Treatment results of adjuvant chemotherapy after radical hysterectomy for intermediate- and high-risk stage IB–IIA cervical cancer

2006 ◽  
Vol 103 (2) ◽  
pp. 618-622 ◽  
Author(s):  
Nobuhiro Takeshima ◽  
Kenji Umayahara ◽  
Kiyoshi Fujiwara ◽  
Yasuo Hirai ◽  
Ken Takizawa ◽  
...  
2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6094-TPS6094
Author(s):  
Akiko Furusawa ◽  
Munetaka Takekuma ◽  
Tomoka Usami ◽  
Eiji Kondo ◽  
Shin Nishio ◽  
...  

TPS6094 Background: Cervical cancer is one of the common gynecologic cancer and the incidence of invasive cervical cancer has increased over the past few decades, particularly in younger women. The standard treatment for stage IB to IIB cervical cancer is a radical hysterectomy. In Japan, more than 80% of institutions, radical hysterectomy is chosen as the primary treatment for patients with stage IB1 and IIA1 cervical cancer. Patients with high-risk factors would be recommend adjuvant concurrent chemoradiotherapy (CCRT). However, adjuvant CCRT might not reduce distant metastasis and might cause of severe gastrointestinal and urinal toxicity. To avoid those adverse events of adjuvant CCRT, many Japanese gynecologic oncologists perform chemotherapy as adjuvant therapy. In the first multi-institutional phase II trial conducted in stage IB-IIA cervical cancer with pelvic lymph node metastasis (JGOG1067), we found a 5-years disease free-survival rate of 86.5%, suggesting the adjuvant chemotherapy had promising efficacy and would be feasible for a long time. No prospective study reported that adjuvant chemotherapy would improve overall survival in patients with the high-risk cervical cancer. Methods: High risk stage IB-IIB cervical cancer patients who underwent radical hysterectomy are eligible for the study. Patients with high risk are defined as those with pelvic lymph-node metastasis and/or parametrial invasion. Patents with SCC, adenocarcinoma, adenosquamous cell carcinoma are eligible for the study. After providing informed consent, patients are randomized on a 1:1 basis to receive CCRT or chemotherapy. Randomization is stratified by the faculty, FIGO stage, and pathological subtype (SCC or non-SCC). Treatment have to be started within 6 weeks after surgery. CCRT group is given whole pelvis irradiation 50.4Gy and cisplatin (40mg/m2/week). Chemotherapy group is given paclitaxel (175mg/m2) plus cisplatin (50mg/m2) or paclitaxel (175mg/m2) plus carboplatin(AUC of 6). The primary endpoint is overall survival (OS). Secondary endpoints are disease free survival (DFS), adverse events and QOL. This study began in November 2019 and a total of 290 patients will be accrued within 5 years. The study is coordinated by of the JGOG cervical cancer committee. Clinical trial information: 041190042.


2015 ◽  
Vol 06 (12) ◽  
pp. 1075-1082 ◽  
Author(s):  
Hongwu Wen ◽  
Tongyu Liu ◽  
Zhaoyi Feng ◽  
Weiping Huang ◽  
Ke Ma ◽  
...  

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17024-e17024
Author(s):  
Munetaka Takekuma ◽  
Yuka Kasamatsu ◽  
Shin Nishio ◽  
Hideo Omi ◽  
Tsutomu Tabata ◽  
...  

e17024 Background: A multicenter phase II trial was conducted to assess the efficacy and toxicity of paclitaxel and nedaplatin as the initial postoperative adjuvant chemotherapy for high-risk uterine cervical cancer. Methods: The patients with FIGO stages IB1-IIA2 squamous cell carcinoma of the uterine cervix were enrolled. Histologic confirmation of lymph node metastasis was mandatory. Intravenous paclitaxel 175 mg/m(2) over 3hours and nedaplatin 80 mg/m(2) over 1 hour were administered on day 1 of a every 28 day cycle, of which there were 5 cycles after radical hysterectomy. Results: 62 patients were enrolled into the study protocol from November 2011 to July 2015. The median age of patients was 48.5 years (range; 28-64). Median tumor diameter was 37 mm (0-34). 10 patients (16.1%) had parametrial invasion, 44 (71.0%) had deep stromal invasion, and 53 (85.5%) had lymph-vascular invasion. 30 patients (48.4%) had one metastatic lymph node, 11 (17.7%) had two, 3 (4.8%) had three, 5 (8.1%) had four and 13 (21.0%) had five or more. With a median follow-up of 36.9 months (range: 17.2-61.5), the 2-year progression-free survival rate and pelvic disease progression-free rate were 78.9% (95% CI, 68.5% to 89.3%) and 85.0% (95% CI, 75.8% to 94.3%), respectively. The 2-year overall survival rate was 93.3% (95% CI, 86.8% to 99.8%). Adverse events were almost acceptable. Grade 3-4 adverse events (NCI-CTC ver4.0) that occurred in 5% or more patients were neutropenia (60.7%) and infection (6.6%). The proportion of patients who completed 5 cycles of treatment was 90.3%. Conclusions: Adjuvant chemotherapy with paclitaxel and nedaplatin for patients with high-risk cervical cancer after radical hysterectomy was demonstrated to be an effective and feasible treatment. Phase III trial should compare this with concurrent chemoradiotherapy. Clinical trial information: 000005605.


2019 ◽  
Vol 50 (2) ◽  
pp. 99-103
Author(s):  
Muneaki Shimada ◽  
Hideki Tokunaga ◽  
Hiroaki Kobayashi ◽  
Mitsuya Ishikawa ◽  
Nobuo Yaegashi

Abstract Japan Society of Gynecologic Oncology guidelines recommended either radical hysterectomy-based approach or the definitive radiotherapy including concurrent chemoradiotherapy as primary treatment for patients with not only stage IB1/IIA1, but also stages IB2, IIA2 and IIB. Based on pathological findings of surgical specimens, patients who underwent radical hysterectomy are divided into three recurrent-risk groups, low-risk, intermediate, and high-risk groups. Although some authors reported the usefulness of adjuvant chemotherapy for intermediate/high-risk patients, radiotherapy was standard adjuvant treatment for pathological-risk patients after radical hysterectomy. It has been uncertain whether neoadjuvant chemotherapy followed by radical hysterectomy is beneficial for stage IB2–IIB patients. Recently, the randomized phase III study revealed that neoadjuvant chemotherapy followed by radical hysterectomy failed to improve survival of stage IB2–IIB patients compared to concurrent chemoradiotherapy. Majority of stage IB2–IIB patients are required adjuvant radiotherapy after radical hysterectomy. The multimodality strategy consisting of radical hysterectomy followed by adjuvant radiotherapy is associated with not only impaired quality of life, but also conflicting of cost-effectiveness. Thereby, some authors investigated the significance of multimodality strategy consisting of chemotherapy before/after radical hysterectomy for stage IB2–IIB cervical cancer. Multimodality strategy consisting of radical hysterectomy/perioperative chemotherapy needs higher curability of radical hysterectomy, higher response to perioperative chemotherapy and less perioperative complications. Consequently, gynecologic oncologists have to examine the patients strictly before treatment and judge whether radical hysterectomy-based approach or definitive irradiation is appropriate for the patient with stage IB–IIB cervical cancer.


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