FIGO Stage IB Cervical Cancer Research Articles

Conservative surgical approaches for small volume FIGO stage IB1 cervical cancer. Updated survival and obstetric outcomes of an expanded cohort

ObjectiveStandard surgical treatment of FIGO stage 1B1 cervical cancer is open radical surgery. However, there is increasing evidence that for small tumours a more conservative approach can minimise fertility consequences without impacting on long term oncologic outcomes. The objective of our study is to present survival and obstetric outcomes following extended follow-up for patients who underwent conservative management of small-volume stage 1B1 disease. MethodsAll patients with FIGO stage 1B1 cancer and estimated tumour volume of <500 mm3 in a loop biopsy specimen treated in Northern Gynaecological Oncology Centre between December 2000 and December 2021, were included in the study. Clinico-pathological and demographic data were collated alongside detailed follow-up and obstetric outcomes in conjunction with primary care and death register. Results117 patients underwent conservative surgery for small volume stage 1B1 disease. 58 (49.5%) underwent fertility sparing conservative management with LLETZ while 59 (50.5%) underwent simple hysterectomy. Overall, 95% (111/117) of the patients underwent bilateral pelvic lymphadenectomy and 1 positive node was identified. There was no death related to cervical cancer and 1 recurrence identified during a median follow up of 8.5 years (1−20). 17 pregnancies have been recorded in patients underwent LLETZ and 17 live babies were born. No second trimester miscarriages were noted and there was one preterm delivery (36 weeks). ConclusionNon-radical surgery with negative pelvic lymphadenectomy for smallvolume stage 1B1 cervical cancer ensures excellent survival without compromising obstetric outcomes. Should these results be verified by the ongoing prospective studies, radical surgery for these patients may be avoided.

Effect of modified radical laparoscopic hysterectomy versus open radical hysterectomy on short-term clinical outcomes in early-stage cervical cancer: a single-center, prospective, randomized controlled trial

BackgroundThe long-term prognosis of minimally invasive surgery and open surgery for early cervical cancer is controversial. This study mainly discusses the feasibility and effectiveness of the endocutter in radical laparoscopic hysterectomy for early cervical cancer.MethodsA single-center, prospective, randomized controlled trial of modified radical laparoscopic hysterectomy on patients with FIGO stage IA1 (lymphovascular invasion), IA2, and IB1 cervical cancer, between January 2020 and July 2021. Patients were randomly assigned into laparoscopic radical hysterectomy (LRH) and open radical hysterectomy (ORH) groups. The ORH group used right-angle sealing forceps for vaginal stump closure, whereas the LRH group used endoscopic staplers. The primary outcomes included the evaluation of the patient’s perioperative indicators, as well as short- and long-term complications. Recurrence and overall survival were considered secondary outcomes.ResultsAs of July 2021, 17 patients were enrolled in the laparoscopic surgery group and 17 in the open surgery group. The hospitalization time of the laparoscopic group was significantly shorter than those of the open group (15 min vs. 9 min, P < 0.001). The vaginal stump closure time in the laparoscopic group was longer than that in the open surgery group, and the difference was statistically significant (P < 0.001). Post-operative catheter removal (P = 0.72), drainage tube removal time (P = 0.27), number of lymph node dissections (P = 0.72), and incidence of intraoperative and post-operative complications between the two groups (P > 0.05). The median blood loss in the laparoscopic group was 278 ml, and it was 350 ml in the laparotomy group. The intraoperative blood transfusion rate was lower in the laparoscopic group; however, these differences did not reach statistical significance (P = 0.175). Vaginal margin pathology and peritoneal lavage cytology were negative, and all the patient’s vaginal stumps healed without infection. The median follow-up time of the laparoscopic group was 20.5 months, and it was 22 months for the open surgery group. There was no recurrence in all patients during the follow-up period.ConclusionsModified LRH with endocutter closure of the vaginal stump is an effective approach and not inferior to ORH in treating patients with early-stage cervical cancer.Trial registrationChiCTR2000030160, date of registration February 26, 2020 (https://www.chictr.org.cn/showprojen.aspx?proj=49809).

A confirmatory trial of modified radical hysterectomy for patients with FIGO stage IB1 cervical cancer with tumor diameter preoperatively estimated at 2 cm or less: Japan Clinical Oncology Group study, JCOG1101.

