Survival impact of neoadjuvant treatment in cervical cancer stage IIB

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16559-e16559
Author(s):  
H. F. Oliveira ◽  
F. M. Peria ◽  
J. M. Andrade ◽  
H. R. Marana ◽  
A. C. Santos ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Concurrent Chemoradiotherapy ◽  
Neoadjuvant Treatment ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Alternative Approach ◽  
Disease Free

e16559 Background: A few previous studies demonstrated that neoadjuvant chemotherapy, followed by preoperative radiotherapy in diagnosed IIB cervical cancer patients, had similar therapeutic results as the standard protocol with concurrent chemoradiotherapy, considering complete response; overall survival; disease free survival and toxicity; requiring its evaluation as an alternative approach. Methods: One hundred sixteen women with IIB stage cervical cancer stages were submitted to a platinum combined based neoadjuvant chemotherapy followed by chemoradiotherapy with cisplatin. Those who had a good response, allowing a surgical approach, underwent the Wertheim-Meigs procedure. Those that could not be submitted to surgery remained in clinical follow-up. Results: The age of the patients were 22 to 75 years old (48.7±11.4 years). The average follow-up was about 48 months (1–120). The good response to the neoadjuvant treatment was found in 76 patients (65.5%), and surgery was possible in 86 (74%). The pathological complete response was found in 39 (33%), and the partial response in 40%. The global recurrence was diagnosed in 37 (32%) patients. In the operated group (n = 86), the overall-five years survival was 76%, and in the non-operated group (n = 30) was 17,5%. The five years-global survival was 79,2% in “good response” (GR) patients, and 27.4% in that with “no-good response” (NGR) to combined neoadjuvant treatment ( p < 0.01). The free-relapse survival was 79.4% in GR, and 32.5% in NGR group (p < 0.01). Conclusions: Amongst the studied prognostic factors, the most important one for interval of relapse and survival (global and free-relapse) was a good response to the neoadjuvant treatment, and that this treatment had an acceptable toxicity and could be considered in other trials as an option to standard treatment. No significant financial relationships to disclose.

Neoadjuvant chemotherapy in early-stage cervical cancer (<2 cm) before conization for fertility preservation: is there any advantage over upfront conization?

2021 ◽  
Vol 31 (3) ◽  
pp. 379-386
Author(s):  
Florencia Noll ◽  
Ana Tatiana Palacios Torres ◽  
Pablo Pecci ◽  
Sergio Martin Lucchini ◽  
Fernando Heredia
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Fertility Preservation ◽  
Disease Free Survival ◽  
Free Survival ◽  
Fertility Sparing ◽  
Preservation Rate ◽  
Disease Free ◽  
Cervical Conization

BackgroundNeoadjuvant chemotherapy before fertility-sparing surgery is an accepted option for patients with cervical tumors between 2 cm and 4 cm. There is a paucity of data regarding its role in patients with tumors <2 cm. Our objective was to compare the oncological and obstetrical outcomes between patients who underwent neoadjuvant chemotherapy before cervical conization versus upfront cervical conization in patients with cervical cancer with tumors <2 cm.MethodsWe conducted a systematic literature review and searched MEDLINE, EMBASE, and CINAHL (from 1995 to March 2020) using the terms: uterine cervix neoplasms, cervical cancer, fertility-sparing surgery, fertility preservation, conization, cone biopsy, and neoadjuvant chemotherapy. We included manuscripts with information on patients with tumor size <2 cm, lymph node status, follow-up, oncological and obstetrical outcome, and toxicity related to neoadjuvant chemotherapy. We excluded review articles or articles with duplicated patient information.ResultsWe identified 12 articles, including 579 patients. For final analysis, 261 patients met inclusion criteria. The most common histology was non-squamous cell carcinoma (62%). Median follow-up time was 63.5 (range 7–122) months for the neoadjuvant chemotherapy group and 48 (range 12–184) months for the upfront cervical conization group. There was no difference in either overall survival (neoadjuvant chemotherapy group 100% vs upfront cervical conization 99.7%, p=0.79) or disease-free survival (neoadjuvant chemotherapy 100% vs upfront cervical conization 98.9%, p=0.59) between the groups. Fertility preservation rate was 81.4% versus 99.1% (p<0.001) favoring upfront cervical conization. No statistically significant differences were seen in live birth rate or pregnancy loss. Also, we found that all neoadjuvant chemotherapy patients reported chemotherapy-related toxicity (30.7% grade 3 and 69.2% grade 1–2).ConclusionsThere was no difference in disease-free survival or overall survival between patients who underwent neoadjuvant chemotherapy followed by conization and upfront cervical conization. Patients who underwent upfront cervical conization had a higher fertility preservation rate.

