-
Trials Apr 2022A retrospective study and a randomized controlled trial published in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival...
A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial.
BACKGROUND
A retrospective study and a randomized controlled trial published in late 2018 have shown that laparoscopic radical hysterectomy (RH) was associated with worse survival than abdominal RH among patients with early-stage cervical cancer. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology; therefore, this conclusion is pivotal. The current trial is designed to reconfirm whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB1, IB2, and IIA1) patient survival under stringent operation standards and consistent surgical oncologic principles.
METHODS/DESIGN
This is an investigator-initiated, Prospective, Randomized, Open, Blinded End-point (PROBE)-controlled non-inferiority trial. A total of 780 patients with stage IB1, IB2, and IIA1 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary endpoint will be 5-year progression-free survival, and secondary endpoints include 5-year overall survival, recurrence, and quality of life measurements.
DISCUSSION
The debate on laparoscopic versus abdominal RH is still ongoing, and high-quality evidences are needed to guide clinical practice. The study results will provide more convincing evidence-based information for early-stage cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04929769 . Registered on 18 June 2021.
Topics: Disease-Free Survival; Female; Humans; Hysterectomy; Laparoscopy; Multicenter Studies as Topic; Neoplasm Staging; Prospective Studies; Quality of Life; Randomized Controlled Trials as Topic; Retrospective Studies; Uterine Cervical Neoplasms
PubMed: 35395868
DOI: 10.1186/s13063-022-06245-5 -
Gynecologic Oncology Feb 1996
Topics: Female; History, 20th Century; Humans; Hysterectomy; United States
PubMed: 8631536
DOI: 10.1006/gyno.1996.0023 -
Journal of Minimally Invasive Gynecology Mar 2024The investigation of the role of preoperative conization in cervical cancer aiming to explore its potential clinical significance. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The investigation of the role of preoperative conization in cervical cancer aiming to explore its potential clinical significance.
DATA SOURCES
Cochrane Library, Embase, PubMed, and Web of Science, up to April 28, 2023.
METHODS OF STUDY SELECTION
(1) Observational cohort studies, (2) studies comparing radical hysterectomy with preoperative conization (CO) vs radical hysterectomy without preoperative conization (NCO) in patients with early-stage cervical cancer, and (3) studies comparing disease-free survival outcomes.
TABULATION, INTEGRATION, AND RESULTS
Two reviewers independently extracted the data and assessed the quality of the studies. The meta-analysis used combined hazard ratios along with their corresponding 95% confidence intervals to compare CO and NCO. We conducted a Bayesian network meta-analysis using Markov chain Monte Carlo methods to compare minimally invasive CO, open CO, minimally invasive NCO, and open NCO. Our study included 15 retrospective trials, 10 of which were used to traditional pairwise meta-analysis and 8 for network meta-analysis. The NCO group exhibited a notably higher probability of cancer recurrence than the CO group (hazard ratio, 0.52; 95% confidence interval, 0.41-0.65). In the network meta-analysis, minimally invasive NCO showed the worst survival outcome.
CONCLUSION
Preoperative conization seems to be a protective factor in decreasing recurrence risk, assisting clinicians in predicting survival outcomes for patients with early-stage cervical cancer. It may potentially aid in selecting suitable candidates for minimally invasive surgery in clinical practice.
Topics: Female; Humans; Uterine Cervical Neoplasms; Conization; Retrospective Studies; Bayes Theorem; Network Meta-Analysis; Neoplasm Recurrence, Local; Disease-Free Survival; Hysterectomy; Minimally Invasive Surgical Procedures; Neoplasm Staging
PubMed: 38016630
DOI: 10.1016/j.jmig.2023.11.019 -
World Journal of Surgical Oncology Jul 2023This study compared the survival outcomes of abdominal radical hysterectomy (ARH) (N = 32), laparoscopic radical hysterectomy (LRH) (N = 61), robot-assisted...
Survival outcomes of abdominal radical hysterectomy, laparoscopic radical hysterectomy, robot-assisted radical hysterectomy and vaginal radical hysterectomy approaches for early-stage cervical cancer: a retrospective study.
