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The New England Journal of Medicine Feb 2024Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking.
METHODS
We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was 4 percentage points.
RESULTS
Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB according to the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%). With a median follow-up time of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (an absolute difference of 0.35 percentage points; 90% confidence interval, -1.62 to 2.32). Results were similar in a per-protocol analysis. The incidence of urinary incontinence was lower in the simple hysterectomy group than in the radical hysterectomy group within 4 weeks after surgery (2.4% vs. 5.5%; P = 0.048) and beyond 4 weeks (4.7% vs. 11.0%; P = 0.003). The incidence of urinary retention in the simple hysterectomy group was also lower than that in the radical hysterectomy group within 4 weeks after surgery (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001).
CONCLUSIONS
In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).
Topics: Female; Humans; Canada; Carcinoma, Squamous Cell; Hysterectomy; Lymph Nodes; Neoplasm Recurrence, Local; Neoplasm Staging; Prognosis; Retrospective Studies; Urinary Incontinence; Urinary Retention; Uterine Cervical Neoplasms
PubMed: 38416430
DOI: 10.1056/NEJMoa2308900 -
The Indian Journal of Medical Research Aug 2021Surgery plays an important role in the management of early-stage cervical cancer. Type III radical hysterectomy with bilateral pelvic lymph node dissection using open... (Review)
Review
Surgery plays an important role in the management of early-stage cervical cancer. Type III radical hysterectomy with bilateral pelvic lymph node dissection using open route is the standard surgical procedure. There is level I evidence against the use of laparoscopic/robotic approach for radical hysterectomy for cervical cancer. Emerging data support the use of sentinel lymph node biopsy and nerve sparing radical hysterectomy in carefully selected patients with early-stage disease. In locally advanced cervical cancer patients, the use of neoadjuvant chemotherapy (NACT) followed by radical surgery yields inferior disease-free survival compared to definitive concurrent chemoradiation therapy. Therefore, definitive concurrent chemoradiation is the standard treatment for locally advanced disease. Fertility preserving surgery is feasible in highly selected young patients. Role of less-radical surgical procedures in patients' with low-stage disease with good prognostic factors is under evaluation.
Topics: Consensus; Female; Humans; Hysterectomy; Lymph Node Excision; Neoadjuvant Therapy; Neoplasm Staging; Uterine Cervical Neoplasms
PubMed: 34854431
DOI: 10.4103/ijmr.IJMR_4240_20 -
International Journal of Environmental... Sep 2022Radical hysterectomy and plus pelvic node dissection are the primary methods of treatment for patients with early stage cervical cancer. During the last decade, growing... (Review)
Review
Radical hysterectomy and plus pelvic node dissection are the primary methods of treatment for patients with early stage cervical cancer. During the last decade, growing evidence has supported the adoption of a minimally invasive approach. Retrospective data suggested that minimally invasive surgery improves perioperative outcomes, without neglecting long-term oncologic outcomes. In 2018, the guidelines from the European Society of Gynaecological Oncology stated that a "minimally invasive approach is favored" in comparison with open surgery. However, the phase III, randomized Laparoscopic Approach to Cervical Cancer (LACC) trial questioned the safety of the minimally invasive approach. The LACC trial highlighted that the execution of minimally invasive radical hysterectomy correlates with an increased risk of recurrence and death. After its publication, other retrospective studies investigated this issue, with differing results. Recent evidence suggested that robotic-assisted surgery is not associated with an increased risk of worse oncologic outcomes. The phase III randomized Robotic-assisted Approach to Cervical Cancer (RACC) and the Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC) trials will clarify the pros and cons of performing a robotic-assisted radical hysterectomy (with tumor containment before colpotomy) in early stage cervical cancer.
Topics: Female; Humans; Hysterectomy; Laparoscopy; Neoplasm Staging; Retrospective Studies; Robotic Surgical Procedures; Uterine Cervical Neoplasms
PubMed: 36141917
DOI: 10.3390/ijerph191811641 -
Human Reproduction Update Nov 2016Uterine fibroids (also known as leiomyomas or myomas) are the most common form of benign uterine tumors. Clinical presentations include abnormal bleeding, pelvic masses,... (Review)
Review
Uterine fibroids (also known as leiomyomas or myomas) are the most common form of benign uterine tumors. Clinical presentations include abnormal bleeding, pelvic masses, pelvic pain, infertility, bulk symptoms and obstetric complications.Almost a third of women with leiomyomas will request treatment due to symptoms. Current management strategies mainly involve surgical interventions, but the choice of treatment is guided by patient's age and desire to preserve fertility or avoid 'radical' surgery such as hysterectomy. The management of uterine fibroids also depends on the number, size and location of the fibroids. Other surgical and non-surgical approaches include myomectomy by hysteroscopy, myomectomy by laparotomy or laparoscopy, uterine artery embolization and interventions performed under radiologic or ultrasound guidance to induce thermal ablation of the uterine fibroids.There are only a few randomized trials comparing various therapies for fibroids. Further investigations are required as there is a lack of concrete evidence of effectiveness and areas of uncertainty surrounding correct management according to symptoms. The economic impact of uterine fibroid management is significant and it is imperative that new treatments be developed to provide alternatives to surgical intervention.There is growing evidence of the crucial role of progesterone pathways in the pathophysiology of uterine fibroids due to the use of selective progesterone receptor modulators (SPRMs) such as ulipristal acetate (UPA). The efficacy of long-term intermittent use of UPA was recently demonstrated by randomized controlled studies.The need for alternatives to surgical intervention is very real, especially for women seeking to preserve their fertility. These options now exist, with SPRMs which are proven to treat fibroid symptoms effectively. Gynecologists now have new tools in their armamentarium, opening up novel strategies for the management of uterine fibroids.
