Randomized Trial of Neoadjuvant Cisplatin, Vincristine, Bleomycin, and Radical Hysterectomy Versus Radiation Therapy for Bulky Stage IB and IIA Cervical Cancer

2000 ◽  
Vol 18 (8) ◽  
pp. 1740-1747 ◽  
Author(s):  
Ting-Chang Chang ◽  
Chyong-Huey Lai ◽  
Ji-Hong Hong ◽  
Suei Hsueh ◽  
Kuan-Gen Huang ◽  
...  

PURPOSE: To compare the efficacy of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy with that of radiotherapy (R/T) for bulky early-stage cervical cancer. PATIENTS AND METHODS: Women with previously untreated bulky (primary tumor ≥ 4 cm) stage IB or IIA non–small-cell carcinoma of the uterine cervix were randomly assigned to receive either cisplatin 50 mg/m2 and vincristine 1 mg/m2 for 1 day and bleomycin 25 mg/m2 for 3 days for three cycles followed by radical hysterectomy (NAC arm) or receive primary pelvic radiotherapy only (R/T arm). The ratio of patient allocation was 6:4 for the NAC and R/T arms. Women with enlarged para-aortic lymph nodes on image study were ineligible unless results of cytologic or histologic studies were negative. RESULTS: Of the 124 eligible patients, 68 in the NAC arm and 52 in the R/T arm could be evaluated. The median duration of follow-up was 39 months. Thirty-one percent of patients in the NAC arm and 27% in the R/T arm had relapse or persistent diseases after treatment, and 21% in each group died of disease. Estimated cumulative survival rates at 2 years were 81% for the NAC arm and 84% for the R/T arm; the 5-year rates were 70% and 61%, respectively. There were no significant differences in disease-free survival and overall survival. CONCLUSION: NAC followed by radical hysterectomy and primary R/T showed similar efficacy for bulky stage IB or IIA cervical cancer. Further study to identify patient subgroups better suited for either treatment modality and to evaluate the concurrent use of cisplatin and radiation without routine hysterectomy is necessary.

2022 ◽  
Vol 2022 ◽  
pp. 1-10
Author(s):  
R. Wojdat ◽  
E. Malanowska

Background. LACC trial demonstrated inferiority of laparoscopic approach for the treatment of early-stage cervical cancer. There are still limited data from retrospective trials regarding whether survival outcomes after laparoscopic radical hysterectomy are equivalent to those after open abdominal radical hysterectomy. In this study, we present results of combined vaginal radical laparoscopic hysterectomy in the treatment of early-stage cervical cancer. Methods. This retrospective study was carried out at the Department of Gynecology in Mathilden Hospital (Herford, Germany). Between January 2008 and April 2018, all the patients with invasive cervical cancer who underwent combined vaginal assisted radical laparoscopic hysterectomy (VARLH) without the use of any uterine manipulator were enrolled to the study. Results. A total number of 124 patients with diagnosis of invasive cervical cancer were enrolled in the study. All of the patients underwent minimally invasive surgery and were divided according to FIGO 2019: stage IA (25.9%), IB1 (25.0%), IB2-IIB (28.4%), and III/IV (20.7%). Overall, the mean age of the patients was 51.84 years. After a study collection, a median follow-up was 45.6 (range 23.7-76.5) months. The 3- and 5-year disease-free survival rates for early-stage cervical cancer were both 98%, and the 3- and 5-year overall survival rates were 100% and 97%, respectively. We have not observed any recurrence in our study group of patients with early-stage cervical cancer. Conclusions. Combined VARLH can be considered a safe and effective procedure for the treatment of early-stage cervical cancer. Surgical strategy with oncological principles determines the quality and long-term success of the operation in early cervical cancer regardless of laparoscopic approach.


2021 ◽  
pp. ijgc-2020-002086
Author(s):  
Juliana Rodriguez ◽  
Jose Alejandro Rauh-Hain ◽  
James Saenz ◽  
David Ortiz Isla ◽  
Gabriel Jaime Rendon Pereira ◽  
...  

