Publications by authors named "Alexander Melamed"

107 Publications

Use and outcomes of neoadjuvant chemotherapy for metastatic uterine cancer.

Gynecol Oncol 2021 Jun 19. Epub 2021 Jun 19.

Columbia University Vagelos College of Physicians and Surgeons, USA; Joseph L. Mailman School of Public Health, Columbia University, USA; Herbert Irving Comprehensive Cancer Center, USA; NewYork-Presbyterian Hospital, USA.

Objective: Neoadjuvant chemotherapy (NACT) has emerged as an alternative to primary cytoreductive surgery (PCS) for stage IV uterine cancer. We examined utilization, perioperative outcomes and survival for NACT and PCS for stage IV uterine cancer.

Methods: The Surveillance, Epidemiology, End Results-Medicare database was used to identify women with stage IV uterine cancer treated from 2000 to 2015. Women were classified as NACT or PCS. Interval cytoreductive surgery (after NACT) or chemotherapy (after PCS) were recorded. The extent of surgery and perioperative outcomes were estimated for the groups. Multivariable proportional hazards models and Kaplan-Meier analyses were used to examine survival.

Results: Among 3037 women, 1629 (53.6%) were treated with primary cytoreductive surgery, 554 (18.2%) with NACT, and 854 (28.1%) received no treatment. Use of NACT increased from 9.5% to 29.2%. After NACT, interval hysterectomy was performed in 159 (28.6%), while within the PCS group, 1052 (64.6%) received chemotherapy. Extended cytoreductive procedures were performed in 71.7% of women who received NACT vs. 79.1% after PCS (P = 0.03). The complication rate was 52.8% for NACT versus 56.2% for PCS (P = 0.42); medical complications were more frequently seen in the PCS group (39.4% versus 28.9%; P = 0.01). There was no difference in cancer specific (P = 0.48) or overall survival (P = 0.25) in women who received both chemotherapy and surgery regardless of whether the initial treatment was NACT or PCS.

Conclusion: Use of NACT is increasing for advanced stage uterine cancer. There was no difference in survival between NACT and primary cytoreductive surgery and NACT was associated with fewer perioperative medical complications.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2021.06.016DOI Listing
June 2021

New and persistent controlled substance use among patients undergoing mastectomy and reconstructive surgery.

Breast Cancer Res Treat 2021 Jun 4. Epub 2021 Jun 4.

Columbia University College of Physicians and Surgeons, New York, USA.

Purpose: Prolonged use of controlled substances can place patients at increased risk of dependence and complications. Women who have mastectomy and reconstructive surgery (M + R) may be vulnerable to becoming new persistent users (NPUs) of opioid and sedative-hypnotic medications.

Methods: Using the MarketScan health-care claims database, we identified opioid- and sedative-hypnotic-naïve women who had M + R from 2008 to 2017. Women who filled ≥ 1 peri-operative prescription and ≥ 2 post-operative prescriptions within one year after surgery were classified as NPUs. Univariate and multivariable logistic regression analyses were used to estimate rates of new persistent use and predictive factors. Risk summary scores were created based on the sum of associated factors.

Results: We evaluated 23,025 opioid-naïve women and 25,046 sedative-hypnotic-naïve women. We found that 17,174 opioid-naïve women filled a peri-operative opioid prescription, and of those, 2962 (17.2%) became opioid NPUs post-operatively. Additionally, 9426 sedative-hypnotic-naïve women filled a peri-operative sedative-hypnotic prescription, and of those, 1612 (17.1%) became sedative-hypnotic NPUs. Development of new persistent sedative-hypnotic use was associated with age ≤ 49 [OR 1.77 (95% CI 1.40-2.24)] and age 50-64 [1.60 (1.27-2.03)] compared to age ≥ 65; Medicaid insurance [2.34 (1.40-3.90)]; southern residence [1.42 (1.22-1.64)]; breast cancer diagnosis [2.24 (1.28-3.91)]; and chemotherapy [2.17 (1.94-2.42)]. Risk of NPU increased with higher risk score. Women with ≥ 3 of these risk factors were three times more likely to become sedative-hypnotic NPUs than patients with 0 or 1 factors [2.94 (2.51-3.43)]. Comparable findings were seen regarding new persistent opioid use.

Conclusion: Women who have M + R are at risk of developing both new persistent opioid and new persistent sedative-hypnotic use. A patient's risk of becoming an NPU increases as their number of risk factors increases. Non-pharmacologic strategies are needed to manage pain and anxiety following cancer-related surgery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s10549-021-06275-8DOI Listing
June 2021

Association of New Perioperative Benzodiazepine Use With Persistent Benzodiazepine Use.

JAMA Netw Open 2021 Jun 1;4(6):e2112478. Epub 2021 Jun 1.

Columbia University College of Physicians and Surgeons, New York, New York.

Importance: Increased use of benzodiazepines has resulted in increasing rates of misuse and adverse effects associated with these drugs. Little is known about the initial exposure and source of benzodiazepines among those who use them persistently.

Objective: To examine the frequency of use and persistent use of benzodiazepines among patients undergoing major and minor surgical procedures.

Design, Setting, And Participants: This cohort study included 2 509 599 adult patients who underwent 1 of 11 common surgical procedures in the United States from 2009 to 2017 and were recorded in the MarketScan database. The rates of perioperative and persistent benzodiazepine use were examined in benzodiazepine-naive patients. Data analysis was conducted from July to November 2020.

Main Outcomes And Measures: Receipt of a perioperative benzodiazepine prescription and persistent use (ie, fill of a second prescription 90-180 days after surgery) among those who received a benzodiazepine perioperatively.

Results: Among 2 509 599 included patients, the mean (SD) age was 54.4 (15.3) years, and 1 596 137 (63.6%) were women. Perioperative benzodiazepine use was noted in 63 931 patients (2.6%). The median (interquartile range) benzodiazepine supply was 10 (5-23) days. Among benzodiazepine-naive patients prescribed a perioperative benzodiazepine, the rate of persistent benzodiazepine use was 19.5% (95% CI, 19.2%-19.8%). During the 90 to 180-day period after surgery, 7013 of 12 468 patients (56.2%) received 1 prescription for benzodiazepines while 5455 (43.8%) received 2 or more prescriptions. Among patients prescribed a benzodiazepine, persistent use was more common in Medicaid recipients (vs patients with commercial insurance: adjusted rate ratio [aRR], 1.29; 95% CI, 1.03-1.62), patients 70 years or older (vs those aged 40-49 years: aRR, 1.14; 95% CI, 1.05-1.23), in women (vs men: aRR, 1.10; 95% CI, 1.06-1.15), in patients with more medical comorbidities (eg, Elixhauser comorbidity score ≥3 vs 0: aRR, 1.11; 95% CI, 1.04-1.19), and in those with diagnoses of anxiety, depression, insomnia or substance use disorder (eg, with vs without anxiety: aRR, 1.43; 95% CI, 1.37-1.50).

Conclusions And Relevance: In this study, a relatively small percentage of surgical patients were prescribed benzodiazepines in the perioperative period; however, 1 in 5 of these patients went on to persistent benzodiazepine use.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2021.12478DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176328PMC
June 2021

Fragmentation of surgery and chemotherapy in the initial phase of ovarian cancer care and its association with overall survival.

Gynecol Oncol 2021 Jul 6;162(1):56-64. Epub 2021 May 6.

