Killer Cell Immunoglobulin-like Receptor Genotypes and Reproductive Outcomes in a Group of Infertile Women: A Romanian Study.

A growing body of evidence suggests that endometrial immune disorders may be responsible for endometrial dysfunctions that can lead to gynecological and obstetrical pathology. The aim of this study was to explore the potential relationship between different killer cell immunoglobulin-like receptor (KIR) genotypes and reproductive outcomes. We conducted a prospective cohort study that included 104 infertile patients undergoing an in vitro fertilization procedure. All participants underwent clinical and ultrasound examination, genetic evaluation (KIR genotyping), endometrial washing fluid sampling for cytokine determination, endometrial tissue sampling for histologic assessment and hysteroscopic evaluation. Our analysis showed statistically significant lower levels of uterine cytokines TNF-α (p = 0.001) and IL-1beta (p = 0.000) in the KIR AA genotype group as compared to KIR AB and BB among study participants with chronic endometritis. The study results suggest that the KIR AA genotype population subgroups may be more susceptible to developing endometrial disorders such as chronic endometritis. The changes in the behavior of NK cells seem to be subtle and expressed as an altered regulatory pattern.

Analysis of risk factors for recurrence in cervical cancer patients after fertility-sparing treatment: The FERTIlity Sparing Surgery retrospective multicenter study.

BACKGROUND: Fertility-sparing treatment in patients with cervical cancer should, in principle, follow identical algorithms to that in patients without future reproductive plans. In recent years, a trend toward nonradical procedures, such as conization or simple trachelectomy, has become apparent in medical literature, because of their associations with better pregnancy outcomes. However, the published reports included small numbers of patients and heterogenous treatment strategies to ascertain the safety of such approaches. OBJECTIVE: This study aimed to collect multi-institutional data regarding the oncological outcomes after fertility-sparing treatment in patients with cervical cancer and to identify prognostic risk factors, including the influence of the radicality of individual cervical procedures. STUDY DESIGN: Patients aged 18 to 40 years with International Federation of Gynecology and Obstetrics 2018 stage IA1 with positive lymphovascular space invasion or ≥IA2 cervical cancer who underwent any type of fertility-sparing procedure were eligible for this retrospective observational study, regardless of their histotype, tumor grade, and history of neoadjuvant chemotherapy. Associations between disease- and treatment-related characteristics with the risk of recurrence were analyzed. RESULTS: A total of 733 patients from 44 institutions across 13 countries were included in this study. Almost half of the patients had stage IB1 cervical cancer (49%), and two-thirds of patients were nulliparous (66%). After a median follow-up of 72 months, 51 patients (7%) experienced recurrence, of whom 19 (2.6%) died because of the disease. The most common sites of recurrence were the cervix (53%) and pelvic nodes (22%). The risk of recurrence was 3 times higher in patients with tumors >2 cm in size than in patients with smaller tumors, irrespective of the treatment radicality (19.4% vs 5.7%; hazard ratio, 2.982; 95% confidence interval, 1.383-6.431; P=.005). The recurrence risk in patients with tumors ≤2 cm in size did not differ between patients who underwent radical trachelectomy and patients who underwent nonradical (conization and simple trachelectomy) cervical procedures (P=.957), regardless of tumor size subcategory (<1 or 1-2 cm) or lymphovascular space invasion. CONCLUSION: Nonradical fertility-sparing cervical procedures were not associated with an increased risk of recurrence compared with radical procedures in patients with tumors ≤2 cm in size in this large, multicenter retrospective study. The risk of recurrence after any type of fertility-sparing procedure was significantly greater in patients with tumors >2 cm in size.

Long-Term Survival, Prognostic Factors, and Quality of Life of Patients Undergoing Pelvic Exenteration for Cervical Cancer.

