Molecular profiles and immune checkpoint inhibitor-related biomarkers analysis in advanced cervical cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18003-e18003
Author(s):  
Qin Xu ◽  
Chuanben Chen ◽  
Yang Sun ◽  
Yibin Lin ◽  
Jing Liu ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Figo Stage ◽  
Advanced Cervical Cancer ◽  
Single Nucleotide Variants ◽  
Paired Samples ◽  
Target Capture ◽  
Pathological Subtype ◽  
Molecular Profiles

e18003 Background: Treatment options for advanced cervical cancer (ACC) are limited and patients experiencing recurrence after first-line chemotherapy and bevacizumab have a poor prognosis. Checkpoint inhibitors targeting the PD-1/PD-L1 are promising treatment option. However, related genomic biomarker study is rare reported in ACC. Methods: We prospectively enrolled 102 pts with ACC. Tumor and plasma samples were obtained to analysis genomic profiles. DNA was sequenced by target-capture deep sequencing with the pan-cancer panel. TMB of tissue (tTMB) and blood (bTMB) analysis interrogated single nucleotide variants, small insertion and deletion. PD-L1 expression was evaluated in tumor specimens by immunohistochemistry (IHC) using a combined-positive-score (CPS) cutoff of ≥1. Results: The median age of enrolled pts was 63 yrs, and most (84.3 %, 86/102 pts) weresquamous carcinoma. A total of 93 tissues and 96 plasma were collected from 102 pts. The most frequently mutated genes were PIK3CA (40.9%, 38/93 pts), KMT2D (35.5%, 33/93 pts), and KMT2C (28.0%, 26/93 pts) in tissues. 80% (77/96 pts) of plasma was detected positive, with PIK3CA (23.4%, 18/77 pts), KMT2D (20.8%, 16/77 pts), KMT2C (20.8%, 17/77 pts) mutant frequently. Among 87 pts with paired samples, at least a tumor-derived mutation was detected in 35 (40.2%)plasma. Median of tTMB was 11.9 mut/Mb, and 45% pts were TMB-H. Significant correlation was found between tTMB and bTMB (Pearson r = 0.39, P = 0.001). Higher tTMB was identified in KMT2D- or KMT2C-mut pts (P = 0.002 or P = 0.01, respectively). tTMB showed no relation with clinic characteristics, including pathological subtype, FIGO stage, and status of distant metastasis. PD-L1 expression (CPS≥1) was identified in 53 pts (93 %, 53/57) and mutually independent with TMB status. Conclusions: Molecular profiles and TMB in plama showed high consistence with that in tissue. Prospective clinical trial is ongoing to determine the genomic biomarkers and the PD-L1 expression as predictive factors for the ICI efficacy in ACC (ChiCTR1900023015).

scholarly journals Dual PD-1 and CTLA-4 Checkpoint Blockade Using Balstilimab and Zalifrelimab Combination as Second-Line Treatment for Advanced Cervical Cancer: An Open-Label Phase II Study

2021 ◽  
Author(s):  
David M. O'Malley ◽  
Maryna Neffa ◽  
Bradley J. Monk ◽  
Tamar Melkadze ◽  
Marilyn Huang ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Phase Ii ◽  
T Lymphocyte ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Clinical Activity ◽  
Advanced Cervical Cancer ◽  
Programmed Death Ligand 1 ◽  
Programmed Death ◽  
Duration Of Response