5532 Background: The standard surgery for Stage IB1 uterine cervical cancer is radical hysterectomy (RH, Piver class III hysterectomy). However, RH is highly invasive, and there is a need to establish less invasive techniques. We conducted a single-arm confirmatory trial (JCOG1101) to evaluate the efficacy and safety of modified radical hysterectomy (MRH) in patients with tumor diameter ≤ 2 cm Stage IB1 cervical cancer (jRCT: jRCTs031180167). Methods: From January 2013 to August 2017, 240 patients were enrolled from 40 institutions in Japan. Eligibility criteria included: (1) FIGO 2008 Stage IB1 cervical cancer; (2) histologically proven squamous cell carcinoma, adenocarcinoma (mucinous or endometrioid) or adenosquamous carcinoma; (3) tumor diameter ≤ 2 cm (measured by MRI or conization specimen); and (4) neither distant LN metastasis nor distant metastasis in CT. In case that the cancer could be microinvasive, conization was required to exclude Stage IA cases. The protocol surgery involved cutting the anterior layer of the vesicouterine ligament of the uterus and dissecting regional lymph nodes. Only laparotomy was permitted: laparoscopy and robotic surgery were not allowed. Postoperative irradiation was administered in cases where pelvic LN or parametrial invasion was positive, depth in the cervical wall invasion was ≥ 2/3, or surgical margin was &lt; 1 cm by pathological findings. The primary endpoint was 5-year overall survival (OS). We set the expected 5-year OS of MRH at 95.8% (5-year OS of RH in JCOG0806A, retrospective observational study) and the threshold 5-year OS at 90.8%. Results: Among 225 eligible patients, 193 (85.8%) were pT1b1 (UICC 7th), and 184 (81.8%) had pathological maximal tumor diameter ≤ 2 cm. Parametrial involvement, lymph node metastasis, ≥ 2/3 stromal invasion and &lt; 1 cm surgical margin were observed in 3 (1.3%), 16 (7.1%), 30 (13.3%) and 11 (4.9%) patients, respectively. Thirty-nine patients (17.3%) underwent adjuvant (chemo)radiation. Median follow-up was 77.7 months. Five patients (2.2%) died, and 5-year OS was 98.2% (90% CI: 96.0-99.2, &gt; 90.8%). Thirteen patients (5.8%) relapsed (8 local recurrence and 5 distant recurrence), and 5-year relapse-free survival was 94.7% (95% CI: 90.8-96.9%). Self-urination was observed in all patients, and residual urine disappearance up to 56 days after urethral catheter removal was observed in 213 patients (94.7%). Median time to disappearance of residual urine after urethral catheter removal was 1 day. There was no treatment-related death. Grade 3/4 non-hematological adverse events were observed in 17 patients (7.6%), including 8 infection and 4 hemorrhage. Conclusions: In this study, MRH was as effective as RH and less invasive. MRH can be considered a standard surgery for tumor diameter ≤ 2 cm Stage IB1 uterine cervical cancer. Clinical trial information: UMIN000009726 , jRCTs031180167 .

Survival outcomes of laparoscopic versus open radical hysterectomy in early cervical cancer with incidentally identified high-risk factors

ObjectivePreviously, we suggested that patients with cervical cancer (CC) with tumors ≤2 cm on preoperative magnetic resonance imaging (MRI) are safe candidates for laparoscopic radical hysterectomy (LRH). Here, we aim to investigate whether LRH deteriorates the prognosis of patients with incidentally identified high-risk factors; lymph node metastasis (LNM) or parametrial invasion (PMI). MethodsWe identified patients with 2009 FIGO stage IB1 CC who underwent Type C LRH or open radical hysterectomy (ORH) at three tertiary hospitals between 2000 and 2019. Those with a tumor ≤2 cm on preoperative MRI who were not suspicious of LNM or PMI preoperatively were included, while those who were indicated to receive adjuvant treatment but did not actually receive it were excluded. Survival outcomes were compared between the LRH and ORH groups in the overall population, then narrowed down to those with LNM, and then to those with PMI. ResultsIn total, 498 patients were included: 299 in the LRH group and 199 in the ORH group. The LRH and ORH groups showed similar 3-year progression-free survival (PFS) (94.0% vs. 93.6%; P = 0.615) and 5-year overall survival (OS) rates (97.2% vs. 96.8%; P = 0.439). On pathologic examination, 49 (9.8%) and 16 (3.2%) patients had LNM and PMI, respectively, and 10 (2.0%) had both. In the LNM subgroup, 5-year PFS rate was not significantly different between the LRH and ORH groups (73.2% vs. 91.7%; P = 0.169). In the PMI subgroup, no difference in PFS was observed between the two groups (P = 0.893). ConclusionsLRH might not deteriorate recurrence and mortality rates in CC patients with tumors ≤2 cm when adjuvant treatment is appropriately administered, even if pathologic LNM and PMI are incidentally identified.

