Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study

2020 ◽  
Vol 31 (1) ◽  
pp. 129-133
Author(s):  
Hua Tu ◽  
He Huang ◽  
Yi Ouyang ◽  
Qing Liu ◽  
Bingna Xian ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Sample Size ◽  
Primary Endpoint ◽  
Concurrent Chemoradiotherapy ◽  
Radical Surgery ◽  
Disease Free Survival ◽  
Squamous Carcinoma ◽  
Figo Stage ◽  
Paraaortic Lymphadenectomy

BackgroundConcurrent chemoradiotherapy is the first-line treatment for FIGO stage IIB cervical cancer. Neoadjuvant chemotherapy followed by radical surgery may provide another treatment option.Primary objectiveTo compare the therapeutic outcomes of neoadjuvant chemotherapy followed by surgery with cisplatin-based concurrent chemoradiotherapy for stage IIB cervical cancer.Study hypothesisWe hypothesize that the therapeutic effect of neoadjuvant chemotherapy combined with surgery and risk-adapted adjuvant treatment will be superior to that of concurrent chemoradiotherapy in stage IIB cervical cancer.Trial designPatients with stage IIB cervical cancer will be randomized 1:1 to neoadjuvant chemotherapy followed by surgery (Arm A) or concurrent chemoradiotherapy (Arm B). In arm A, patients will receive three cycles of paclitaxel and cisplatin followed by a type C radical hysterectomy and pelvic ±paraaortic lymphadenectomy. Patients showing progression after neoadjuvant chemotherapy will be referred to concurrent chemoradiotherapy. Adjuvant therapy will be recommended according to the presence of pathological risks. In Arm B, all patients will receive definitive concurrent chemoradiotherapy, including external beam pelvic radiotherapy combined with concurrent weekly cisplatin followed by brachytherapy.Major inclusion/exclusion criteriaPatients between 18 and 60 years with histologically confirmed, untreated stage IIB cervical squamous carcinoma, adenocarcinoma, or adeno-squamous carcinoma.Primary endpointThe primary endpoint is 2-year disease-free survival.Sample sizeAn estimated sample size of 240 is required to fulfill the study objectives.Estimated dates for completing accrual and presenting resultsAs of February 2020, 115 eligible patients from four institutions have been enrolled. Enrollment is expected to be completed by December 2022.Trial registration numberClinicalTrials. gov identifier: NCT02595554.

scholarly journals Clinical Outcome of Figo 2018 Stage Ib3/Iia2 Cervical Cancer Submitted to Neoadjuvant Chemotherapy Followed by Radical Surgery in Lack of Radiotherapy Equipment: A Retrospective Comparison with Concurrent Chemoradiotherapy

2021 ◽  
Vol 4 (1) ◽  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Concurrent Chemoradiotherapy ◽  
Radical Surgery ◽  
Study Groups ◽  
Figo Stage ◽  
Late Complications ◽  
Clinicopathologic Characteristics ◽  
Significant Difference ◽  
Characteristics Analysis

Purpose: To compare the clinical outcomes between concurrent chemoradiotherapy (CCRT) and neoadjuvant chemotherapy followed by radical surgery ((NACT-RS) among patients with cervical cancer stage IB3 and IIA2. Methods: The study retrospectively reviewed patients with (2018 FIGO) stage IB3 and IIA2 cervical cancer. The patients received either preoperative neoadjuvant chemotherapy, followed by NACT-RS or CCRT. The outcome measures were the 5-year survival and complication rate between the two groups. Results: The median follow-up was 75 months. In total, 218 patients had stage IIA2, 136 patients had stage IB3, 201 patients received CCRT, and 153 patients received preoperative NACT-RS. In the CCRT group, the incidence of early complications (Myelosuppression, gastrointestinal and urinary) was higher compared with that in the NACT-RS group (76.1 vs. 26.1%, p <0.001; respectively). However, there was no significant difference between the two study groups concerning late complications. Five-year PFS was 79.9% and 85.5% in the NACT-RS and CCRT groups, respectively (p = 0.093). Five-year OS was 86.9% and 85.5% in the NACT-RS and CCRT groups, respectively (p = 0.97). In the multivariate clinicopathologic characteristics analysis for OS, initial tumor size >4.3 cm (HR, 5.11; p<0.001), AC/ASC (HR, 1.89; p = 0.02), histologic grade 2-3 (HR, 2.25; p = 0.04), and 2018 FIGO stage IIA2 (HR, 8.67; p<0.001) were independent risk factors. Conclusions: The survival of patients with stage IB3 and IIA2 cervical cancer treated with NACT-RS was similar to that of patients treated with CCRT without increasing side effects.