PURPOSE Balstilimab (antiprogrammed death-1) and zalifrelimab (anticytotoxic T-lymphocyte–associated antigen-4) are two new checkpoint inhibitors emerging as promising investigational agents for the treatment of advanced cervical cancer. This phase II trial (ClinicalTrials.gov identifier: NCT03495882 ) evaluated the combination of balstilimab plus zalifrelimab in patients with recurrent and/or metastatic cervical cancer who relapsed after prior platinum-based therapy. PATIENTS AND METHODS Patients were intravenously dosed with balstilimab 3 mg/kg once every 2 weeks and zalifrelimab 1 mg/kg once every 6 weeks, for up to 24 months. The primary end point was objective response rate (ORR, RECIST version 1.1, assessed by independent central review). Secondary end points included duration of response, safety and tolerability, and survival. RESULTS In total, 155 women (median age, 50 years [range 24-76 years]) were enrolled and treated with balstilimab plus zalifrelimab; 125 patients had measurable disease at baseline and one prior line of platinum-based therapy in the advanced setting, and these patients constituted the efficacy-evaluable population. The median follow-up was 21 months. The confirmed ORR was 25.6% (95% CI, 18.8 to 33.9), including 10 complete responders and 22 partial responders, with median duration of response not reached (86.5%, 75.5%, and 64.2% at 6, 9, and 12 months, respectively). The ORRs were 32.8% and 9.1% in patients with programmed death ligand-1–positive and programmed death ligand-1–negative tumors, respectively. For patients with squamous cell carcinoma, the ORR was 32.6%. The overall disease control rate was 52% (95% CI, 43.3 to 60.6). Hypothyroidism (14.2%) and hyperthyroidism (7.1%) were the most common immune-mediated adverse events. CONCLUSION Promising and durable clinical activity, with favorable tolerability, was seen in this largest trial to date evaluating dual programmed death-1/cytotoxic T-lymphocyte–associated antigen-4 blockade in patients with recurrent and/or metastatic cervical cancer. Further investigation of the balstilimab and zalifrelimab combination in this setting is continuing.

A new marker based on risk stratification of human papillomavirus DNA and tumor size to predict survival of locally advanced cervical cancer

2019 ◽  
Vol 29 (3) ◽  
pp. 459-465 ◽  
Author(s):  
Yecai Huang ◽  
Qiao He ◽  
Ke Xu ◽  
Jie Zhou ◽  
Jun Yin ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Risk Stratification ◽  
Tumor Size ◽  
Locally Advanced ◽  
Figo Stage ◽  
Advanced Cervical Cancer ◽  
Hpv Dna ◽  
Locally Advanced Cervical Cancer ◽  
Advanced Cervical Carcinoma

ObjectiveTo assess the prognostic value of human papillomavirus (HPV) viral load in locally advanced cervical carcinoma treated with radical concurrent chemoradiotherapy.MethodsFrom January 2012 to October 2013, a total of 246 locally advanced cervical carcinoma patients were included in this retrospective study. HPV DNA status was tested by Hybrid Capture 2 assay. Tumor size was measured on T2WI. All the patients in the study received concurrent cisplatin-based chemoradiotherapy with intensity-modulated radiotherapy and three-dimensional brachytherapy. Survival rate was calculated by the Kaplan-Meier method, and a log-rank test was used to compare the survival. Multivariate analysis employed the Cox regression model.ResultsThe median follow-up time was 52 months. The median value of HPV DNA was 163.13 relative light unit/cut-off (RLU/CO) (range 1.65–2162.62 RLU/CO). The 5-year overall survival, distant metastasis-free survival of patients in the low HPV DNA group (HPV DNA ≤ 163.13 RLU/CO) and the high HPV DNA group (HPV DNA > 163.13 RLU/CO) were 46.3 % vs 58.5 % (p = 0.009) and 65.9 % vs 75.6% (p = 0.003), respectively. Multivariate analysis showed that the HPV DNA, tumor size, and International Federation of Gynecology and Obstetrics (FIGO) stage were independent prognostic factors for overall survival and distant metastasis-free survival. We choose the tumor size and HPV DNA as the risk stratification factors to build a new prediction marker which can better predict overall survival for locally advanced cervical cancer than can the FIGO stage.ConclusionsHPV DNA may be a useful biomarker for locally advanced cervical cancer. Low HPV load predicts a worse survival. The new marker based on risk stratification by combining HPV DNA and tumor size is better associated with overall survival of locally advanced cervical cancer treated with concurrent chemoradiotherapy.

