Therapeutic efficacy of epidermal growth factor receptor monoclonal antibody combined with concurrent chemoradiotherapy in treatment of locally advanced cervical cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17012-e17012
Author(s):  
Wenli Chen ◽  
Tao Li ◽  
Wei Zhang ◽  
Jialin Yang ◽  
Jian Wang ◽  
...  

e17012 Background: There are few studies about epidermal growth factor receptor monoclonal antibody nimotuzumab for the treatment of locally advanced cervical cancer. We aimed to assess the therapeutic efficacy and analyse prognostic factors of chemoradiotherapy combined with nimotuzumab in cervical cancer (stage IIB-IVA) . Methods: We retrospectively analyzed 23 patients with locally advanced cervical cancer(stage IIB-IVA) ,who received concurrent chemoradiotherapy combined with nimotuzumab from 2012 to 2014 (the study group) ,and 30 patients with the similar baseline characteristics who received concurrent chemoradiotherapy alone (the control group). The overall response rates, 5-year overall survival rates, progression-free survival and acute adverse events of the two groups were compared .Multivariate prognostic analysis was performed by a Cox proportional hazards model. Results: The median follow-up time were 46 months (IQR 16-60) in the study group and 42 months (2-60) in the control group.The overall response rates were 87% and 73.3% (P = 0.384) . The 5-year overall survival rates were 63.6% and 36.1% (hazard ratio 2.208,95% CI 0.878-5.557,P = 0.092) .The median progression-free survival in the study group was not achieved (95%CI 9-55) versus 27 months (1-60) in the control group (hazard ratio 2.635, 95% CI 1.030-6.737, P= 0.043).Multivariate prognostic analysis indicated that stage and whether to be combined with nimotuzumab were the influential factors for progression-free survival time.Adverse events were similar between groups.The most common grade 3 or 4 adverse events during treatment in the study group versus the control group were leucopenia(9 [39%] vs 11 [36%]),thrombocytopenia (3 [13%] vs 6 [20%]),anaemia (4 [17%] vs 4 [13%]). Conclusions: Concurrent chemoradiotherapy combined with nimotuzumab in the treatment can improve the progression-free survival time of advanced cervical cancer, while not increasing the incidence of adverse reactions.However, because of the small size of sample in this research, these findings suggest that it is necessary to perform a prospective study with expanded sample size.

2018 ◽  
Vol 28 (5) ◽  
pp. 1029-1037
Author(s):  
Ping Li ◽  
Rui Zhang ◽  
Zhihua Nie ◽  
Mengjuan Long ◽  
Gong Zhang ◽  
...  

PurposeThe aim of this study was to evaluate the efficacy of using nedaplatin to replace cisplatin for concurrent chemoradiotherapy (CCRT) in patients with newly diagnosed locally advanced cervical cancer.MethodsThe medical records of 155 patients with cervical cancer who had undergone CCRT with cisplatin (n = 85) or nedaplatin (n = 70) between January 2012 and January 2017 were retrospectively reviewed. Propensity score analysis with 1:1 matching with the nearest neighbor matching method was performed to assess response rates, progression-free survival, overall survival, and toxicity between 2 groups.ResultsPropensity score matching identified 63 patients in each group. After matching, compared with patients treated with cisplatin-based concurrent chemoradiotherapy (CisRT), we found that patients treated with nedaplatin-based concurrent chemoradiotherapy (NedaRT) had a significant higher recurrence rate (25.4% vs 42.9%; P = 0.04). In addition, the 3-year progression-free survival rate for NedaRT group was also worse than that for the CisRT group (52.2% vs 63.4%, P = 0.03). There was no difference in the overall response rates between the CisRT and NedaRT groups (87.3% and 90.5%, respectively; P = 0.57). The rates of 3-year overall survival and grades 3 to 4 toxicities were similar between the 2 groups.ConclusionsThe clinical outcome of this cohort of patients with locally advanced cervical cancer treated with CCRT did in no way provide support for the use of nedaplatin in place of cisplatin in chemoradiation and demonstrated no equivalence of the 2 drugs. Cautions should be taken for the replacement among platinum complexes in cancer treatment.


