-125 ≥ 20. In multivariable analysis, preoperative CA-125 < 20 was a predictor of PFS (HR, 0.37; 95% CI, 0.20–0.66; P < 0.001) but not OS (HR, 0.64; 95% CI, 0.34–1.21; P = 0.17). Conclusions A reduction in CA-125 of at least 90% is associated with complete IDS, favorable pathologic response, and fewer bowel resections. A preoperative CA-125 < 20 suggests improved outcome. These findings are helpful for treatment planning and patient counseling.

Referring survivors of endometrial cancer and complex atypical hyperplasia to bariatric specialists: a prospective cohort study

OBJECTIVE The purpose of this study was to describe the acceptability of bariatric referrals when offered by gynecologic oncologists to women with a history of complex atypical hyperplasia or early-stage endometrial cancer and to detail compliance with referrals and weight loss attempts that are initiated 3 months after the referral. STUDY DESIGN Obese women with complex atypical hyperplasia or early-stage endometrial cancer were approached for inclusion in this prospective cohort study. Those women who were not in the care of a bariatric specialist were offered a medical referral with or without a surgical referral. A survey was administered at inclusion and after 3 months. RESULTS Of 121 women who were approached, 106 women were consented. Women reported that it was acceptable for their gynecologic oncologist to discuss weight loss (91.09%) and that a 10% loss of body weight would be beneficial (86.14%). Six women were already in the care of a bariatric specialist. Of the remaining 100 women, 43 accepted a referral: 35 of 100 medical and 8 of 66 surgical referrals that were offered. At 3 months, 17 women complied with a referral (16 medical and 1 surgical), and 59 women had initiated any weight loss attempt. On multivariate analysis, a higher initial weight (P = .0403), Charlson Comorbidity Index ≥5 (P = .0278), and shorter time from surgery to bariatric referral (P = .0338) predicted acceptance of a referral. CONCLUSION Weight-loss counseling is well received by these women. After being offered bariatric referral, only 17% comply, but most women (59%) subsequently initiate a weight loss attempt. Referrals should be offered early in the course of cancer care to maximize acceptance.

An Evaluation of the Cobas4800 HPV Test on Cervico-Vaginal Specimens in Liquid versus Solid Transport Media.

Objectives Determine the ability of the Cobas 4800 assay to detect high-risk human papillomavirus (HrHPV) and high-grade cervical lesions when using cervico-vaginal samples applied to liquid medium and solid media cards compared to a direct cervical sample. Methods Two cervico-vaginal specimens (pseudo self-collected) were obtained from 319 women. One was applied to an iFTA Card (FTA) then the brush placed in liquid-based medium (LSELF); the other was applied to a new solid media: POI card (POI). The clinical performance of Cobas4800 assay using the three aforementioned specimens was compared to direct collected endocervical specimens in liquid media (LDOC). Results The overall agreements of HrHPV detection were 84.2% (LSELF vs. LDOC), 81.0% (FTA vs. LDOC), and 82.3% (POI vs. LDOC). LSELF, FTA and POI identified 98.0%, 79.6%, and 97.5% positive cases of LDOC. Sensitivity to identify CIN2+ were 98.4% (LSELF), 73.8% (FTA), 95.1% (POI), and 93.4% (LDOC) respectively. FTA had 78.1% and 90.4% agreement with the LSELF samples for all HrHPV and HPV16/18 detection respectively, while POI had 91.6% for both. Conclusions Cobas4800 HPV test combined with cervico-vaginal specimens applied to both liquid media and POI solid card are accurate to detect HrHPV infection and high-grade cervical lesions as compared with direct endocervical samples in liquid media.