Columbia University Vagelos College of Physicians and Surgeons, United States of America; New York Presbyterian Hospital, United States of America; Herbert Irving Comprehensive Cancer Center, United States of America; Joseph L. Mailman School of Public Health, United States of America. Electronic address:

Background: Fragmentation occurs when a patient receives care at more than one hospital, and the long-term effects in ovarian cancer are unknown. We examined the association between fragmentation of primary debulking surgery (PDS) and adjuvant chemotherapy (AC) and overall survival (OS).

Methods: The National Cancer Database was used to identify women with stage II-IV epithelial ovarian cancer between 2004 and 2016 who underwent PDS followed by AC. Fragmentation was defined as receipt of AC at a different institution than where PDS was performed. After propensity score weighting, proportional hazard models were developed to estimate the association between fragmented care and OS.

Results: Of the 36,300 patients identified, 13,347 (36.8%) had fragmented care. Patient factors associated with fragmentation included older age, higher income, and longer travel distance for PDS; hospital factors included PDS performed at a community center or a facility with lower annual surgical volume (P < 0.05, all). Fragmentation was associated with a 15% risk of 30-day delay to AC (aRR 1.15, 95% CI 1.09-1.22). In a propensity scoring weighted analysis, mortality was reduced when AC was fragmented (HR 0.95, 95% CI 0.92-0.97). Sensitivity analyses indicated fragmentation was associated with improved survival in metropolitan residents. Stratified analyses indicated patients who traveled 50 miles or more with PDS and AC at the same institution had the worst OS.

Conclusion: Fragmentation of PDS and AC has no adverse effects on long-term survival. Survival outcomes were worst for those who received care at the same institution 50 miles or more away.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2021.04.032DOI Listing
July 2021

Outcomes of the First Pregnancy After Fertility-Sparing Surgery for Early-Stage Ovarian Cancer.

Obstet Gynecol 2021 06;137(6):1109-1118

Department of Gynecologic Oncology and Reproductive Medicine, the Department of Health Services Research, Division of Cancer Prevention and Population Sciences, and the Department of Breast Medical Oncology, the University of Texas MD Anderson Cancer Center, Houston, Texas; the Department of Obstetrics and Gynecology, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts; the Department of Obstetrics and Gynecology, the University of Texas Medical Branch at Galveston, Galveston, Texas; and the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, and the Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York.

Objective: To evaluate the outcomes of the first pregnancy after fertility-sparing surgery in patients treated for early-stage ovarian cancer.

Methods: We performed a retrospective study of women aged 18-45 years with a history of stage IA or IC ovarian cancer reported to the California Cancer Registry for the years 2000-2012. These data were linked to the 2000-2012 California Office of Statewide Health Planning and Development birth and discharge data sets to ascertain oncologic characteristics and obstetric outcomes. We included in the case group ovarian cancer patients who conceived at least 3 months after fertility-sparing surgery. The primary outcome was preterm birth, and only the first pregnancy after cancer diagnosis was considered. Secondary outcomes included small-for-gestational-age (SGA) neonates, neonatal morbidity (respiratory support within 72 hours after birth, hypoxic-ischemic encephalopathy, seizures, infection, meconium aspiration syndrome, birth trauma, and intracranial or subgaleal hemorrhage), and severe maternal morbidity as defined by the Centers for Disease Control and Prevention. Propensity scores were used to match women in a 1:2 ratio for the case group and the control group. Wald statistics and logistic regressions were used to evaluate outcomes.

Results: A total of 153 patients who conceived after fertility-sparing surgery were matched to 306 women in a control group. Histologic types included epithelial (55%), germ-cell (37%), and sex-cord stromal (7%). Treatment for ovarian cancer was not associated with preterm birth before 37 weeks of gestation (13.7% vs 11.4%; odds ratio [OR] 1.23, 95% CI 0.69-2.20), SGA neonates (birth weight less than the 10th percentile: 11.8% vs 12.7%; OR 0.91, 95% CI 0.50-1.66), severe maternal morbidity (2.6% vs 1.3%; OR 2.03, 95% CI 0.50-8.25), or neonatal morbidity (both 5.9% OR 1.00, 95% CI 0.44-2.28).

Conclusion: Patients who conceived at least 3 months after surgery for early-stage ovarian cancer did not have an increased risk of adverse obstetric outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/AOG.0000000000004394DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8141030PMC
June 2021

Primary cytoreductive surgery for advanced stage endometrial cancer: a systematic review and meta-analysis.

Am J Obstet Gynecol 2021 May 4. Epub 2021 May 4.

Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.

Objective: Endometrial cancer uncommonly presents at an advanced stage and little prospective evidence exists to guide the management thereof. We aimed to summarize the evidence about primary cytoreductive surgery in the treatment of advanced stage endometrial cancer.

Data Sources: MEDLINE, Embase, and Scopus databases were searched from inception to September 11, 2020, using search terms representing the themes "endometrial cancer," "advanced stage," and "primary cytoreductive surgery."

Study Eligibility Criteria: We included full-text, English reports that included ≥10 patients undergoing primary cytoreductive surgery for advanced stage endometrial cancer and that reported on the outcomes of primary cytoreductive surgery and survival rates based on the residual disease burden.

Methods: Two reviewers independently screened the studies and with disagreements between the reviewers resolved by a third reviewer. Data were extracted using a standardized form. The percentage of cases reaching maximal (no gross residual disease) and optimal (<1 cm or <2 cm residual disease) cytoreduction were assessed by summing binomials proportions, and the association with survival was assessed using an inverse variance-weighted meta-analysis of logarithmic hazard ratios.

Results: From 1219 unique records identified, 34 studies were selected for inclusion. Studies consisted of single or multi-institutional cohorts of patients collected over a period of 6 to 24 years and included various mixes of histologies (endometrioid, serous, clear cell, and carcinosarcoma) and disease stages (III or IV). In a meta-analysis of the extent of residual disease after primary cytoreductive surgery, we found that 52.1% of cases reached no gross residual disease status (n=18 studies; 1329 patients) and 75% reached <1 cm residual disease status (n=27 studies; 2343 patients). The proportion of cytoreduction for both thresholds was lower for studies of stage IV vs stage III to IV disease (41.4% vs 69.8% for no gross residual disease; 63.2% vs 82.2% for <1 cm residual disease) but did not vary notably by histology. In a meta-analysis of the reported hazard ratios, submaximal (any gross residual disease vs no gross residual disease) and suboptimal (≥1 cm vs <1 cm) cytoreduction thresholds were associated with worse progression-free survival (submaximal hazard ratio, 2.16; 95% confidence interval, 1.45-3.21; I=68%; suboptimal hazard ratio, 2.55; 95% confidence interval, 1.93-3.37; I=63%) and overall survival rates (submaximal hazard ratio, 2.57; 95% confidence interval, 2.13-3.10; I=1%; suboptimal hazard ratio, 2.62; 95% confidence interval, 2.20-3.11; I=15%). Sensitivity analyses limited to high-quality studies demonstrated consistent results.

Conclusion: Among cases of advanced stage endometrial cancer undergoing primary cytoreductive surgery, a significant proportion of patients are left with residual disease, which is associated with worse survival outcomes. Further investigations about the roles of neoadjuvant chemotherapy and primary cytoreductive surgery in prospective trials is warranted in this population.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajog.2021.04.254DOI Listing
May 2021

Overuse of Cervical Cancer Screening Tests Among Women With Average Risk in the United States From 2013 to 2014.