scholarly journals STAGE IB2–IIIB CERVICAL CANCER: NEOADJUVANT CHEMOTHERAPY, RADICAL SURGERY AND PATIENT SURVIVAL

2021 ◽  
Vol 20 (3) ◽  
pp. 82-89
Author(s):  
D. L. Ovodenko ◽  
G. N. Khabas ◽  
Yu. M. Kreinina ◽  
A. A. Seregin ◽  
O. I. Aleshikova ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Survival Rate ◽  
Neoadjuvant Chemotherapy ◽  
Radical Surgery ◽  
Disease Free Survival ◽  
Cytostatic Drugs ◽  
Free Survival ◽  
Long Term Treatment ◽  
Disease Free

 The aim of the study was to evaluate the five-year survival rate in patients with stage ib2–iiib cervical cancer treated with neoadjuvant chemotherapy and radical surgery.Material and Methods. Long-term treatment outcomes were studied in 173 patients with histologically-verified stage ib2–iiib cervical squamous cell carcinoma. The patients underwent neoadjuvant chemotherapy using intravenous infusion of cytostatic drugs (n=106) and intra-arterial infusion of cytostatic drugs in combination with embolization of tumor-feeding arteries (n=67). Patients with resectable tumors underwent radical surgery. Disease-free survival was assessed.Results. The median follow-up time was 66 months, and the maximum follow-up period was 144 months. 160 (92.5 %) patients underwent radical surgery after chemotherapy. 55 (34.4 %) patients did not receive adjuvant radiation therapy. The five-year disease-free survival rate was 79.6 %.Conclusion. For the group of patients with locally advanced cervical cancer, who achieved respectability following neoadjuvant chemotherapy, radical surgery could be performed. Chemotherapy followed by radical surgery can improve disease-free survival rates in patients with stage ib2–iiib cervical cancer.

Radical hysterectomy in early cervical cancer in Europe: characteristics, outcomes and evaluation of ESGO quality indicators

2021 ◽  
pp. ijgc-2021-002587
Author(s):  
Felix Boria ◽  
Luis Chiva ◽  
Vanna Zanagnolo ◽  
Denis Querleu ◽  
Nerea Martin-Calvo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Quality Indicators ◽  
Radical Hysterectomy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Operative Complications ◽  
Early Cervical Cancer ◽  
Disease Free

IntroductionComprehensive updated information on cervical cancer surgical treatment in Europe is scarce.ObjectiveTo evaluate baseline characteristics of women with early cervical cancer and to analyze the outcomes of the ESGO quality indicators after radical hysterectomy in the SUCCOR database.MethodsThe SUCCOR database consisted of 1272 patients who underwent radical hysterectomy for stage IB1 cervical cancer (FIGO 2009) between January 2013 and December 2014. After exclusion criteria, the final sample included 1156 patients. This study first described the clinical, surgical, pathological, and follow-up variables of this population and then analyzed the outcomes (disease-free survival and overall survival) after radical hysterectomy. Surgical-related ESGO quality indicators were assessed and the accomplishment of the stated recommendations was verified.ResultsThe mean age of the patients was 47.1 years (SD 10.8), with a mean body mass index of 25.4 kg/m2 (SD 4.9). A total of 423 (36.6%) patients had a previous cone biopsy. Tumor size (clinical examination) <2 cm was observed in 667 (57.7%) patients. The most frequent histology type was squamous carcinoma (794 (68.7%) patients), and positive lymph nodes were found in 143 (12.4%) patients. A total of 633 (54.8%) patients were operated by open abdominal surgery. Intra-operative complications occurred in 108 (9.3%) patients, and post-operative complications during the first month occurred in 249 (21.5%) patients, with bladder dysfunction as the most frequent event (119 (10.3%) patients). Clavien-Dindo grade III or higher complication occurred in 56 (4.8%) patients. A total of 510 (44.1%) patients received adjuvant therapy. After a median follow-up of 58 months (range 0–84), the 5-year disease-free survival was 88.3%, and the overall survival was 94.9%. In our population, 10 of the 11 surgical-related quality indicators currently recommended by ESGO were fully fulfilled 5 years before its implementation.ConclusionsIn this European cohort, the rate of adjuvant therapy after radical hysterectomy is higher than for most similar patients reported in the literature. The majority of centers were already following the European recommendations even 5 years prior to the ESGO quality indicator implementations.