IntroductionRecent evidence has shown adverse oncological outcomes when minimally invasive surgery is used in early-stage cervical cancer. The objective of this study was to compare disease-free survival in patients that had undergone radical hysterectomy and pelvic lymphadenectomy, either by laparoscopy or laparotomy.MethodsWe performed a multicenter, retrospective cohort study of patients with cervical cancer stage IA1 with lymph-vascular invasion, IA2, and IB1 (FIGO 2009 classification), between January 1, 2006 to December 31, 2017, at seven cancer centers from six countries. We included squamous, adenocarcinoma, and adenosquamous histologies. We used an inverse probability of treatment weighting based on propensity score to construct a weighted cohort of women, including predictor variables selected a priori with the possibility of confounding the relationship between the surgical approach and survival. We estimated the HR for all-cause mortality after radical hysterectomy with weighted Cox proportional hazard models.ResultsA total of 1379 patients were included in the final analysis, with 681 (49.4%) operated by laparoscopy and 698 (50.6%) by laparotomy. There were no differences regarding the surgical approach in the rates of positive vaginal margins, deep stromal invasion, and lymphovascular space invasion. Median follow-up was 52.1 months (range, 0.8–201.2) in the laparoscopic group and 52.6 months (range, 0.4–166.6) in the laparotomy group. Women who underwent laparoscopic radical hysterectomy had a lower rate of disease-free survival compared with the laparotomy group (4-year rate, 88.7% vs 93.0%; HR for recurrence or death from cervical cancer 1.64; 95% CI 1.09–2.46; P=0.02). In sensitivity analyzes, after adjustment for adjuvant treatment, radical hysterectomy by laparoscopy compared with laparotomy was associated with increased hazards of recurrence or death from cervical cancer (HR 1.7; 95% CI 1.13 to 2.57; P=0.01) and death for any cause (HR 2.14; 95% CI 1.05–4.37; P=0.03).ConclusionIn this retrospective multicenter study, laparoscopy was associated with worse disease-free survival, compared to laparotomy.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e038020
Author(s):  
Xiaopei Chao ◽  
Ming Wu ◽  
Shuiqing Ma ◽  
Xianjie Tan ◽  
Sen Zhong ◽  
...  

IntroductionRecent studies have revealed that the oncological survival outcomes of minimally invasive radical hysterectomy (MIRH) are inferior to those of abdominal radical hysterectomy (ARH) in early-stage cervical cancer, but the potential reasons are unclear.Methods and analysisEach expert from 28 study centres participating in a previously reported randomised controlled trial (NCT03739944) will provide successive eligible records of at least 100 patients who accepted radical hysterectomy for early-stage cervical cancer between 1 January 2009 and 31 December 2015. Inclusion criteria consist of a definite pathological evaluation of stages IA1 (with positive lymphovascular space invasion), IA2 and IB1 according to the International Federation of Gynecology and Obstetrics 2009 staging system and a histological subtype of squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. The primary endpoint is 5-year disease-free survival between the MIRH and ARH groups. The secondary endpoints include the MIRH learning curves of participating surgeons, 5-year overall survival between the MIRH and ARH groups, survival outcomes according to surgical chronology, surgical outcomes and sites of recurrence and potential risk factors that affect survival outcomes. A subgroup analysis in patients with tumour diameter less than 2 cm will follow the similar flow diagram.Ethics and disseminationThis study has been approved by the Institutional Review Board of Peking Union Medical College Hospital (registration no. JS-1711), and is also filed on record by all other 27 centres. The results will be disseminated through community events and peer-reviewed journals.Trial registration numberNCT03738969


2020 ◽  
Vol 30 (8) ◽  
pp. 1143-1150
Author(s):  
Ting wen yi Hu ◽  
Yue Huang ◽  
Na Li ◽  
Dan Nie ◽  
Zhengyu Li

IntroductionRecently, the safety of minimally invasive surgery in the treatment of cervical cancer has been questioned. This study was designed to compare the disease-free survival and overall survival of abdominal radical hysterectomy and laparoscopic radical hysterectomy in patients with early-stage cervical cancer.MethodsA total of 1065 patients with early-stage cervical cancer who had undergone abdominal/laparoscopic radical hysterectomy between January 2013 and December 2016 in seven hospitals were retrospectively analyzed. The 1:1 propensity score matching was performed in all patients. Patients with tumor size ≥2 cm and <2 cm were stratified and analyzed separately. Disease-free survival and overall survival were compared between matched groups. After confirming the normality by the Shapiro-Wilks test, the Mann-Whitney U test and the χ2 test were used for the comparison of continuous and categorical variables, respectively. The survival curves were generated by the Kaplan-Meier method and compared by log-rank test.ResultsAfter matching, a total of 812 patients were included in the disease-free survival and overall survival analyses. In the entire cohort, the laparoscopic radical hysterectomy group had a significantly shorter disease-free survival (HR 1.65, 95% CI 1.00 to 2.73; p=0.048) but not overall survival (HR 1.60, 95% CI 0.89 to 2.88; p=0.12) when compared with the abdominal radical hysterectomy group. In patients with tumor size ≥2 cm, the laparoscopic radical hysterectomy group had a significantly shorter disease-free survival (HR 1.93, 95% CI 1.05 to 3.55; p=0.032) than the abdominal radical hysterectomy group, whereas no significant difference in overall survival (HR 1.90, 95% CI 0.95 to 3.83; p=0.10) was found. Additionally, in patients with tumor size <2 cm, the laparoscopic radical hysterectomy and abdominal radical hysterectomy groups had similar disease-free survival (HR 0.71, 95% CI 0.24 to 2.16; p=0.59) and overall survival (HR 0.59, 95% CI 0.11 to 3.13; p=0.53).ConclusionLaparoscopic radical hysterectomy was associated with inferior disease-free survival compared with abdominal radical hysterectomy in the entire cohort, as well as in patients with tumor size ≥2 cm. For the surgical treatment of patients with early-stage cervical cancer, priority should be given to open abdominal radical hysterectomy.