JAMA Netw Open 2021 Apr 1;4(4):e218373. Epub 2021 Apr 1.

Columbia University College of Physicians and Surgeons, New York, New York.

Importance: While cervical cancer screening with cytologic and human papillomavirus (HPV) testing has reduced mortality from cervical cancer, overuse of these tests is associated with downstream psychological and medical consequences, as well as significant costs. Guidelines now recommend less frequent testing, although adherence to these recommendations is uncertain.

Objective: To determine the frequency of overuse of cervical cancer screening tests.

Design, Setting, And Participants: This cohort study included 2 299 177 women aged 30 to 65 years recorded in the MarketScan database who underwent cervical cancer screening with cervical cytologic testing, cotesting, or primary HPV testing in 2013 through 2014. Women were followed-up for 3 years, and use of repeat testing during this period was noted. Clinical and demographic characteristics associated with overuse of screening and the association between screening and performance of routine gynecologic examinations were recorded. Data were analyzed from June 15 to September 15, 2020.

Main Outcomes And Measures: Cumulative performance of overuse of cervical cancer screening with repeat cytologic or HPV testing within 36 months of the index screening test.

Results: A total of 2 299 177 women with a median (interquartile range) age of 47 (39-54) years were identified. Initial cervical cancer screening consisted of cytologic testing alone in 1 286 179 women (55.9%), cotesting in 991 583 women (43.1%) and HPV testing in 21 415 women (0.9%). The cumulative incidence of repeat cervical cancer screening was 17.7% (95% CI, 17.6%-17.7%) at 12 months, 51.1% (95% CI, 51.0%-51.2%) at 24 months and 65.8% (65.7%-65.8%) at 36 months. Repeat screening was less common in older women (32 198 women [60.2%] aged 60-64 years vs 194 665 women [67.8%] aged 30-39 years; P < .001), women with medical comorbidities (125 197 women [64.1%] with ≥2 comorbidities vs 423 012 women [64.7%] with no comorbidities; P < .001), women screened in 2014 (176 734 women [53.4%] in 2014 vs 555 767 women [69.4%] in 2013; P < .001), and those screened with cotesting (277 032 women [56.9%] for cotesting vs 450 438 [71.2%] for cytologic testing; P < .001). In contrast, overuse of testing was more common in the Northeastern US (143 916 women [68.1%] in the Northeast vs 81 552 women [51.6%] in the West; P < .001), in women with more frequent outpatient visits (238 510 women [71.1%] with ≥6 visits vs 279 412 [58.7%] with ≤2 visits; P < .001). Women with a sexually transmitted infection after their index testing were also more likely to undergo repeat testing (adjusted odds ratio, 1.42 [95% CI, 1.21-1.68]). Women who did not undergo repeat screening were significantly less likely to undergo a gynecological exam after the index screening test: during year 2 of follow-up, 657 749 women (96.7%) who underwent repeating screening had a gynecological examination compared with 203 566 women (26.2%) who did not undergo a gynecological examination.

Conclusions And Relevance: These findings suggest that among commercially insured women with average risk, cervical cancer screening tests were frequently overused.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2021.8373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8085723PMC
April 2021

Uptake and Outcomes of Sentinel Lymph Node Mapping in Women With Atypical Endometrial Hyperplasia.

Obstet Gynecol 2021 05;137(5):924-934

Columbia University College of Physicians and Surgeons, the Joseph L. Mailman School of Public Health, Columbia University, the Herbert Irving Comprehensive Cancer Center, and New York Presbyterian Hospital, New York, New York.

Objective: To examine the utilization, morbidity, and cost of sentinel lymph node mapping in women undergoing hysterectomy for complex atypical endometrial hyperplasia.

Methods: Women with complex atypical endometrial hyperplasia who underwent hysterectomy from 2012 to 2018 in the Perspective database were examined. Perioperative morbidity, mortality, and cost were examined based on performance of sentinel lymph node mapping, lymph node dissection or no nodal evaluation.

Results: Among 10,266 women, sentinel lymph node mapping was performed in 620 (6.0%), lymph node dissection in 538 (5.2%), and no lymphatic evaluation in 9,108 (88.7%). Use of sentinel lymph node mapping increased from 0.8% in 2012 to 14.0% in 2018, and the rate of lymph node dissection rose from 5.7% to 6.4% (P<.001). In an adjusted model, residence in the western United States, treatment by high-volume hospitals and use of robotic-assisted hysterectomy were associated with sentinel lymph node mapping (P<.05 for all). The complication rates were similar between the three groups. The median cost for sentinel lymph node mapping ($9,673) and lymph node dissection ($9,754) were higher than in those who did not undergo nodal assessment ($8,435) (P<.001).

Conclusion: Performance of sentinel lymph node mapping is increasing rapidly for women with complex atypical endometrial hyperplasia but is not associated with increased perioperative morbidity or mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/AOG.0000000000004352DOI Listing
May 2021

Trends in Use of Myomectomy for the Surgical Management of Uterine Leiomyomas in Perimenopausal and Postmenopausal Women.

Obstet Gynecol 2021 05;137(5):843-845

Columbia University College of Physicians and Surgeons, the Joseph L. Mailman School of Public Health, Columbia University, the Herbert Irving Comprehensive Cancer Center, and New York Presbyterian Hospital, New York, New York.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/AOG.0000000000004354DOI Listing
May 2021

Trends in ovarian conservation and association with survival in premenopausal patients with stage I leiomyosarcoma.

Gynecol Oncol 2021 Jun 31;161(3):734-740. Epub 2021 Mar 31.

Columbia University Irving Medical Center, New York, NY, United States of America; Herbert Irving Comprehensive Cancer Center, United States of America. Electronic address:

Objective: To explore trends of ovarian conservation (OCN) over time in young women with early stage leiomyosarcoma (LMS) and examine the association between OCN and survival.

Methods: Patients under the age of 50 who were diagnosed with stage I LMS who underwent hysterectomy with and without oophorectomy between 2010 and 2016 were identified in the National Cancer Database (NCDB). Performance of oophorectomy vs. OCN was determined using surgery codes. Trends of OCN were reported. Multivariable regression models were fit to estimate predictors of OCN. An inverse probability of treatment weighted propensity score method was used to examine the association between all-cause mortality and OCN.

Results: Overall, 225 patients (28%) underwent OCN. Rates of OCN decreased from 41.2% (2010) to 14.3% (2016); this finding was consistent across age groups: <35, 35-39, 40-44, and 45-49 years. Race, insurance, and stage did not affect performance of OCN. Women with poorly differentiated tumors were less likely to undergo OCN compared to well-differentiated tumors (aRR 0.59; 95% CI 0.40-0.86). After propensity score weighting, there was no association between OCN and mortality (HR 1.19, 95% CI 0.80-1.77). Five-year survival for the OCN group was 67.1% (95% CI 59.8-75.2%) compared to 72.2% for the oophorectomy group (95% CI 67.2-77.5%).

Conclusions: OCN for early stage LMS in premenopausal women has decreased over time. There was no association between OCN and mortality among women with stage I LMS. OCN should be considered in premenopausal women with stage I LMS given the health benefits.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2021.03.027DOI Listing
June 2021

Incidence of myelodysplastic syndrome and acute myeloid leukemia in patients receiving poly-ADP ribose polymerase inhibitors for the treatment of solid tumors: A meta-analysis of randomized trials.