Background: Considerable efforts have been carried out over the past 30 years to support patients with advanced cervical cancer. Throughout this time, Eastern European countries have been left aside from the decision-making groups on this matter, hence the absence of similar studies in this geographical area. In these countries, the quality of life (QoL) of patients with cervical cancer might be considered a "caprice", and the discomforts they encounter following pelvic exenteration for cervical cancer are often perceived as a "normal phenomenon". Methods: This study examined forty-seven patients submitted to pelvic exenteration followed up for nine years after the surgical intervention. The first objective of this study is to identify the prognostic factors that influence the overall survival (OS) of patients undergoing pelvic exenteration for FIGO stage IVA, recurrent or persistent cervical cancer after previous conclusive treatments. The second objective is to assess the QoL of the surviving patients using the QLQ-C30 and QLQ-CX24 standardized questionnaires. Results: The mean age of the participants was 54 years (range 36−67). At the time of the study, there were 25 living patients (53.2%), the 3-year OS was 61%, and the 5-year OS was 48.7%. Cox regression analysis recognized parameter invasion, pelvic lymph node metastases, positive resection margins, early postoperative complications, and infralevatorian pelvic exenteration as negative prognostic factors influencing the OS (p < 0.05). Of the 25 survivors, 18 patients answered the QoL questionnaires. The cost of favorable survival has been translated into poor overall QoL, unsatisfactory functional, social, and symptom scores, a high prevalence of cervical cancer-specific symptoms such as lymphedema, peripheral neuropathy, severe menopausal symptoms, distorted body image, and lack of sexual desire. The lower scores are comparable to the only three studies available in the literature that assessed the QoL of patients undergoing pelvic exenteration precisely for cervical cancer. Conclusions: Despite its retrospective nature and some limitations, this paper, similar to other studies, shows a decent OS but with a marked adverse impact on QoL, suggesting the importance of adequate psycho-emotional and financial support for these patients following pelvic exenteration. This study also contributes to the current knowledge regarding advanced cervical cancer treatment, depicting survival, prognostic factors, and QoL of patients undergoing pelvic exenteration for cervical cancer in a reference center in Eastern Europe. Our study can provide a comparison for future prospective randomized trials needed to confirm these results.

The Overall Quality of Life and Oncological Outcomes Following Radical Hysterectomy in Cervical Cancer Survivors Results from a Large Long-Term Single-Institution Study.

(1) Background: Cervical cancer patients have been found to have worse quality of life (QoL) scores due to cancer treatment, not only when compared to the general population, but also when compared to other gynecological cancer survivors. In Eastern European developing countries, the health care system often cannot afford the uppermost standardized treatment for these patients. In the absence of a comparable study in our country, the authors' aim for this retrospective cross-sectional observational study was to evaluate the overall survival (OS) and the QoL o cervical cancer survivors; (2) Methods: 430 patients were analyzed. The first objective is to evaluate the OS rates of patients with cervical cancer stages IA2 to IIB undergoing radical hysterectomy (RH) +/- neoadjuvant or adjuvant radiotherapy +/- chemoradiotherapy treatment combinations. The second objective is to assess their QoL, using two standardized questionnaires issued by the European Organisation for Research and Treatment of Cancer (EORTC), namely QLQ-C30 and QLQ-CX24. (3) Results: The mean age of the participants was 51 years (22-76) and the average follow-up time was 65 months (2-128). At the time of the analysis, 308 out of 430 patients were alive, with a mean five-year OS of 72.4%. The multivariate Cox regression analysis identified stage IIB, parametrial invasion, and the lymph node metastases as independent prognostic risk factors negatively impacting the OS. Of the 308 patients still alive at the time of the analysis, 208 (68%) answered the QoL questionnaires. The QLQ-C30 shows a good long-term Global QoL of 64.6 (median), good functioning scores, and a decent symptom scale value. However, the EORTC QLQ-CX24 showed high values of cervical cancer-specific symptoms, namely: lymphedema, peripheral neuropathy, severe menopausal symptoms, and distorted body-image perception. The results also indicate a significant decline in the quality of sexual life with a low sexual enjoyment and decreased level of sexual activities. (4) Conclusion: Despite a good OS, in this setting of patients, cervical cancer survivors have a modest QoL and sexual function. Our study may provide a comparison for future randomized, controlled trials in Eastern European countries needing to confirm these results.

SUCCOR cone study: conization before radical hysterectomy.