Conization before radical hysterectomy in patients with early-stage cervical cancer: A Korean multicenter study (COBRA-R)

ObjectiveTo investigate the impact of conization on survival outcomes and to identify a specific population that might benefit from conization before radical hysterectomy (RH) in patients with early-stage cervical cancer. MethodsFrom six institutions in Korea, we identified node-negative, margin-negative, parametria-negative, 2009 FIGO stage IB1 cervical cancer patients who underwent primary type C RH between 2006 and 2021. The patients were divided into multiple groups based on tumor size, surgical approach, and histology. We performed a series of independent 1:1 propensity score matching and compared the survival outcomes between the conization and non-conization groups. ResultsIn total, 1254 patients were included: conization (n = 355) and non-conization (n = 899). Among the matched patients with a tumor size of >2 cm, the conization group showed a significantly better 3-year disease-free survival (DFS) rate compared with the non-conization group when RH was conducted via minimally invasive surgery (MIS), in those with squamous cell carcinoma (96.3% vs. 87.4%, P = 0.007) and non-squamous cell carcinoma (97.0% vs. 74.8%, P = 0.021). However, no difference in DFS was observed between the two groups among the matched patients with a tumor size of ≤2 cm, regardless of surgical approach or histological type. In patients who underwent MIS RH, DFS significantly worsened as the residual tumor size increased (P < 0.001). ConclusionCervical conization was associated with a lower recurrence rate in patients with early-stage cervical cancer with a tumor size of >2 cm who underwent primary MIS RH. Cervical conization may be performed prior to MIS RH to minimize the uterine residual tumor.

Cervical conization before primary radical hysterectomy has a protective effect on disease recurrence in early cervical cancer: A two-center matched cohort study (174)

Objectives: Preoperative cervical conization, while reducing the cervical mass size, might decrease the chance of tumor spillage during surgery. This study aimed to ascertain whether cervical conization before primary radical hysterectomy (RH) has a protective effect in patients with early cervical cancer. Methods: We retrospectively identified node-negative, marginnegative, parametria-negative, 2009 FIGO stage IB1 cervical cancer patients who received primary Type C RH at two tertiary institutional hospitals between July 2006 and June 2020. Whether they received preoperative cervical conization or not, patients were divided into conization group (n=144) and control group (n=434). To adjust for confounders, we conducted a 1:1 propensity score matching for histology, surgical approach, lymphovascular space invasion, and cervical mass size (calculated by summing pathologic tumor size on conization and uterine specimens). Then, survival outcomes were compared between the matched groups. Results: Overall, the conization group had less cervical mass size and received minimally invasive surgery (MIS) more frequently (p=0.010) and adjuvant treatment less often (p=0.002) compared to the control group. Of 37 patients who received preoperative conization and had no residual tumor in the uterine specimen, only one (2.7%) recurred during 56.5 months of a median observation period. After matching, the conization group showed significantly better progression-free survival (PFS) than the control group (3-year: 94.2% vs 86.3%; p=0.012), whereas no significant difference in overall survival (OS) was found. Subgroup analysis in the open RH (n=91) revealed that PFS did not differ by preoperative conization (p=0.799). In contrast, in the MIS RH subgroup (n=197), preoperative conization was associated with significantly better PFS (p=0.005). Conclusions: Despite the retrospective design, our matched cohort study suggests that preoperative cervical conization might have a protective effect on disease recurrence in early cervical cancer, especially for those who are planning to undergo MIS RH. Further prospective studies are warranted. Objectives: Preoperative cervical conization, while reducing the cervical mass size, might decrease the chance of tumor spillage during surgery. This study aimed to ascertain whether cervical conization before primary radical hysterectomy (RH) has a protective effect in patients with early cervical cancer. Methods: We retrospectively identified node-negative, marginnegative, parametria-negative, 2009 FIGO stage IB1 cervical cancer patients who received primary Type C RH at two tertiary institutional hospitals between July 2006 and June 2020. Whether they received preoperative cervical conization or not, patients were divided into conization group (n=144) and control group (n=434). To adjust for confounders, we conducted a 1:1 propensity score matching for histology, surgical approach, lymphovascular space invasion, and cervical mass size (calculated by summing pathologic tumor size on conization and uterine specimens). Then, survival outcomes were compared between the matched groups. Results: Overall, the conization group had less cervical mass size and received minimally invasive surgery (MIS) more frequently (p=0.010) and adjuvant treatment less often (p=0.002) compared to the control group. Of 37 patients who received preoperative conization and had no residual tumor in the uterine specimen, only one (2.7%) recurred during 56.5 months of a median observation period. After matching, the conization group showed significantly better progression-free survival (PFS) than the control group (3-year: 94.2% vs 86.3%; p=0.012), whereas no significant difference in overall survival (OS) was found. Subgroup analysis in the open RH (n=91) revealed that PFS did not differ by preoperative conization (p=0.799). In contrast, in the MIS RH subgroup (n=197), preoperative conization was associated with significantly better PFS (p=0.005). Conclusions: Despite the retrospective design, our matched cohort study suggests that preoperative cervical conization might have a protective effect on disease recurrence in early cervical cancer, especially for those who are planning to undergo MIS RH. Further prospective studies are warranted.

