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1.
Am J Obstet Gynecol ; 230(6): 663.e1-663.e13, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38365097

ABSTRACT

BACKGROUND: Cervical cancer incidence among premenopausal women is rising, and fertility-sparing surgery serves as an important option for this young population. There is a lack of evidence on what tumor size cutoff should be used to define candidacy for fertility-sparing surgery. OBJECTIVE: We sought to describe how the association between fertility-sparing surgery (compared with standard surgery) and life expectancy varies by tumor size among patients with cervical cancers measuring ≤4 cm in largest diameter. Our secondary objective was to quantify the probability of undergoing adjuvant radiotherapy among patients who underwent fertility-sparing surgery as a function of tumor size. STUDY DESIGN: We identified patients in the National Cancer Database aged ≤45 years, diagnosed with stage I cervical cancer with tumors ≤4 cm between 2006 and 2018, who received no preoperative radiation or chemotherapy, and who underwent either fertility-sparing surgery (cone or trachelectomy, either simple or radical) or standard surgery (simple or radical hysterectomy) as their primary treatment. Propensity-score matching was performed to compare patients who underwent fertility-sparing surgery with those who underwent standard surgery. A flexible parametric model was employed to quantify the difference in life expectancy within 5 years of diagnosis (restricted mean survival time) based on tumor size among patients who underwent fertility-sparing and those who underwent standard surgery. In addition, among those who underwent fertility-sparing surgery, a logistic regression model was used to explore the relationship between tumor size and the probability of receiving adjuvant radiation. RESULTS: A total of 11,946 patients met the inclusion criteria of whom 904 (7.6%) underwent fertility-sparing surgery. After propensity-score matching, 897 patients who underwent fertility-sparing surgery were matched 1:1 with those who underwent standard surgery. Although the 5-year life expectancy was similar among patients who had fertility sparing surgery and those who had standard surgery regardless of tumor sizes, the estimates of life-expectancy differences associated with fertility-sparing surgery were more precise among patients with smaller tumors (1-cm tumor: restricted mean survival time difference, -0.10 months; 95% confidence interval, -0.67 to 0.47) than among those with larger tumors (4-cm tumor: restricted mean survival time difference, -0.11 months; 95% confidence interval, -3.79 to 3.57). The probability of receiving adjuvant radiation increased with tumor size, ranging from 5.6% (95% confidence interval, 3.9-7.9) for a 1-cm tumor to 37% (95% confidence interval, 24.3-51.8) for a 4-cm tumor. CONCLUSION: Within 5 years of diagnosis, young patients with stage I cancers measuring ≤4 cm had similar survival outcomes after either fertility-sparing surgery or standard surgery. However, because few patients with tumors >2 cm underwent fertility-sparing surgery, a clinically important survival difference could not be excluded in this population.


Subject(s)
Fertility Preservation , Hysterectomy , Life Expectancy , Neoplasm Staging , Trachelectomy , Tumor Burden , Uterine Cervical Neoplasms , Humans , Female , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/pathology , Uterine Cervical Neoplasms/mortality , Fertility Preservation/methods , Adult , Hysterectomy/methods , Trachelectomy/methods , Radiotherapy, Adjuvant , Conization/methods , Propensity Score , Middle Aged
2.
Am J Obstet Gynecol ; 230(1): 69.e1-69.e10, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37690596

ABSTRACT

BACKGROUND: After the publication of the Laparoscopic Approach to Cervical Cancer trial, the standard surgical approach for early-stage cervical cancer is open radical hysterectomy. Only limited data were available regarding whether the change to open abdominal hysterectomy observed after the Laparoscopic Approach to Cervical Cancer trial led to an increase in postoperative complication rates as a consequence of the decrease in the use of the minimally invasive approach. OBJECTIVE: This study aimed to analyze whether there was a correlation between the publication of the Laparoscopic Approach to Cervical Cancer trial and an increase in the 30-day complications associated with surgical treatment of invasive cervical cancer. STUDY DESIGN: Data from the American College of Surgeons National Surgical Quality Improvement Program were used to compare the results in the pre-Laparoscopic Approach to Cervical Cancer period (January 2016 to December 2017) vs the results in the post-Laparoscopic Approach to Cervical Cancer period (January 2019 to December 2020). The rates of each surgical approach (open abdominal or minimally invasive) hysterectomy for invasive cervical cancer during the 2 periods were assessed. Subsequently, 30-day major complication, minor complication, unplanned hospital readmission, and intra- or postoperative transfusion rates before and after the publication of the Laparoscopic Approach to Cervical Cancer trial were compared. RESULTS: Overall, 3024 patients undergoing either open abdominal hysterectomy or minimally invasive hysterectomy for invasive cervical cancer were included in the study. Of the patients, 1515 (50.1%) were treated in the pre-Laparoscopic Approach to Cervical Cancer period, and 1509 (49.9%) were treated in the post-Laparoscopic Approach to Cervical Cancer period. The rate of minimally invasive approaches decreased significantly from 75.6% (1145/1515) in the pre-Laparoscopic Approach to Cervical Cancer period to 41.1% (620/1509) in the post-Laparoscopic Approach to Cervical Cancer period, whereas the rate of open abdominal approach increased from 24.4% (370/1515) in the pre-Laparoscopic Approach to Cervical Cancer period to 58.9% (889/1509) in the post-Laparoscopic Approach to Cervical Cancer period (P<.001). The overall 30-day major complications remained stable between the pre-Laparoscopic Approach to Cervical Cancer period (85/1515 [5.6%]) and the post-Laparoscopic Approach to Cervical Cancer period (74/1509 [4.9%]) (adjusted odds ratio, 0.85; 95% confidence interval, 0.61-1.17). The overall 30-day minor complications were similar in the pre-Laparoscopic Approach to Cervical Cancer period (103/1515 [6.8%]) vs the post-Laparoscopic Approach to Cervical Cancer period (120/1509 [8.0%]) (adjusted odds ratio, 1.17; 95% confidence interval, 0.89-1.55). The unplanned hospital readmission rate remained stable during the pre-Laparoscopic Approach to Cervical Cancer period (7.9% per 30 person-days) and during the post-Laparoscopic Approach to Cervical Cancer period (6.3% per 30 person-days) (adjusted hazard ratio, 0.78; 95% confidence interval, 0.58-1.04)]. The intra- and postoperative transfusion rates increased significantly from 3.8% (58/1515) in the pre-Laparoscopic Approach to Cervical Cancer period to 6.7% (101/1509) in the post-Laparoscopic Approach to Cervical Cancer period (adjusted odds ratio, 1.79; 95% confidence interval, 1.27-2.53). CONCLUSION: This study observed a significant shift in the surgical approach for invasive cervical cancer after the publication of the Laparoscopic Approach to Cervical Cancer trial, with a reduction in the minimally invasive abdominal approach and an increase in the open abdominal approach. The change in surgical approach was not associated with an increase in the rate of 30-day major or minor complications and unplanned hospital readmission, although it was associated with an increase in the transfusion rate.