Gynecol Oncol 2021 Jun 15;161(3):653-659. Epub 2021 Mar 15.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address:

Background: Clinical trials demonstrated that PARPi (poly [adenosine diphosphate-ribose]-ADP polymerase inhibitor) therapy is effective in solid tumors. However, long term effects such as therapy-related myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) are poorly described. We sought to quantify whether PARPi therapy is associated with the development of MDS/AML.

Methods: Medline, Embase, and Cochrane databases were searched (inception to January 6, 2020) and phase 2 and 3 clinical trials that randomized patients with solid tumors to a PARPi or control therapy were included. The PRISMA guidelines were used to extract data independently by multiple authors. We extracted person-time and number of cases of MDS/AML in the PARPi and control arms of each study and pooled results with a random-effects Poisson regression model. The pooled incidence rate ratio (IRR) for MDS/AML among patients randomized to PARPi therapy was compared to those randomized to a control.

Results: We identified 14 studies that included 5739 patients. Accounting for intra-study clustering, the risk of MDS/AML was similar in patients who were randomly assigned to receive PARPi compared to controls (IRR 1.32, 95% confidence interval [CI] 0.78-2.26). In the front-line setting, PARPi therapy was associated with developing MDS/AML (IRR 5.43, 95% CI 1.51-19.60). Among patients treated for recurrence, however, the risk of MDS/AML appeared to be similar among patients randomized to PARPi or control treatment. Among studies that included only patients with a BRCA mutation, the risk of MDS/AML was similar in both treatment groups (IRR 0.83, 95% CI 0.45-1.53), but PARPi therapy was associated with MDS/AML in studies with an unrestricted population (IRR 2.43, 95% CI 1.17-5.06).

Conclusion: The pooled overall effect was not statistically significant. However, treatment with PARPi was associated with a statistically significant increase in the incidence of MDS/AML among patients receiving front-line cancer therapy and those with limited prior exposure to chemotherapy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2021.03.011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164998PMC
June 2021

Use of fertility preservation services in male reproductive-aged cancer patients.

Gynecol Oncol Rep 2021 May 10;36:100716. Epub 2021 Feb 10.

Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, United States.

While fertility preservation is a major concern among reproductive age cancer patients, little is known about access and use of fertility preserving services. We examined use of fertility preserving services among men with common solid tumors. A total of 3648 men age 18-40 including 2610 (71.6%) with testicular cancer, 939 (25.7%) with colorectal and 99 (2.7%) with prostate cancer were identified. Fertility preservation services were utilized in 9.3% of men overall including 4.1% who underwent fertility evaluation only and 7.8% who had a fertility preservation procedure. The rate of fertility preservation services rose from 6.6% (95%CI, 3.2-10.0) in 2008 to 12.4% (95%CI, 7.3-17.5) in 2017 (P = 0.04). Use of fertility preservation service was more common in patients with testicular (11.6%, aRR = 3.31; 95% CI 2.22-4.92) and prostate cancer (6.1%, aRR = 3.14; 95% CI 1.28-7.70) compared to those with colon cancer (3.4%). Younger men were more likely to utilize fertility preservation services. 11.5% of men age ≤ 35 years vs. 5.2% of men 36-40 used these services (P < 0.0001). Fertility preservation services were used in 10.8% of those who received chemotherapy (aRR = 1.81; 95% CI, 1.45-2.27) and in 8.1% of those who received radiation (aRR = 1.30 95% CI, 0.98-1.73). Medicaid patients were less likely to receive fertility preservation services than those with commercial insurance (0.7% vs. 10.1%; aRR = 11.58, 95%CI 2.10-63.69). These data indicate that while use of fertility preserving services is increasing, overall use of services is low among reproductive age males with cancer.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.gore.2021.100716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7907757PMC
May 2021

Facilitated cascade testing (FaCT): a randomized controlled trial.

Int J Gynecol Cancer 2021 May 18;31(5):779-783. Epub 2020 Dec 18.

Division of Gynecologic Oncology, Weill Cornell Medicine, New York, New York, USA

Background: Identifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing.

Primary Objective: Our primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed mutation randomized to a facilitated cascade testing strategy versus standard of care, proband-mediated, information sharing.

Study Hypothesis: We hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care.

Trial Design: The FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known mutation (probands) cared for at participating sites will be randomized. Probands randomized to the standard of care group will be instructed to share a family letter with their first-degree relatives and encourage them to complete genetic testing. First-degree relatives of probands randomized to the intervention arm will receive engagement strategies with a patient navigator, an educational video, and accessible genetic testing services.

Major Inclusion/exclusion Criteria: Adult participants who are first-degree relatives of a patient with a mutation and have not had prior genetic testing will be included.

Primary Endpoint: Analyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm.

Sample Size: One hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants.

Estimated Dates For Completing Accrual And Presenting Results: January 2024.

Trial Registration: NCT04613440.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/ijgc-2020-002118DOI Listing
May 2021

Less radical surgery for early-stage cervical cancer: a systematic review.

Am J Obstet Gynecol 2021 04 9;224(4):348-358.e5. Epub 2020 Dec 9.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, New York, NY; Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY; New York-Presbyterian Hospital, New York, NY; Department of Medicine, Columbia University Vagelos College of Physicians and Surgeons, New York, NY. Electronic address:

Objective: A systematic review was performed to examine the outcomes of simple hysterectomy for women with low-risk, early-stage cervical cancer.

Data Sources: MEDLINE, Embase, Web of Science, and ClinicalTrials.gov were searched from inception until November 4, 2020.

Study Eligibility Criteria: Original research reporting recurrence or survival outcomes among women with early-stage cervical cancer (defined as stage IA2 to IB1 disease) who were treated with simple hysterectomy.

Methods: Data regarding study characteristics, tumor characteristics, other treatment modalities, adjuvant therapy, recurrence, and survival outcomes were analyzed. Studies that reported both simple hysterectomy and radical hysterectomy outcomes were compared in a subgroup analysis. Summary statistics were reported and eligible studies were further analyzed to determine an estimated hazard ratio comparing simple hysterectomy with radical hysterectomy.

Results: A total of 21 studies were included, of which 3 were randomized control trials, 14 retrospective studies, 2 prospective studies, and 2 population-level data sets. The cohort included 2662 women who underwent simple hysterectomy, of which 36.1% had stage IA2 disease and 61.0% stage IB1 disease. Most cases (96.8%) involved tumors of ≤2 cm in size, and 15.4% of cases were lymphovascular space invasion positive. Approximately 71.8% of women who underwent simple hysterectomy had a lymph node assessment, and 30.7% of women underwent adjuvant chemotherapy or radiation. The most common complications described were lymphedema (24%), lymphocysts (22%), and urinary incontinence (18.5%). The total death rate for studies that reported deaths was 5.5%. By stage, there was a 2.7% mortality rate among IA2 disease and a 7.3% mortality rate among IB1 disease. Of note, 18 studies reported outcomes for both simple and radical hysterectomy, with a 4.5% death rate in the radical hysterectomy group and a 5.8% death rate in the simple hysterectomy group. Estimated and reported hazard ratio demonstrated no significant association for mortality between radical and nonradical surgeries for IA2 disease but potentially increased risk of mortality among IB1 disease. All studies had a moderate to high risk of bias, including the 3 randomized control trials. Level of evidence was limited to III to IV.