Topics: Contraceptive Agents; Female; Humans; Hysterectomy; Leiomyoma; Magnetic Resonance Imaging; Norpregnadienes; Pelvic Pain; Progesterone; Randomized Controlled Trials as Topic; Risk Factors; Uterine Artery; Uterine Neoplasms
PubMed: 27466209
DOI: 10.1093/humupd/dmw023 -
The New England Journal of Medicine Nov 2018Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before...
BACKGROUND
Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer.
METHODS
We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database.
RESULTS
In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend).
CONCLUSIONS
In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).
Topics: Adenocarcinoma; Adult; Carcinoma, Adenosquamous; Carcinoma, Squamous Cell; Cause of Death; Chi-Square Distribution; Cohort Studies; Female; Humans; Hysterectomy; Middle Aged; Minimally Invasive Surgical Procedures; Neoplasm Recurrence, Local; Neoplasm Staging; Propensity Score; SEER Program; Survival Analysis; Survival Rate; Uterine Cervical Neoplasms
PubMed: 30379613
DOI: 10.1056/NEJMoa1804923 -
Annals of Surgical Oncology Oct 2017One of the most important principles in modern cervical cancer surgery is the concept of tailoring surgical radicality. In practice, this means abandoning the...
BACKGROUND
One of the most important principles in modern cervical cancer surgery is the concept of tailoring surgical radicality. In practice, this means abandoning the "one-fits-all" concept in favor of tailored operations. The term "radical hysterectomy" is used to describe many different procedures, each with a different degree of radicality. Anatomic structures are subjected to artificial dissection artifacts, as well as different interpretations and nomenclatures. This study aimed to refine and standardize the principles and descriptions of the different classes of radical hysterectomy as defined in the Querleu-Morrow classification and to propose its universal applicability.
METHODS
All three authors independently examined the current literature and undertook a critical assessment of the original classification. Images and pathologic slides demonstrating different types of radical hysterectomy were examined to document a consensual vision of the anatomy. The Cibula 3-D concept also was included in this update.
RESULTS
The Querleu-Morrow classification is based on the lateral extent of resection. Four types of radical hysterectomy are described, including a limited number of subtypes when necessary. Two major objectives remain constant: excision of central tumor with clear margins and removal of any potential sites of nodal metastasis.
CONCLUSION
Studies evaluating radicality in the surgical management of cervical cancer should be based on precise, universally accepted descriptions. The authors' updated classification presents standardized, universally applicable descriptions of different types of hysterectomies performed worldwide, categorized according to degree of radicality, independently of theoretical considerations.
Topics: Female; Humans; Hysterectomy; Lymph Node Excision; Prognosis; Uterine Cervical Neoplasms
PubMed: 28785898
DOI: 10.1245/s10434-017-6031-z -
BMC Cancer May 2018Neuroendocrine carcinoma of the cervix (NECC) is a rare variant of cervical cancer. The prognosis of women with NECC is poor and there is no standardized therapy for...
BACKGROUND
Neuroendocrine carcinoma of the cervix (NECC) is a rare variant of cervical cancer. The prognosis of women with NECC is poor and there is no standardized therapy for this type of malignancy based on controlled trials.
METHODS
We performed a systematic literature search of the databases PubMed and Cochrane Central Register of Controlled Trials to identify clinical trials describing the management and outcome of women with NECC.