BACKGROUND
This study compared the survival outcomes of abdominal radical hysterectomy (ARH) (N = 32), laparoscopic radical hysterectomy (LRH) (N = 61), robot-assisted radical hysterectomy (RRH) (N = 100) and vaginal radical hysterectomy (VRH) (N = 45) approaches for early-stage cervical cancer to identify the surgical approach that provides the best survival.
METHODS
Disease-free survival (DFS) and overall survival (OS) were calculated using the Kaplan-Meier method, and survival curves were compared using the log-rank test.
RESULTS
The volume of intraoperative blood loss was greater in the ARH group than in the LRH group, the RRH group or the VRH group [(712.50 ± 407.59) vs. (224.43 ± 191.89), (109.80 ± 92.98) and (216.67 ± 176.78) ml, respectively; P < 0.001]. Total 5-year OS was significantly different among the four groups (ARH, 96.88%; LRH, 82.45%; RRH, 94.18%; VRH, 91.49%; P = 0.015). However, no significant difference in 5-year DFS was observed among the four groups (ARH, 96.88%; LRH, 81.99%; RRH, 91.38%; VRH, 87.27%; P = 0.061).
CONCLUSION
This retrospective study demonstrated that ARH and RRH achieved higher 5-year OS rates than LRH for early-stage cervical cancer.
Topics: Female; Humans; Retrospective Studies; Robotics; Uterine Cervical Neoplasms; Neoplasm Staging; Hysterectomy; Laparoscopy
PubMed: 37403056
DOI: 10.1186/s12957-023-03051-4 -
Gynecologic Oncology Oct 2022To compare survival outcomes of minimally invasive surgery (MIS) and open surgery for radical hysterectomy (RH) in early cervical cancer patients with histologic...
Open versus minimally invasive radical hysterectomy for early cervical cancer: A two-center retrospective cohort study with pathologic review of usual-type adenocarcinoma and adenosquamous carcinoma.
OBJECTIVE
To compare survival outcomes of minimally invasive surgery (MIS) and open surgery for radical hysterectomy (RH) in early cervical cancer patients with histologic subtypes of usual-type adenocarcinoma and adenosquamous carcinoma.
METHODS
From two centers' cervical cancer cohorts, patients with 2009 FIGO stage IB1-IB2 who underwent RH between 2007 and 2020 were retrospectively identified. Patients with usual-type adenocarcinoma and adenosquamous carcinoma were included in the analysis after pathologic review according to the updated World Health Organization Classification of Tumors. Clinicopathologic characteristics and survival outcomes were compared in terms of open surgery or MIS.
RESULTS
This study included 161 patients. No significant differences were noted in overall survival (OS; P = 0.241) and disease-free survival (DFS; P = 0.156) between patients with usual-type adenocarcinoma (n = 136) and those with adenosquamous carcinoma (n = 25). MIS RH group (n = 99) had a significantly smaller tumor size (P < 0.001), lesser pathologic parametrial invasion (P = 0.001), and lesser lymph node metastasis (P < 0.001) than open RH group (n = 62). MIS and open RH groups showed similar OS (P = 0.201) and 3-year DFS rate (87.9% vs. 75.1%; P = 0.184). In multivariate analysis, worse DFS was not associated with MIS (P = 0.589) but was associated with pathologic parametrial invasion (adjusted HR, 3.41; 95% CI, 1.25-9.29; P = 0.016). Consistent results were observed among patients with usual-type adenocarcinoma; MIS was not associated with worse DFS.
CONCLUSIONS
Comparable survival outcomes were found for MIS and open RH in early-stage cervical usual-type adenocarcinoma and adenosquamous carcinoma. Although MIS RH was not a poor prognostic factor, pathologic parametrial invasion was significantly associated with worse DFS in cervical usual-type adenocarcinoma and adenosquamous carcinoma.
