scholarly journals Intratumoral Injection of H101 in Combination With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

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).

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.


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.


2019 ◽  
Vol 37 (33) ◽  
pp. 3124-3131 ◽  
Author(s):  
Samantha Cabral S. da Costa ◽  
Renata Colombo Bonadio ◽  
Flavia Carolina G. Gabrielli ◽  
Andrea S. Aranha ◽  
Maria Luiza N. Dias Genta ◽  
...  

PURPOSE Although chemoradiation therapy (CRT) with cisplatin remains the standard treatment of patients with locally advanced cervical cancer (LACC), 40% of patients present with disease recurrence. Additional treatment strategies are required to improve outcomes. We conducted a trial to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with cisplatin and gemcitabine followed by CRT. METHODS In this phase II trial, patients with LACC (International Federation of Gynecology and Obstetrics stage IIB to IVA or with positive lymph nodes) were randomly assigned to three cycles of NAC with cisplatin and gemcitabine followed by standard CRT with weekly cisplatin plus pelvic radiotherapy or to standard CRT alone. The primary end point was 3-year progression-free survival (PFS). Secondary end points were response rate, 3-year locoregional control, 3-year overall survival (OS), safety, and quality of life. RESULTS From 107 patients enrolled in the trial, 55 were randomly assigned to the NAC arm and 52 to the CRT-alone arm. The majority of patients had squamous cell carcinoma (87.8%). After a median follow-up of 31.7 months, NAC was associated with an inferior PFS, with 3-year PFS rates of 40.9% v 60.4% in the CRT arm (hazard ratio, 1.84; 95% CI, 1.04 to 3.26; P = .033). NAC also was associated with a lower OS (3-year OS rate, 60.7% v 86.8%; hazard ratio, 2.79; 95% CI, 1.29 to 6.01; P = .006). After treatment completion, complete response rates were 56.3% in the NAC arm and 80.3% in the CRT arm ( P = .008). Toxicities were similar in both arms, with the exception of hypomagnesemia and neuropathy being more common with NAC. CONCLUSION This study shows that the addition of NAC consisting of cisplatin and gemcitabine to standard CRT is not superior and is possibly inferior to CRT alone for the treatment of LACC.


2018 ◽  
Vol 28 (8) ◽  
pp. 1560-1568 ◽  
Author(s):  
Arya Amini ◽  
Tyler P. Robin ◽  
Priscilla K. Stumpf ◽  
Chad Rusthoven ◽  
Tracey E. Schefter ◽  
...  

ObjectiveIn this study, we analyzed patterns of care for patients with locally advanced cervical cancer to identify predictors for upfront surgery compared with definitive chemoradiation (CRT).MethodsThe National Cancer Database was queried for patients aged 18 years or older with Federation of Gynecology and Obstetrics IB2–IIB cervical cancer. All patients underwent either upfront hysterectomy with or without postoperative radiation therapy versus definitive CRT. Logistic regression was used to assess variables associated with modality of treatment (surgery vs CRT).ResultsOf the 9494 patients included, 2151 (22.7%) underwent upfront surgery. Of those undergoing surgery, 380 (17.7%) had positive margins, 478 (22.2%) had positive nodes, and 458 (21.3%) had pathologic involvement of the parametrium. Under multiple logistic regression, rates of surgery significantly increased from 2004 (12.2%) to 2012 (31.2%) (odds ratio [OR] per year increase, 1.15; confidence interval [CI], 1.12–1.17; P < 0.001). Upfront surgery was more commonly performed in urban (OR, 1.21; 95% CI, 1.03–1.41; P = 0.018) and rural counties (OR, 1.79; 95% CI, 1.24–2.58; P = 0.002), for adenocarcinoma (OR, 2.14; 1.88–2.44; P < 0.001) and adenosquamous (OR, 2.69; 2.11–3.43; P < 0.001) histologies, and in patients from higher median income communities (ORs, 1.19–1.37). Upfront surgery was less common at academic centers (OR, 0.73; 95% CI, 0.58–0.93; P = 0.011).ConclusionsRates of upfront surgery relative to definitive CRT have increased significantly over the past decade. In the setting of level 1 evidence supporting the use of definitive CRT alone for these women, the rising rates of upfront surgery raises concern for both unnecessary surgical procedures with higher rates of treatment-related morbidity and greater health care costs.


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