Conclusion: The use of less radical surgery for women with stage IA2 and small volume IB1 cervical cancers appears favorable. However, there is concern that simple hysterectomy in women with stage IB1 tumors may adversely impact survival. Overall, the quality of studies available is modest, limiting the conclusions that can be drawn from the available literature.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajog.2020.11.041DOI Listing
April 2021

Association of Neoadjuvant Chemotherapy With Overall Survival in Women With Metastatic Endometrial Cancer.

JAMA Netw Open 2020 12 1;3(12):e2028612. Epub 2020 Dec 1.

Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.

Importance: Although primary debulking surgery (PDS) is often considered the criterion standard for treatment of stage IV endometrial cancer, PDS is associated with significant morbidity and poor survival. Neoadjuvant chemotherapy (NACT) has been proposed as an alternative treatment strategy.

Objective: To determine the use of and outcomes associated with NACT for women with stage IV endometrial cancer.

Design, Setting, And Participants: This cohort study used the National Cancer Database to identify women with stage IV endometrial cancer treated from January 1, 2010, to December 31, 2015. The cohort was limited to women aged 70 years or younger with minimal comorbidity (comorbidity score = 0). Women were stratified based on receipt of NACT or PDS. A propensity score analysis with inverse probability weighting was performed to balance the clinical characteristics of the groups. Survival was examined using flexible parametric Royston-Parmer models to account for time-varying hazards associated with use of NACT. An intention-to-treat (ITT) analysis was performed, as was a per-protocol (PP) analysis that included only women who received treatment with both chemotherapy and surgery (in either sequence). Data were analyzed from March 15, 2018, to July 20, 2018.

Main Outcomes And Measures: Use of NACT and overall survival.

Results: Of a total of 4890 women (median age, 60 years [interquartile range, 54-65 years]) with stage IV endometrial cancer, NACT was used in 952 women (19.5%). Use of NACT increased from 106 of 661 women (16.0%; 95% CI, 13.2%-18.8%) in 2010 to 224 of 938 women (23.9%; 95% CI, 21.2%-26.6%) in 2015 (P < .001). In a multivariate model, more recent year of diagnosis (risk ratio [RR], 1.42; 95% CI, 1.21-1.79 for 2015 vs 2010), stage IVB disease (RR, 1.31; 95% CI, 1.03-1.67 for stage IVB vs IVA), and serous histology (RR, 1.38; 95% CI, 1.13-1.69 for serous vs endometrioid histology) were associated with use of NACT. In a propensity score-balanced cohort, use of NACT displayed a time-varying association with survival. In the ITT analysis, use of NACT was associated with decreased mortality for the first 3 months after diagnosis (hazard ratio [HR] at 2 months, 0.81; 95% CI, 0.66-0.99). After 4 months, the survival curves crossed, and receipt of NACT was associated with increased mortality (HR at 6 months, 1.23; 95% CI, 1.09-1.39). In the PP analysis, use of NACT was associated with decreased mortality for the first 8 months after diagnosis (HR at 6 months, 0.79; 95% CI, 0.63-0.98). After 9 months, the survival curves crossed, and receipt of NACT was associated with increased mortality (HR at 12 months, 1.22; 95% CI, 1.04-1.43).

Conclusions And Relevance: The results of this cohort study suggest that women treated with PDS are at increased risk of early death but have a more favorable long-term prognosis. In contrast, results suggest that women treated with NACT, particularly if they ultimately undergo surgery, may have superior survival in the short term. Based on these findings, NACT may be appropriate for select patients with advanced uterine serous carcinoma.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.28612DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726635PMC
December 2020

The Role of Minimally Invasive Surgery in the Care of Women with Ovarian Cancer: A Systematic Review and Meta-analysis.

J Minim Invasive Gynecol 2021 03 14;28(3):537-543. Epub 2020 Nov 14.

Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian/Columbia University Irving Medical Center, New York, New York (all authors).. Electronic address:

Objective: To synthesize evidence from studies investigating survival outcomes for patients with ovarian cancer undergoing minimally invasive surgery (traditional or robotic laparoscopy) compared with those for patients with ovarian cancer undergoing laparotomy.

Data Sources: We searched Ovid MEDLINE and Embase (from inception to December 2019).

Methods Of Study Selection: Observational cohort studies and randomized controlled trials that compared risk of recurrence or death between women undergoing minimally invasive and open procedures for staging (10), interval cytoreduction (4), secondary cytoreduction (2), and evaluation of resectability (1) were included.

Tabulation, Integration, And Results: Data on the number of participants, number of deaths and recurrences, and results of analyses of overall or progression-free survival were abstracted for all studies. A random-effects meta-analysis was used to pool the results of studies comparing minimally invasive staging and open staging. The surgical approach (minimally invasive versus open) was not significantly associated with hazard of death or recurrence (pooled hazard ratio 0.92; 95% confidence interval, 0.61-1.38) or all-cause mortality (pooled hazard ratio 0.96; 95% confidence interval, 0.49-1.89). One randomized trial demonstrated that diagnostic laparoscopy could triage patients to neoadjuvant chemotherapy and avoid suboptimal primary surgery, without affecting recurrence-free or overall survival. Most studies included in this review were observational and at high risk for bias, and few studies accounted for potential confounding.

Conclusion: Although existing studies do not demonstrate deleterious survival effects associated with minimally invasive surgery for ovarian cancer, these data must be viewed with caution given the significant methodologic shortcomings in the existing literature.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jmig.2020.11.007DOI Listing
March 2021

Employment disruption following the diagnosis of endometrial cancer.

Gynecol Oncol 2021 01 9;160(1):199-205. Epub 2020 Nov 9.

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address:

Background: Oncologic treatment has been associated with unemployment. As endometrial cancer is highly curable, it is important to assess whether patients experience employment disruption after treatment. We evaluated the frequency of employment change following endometrial cancer diagnosis and assessed factors associated with it.

Methods: A cohort of patients 18-63 years-old who were diagnosed with endometrial cancer (January 2009-December 2017) were identified in the Truven MarketScan database, an insurance claims database of commercially insured patients in the United States. All patients who were working full- or part-time at diagnosis were included and all employment changes during the year following diagnosis were identified. Clinical information, including use of chemotherapy and radiation, were identified using Common Procedural Terminology codes, and International Statistical Classification of Diseases codes. Cox proportional hazards models incorporating measured covariates were used to evaluate the impact of treatment and demographic variables on change in employment status.

Results: A total of 4381 women diagnosed with endometrial cancer who held a full-time or part-time job 12 months prior to diagnosis were identified. Median age at diagnosis was 55 and a minority of patients received adjuvant therapy; 7.9% received chemotherapy, 4.9% received external-beam radiation therapy, and 4.1% received chemoradiation. While most women continued to work following diagnosis, 21.7% (950) experienced a change in employment status. The majority (97.7%) of patients had a full-time job prior to diagnosis. In a multivariable analysis controlling for age, region of residence, comorbidities, insurance plan type and presence of adverse events, chemoradiation recipients were 34% more likely to experience an employment change (HR 1.34, 95% CI 1.01-1.78), compared to those who only underwent surgery.

Conclusion: Approximately 22% of women with employer-subsidized health insurance experienced a change in employment status following the diagnosis of endometrial cancer, an often-curable disease. Chemoradiation was an independent predictor of change in employment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2020.10.041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7779695PMC
January 2021

Placental cord insertion distance from the placental margin and its association with adverse perinatal outcomes.

Eur J Obstet Gynecol Reprod Biol 2020 Dec 10;255:51-55. Epub 2020 Oct 10.

