Mucoepidermoid Carcinoma of the Uterine Cervix—Single-Center Study Over a 10-Year Period

Background and objectives: Adenosquamous cancer of the uterine cervix is a rare type of cervical cancer with both malignant squamous and glandular components. A very rare subtype is mucoepidermoid carcinoma (MEC), which was first described as a salivary gland tumor. It has been described as having the appearance of a squamous cell carcinoma without glandular formation and contains intracellular mucin. The postoperative evolution of this tumor and the potentially poorer prognosis may indicate an intensification of the follow-up. The objective of our study was to analyze the frequency of mucoepidermoid carcinoma in hospitalized women with cervical cancer, clinical characteristics and prognosis. Material and Methods: A retrospective study of all cases of mucoepidermoid carcinoma of the cervix at Department of Gynecologic Oncology, University Hospital—Pleven, Pleven Bulgaria between 1 January 2007 and 31 December 2016 was performed. All patients were followed-up till December 2019. We analyzed certain clinical characteristics of the patients; calculated the frequency of mucoepidermoid carcinoma of the cervix from all patients with stage I cervical cancer; and looked at the overall survival rate, correlation between overall survival, lymph node status and the size of the tumor. Results: The frequency of MEC was 1.12% of all patients with stage I cervical cancer in this study. The median age of the patients with MEC was 46.7 years (range 38–62). Four patients (57.1%) were staged as FIGO IB1, and three patients (42.8%) were FIGO IB2. The size of the primary tumor was <2 cm in 2 patients (28.57%), 2–4 cm in 2 patients (28.57%) and >4 cm in 3 patients (42.8%). Metastatic lymph nodes were found in two patients (28.57%), and nonmetastatic lymph nodes were found in five patients (71.43%). There were two (28.57%) disease-related deaths during the study period. The five-year observed survival in the MEC group was 85.7% and in the other subtypes of adenosquamous cancer group was 78.3%. Conclusions: MEC of the uterine cervix is a rare entity diagnosis. As a mucin-producing tumor, it is frequently regarded as a subtype with worse clinical behavior and patients’ outcomes. Nevertheless, our data did not confirm this prognosis. New molecular markers and better stratification are needed for better selection of patients with CC, which may benefit more from additional treatment and new target therapies.

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The 5-year overall survival of cervical cancer in stage IIIC-r was little different to stage I and II: a retrospective analysis from a single center

BMC Cancer ◽

10.1186/s12885-021-07890-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

E Yang ◽

Shuying Huang ◽

Xuting Ran ◽

Yue Huang ◽

Zhengyu Li

Keyword(s):

Cervical Cancer ◽

Overall Survival ◽

Lymph Nodes ◽

Stage I ◽

Stage Ii ◽

Maximum Diameter ◽

Clinical Practices ◽

Stage Iiic ◽

Pelvic Lymph Nodes ◽

The Mean

Abstract Background The 2018 International Federation of Gynecology and Obstetrics (FIGO) staging guideline for cervical cancer includes stage IIIC recognized by preoperative radiology (IIIC-r) to state there are lymph nodes metastases (LNM) identified by imaging tools. We aim to explore the reasonability and limitations of stage IIIC-r and try to explore the potential reasons. Methods Electronic medical records were used to identify patients with cervical cancer. According to the new staging guidelines, patients were reclassified and assigned into five cohorts: stage I, stage II, stage IIIC-r, LNM confirmed by pathology (IIIC-p) and LNM detected by radiology and confirmed by pathology (IIIC r + p). Five-year overall survivals were estimated for each cohort. The diagnosis accuracy of computed tomography (CT), magnetic resonance imaging (MRI) and diameter of detected lymph nodes were also evaluated. Results A total of 619 patients were identified. The mean follow-up months were 65 months (95% CI 64.43–65.77) for all patients. By comparison, the 5-year overall survival rates were not statistically different (p = 0.21) among stage IIIC-r, stage I and stage II. While, the rates were both statistical different (p<0.001) among stage IIIC-p, IIIC r + p and stage I and stage II. The sensitivities of CT and MRI in detecting LNM preoperatively were 51.2 and 48.8%. The mean maximum diameter of pelvic lymph nodes detected by CT cohort was 1.2 cm in IIIC-r cohort, and was 1.3 cm in IIIC r + p cohort. While, the mean maximum diameter of pelvic lymph nodes detected by MRI was 1.2 cm in IIIC-r cohort, and was 1.48 cm in IIIC r + p cohort. When the diagnosis efficacy of the diameter of pelvic lymph nodes in detecting LNM were evaluated, the area under the receiver operating characteristic curve (ROC curve) was 0.58 (p = 0.05). Conclusions It seems that the FIGO 2018 staging guideline for cervical cancer is likely to has certain limitations for the classification of those with LNM. CT or MRI, however, has limitations on detecting LNM. It would be better to use more accurate imaging tools to identify LNM in the clinical practices.