RESULTS
Three thousand five hundred thirty-eight cases of NECC in 112 studies were identified. The pooled proportion of NECC among women with cervical cancer was 2303/163470 (1.41%). Small cell NECC, large cell NECC, and other histological subtypes were identified in 80.4, 12.0, and 7.6% of cases, respectively. Early and late stage disease presentation were evenly distributed with 1463 (50.6%) and 1428 (49.4%) cases, respectively. Tumors expressed synaptophysin (424/538 cases; 79%), neuron-specific enolase (196/285 cases; 69%), chromogranin (323/486 cases; 66%), and CD56 (162/267; 61%). The most common primary treatment was radical surgery combined with chemotherapy either as neoadjuvant or adjuvant chemotherapy, described in 42/48 studies. Radiotherapy-based primary treatment schemes in the form of radiotherapy, radiochemotherapy, or radiotherapy with concomitant or followed by chemotherapy were also commonly used (15/48 studies). There is no standard chemotherapy regimen for NECC, but cisplatin/carboplatin and etoposide (EP) was the most commonly used treatment scheme (24/40 studies). Overall, the prognosis of women with NECC was poor with a mean recurrence-free survival of 16 months and a mean overall survival of 40 months. Immune checkpoint inhibitors and targeted agents were reported as being active in three case reports.
CONCLUSION
NECC is a rare variant of cervical cancer with a poor prognosis. Multimodality treatment with radical surgery and neoadjuvant/adjuvant chemotherapy with cisplatin and etoposide with or without radiotherapy is the mainstay of treatment for early stage disease while chemotherapy with cisplatin and etoposide or topotecan, paclitaxel, and bevacizumab is appropriate for women with locally advanced or recurrent NECC. Immune checkpoint inhibitors may be beneficial, but controlled evidence for their efficacy is lacking.
Topics: Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Neuroendocrine; Cervix Uteri; Chemoradiotherapy, Adjuvant; Clinical Trials as Topic; Female; Humans; Hysterectomy; Neoadjuvant Therapy; Neoplasm Recurrence, Local; Neoplasm Staging; Prognosis; Survival Rate; Treatment Outcome; Uterine Cervical Neoplasms
PubMed: 29728073
DOI: 10.1186/s12885-018-4447-x -
JAMA Oncology Jul 2020Minimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Minimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive radical hysterectomy for cervical cancer.
OBJECTIVE
To quantify the risk of recurrence and death associated with minimally invasive vs open radical hysterectomy for early-stage cervical cancer reported in observational studies optimized to control for confounding.
DATA SOURCES
Ovid MEDLINE, Ovid Embase, PubMed, Scopus, and Web of Science (inception to March 26, 2020) performed in an academic medical setting.
STUDY SELECTION
In this systematic review and meta-analysis, observational studies were abstracted that used survival analyses to compare outcomes after minimally invasive (laparoscopic or robot-assisted) and open radical hysterectomy in patients with early-stage (International Federation of Gynecology and Obstetrics 2009 stage IA1-IIA) cervical cancer. Study quality was assessed with the Newcastle-Ottawa Scale and included studies with scores of at least 7 points that controlled for confounding by tumor size or stage.
DATA EXTRACTION AND SYNTHESIS
The Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist was used to abstract data independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between surgical approach and oncologic outcomes.
MAIN OUTCOMES AND MEASURES
Risk of recurrence or death and risk of all-cause mortality.
RESULTS
Forty-nine studies were identified, of which 15 were included in the meta-analysis. Of 9499 patients who underwent radical hysterectomy, 49% (n = 4684) received minimally invasive surgery; of these, 57% (n = 2675) received robot-assisted laparoscopy. There were 530 recurrences and 451 deaths reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent minimally invasive radical hysterectomy compared with those who underwent open surgery (hazard ratio [HR], 1.71; 95% CI, 1.36-2.15; P < .001), and the hazard of death was 56% higher (HR, 1.56; 95% CI, 1.16-2.11; P = .004). Heterogeneity of associations was low to moderate. No association was found between the prevalence of robot-assisted surgery and the magnitude of association between minimally invasive radical hysterectomy and hazard of recurrence or death (2.0% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -3.4% to 7.7%]) or all-cause mortality (3.7% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -4.5% to 12.6%]).
CONCLUSIONS AND RELEVANCE
This systematic review and meta-analysis of observational studies found that among patients undergoing radical hysterectomy for early-stage cervical cancer, minimally invasive radical hysterectomy was associated with an elevated risk of recurrence and death compared with open surgery.
Topics: Female; Humans; Hysterectomy; Minimally Invasive Surgical Procedures; Observational Studies as Topic; Survival Analysis; Uterine Cervical Neoplasms
PubMed: 32525511
DOI: 10.1001/jamaoncol.2020.1694 -
The Pan African Medical Journal 2022hemostasis hysterectomy is the radical treatment for postpartum hemorrhage. The purpose of this study is to identify risk factors, indications and complications of...
INTRODUCTION
hemostasis hysterectomy is the radical treatment for postpartum hemorrhage. The purpose of this study is to identify risk factors, indications and complications of hemostasis hysterectomy and to determine factors influencing the types of approaches to hysterectomy.