Topics: Adenocarcinoma; Carcinoma, Adenosquamous; Disease-Free Survival; Female; Humans; Hysterectomy; Minimally Invasive Surgical Procedures; Neoplasm Staging; Retrospective Studies; Uterine Cervical Neoplasms
PubMed: 35970602
DOI: 10.1016/j.ygyno.2022.08.003 -
Journal of Cancer Research and Clinical... May 2024We conducted this study to evaluate the efficacy of total hysterectomy versus radical hysterectomy in the treatment of neuroendocrine cervical cancer (NECC). (Comparative Study)
Comparative Study
PURPOSE
We conducted this study to evaluate the efficacy of total hysterectomy versus radical hysterectomy in the treatment of neuroendocrine cervical cancer (NECC).
METHODS
Eligible NECC patients were identified from the Surveillance, Epidemiology and End Results (SEER) database. Demographic characteristics, clinical treatment and survival of the patients were collected. The overall survival (OS) and cancer-specific survival (CSS) were estimated by Kaplan-Meier analysis with log-rank test.
RESULTS
A total of 286 patients were included, with 104 patients undergoing total hysterectomy and 182 patients undergoing radical hysterectomy. The 5-year OS were 50.8% in the total hysterectomy group and 47.5% in the radical hysterectomy group (p = 0.450); and the corresponding 5-year CSS were 51.6% and 49.1% (p = 0.494), respectively. Along with surgery, radiotherapy was given to 49.0% of patients in the total hysterectomy group and 50.5% in the radical hysterectomy group; and chemotherapy was administered to 77.9% of patients in the total hysterectomy group and 85.7% in the radical hysterectomy group. Unexpectedly, in patients who received adjuvant radiotherapy with or without chemotherapy, the OS was superior in the total hysterectomy group compared with the radical hysterectomy group (p = 0.034). While in patients who received chemotherapy alone and those who received neither radiotherapy nor chemotherapy, the OS still remained comparable between the total hysterectomy and radical hysterectomy group.
CONCLUSION
Compared with radical hysterectomy, total hysterectomy was not associated with compromised survival prognosis in patients with NECC. Total hysterectomy has the potential to be a surgical alternative in the multimodal management of NECC.
Topics: Humans; Female; Hysterectomy; Uterine Cervical Neoplasms; SEER Program; Middle Aged; Adult; Carcinoma, Neuroendocrine; Aged
PubMed: 38710946
DOI: 10.1007/s00432-024-05773-8 -
Annals of Oncology : Official Journal... Oct 2009Radical hysterectomy combined with a pelvic lymphadenectomy or chemoradiation are traditionally the mainstays of treatment of International Federation of Gynecology and... (Review)
Review
Quality assurance for radical hysterectomy for cervical cancer: the view of the European Organization for Research and Treatment of Cancer--Gynecological Cancer Group (EORTC-GCG).
Radical hysterectomy combined with a pelvic lymphadenectomy or chemoradiation are traditionally the mainstays of treatment of International Federation of Gynecology and Obstetrics stages Ia2-IIa cervical cancer. The quality of radical surgery for cervical cancer influences local tumor control and survival. Hence, it is important to optimize and ensure the quality of surgical care for cervical cancer patients. In this paper, we discuss factors that are related to outcome after radical hysterectomy and propose a set of quality indicators that can be used to audit and improve the quality of surgical care for cervical cancer patients.
Topics: Female; Humans; Hysterectomy; Practice Guidelines as Topic; Quality Control; Treatment Outcome; Uterine Cervical Neoplasms
PubMed: 19556323
DOI: 10.1093/annonc/mdp196 -
European Journal of Cancer (Oxford,... Jul 2019The aim of the study was to compare overall survival (OS) and disease-free survival (DFS) after open and robotic radical hysterectomy for early-stage cervical cancer.
PURPOSE
The aim of the study was to compare overall survival (OS) and disease-free survival (DFS) after open and robotic radical hysterectomy for early-stage cervical cancer.
PATIENTS AND METHODS
This was a nationwide population-based cohort study on all women with cervical cancer stage IA1-IB of squamous, adenocarcinoma or adenosquamous histological subtypes, from January 2011 to December 2017, for whom radical hysterectomy was performed. The Swedish Quality Register of Gynaecologic Cancer was used for identification. To ensure quality and conformity of data and to disclose patients not yet registered, hospital registries were reviewed and validated. Cox and propensity score regression analysis and univariable and multivariable regression analysis were performed in regard to OS and DFS.