CALLA: Efficacy and safety of durvalumab with and following concurrent chemoradiotherapy (CCRT) versus CCRT alone in women with locally advanced cervical cancer: A phase III, randomized, double-blind, multicenter study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5597-TPS5597 ◽  
Author(s):  
Bradley J. Monk ◽  
Jyoti Mayadev ◽  
Ana T Nunes ◽  
Alicja Dabrowska Brown ◽  
Michelle Marcovitz ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Locally Advanced ◽  
Figo Stage ◽  
Stage Iii ◽  
Disease Stage ◽  
Advanced Cervical Cancer ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Locally Advanced Cervical Cancer ◽  
Eortc Qlq

TPS5597 Background: CCRT is the standard of care for locally advanced cervical cancer. CCRT with PD-1/PD-L1 pathway blockade may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance. This Phase 3, randomized, multicenter, international, double-blind, placebo-controlled study is designed to determine the efficacy and safety of durvalumab with and following CCRT vs. CCRT alone in women with locally advanced cervical cancer (NCT03830866). Methods: The study will enroll immunotherapy-naïve adult patients (pts) with histologically confirmed cervical adenocarcinoma or cervical squamous or adenosquamous carcinoma (FIGO Stages IB2-IIB with node [N] positive and IIIA-IVA with any N) and no prior definitive surgical, radiation, or systemic therapy for cervical cancer. Approximately 714 pts will be randomized 1:1 to receive either durvalumab (1500 mg intravenously [IV]) or placebo every 4 weeks for 96 weeks. All pts will receive CCRT to the pelvis or pelvis + para-aortic radiotherapy field (45 Gy), followed by image-guided brachytherapy with cisplatin (40 mg/m2) IV or carboplatin (AUC2) IV once weekly for 5 weeks (6th dose optional). Randomization will be stratified by disease stage (FIGO Stage < III and N positive, FIGO Stage ≥III and N negative, or FIGO Stage ≥III and N positive) and region (US, Canada, EU, South Korea, and Japan vs. rest of the world). The primary endpoint is progression-free survival (assessed by investigator per RECIST v1.1 or histopathologic confirmation of local tumor progression). Secondary endpoints are overall survival, objective response and complete response (CR) rates, duration of response in pts with CR, incidence of local or distant disease progression or secondary malignancy, disease-related symptoms, and health-related quality of life (EORTC QLQ-C30 and EORTC QLQ-CX24). Pharmacokinetics, immunogenicity, and safety of durvalumab will also be assessed. Pt enrollment is ongoing. Clinical trial information: NCT03830866.

scholarly journals Tomotherapy for Advanced Cervical Cancer: A Comparison of Dosimetric and Clinical Outcomes With Intensity Modulated Radiation Therapy

2020 ◽  
Author(s):  
Yueju Yin ◽  
Dandan Wang ◽  
Dapeng Li ◽  
Jian Zhu ◽  
Quancai Chen ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Femoral Head ◽  
Statistical Difference ◽  
Intensity Modulated Radiation Therapy ◽  
Figo Stage ◽  
Radiation Toxicity ◽  
Advanced Cervical Cancer ◽  
Lower Rectum ◽  
Radiation Cystitis ◽  
Grade 3