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Single-Center Study of Lymphoepithelioma-Like Carcinoma of Uterine Cervix over a 10-Year Period

Medicina ◽

10.3390/medicina55120780 ◽

2019 ◽

Vol 55 (12) ◽

pp. 780

Author(s):

Angel Yordanov ◽

Martin Karamanliev ◽

Milena Karcheva ◽

Assia Konsoulova ◽

Mariela Vasileva-Slaveva ◽

...

Keyword(s):

Overall Survival ◽

Survival Rate ◽

Uterine Cervix ◽

Good Prognosis ◽

Stage I ◽

University Hospital ◽

Lymph Node Status ◽

Epithelial Tissue ◽

Overall Survival Rate ◽

Single Center Study

Background and objectives: Lymphoepithelioma-like carcinoma (LELC) is a histological type of malignant tumor arising from the uncontrolled mitosis of transformed cells originating in epithelial tissue. It is a rare subtype of squamous cell carcinoma of the uterine cervix. There are significant differences in frequency, mean age, viral status, and outcomes in Asian or Caucasian patients. Materials and Methods: A retrospective study of all cases of lymphoepithelioma-like carcinoma of the cervix at the Clinic of Oncogynecology, University Hospital, Pleven, Bulgaria between 1 January 2007 and 31 December 2016 was performed. All patients were followed-up till March 2019. We analyzed some clinical characteristics of the patients, calculated the frequency of lymphoepithelioma-like carcinoma of the cervix from all patients with stage I cervical cancer, and looked at the overall survival rate, the 5-year survival rate, and the correlation between overall survival, lymph node status, and the size of the tumor. Results: The frequency of lymphoepithelioma-like carcinoma was 3.3% for all cases with cervical carcinoma at stage I. The mean age of the patients with LELC was 49.6 years (range 32–67). Fourteen patients (82.4%) were in the FIGO IB1 stage, three patients (17.6%) were in the FIGO IB2 stage. Lymph nodes were metastatic in three patients (17.6%), non-metastatic in 13 patients (76.5%), and unknown in one patient. The overall survival rate was 76.47% for the study period and the 5-year survival rate of the patients that were followed-up until the 5th year (14 patients) was 69.23%. Conclusions: Lymphoepithelioma-like carcinoma is a rare SCC subtype, but it could be more frequent among western patients than previously thought. Our results do not confirm the data showing low risk of lymph metastasis and good prognosis of LELC, which is why we think that the treatment in these cases has to be more aggressive than is reported in the literature.

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Low value of whole-body dual-modality [18f]fluorodeoxyglucose positron emission tomography/computed tomography in primary staging of stage I–II nasopharyngeal carcinoma: a nest case-control study

European Radiology ◽

10.1007/s00330-020-07478-1 ◽

2021 ◽

Author(s):

Bei-Bei Xiao ◽

Qiu-Yan Chen ◽

Xue-Song Sun ◽

Ji-Bin Li ◽

Dong-hua Luo ◽

...

Keyword(s):