2021 ◽  
Author(s):  
Xiao-Li Yu ◽  
Miao-Fang Wu ◽  
Lin Ding ◽  
Jin Yang ◽  
Shou-Min Bai

Abstract Background: This study was aimed to determine the effect of neoadjuvant chemotherapy consisting of nab-paclitaxel and cisplatin (NACT-nPC) in patients with locally advanced cervical cancer.Materials and Methods: The consecutive, newly diagnosed, non-metastatic and locally advanced cervical cancer patients were retrospectively recruited between October 2016 and June 2020 in our hospital. All patients received concurrent chemoradiotherapy alone or following neoadjuvant chemotherapy. Patients were divided into two groups: one receiving NACT-nPC, and the control group receiving no or other regimes of neoadjuvant chemotherapy. We compared the complete remission rate of primary tumor at the end of external radiotherapy and chemoradiotherapy between the two groups. Results: A total of 198 patients were enrolled in this study, including 60 in NACT-nPC group and 138 in control group. At the end of external radiotherapy, 27 patients in NACT-nPC group and 32 patients in control group achieved complete remission (P = 0.002). At the end of chemoradiotherapy, 56 patients in NACT-nPC group and 114 patients in control group achieved complete remission (P = 0.033). The acute side effects above grade 3 in NACT-nPC group was 41.7% (25/60) and manageable, lower than control group which was 77/138 (55.8%).Conclusions: NACT-nPC can improve the complete response rate of patients with locally advanced cervical cancer followed by concurrent chemoradiotherapy, and the toxicity is tolerable. Furthermore, we suspect the NACT-nPC can improve the survival of the patients. However, further prospective studies are needed to confirm this result.


2020 ◽  
Vol 30 (7) ◽  
pp. 1065-1070
Author(s):  
Jyoti Mayadev ◽  
Ana T Nunes ◽  
Mary Li ◽  
Michelle Marcovitz ◽  
Mark C Lanasa ◽  
...  

BackgroundConcurrent chemoradiotherapy is the standard of care for locally advanced cervical cancer. Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.Primary ObjectiveThe CALLA trial is designed to determine the efficacy and safety of the programmed cell death-ligand 1 blocking antibody, durvalumab, with and following concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in women with locally advanced cervical cancer.Study HypothesisDurvalumab concurrent with and following concurrent chemoradiotherapy will improve progression-free survival in patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA cervical cancer compared with concurrent chemoradiotherapy alone.Trial DesignCALLA is a phase III, randomized, multicenter, international, double-blind, placebo-controlled study. Patients will be randomized 1:1 to receive either durvalumab (1500 mg intravenously (IV)) or placebo every 4 weeks for 24 cycles. All patients will receive external beam radiotherapy with cisplatin (40 mg/m2) IV or carboplatin (area under the curve 2) IV once a week for 5 weeks, followed by image-guided brachytherapy.Major Inclusion/Exclusion CriteriaThe study will enroll immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2–IIB node positive and stage IIIA–IVA with any node stage. Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer.Primary EndpointThe primary endpoint is progression-free survival (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors v1.1, histopathological confirmation of local tumor progression or death).Sample SizeApproximately 714 patients will be randomized 1:1 to receive either durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy.Estimated Dates for Completing Accrual and Presenting ResultsPatient enrollment is continuing globally with an estimated completion date of April 2024.Trial RegistrationNCT03830866.


2018 ◽  
pp. 1-8 ◽  
Author(s):  
Kathy Han ◽  
Eric Leung ◽  
Lisa Barbera ◽  
Elizabeth Barnes ◽  
Jennifer Croke ◽  
...  