Is minimally invasive surgery safe for cervical cancer patients with a diameter of less than 2 cm? (565)

<b>Objectives:</b> Several authors have suggested that minimally invasive surgery was not a poor prognostic factor among those with 2018 FIGO stage IB1. However, it is necessary to accurately analyze risk factors related to pelvic recurrence in this patient group. This study aimed to identify the clinical-pathologic prognostic factors associated with pelvic recurrence for patients with 2018 FIGO stage IA2 and IB1 cervical cancer treated with laparoscopic/robotic radical hysterectomy. <b>Methods:</b> A total of 117 FIGO stage IA2 and IB1 cervical cancer patients were identified between April 2006 and January 2021. One patient with lung metastasis was excluded. Sites of disease recurrence and all possible clinical-pathologic factors related to the risk of pelvic recurrence were analyzed. Disease-free survival (DFS) was estimated using the Kaplan-Meier method, and groups were compared by univariate analysis, employing the log-rank test. The Cox proportional hazard regression model with a backward elimination method was used to determine prognostic factors for DFS. <b>Results:</b> Of the 116 patients, eight (6.9 %) showed disease recurrence (four vaginal stumps, two pelvic lymph nodes, two peritonea). Five- year DFS rates were 92.9%. In multivariate analysis, the risk factors associated with pelvic recurrence during and after surgery were intracorporeal colpotomy (p < 0.044, odds ratio [OR]: 5.281, 95% CI: 1.046-26.665), the size of residual tumor (p < 0.003, OR: 4.081, 95% CI: 1.611-10.340), deep stromal invasion of the outer third of the cervix (p < 0.015, OR: 9.852, 95% CI: 1.563-62.093), and the positivity of the vaginal cuff margin (p < 0.001, OR: 64.912, 95% CI: 6.193-680.414). Conversely preoperative conization reduced the risk of pelvic recurrence (p < 0.044, OR: 0.092, 95% CI: 0.009-0.943). Four patients with vaginal stump recurrence responded to additional chemoradiation and are still alive. However, two patients with peritoneal recurrences showed disease progression with peritoneal carcinomatosis despite additional chemoradiation and died. <b>Conclusions:</b> There is no guarantee that minimally invasive surgery is safe in FIGO stage IB1 patients with tumors less than 2 cm in size. Surgical techniques to prevent tumor spillage during colpotomy should be performed even in patients with tumors less than 2 cm in diameter. In addition, preoperative conization and the absence of residual tumor at the time of surgery might have a preventive effect on the recurrence of minimally invasive radical hysterectomy.

Risk Factor Assessment of Lymph Node Metastasis in Patients With FIGO Stage IB1 Cervical Cancer.

ObjectivesTo assess the risk factors of lymph node metastasis (LNM) in patients with FIGO stage (2009) IB1 cervical cancer (CC).MethodsPatients with FIGO stage IB1 CC who underwent radical resection between 2012 and 2018 were recruited. The risk factors for LNM were analysed. A recursive partitioning analysis (RPA) was used to divide the patients into risk groups and assess their risk of LNM.ResultsThe 5-year overall survival rate was 91.72%, while 80.0% and 93.5% for patients with or without LNM (P<0.05). Multivariable logistic regression analysis showed that lymphovascular invasion (LVI), depth of invasion (DI), tumour size (TS), squamous cell carcinoma (SCC) antigen level were independent risk factors (all P<0.05). Patients were divided into low-risk (no LVI, DI <1/2, TS <2 cm), intermediate-risk (no LVI, DI <1/2, TS ≥2 cm; no LVI, DI ≥1/2, normal SCC level; LVI, DI <1/2, TS <2 cm), and high-risk (no LVI, DI ≥1/2, SCC level ≥1.5 ng/ml; LVI, TS <2 cm, DI ≥1/2; LVI, TS ≥2 cm) groups by RPA according to these four factors. The incidence of LNM among the three groups was 0.00%, 4.40%, and 24.10%, respectively (all P<0.001). The 5-year overall survival rates differed among the groups (98.2%, 92.7%, 83.0%, respectively, P=0.001).ConclusionsLNM affects the prognosis of patients with FIGO stage IB1 CC. Lymphadenectomy may be avoided for patients in the low-risk group and recommended for those in the high-risk group. Whether dissection is performed in the intermediate-risk group depends on the lymph node biopsy results.