Subject(s)
Laparoscopy , Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/complications , Hysterectomy/methods , Postoperative Complications/etiology , Patient Readmission , Laparoscopy/methods , Retrospective Studies
3.
Am J Obstet Gynecol ; 230(2): 241.e1-241.e18, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37827271

ABSTRACT

BACKGROUND: There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. OBJECTIVE: This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. STUDY DESIGN: We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. RESULTS: The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. CONCLUSION: Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.


Subject(s)
Hysterectomy , Patient Reported Outcome Measures , Humans , Female , Prospective Studies , Hysterectomy/methods , Abdominal Pain , Fatigue/epidemiology , Minimally Invasive Surgical Procedures
4.
Int J Gynecol Cancer ; 2024 Jul 02.
Article in English | MEDLINE | ID: mdl-38858104

ABSTRACT

In the last decade, we have witnessed important advances in novel therapeutics in the management of gynecologic cancers. These studies have built on the findings from preexisting data and have provided incremental contributions leading to changes that have not only impacted the accuracy of cancer detection and its metastatic components but also led to improvements in oncologic outcomes and quality of life. Key landmark trials have changed the standard of care in cervix, uterine, and ovarian cancer. A number of these have been controversial and have generated significant debate among gynecologic oncologists. The main objective of this review was to provide an overview on each of these trials as a reference for immediate and consolidated access to the study aims, methodology, results, and conclusion.

5.
Int J Gynecol Cancer ; 34(5): 669-674, 2024 May 06.
Article in English | MEDLINE | ID: mdl-38627032

ABSTRACT

OBJECTIVE: To determine if reviewer experience impacts the ability to discriminate between human-written and ChatGPT-written abstracts. METHODS: Thirty reviewers (10 seniors, 10 juniors, and 10 residents) were asked to differentiate between 10 ChatGPT-written and 10 human-written (fabricated) abstracts. For the study, 10 gynecologic oncology abstracts were fabricated by the authors. For each human-written abstract we generated a ChatGPT matching abstract by using the same title and the fabricated results of each of the human generated abstracts. A web-based questionnaire was used to gather demographic data and to record the reviewers' evaluation of the 20 abstracts. Comparative statistics and multivariable regression were used to identify factors associated with a higher correct identification rate. RESULTS: The 30 reviewers discriminated 20 abstracts, giving a total of 600 abstract evaluations. The reviewers were able to correctly identify 300/600 (50%) of the abstracts: 139/300 (46.3%) of the ChatGPT-generated abstracts and 161/300 (53.7%) of the human-written abstracts (p=0.07). Human-written abstracts had a higher rate of correct identification (median (IQR) 56.7% (49.2-64.1%) vs 45.0% (43.2-48.3%), p=0.023). Senior reviewers had a higher correct identification rate (60%) than junior reviewers and residents (45% each; p=0.043 and p=0.002, respectively). In a linear regression model including the experience level of the reviewers, familiarity with artificial intelligence (AI) and the country in which the majority of medical training was achieved (English speaking vs non-English speaking), the experience of the reviewer (ß=10.2 (95% CI 1.8 to 18.7)) and familiarity with AI (ß=7.78 (95% CI 0.6 to 15.0)) were independently associated with the correct identification rate (p=0.019 and p=0.035, respectively). In a correlation analysis the number of publications by the reviewer was positively correlated with the correct identification rate (r28)=0.61, p<0.001. CONCLUSION: A total of 46.3% of abstracts written by ChatGPT were detected by reviewers. The correct identification rate increased with reviewer and publication experience.