Effects of Neoadjuvant Chemotherapy Plus Radical Surgery as Front Line Treatment Strategy in Patients Affected by FIGO Stage III Cervical Cancer

2016 ◽  
Vol 23 (S5) ◽  
pp. 841-849 ◽  
Author(s):  
Violante Di Donato ◽  
Michele Carlo Schiavi ◽  
Ilary Ruscito ◽  
Virginia Sibilla Visentin ◽  
Innocenza Palaia ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Treatment Strategy ◽  
Radical Surgery ◽  
Figo Stage ◽  
Stage Iii ◽  
Line Treatment ◽  
Front Line

scholarly journals Effect of neoadjuvant chemotherapy followed by radical surgery for FIGO stage IB2/IIA2 cervical cancer

Medicine ◽  
2019 ◽  
Vol 98 (21) ◽  
pp. e15604 ◽  
Author(s):  
Hui Zhao ◽  
Yue He ◽  
Li-Rong Zhu ◽  
Jian-Liu Wang ◽  
Hong-Yan Guo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Figo Stage

Is Neoadjuvant Chemotherapy Followed by Radical Surgery More Effective Than Radiation Therapy for Stage IIB Cervical Cancer?

2013 ◽  
Vol 23 (7) ◽  
pp. 1303-1310 ◽  
Author(s):  
Dae Woo Lee ◽  
Keun Ho Lee ◽  
Jung Won Lee ◽  
Sung Taek Park ◽  
Jong Sup Park ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Radiation Therapy ◽  
Prognostic Factors ◽  
Neoadjuvant Chemotherapy ◽  
Patient Survival ◽  
Radical Surgery ◽  
Therapy Group ◽  
Disease Free Survival ◽  
Free Survival ◽  
Disease Free

ObjectiveThe primary objective of the study was to compare the survival rate of patients who had received neoadjuvant chemotherapy with that of patients who had received radiation therapy for stage IIB cervical cancer. The secondary objective was to analyze the effect of neoadjuvant chemotherapy on pathological prognostic factors.Materials and MethodsWe retrospectively reviewed the medical records of patients who had received therapy for stage IIB cervical cancer. Based on the primary therapy, 192 patients were divided into 2 groups; patients in the neoadjuvant chemotherapy group (n =103) underwent a type III radical hysterectomy after completion of the neoadjuvant chemotherapy. Patients in the other group (n = 89) were treated with radiation alone or a combination of chemotherapy and radiotherapy.ResultsAfter neoadjuvant chemotherapy, the level of squamous cell carcinoma antigen, tumor size, lymph node involvement, and parametrium involvement were significantly decreased. However, 90.3% of the patients who had received neoadjuvant chemotherapy needed to have adjuvant therapy after radical surgery because of poor pathological prognostic factors. The rate of disease-free survival did not differ significantly between the 2 groups. However, the overall survival rate was significantly lower in the neoadjuvant chemotherapy group for patients who were 60 years or older (P = 0.03). The rates of disease-free survival and overall survival for patients who had a good (complete or partial) response to the neoadjuvant chemotherapy were not significantly higher than the rates for patients in the radiation therapy group.ConclusionsAlthough neoadjuvant chemotherapy improved pathological prognostic factors in patients with stage IIB cervical cancer, it was not sufficiently effective to decrease adjuvant therapy. Neoadjuvant chemotherapy also did not improve the rate of patient survival compared to the rate of patient survival in the radiation therapy group.

scholarly journals Radical Hysterectomy After Neoadjuvant Chemotherapy for Locally Bulky-Size Cervical Cancer: A Retrospective Comparative Analysis between the Robotic and Abdominal Approaches

2019 ◽  
Vol 16 (20) ◽  
pp. 3833 ◽  
Author(s):  
Chia-Hao Liu ◽  
Yu-Chieh Lee ◽  
Jeff Chien-Fu Lin ◽  
I-San Chan ◽  
Na-Rong Lee ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Radical Hysterectomy ◽  
Disease Free Survival ◽  
Figo Stage ◽  
Lower Percentage ◽  
Perioperative Outcomes ◽  
Survival Outcomes ◽  
Agent Based ◽  
Multi Agent

Radical hysterectomy (RH) is the standard treatment for early stage cervical cancer, but the surgical approach for locally bulky-size cervical cancer (LBS-CC) is still unclear. We retrospectively compared the outcomes of women with LBS-CC treated with neoadjuvant chemotherapy (NACT) and subsequent RH between the robotic (R-RH) and abdominal approaches (A-RH). Between 2012 and 2014, 39 women with LBS-CC FIGO (International Federation of Gynecology and Obstetrics) stage IB2–IIB were treated with NACT-R-RH (n = 18) or NACT-A-RH (n = 21). Surgical parameters and prognosis were compared. Patient characteristics were not significantly different between the groups, but the NACT-R-RH group had significantly more patients with FIGO stage IIB disease, received multi-agent-based NACT, and had a lower percentage of deep stromal invasion than the NACT-A-RH group. After NACT-R-RH, surgical parameters were better, but survival outcomes, such as disease-free survival (DFS) and overall survival (OS), were significantly worse. On multivariate analysis, FIGO stage IIB contributed to worse DFS (p = 0.003) and worse OS (p = 0.012) in the NACT-A-RH group. Women with LBS-CC treated with NACT-R-RH have better perioperative outcomes but poorer survival outcomes compared with those treated with NACT-A-RH. Thus, patients with FIGO stage IIB LBS-CC disease might not be suitable for surgery after multi-agent-based NACT.