Utility of 3T MRI in Women with IB1 Cervical Cancer in Determining the Necessity of Less Invasive Surgery.

Cervical cancer that is invisible on magnetic resonance imaging (MRI) may suggest lower tumor burden than physical examination. Recently, 3 tesla (3T) MRI has been widely used prior to surgery because of its higher resolution than 1.5T MRI. The aim was to retrospectively evaluate the utility of 3T MRI in women with early cervical cancer in determining the necessity of less invasive surgery. Between January 2010 and December 2015, a total of 342 women with FIGO stage IB1 cervical cancer underwent 3T MRI prior to radical hysterectomy, vaginectomy, and lymph node dissection. These patients were classified into cancer-invisible (n = 105) and cancer-visible (n = 237) groups based on the 3T MRI findings. These groups were compared regarding pathologic parameters and long-term survival rates. The cancer sizes of the cancer-invisible versus cancer-visible groups were 11.5 ± 12.2 mm versus 30.1 ± 16.2 mm, respectively (p < 0.001). The depths of stromal invasion in these groups were 20.5 ± 23.6% versus 63.5 ± 31.2%, respectively (p < 0.001). Parametrial invasion was 0% (0/105) in the cancer-invisible group and 21.5% (51/237) in the cancer-visible group (odds ratio = 58.3, p < 0.001). Lymph node metastasis and lymphovascular space invasion were 5.9% (6/105) versus 26.6% (63/237) (5.8, p < 0.001) and 11.7% (12/105) versus 40.1% (95/237) (5.1, p < 0.001), respectively. Recurrence-free and overall 5-year survival rates were 99.0% (104/105) versus 76.8% (182/237) (p < 0.001) and 98.1% (103/105) versus 87.8% (208/237) (p = 0.003), respectively. 3T MRI can play a great role in determining the necessity of parametrectomy in women with IB1 cervical cancer. Therefore, invisible cervical cancer on 3T MRI will be a good indicator for less invasive surgery.

Significance of histology and nodal status on the survival of women with early-stage cervical cancer: validation of the 2018 FIGO cervical cancer staging system.

ObjectiveTo assess the efficacy of the FIGO 2018 classification system for nodal-specific classifications for early-stage cervical cancer; specifically, to examine the impact of nodal metastasis on survival and the effect of postoperative treatments, according to histological subtypes.MethodsThis society-based retrospective observational study in Japan examined 16,539 women with the 2009 FIGO stage IB1 cervical cancer who underwent primary surgical treatment from 2004 to 2015. Associations of cause-specific survival (CSS) with nodal metastasis and postoperative adjuvant therapy were examined according to histology type (squamous cell carcinoma [SCC], n=10,315; and non-SCC, n=6,224).ResultsThe nodal metastasis rate for SCC was higher than that for non-SCC (10.7% vs. 8.3%, p<0.001). In multivariable analysis, the impact of nodal metastasis on CSS was greater for non-SCC tumors (adjusted-hazard ratio [HR], 3.11; 95% confidence interval [CI], 2.40–4.02) than for SCC tumors (adjusted-HR, 2.20; 95% CI, 1.70–2.84; p<0.001). Propensity score matching analysis showed significantly lower CSS rates for women with pelvic nodal metastasis from non-SCC tumors than from SCC tumors (5-year CSS rate, 75.4% vs. 90.3%, p<0.001). The CSS rates for women with nodal metastasis in SCC histology were similar between the postoperative concurrent chemoradiotherapy/radiotherapy and chemotherapy groups (89.2% vs. 86.1%, p=0.42), whereas those in non-SCC histology who received postoperative chemotherapy improved the CSS (74.1% vs. 67.7%, p=0.043).ConclusionThe node-specific staging system in the 2018 FIGO cervical cancer classification is applicable to both non-SCC tumors and SCC tumors; however, the prognostic significance of nodal metastases and efficacy of postoperative therapies vary according to histology.