Overall Survival ◽

Lymph Node ◽

Lymph Nodes ◽

Stage I ◽

Relapse Free Survival ◽

Retropharyngeal Lymph Node ◽

Free Survival ◽

Pet Ct ◽

Pre Treatment

Abstract Objectives The value of using PET/CT for staging of stage I–II NPC remains unclear. Hence, we aimed to investigate the survival benefit of PET/CT for staging of early-stage NPC before radical therapy. Methods A total of 1003 patients with pathologically confirmed NPC of stages I–II were consecutively enrolled. Among them, 218 patients underwent both PET/CT and conventional workup ([CWU], head-and-neck MRI, chest radiograph, liver ultrasound, bone scintigraphy) before treatment. The remaining 785 patients only underwent CWU. The standard of truth (SOT) for lymph node metastasis was defined by the change of size according to follow-up MRI. The diagnostic efficacies were compared in 218 patients who underwent both PET/CT and CWU. After covariate adjustment using propensity scoring, a cohort of 872 patients (218 with and 654 without pre-treatment PET/CT) was included. The primary outcome was overall survival based on intention to treat. Results Retropharyngeal lymph nodes were metastatic based on follow-up MRI in 79 cases. PET/CT was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions (72.2% [62.3–82.1] vs. 91.1% [84.8–97.4], p = 0.004). Neck lymph nodes were metastatic in 89 cases and PET/CT was more sensitive than MRI (96.6% [92.8–100.0] vs. 76.4% [67.6–85.2], p < 0.001). In the survival analyses, there was no association between pre-treatment PET/CT use and improved overall survival, progression-free survival, local relapse-free survival, regional relapse-free survival, and distant metastasis-free survival. Conclusions This study showed PET/CT is of little value for staging of stage I–II NPC patients at initial imaging. Key Points • PET/CT was more sensitive than MRI in detecting neck lymph node lesions whereas it was significantly less sensitive than MRI in detecting retropharyngeal lymph node lesions. • No association existed between pre-treatment PET/CT use and improved survival in stage I–II NPC patients.

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Should the Number of Metastatic Pelvic Lymph Nodes Be Integrated into the 2018 Figo Staging Classification of Early Stage Cervical Cancer?

Cancers ◽

10.3390/cancers12061552 ◽

2020 ◽

Vol 12 (6) ◽

pp. 1552

Author(s):

Luigi Pedone Anchora ◽

Vittoria Carbone ◽

Valerio Gallotta ◽

Francesco Fanfani ◽

Francesco Cosentino ◽

...

Keyword(s):

Cervical Cancer ◽

Lymph Nodes ◽

Early Stage ◽

Disease Free Survival ◽

Staging System ◽

Lymph Node Status ◽

P Value ◽

Pelvic Lymph Nodes ◽

Early Stage Cervical Cancer ◽

The Impact

Introduction: Lymph node status has become part of the new staging system for cervical cancer (CC). It has been shown that patients staged as IIIC1 had heterogeneous prognoses and, in some cases, experienced better outcomes than patients with lower stages. We evaluated the impact of the number of metastatic pelvic lymph nodes (MPLNs) among patients with stage IIIC1 cervical cancer. Methods: Survival analyses were conducted in order to identify the best cut-off prognostic value relative to the number of MPLNs. Disease free survival (DFS) was considered the main outcome. Results: 541 patients were included in the study. Eighty-nine patients were of stage IIIC1. The best prognostic cut-off value of the number of MPLNs was 2. Patients with >2 MPLNs (n > 2 group) had worse DFS compared with those having <2 (N1-2 group) (5 yr DFS: 54.7% vs. 78.1%, p value = 0.006). Multivariate analyses demonstrated that the extent of MPLNs had little impact on DFS and that replacement of IIIC1 staging with N1-2 and n > 2 grouping provided a better, statistically significant model (p value = 0.006). Discussion: Using a cut-off value of 2, the number of MPLNs could better predict prognostic outcomes within stage IIIC1 cervical cancer and have potential implications for therapeutic decision-making in the treatment of patients with stage IIIC1 CC.

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Clinical Characteristics and Outcomes of Limited-Stage Primary Extranodal Versus Nodal Diffuse Large B-Cell Lymphoma (DLBCL) in Thailand: A Nationwide Multi-Institutional Registry of 920 Cases in Thailand

Blood ◽

10.1182/blood.v126.23.2676.2676 ◽

2015 ◽

Vol 126 (23) ◽

pp. 2676-2676

Author(s):

Lalita Norasetthada ◽

Weerasak Nawarawong ◽

Arnuparp Lekhakula ◽

Jakrawadee Julamanee ◽

Chittima Sirijerachai ◽

...