Purpose To determine whether plasma human papillomavirus (HPV) DNA predates clinical recurrence and compare its accuracy with 3-month fluorodeoxyglucose positron emission tomography (FDG-PET) in locally advanced cervical cancer. Methods This prospective multicenter study accrued 23 women with stage IB to IVA cervical cancer planned for definitive chemoradiation therapy (CRT). Plasma HPV DNA was measured serially by digital polymerase chain reaction, and FDG-PET was performed at 3 months post-CRT. Results Of the 19 women with HPV+ cervical cancer included in this analysis, 32% were stage IB, 58% IIB, and 10% IIIB/IVA. Median follow-up was 24 months (range, 18 to 30 months). All patients had detectable plasma HPV DNA before treatment. Six patients had detectable plasma HPV DNA at the end of CRT, and three of them developed metastases at 3 months. Of the 13 patients with undetectable plasma HPV DNA at end of CRT, to date, only one has developed recurrence. Six of those 13 patients had a positive 3-month FDG-PET with no definite residual disease on subsequent imaging or clinical examination to date, and four of these six had undetectable plasma HPV DNA at 3 months. Patients with undetectable plasma HPV DNA at end of CRT had significantly higher 18-month progression-free survival than those with detectable plasma HPV DNA (92% v 50%; P = .02). The area under the receiver operating characteristic curve (accuracy) of 3-month plasma HPV DNA and 3-month FDG-PET imaging for predicting recurrence at 18 months were 77% and 60%, respectively ( P = .008). Conclusion Detectable plasma HPV DNA at end of CRT predates the clinical diagnosis of metastases and is associated with inferior progression-free survival. Moreover, 3-month plasma HPV DNA level is more accurate than 3-month FDG-PET imaging in detecting residual disease. The clinical utility of plasma HPV DNA detection for guiding adjuvant/salvage therapy should be evaluated in future studies.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16056-16056
Author(s):  
Y. Aoki ◽  
Y. Nagai ◽  
T. Toita ◽  
M. Hirakawa ◽  
M. Toma ◽  
...  

16056 Background: The purpose of this study was to report the feasibility and efficacy of concurrent chemoradiotherapy (CCRT) for the locally advanced cervical cancer in our institute. Methods: We retrospectively reviewed 147 patients (stage Ib: 9, II: 82, III: 80, and IVa: 7) with squamous cell carcinoma of the cervix treated with CCRT. Cisplatin (20mg/m2/day) was administered for 5 days every 3 weeks for a median of three courses (range: 1–5 courses) during radiotherapy (RT). The patients with paraaortic and/or common iliac lymphadenopathy were excluded. RT consisted of pelvic external beam RT (EBRT) with 40Gy/20 fractions followed by high-dose rate brachytherapy (HDR-BT) with 18Gy/3 fractions and pelvic EBRT with 10Gy/5 fractions using a midline block. Late complications were graded by the RTOG/EORTC criteria. Results: The 5-year actuarial overall survival (OS), disease-free survival (DFS), and pelvic relapse-free survival were 78.5%, 70.7%, and 78.0%, respectively. The 5-year OS by the disease stage was as follows: stage Ib 100%, II 82.0%, III 62.3%, and IVa 35.7%. Multivariate analysis identified pelvic lymphadenopathy, tumor diameter > 7cm, and pretreatment hemoglobin < 9.0g/dl as an independent prognostic factor for both OS and DFS. Only one patient suffered from grade 3 enterocolitis, but no grade 4 complication developed. Conclusions: Our experience suggests that CCRT using HDR-BT for locally advanced cervical cancer could achieve favorable local control without suffering from severe late complications. No significant financial relationships to disclose.


2021 ◽  
Vol 11 ◽  
Author(s):  
Mengting Cai ◽  
Fei Yao ◽  
Jie Ding ◽  
Ruru Zheng ◽  
Xiaowan Huang ◽  
...  