Subject(s)
Abstracting and Indexing , Humans , Abstracting and Indexing/standards , Female , Peer Review, Research , Writing/standards , Gynecology , Surveys and Questionnaires , Publishing/statistics & numerical data
6.
Int J Gynecol Cancer ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38876786

ABSTRACT

Surgical site infection rates are among 5-35% in all gynecologic oncology procedures. Such infections lead to increased patient morbidity, reduction in quality of life, higher likelihood of readmissions, and reinterventions, which contribute directly to mortality and increase in health-related costs. Some of these are potentially preventable by applying evidence-based strategies in the peri-operative patient setting. The objective of this review is to provide recommendations for the individual components that most commonly comprise the surgical site infection prevention bundles that could be implemented in gynecologic oncology procedures. We searched articles from relevant publications with specific topics related to each surgical site infection intervention chosen to be reviewed. Studies on each topic were selected with an emphasis on meta-analyses, systematic reviews, randomized control studies, non-randomized controlled studies, reviews, clinical practice guidelines, and case series. Data synthesis was done through content and thematic analysis to identify key themes in the included studies. This review intends to serve as the most up-to-date frame of evidence-based peri-operative care in our specialty and could serve as the first initiative to introduce an enhanced recovery after surgery (ERAS) program.

7.
Int J Gynecol Cancer ; 34(4): 504-509, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38378695

ABSTRACT

OBJECTIVE: The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. METHODS: A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. RESULTS: Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. CONCLUSION: Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been identified based on consensus among international experts. These represent a surgical guide that may be used by surgeons in clinical trials and for quality assurance in routine practice.


Subject(s)
Uterine Cervical Neoplasms , Female , Humans , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/pathology , Lymphatic Metastasis/pathology , Consensus , Lymph Node Excision/methods , Sentinel Lymph Node Biopsy/methods , Indocyanine Green , Lymph Nodes/pathology
8.
Article in English | MEDLINE | ID: mdl-38992749

ABSTRACT

STUDY OBJECTIVE: To characterize robotic surgery publications in gynecologic oncology, and to identify factors associated with high citation metrics. DESIGN: A cross-sectional study SETTING: Original articles on robotic surgery in gynecologic oncology. PATIENTS: No patients involved. INTERVENTIONS: Robotic surgeries in gynecologic oncology. MEASUREMENTS AND MAIN RESULTS: We performed PubMed MeSH search for original articles on robotic surgery in gynecologic oncology. We analyzed citation scores and income level of country of publication, as well as factors associated with high citation metrics. Overall, 566 studies during 2005 - 2023 were included. Of those 292, 51.6% were from North America and 182 32.2% from Europe. The leading tumor site studied was endometrial cancer (57.4%). The majority (87.6%) of studies were retrospective and 13 (2.3%) were randomized controlled trials. Most studies (94.2%) originated in high-income countries. Articles from middle-income countries had lower citations per year as compared to high-income countries (median 1.6 vs. 2.5, p=.002) and were published in lower impact factor journals (median 2.6 vs. 4.3, p<.001) when compared with high-income countries. Cervical cancer studies had higher representation in middle-income countries than in high income countries (48.5% vs. 18.4%, p<.001). In a multivariable regression analysis, journal's impact factor [aOR 95% CI 1.26 (1.12-1.40)], cervical cancer topic [aOR 95% CI 3.0 (1.58-5.91)] and North American publications [aOR 95% CI 2.07 (1.08-3.97)] were independently associated with higher number of citations per year. CONCLUSION: The majority of robotic surgery research in gynecologic oncology is retrospective and from high-income countries. Middle-income countries are not as frequently cited and are predominantly in lower impact factor journals.

9.
J Low Genit Tract Dis ; 28(1): 26-31, 2024 Jan 01.
Article in English | MEDLINE | ID: mdl-37924263

ABSTRACT

ABSTRACT: The aim of the study is to assess the recurrence rate (as cervical intraepithelial neoplasia 2+ [CIN2+]) in patients who had a confirmed high-grade squamous intraepithelial lesion (CIN2-3) in a cervical biopsy specimen followed by a negative conization specimen. MATERIALS AND METHODS: A systematic literature review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. Ovid/MEDLINE, Ovid/Embase, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov were searched from inception until January 2023. The study protocol was registered in PROSPERO (ID number CRD42023393951). The search identified 3,089 articles; 1,530 were removed as duplicates, and 1,559 titles and abstracts were assessed for inclusion. The full text of 26 studies was assessed for eligibility, and finally, 12 studies with 1,036 patients were included. All included studies were retrospective cohort studies. A proportion meta-analysis was performed. RESULTS: For patients with negative conization specimens, the recurrence rate as CIN2+ during follow-up was 6% (95% CI, 1.8%-12.1%; I2 = 49.2; p < .0001, 215 patients and 4 studies) in the proportion meta-analysis, ranging from 0.3% to 13.0% for the individual studies. For patients with ≤CIN1 conization specimens, the recurrence rate as CIN2+ during follow-up was 3.6% (95% CI, 1.2%-7%; I2 = 75.1; p < .0001, 991 patients and 10 studies) in the proportion meta-analysis and ranged from 0.6% to 13.0% for the individual studies. CONCLUSIONS: The recurrence rate as CIN2+ for patients with a confirmed high-grade intraepithelial lesion on a cervical biopsy followed by a negative conization specimen is 6%. In patients with negative and CIN1 conization specimens, the recurrence rate is 3.6%.