2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Seracchioli Renato ◽  
Mabrouk Mohamed ◽  
Solfrini Serena ◽  
Montanari Giulia ◽  
Ferrini Giulia ◽  
...  

Robot-assisted procedures are being increasingly incorporated in gynaecologic oncology. Several studies have confirmed the feasibility and safety of robotic radical hysterectomy for selected patients with early-stage cervical cancer. It has been demonstrated that robotic radical hysterectomy offers an advantage over other surgical approaches with regard to operative time, blood loss, and hospital stay. Also initial evidences concerning oncological outcomes seem to confirm the equivalence to traditional open technique. Despite the fact that costs of robotic system are still high, they could be partially offset by several health-related and social benefits: less pain, faster dismissal, and return to full activity than other surgical approaches. The development of robotic technology may facilitate the spread of minimally invasive surgery in gynaecological oncology, overcoming some drawbacks of laparoscopic technique for challenging intervention such as radical hysterectomy. Further studies are needed to evaluate overall and disease-free survival of this technique and associated morbidity after adjuvant therapies.


2021 ◽  
Vol 10 (17) ◽  
pp. 3761
Author(s):  
Jona Röseler ◽  
Robert Wolff ◽  
Dirk O. Bauerschlag ◽  
Nicolai Maass ◽  
Peter Hillemanns ◽  
...  

Objective: The aim of the study was to perform a systematic assessment of disease-free survival (DFS), overall survival, and morbidity rates after open radical hysterectomy (ORH) and minimally invasive surgery (MIS) for early-stage cervical cancer and discuss with experts the consequences of the LACC trial (published by Ramirez et al. in 2018) on clinical routine. Methods: A total of 5428 records were retrieved. After exclusion based on text screening, four records were identified for inclusion. Five experts from three independent large-volume medical centers in Europe were interviewed for their interpretation of the LACC trial. Results: The LACC trial showed a significantly higher risk of disease progression with MIS compared to ORH (HR 3.74, 95% CI 1.63 to 8.58). This was not seen in one epidemiological study and was contradicted by one prospective cohort study reported by Greggi et al. A systematic review by Zhang et al. mentioned a similar DFS for robot-assisted radical hysterectomy (RRH) and LRH. Recurrence rates were significantly higher with MIS compared to ORH in the LACC trial (HR 4.26, 95% CI 1.44 to 12.60). In contrast, four studies presented by Greggi reported no significant difference in recurrence rates between LRH/RRH and ORH, which concurred with the systematic reviews of Zhang and Zhao. The experts mentioned various limitations of the LACC trial and stated that clinicians were obliged to provide patients with detailed information and ensure a shared decision-making process. Conclusions: The surgical treatment of early-stage cervical cancer remains a debated issue. More randomized controlled trials (RCT) will be needed to establish the most suitable treatment for this condition.


2020 ◽  
Vol 30 (9) ◽  
pp. 1308-1316
Author(s):  
Junshen He ◽  
Min Hao ◽  
Ping Liu ◽  
Zhihua Liu ◽  
Jinghe Lang ◽  
...  

