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Cisplatin-based chemotherapy with or without bevacizumab for Chinese postmenopausal women with advanced cervical cancer: a retrospective observational study.

ABSTRACT: BACKGROUND:The purpose of this study was to assess the efficacy and safety of cisplatin-based chemotherapy with or without bevacizumab (BEV) in Chinese women with advanced cervical cancer (ACC). METHODS:For this observational study, we analysed the data of 316 Chinese women with ACC who were treated at the Henan provincial people's hospital between Jan 1, 2014, and Dec 31, 2018, with cisplatin-based chemotherapy plus BEV (CB) or cisplatin-based chemotherapy alone (CA) until disease progression, unacceptable toxicity, or death. The co-primary endpoints were overall survival (OS) and progression-free survival (PFS); the secondary endpoint was the occurrence of adverse events (AEs). RESULTS:A total of 264 patients with ACC were included in the assessment (CB, n?=?130 and CA, n?=?134). At a median follow-up of 38?months (IQR 36-40), the median OS in the CB cohort was significantly longer than that in the CA cohort (hazard ratio [HR] 1.21, 95% confidence interval[CI] 1.14-1.73; p?=?0.002); additionally, the median PFS was 345?days (95% CI, 318-372) for CB and 261?days (95% CI, 165-357) for CA(HR 1.61, 95% CI 1.12-2.17; p?=?0.000). Significant differences were noted between groups in terms of thrombosis/embolism, neutropenia, and febrile neutropenia. CONCLUSIONS:In Chinese women with ACC, cisplatin-based chemotherapy plus BEV is associated with improved survival compared to cisplatin-based chemotherapy alone. This finding suggests a positive survival benefit of anti-angiogenesis therapy in this population.

SUBMITTER: He X

PROVIDER: S-EPMC7201988 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Cisplatin-based chemotherapy with or without bevacizumab for Chinese postmenopausal women with advanced cervical cancer: a retrospective observational study.

He Xiaoli X Liu Jun J Xiao Li L Zhao Mingdong M Su Tingting T Liu Tiejian T Han Guowei G Wang Yue Y

BMC cancer 20200505 1

<h4>Background</h4>The purpose of this study was to assess the efficacy and safety of cisplatin-based chemotherapy with or without bevacizumab (BEV) in Chinese women with advanced cervical cancer (ACC).<h4>Methods</h4>For this observational study, we analysed the data of 316 Chinese women with ACC who were treated at the Henan provincial people's hospital between Jan 1, 2014, and Dec 31, 2018, with cisplatin-based chemotherapy plus BEV (CB) or cisplatin-based chemotherapy alone (CA) until diseas ...[more]

PMID: 32370739

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Project description:BackgroundVascular endothelial growth factor (VEGF) promotes angiogenesis, a mediator of disease progression in cervical cancer. Bevacizumab, a humanized anti-VEGF monoclonal antibody, has single-agent activity in previously treated, recurrent disease. Most patients in whom recurrent cervical cancer develops have previously received cisplatin with radiation therapy, which reduces the effectiveness of cisplatin at the time of recurrence. We evaluated the effectiveness of bevacizumab and nonplatinum combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer.MethodsUsing a 2-by-2 factorial design, we randomly assigned 452 patients to chemotherapy with or without bevacizumab at a dose of 15 mg per kilogram of body weight. Chemotherapy consisted of cisplatin at a dose of 50 mg per square meter of body-surface area, plus paclitaxel at a dose of 135 or 175 mg per square meter or topotecan at a dose of 0.75 mg per square meter on days 1 to 3, plus paclitaxel at a dose of 175 mg per square meter on day 1. Cycles were repeated every 21 days until disease progression, the development of unacceptable toxic effects, or a complete response was documented. The primary end point was overall survival; a reduction of 30% in the hazard ratio for death was considered clinically important.ResultsGroups were well balanced with respect to age, histologic findings, performance status, previous use or nonuse of a radiosensitizing platinum agent, and disease status. Topotecan-paclitaxel was not superior to cisplatin-paclitaxel (hazard ratio for death, 1.20). With the data for the two chemotherapy regimens combined, the addition of bevacizumab to chemotherapy was associated with increased overall survival (17.0 months vs. 13.3 months; hazard ratio for death, 0.71; 98% confidence interval, 0.54 to 0.95; P=0.004 in a one-sided test) and higher response rates (48% vs. 36%, P=0.008). Bevacizumab, as compared with chemotherapy alone, was associated with an increased incidence of hypertension of grade 2 or higher (25% vs. 2%), thromboembolic events of grade 3 or higher (8% vs. 1%), and gastrointestinal fistulas of grade 3 or higher (3% vs. 0%).ConclusionsThe addition of bevacizumab to combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer was associated with an improvement of 3.7 months in median overall survival. (Funded by the National Cancer Institute; GOG 240 ClinicalTrials.gov number, NCT00803062.).

Project description:AbstractBevacizumab (BV) plus chemotherapy is broadly used in advanced ovarian cancer (OC). However, the efficacy of BV-based regimens for advanced OC patients is not satisfactory. Therefore, it is urgent to explore the predictive genetic biomarkers for BV.Tumor tissues from advanced OC patients receiving BV-based regimens were analyzed with a 150-gene targeted panel for next generation sequencing. The associations between gene alterations or clinicopathology features and progression-free survival (PFS) were analyzed by Kaplan-Meier curves or Cox regression. The association of the genetic alteration in potential predictive genes and expressions of 11 vascular endothelial growth factor-related genes were analyzed in The Cancer Genome Atlas cohort using 292 OC cases.Sixty two Chinese advanced OC patients treated with BV-based therapy were included. The median PFS of was 6.9 months, and objective response rate was 14.5%. In multivariate Cox regression analysis, the status of endothelial growth factor receptor (EGFR) (hazard ratio = 6.39, 95% confidence interval [CI] 2.25-18.13, P < .001) and human epidermal growth factor receptor 2 (HER2) (hazard ratio = 3.58, 95% CI 1.27-10.08, P = .016) were significantly correlated with PFS. MYC Proto-Oncogene amplification seemed to have a positive trend (hazard ratio = 0.21, 95% CI 0.05-1.02, P = .052). Moreover, EGFR and HER2 alterations were not prognostic factors of overall survival for OC in The Cancer Genome Atlas OC cohort. The vascular endothelial growth factor-related signature analysis indicated vascular endothelial factor A expression was upregulated with EGFR alterations (P = .034) which may be involved in BV resistance, and HER2 alterations were associated with hypoxia inducible factor 1 subunit alpha overexpression significantly (P = .029).EGFR or HER2 alterations are negative predictors of PFS for OC patient treated with BV plus chemotherapy. Therefore, the clinicians may consider to use alternative regimens such as anti-EGFR or anti-HER2 targeted therapy instead of BV-based regimens on these patients when standard care fail.

Dataset Information

Cisplatin-based chemotherapy with or without bevacizumab for Chinese postmenopausal women with advanced cervical cancer: a retrospective observational study.

Publications

Cisplatin-based chemotherapy with or without bevacizumab for Chinese postmenopausal women with advanced cervical cancer: a retrospective observational study.

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