Subject(s)
Uterine Cervical Dysplasia , Uterine Cervical Neoplasms , Female , Humans , Conization/methods , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/pathology , Retrospective Studies , Cervix Uteri/pathology , Uterine Cervical Dysplasia/pathology , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/pathology
10.
Gynecol Oncol ; 172: 130-137, 2023 05.
Article in English | MEDLINE | ID: mdl-36977622

ABSTRACT

OBJECTIVE: Assess outcomes of interval debulking surgery (IDS) after neoadjuvant chemotherapy via minimally invasive surgery (MIS) compared with laparotomy in patients with advanced epithelial ovarian cancer. METHODS: Patients diagnosed with stage IIIC or IV epithelial ovarian cancer between 2013 and 2018 who received neoadjuvant chemotherapy and IDS were identified in the National Cancer Database. Primary outcome was overall survival. Secondary outcomes were 5-year survival, 30- and 90-day postoperative mortality, extent of surgery, residual disease, hospitalization duration, surgical conversions, and unplanned readmissions. Propensity score matching was used to compare MIS and laparotomy for IDS. Association of treatment approach with overall survival was assessed using Kaplan-Meier method and Cox regression. Sensitivity analysis was conducted for effect of unmeasured confounders. RESULTS: A total of 7897 patients met inclusion criteria; 2021 (25.6%) underwent MIS. Percentage undergoing MIS increased from 20.3%-29.0% over the study period. After propensity score matching, median overall survival was 46.7 months in the MIS group versus 41.0 months in the laparotomy group [hazard ratio (HR) 0.86 (95%CI 0.79-0.94)]. Five-year survival probability was higher in MIS versus laparotomy (38.3% vs 34.8%, p < 0.01). There was lower 30- and 90-day mortality (0.3% vs 0.7% [p = 0.04] and 1.4% vs 2.5% [p = 0.01], respectively), shorter length of stay (median 3 vs 5 days, p < 0.01), lower residual disease (23.9% vs 26.7%, p < 0.01), and lower additional cytoreductive procedures (59.3% vs 70.8%, p < 0.01) in MIS compared to laparotomy, with similar rates of unplanned readmission (2.7% vs 3.1%, p = 0.39). CONCLUSIONS: Patients who undergo IDS by MIS have similar overall survival and decreased morbidity compared with laparotomy.


Subject(s)
Neoadjuvant Therapy , Ovarian Neoplasms , Humans , Female , Carcinoma, Ovarian Epithelial/drug therapy , Carcinoma, Ovarian Epithelial/surgery , Ovarian Neoplasms/drug therapy , Ovarian Neoplasms/surgery , Ovarian Neoplasms/pathology , Cytoreduction Surgical Procedures/methods , Chemotherapy, Adjuvant , Retrospective Studies , Minimally Invasive Surgical Procedures , Neoplasm Staging
11.
Gynecol Oncol ; 177: 157-164, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37703622

ABSTRACT

OBJECTIVE: To assess the diagnostic accuracy of intraoperative SLN frozen section analysis compared with ultrastaging in patients with early-stage cervical cancer. METHODS: A systematic literature review was conducted following the PRISMA checklist. MEDLINE (via Ovid), Embase, and the Cochrane Central Register of Controlled Trials were searched from inception until February 2023. The inclusion criteria were patients with early-stage cervical cancer (2018 FIGO stage I-II), consisting of the histological subtype squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (≥90% of the patients in each study), who underwent SLN detection (with any tracer) and intraoperative frozen section followed by SLN ultrastaging. Randomized controlled trials, prospective and retrospective observational studies were considered. The detection rates and measures of diagnostic accuracy were pooled using a random effects univariate model. A preplanned subgroup meta-analysis was conducted, with isolated tumor cells excluded as positive lymph nodes. The review was registered in PROSPERO (CRD42023397147). RESULTS: The search identified 190 articles, with 153 studies considered potentially eligible after removing duplicates. Fourteen studies met the selection criteria, including a total of 1720 patients. Seven studies were retrospective, and the other seven were prospective. Frozen section analysis detected 159 of 292 (54.5%) patients with lymph node metastases. In 281 patients the type of volume metastasis was reported: 1 of 41 (2.4%) patients had isolated tumor cells, 21 of 78 (26.9%) patients had micrometastases, and 133 of 162 (82.1%) patients had macrometastases. The pooled sensitivity of intraoperative SLN frozen section analysis was 65% (95% CI, 51-77%) for macrometastases, micrometastases, and isolated tumor cells. When we excluded patients with isolated tumor cells, the pooled sensitivity increased to 72% (95% CI, 60-82%). CONCLUSION: SLN frozen section detects 65% of lymph node metastases compared with SLN ultrastaging and may prevent unnecessary radical surgery in some patients with early-stage cervical cancer.