BackgroundEarly stage cervical cancer is prevalent in China and remains a major public health burden in developing countries. We aimed to determine the long term oncologic outcomes between laparoscopic and abdominal radical hysterectomy in patients with early cervical cancer.MethodsWe conducted a multicenter, retrospective, case-control study of 37 hospitals. All consecutive early stage cervical cancer patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA1 with lymphovascular space invasion to IB1, who underwent laparoscopic or abdominal radical hysterectomy between January 2004 and December 2016, were included. We compared the disease free survival and overall survival of the two approaches in 1:1 case-control matched settings based on prognosis related factors.ResultsWe selected 8470 of 46 313 patients. After matching (n=1601/1601), we found that laparoscopic surgery was associated with significantly worse 5 year disease free survival (89.5% vs 93.1%, p=0.001; hazard ratio (HR) 1.60, p=0.001), but not 5 year overall survival (94.3% vs 96.0%, HR=1.48, p=0.058). In the subgroup analysis, in patients with a tumor diameter <2 cm (n=739/739), both 5 year disease free survival and overall survival were similar between the laparoscopic and abdominal radical hysterectomy groups. However, when tumor diameter was 2–4 cm (n=898/898), laparoscopic surgery was a poor prognosis risk factor for 5 year disease free survival (84.7% vs 90.8%, p=0.001; HR=1.81, p<0.001), but not 5 year overall survival (90.9% vs 93.8%, p=0.077; HR=1.53, p=0.059).ConclusionsIn patients with early cervical cancer, laparoscopic radical hysterectomy was associated with significantly poorer long term oncologic outcome, although in patients with tumors <2 cm, the 5 year overall survival and 5 year disease free survival were similar.


2014 ◽  
Vol 24 (4) ◽  
pp. 735-743 ◽  
Author(s):  
Mignon Dingena Johanna Maria van Gent ◽  
Lukas Wesley van den Haak ◽  
Katja Nicolien Gaarenstroom ◽  
Alexander A. W. Peters ◽  
Mariette Inie Elisabeth van Poelgeest ◽  
...  

ObjectivesStandard treatment in early-stage cervical cancer is a radical hysterectomy (RH) with pelvic lymphadenectomy. In women who wish to preserve fertility radical vaginal trachelectomy has been proposed; however, this is not feasible in larger tumors, and nerve-sparing surgery is not possible. Nerve-sparing radical abdominal trachelectomy (NSRAT) overcomes these disadvantages.MethodsCase-control study of women with early-stage cervical cancer (International Federation of Gynecology and Obstetrics IA2-IB) submitted to NSRAT from 2000 until 2011. Women submitted to nerve-sparing RH with early-stage cervical cancer were included as control subjects.ResultsTwenty-eight patients and 77 control subjects were included. Neoadjuvant chemotherapy was administered in 3 women before NSRAT because the linear extension was or exceeded 40 mm. Local recurrence rate was 3.6% (95% confidence interval [CI], 0.00–10.6) in the NSRAT group compared with 7.8% (95% CI, 1.7–13.9) in the control group (P = 0.44). No significant difference was found between both groups regarding disease-free survival and survival. The overall pregnancy rate was 52.9% (95% CI, 28.7%–77.2%). The mean follow-up was 47.3 months (range, 6–122 months) for NSRAT and 51.8 months (11–129.6 months) for nerve-sparing RH.ConclusionsNerve-sparing radical abdominal trachelectomy seems safe and effective in women with early-stage cervical cancer who wish to preserve fertility. Respective women should be informed about this treatment option, especially if the tumor is too large for radical vaginal trachelectomy.


2021 ◽  
Author(s):  
Xuqing Li ◽  
Xueting Pei ◽  
Hongyan Li ◽  
Yan Wang ◽  
Youwei Zhou ◽  
...  

Abstract Background: To investigate the safety and efficacy of modified laparoscopic radical hysterectomy (MLRH) in the treatment of early stage cervical cancer by comparing relevant indices of different surgical procedures in patients with early stage cervical cancer.Methods: Patients with 2014 International Federation of Gynecology and Obstetrics (FIGO) clinical stages IB1 and IIA1 cervical cancer who underwent radical hysterectomy in the Gynecological Department of our hospital from October 2015 to June 2018 were enrolled. Patients were divided into two groups based on the surgical procedure: the open radical hysterectomy (ORH) group (n=336) and MLRH group (n=302). We retrospectively analyzed and compared the clinical characteristics, surgical indices, and survival prognosis between the groups.Results: Compared to the ORH group, the MLRH group exhibited a longer operative time, normal bladder function recovery time, less intraoperative blood loss volume, and more harvested pelvic lymph nodes (P<0.05). No significant differences were observed in postoperative complications, the 2.5-year overall survival (OS) rate, 2.5-year disease-free survival (DFS) rate, and recurrence rate between the groups (P>0.05), but the recurrence pattern was significantly different between the groups (P<0.05). Stratified analysis revealed that OS time was shorter in the ORH group than in the MLRH group in patients with stage IB1 and middle invasion (P<0.05). Pathological type was an independent factor for DFS and OS in early stage cervical cancer.Conclusion: MLRH incorporates a series of measures to prevent tumor spillage. It is a feasible and effective surgical procedure for the treatment of early stage cervical cancer.Trial registration: Present research is a retrospective study. The study had retrospectively registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/) and the registered number is ChiCTR1900026306.


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