Abstract Purpose: The aim of this study was to investigate the therapeutic response (loco-regional control, disease-free, overall survival), toxicities (acute and long-term toxicities) and dosimetric parameters between intensity-modulated radiation therapy (IMRT) and tomotherapy (TOMO) in patients with advanced cervical cancer.Materials and Methods: This study included 310 patients with advanced cervical cancer and who received concurrent chemoradiation (CCRT) from August 2015 to March 2018. All patients were initially diagnosed with International Federation of Gynecology and Obstetrics (FIGO 2009) stage ⅡB–ⅢB cervical cancer. A total of 155 patients were treated with TOMO, whereas the remaining 155 patients underwent IMRT. Intracavitary brachytherapy and concurrent chemotherapy were performed during external irradiation.Results: A total of 310 patients were included in the present study. There was no statistical difference in age, FIGO stage, histologictype, tumor size, tumor grade, pathologic morphology type, between the 2 groups (P=0.924, 0.352,0.954, 0.36, 0.11, and 0.123, respectively). In comparing TOMO with IMRT, better dose conformity (0.82±0.033 vs. 0.75±0.064, P= 0.006) and dose homogeneity (1.03±0.006 vs. 1.09±0.076, p＜0.001) were observed by TOMO planning. TOMO provided better critical organ sparing than IMRT in the lower bladder V20 (p=0.001), femoral head V40 (p=0.014), and lower rectum V40 (p=0.035), V20 (p=0.005) were observed in the planning by TOMO compared to IMRT for patients with advanced cervical cancer. TOMO demonstrated a superior ability to protect the ovary (Dmax: 4.61Gy versus 5.81Gy, P=0.026; Dmean: 2.99Gy versus 3.97Gy, P=0.017). A few OARs and dosimetric parameters, including bladder V40 (p=0.113), and femoral head V20 (p=0.066), exhibited a tendency toward more favorable values in TOMO than IMRT. There were no statistically signifcant diferences in small bowel V20 (p=0.251), V40 (p=0.575) or bone marrow protection V20 (p=0.917), V40 (p=0.53) between the IMRT plan and the TOMO plan. But it gave significantly better values for Dmax parameters for bone marrow and small bowel with a statistically significant level (P= 0.004, and 0.002, respectively). Acute major toxic effects included cystitis, proctitis, leukopenia, dermatitis, and enteritis. Seventeen (11%) patients in the IMRT group and 5(3.22%) in the TOMO group experienced grade 3/4 acute proctitis. Grade 3/4 leukopenia occurred in 71 (45.81%) patients in the IMRT group and 60 (38.71%) patients in TOMO group. Eleven (7.1%) patients in the IMRT group experienced grade 3/4 late radiation cystitis. And grade 3/4 late radiation enterocolitis occurred in 10 (6.45%) patients in the IMRT group. The incidence of chronic radiation cystitis and enterocolitis in the TOMO group was 3.87% (6/155). The acute radiation toxicity of proctitis, and leukopenia was significantly lower in TOMO group than IMRT group (P=0.034, and 0.025, respectively). There was no statistical difference in the acute radiation toxicity of cystitis, enteritis, and dermatitis between the 2 groups (P= 0.084, 0.082 and 0.616, respectively). The chronic radiation toxicity of radiation enterocolitis and cystitis was lower in the IMRT group (P= 0.032 and 0.048, respectively). But there was no statistical difference for 1- and 3-year OS between the TOMO and IMRT groups (98.7% vs 98.5%, P= 0.149；91.3% vs 96.3%, P= 0.142). No obvious difference was found in 1- and3-year PFS rates between 2 groups (1-year: 91.4% vs 91.6%, P= 0.82; 3-year: 86.8% vs 88.3%, P= 0.751). Conclusions: This study has shown that TOMO and IMRT are comparable in dose conformity, dose homogeneity, and protection of the ovary. TOMO provided better critical organ sparing than IMRT in lower bladder, femoral head, ovary sparing and lower rectum were observed in the planning. The acute and chronic toxicities were acceptable. So TOMO is a good option for adjuvant treatment of FIGO stage ⅡB–ⅢB cervical cancer, especially to young patients. Further prospective randomized multicenter studies are needed to confirm the benefits of TOMO.

Anlotinib plus sintilimab in patients with recurrent advanced cervical cancer: A prospective, multicenter, single-arm, phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5524-5524
Author(s):  
Qin Xu ◽  
Chuanben Chen ◽  
Yang Sun ◽  
Zhangzhou Huang ◽  
Yibin Lin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Phase Ii ◽  
Kinase Inhibitor ◽  
Checkpoint Inhibitors ◽  
Antiangiogenic Therapy ◽  
Objective Response ◽  
Advanced Cervical Cancer ◽  
Median Response ◽  
Platinum Based Chemotherapy