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.

Minimally invasive radical hysterectomy: an analysis of oncologic outcomes from Hospital Italiano (Argentina)

2019 ◽  
Vol 29 (5) ◽  
pp. 863-868 ◽  
Author(s):  
Diego Odetto ◽  
Maria Celeste Puga ◽  
Jose Saadi ◽  
Florencia Noll ◽  
Myriam Perrotta
Keyword(s):  
Cervical Cancer ◽  
Recurrence Rate ◽  
Radical Hysterectomy ◽  
Adenosquamous Carcinoma ◽  
Disease Free Survival ◽  
Laparoscopic Approach ◽  
Free Survival ◽  
Laparoscopic Radical Hysterectomy ◽  
Disease Free

BackgroundThe Laparoscopic Approach to Cervical Cancer (LACC) trial demonstrated a higher rate of disease recurrence and worse disease-free survival in patients who underwent minimally invasive radical hysterectomy.ObjectivesTo evaluate surgical and oncological outcome of laparoscopic radical hysterectomy performed at Hospital Italiano in Buenos Aires, Argentina.MethodsThis retrospective study included all patients with cervical cancer, 2009 FIGO stage IA1, with lymphovascular invasion to IB1 (<4 cm) who underwent a laparoscopic radical hysterectomy between June 2010 and June 2015. Patients were eligible if they had squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, and no lymph node involvement by imaging. Patients must have undergone a type C1 radical hysterectomy. Only patients who were treated by a laparoscopic approach were included. Patients were excluded if histopathology showed a component of neuroendocrine carcinoma before or after surgery; if they had synchronous primary tumors, history of abdominal or pelvic radiotherapy, or were operated on at an outside institution; and if they had only surgery and no follow-up in our institution. Relapse rate and disease-free survival were evaluated using the Kaplan-Meier method.ResultsA total of 108 patients were evaluated. The median age was 41 years (range 27–70). Distribution of histologic sub-types was squamous carcinoma in 77 patients (71%), adenocarcinoma in 27 patients (25%), and adenosquamous carcinoma in four patients (4%). Ninety-nine patients (92%) had stage IB1 tumors and 58 (54%) patients had tumors ≤2 cm. The median surgical time was 240 min (range 190–290), the median estimated blood loss was 140 mL (range 50–500) and the transfusion rate was 3.7%. The median length of hospital stay was 2 days (range 1–11). The median follow-up time was 39 months (range 11–83). The global recurrence rate after laparoscopic radical hysterectomy was 15% (16/108). According to tumor size, the recurrence rate was 12% in patients with tumors ≤2 cm (7/58) and 18% in patients with tumors >2 cm (9/50) (OR=0.76; 95% CI 0.26 to 2.22; p=0.62) The 3- and 5-year relapse rate was 17% (95% CI 11% to 27%). The 3- and 5-year disease-free survival was 81% (95% CI 71% to 88%) and 70% (95% CI 43% to 86%), respectively. Overall survival at 3 years was 87% (95% CI 76% to 93%).ConclusionThe recurrence rate after laparoscopic radical hysterectomy was 15%, and in tumors ≤2 cm it was 12%. The 3-year disease-free survival was 81%. Given these results our hospital has changed the approach to open radical hysterectomy.

Survival and recurrence of breast cancer patients with pathologic complete response after neoadjuvant chemotherapy.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12121-e12121
Author(s):  
Young Joo Lee ◽  
Sei-Hyun Ahn ◽  
Byung Ho Sohn ◽  
jong Won Lee ◽  
Il Yong Chung ◽  
...  
Keyword(s):  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Good Prognosis ◽  
Her2 Status ◽  
Nodal Disease ◽  
Ki 67 ◽  
Free Survival ◽  
Disease Free

