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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 -
Surgery Journal (New York, N.Y.) Dec 2021Recently, radical vaginal hysterectomy (RVH) has developed into laparoscopically assisted radical vaginal hysterectomy (LARVH), which is associated with the...
Recently, radical vaginal hysterectomy (RVH) has developed into laparoscopically assisted radical vaginal hysterectomy (LARVH), which is associated with the laparoscopical procedure, and it is applied as radical vaginal trachelectomy and semi-radical vaginal hysterectomy. LARVH is indicated for patients with stage IB1 and IIA1 cervical carcinoma, especially those with a tumor size of less than 2 cm, because the cardinal ligaments cannot be resected widely. Although RVH that is associated with laparoscopic pelvic lymphadenectomy is the most used surgical procedure, radical trachelectomy may be performed either abdominally or vaginally (laparoscopic or robotic). One report found that the pregnancy rate was higher in patients who underwent minimally invasive or radical vaginal trachelectomy than in those who underwent radical abdominal trachelectomy.
PubMed: 35111936
DOI: 10.1055/s-0041-1739120 -
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 -
Surgery Journal (New York, N.Y.) Dec 2021Abdominal radical trachelectomy is a fertility-sparing surgery for early invasive cervical cancer. The surgical steps involved in abdominal radical trachelectomy are...
Abdominal radical trachelectomy is a fertility-sparing surgery for early invasive cervical cancer. The surgical steps involved in abdominal radical trachelectomy are similar to those for radical hysterectomy prior to removal of the uterus. The difference is that in trachelectomy, the uterine corpus and infundibulopelvic ligament are conserved and the cervical remnant is connected to the vaginal wall. Surgeons should pay close attention to avoiding postsurgical complications such as infection and ileus, which might interfere with subsequent fertility treatments.
PubMed: 35111935
DOI: 10.1055/s-0041-1728750 -
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 -
American Journal of Obstetrics and... Mar 2020Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Standard treatment of early cervical cancer involves a radical hysterectomy and retroperitoneal lymph node dissection. The existing evidence on the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer is either nonrandomized or retrospective.
OBJECTIVE
The purpose of this study was to compare the incidence of adverse events after minimally invasive vs open radical hysterectomy for early cervical cancer.
STUDY DESIGN
The Laparoscopic Approach to Carcinoma of the Cervix trial was a multinational, randomized noninferiority trial that was conducted between 2008 and 2017, in which surgeons from 33 tertiary gynecologic cancer centers in 24 countries randomly assigned 631 women with International Federation of Gynecology and Obstetrics 2009 stage IA1 with lymph-vascular invasion to IB1 cervical cancer to undergo minimally invasive (n = 319) or open radical hysterectomy (n = 312). The Laparoscopic Approach to Carcinoma of the Cervix trial was suspended for enrolment in September 2017 because of an increased risk of recurrence and death in the minimally invasive surgery group. Here we report on a secondary outcome measure: the incidence of intra- and postoperative adverse events within 6 months after surgery.
RESULTS
Of 631 randomly assigned patients, 536 (85%; mean age, 46.0 years) met inclusion criteria for this analysis; 279 (52%) underwent minimally invasive radical hysterectomy, and 257 (48%) underwent open radical hysterectomy. Of those, 300 (56%), 91 (16.9%), and 69 (12.8%) experienced at least 1 grade ≥2 or ≥3 or a serious adverse event, respectively. The incidence of intraoperative grade ≥2 adverse events was 12% (34/279 patients) in the minimally invasive group vs 10% (26/257) in the open group (difference, 2.1%; 95% confidence interval, -3.3 to 7.4%; P=.45). The overall incidence of postoperative grade ≥2 adverse events was 54% (152/279 patients) in the minimally invasive group vs 48% (124/257) in the open group (difference, 6.2%; 95% confidence interval, -2.2 to 14.7%; P=.14).
CONCLUSION
For early cervical cancer, the use of minimally invasive compared with open radical hysterectomy resulted in a similar overall incidence of intraoperative or postoperative adverse events.
Topics: Adenocarcinoma; Blood Loss, Surgical; Blood Transfusion; Body Mass Index; Carcinoma, Adenosquamous; Carcinoma, Squamous Cell; Conversion to Open Surgery; Female; Humans; Hysterectomy; Intraoperative Complications; Laparoscopy; Length of Stay; Lymph Node Excision; Middle Aged; Operative Time; Postoperative Complications; Risk Factors; Robotic Surgical Procedures; Uterine Cervical Neoplasms
PubMed: 31586602
DOI: 10.1016/j.ajog.2019.09.036 -
European Journal of Cancer (Oxford,... May 2021Pelvic lymph node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase the... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Pelvic lymph node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase the detection of metastatic disease, but benefits of omitting pelvic lymph node dissection in terms of decreased morbidity have not been demonstrated.
MATERIALS AND METHODS
In an open-label study, patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1) were randomly assigned to SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN + PLND arm). SN resection was followed by radical surgery of the tumour (radical hysterectomy or radical trachelectomy). The primary end-point was morbidity related to the lymph node dissection; 3-year recurrence-free survival was a secondary end-point.
RESULTS
A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) or SN + PLND arm (101 patients). Most patients had stage IB1 lesion (87.4%). No false-negative case was observed in SN + PLND arm. Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively). However, there was no significant difference in the proportion of patients with significant lymphoedema between the two groups. During the 6-month postoperative period, the difference in morbidity decreased over time. The 3-year recurrence-free survival was not significantly different (92.0% in SN arm and 94.4% in SN + PLND arm).
CONCLUSION
SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.
Topics: Adenocarcinoma; Adult; Carcinoma, Squamous Cell; Female; Follow-Up Studies; Humans; Hysterectomy; Lymph Node Excision; Middle Aged; Morbidity; Neoplasm Recurrence, Local; Prognosis; Prospective Studies; Sentinel Lymph Node Biopsy; Survival Rate; Uterine Cervical Neoplasms
PubMed: 33773275
DOI: 10.1016/j.ejca.2021.02.009