Cervical conization before primary radical hysterectomy has a protective effect on disease recurrence in early cervical cancer: A two-center matched cohort study according to surgical approach

ObjectiveTo ascertain whether cervical conization before radical hysterectomy (RH) has a protective effect on survival outcomes in early cervical cancer, taking into account the surgical approach. MethodsFrom cervical cancer cohorts of two institutions, we identified node-negative, margin-negative, parametria-negative, 2009 FIGO stage IB1 cervical cancer patients who received primary Type C RH between July 2006 and June 2020. Patients were divided into conization group (n = 144) and control group (n = 434). We conducted three independent 1:1 propensity score matching processes for histology, lymphovascular space invasion, cervical tumor size, and surgical approach (all patients, those who underwent open surgery, and those who underwent minimally invasive surgery [MIS]). Survival outcomes were compared. ResultsOverall, the conization group had less cervical tumor size and received MIS more frequently (P = 0.010) and adjuvant treatment less often (P = 0.002) versus the controls. After matching, the conization group showed significantly better disease-free survival (DFS) versus control (3-year DFS rate, 94.2% vs. 86.3%; P = 0.012), but similar overall survival. Among the open RH matched patients (n = 96), no difference in DFS was observed between the conization and control groups (P = 0.984). In contrast, among the MIS RH matched patients (n = 192), the conization group showed significantly better DFS versus control (3-year DFS rate, 95.7% vs. 82.9%; P = 0.005). In multivariate analysis adjusting for cervical tumor size and adjuvant treatment, conization was identified as an independent favorable prognostic factor for DFS (adjusted HR, 0.318; 95% CI, 0.134–0.754; P = 0.009). ConclusionsPreoperative cervical conization might reduce the disease recurrence rate in early cervical cancer patients who undergo primary MIS RH.

Machine Learning Models to Predict Survival Outcomes According to the Surgical Approach of Primary Radical Hysterectomy in Patients with Early Cervical Cancer

Simple SummaryAn increased risk of relapse and death from minimally invasive radical hysterectomy has been reported in some patients with early cervical cancer. Thus, the development of an intuitive and precise decision-aid tool, which estimates recurrence and mortality rates by surgical approach, is necessary. To develop models predicting survival outcomes according to the surgical approach, we collected clinicopathologic and survival data of patients with 2009 FIGO stage IB cervical cancer who underwent a radical hysterectomy. Using only variables that could be obtained preoperatively, we developed various models predicting the probability of 5-year progression-free survival and overall survival. Among them, hybrid ensemble models, combined with logistic regression and multiple machine learning models, achieved the best predictive performance. The developed models are expected to help physicians’ and patients’ decision making related to the surgical approach for primary radical hysterectomy.We purposed to develop machine learning models predicting survival outcomes according to the surgical approach for radical hysterectomy (RH) in early cervical cancer. In total, 1056 patients with 2009 FIGO stage IB cervical cancer who underwent primary type C RH by either open or laparoscopic surgery were included in this multicenter retrospective study. The whole dataset consisting of patients’ clinicopathologic data was split into training and test sets with a 4:1 ratio. Using the training set, we developed models predicting the probability of 5-year progression-free survival (PFS) and overall survival (OS) with tenfold cross validation. The developed models were validated in the test set. In terms of predictive performance, we measured the area under the receiver operating characteristic curve (AUC) values. The logistic regression models comprised of preoperative variables yielded AUCs of 0.679 and 0.715 for predicting 5-year PFS and OS rates, respectively. Combining both logistic regression and multiple machine learning models, we constructed hybrid ensemble models, and these models showed much improved predictive performance, with 0.741 and 0.759 AUCs for predicting 5-year PFS and OS rates, respectively. We successfully developed models predicting disease recurrence and mortality after primary RH in patients with early cervical cancer. As the predicted value is calculated based on the preoperative factors, such as the surgical approach, these ensemble models would be useful for making decisions when choosing between open or laparoscopic RH.

Type of hysterectomy and survival for FIGO stage IB cervical cancer: Is more radical surgery necessary?

Type of hysterectomy and survival for FIGO stage IB cervical cancer: Is more radical surgery necessary?