OBJECTIVE: To evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009). METHODS: A multicenter retrospective observational cohort study was conducted including patients from the Surgery in Cervical Cancer Comparing Different Surgical Aproaches in Stage IB1 Cervical Cancer (SUCCOR) database with FIGO 2009 IB1 cervical carcinoma treated with radical hysterectomy between January 1, 2013, and December 31, 2014. We used propensity score matching to minimize the potential allocation biases arising from the retrospective design. Patients who underwent conization but were similar for other measured characteristics were matched 1:1 to patients from the non-cone group using a caliper width ≤0.2 standard deviations of the logit odds of the estimated propensity score. RESULTS: We obtained a weighted cohort of 374 patients (187 patients with prior conization and 187 non-conization patients). We found a 65% reduction in the risk of relapse for patients who had cervical conization prior to radical hysterectomy (hazard ratio (HR) 0.35, 95% confidence interval (CI) 0.16 to 0.75, p=0.007) and a 75% reduction in the risk of death for the same sample (HR 0.25, 95% CI 0.07 to 0.90, p=0.033). In addition, patients who underwent minimally invasive surgery without prior conization had a 5.63 times higher chance of relapse compared with those who had an open approach and previous conization (HR 5.63, 95% CI 1.64 to 19.3, p=0.006). Patients who underwent minimally invasive surgery with prior conization and those who underwent open surgery without prior conization showed no differences in relapse rates compared with those who underwent open surgery with prior cone biopsy (reference) (HR 1.94, 95% CI 0.49 to 7.76, p=0.349 and HR 2.94, 95% CI 0.80 to 10.86, p=0.106 respectively). CONCLUSIONS: In this retrospective study, patients undergoing cervical conization before radical hysterectomy had a significantly lower risk of relapse and death.

Malignant mixed Müllerian tumor of the fallopian tube: Case report and literature review.

Carcinosarcoma, also known as malignant mixed Müllerian tumor (MMMT), includes both malignant epithelial and mesenchymal elements. While the endometrium is the most frequent known site for carcinosarcomas, their development in the fallopian tube is rare condition, only accounting for 0.1 to 0.5% among all gynecological malignancies. Fallopian tube MMMT is associated with an aggressive progression. A total of 94 previous case reports were reviewed and divided, after applying the exclusion criteria, into 2 groups: No evidence of disease (NED) Group including 33 patients reported to be without any residual disease at the end of the follow-up period; death of disease (DOD) Group including 51 patients who died due to the progression of fallopian carcinosarcoma or its complications. The gathered data were statistically analyzed together with a case from our clinical experience: a 65-year-old postmenopausal patient with a final histological diagnosis of fallopian carcinosarcoma staged FIGO IC2, synchronous with a serous endometrial intraepithelial carcinoma. Patient age between 41 and 60 years, symptoms at presentation and computed tomography (CT)/magnetic resonance imaging (MRI) tumor evidence are prognostic factors (P<0.05). Omentectomy [odds ratio (OR)=0.3545] and pelvic lymphadenectomy (OR=0.3732) were found to be significant factors for survival (P<0.05). Fimbrial localization of the tumor is a negative prognosis factor (OR=4.263), as well as the heterologous type of tumor (OR=2.880). Chemotherapy was found to improve survival (OR=0.2679) while radiotherapy had no influence on patient prognosis. Reporting these rare cases could be essential for obtaining more precise information regarding the treatment and prognosis of patients with MMMT of the fallopian tube, in order to improve patient survival and quality of life.

Primary pelvic exenteration: Our experience with 23 patients from a single institution.

This study was designed with an aim to share our experience of primary pelvic exenterations. The study included 23 patients with different types of pelvic cancer enrolled at a single institution between November 2011 and July 2020. The patient mean age was 55 years (range, 43-72 years) and the oncological indications included: Stage IVa cervical cancer (11 cases, 48.9%), stage IVa endometrial cancer (1 case, 4.3%), stage IVa vaginal cancer (6 cases, 26%), stage IIIb bladder cancer (3 cases, 13%), stage IIIc rectal cancer (1 case, 4.3%) and undifferentiated pelvic sarcoma (1 case, 4.3%). Total, anterior, and posterior pelvic exenterations were performed on 34.4, 56.5 and 13% of cases, respectively. Related to levator ani muscle, 13 (56.5%) pelvic exenterations were supralevatorian, 10 (43.5%) infralevatorian, and 5 (21.7%) were infralevatorian with vulvectomy. No major intraoperative complications occurred. Seven patients (30.5%) developed early complications, 4 of them (17.4%) required reoperation and 1 (4.3%) perioperative death caused by a pulmonary embolism was recorded. Only 1 patient experienced a late complication, a urostomy stenosis. Over a median follow-up period of 35 months, 8 (34.8%) patients died. The median overall survival (OS) was 33 months (range, 1-96 months). The 2-year and 5-year survival rates were 72 and 66%, respectively. Primary pelvic exenteration may be related with various postoperative complications, without high perioperative morality and with long-term survival.