e12121 Background: Patients with Pathologic complete response after neoadjuvant chemotherapy is known to have a good prognosis. However, there is a difference depending on how the complete remission is defined. Methods: We analyzed basic characteristics and outcomes of 295 patients who had pathologic complete response defined as ypT0 and ypTis after neoadjuvant chemotherapy for breast cancer at Asan Medical Center in Seoul, Korea. Results: Median follow up period was 66.5 month(6~128 month). Overall survival was 94% at 5-year and 10-year. No difference was shown in preoperative age, grade, HR/HER2 status, Ki-67 level. Clinical stage III showed worst outcome(85.8%). Survival rate between ypT0N0 (98.8%) and ypTis (89.1%, p=0.00) and between ypT0/TisN residual (85.7%, p=0.00) was shown, but no statistical difference between ypTis and ypT0/Tis with residual nodes(p=0.539). Disease free survival also showed no statistical significance between age, HR/Her2 status. But patients with low Ki-67 level(0~20%)(68.2%) at diagnosis had worse DFS compared to high Ki-67 level(>20%)(87.5%)(P=0.013). No difference between intrinsic subtypes was shown. Patients with residual nodal disease had worse DFS(66.1%) than ypN0(89.1%)(p=0.00). DFS of ypT0N0 was 92.7% and ypTisN0(75.5%), ypT0/Tis with residual metastatic nodes(71.4%). There was no significant difference in type of chemotherapy regimen. Conclusions: Overall survival and disease free survival was different in ypT0N0 with ypTis and residual nodal disease. Good prognosis of pathologic complete response should be limited to cases in which the cancer has completely disappeared.

scholarly journals Neoadjuvant Chemotherapy with Taxane and Platinum Followed by Radical Hysterectomy for Stage IB2-IIB Cervical Cancer: Impact of Histology Type on Survival

2019 ◽  
Vol 8 (2) ◽  
pp. 156 ◽  
Author(s):  
Koji Matsuo ◽  
Muneaki Shimada ◽  
Satoshi Yamaguchi ◽  
Junzo Kigawa ◽  
Hideki Tokunaga ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Radical Hysterectomy ◽  
Clinical Stage ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Free Survival ◽  
Platinum Chemotherapy ◽  
Disease Free ◽  
Cause Specific Survival

The current study examined the histology-specific impact of neoadjuvant chemotherapy (NACT) with a taxane/platinum regimen on survival in women with locally-advanced cervical cancer who underwent radical hysterectomy. This nation-wide retrospective cohort study examined women with clinical stage IB2-IIB cervical cancer who received NACT prior to radical hysterectomy from 2004–2008 (n = 684). NACT type (taxane/platinum versus others) was correlated with survival based on histology: 511 squamous versus 173 non-squamous. Taxane/platinum chemotherapy use was more common in non-squamous compared to squamous tumors (53.8% versus 20.7%, P < 0.001). In both histology types, the taxane/platinum regimen was more frequently utilized over time (both, P < 0.01). Among squamous tumors, women who received taxane/platinum chemotherapy had survival comparable to those who received other regimens: 5-year rates for disease-free survival, 69.0% versus 70.1%, P = 0.98; and cause-specific survival, 80.0% versus 81.0%, P = 0.93. Similarly, in non-squamous tumors, disease-free survival (5-year rates: 60.4% versus 59.0%, P = 0.86) and cause-specific survival (74.7% versus 76.3%, P = 0.70) were similar. In conclusion, use of taxane/platinum regimens for NACT significantly increased during the study period. Irrespective of histology type, in women with clinical stage IB2-IIB cervical cancer who underwent NACT prior to radical hysterectomy, taxane/platinum regimens had a similar effect on survival compared to non-taxane/platinum regimens.

The 50-month results of the four non-platinum concurrent chemoradiation regimens for locally advanced cervical cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 5540-5540
Author(s):  
P. Kamnerdsupaphon ◽  
I. Chitapanarux ◽  
V. Sukthomya ◽  
V. Lorvidhaya
Keyword(s):  
Cervical Cancer ◽  
Locally Advanced ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Complete Response ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Randomized Clinical Study ◽  
Disease Free