scholarly journals Neoadjuvant Chemotherapy Followed by Radical Surgery versus Radiotherapy (with or without Chemotherapy) in Patients with Stage IB2, IIA, or IIB Cervical Cancer: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Qingjian Ye ◽  
Yuebo Yang ◽  
Xinran Tang ◽  
Jing Li ◽  
Xiaomao Li ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Adverse Events ◽  
Radical Surgery ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Cochrane Library ◽  
Therapeutic Effects ◽  
Long Term Effects ◽  
Case Control Studies

Background. This study was to compare the efficacy and safety between neoadjuvant chemotherapy followed by radical surgery (NACT+RS) and radiotherapy only (RT) or concurrent chemoradiotherapy (CCRT) for treatment of patients with stage IB2, IIA, or IIB cervical cancer. Method. The electronic databases of PubMed, Embase, and the Cochrane Library were searched to screen relevant studies from their inception to October 2018. Clinical data including overall survival (OS), disease-free survival (DFS), and adverse events were extracted. Egger’s test was used to evaluate the publication bias, and sensitivity analysis was conducted to estimate the robustness of results. Results. Finally, three randomized controlled trials (RCTs) and two case-control studies consisting of 1,275 patients with stage IB2, IIA, or IIB cervical cancer were included in the current study. Overall, pooled results showed no significant differences in OS ((hazard ratio HR=0.603, 95%CI=0.350−1.038) and DFS (HR=0.678, 95%CI=0.242−1.904) for patients treated with NACT+RS compared with RT only or CCRT, but the subgroup analysis showed that the OS and DFS were significantly longer in the NACT+RS groups than the RT or CCRT group (OS: HR=0.431, 95%CI=0.238−0.781, p=0.006; DFS: HR=0.300, 95%CI=0.187−0.482, p<0.001) for the population with median follow-up time of more than 60 months. For adverse events, the incidence of thrombocytopenia in the NACT+RS group was significantly higher than that in the RT only or CCRT group (relative risk RR=3.240, 95% CI 1.575-6.662), while the incidence of diarrhea was significantly lower than that in the RT only or CCRT group (RR=0.452, 95% CI =0.230-0.890). Conclusion. These findings suggest that the short-term therapeutic effects of the two treatments may be possibly equal for patients with stage IB2-IIB cervical cancer, but the long-term effects for improving OS and DFS may be better using NACT+RS compared with the RT only or CCRT.

scholarly journals Effect of neoadjuvant chemotherapy followed by surgery for FIGO stage I–II cervical cancer: a meta-analysis

2020 ◽  
Vol 48 (8) ◽  
pp. 030006052094550
Author(s):  
Shu-Li Yang ◽  
Ling Chen ◽  
Yue He ◽  
Hui Zhao ◽  
Yu-Mei Wu
Keyword(s):  
Cervical Cancer ◽  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Meta Analysis ◽  
Locally Advanced ◽  
Figo Stage ◽  
Stage I ◽  
Oncological Outcomes ◽  
Gynecology And Obstetrics

Objective In this meta-analysis, we aimed to evaluate the oncological outcomes of preoperative neoadjuvant chemotherapy followed by radical surgery compared with radical surgery alone for treatment of International Federation of Gynecology and Obstetrics (FIGO) stage I–II cervical cancer. Method We searched for studies comparing the safety and efficacy of neoadjuvant chemotherapy plus surgery versus surgery alone in treatment outcomes of locally advanced cervical cancer. Meta-analysis was used to calculate the pooled odds ratios with corresponding 95% confidence intervals (CI). Results Sixteen studies were included in our analysis. Pooled analysis of overall survival rate [odds ratio (OR) = 1.09, 95% CI: 0.83–1.43] and progression-free survival rate (OR = 1.10, 95% CI: 0.77–1.57) showed that preoperative neoadjuvant chemotherapy did not have a benefit compared with surgery alone in terms of survival rates. The pooled results for postoperative parameters indicated that preoperative neoadjuvant chemotherapy followed by radical surgery was associated with a high rate of vascular space involvement (OR = 0.25, 95% CI: 0.17–0.35) and parametrial infiltration (OR = 0.60, 95% CI: 0.45–0.79). Conclusions This meta-analysis indicated that surgery following neoadjuvant chemotherapy for FIGO stage I–II cervical cancer and surgery alone had similar oncological outcomes.

Sign in / Sign up

Export Citation Format

Share Document