Radical hysterectomy in early cervical cancer in Europe: characteristics, outcomes and evaluation of ESGO quality indicators.

INTRODUCTION: Comprehensive updated information on cervical cancer surgical treatment in Europe is scarce. OBJECTIVE: To evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database. METHODS: The SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified. RESULTS: The mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0-84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation. CONCLUSIONS: In this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

Laterally extended parametrectomy.

OBJECTIVE: To describe the laterally extended parametrectomy (LEP) surgical technique, emphasizing the main challenges of the procedure. METHODS: LEP was designed as a more radical surgical procedure aiming to remove the entire parametrial tissue from the pelvic sidewall. Its initial indications were for lymph node positive Stage Ib (current International Federation of Gynecology and Obstetrics 2018 Stage IIIc) and Stage IIb cervical cancer. Currently, with most guidelines recommending definitive radiochemotherapy for these cases, initial LEP indications have become debatable. LEP is now mainly indicated for removing tumors involving the soft structures of the pelvic sidewall during a pelvic exenteration, aiming to obtain lateral free margins. This expands the lateral borders of the dissection to not only the medial surface of internal iliac vessels, but also to the true limits of the pelvic sidewall. RESULTS: During LEP, the parietal and visceral branches of the hypogastric vessels are divided at the entry and exit level of the pelvis. Consequently, the entire internal iliac system is excised, and no connective or lymphatic tissue remain on the pelvic sidewall. The main technical challenges of LEP are caused by the difficulty in ligating large caliber vessels (internal iliac artery and vein) and the variable anatomic distribution of pelvic sidewall veins. CONCLUSION: LEP is a feasible technique for removing pelvic sidewall recurrences, aiming to obtain surgical free margins.

Abdominal radical trachelectomy as fertility-sparing management for early stages of cervical cancer: Our experience in 18 cases.

The aim of this study was to present our experience of 18 cases of abdominal radical trachelectomy (ART), including 5 performed during pregnancy, analyzing patient selection, surgical complications, and oncological and obstetrical outcomes. This reproductive study included all early stage cervical cancer patients referred for ART at the 1st Obstetrics and Gynecology Clinic of the Emergency Clinical County Hospital Targu Mures, between 2010 and 2020. A total of 19 women were considered for ART, and only 1 case required conversion to radical hysterectomy. The patient mean age was 31 years (range 24-38 years), and 66.67% of the patients were nulliparous. Six women (33.33%) had stage IA2, 4 (22.22%) had stage IB1, 5 (27.78%) had stage IB2, and 4 (22.22%) had stage IB3 disease. One intraoperative complication occurred in this series, which consisted in both right ureteral and bladder injuries. Early postoperative complications were represented by urinary bladder dysfunction (33.33%), symptomatic pelvic lymphocele (11.1%), peritonitis (5.5%), and wound infection (5.5%). Late postoperative complications included cervical stenosis (5.5%), amenorrhea (11.1%), and pelvic abscess (5.5%). Four out of the 18 patients were operated on during pregnancy between 14 and 20 weeks; 2 of them gave birth at term, 2 of them aborted shortly after the surgery. Two vaginal recurrences were recorded; both were managed by hysterectomy, partial colpectomy and adjuvant chemoradiotherapy. At this moment, all patients are alive with no evidence of disease and 3 of them managed to conceive. In conclusion, ART should be recommended as a fertility-preserving procedure for women in their reproductive age. In selected cases, ART can be performed during pregnancy with encouraging results.

Prognostic Factors Associated with 5-Year Overall Survival in Cervical Cancer Patients Treated with Radical Hysterectomy Followed by Adjuvant Concurrent Chemoradiation Therapy at a Tertiary Care Center in Eastern Europe.