Icahn School of Medicine at Mount Sinai, Department of Obstetrics, Gynecology, and Reproductive Science, Division of Maternal-Fetal Medicine, One Gustave L. Levy Place, New York, NY 10029, USA.

Objective: The placental cord insertion (PCI) to the placental margin has not been well studied as a continuous variable in relation to birth outcomes. We sought to evaluate the impact of PCI distance on outcomes associated with placental function and development of fetal growth restriction (FGR).

Study Design: This was a retrospective study of singleton gestations that underwent a fetal anatomy ultrasound from 2011-2013. The PCI was recorded as the distance in centimeters from the placental margin. Patients had FGR if the overall estimated fetal weight was <10 % for gestational age or abdominal circumference <5 % in the third trimester. Delivery, obstetric, and neonatal outcomes were obtained via medical chart review. Logistic and linear regression models were used to assess the impact of PCI distance on maternal and neonatal delivery outcomes.

Results: Of the 1443 women who met inclusion criteria, 93.6 % delivered at term. The mean (±SD) PCI distance was 4.4 ± 1.4 cm. There was no association between PCI and cesarean delivery, peripartum hemorrhage (PPH), pre-eclampsia, 5-min Apgar, or intrauterine fetal demise. PCI distance was statistically significantly shorter in patients requiring neonatal intensive care unit (NICU) admission (4.1 ± 1.5 cm vs. 4.4 ± 1.4 cm, p = 0.02) and was associated with lower birthweight (p = 0.01), though this association was no longer seen when corrected for gestational age. There were 3.5 % of patients who developed FGR; PCI distances from the placental edge were not significantly different for patients who developed FGR compared to those who did not (4.2 ± 1.4 cm vs. 4.5 ± 1.4 cm, p = 0.18). Furthermore, a receiver operating characteristic (ROC) curve for PCI had poor sensitivity (area under the curve [AUC] 0.57, 95 % CI 0.49-0.65).

Conclusion: PCI distance at the time of fetal anatomic survey is significantly associated with NICU admission, though does not appear to impact rates of preterm birth, pre-eclampsia, PPH or cesarean delivery. PCI distance in singleton gestations does not appear to be predictive of FGR.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejogrb.2020.10.006DOI Listing
December 2020

Perioperative Morbidity and Mortality of Patients With COVID-19 Who Undergo Urgent and Emergent Surgical Procedures.

Ann Surg 2021 01;273(1):34-40

Columbia University Vagelos College of Physicians and Surgeons, New York City, New York.

Objective: To evaluate the perioperative morbidity and mortality of patients with COVID-19 who undergo urgent and emergent surgery.

Summary Background Data: Although COVID-19 infection is usually associated with mild disease, it can lead to severe respiratory complications. Little is known about the perioperative outcomes of patients with COVID-19.

Methods: We examined patients who underwent urgent and emergent surgery at 2 hospitals in New York City from March 17 to April 15, 2020. Elective surgical procedures were cancelled throughout and routine, laboratory based COVID-19 screening was instituted on April 1. Mortality, complications, and admission to the intensive care unit were compared between patients with COVID-19 detected perioperatively and controls.

Results: Among 468 subjects, 36 (7.7%) had confirmed COVID-19. Among those with COVID-19, 55.6% were detected preoperatively and 44.4% postoperatively. Before the routine preoperative COVID-19 laboratory screening, 7.7% of cases were diagnosed preoperatively compared to 65.2% after institution of screening (P = 0.0008). The perioperative mortality rate was 16.7% in those with COVID-19 compared to 1.4% in COVID-19 negative subjects [aRR = 9.29; 95% confidence interval (CI), 5.68-15.21]. Serious complications were identified in 58.3% of COVID-19 subjects versus 6.0% of controls (aRR = 7.02; 95%CI, 4.96-9.92). Cardiac arrest, sepsis/shock, respiratory failure, pneumonia, acute respiratory distress syndrome, and acute kidney injury were more common in those with COVID-19. The intensive care unit admission rate was 36.1% in those with COVID-19 compared to 16.4% of controls (aRR = 1.34; 95%CI, 0.86-2.09).

Conclusions: COVID-19 is associated with an increased risk for serious perioperative morbidity and mortality. A substantial number of patients with COVID-19 are not identified until after surgery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/SLA.0000000000004420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737869PMC
January 2021

Palliative care referral patterns and measures of aggressive care at the end of life in patients with cervical cancer.

Int J Gynecol Cancer 2021 Jan 12;31(1):66-72. Epub 2020 Oct 12.

Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA

Introduction: Fifteen per cent of women with cervical cancer are diagnosed with advanced disease and carry a 5 year survival rate of only 17%. Cervical cancer may lead to particularly severe symptoms that interfere with quality of life, yet few studies have examined the rate of palliative care referral in this population. This study aims to examine the impact of palliative care referral on women who have died from cervical cancer in two tertiary care centers.

Methods: We conducted a retrospective review of cervical cancer decedents at two tertiary institutions from January 2000 to February 2017. We examined how aggressive measures of care at the end of life, metrics defined by the National Quality Forum, interacted with clinical variables to understand if end-of-life care was affected. Univariate and multivariate parametric and non-parametric testing was used, and linear regression models were generated to determine unadjusted and adjusted associations between aggressive measures of care at the end of life with receipt of palliative care as the main exposure.

Results: Of 153 cervical cancer decedents, 73 (47%) received a palliative care referral and the majority (57%) of referrals occurred during an inpatient admission. The median time from palliative care consultation to death was 2.3 months and 34% were referred to palliative care in the last 30 days of life. Palliative care referral was associated with fewer emergency department visits (OR 0.18, 95% CI 0.05 to 0.56), inpatient stays (OR 0.21, 95% CI 0.07 to 0.61), and intensive care unit admissions (OR 0.24, 95% CI 0.06 to 0.93) in the last 30 days of life. Palliative care did not affect chemotherapy or radiation administration within 14 days of death (p=0.36). Women evaluated by palliative care providers were less likely to die in the acute care setting (OR 0.19, 95% CI 0.07 to 0.51).

Discussion: In two tertiary care centers, less than half of cervical cancer decedents received palliative care consultations, and those referred to palliative care were often evaluated late in their disease course. Palliative care utilization was also associated with a lower incidence of poor-quality end-of-life care.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/ijgc-2020-001812DOI Listing
January 2021

Using machine learning to create prognostic systems for endometrial cancer.

Gynecol Oncol 2020 12 2;159(3):744-750. Epub 2020 Oct 2.

Columbia University, Vagelos College of Physicians and Surgeons, United States of America; Herbert Irving Comprehensive Cancer Center, United States of America; NewYork-Presbyterian Hospital, United States of America. Electronic address:

Objective: We used a novel machine learning algorithm to develop a precision prognostication system for endometrial cancer.

Methods: The Ensemble Algorithm for Clustering Cancer Data (EACCD) unsupervised machine learning algorithm was applied to women with endometrioid endometrial cancer in the Surveillance, Epidemiology, and End Results database from 2004 to 2015. The prognostic system was created based on TNM stage, grade, and age. The concordance (C-index) was used to cut dendrograms and create prognostic groups. Kaplan-Meier cancer-specific survival was employed to visualize the survival function of EACCD-based prognostic groups and AJCC groups.