12.
Am J Obstet Gynecol ; 229(2): 140.e1-140.e7, 2023 08.
Article in English | MEDLINE | ID: mdl-37150284

ABSTRACT

BACKGROUND: Venous thromboembolism is a life-threatening complication of surgery. An Enhanced Recovery After Surgery program is a multimodal care pathway that facilitates faster recovery from surgery. The rate of venous thromboembolism after gynecologic surgery on an Enhanced Recovery After Surgery program is unknown. OBJECTIVE: This study aimed to evaluate the rate of venous thromboembolism within 30 days of gynecologic surgery on an Enhanced Recovery After Surgery pathway performed at a cancer center. STUDY DESIGN: Data were collected prospectively on Enhanced Recovery After Surgery pathway gynecologic patients undergoing open surgery (November 3, 2014, to March 31, 2021) and minimally invasive surgery (February 1, 2017, to March 31, 2021). Care was delivered at a tertiary cancer care center located in a large urban area. Patients undergoing emergency surgery or multispecialty surgeries were excluded. Patients undergoing open surgery were to receive heparin prophylaxis before surgery, sequential compression devices during surgery and admission, and low-molecular-weight heparin prophylaxis during admission. If diagnosed with malignancy, patients were to receive extended venous thromboembolism prophylaxis for 28 days after surgery. For minimally invasive surgery, patients received only sequential compression devices during surgery and no heparin prophylaxis before or after surgery. Venous thromboembolism events were included if detected on imaging obtained for symptoms or other indications. Descriptive statistics and bivariate statistical analyses were performed. RESULTS: Of 3329 patients, 1519 (45.6%) underwent laparotomy, 1452 (43.6%) underwent laparoscopy, and 358 (10.8%) underwent robotic surgery. The incidence rates of venous thromboembolism were 0.6% (n=21; 95% confidence interval, 0.4%-0.9%) overall, 1.1% (n=16, 95% confidence interval, 0.6%-1.7%) in the open approach, and 0.3% (n=5; 95% confidence interval, 0.3%-0.6%) in the minimally invasive approach (P=.02). The incidence rates of venous thromboembolism among the 1999 patients with malignancy were 0.9% (n=18; 95% confidence interval, 0.5%-1.4%) overall, 1.4% (n=15; 95% confidence interval, 0.7%-2.2%) in the open approach, and 0.3% (n=3; 95% confidence interval, 0.1%-0.9%) in the minimally invasive approach. The incidence rates of venous thromboembolism among the 1165 patients with benign disease were 0.3% (n=3; 95% confidence interval, 0.1%-0.7%) overall, 0.3% (n=1; 95% confidence interval, 0.0%-1.7%) in the open approach, and 0.2% (n=2; 95% confidence interval, 0.0%-0.9%) in the minimally invasive approach. CONCLUSION: The rate of venous thromboembolism among patients undergoing laparotomy and minimally invasive surgery on an Enhanced Recovery After Surgery pathway was ≤1%. This study established a benchmark for the rate of venous thromboembolism after gynecologic surgery on an Enhanced Recovery After Surgery pathway performed at a cancer center.


Subject(s)
Venous Thromboembolism , Humans , Female , Venous Thromboembolism/epidemiology , Venous Thromboembolism/etiology , Venous Thromboembolism/prevention & control , Gynecologic Surgical Procedures/methods , Hospitalization , Heparin , Minimally Invasive Surgical Procedures/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology
13.
Am J Obstet Gynecol ; 229(4): 428.e1-428.e12, 2023 10.
Article in English | MEDLINE | ID: mdl-37336255

