Matched-case comparison for the efficacy of neoadjuvant chemotherapy before surgery in FIGO stage IB1-IIA cervical cancer

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.

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Matched-Case Comparison for the Role of Surgery in FIGO Stage Ib1–IIa Squamous Cell Carcinoma of Cervix and Suspicious Para-Aortic Lymph Node Metastasis

Annals of Surgical Oncology ◽

10.1245/s10434-008-0197-3 ◽

2009 ◽

Vol 16 (1) ◽

Cited By ~ 3

Author(s):

Hee Seung Kim ◽

Noh Hyun Park ◽

Hong Gyun Wu ◽

Jeong Yeon Cho ◽

Hyun Hoon Chung ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Lymph Node ◽

Lymph Node Metastasis ◽

Figo Stage ◽

Node Metastasis ◽

Carcinoma Of Cervix ◽

Aortic Lymph Node ◽

Case Comparison ◽

Matched Case

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Efficacy of neoadjuvant chemotherapy in patients with FIGO stage IB1 to IIA cervical cancer: An international collaborative meta-analysis

European Journal of Surgical Oncology ◽

10.1016/j.ejso.2012.09.003 ◽

2013 ◽

Vol 39 (2) ◽

pp. 115-124 ◽

Cited By ~ 66

Author(s):

H.S. Kim ◽

J.E. Sardi ◽

N. Katsumata ◽

H.S. Ryu ◽

J.H. Nam ◽

...

Keyword(s):

Cervical Cancer ◽

Neoadjuvant Chemotherapy ◽

Meta Analysis ◽

Figo Stage ◽

International Collaborative

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A STUDY ON THE NEOADJUVANT CHEMOTHERAPY WITH CHEMORADIATION VERSUS DEFINITIVE CHEMORADIATION IN LOCALLY ADVANCED STAGE OF CERVICAL CANCER

10.36106/ijsr/2413896 ◽

2021 ◽

pp. 67-69

Author(s):

Subhas Haldar ◽

Archana Dixit ◽

Dinesh Kumar Saroj ◽

Debarshi Jana

Keyword(s):

Cervical Cancer ◽

Neoadjuvant Chemotherapy ◽

Response Rate ◽

Locally Advanced ◽

Figo Stage ◽

Cancer Center ◽

Open Label ◽

Randomized Control ◽

Control Study ◽

Better Than

Introduction: Ajoint study on cervical cancer prepared by ASSOCHAM-National Institute of Cancer Prevention and Research (NICPR) reveals, India alone accounts for one-fourth of global burden of cervical cancers. To compare the response rate in neoadjuvant chemotherapy arm versus only denitive chemoradiation for cervical stage IIB to IVApatients. Materials and methods: The study involves accrual of patients at the Department of Radiotherapy, Saroj Gupta Cancer center and research institute. Allocation: Prospective, parallel, open label, single institutional randomized control study. Conclusion: We concluded that the response rate in neoadjuvant chemotherapy arm was better than only denitive chemoradiation for cervical FIGO stage IIB to IVApatient

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Case Selection Is a Fundamental Prerequisite to the Successful Surmounting of Learning Curve of Laparoscopic Radical Hysterectomy in Early-Stage Cervical Cancer: A Matched-Case Comparison in a Single Institution

Journal of Minimally Invasive Gynecology ◽

10.1016/j.jmig.2015.08.261 ◽

2015 ◽

Vol 22 (6) ◽

pp. S97

Author(s):

YB Kim ◽

DH Suh ◽

K Kim ◽

JH No

Keyword(s):

Cervical Cancer ◽

Learning Curve ◽

Radical Hysterectomy ◽

Early Stage ◽

Single Institution ◽

Laparoscopic Radical Hysterectomy ◽

Case Selection ◽

Case Comparison ◽

Early Stage Cervical Cancer ◽

Matched Case

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

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph16203833 ◽

2019 ◽

Vol 16 (20) ◽

pp. 3833 ◽

Cited By ~ 1

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.

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