Keyword(s):

Overall Survival ◽

Clinical Outcomes ◽

Clinical Characteristics ◽

B Cell Lymphoma ◽

Primary Site ◽

Stage I ◽

Overall Response ◽

Limited Stage ◽

Extranodal Disease ◽

Baseline Characteristics

Abstract Introduction The difference in origin between nodal and extranodal DLBCL may contribute to the distinct clinical outcomes and prognoses. Previous studies including patients with both limited and advanced diseases showed various clinical results. The purpose is to study the clinical characteristics, and outcomes of patients with limited stage DLBCL according to the primary site of lymphoma. Methods From the 4,371 patients in a multi-institutional registry of newly diagnosed lymphoma in Thailand between 2007-2014, there were 920 patients with limited stage DLBCL, excluding those with primary central nervous system lymphoma. The baseline patient characteristics and clinical outcomes were analyzed according to the primary site of diseases. Results Majority of patients had extranodal diseases (n= 535, 58.2%) while the other 385 cases (41.8%) had nodal DLBCL. The five most common primary sites of extranodal disease were Waldeyer ring (12.2%), stomach (7.3%), intestine (6.8%), sinonasal cavity (6.7%) and breast (2.8%) (Figure 1). Baseline characteristics, treatment and responses were well balanced between the two groups except for a slightly higher proportion of stage I disease in extranodal DLBCL (36.8% vs 28.8%, P =0.01) (Table 1). Two-third of patients received CHOP chemotherapy while the others were treated with R-CHOP. Radiotherapy (RT) was delivered to one-fifth of the patients in each group. Overall response rates were comparable between patients with nodal and extranodal diseases (68.6% vs 66.7%). With a median follow up of 52 months, there were no significant differences of progression free (PFS) (57.6 vs. 60.8%, P =0.46) and overall survival (OS) (63.1% vs. 65.6%, P =0.20) between patients with extranodal and nodal diseases. Among patients with extranodal manifestations, those with primary lymphoma at pancreas & gall bladder, pleura & lung, adrenal gland & kidney and intestine had the worst 4-year OS (33.3%, 39.3%, 53.3%, and 53.7%, respectively) (Figure 2). RT improved PFS (71.7% vs. 54.5%, P =0.03) and OS (74.7% vs. 62.9%, P =0.02) only in primary nodal DLBCL. The two prognostic factors for survivals were being treated with R-CHOP (HR for PFS 0.84, 95%CI: 0.74-0.96; HR for OS 0.70, 95%CI: 0.55-0.91) and the IPI scores (HR for PFS 1.49, 95%CI: 1.24-1.80; HR for OS 1.86, 95%CI: 1.37-2.51). Conclusion Among limited stage DLBCL in Thailand, primary extranodal disease was more common than the nodal manifestations. Primary sites of origins did not affect baseline characteristics as well as the outcomes. Patients with unusual site lymphomas, however, had an inferior survivals warranted a further investigational therapy. Table 1. The clinical characteristics of limited stage DLBCL according to disease of origin Clinical characteristics Nodal DLBCL(n = 385) Extranodal DLBCL(n = 535) p-value Male 205 (53.2%) 294 (55%) 0.60 Median age (years) 54.9 56.2 0.23 Stage Stage I Stage II 111 (28.8%) 274 (71.2%) 197 (36.8%) 338 (63.2%) 0.01 HIV seropositivity 11 (3.4%) 19 (4.3%) 0.53 Age ≥ 60 164 (42.6%) 230 (43%) 0.90 High serum LDH 183 (47.5%) 230 (43%) 0.17 ECOG ≥ 2 46 (11.9%) 60 (11.2%) 0.73 IPI Low (IPI = 0-1) Low-intermediate (IPI =2) High-intermediate (IPI = 3) 285 (74.0%) 81 (21.0%) 19 (4.9%) 406 (75.9%) 108 (20.2%) 21 (3.9%) 0.82 Chemotherapy regimens R-CHOP CHOP 98 (29.0%) 227 (67.2%) 160 (33.7%) 286 (60.2%) 0.25 Radiotherapy 94 (24.9%) 120 (22.8%) 0.46 Response Overall response Complete response 261 (68.6%) 227 (59.7%) 352 (66.7%) 322 (61%) 0.24 *IPI: International prognostic index Figure 1. Sites of origin among limited stage DLBCL Figure 1. Sites of origin among limited stage DLBCL Figure 2. Overall survival of patients with limited stage DLBCL according to primary sites of lymphoma Figure 2. Overall survival of patients with limited stage DLBCL according to primary sites of lymphoma Disclosures Khuhapinant: Roche: Honoraria.

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Final Overall Survival Analysis of the Phase III Randomized Trial of Chemotherapy with and Without Bevacizumab for Advanced Cervical Cancer: a Nrg Oncology - Gynecologic Oncology Group Study

Annals of Oncology ◽

10.1093/annonc/mdu438.27 ◽

2014 ◽

Vol 25 ◽

pp. v1 ◽

Cited By ~ 5

Author(s):

K.S. Tewari ◽

M.W. Sill ◽

R.T. Penson ◽

H. Huang ◽

L.M. Ramondetta ◽

...