1049P - Spread of tumour and adverse events after modified radical hysterectomy for FIGO Stage IB1 cervical cancer patients with tumour diameter preoperatively estimated 2 cm or less: Japan Clinical Oncology Group trial (JCOG1101); exploratory analysis before primary analysis

BackgroundA single-arm confirmatory trial (JCOG1101) is now on follow-up, which is to evaluate the efficacy of modified radical hysterectomy for FIGO Stage IB1 uterine cervical cancer patients (pts) with clinical maximal tumor diameter (MTD) estimated 2cm or less (UMIN-CTR: UMIN000009726). It is needed to evaluate whether application of modified radical hysterectomy is feasible or not. MethodsFrom Jan 2013 to Aug 2017, 240 pts were enrolled. We analyzed the data of 224 eligible pts who underwent modified radical hysterectomy to elucidate the relationship between clinical maximal tumor diameter (cMTD) and pathological MTD (pMTD), degree of tumor extension and adverse events (AEs). ResultsIn 224 eligible pts, median pMTD was 1.5cm (range, 0-4.5), and. pMTD were<= 2cm in 184 pts (82.1%). Parametrial involvement and lymph node metastasis were observed in 3 pts (1.3%) and 16 pts (7.1%). cMTD (MTD) 2cm or less were determined prior to surgery by clinical diagnosis with MRI in 164 pts (clinical group), and by conization in 60 pts (cone group). Of clinical group, 128 (78.0%) had<=2cm tumor pathologically. There was no remarkable difference of the proportion of lymph node metastasis between clinical group and cone group (10/164 (6.1%) vs. 6/60 (10.0%)). No intraoperative Grade 3/4 complication was observed. Grade 2 intraoperative urinary tract injury was found in one (0.4%). Grade 3/4 acute nonhematological AEs were observed in 18 pts (8.0%), including infection in 8 pts and hemorrhage in 4 pts. ConclusionsThough cMTD does not always correspond to pMTD on stage IB1 cervical cancer, low incidence of parametrial involvement and lymph node metastasis indicate that cMTD is useful as presurgical diagnosis. In addition, there was low frequency of AEs by modified radical hysterectomy, which was presumed to be less invasive than radical hysterectomy. Modified radical hysterectomy will be a standard surgery if the efficacy of modified radical hysterectomy in overall survival is confirmed by the primary analysis planned in 2022. Clinical trial identificationUMIN-CTR: UMIN000009726, 08/Jan/2013. Legal entity responsible for the studyJCOG (Japan Clinical Oncology Group). FundingNational Cancer Center Research and Development Funds. DisclosureAll authors have declared no conflicts of interest.

Number of Removed Pelvic Lymph Nodes as a Prognostic Marker in FIGO Stage IB1 Cervical Cancer with Negative Lymph Nodes

Study ObjectiveTo investigate whether the number of removed lymph nodes (RLNs) influences the clinical outcome of stage IB1 cervical cancer on the premise of uniform pelvic lymphadenectomy. DesignRetrospective cohort study. SettingObstetrics and Gynecology Hospital of Fudan University. PatientsWomen (n = 782) with stage IB1 cervical cancer. InterventionsLaparoscopic radical hysterectomy and uniform pelvic lymphadenectomy (common iliac, external iliac, internal iliac, obturator) for stage IB1 cervical cancer. The median time of follow-up was 64.7 months (range, 4.3–102.8). Measurements and Main ResultsOf 782 patients with stage IB1 cervical cancer, the median number of pelvic RLNs was 19 (range, 7–49). Twenty-one patients (2.7%) had RLNs ≤ 10, 461 (59.0%) had 11 to 20, 263 (33.6%) had 21 to 30, and 37 (4.7%) had RLNs ≥ 31. The differences were not statistically significant in the clinicopathologic characteristics between the 4 groups (p >.05). In the multivariate analysis, pelvic RLN number became an independent prognostic factor for progression-free survival (PFS) and cancer-specific survival (CSS) in stage IB1 cervical cancer (p = .029; .015 for CSS and PFS). After the stratified analysis by lymph node metastasis, RLN number remained an independent predictive value (p = .026 for CSS, p = .012 for PFS) in patients with negative pelvic lymph nodes. Moreover, patients with RLN number ≤ 10 carried a 5.550-fold higher risk for progression (p <.001) and 5.596-fold greater likelihood of death (p = .001) than those with RLN number > 10 in case of no lymph node metastasis. ConclusionWith uniform pelvic lymphadenectomy, the total pelvic RLN number could be a valuable predictor of outcome in stage IB1 cervical cancer without lymph node metastasis during a follow-up of at least 5 years.