Results: A total of 46,773 women were identified. Using the machine learning algorithm with TNM stage, grade, and three age groups, eleven prognostic groups were generated with a C-index of 0.8380. The five-year survival rates for the eleven groups ranged from 37.9-99.8%. To simplify the classification system further, using visual inspection of the data we created a modified EACCD grouping, and combined the top six survival groups into three new prognostic groups. The new five-year survival rates for these eight modified prognostic groups included: 99.1% for group 1, 96.5% for group 2, 92.2% for group 3, 84.8% for group 4, 72.7% for group 5, 61.1% for group 6, 52.6% for group 7, and 37.9% for group 8. The C-index for the modified eight prognostic groups was 0.8313.

Conclusion: This novel machine learning algorithm demonstrates improved prognostic prediction for patients with endometrial cancer. Using machine learning for endometrial cancer allows for the integration of multiple factors to develop a precision prognostication system.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2020.09.047DOI Listing
December 2020

Toxicity after adjuvant therapy for stage III uterine cancer.

Gynecol Oncol 2020 12 30;159(3):737-743. Epub 2020 Sep 30.

Columbia University Vagelos College of Physicians and Surgeons, USA; Herbert Irving Comprehensive Cancer Center, USA; NewYork-Presbyterian Hospital, USA. Electronic address:

Objective: The optimal adjuvant therapy for stage III endometrial cancer is unknown. Studies have suggested that combination therapy with chemotherapy and radiation is associated with improved survival. We examined early and late-term toxicities associated with chemotherapy (CT), external beam radiotherapy (RT), or combination chemoradiotherapy for stage III uterine cancer.

Methods: The SEER-Medicare database was used to identify women age ≥ 65 years with stage III uterine cancer who received adjuvant CT, RT, or chemoradiotherapy from 2000 to 2015. The associations between therapy and early and late-term toxicities identified with billing claims, hospitalizations and emergency department visits were examined using multivariable regression models.

Results: A total of 2185 patients were identified including 574 (26.3%) who received CT, 636 (29.1%) who received RT, and 975 (44.6%) who received chemoradiotherapy. The proportion of patients receiving chemoradiotherapy or CT increased over time. During the first 6 and 12 months of adjuvant therapy, RT was associated with a lower risk of early-term toxicity compared to chemoradiotherapy (aRR = 0.59, 95%CI 0.49-0.70 and aRR = 0.76, 95%CI 0.67-0.86, respectively) while CT shared a similar risk of early toxicities as chemoradiotherapy. CT and RT shared a similar risk of late-term toxicities compared to chemoradiotherapy. CT and RT alone were associated with a higher hazard for overall mortality than chemoradiotherapy (aHR = 1.27, 95% CI 1.10-1.47 and aHR = 1.25, 95% CI 1.08-1.44, respectively).

Conclusion: Chemoradiotherapy is associated with lower mortality compared to single modality therapy and has a similar risk of early and late term toxicities compared to CT, though higher risk of early toxicities compared to RT.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2020.09.033DOI Listing
December 2020

Trends in Primary Treatment and Median Survival Among Women With Advanced-Stage Epithelial Ovarian Cancer in the US From 2004 to 2016.

JAMA Netw Open 2020 09 1;3(9):e2017517. Epub 2020 Sep 1.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian/Columbia University Irving Medical Center, New York.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1001/jamanetworkopen.2020.17517DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7519417PMC
September 2020

Cost of care for the initial management of cervical cancer in women with commercial insurance.

Am J Obstet Gynecol 2021 03 17;224(3):286.e1-286.e11. Epub 2020 Aug 17.

Columbia University College of Physicians and Surgeons, New York, NY; Herbert Irving Comprehensive Cancer Center, Columbia University, New York, NY; NewYork-Presbyterian Hospital, New York, NY. Electronic address:

Background: Women with newly diagnosed cervical cancer are often treated with extensive, multimodal therapies that may include a combination of surgery, radiation, and chemotherapy. Little is known about the cost of treatment or how these costs are passed on to the patients.

Objective: The objectives of this study were to examine the cost of care during the first year after a diagnosis of cervical cancer, to estimate the sources of the costs, and to explore the out-of-pocket costs.

Study Design: We performed a study of women with commercial insurance who received a new diagnosis of cervical cancer, and whose cases were recorded in the MarketScan database from 2008 to 2016. Patients were categorized based on the primary treatment received being either surgery (hysterectomy with or without adjuvant radiation or chemotherapy) or radiation. The inflation-adjusted medical expenditures for a 12-month period beginning on the date of the first treatment were estimated. The payments were divided into the expenditures of inpatient care, outpatient care (including chemotherapy), and outpatient pharmacy costs. The out-of-pocket costs incurred by the patients in the form of copayments, coinsurance, and deductibles were estimated.

Results: A total of 4495 patients, including 3014 (67%) who underwent surgery and 1481 (33%) who primarily underwent radiotherapy, were identified. The median total expenditure per patient during the first year after the diagnosis was $56,250 (interquartile range, $25,767-$107,532). The median total expenditure for patients with surgery as the primary treatment was $37,222 (interquartile range, $20,957-$75,555). The median total expenditure for patients treated primarily with radiotherapy was $101,266 (interquartile range, $63,155-$160,760). For patients treated primarily with surgery, inpatient services accounted for $15,145 (interquartile range, $0-$26,898), outpatient services accounted for $18,430 (interquartile range, $5354-$48,047), and outpatient pharmacy costs accounted for $628 (interquartile range, $141-$1847). The median cost for those women who did not require adjuvant therapy was $26,164 compared with $89,760 for women treated with adjuvant radiation. The median out-of-pocket costs for the cohort was $2253 (interquartile range, $1137-$3990) or 3.9% of the total costs.

Conclusion: The cost of care for women with newly diagnosed cervical cancer is substantial. Overall, patients are responsible for approximately 3.9% of the costs in the form of out-of-pocket expenditures.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ajog.2020.08.039DOI Listing
March 2021

The effect of guideline-concordant care in mitigating insurance status disparities in cervical cancer.

Gynecol Oncol 2020 11 14;159(2):309-316. Epub 2020 Aug 14.

Columbia University College of Physicians and Surgeons, USA; Herbert Irving Comprehensive Cancer Center, USA; New York Presbyterian Hospital, USA. Electronic address:

Objective: To evaluate whether the receipt of evidence-based care could mitigate survival disparities among Medicaid recipients and uninsured women with cervical cancer.

Methods: The National Cancer Database was utilized to identify women with cervical cancer treated from 2004 to 2016. Eight quality metrics were determined. Survival outcomes were examined stratified by insurance status and stage. To measure the impact of guideline-concordant care on the mitigation of disparities, we compared survival outcomes of the overall cohort to one that was perfectly adherent to all quality metrics.

Results: A total of 103,400 patients were identified; 47.0% of patients had private insurance, 21.5% Medicaid and 9.2% uninsured. Medicaid and uninsured patients were significantly less likely than privately insured patients to receive timely completion of radiation and timely initiation of treatment; uninsured patients were also significantly less likely to receive treatment for locally advanced disease. Medicaid and uninsured patients were also less likely to receive lymph node assessment and primary chemoradiation. Medicaid and uninsured patients had an increased risk of mortality compared to privately insured patients (aHR = 1.36, 95% CI 1.31-1.41 and aHR 1.29, 95% CI 1.23-1.36 respectively). While the receipt of these quality metrics was associated with improved survival, Medicaid and uninsured women who received guideline-concordant care were still at an increased risk of death compared to women with private insurance (aHR = 1.38, 95% CI 1.35-1.49 and aHR = 1.24; 95% CI, 1.16-1.32 respectively).