5524 Background: It is difficult for patients with recurrent advanced cervical cancer to obtain clinical benefits after the failure of standard chemotherapy. However, antiangiogenic therapy combined with immune checkpoint inhibitors have become a promising strategy for advanced cervical cancer. Anlotinib is a novel multi-target tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. Sintilimab is a fully humanized, high-affinity monoclonal antibody against programmed cell death-1 (PD-1). This phase II, single-arm study (ChiCTR1900023015) aims to evaluate the efficacy and safety of anlotinib plus sintilimab in patients with recurrent advanced cervical cancer. Methods: Patients who have received at least once platinum-based chemotherapy, histopathologically confirmed recurrent advanced cervical cancer (including squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma), more than 1% PD-L1 expression, ECOG 0-1 were considered eligible for enrollment. Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle), and sintilimab was administered intravenously (200mg once every 3 weeks). The treatment was continued until disease progression, death or intolerant toxicity. The primary endpoint was objective response rate (ORR) and the secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety. Results: Between September 2019 and February 2021, 42 patients with a median age of 52 years (range:47-58), FIGO histopathological stage I (11.9%), II (31.0%), III (33.3%), IV (9.5%) and undiagnosed (14.3%) were enrolled. 39 of these patients were evaluable. In the efficacy-evaluable population (n = 39), the therapeutic evaluation showed that 2 and 20 patients achieved complete response and partial response respectively, yielding the ORR of 56.4% (22/39, 95% CI:40.2 to 71.5). The DCR was 94.9% (37/39, 95% CI:80.7 to 98.8). The median response time was 1.6 months. The median PFS was not reached. The most common adverse events (AEs) were grade 1 or 2, which included hypothyroidism (33.3%), hypertension (23.8%), AST (21.4%), diarrhea (19.0%), ALT (16.7%), hand-foot syndrome(14.3%), hypertriglyceridemia (14.3%) and anemia (11.9%). The grade 3 AEs were hypertension (4.8%), hyponatremia (4.8%), immune pneumonia (2.4%) and immune myocarditis (2.4%). No higher AEs and treatment-related death were observed. Conclusions: Anlotinib plus sintilimab showed a promising efficacy with a favorable toxicity profile for patients with recurrent advanced cervical cancer. We will report more data in the future. Clinical trial information: ChiCTR1900023015.

Prognostic value of tumor parameters measured by MRI in cervical cancer patients receiving CCRT.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17027-e17027
Author(s):  
Chang Sun ◽  
Shun Lu ◽  
Ran Lin Wang ◽  
Hanyi Zhang ◽  
Mingyu Tan ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Multivariate Analysis ◽  
Tumor Volume ◽  
Locally Advanced ◽  
Reduction Rate ◽  
Figo Stage ◽  
Advanced Cervical Cancer ◽  
Locally Advanced Cervical Cancer ◽  
Tumor Volume Reduction

e17027 Background: This study aimed to evaluate the response of solid tumors after the completion of external beam radiotherapy (EBRT) and investigate the prognostic value of tumor parameters such as tumor volume and size (TV & TS) and tumor volume reduction rate (TVRR) early during the treatment in local advanced cervical cancer patients. Methods: We retrospectively reviewed 310 Chinese patients with locally advanced cervical cancer. They were all received concurrent chemoradiotherapy (CCRT) during the treatment based on intensity modulated radiotherapy (IMRT). Clinical data at the time of diagnosis, including FIGO stage, TV and TS were measured by pelvic magnetic resonance imaging (MRI) before and after EBRT were available. Information about distant metastasis, relapse and date of death was also collected, with a follow-up until Aug 2018. Youden index was used to identify the optimal cut-off point of continuous tumor parameters and divide patients into subgroups. Prognostic factors (age, FIGO stage, RT dose, pre-RT TS and TV, mid-RT TS and TV, TVRR) were using the log-rank test and Cox regression models to analyze the association between predictors and time-to-event outcomes. Results: The median follow-up time was 50 months. In univariate analysis, the FIGO stage, TVRR, TV and TS were associated with overall survival rate. Interestingly, the group of higher TVRR showed a better OS, PFS and LRFS than the group of lower TVRR ( P <0.05). Moreover, the groups of lower TV and TS showed better OS, PFS and LRFS than the higher groups, respectively. In the OS-related multivariate analysis, the mid-RT TV remained statistically significant after adjustment for age and FIGO stage ( P < 0.05). In the PFS-related multivariate analysis, the tumor volume reduction rate (TVRR) remained statistically significant after adjustment for age, FIGO stage, TS, and TV ( P <0.05). In addition, in the LRFS-related multivariate analysis, TVRR also remained statistically significant after adjustment for age, FIGO stage, TS, and TV ( P <0.05). Conclusions: Our results confirmed that tumor parameters including TS, TV and TVRR, measured before the completion of CCRT, are valuable prognostic factors in patients with locally advanced cervical cancer.