Evaluation of a new solid media specimen transport card for high risk HPV detection and cervical cancer prevention

BACKGROUND Solid media transport can be used to design adaptable cervical cancer screening programs but currently is limited by one card with published data. OBJECTIVE To develop and evaluate a solid media transport card for use in high-risk human papillomavirus detection (HR-HPV). STUDY DESIGN The Preventative Oncology International (POI) card was constructed using PK 226 paper(®) treated with cell-lysing solution and indicating dye. Vaginal samples were applied to the POI card and the indicating FTA (iFTA) elute card. A cervical sample was placed in liquid media. All specimens were tested for HR-HPV. Color change was assessed at sample application and at card processing. Stability of the POI card and iFTA elute card was tested at humidity. RESULTS 319 women were enrolled. Twelve women had at least one insufficient sample with no difference between media (p=0.36). Compared to liquid samples, there was good agreement for HR-HPV detection with kappa of 0.81 (95% CI 0.74-0.88) and 0.71 (95% CI 0.62-0.79) for the POI and iFTA elute card respectively. Sensitivity for ≥CIN2 was 100% (CI 100-100%), 95.1% (CI 92.7-97.6%), and 93.5% (CI 90.7-96.3%) for the HR-HPV test from the liquid media, POI card, and iFTA elute card respectively. There was no color change of the POI card noted in humidity but the iFTA elute card changed color at 90% humidity. CONCLUSIONS The POI card is suitable for DNA transport and HR-HPV testing. This card has the potential to make cervical cancer screening programs more affordable worldwide.

Too many women are dying from cervix cancer: Problems and solutions

One woman dies from cervix cancer every 2 min, adding up to over 270,000 deaths globally per year. This cancer affects a young population, and hence, the loss of life is staggering. There are many aspects of prevention, screening, and care that are suboptimal. A great deal is known about HPV induced carcinogenesis, yet clinical outcomes have been stagnant over decades. There has been no improvement in cervix cancer survival in the US since the mid-1970s [1]. With increased knowledge of the disease and greater worldwide resources including prevention, screening, and improved therapeutics, there is significant promise for fewer women to die from this virally induced cancer. We focus here on the major problems in prevention, screening, and delivery of care for cervix cancer and provide concrete solutions. With appropriate focus, a major improvement in survival from cervix cancer could be achieved in a short time span.

Universal tolerance of nab-paclitaxel for gynecologic malignancies in patients with prior taxane hypersensitivity reactions

Objective To report on the incidence of nab-paclitaxel hypersensitivity reactions (HSRs) in patients with prior taxane HSR. Methods From 2005 to 2015, all patients who received nab-paclitaxel for a gynecologic malignancy were identified. Chart abstraction included pathology, prior therapy, indication for nab-paclitaxel, dosing, response, toxicities including any HSR, and reason for discontinuation of nab-paclitaxel therapy. Results We identified 37 patients with gynecologic malignancies with a history of paclitaxel HSR who received nab-paclitaxel. Six patients (16.2%) had a prior HSR to both paclitaxel and docetaxel while the other 31 patients had not received docetaxel. No patients experienced a HSR to nab-paclitaxel. Median number of cycles of nab-paclitaxel was 6 (range 2–20). Twelve patients received weekly dosing at 60 to 100 mg/m2. The remainder of patients received 135 mg/m2 (n=13), 175 mg/m2 (n=9), or 225 mg/m2 (n=3). Thirty four patients (91.9%) received nab-paclitaxel in combination with carboplatin (n=28, 75.7%), IP cisplatin (n=1, 2.7%), carboplatin and bevacizumab (n=3, 8.1%), or carboplatin and gemcitabine (n=2, 5.4%). Reasons for discontinuing nab-paclitaxel included completion of adjuvant therapy (n=16), progressive disease (n=18), toxicity (n=1), and death (n=1). There were no grade 4 complications identified during nab-paclitaxel administration. Grade 3 complications included: neutropenia (n=9), thrombocytopenia (n=4), anemia (n=1), and neurotoxicity (n=1). Conclusion Nab-paclitaxel is well-tolerated with no HSRs observed in this series of patients with prior taxane HSR. Given the important role of taxane therapy in nearly all gynecologic malignancies, administration of nab-paclitaxel should be considered prior to abandoning taxane therapy.