5540 Objectives: To determine the efficacy, disease free and overall survivals of radiation therapy in combination with four non-platinum chemotherapy regimens for locally advanced cervical cancer. Materials and Methods: Eligible patients were those with a diagnosis of locally advanced cervical cancer, under 70 years of age, and undergone the necessary prestudy investigations. All patients received external-beam pelvic irradiation to a minimum dose of 5,000 cGy, and brachytherapy delivered to bring the minimum total dose at point A to 7,500 cGy. Patients were randomized to receive one of four chemotherapy regimens: Arm1: oral 5FU 250 mg/m2/day, Arm2: mitomycin 12 mg/m2 on days 1 and 28 + oral 5FU 200 mg/m2/day, Arm3: mitomycin 12 mg/m2 on days 1 and 28 followed by 5FU 1,000 mg/m2/day on days 1 through 4 and 28 through 31, Arm4: oral hydroxyurea 25 mg/kg/day. Results: From September 1995 to October 2001, the study include 921 women; 226 in arm 1, 229 in arm 2, 234 in arm 3, and 232 in arm 4. The median follow-up time was 51.69 months. More than 89% of the patients achieved complete response. Disease free survival rates were 62.4% among arm 1, 63.8% among arm 2, 66.2% among arm 3, and 68.5% among arm 4. Overall survival rates were 77.4%, 79.5%, 80.8%, and 84.5% respectively. Conclusion: The efficacy of these regimens were not inferior to the standard platinum based regimen for locally advanced cervical cancer. This study demonstrates the results of large randomized clinical study of radiochemotherapy and requires the longer follow up time for the late complications. No significant financial relationships to disclose.

Does weekly versus daily low-dose of concurrent cisplatin have any effect on compliance and clinical outcomes in cases of locally advanced head and neck cancers?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17569-e17569
Author(s):  
Ayush Garg ◽  
Piyush Kumar ◽  
Arvind Kumar Chauhan ◽  
Pavan Kumar
Keyword(s):  
Statistical Difference ◽  
Low Dose ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Group I ◽  
Group Ii ◽  
Disease Free

e17569 Background: Concurrent Cisplatin with radiotherapy improves outcomes in locally advanced squamous cell carcinomas of the head neck.Cisplatin at 35mg/m2(weekly) raise compliance & hospitalization. There are only few reports on efficacy and toxicity of low dose Cisplatin (6mg/m2). Hence the purpose of this study was to evaluate the compliance and clinical outcomes between two concurrent cisplatin chemotherapy regimens & to see long term effects. Methods: Total 50 patients were included in study from Nov 2015 to Mar 2017 with 25 in each group. Radiotherapy given 70Gy/35# in 7weeks & Cisplatin at 35mg/m2 weekly (Group I) and 6mg/m2 daily (Group II). Assessment of toxicity was done by RTOG scoring criteria. WHO Response criterion was used to assess clinical response. Median follow up was 6 months. Results: Group I(80%) and Group II(84%)patients completed Radiotherapy. In Group I 48% patients received less than 6 cycles and Group II 40% received ≤25 cycles chemotherapy. Median OTT in Group I & II in was 51 & 52days. Neutropenia & Mucositis statistically insignificant between both groups.There was no statistical difference in complete response between the two groups. In Group I 40% patients developed Progressive disease on follow up as compared to 12% in Group II(p-0.02). After 1.5 years of follow up, Group I vs Group II 4 patients had complete response, 6 had recurrence & 11 vs 4 patients expired (p-0.03). At a median follow up of 6 months overall survival in Group I and II was 56% and 44%(p-0.39). While as median disease free survival in Group I & II was 6.6 & 11.9 months(p-0.14). Conclusions: Low dose daily Cisplatin offers ease of administration in the outpatient clinic, better tolerability and better quality of life.Group II patients were more compliant in terms of patients receiving chemotherapy or completing radiotherapy. At median follow up of 6 months there was no statistical difference in terms of overall and disease-free survival. The statistical difference was seen in terms of patients expired in Group I (44%) as compared to Group II (16%). Therefore, we need a larger number of patients for the use of low dose Cisplatin to be evaluated in future clinical trials.

A randomized phase III trial of adjuvant chemotherapy versus concurrent chemoradiotherapy (CCRT) for postoperative cervical cancer: Japanese Gynecologic Oncology Group study (JGOG1082).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6094-TPS6094
Author(s):  
Akiko Furusawa ◽  
Munetaka Takekuma ◽  
Tomoka Usami ◽  
Eiji Kondo ◽  
Shin Nishio ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Radical Hysterectomy ◽  
Concurrent Chemoradiotherapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Stage Ib ◽  
Pelvic Lymph Node Metastasis ◽  
Disease Free

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.

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