ObjectivesTo investigate the prognostic role of radiomic features based on pretreatment MRI in predicting progression-free survival (PFS) of locally advanced cervical cancer (LACC).MethodsAll 181 women with histologically confirmed LACC were randomly divided into the training cohort (n = 126) and the validation cohort (n = 55). For each patient, we extracted radiomic features from whole tumors on sagittal T2WI and axial DWI. The least absolute shrinkage and selection operator (LASSO) algorithm combined with the Cox survival analysis was applied to select features and construct a radiomic score (Rad-score) model. The cutoff value of the Rad-score was used to divide the patients into high- and low-risk groups by the X-tile. Kaplan–Meier analysis and log-rank test were used to assess the prognostic value of the Rad-score. In addition, we totally developed three models, the clinical model, the Rad-score, and the combined nomogram.ResultsThe Rad-score demonstrated good performance in stratifying patients into high- and low-risk groups of progression in the training (HR = 3.279, 95% CI: 2.865–3.693, p &lt; 0.0001) and validation cohorts (HR = 2.247, 95% CI: 1.735–2.759, p &lt; 0.0001). Otherwise, the combined nomogram, integrating the Rad-score and patient’s age, hemoglobin, white blood cell, and lymph vascular space invasion, demonstrated prominent discrimination, yielding an AUC of 0.879 (95% CI, 0.811–0.947) in the training cohort and 0.820 (95% CI, 0.668–0.971) in the validation cohort. The Delong test verified that the combined nomogram showed better performance in estimating PFS than the clinical model and Rad-score in the training cohort (p = 0.038, p = 0.043).ConclusionThe radiomics nomogram performed well in individualized PFS estimation for the patients with LACC, which might guide individual treatment decisions.


2021 ◽  
Author(s):  
Xiang Zhang ◽  
Yingchang Wang ◽  
xiaojuan Lv ◽  
Fangfang Wang ◽  
Qiong Zhou ◽  
...  

Abstract BackgroundTo evaluate the clinical benefit of concurrent chemoradiotherapy in combination with H101 injection for the treatment of locally advanced cervical cancer (LACC) patients.MethodsThe patients, all diagnosed with stage IIB or III cervical cancer according to The International Federation of Gynecology and Obstetrics (FIGO) stage (2009) with tumor length ≥6cm were enrolled at Zhejiang Cancer Hospital from July 2015 to April 2017. All patients received concurrent chemoradiotherapy (CCRT) in combination with intratumoral H101 injection before and during external beam radiotherapy (EBRT). The parameters recorded and analyzed included progression-free survival (PFS), overall survival (OS), tumor regression after EBRT and side effects, which were compared to another group of patients with similar characteristics treated with CCRT alone.ResultsTwenty patients were treated with CCRT in combination with intratumoral H101 injection and another group of 20 patients treated with CCRT alone was selected as control. The median follow-up time was 38 months (range 10-58 months). The 3-year local, regional, and overall PFS rates were 95% vs 66.6%(p = 0.02), 95% vs 62.5%(p = 0.029), and 65% vs 43.8%(p = 0.19), for H101 group and control group respectively. The 3-year (OS) was 74.3% vs 54.5%(p = 0.098), respectively. The median reduction of tumor length and volume for H101 group and control group were 37.7% vs 28.7%(p = 0.016) and 75.1% vs 62.4%(p = 0.001), respectively. The major adverse event related to H101 was fever.ConclusionCCRT in combination with intratumoral H101 injection is effective in treating LACC, and has an acceptable safety profile.Trial registrationThe study was registered at Chinese Clinical Trail Registry (ChiCTR-OPC-15006142).


2015 ◽  
Vol 33 (19) ◽  
pp. 2136-2142 ◽  
Author(s):  
Peter G. Rose ◽  
James Java ◽  
Charles W. Whitney ◽  
Frederick B. Stehman ◽  
Rachelle Lanciano ◽  
...  