BACKGROUND: This retrospective observational study aims to assess the 5-year overall survival and the prognostic significance of risk factors of patients who underwent radical hysterectomy followed by adjuvant concurrent chemoradiation therapy (CCRT) for FIGO stage IB1-IIB cervical cancer in a tertiary care center in Eastern Europe. METHODS: From January 2010 to February 2019, 222 patients with stage IB1-IIB cervical cancer were treated with radical hysterectomy followed by adjuvant CCRT in our institution. The baseline information consisting of demographic and clinicopathologic data, treatment choices, recurrences, and outcome information was collected and examined. The survival rates were illustrated using Kaplan-Meier curves and prognosis analyses were accomplished using Cox multivariate analyses. RESULTS: The 222 participants had a mean age of 51.2 years (28-76). The median follow-up time was 65.5 months (3-128). Tumor characteristics revealed FIGO stage (IB1 2.3%, IB2 35.1%, IB3 16.7%, IIA1 9%, IIA2 8.6%, IIB 28.4%) and the most encountered histologic cell type was squamous cell carcinoma (80.06%) followed by adenocarcinoma (11.3%). At the time of examination, 157 patients (70.07%) were alive, of which 135 (61%) were alive free of disease and 22 (9%) were alive with disease. The multivariate Cox regression analysis acknowledged stage IIB, parametrial involvement, and the presence of lymph node metastases as independent prognostic risk factors, significantly worsening the oncologic outcomes influencing the survival with a P-value of 0.076, 0.0001, and 0.008, respectively. The 5-year overall survival was 69.9%. CONCLUSIONS: Altogether, the study enhances the significance of prognostic risk factors on the 5-year overall survival of patients who underwent radical hysterectomy followed by adjuvant CCRT for FIGO stages IB1-IIB cervical cancer, allowing comparisons with other regions.

The Double Life-Saving Approach of Abdominal Radical Trachelectomy during Pregnancy for Early-Stage Cervical Cancer-An Overview of the Literature and Our Institutional Experience.

(1) Background: Cervical cancer is the most common type of cancer encountered during pregnancy, with a frequency of 0.8-1.5 cases per 10,000 births. It is a dire condition endangering patients' lives and pregnancy outcomes, and jeopardizing their fertility. However, there is a lack of current evidence and consensus regarding a standard surgical technique for pregnant patients who suffer from this condition during pregnancy. The study aims to comprehensively update all published data, evaluating the obstetrical and oncological results of pregnant patients who underwent abdominal radical trachelectomy during early stages of cervical cancer. (2) Methods: A literature search on the Medline, PubMed, and Google Scholar databases was performed, including all articles in question up to July 2020. This study presents an overview of the literature and our institutional experience. (3) Results: A total of 25 cases of abdominal radical trachelectomy were performed during pregnancy for early cervical cancer, including the five cases managed by the authors. Of these, 81% (19 patients) gave birth to live newborns through elective C-section, and 19% (6 patients) experienced miscarriage shortly after the procedure. None of the 25 patients (100%) reported disease recurrence. (4) Conclusions: The results of the current study were satisfactory. However, abdominal radical trachelectomy does not represent the current standard of care for cervical cancer during pregnancy, but it could play an important role if more evidence on its effectiveness will be provided.

SUCCOR study: an international European cohort observational study comparing minimally invasive surgery versus open abdominal radical hysterectomy in patients with stage IB1 cervical cancer.