RESULTS
There were 864 women (236 open and 628 robotic) included in the study. The 5-year OS was 92% and 94% and DFS was 84% and 88% for the open and robotic cohorts, respectively. The recurrence pattern was similar in both groups. Using propensity score analysis and matched cohorts of 232 women in each surgical group, no significant differences were seen in survival: 5-year OS of 92% in both groups (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.50-2.01) and DFS of 85% vs 84% in the open and robotic cohort, respectively (HR, 1.08; 95% CI, 0.66-1.78). In univariable and multivariable analysis with OS as the end-point, no significant factors were found, and in regard to DFS, tumour size (p < 0.001) and grade 3 (p = 0.02) were found as independent significant risk factors.
CONCLUSION
In a complete nationwide population-based cohort, where radical hysterectomy for early-stage cervical cancer is highly centralised, neither long-term survival nor pattern of recurrence differed significantly between open and robotic surgery.
Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Disease-Free Survival; Female; Humans; Hysterectomy; Middle Aged; Neoplasm Recurrence, Local; Robotic Surgical Procedures; Sweden; Treatment Outcome; Uterine Cervical Neoplasms; Young Adult
PubMed: 31200323
DOI: 10.1016/j.ejca.2019.05.016 -
Trials Aug 2023Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs....
A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial.
BACKGROUND
Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial.
METHODS/DESIGN
This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements.
DISCUSSION
The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04939831 , retrospectively registered on 25 June 2021.
Topics: Humans; Female; Uterine Cervical Neoplasms; Prospective Studies; Quality of Life; Laparoscopy; Hysterectomy; Randomized Controlled Trials as Topic; Multicenter Studies as Topic
PubMed: 37592299
DOI: 10.1186/s13063-023-07573-w -
Journal of Gynecologic Oncology Apr 2015A prospective, randomized controlled trial was conducted to evaluate the efficacy of nerve-sparing radical hysterectomy (NSRH) in preserving bladder function and its... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
A prospective, randomized controlled trial was conducted to evaluate the efficacy of nerve-sparing radical hysterectomy (NSRH) in preserving bladder function and its oncologic safety in the treatment of cervical cancer.
METHODS
From March 2003 to November 2005, 92 patients with cervical cancer stage IA2 to IIA were randomly assigned for surgical treatment with conventional radical hysterectomy (CRH) or NSRH, and 86 patients finally included in the analysis. Adequacy of nerve sparing, radicality, bladder function, and oncologic safety were assessed by quantifying the nerve fibers in the paracervix, measuring the extent of paracervix and harvested lymph nodes (LNs), urodynamic study (UDS) with International Prostate Symptom Score (IPSS), and 10-year disease-free survival (DFS), respectively.
RESULTS
There were no differences in clinicopathologic characteristics between two groups. The median number of nerve fiber was 12 (range, 6 to 21) and 30 (range, 17 to 45) in the NSRH and CRH, respectively (p<0.001). The extent of resected paracervix and number of LNs were not different between the two groups. Volume of residual urine and bladder compliance were significantly deteriorated at 12 months after CRH. On the contrary, all parameters of UDS were recovered no later than 3 months after NSRH. Evaluation of the IPSS showed that the frequency of long-term urinary symptom was higher in CRH than in the NSRH group. The median duration before the postvoid residual urine volume became less than 50 mL was 11 days (range, 7 to 26 days) in NSRH group and was 18 days (range, 10 to 85 days) in CRH group (p<0.001). No significant difference was observed in the 10-year DFS between two groups.
CONCLUSION
NSRH appears to be effective in preserving bladder function without sacrificing oncologic safety.
Topics: Adenocarcinoma; Adult; Carcinoma, Adenosquamous; Carcinoma, Squamous Cell; Female; Humans; Hysterectomy; Middle Aged; Organ Sparing Treatments; Pelvis; Recovery of Function; Survival Analysis; Treatment Outcome; Urinary Bladder; Uterine Cervical Neoplasms; Uterus
PubMed: 25872890
DOI: 10.3802/jgo.2015.26.2.90