ABSTRACT

BACKGROUND: International guidelines recommend tailoring the radicality of hysterectomy according to the known preoperative tumor characteristics in patients with early-stage cervical cancer. OBJECTIVE: This study aimed to assess whether increased radicality had an effect on 5-year disease-free survival in patients with early-stage cervical cancer undergoing radical hysterectomy. The secondary aims were 5-year overall survival and pattern of recurrence. STUDY DESIGN: This was an international, multicenter, retrospective study from the Surveillance in Cervical CANcer (SCCAN) collaborative cohort. Patients with the International Federation of Gynecology and Obstetrics 2009 stage IB1 and IIA1 who underwent open type B/C1/C2 radical hysterectomy according to Querleu-Morrow classification between January 2007 and December 2016, who did not undergo neoadjuvant chemotherapy and who had negative lymph nodes and free surgical margins at final histology, were included. Descriptive statistics and survival analyses were performed. Patients were stratified according to pathologic tumor diameter. Propensity score match analysis was performed to balance baseline characteristics in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy. RESULTS: A total of 1257 patients were included. Of note, 883 patients (70.2%) underwent nerve-sparing radical hysterectomy, and 374 patients (29.8%) underwent non-nerve-sparing radical hysterectomy. Baseline differences between the study groups were found for tumor stage and diameter (higher use of non-nerve-sparing radical hysterectomy for tumors >2 cm or with vaginal involvement; P<.0001). The use of adjuvant therapy in patients undergoing nerve-sparing and non-nerve-sparing radical hysterectomy was 27.3% vs 28.6%, respectively (P=.63). Five-year disease-free survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 90.1% (95% confidence interval, 87.9-92.2) vs 93.8% (95% confidence interval, 91.1-96.5), respectively (P=.047). Non-nerve-sparing radical hysterectomy was independently associated with better disease-free survival at multivariable analysis performed on the entire cohort (hazard ratio, 0.50; 95% confidence interval, 0.31-0.81; P=.004). Furthermore, 5-year overall survival in patients undergoing nerve-sparing vs non-nerve-sparing radical hysterectomy was 95.7% (95% confidence interval, 94.1-97.2) vs non-nerve-sparing 96.5% (95% confidence interval, 94.3-98.7), respectively (P=.78). In patients with a tumor diameter ≤20 mm, 5-year disease-free survival was 94.7% in nerve-sparing radical hysterectomy vs 96.2% in non-nerve-sparing radical hysterectomy (P=.22). In patients with tumors between 21 and 40 mm, 5-year disease-free survival was 90.3% in non-nerve-sparing radical hysterectomy vs 83.1% in nerve-sparing radical hysterectomy (P=.016) (no significant difference in the rate of adjuvant treatment in this subgroup, P=.47). This was confirmed after propensity match score analysis (balancing the 2 study groups). The pattern of recurrence in the propensity-matched population did not demonstrate any difference (P=.70). CONCLUSION: For tumors ≤20 mm, no survival difference was found with more radical hysterectomy. For tumors between 21 and 40 mm, a more radical hysterectomy was associated with improved 5-year disease-free survival. No difference in the pattern of recurrence according to the extent of radicality was observed. Non-nerve-sparing radical hysterectomy was associated with better 5-year disease-free survival than nerve-sparing radical hysterectomy after propensity score match analysis.


Subject(s)
Carcinoma, Squamous Cell , Uterine Cervical Neoplasms , Female , Pregnancy , Humans , Uterine Cervical Neoplasms/pathology , Retrospective Studies , Neoplasm Staging , Hysterectomy/adverse effects , Disease-Free Survival , Carcinoma, Squamous Cell/pathology
14.
Int J Gynecol Cancer ; 33(2): 183-189, 2023 02 06.
Article in English | MEDLINE | ID: mdl-36631152

ABSTRACT

OBJECTIVE: Altmetric Attention Score (AAS) is an alternative metric for estimating the impact of academic publications. We studied the association of using podcasting to highlight publications about gynecological cancer with AAS and citation scores. METHODS: Articles that were featured in the International Journal of Gynecological Cancer (IJGC) podcast series January 2019 to September 2022 were matched 1:1 to control articles by the journal in which the article was published, study topic and design, single/multicenter data, and year of publication. Podcast articles were compared with matched-controls by citation metrics and altmetric scores. RESULTS: A total of 99 podcasted articles published in 16 journals were matched. Median AAS was significantly higher in the podcast group than the matched-control group (22 (14-42) vs 5 (1-17), p<0.001). In a multivariable regression analysis, podcasting was the only factor associated with a high AAS (adjusted odds ratio (aOR) 8.6, 95% CI 3.8 to 19.7). In the podcast group, the median number of citations per year was higher than matched-control studies (5.5 (3.0-12.7) vs 4.5 (2.0-9.5), p=0.047). The only article characteristics that were independently associated with ≥12 citations per year were if the publication described a randomized controlled trial (aOR 4.7, 95% CI 1.6 to 13.6) or featured cervical carcinoma as the subject focus (aOR 2.9, 95% CI 1.3 to 6.5). Compared with all articles published in IJGC during the study period, articles that were featured in a podcast had higher median citations per year (5 (2-10) vs 1 (0-2.5), p<0.001). CONCLUSION: When compared with matched-controls, podcasting an article is associated with a higher AAS but is not associated with generating a high (≥12) number of citations per year. When compared with all articles published in the same journal during the same study period, articles that were featured in a podcast had higher median citations per year.


Subject(s)
Bibliometrics , Neoplasms , Social Media , Humans
15.
Int J Gynecol Cancer ; 33(6): 957-963, 2023 06 05.
Article in English | MEDLINE | ID: mdl-37001895

ABSTRACT

OBJECTIVE: Bibliometric literature in gynecologic oncology is limited. We aimed to study the association between the level of income of the country of authorship and citation metrics. METHODS: A retrospective study including all articles and reviews published during 1977-2022 in the International Journal of Gynecological Cancer (IJGC) and Gynecologic Oncology journals. Country of origin was defined as the corresponding author's address. We classified articles into groups by level of income of the country of origin, as defined by the World Bank. The primary outcome measure was the median number of citations per year. RESULTS: A total of 9835 articles were included in the analysis (IJGC n=3786 (38.5%), Gynecologic Oncology n=6049 (61.5%)). There were 8587 (87.3%) publications from high income countries, 1134 (11.5%) from upper-middle income countries, and 114 (1.2%) from lower-middle income countries. There were no publications from countries of low income. Most publications originated in the United States with 4089 (41.6%), followed by China (n=730, 7.4%), Italy (n=533, 5.4%), Canada (n=467, 4.7%), and Japan (n=461, 4.7%). Over the most recent 5 years there was a decrease in the representation of upper-middle income countries and lower-middle income countries; 16.3% (91/557) in 2018 versus 9.1% (38/417) in 2022 (p=0.005). In a multivariable regression analysis that included year of publication, open access publication model, study being supported by funding, publishing journal, review article, and level of income, all factors were associated with high citation per year score except the income classification of the article's country of origin (adjusted OR 1.59-1.72, 95% CI 0.61 to 4.30). CONCLUSION: High income countries have a disproportionate representation in gynecologic oncology publications. After adjusting for confounders, the country's level of income was not independently associated with a high citation per year score. This implies that the number of citations per year is not compromised by the country's level of income.