Keyword(s):

Cervical Cancer ◽

Overall Survival ◽

Survival Analysis ◽

Gynecologic Oncology ◽

Phase Iii ◽

Gynecologic Oncology Group ◽

Advanced Cervical Cancer ◽

Oncology Group ◽

Oncology Group Study ◽

Overall Survival Analysis

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Pancreatic Ductal Adenocarcinoma at CT: A Combined Nomogram Model to Preoperatively Predict Cancer Stage and Survival Outcome

Frontiers in Oncology ◽

10.3389/fonc.2021.594510 ◽

2021 ◽

Vol 11 ◽

Author(s):

Chunyuan Cen ◽

Liying Liu ◽

Xin Li ◽

Ailan Wu ◽

Huan Liu ◽

...

Keyword(s):

Overall Survival ◽

Pancreatic Ductal Adenocarcinoma ◽

Clinical Characteristics ◽

Validation Cohort ◽

Stage I ◽

Ductal Adenocarcinoma ◽

Training Cohort ◽

Calibration Curves ◽

Kaplan Meier ◽

Radiomics Signature

ObjectivesTo construct a nomogram model that combines clinical characteristics and radiomics signatures to preoperatively discriminate pancreatic ductal adenocarcinoma (PDAC) in stage I-II and III-IV and predict overall survival.MethodsA total of 135 patients with histopathologically confirmed PDAC who underwent contrast-enhanced CT were included. A total of 384 radiomics features were extracted from arterial phase (AP) or portal venous phase (PVP) images. Four steps were used for feature selection, and multivariable logistic regression analysis were used to build radiomics signatures and combined nomogram model. Performance of the proposed model was assessed by using receiver operating characteristic (ROC) curves, calibration curves and decision curve analysis (DCA). Kaplan-Meier analysis was applied to analyze overall survival in the stage I-II and III-IV PDAC groups.ResultsThe AP+PVP radiomics signature showed the best performance among the three radiomics signatures [training cohort: area under the curve (AUC) = 0.919; validation cohort: AUC = 0.831]. The combined nomogram model integrating AP+PVP radiomics signature with clinical characteristics (tumor location, carcinoembryonic antigen level, and tumor maximum diameter) demonstrated the best discrimination performance (training cohort: AUC = 0.940; validation cohort: AUC = 0.912). Calibration curves and DCA verified the clinical usefulness of the combined nomogram model. Kaplan-Meier analysis showed that overall survival of patients in the predicted stage I-II PDAC group was longer than patients in stage III-IV PDAC group (p<0.0001).ConclusionsWe propose a combined model with excellent performance for the preoperative, individualized, noninvasive discrimination of stage I-II and III-IV PDAC and prediction of overall survival.

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Open Versus Laparoscopic Pelvic Lymph Node Dissection in Early Stage Cervical Cancer: No Difference in Surgical or Disease Outcome

International Journal of Gynecological Cancer ◽

10.1097/igc.0b013e31822c273d ◽

2012 ◽

Vol 22 (1) ◽

pp. 107-114 ◽

Cited By ~ 14

Author(s):

Jonas van de Lande ◽

Silvia von Mensdorff-Pouilly ◽

Roelof G. Lettinga ◽

Jurgen M. Piek ◽

René H.M. Verheijen

Keyword(s):