Purpose To evaluate the prognostic factors in locally advanced cervical cancer limited to the pelvis and develop nomograms for 2-year progression-free survival (PFS), 5-year overall survival (OS), and pelvic recurrence. Patients and Methods We retrospectively reviewed 2,042 patients with locally advanced cervical carcinoma enrolled onto Gynecologic Oncology Group clinical trials of concurrent cisplatin-based chemotherapy and radiotherapy. Nomograms for 2-year PFS, five-year OS, and pelvic recurrence were created as visualizations of Cox proportional hazards regression models. The models were validated by bootstrap-corrected, relatively unbiased estimates of discrimination and calibration. Results Multivariable analysis identified prognostic factors including histology, race/ethnicity, performance status, tumor size, International Federation of Gynecology and Obstetrics stage, tumor grade, pelvic node status, and treatment with concurrent cisplatin-based chemotherapy. PFS, OS, and pelvic recurrence nomograms had bootstrap-corrected concordance indices of 0.62, 0.64, and 0.73, respectively, and were well calibrated. Conclusion Prognostic factors were used to develop nomograms for 2-year PFS, 5-year OS, and pelvic recurrence for locally advanced cervical cancer clinically limited to the pelvis treated with concurrent cisplatin-based chemotherapy and radiotherapy. These nomograms can be used to better estimate individual and collective outcomes.


2020 ◽  
Author(s):  
Agnieszka Lewandowska ◽  
Lukasz Wicherek ◽  
Krzysztof Koper ◽  
Sebastian Szubert ◽  
Joanna Terlikiewicz ◽  
...  

Abstract AimStandard treatment for locally advanced cervical cancer patients (LACC) consists of chemoradiation followed by vaginal brachytherapy. However, many patients with LACC surgery undergo surgical treatment with hysterectomy during comprehensive cancer treatment. The aim of the present study has been to analyze the survival data of those who underwent hysterectomy due to vaginal bleeding or hemorrhage prior to definitive chemoradiation. Materials and methodsThe study group included 35 patients with stage IIB (according to the FIGO classification) cervical cancer who received chemoradiation following salvage hysterectomy performed because of severe bleeding. The control group consisted of 44patients with stage IIB cervical cancer treated with primary chemoradiation without completion hysterectomy. ResultsThe median period for patient follow-up was 100 months. We did not observe inferior survival rates among the patients treated with salvage hysterectomy prior to chemoradiation compared to those treated with chemoradiation alone (P=0.77). The 5-year survival rate for patients treated with initial surgery was 62% compared to 61% for those treated with primary chemoradiation. Six (17%) patients from the group treated with hysterectomy experienced severe adverse events. ConclusionWhen hysterectomy due to vaginal bleeding or hemorrhage in patients with locally advanced cervical cancer is performed prior to chemoradiation, it may have curative significance and provide some overall survival benefit.


Author(s):  
Heming Lu ◽  
Yuying Wu ◽  
Xu Liu ◽  
Huixian Huang ◽  
Hailan Jiang ◽  
...  

This phase II randomized clinical trial aimed to assess the efficacy and toxicity of Endostar, an anti-angiogenesis inhibitor, combined with concurrent chemoradiotherapy (CCRT) for locally advanced cervical cancer (LACC). Patients with LACC were randomly assigned to either CCRT plus Endostar(CCRT+E arm) or CCRT alone (CCRT arm). All patients received pelvic intensity-modulated radiation therapy (IMRT)and brachytherapy. Weekly cisplatin was administered concurrently with IMRT. Patients in the CCRT+E arm also received concurrent Endostar every 3 weeks for 2 cycles. The primary endpoint was progression-free survival (PFS) and acute toxicities. The exploratory endpoint was the impact of vascular endothelial growth factor receptor-2 (VEGFR2) expression on long-term survival. A total of 116patientswere enrolled. Patients in the CCRT+E arm and in the CCRT arm had similar acute and late toxicity profile. The 1-and 2-year PFS were 91.4% vs. 82.1% and 80.8% vs. 63.5%(p=0.091), respectively. The1-and 2-year distance metastasis-free survival (DMFS)were92.7% vs. 81.1% and 86.0% vs. 65.1%(p=0.031), respectively. Patients with positive VEGFR2 expression had significant longer PFS and overall survival (OS), compared with those with negative VEGFR2 expression. Patients in the CCRT+E arm had significantly longer PFS, OS, and DMFS than those in the CCRT arm whenVEGFR2 expression was positive. In conclusion, CCRT plus Endostar significantly improved DMFS but not PFS over CCRT alone. The addition of Endostar could significantly improve survival for patients with positive VEGFR2 expression.


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