Subject(s)
Genital Neoplasms, Female , Humans , Female , United States , Genital Neoplasms, Female/therapy , Retrospective Studies , Benchmarking , Bibliometrics , Income
16.
Int J Gynecol Cancer ; 33(3): 323-332, 2023 03 06.
Article in English | MEDLINE | ID: mdl-36878559

ABSTRACT

Drug development is paramount to improve outcomes in patients with gynecologic cancers. A randomized clinical trial should measure whether a clinically relevant improvement is detected with the new intervention compared with the standard of care, using reproductible and appropriate endpoints. Clinically meaningful improvements in overall survival and/or quality of life (QoL) are the gold standards to measure benefit of new therapeutic strategies. Alternative endpoints, such as progression-free survival, provide an earlier measure of the effect of the new therapeutic drug, and are not confounded by the effect of subsequent lines of therapy. Yet, its surrogacy with improved overall survival or QoL is unclear in gynecologic malignancies. Of relevance to studies assessing maintenance strategies are other time-to-event endpoints, such as progression-free survival two and time to second subsequent treatment, which provide valuable information on the disease control in the longer term. Translational and biomarker studies are increasingly being incorporated into gynecologic oncology clinical trials, as they may allow understanding of the biology of the disease, resistance mechanisms, and enable a better selection of patients who might benefit from the new therapeutic strategy. Globally, the endpoint selection of a clinical trial will differ according to the type of study, population, disease setting, and type of therapeutic strategy. This review provides an overview of primary and secondary endpoint selection of relevance for gynecologic oncology clinical trials.


Subject(s)
Genital Neoplasms, Female , Humans , Female , Genital Neoplasms, Female/therapy , Quality of Life , Drug Development , Progression-Free Survival , Randomized Controlled Trials as Topic
17.
Int J Gynecol Cancer ; 33(9): 1370-1375, 2023 09 04.
Article in English | MEDLINE | ID: mdl-37586759

ABSTRACT

OBJECTIVE: To assess the oncologic outcomes of sentinel lymph node biopsy alone as part of surgical management in patients with early-stage cervical cancer. METHODS: A systematic search of the literature was performed following the PRISMA checklist. MEDLINE (through PubMed), EMBASE, and Scopus databases were searched from June 1991 to May 2023. Studies of women with early-stage cervical cancer International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA-IIA, of any age or histology, and articles only in English language were included. After the removal of duplicates, only articles including sentinel node mapping alone compared with full pelvic lymphadenectomy were retained. RESULTS: Four studies with a total of 2226 patients were included. Among these, 354 (15.9%) underwent sentinel lymph node biopsy alone. A total of 2210 (99.2%) patients had FIGO 2009 stage I disease and 1514 (68%) patients had squamous cell carcinoma. Median body mass index was 25.5 kg/m2 (range 23.5-27). Lymph vascular space invasion was present in 633 patients (34%) who underwent full lymphadenectomy and in 78 patients (22%) who underwent sentinel node biopsy alone. The results of the survival analysis showed that there was no significant difference in the 3-year progression-free survival rates of patients who underwent either sentinel biopsy alone or lymphadenectomy. Three-year recurrence-free survival was 93.1% (95% CI 28.3% to 64.7%) for patients who underwent sentinel node biopsy alone and 92.5% (95% CI 39.0% to 53.4%) for patients who underwent sentinel node biopsy and lymphadenectomy (p=0.773). CONCLUSIONS: In patients with early-stage cervical cancer, performing sentinel lymph node biopsy alone compared with pelvic lymphadenectomy does not appear to independently confer a higher risk or recurrence.


Subject(s)
Sentinel Lymph Node , Uterine Cervical Neoplasms , Humans , Female , Sentinel Lymph Node Biopsy/methods , Uterine Cervical Neoplasms/surgery , Uterine Cervical Neoplasms/pathology , Lymphatic Metastasis/pathology , Neoplasm Staging , Sentinel Lymph Node/surgery , Sentinel Lymph Node/pathology , Lymph Node Excision , Lymph Nodes/pathology , Retrospective Studies
18.
Int J Gynecol Cancer ; 33(7): 1112-1117, 2023 07 03.
Article in English | MEDLINE | ID: mdl-37220951