Cervical Cancer ◽

Lymph Node ◽

Lymph Nodes ◽

Clinical Characteristics ◽

Early Stage ◽

Late Complications ◽

Pelvic Lymph Node Dissection ◽

Early Stage Cervical Cancer ◽

Disease Free ◽

Disease Specific

ObjectiveThis study aimed to investigate in a retrospective study the effect of laparoscopic surgery, introduced in our center in 1994 as part of the standard treatment of early stage cervical cancer, on surgical and disease outcomes.Patients and MethodsA total of 169 women with cervical carcinoma stage IB1 (n = 150) or IB2 (n = 19) were included in the study. Seventy-six patients who underwent laparoscopic pelvic lymph node dissection (LPLND), followed either by open radical hysterectomy (n = 63) or, in case of positive lymph nodes, by primary chemoradiation (n = 13), were compared with an historic cohort of 93 patients who underwent a fully open, traditional Wertheim-Meigs procedure (WM). Recorded clinical characteristics of patients included age, International Federation of Gynecology and Obstetrics stage, histologic diagnosis, differentiation grade, tumor diameter, lymph node status, and adjuvant therapy. Operation time; lymph node yield; intraoperative, early, and late complications; site of recurrences; and disease-free and overall survival rates were analyzed and compared between groups.ResultsClinical characteristics did not differ between groups. Duration of total surgery time was longer in patients with LPLND followed by open radical hysterectomy compared with that in the WM group (P< 0.001). In patients with negative lymph nodes (n = 129), the number of resected nodes was higher (P= 0.002) in the LPLND (median, 26 nodes; range, 8–55 nodes) than in the WM group (median, 21 nodes; range, 7–50 nodes). In patients with positive lymph nodes (n = 40), no significant difference in the number of resected lymph nodes between the 2 groups (P= 0.904) was found. Intraoperative, early, and late complications did not differ between the 2 surgical procedures. The number of locoregional recurrences, but not of distant metastases, was significantly higher (P= 0.018) in the WM group compared with the LPLND group. No difference in disease-free or disease-specific survival was found between the LPLND and WM group, neither with nor without adjuvant or primary (chemo)radiation. A benefit in disease-free survival (P= 0.044), but not in disease-specific survival (P= 0.070), was found in the LPLND compared with the WM group in those patients who received adjuvant therapy or primary chemoradiation.ConclusionsIntroduction of a laparoscopic procedure in the surgical staging and treatment of cervical cancer patients did not have a detrimental effect on surgical or disease outcome, and this can be safely applied to the treatment of early stage cervical cancer.

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Phase III randomized trial of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy (RH) versus RH for bulky stage I/II cervical cancer (JCOG 0102)

Journal of Clinical Oncology ◽

10.1200/jco.2006.24.18_suppl.5013 ◽

2006 ◽

Vol 24 (18_suppl) ◽

pp. 5013-5013 ◽

Cited By ~ 10

Author(s):

N. Katsumata ◽

H. Yoshikawa ◽

T. Hirakawa ◽

T. Saito ◽

K. Kuzuya ◽

...

Keyword(s):

Cervical Cancer ◽

Overall Survival ◽

Neoadjuvant Chemotherapy ◽

Radical Hysterectomy ◽

Performance Status ◽

Locally Advanced ◽

Myometrial Invasion ◽

Stage I ◽

Phase Iii ◽

Rank Test

5013 Background: NAC may represent an alternative to conventional RH for locally advanced cervical cancer. We compared NAC followed by RH with RH for bulky stage I/II cervical cancer. Methods: Patients (pts) with stage IB2, IIA (> 4 cm), or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7mg day 1–5, vincristine 0.7mg/m2 day 5, mitomycin 7mg/m2 day 5 and cisplatin 14 mg/m2 day 1–5,) q21 days, 2 to 4 cycles followed by radical hysterectomy (NAC arm) or undergo RH (RH arm). Pts with positive surgical margins, metastatic nodes, infiltration to parametrium, and/or deep myometrial invasion received postoperative irradiation. Eligibility included preserved organ function, aged 20–70, and Performance Status 0 or 1. Primary endpoint was overall survival (OS) to be compared by log-rank test. Assuming 100 eligible pts in each arm, the study had 80% power to detect a 15% increase in 5-year survival at 0.05 one-sided alpha. Results: 134 pts (67 NAC, 67 RH) were randomized between 12/01 and 08/05. The first planned interim analysis was performed in July 2005 using data from 108 pts registered as of 11/04. Data and Safety Monitoring Committee recommended to terminate the study because overall survival in NAC arm was inferior to that in RH arm (HR 2.11, multiplicity adjusted 99% CI 0.34 to 13.2) and the predictive probability of significant superiority using Spiegelhalter’s method of NAC arm was extremely low (6.4%). No increase of operability and no decrease of surgery-related morbidity were observed in NAC arm. Response Rate of NAC was 61% (33 of 54) using RECIST criteria. One-year progression-free survival and overall survival, updated as of 05/05, were 69.9% and 91.8% (95% CI 84.1–99.6) in NAC arm and 78.6% and 95.4% (95% CI 89.1–100) in RH arm respectively. Conclusions: Neoadjuvant chemotherapy with BOMP regimen followed by radical hysterectomy did not demonstrate clinical benefit, and conventional radical hysterectomy still remains to be a standard treatment option for bulky stage I/II cervical cancer. [Table: see text]

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