BACKGROUND: Minimally invasive surgery in cervical cancer has demonstrated in recent publications worse outcomes than open surgery. The primary objective of the SUCCOR study, a European, multicenter, retrospective, observational cohort study was to evaluate disease-free survival in patients with stage IB1 (FIGO 2009) cervical cancer undergoing open vs minimally invasive radical hysterectomy. As a secondary objective, we aimed to investigate the association between protective surgical maneuvers and the risk of relapse. METHODS: We obtained data from 1272 patients that underwent a radical hysterectomy by open or minimally invasive surgery for stage IB1 cervical cancer (FIGO 2009) from January 2013 to December 2014. After applying all the inclusion-exclusion criteria, we used an inverse probability weighting to construct a weighted cohort of 693 patients to compare outcomes (minimally invasive surgery vs open). The first endpoint compared disease-free survival at 4.5 years in both groups. Secondary endpoints compared overall survival among groups and the impact of the use of a uterine manipulator and protective closure of the colpotomy over the tumor in the minimally invasive surgery group. RESULTS: Mean age was 48.3 years (range; 23-83) while the mean BMI was 25.7 kg/m2 (range; 15-49). The risk of recurrence for patients who underwent minimally invasive surgery was twice as high as that in the open surgery group (HR, 2.07; 95% CI, 1.35 to 3.15; P=0.001). Similarly, the risk of death was 2.42-times higher than in the open surgery group (HR, 2.45; 95% CI, 1.30 to 4.60, P=0.005). Patients that underwent minimally invasive surgery using a uterine manipulator had a 2.76-times higher hazard of relapse (HR, 2.76; 95% CI, 1.75 to 4.33; P<0.001) and those without the use of a uterine manipulator had similar disease-free-survival to the open surgery group (HR, 1.58; 95% CI, 0.79 to 3.15; P=0.20). Moreover, patients that underwent minimally invasive surgery with protective vaginal closure had similar rates of relapse to those who underwent open surgery (HR, 0.63; 95% CI, 0.15 to 2.59; P<0.52). CONCLUSIONS: Minimally invasive surgery in cervical cancer increased the risk of relapse and death compared with open surgery. In this study, avoiding the uterine manipulator and using maneuvers to avoid tumor spread at the time of colpotomy in minimally invasive surgery was associated with similar outcomes to open surgery. Further prospective studies are warranted.

International radical trachelectomy assessment: IRTA study.

BACKGROUND: Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy. PRIMARY OBJECTIVE: To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy. STUDY HYPOTHESIS: We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. STUDY DESIGN: This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data. INCLUSION CRITERIA: Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both). EXCLUSION CRITERIA: Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach. PRIMARY ENDPOINT: The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy. SAMPLE SIZE: An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.

Radical Trachelectomy Performed During Pregnancy: A Review of the Literature.

OBJECTIVE: Cervical cancer is one of the most frequent malignant diseases diagnosed during pregnancy. Abdominal or vaginal radical trachelectomies are fertility-preserving alternatives to radical hysterectomy for young women with early-stage cervical cancer that can be performed during ongoing pregnancy. METHODS: A literature review of articles on this subject was conducted through a Medline search for articles published in English or French. RESULTS: At this moment, 21 cervical cancer patients, including ours (4 stage IA2, 16 IB1, and 1 IB2) who underwent radical trachelectomy during pregnancy have been reported. Of these, 10 were performed by vaginal route and 11 were abdominal radical trachelectomies. CONCLUSIONS: Radical trachelectomy could be offered as an option for pregnant patients with early invasive cervical cancer. It may help women avoid the triple losses of a desired pregnancy, fertility, and motherhood.

Abdominal radical trachelectomy: a Romanian series.

OBJECTIVE: Abdominal radical trachelectomy (ART) is one of the fertility-sparing procedures in women with early-stage cervical cancer. The published results of ART, in comparison with vaginal radical trachelectomy, so far are limited. MATERIALS AND METHODS: This retrospective study comprises all cases of female patients referred to ART with early-stage cervical cancer from 2 gynecologic oncology centers in Romania. RESULTS: A total of 29 women were referred for ART, but subsequently, fertility could not be preserved in 3 of them. Eleven women had stage IA2 disease (42.3%), 14 (53.8%) women had stage IB1 disease, and 1 (3.8%) woman had stage IB2 disease. Histologic subtypes were 15 (57.6%) squamous, 8 (30.7%) adenocarcinoma, and 3 (11.5%) adenosquamous. There were no major intraoperative complications in both hospitals. Early postoperative complications were mainly related to the type C parametrectomy-bladder dysfunction for more than 7 days (8 [30.7%] women) and prolonged constipation (6 [23.0%] women). Other complications consisted in symptomatic lymphocele in 2 (7.6%) patients, which were drained. Median follow-up time was 20 months (range, 4-43 months). Up to the present time, there has been 1 (3.8%) recurrence in our series. Most patients did not experience late postoperative complications. Three (11.5%) women are amenorrheic, and 1 (3.8%) woman developed a cervical stenosis. Of the 23 women who have normal menstruation and maintained their fertility, a total of 7 (30.4%) women have attempted pregnancy, and 3 (42.8%) of them achieved pregnancy spontaneously. These pregnancies ended in 2 first trimester miscarriages and 1 live birth at term by cesarean delivery. CONCLUSIONS: Our results demonstrate that ART preserves fertility and maintains excellent oncological outcomes with low complication rates.