Impact of laparoscopic radical hysterectomy on survival outcome in patients with FIGO stage IB cervical cancer: A matching study of two institutional hospitals in Korea

ObjectiveTo compare survival outcomes of primary laparoscopic radical hysterectomy (LRH) and open radical hysterectomy (ORH) in patients with FIGO stage IB cervical cancer. MethodsWe retrospectively identified stage IB1–IB2 cervical cancer patients who received either LRH (n = 343) or ORH (n = 222) at two tertiary institutional hospitals between 2000 and 2018. To adjust for confounders, we conducted Mahalanobis distance-based sample matching for stage, histology, cervical mass size, parametrial invasion, and lymph node metastasis. Then, survival outcomes were compared between the matched groups. Through the independent matching processes, we narrowed the study population to stage IB1 patients and stage IB1 patients with tumor size ≤2 cm on pre-operative MRI. ResultsAfter matching, LRH group showed poorer progression-free survival (PFS) than ORH group (3-year: 85.4% vs. 91.8%; P = 0.036), whereas no significant difference in overall survival (OS) was found. Regarding recurrence patterns, no significant differences in the incidences of pelvic, retroperitoneal lymph node and abdominal recurrences, or distant metastasis were observed between the two groups. Among the matched patients with stage IB1 who had cervical mass size ≤2 cm, the LRH and ORH groups showed similar PFS (3-year: 90.0% vs. 93.1%; P = 0.8) and OS (5-year: 98.6% vs. 96.4%; P = 0.6). ConclusionsDespite the retrospective design, our matched cohort study suggests that ORH might be preferable for the surgical treatment of FIGO stage IB cervical cancer. However, in stage IB1 patients with tumor size ≤2 cm, LRH might be applicable, as equivalent outcomes were found regardless of the surgical approach. Further prospective studies are warranted.

Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China

IntroductionIn the last three decades, minimally invasive surgery (MIS) for radical hysterectomy (RH) has become a popular treatment option for early-stage cervical cancer. However, a recently published randomised controlled trial...

International radical trachelectomy assessment: IRTA study.

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. 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. We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach. 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. 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). 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. 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. 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.

Updated Opinion of the Uterus Commission of the Gynecological Oncology Working Group (AGO) and the Gynecological Endoscopy Working Group (AGE) of the German Society of Gynecology and Obstetrics (DGGG) on the Randomized Study Comparing Minimally Invasive with Abdominal Radical Hysterectomy for Early-stage Cervical Cancer (LACC).

In this opinion on the randomized study comparing minimally invasive with abdominal radical hysterectomy for early-stage cervical cancer (LACC), the Uterus Commission of the Gynecological Oncology Working Group (AGO) and the Gynecological Endoscopy Working Group (AGE) of the Germany Society of Gynecology and Obstetrics (DGGG) state that, based on their examination of the published data, patients with FIGO stage IA1 (with LVSI), IA2 or IB1 cervical cancer must be informed about the results of this LACC study prior to making a decision on the route for radical hysterectomy.

Less versus more radical surgery in stage IB1 cervical cancer: A population-based study of long-term survival

BackgroundStandard surgical treatment for women with stage IB1 cervical cancer consists of radical hysterectomy. This study assesses survival outcomes of those treated with less radical surgery (LRS; conization, trachelectomy, simple hysterectomy) compared to more radical surgery (MRS; modified radical, radical hysterectomy). MethodsUsing the Surveillance, Epidemiology and End Results database, we identified women <45 years with FIGO stage IB1 cervical cancer diagnosed from 1/1998 to 12/2012. Only those who underwent lymph node (LN) assessment were analyzed. Disease-specific survivals (DSSs) of LRS were compared with those of MRS. ResultsOf 2571 patients, 807 underwent LRS and 1764 underwent MRS, all with LN assessment. For LRS vs. MRS, 28% vs. 23% were diagnosed with adenocarcinoma (p = 0.024), 31% vs. 39% had G3 disease (p < 0.001), 40% vs. 45% had tumor size >2 cm (p < 0.001), and 27% vs. 29% received adjuvant radiation therapy (p = 0.005). Median follow-up was 79 months (range, 0–179). Ten-year DSS for LRS vs. MRS was 93.5% vs. 92.3% (p = 0.511). There was no difference in 10-year DSS when stratified by tumor size ≤2 cm (LRS 95.1% vs. MRS 95.6%, p = 0.80) or > 2 cm (LRS 90.1% vs. MRS 88.2%, p = 0.48). Factors independently associated with increased risk of death included adenosquamous histology (HR 2.37), G3 disease (HR 2.86), tumors >2 cm (HR 1.82), and LN positivity (HR 2.42). Compared to MRS, LRS was not associated with a higher risk of death. ConclusionsIn a select group of young women with stage IB1 cervical cancer, LRS compared to MRS does not appear to compromise DSS.