ABSTRACT

OBJECTIVE: To evaluate whether a citation advantage exists for open access (OA) publications in gynecologic oncology. METHOD: A cross-sectional study of research and review articles published in the International Journal of Gynecological Cancer (IJGC) and in Gynecologic Oncology during 1980-2022. Bibliometric measures were compared between OA publications and non-OA publications. The role of authors in low/middle-income countries was assessed. We analyzed article characteristics associated with a high citations per year (CPY) score. RESULTS: Overall, 18 515 articles were included, of which 2398 (13.0%) articles were published OA. The rate of OA has increased since 2007. During 2018-2022, the average proportion of articles published OA was 34.0% (range 28.5%-41.4%). OA articles had higher CPY (median (IQR), 3.0 (1.5-5.3) vs 1.3 (0.6-2.7), p<0.001). There was a strong positive correlation between OA proportion and impact factor; IJGC - r(23)=0.90, p<0.001, Gynecologic Oncology - r(23)=0.89, p<0.001. Articles by authors from low/middle-income countries were less common among OA articles than among non-OA articles (5.5% vs 10.7%, p<0.001). Articles by authors from low/middle-income countries were less common in the high CPY group than for articles without a high CPY score (8.0% vs 10.2%, p=0.003). The following article characteristics were found to be independently associated with a high CPY: publication after 2007, (adjusted odds ratio (aOR)=4.9, 95% CI 4.3 to 5.7), research funding reported (aOR=1.6, 95% CI 1.4 to 1.8), and being published OA (aOR=1.5, 95% CI 1.3-1.7). Articles written by authors in Central/South America or Asia had lower odds of having high CPY (Central/South America, aOR=0.5, 95% CI 0.3 to 0.8; Asia, aOR=0.6, 95% CI 0.5 to 0.7). CONCLUSION: OA articles have a higher CPY, with a strong positive correlation between OA proportion and impact factor. OA publishing has increased since 2007, but articles written by authors in low/middle-income countries are under-represented among OA publications.


Subject(s)
Access to Information , Genital Neoplasms, Female , Female , Humans , Cross-Sectional Studies , Bibliometrics , Asia
19.
Int J Gynecol Cancer ; 2023 Dec 14.
Article in English | MEDLINE | ID: mdl-38097350

ABSTRACT

OBJECTIVE: To evaluate the detection rate of at least one sentinel lymph node (SLN) in patients with early cervical cancer who underwent open radical hysterectomy or trachelectomy using indocyanine green (ICG) with the SPY Portable Handler Imager (SPY-PHI) system. METHODS: We retrospectively reviewed patients with cervical cancer FIGO 2018 stage IA1 with lymphovascular invasion up to stage IIIC1p who underwent SLN mapping and open radical hysterectomy or trachelectomy from March 2018 through August 2022 at The University of Texas MD Anderson Cancer Center. ICG was the only tracer used with the SPY-PHI system. Patient demographics, surgical approach, and tumor factors were analyzed. Overall detection, bilateral detection, and empty lymph node packet rates were determined. RESULTS: A total of 106 patients were included. Ninety-four (88.7%) patients underwent open radical hysterectomy and 12 (11.3%) open radical trachelectomy. Median age was 40 years (range, 23-71). Median body mass index was 28.8 kg/m2 (range, 17.6-48.4). The most common FIGO 2018 stages were IB1 (35%) and IB2 (30%). The most common histologic subtypes were squamous cell carcinoma (45%) and adenocarcinoma (45%). Most patients had grade 2 disease (61%) and no lymphovascular invasion (58%). Median tumor size was 1.8 cm (range, 0.3-4). Median number of detected SLN was 4 (range, 0-12). An SLN was identified during surgery in 104 patients (98%), with bilateral mapping in 94 (89%) and unilateral mapping in 10 (9%). The empty lymph node packet rate was 4 (3.8%). The external iliac (73%) was the most common site of SLN detection. Fourteen patients had positive lymph nodes (13.5%); 3 (21.4%) had macrometastases, 9 (64.3%) had micrometastases, and 2 (14.3%) had isolated tumor cells. CONCLUSION: SLN mapping using ICG with the SPY-PHI system in open radical hysterectomy or trachelectomy is reliable and results in high overall and bilateral detection rates in patients with early cervical cancer.

20.
Int J Gynecol Cancer ; 33(2): 271-277, 2023 02 06.
Article in English | MEDLINE | ID: mdl-36600503

ABSTRACT

OBJECTIVE: Current gaps in knowledge limit clinicians from fully implementing patient-reported outcomes in routine post-operative care. METHODS: This prospective study assessed symptoms via the gynecologic module of the MD Anderson Symptom Inventory (MDASI-PeriOp-GYN) in patients who underwent open laparotomy. RESULTS: At discharge, patient-reported moderate to severe (≥4 on a 0-10 scale) abdominal bloating or abdominal cramping, combined with length of stay of ≥4 days, were found to be associated with a higher risk of 30-day post-operative grade II-IV complications by the Clavien-Dindo system (all p values <0.01). Also, length of stay of ≥4 days and moderate to severe urinary urgency at discharge were found to be associated with the need for re-admission (all p values <0.01). CONCLUSION: This study defined the clinically meaningful symptoms that related to the risk of developing important complications after discharge from major open gynecological surgery.These findings support the integration of assessment of patient-reported outcomes into patient-centered post-operative care.


Subject(s)
Gynecologic Surgical Procedures , Patient Discharge , Humans , Female , Prospective Studies , Gynecologic Surgical Procedures/adverse effects , Postoperative Complications/etiology , Postoperative Complications/diagnosis , Patient Reported Outcome Measures , Length of Stay
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