scholarly journals Pembrolizumab in cervical cancer: latest evidence and clinical usefulness

2017 ◽  
Vol 9 (6) ◽  
pp. 431-439 ◽  
Author(s):  
Edith Borcoman ◽  
Christophe Le Tourneau
Keyword(s):  
Cervical Cancer ◽  
Checkpoint Inhibitors ◽  
Early Stage ◽  
Precancerous Lesions ◽  
Treatment Options ◽  
Hpv Vaccination ◽  
Developed Countries ◽  
Clinical Usefulness ◽  
Early Stage Cervical Cancer ◽  
Tumor Types

Cervical cancer is the fourth most common cause of cancer-related deaths in women worldwide. With the development of detection of precancerous lesions and preventive human papillomavirus (HPV) vaccination program, a survival improvement has been observed in these patients in developed countries, although disparities in accessibility to treatments exist across countries. While early-stage cervical cancer can be curable with surgery, prognosis of patients who recur remains poor, with limited treatment options. In this latter setting, recently, bevacizumab, an antiangiogenic monoclonal antibody targeting vascular endothelial growth factor (VEGF), has been shown to improve overall survival in combination with chemotherapy as compared with chemotherapy alone. No standard treatments exist beyond this treatment regimen. New effective treatments are therefore much needed in this setting. Immunotherapy has represented a breakthrough in recent years in oncology, with antitumor activity reported with immune-checkpoint inhibitors in a variety of tumor types. We discuss here the latest evidence and clinical usefulness of pembrolizumab, anti-PD-1 checkpoint inhibitor, in the treatment of advanced cervical cancer.

scholarly journals Screening history and FIGO-stages among Danish women with cervical cancer in 2012–2014: a register-based study

2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Abir Khalil Bchtawi ◽  
Sinem Saritas ◽  
Doris Schledermann ◽  
René dePont Christensen ◽  
Kirsten Marie Jochumsen
Keyword(s):  
Cervical Cancer ◽  
Screening Programme ◽  
Treatment Options ◽  
Cervical Screening ◽  
Participation Rate ◽  
Figo Stage ◽  
Risk Of Death ◽  
Study Population ◽  
Node Metastases ◽  
Screening History

AbstractThe objective was to examine whether attendance in the mass cervical screening programme has implications for the prognosis when cervical cancer is diagnosed. We performed a retrospective analysis of all cases of cervical cancer between 1st of January 2012 and 31st of December 2014 in the Region of Southern Denmark. The cases were retrieved from the Danish National Pathology Registry, PatoBank. Odds ratios (OR) with confidence intervals (95% CI) were calculated for attendees versus non-attendees of the screening programme by using χ2-test. 216 patients were included in the study. 61.6% of the study population had not attended the screening programme. Patients who had attended the programme were characterised by disease in low stage (OR = 3.14, 95% CI; 1.66 to 5.92), treatment with surgery alone (OR = 2.63, 95% CI; 1.49 to 4.64) and a lower risk of death (OR = 0.36, 95% CI; 0.15 to 0.87). Adenocarcinomas were more often detected among attendees of the programme compared to squamous cell carcinomas (OR = 4.06, 95% CI; 2.03 to 8.14). Statistically significant results regarding relapse of cancer (OR = 0.62, 95% CI; 0.23 to 1.68, p = 0.47) and lymph node metastases (OR = 0.62, 95% CI; 0.32 to 1.21, p = 0.19) were not found. Cervical cancer detected in women who had attended the mass cervical screening programme prior to the diagnosis, was shown to have a statistically significant lower FIGO stage (p = 0.0004) and was therefore linked to less extensive treatment options. Continued focus on increasing the participation rate of the programme is of importance, as the nonattendance rate continues to be high.

scholarly journals Phase II study of atezolizumab in combination with bevacizumab in patients with advanced cervical cancer

2020 ◽  
Vol 8 (2) ◽  
pp. e001126
Author(s):  
Claire F Friedman ◽  
Alexandra Snyder Charen ◽  
Qin Zhou ◽  
Michael A Carducci ◽  
Alexandre Buckley De Meritens ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Phase Ii ◽  
Response Rate ◽  
Treatment Options ◽  
Objective Response ◽  
Primary Objective ◽  
Advanced Cervical Cancer ◽  
Open Label ◽  
Recurrent Cervical Cancer ◽  
Platinum Based Chemotherapy