Conclusion: Medicaid and uninsured patients were less likely to receive evidence-based care and were at increased risk of mortality at all stages compared to privately insured patients. The receipt of quality care does not eliminate insurance status-based disparities among women with cervical cancer.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ygyno.2020.08.006DOI Listing
November 2020

Time to accept a new old standard of care in cervical cancer.

Int J Gynecol Cancer 2020 09 12;30(9):1278-1279. Epub 2020 Aug 12.

Department of Obstetrics and Gynecology and Herbert Irving Comprehensive Cancer Center, Columbia University Vagelos College of Physicians and Surgeons, New York, New York, USA

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/ijgc-2020-001870DOI Listing
September 2020

Coronavirus Spectrum Infections (COVID-19, MERS, SARS) in Cancer Patients: A Systematic Review of the Literature.

Cancer Invest 2020 Sep 5;38(8-9):436-444. Epub 2020 Oct 5.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York, USA.

Background: Coronavirus 2019 (COVID-19) has spread rapidly around the world to become a global pandemic. There is limited data on the impact of COVID-19 among patients with cancer.

Methods: A systematic review was performed to determine outcomes of adult patients with cancer affected by coronavirus infections, specifically SARS, MERS, and COVID-19. Studies were independently screened by two reviewers and assessed for quality and bias. Outcomes measured included study characteristics, cancer type, phase of care at the time of diagnosis, and clinical presentation. Morbidity and mortality outcomes were analyzed to assess the severity of infection as compared to the general population.

Results: A total of 19 studies with 110 patients were included. Of these, 66.4% had COVID-19 infections, 32.7% MERS and only one patient with SARS. The majority of COVID-19 studies were based on studies in China. There was a 56.6% rate of a severe event, including ICU admission or requiring mechanical ventilation, with an overall 44.5% fatality rate.

Conclusions: Patients with cancer with coronavirus infections may be more susceptible to higher morbidity and mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/07357907.2020.1809668DOI Listing
September 2020

Trends in venous thromboembolism prophylaxis in gynecologic surgery for benign and malignant indications.

Arch Gynecol Obstet 2020 10 29;302(4):935-945. Epub 2020 Jul 29.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, 161 Fort Washington Ave, 8th Floor, New York, NY, 10032, USA.

Purpose: Venous thromboembolism (VTE) is a leading cause of perioperative morbidity and mortality. We analyzed the trends in use of VTE prophylaxis over time in women undergoing hysterectomy for both benign and malignant indications.

Methods: The Premier Database was used to identify women who underwent hysterectomy from 2011 to 2017. Women were stratified by indication for surgery (benign or malignant) and route of hysterectomy. VTE prophylaxis was classified as none, mechanical, pharmacologic, or combination (mechanical and pharmacologic). Trends in use of prophylaxis over time were analyzed. Multivariate models were developed to examine predictors of use of prophylaxis.

Results: Among 920,477 patients identified, 579,824 (63.0%) received VTE prophylaxis, including 15.4% who received pharmacologic, 34.5% who received mechanical, and 13.1% who received combination prophylaxis. Overall use of prophylaxis declined annually from 68.1% in 2011 to 56.7% in 2017 (P < 0.001). Among patients with cancer, the use of prophylaxis declined from 84.5% in 2011 to 78.6% in 2017 (P < 0.001). A similar trend was noted among women with benign conditions, with rates of prophylaxis declining from 66.2 to 53.3% (P < 0.001). Additionally, use of prophylaxis declined for patients undergoing MIS hysterectomy from 65.4% in 2011 to 53.3% in 2017, and from 73.1 to 66.7% in patients who underwent abdominal hysterectomy. Among patients with cancer, rates of pharmacologic and combined prophylaxis was 70.9% in 2011 and 69.7% in 2017. However, among women with benign conditions, the rates of pharmacologic and combined prophylaxis rose from 19.4% in 2011 to 25.6% in 2017 (P < 0.001). Despite these changes in prophylaxis rates and methods, there was no significant change in the rate of VTE between 2011 and 2017 (P = 0.06).

Conclusion: Despite the lack of change in guidelines for VTE prophylaxis in gynecologic surgery, the overall rates of prophylaxis decreased over time independent of the indication or route of surgery. The rates of thromboembolic events did not significantly increase in response to the decreased use of VTE prophylaxis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00404-020-05678-0DOI Listing
October 2020

Influence of Race and Ethnicity on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection Rates and Clinical Outcomes in Pregnancy.

Obstet Gynecol 2020 11;136(5):1040-1043

Division of Maternal-Fetal Medicine and the Division of Gynecological Oncology, Department of Obstetrics and Gynecology, and the Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, NewYork-Presbyterian Hospital, and the Department of Epidemiology, Columbia University Mailman School of Public Health, New York, New York.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1097/AOG.0000000000004088DOI Listing
November 2020

Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE).

Int J Gynecol Cancer 2020 09 20;30(9):1450-1454. Epub 2020 Jul 20.

Department of Women's and Children's Health, Policlinico A Gemelli, Rome, Italy.

Background: Observational studies have supported the practice of offering minimally invasive interval debulking surgery after neoadjuvant chemotherapy for well-selected patients with advanced epithelial ovarian cancer. However, there are no prospective randomized data comparing the oncologic efficacy of minimally invasive and open interval debulking surgery in epithelial ovarian cancer.

Primary Objective: The primary objective of this study is to examine whether minimally invasive surgery is non-inferior to laparotomy in terms of disease-free survival in women with advanced stage epithelial ovarian cancer that responded to three or four cycles of neoadjuvant chemotherapy.

Study Hypothesis: We hypothesize that in patients who had a complete or partial response to neoadjuvant chemotherapy, minimally invasive interval debulking surgery is not inferior to laparotomy.

Trial Design: The Laparoscopic cytoreduction After Neoadjuvant ChEmotherapy (LANCE) trial is an international, prospective, randomized, multicenter, non-inferiority phase III trial to compare minimally invasive surgery vs laparotomy in women with advanced stage high-grade epithelial ovarian cancer that had a complete or partial response to three or four cycles of neoadjuvant chemotherapy and normalization of CA-125. The first 100 participants will be enrolled into a pilot lead-in to determine feasibility. The study will be considered feasible and will continue to Phase III under the following conditions: the accrual rate reaches at least 80% of the target rate after all pilot sites are open; the crossover rate in the minimally invasive group is less than 25%; and the difference of complete gross resection between the minimally invasive and open group is less than 20%. If the study is determined to be feasible, all remaining participants will be enrolled into the Phase III stage.

Major Inclusion/exclusion Criteria: Patients with stage IIIC or IV high-grade epithelial ovarian, primary peritoneal or fallopian tube carcinoma who had a complete or partial response to three or four cycles of neoadjuvant chemotherapy based on imaging and normalization of CA-125 will be enrolled. Patients with evidence of tumor not amenable to minimally invasive resection on pre-operative imaging will be excluded.

Primary Endpoint: The primary endpoint is non-inferiority of disease-free survival in minimally invasive vs laparotomic interval debulking surgery.

Sample Size: To demonstrate non-inferiority with a margin of 33% in the hazard ratio (HR=1.33), 549 patients will be randomized.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/ijgc-2020-001584DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493891PMC
September 2020