METHODS
we conducted a monocentric descriptive and analytical retrospective study in the Department of Obstetrics and Gynecology at the Regional Hospital of Ben Arous from 2003 to 2019. Patients were classified according to the type of surgical treatment they received: total or subtotal hysterectomy.
RESULTS
seventy patients were included in the study. The rate of hemostasis hysterectomy was 1.3%. The average age of patients was 34.5 years (±5.1). Indications for hemostasis hysterectomy were dominated by placenta accreta (39% of cases; n=27), uterine inertia (34% of cases; n=24) and uterine rupture (16% of cases; n=11). Perioperative morbidity rate was 34 % (n=24). The most frequent complications were hemorrhagic shock (17%; n=12), disseminated intravascular coagulation (6%; n=4) and bladder lesions (6%; n=4). We reported six cases of maternal death, reflecting a rate of 8% (n=6). Subtotal hysterectomy was performed in 79% of patients (n=55) and 21% of women (n=15) underwent total hysterectomy. Placenta accreta was significantly associated with total hysterectomy group (aOR: 6.93, 95% CI: 1.07-44,80, p=0.042) and the average operation time was significantly shorter in subtotal hysterectomy group (aOR: 1.023; 95% CI: 1.009-1.03, p= 0.01).
CONCLUSION
hysterectomy is essential in certain patients with severe postpartum hemorrhage. Placenta accreta is the main indication for hysterectomy. Total hysterectomy is not associated with an increased risk of complications compared to subtotal hysterectomy.
Topics: Adult; Female; Gynecology; Hemostasis; Hospitals; Humans; Hysterectomy; Placenta Accreta; Postpartum Hemorrhage; Pregnancy; Retrospective Studies; Tunisia
PubMed: 36187026
DOI: 10.11604/pamj.2022.42.172.34423 -
JAMA Oncology Mar 2021There is no current consensus on the role of chemotherapy in addition to radiation for postoperative adjuvant treatment of patients with early-stage cervical cancer with... (Randomized Controlled Trial)
Randomized Controlled Trial
Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial.
IMPORTANCE
There is no current consensus on the role of chemotherapy in addition to radiation for postoperative adjuvant treatment of patients with early-stage cervical cancer with adverse pathological factors.
OBJECTIVE
To evaluate the clinical benefits of sequential chemoradiation (SCRT) and concurrent chemoradiation (CCRT) compared with radiation alone (RT) as a postoperative adjuvant treatment in early-stage cervical cancer.
DESIGN, SETTING, AND PARTICIPANTS
After radical hysterectomy at 1 of 8 participating hospitals in China, patients with FIGO (International Federation of Gynecology and Obstetrics) stage IB to IIA cervical cancer with adverse pathological factors were randomized 1:1:1 to receive adjuvant RT, CCRT, or SCRT. Data were collected from February 2008 to December 2018.
INTERVENTIONS
Patients received adjuvant RT (total dose, 45-50 Gy), CCRT (weekly cisplatin, 30-40 mg/m2), or SCRT (cisplatin, 60-75 mg/m2, plus paclitaxel, 135-175 mg/m2) in a 21-day cycle, given 2 cycles before and 2 cycles after radiotherapy, respectively.
MAIN OUTCOMES AND MEASURES
The primary end point was the rate of disease-free survival (DFS) at 3 years.
RESULTS
A total of 1048 women (median [range] age, 48 [23-65] years) were included in the analysis (350 in the RT group, 345 in the CCRT group, and 353 in the SCRT group). Baseline demographic and disease characteristics were balanced among the treatment groups except that the rate of lymph node involvement was lowest in the RT group (18.3%). In the intention-to-treat population, SCRT was associated with a higher rate of DFS than RT (3-year rate, 90.0% vs 82.0%; hazard ratio [HR], 0.52; 95% CI, 0.35-0.76) and CCRT (90.0% vs 85.0%; HR, 0.65; 95% CI, 0.44-0.96). Treatment with SCRT also decreased cancer death risk compared with RT (5-year rate, 92.0% vs 88.0%; HR, 0.58; 95% CI, 0.35-0.95) after adjustment for lymph node involvement. However, neither DFS nor cancer death risk was different among patients treated with CCRT or RT.
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial, conducted in a postoperative adjuvant treatment setting, SCRT, rather than CCRT, resulted in a higher DFS and lower risk of cancer death than RT among women with early-stage cervical cancer.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00806117.
Topics: Chemoradiotherapy; Chemotherapy, Adjuvant; Cisplatin; Female; Humans; Hysterectomy; Middle Aged; Neoplasm Staging; Radiotherapy, Adjuvant; Treatment Outcome; Uterine Cervical Neoplasms
PubMed: 33443541
DOI: 10.1001/jamaoncol.2020.7168