BackgroundThere are limited treatment options for patients with metastatic or recurrent cervical cancer. Platinum-based chemotherapy plus the anti-vascular endothelial growth factor antibody bevacizumab remains the mainstay of advanced treatment. Pembrolizumab is Food and Drug Agency approved for programmed death ligand 1 (PD-L1) positive cervical cancer with a modest response rate. This is the first study to report the efficacy and safety of the PD-L1 antibody atezolizumab in combination with bevacizumab in advanced cervical cancer.MethodsWe report the results from a phase II, open-label, multicenter study (NCT02921269). Patients with advanced cervical cancer were treated with bevacizumab 15 mg/kg intravenous every 3 weeks and atezolizumab 1200 mg intravenous every 3 weeks. The primary objective was to measure the objective response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety.ResultsIn the total evaluable population (n=10), zero patients achieved an objective response as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) V.1.1, resulting in a confirmed ORR of 0%. Of note, there were two patients who achieved an unconfirmed PR. The DCR by RECIST V.1.1 was 60% (0% complete response, 0% partial response, 60% stable disease). Median PFS was 2.9 months (95% CI, 1.8 to 6) and median OS was 8.9 months (95% CI, 3.4 to 21.9). Safety results were generally consistent with the known safety profile of both drugs, notably with two high-grade neurologic events.ConclusionsThe combination of bevacizumab and atezolizumab did not meet the predefined efficacy endpoint, as addition of bevacizumab to PD-L1 blockade did not appear to enhance the ORR in cervical cancer.

MRI-based radiomics: promise for locally advanced cervical cancer treated with a tailored integrated therapeutic approach

2021 ◽  
pp. 030089162110142
Author(s):  
Concetta Laliscia ◽  
Angiolo Gadducci ◽  
Roberto Mattioni ◽  
Francesca Orlandi ◽  
Sabina Giusti ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Multivariate Analysis ◽  
Univariate Analysis ◽  
Locally Advanced ◽  
Figo Stage ◽  
High Dose ◽  
Advanced Cervical Cancer ◽  
Primary Tumor Site ◽  
Locally Advanced Cervical Cancer ◽  
Sequential Boost

Objective: To assess prognostic factors by analyzing clinical and radiomic data of patients with locally advanced cervical cancer (LACC) treated with definitive concurrent cisplatin-based chemoradiotherapy (CCRT) using magnetic resonance imaging (MRI). Methods: We analyzed radiomic features from MRI in 60 women with FIGO (International Federation of Gynecology and Obstetrics) stage IB2–IVA cervical cancer who underwent definitive CCRT 45–50.4 Gy (in 25–28 fractions). Thirty-nine (65.0%) received EBRT sequential boost (4–20 Gy) on primary tumor site and 56 (93.3%) received high-dose-rate brachytherapy boost (6–28 Gy) (daily fractions of 5–7 Gy). Moreover, 71.7% of patients received dose-dense neoadjuvant chemotherapy for 6 cycles. The gross tumor volume was defined on T2-weighted sequences and 29 features were extracted from each MRI performed before and after CCRT, using dedicated software, and their prognostic value was correlated with clinical information. Results: In univariate analysis, age ⩾60 years and FIGO stage IB2–IIB had significantly better progression-free survival (PFS) ( p = 0.022 and p = 0.009, respectively). There was a trend for significance for worse overall survival (OS) in patients with positive nodes ( p = 0.062). In multivariate analysis, only age ⩾60 years and FIGO stage IB2–IIB reached significantly better PFS ( p = 0.020 and p = 0.053, respectively). In radiomic dataset, in multivariate analysis, pregray level p75 was significantly associated with PFS ( p = 0.047), pre-D3D value with OS ( p = 0.049), and preinformation measure of correlation value with local control ( p = 0.031). Conclusion: The combination of clinical and radiomics features can provide information to predict behavior and prognosis of LACC and to make more accurate treatment decisions.

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