A single-arm study evaluating bevacizumab, cisplatin, and paclitaxel followed by single-agent bevacizumab in Japanese patients with advanced cervical cancer

Sugiyama, Toru; Mizuno, Mika; Aoki, Yoichi; Sakurai, Minoru; Nishikawa, Tadaaki; Ueda, Eisuke; Tajima, Kosei; Takeshima, Nobuhiro

doi:10.1093/jjco/hyw143

Cited by 22 publications

(22 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Cervical cancer is driven by HPV infection resulting in a more homogeneous tumor characterized by viral oncogene-driven angiogenesis. 11 Although clearly conjecture, it is possible that VEGF inhibition may result in an OS benefit in cervical cancer and not in ovarian cancer because bevacizumab is more effective (i.e., works better) in cervical cancer. In point of fact, Gourley and colleagues from the UK have recently identified an immune subgroup in ovarian cancer that does not respond to bevacizumab and at least two proangiogenic subgroups for which a trend towards PFS is evident with bevacizumab therapy.…”

Section: Discussionmentioning

confidence: 99%

“…This was followed by the United States Food and Drug Administration approval on 14 August 2014 and listing of both bevacizumab-containing triplet regimens studied in GOG 240 as Category 1 in the National Comprehensive Cancer Network (NCCN) Cervical Cancer Treatment Guidelines. 9–11 Following public disclosure of the final analysis, a label for bevacizumab in cervical cancer based on GOG 240 was granted by health authorities in at least 60 countries on six continents. 10,11 …”

Section: Introductionmentioning

confidence: 99%

“…9–11 Following public disclosure of the final analysis, a label for bevacizumab in cervical cancer based on GOG 240 was granted by health authorities in at least 60 countries on six continents. 10,11 …”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)

et al. 2017

View full text Add to dashboard Cite

Background On August 14, 2014, the United States Food and Drug Administration approved the anti-angiogenesis drug, bevacizumab, for women with advanced cervical cancer based on a 2012 interim analysis of 271 deaths on GOG protocol 240. We now report the planned protocol-specified final analysis of the primary objective, overall survival (OS). Methods A phase III randomized trial using a 2×2 factorial design was conducted to determine whether intravenous chemotherapy [(cisplatin 50 mg/m2 plus paclitaxel 135 or 175 mg/m2) or (topotecan 0.75 mg/m2 days 1–3 plus paclitaxel 175 mg/m2)] with or without bevacizumab (15 mg/kg) improves OS in recurrent/persistent/metastatic cervical cancer. Patients were prospectively stratified by performance status, prior radiosensitizing platinum, and disease status. We estimated enrolling 450 patients with 346 deaths at final analysis to provide 90% power to detect a 30% reduction in risk of death. Findings On March 7, 2014, 348 deaths occurred among 452 patients. Regimens administering bevacizumab continued to demonstrate significant improvement in OS: 16.8 vs 13.3 mos (HR 0.77;95% CI 0.62–0.95;p=0.0068). Updated progression-free survival also favored bevacizumab (HR 0.68;95% CI 0.56–0.84;p=0.0002). Final OS among 20% (n=91) not treated with prior pelvic radiotherapy was 24.5 (bevacizumab) vs 16.8 mos (without bevacizumab). Fistula (any grade) occurred in 14.5% (n=32) receiving bevacizumab (all previously irradiated). Grade 3+ fistula developed in 5.9% (n=13) and did not result in surgical emergency, sepsis and/or death. Post-progression OS was not significantly different among those who did and did not receive bevacizumab (median 8.4 vs 7.1 mos: HR 0.32;95% CI 0.66–1.05;p=0.06). Interpretation The benefit conferred by incorporation of bevacizumab is sustained with extended follow-up as evidenced by the survival curves remaining separated. Following progression on bevacizumab, a negative rebound effect was not observed. This represents proof-of-concept of the efficacy and tolerability of anti-angiogenesis therapy in advanced cervical cancer. Funding National Cancer Institute (USA).

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)

et al. 2017

View full text Add to dashboard Cite

show abstract

“…In the phase II J029569 study, the activity and tolerability of cisplatin-paclitaxel-bevacizumab was verified in Japanese women. 55 Dose-dense paclitaxel, carboplatin, and bevacizumab are being studied in the ongoing JCOG1311 randomized trial (ClinicalTrials.gov identifier: NCT000019191). Preliminary toxicity results using carboplatin-paclitaxelbevacizumab in the Latin American phase II trial, global safety study of bevacizumab, carboplatin and paclitaxel therapy for metastatic, recurrent or persistent cervical cancer (CECILIA; ClinicalTrials.gov 024679070), have demonstrated a 10% fistula rate.…”

Section: Management Of Figo Ivb and Recurrent Diseasementioning

confidence: 99%

Evidence-Based Treatment Paradigms for Management of Invasive Cervical Carcinoma

Tewari

Monk

2019

JCO

View full text Add to dashboard Cite

“…TP is a commonly used drug in chemotherapy for patients with NSCLC, and its antitumor efficacy has been demonstrated [ 12 – 16 ]. However, TP chemotherapy is often accompanied by the occurrence of adverse events, and how to improve clinical efficacy and reduce adverse reactions has attracted much attention [ 17 , 18 ].…”

Section: Introductionmentioning

confidence: 99%

Comparative Efficacy of Chinese Herbal Injections Combined with Paclitaxel Plus Cisplatin for Non‐Small‐Cell Lung Cancer: A Multidimensional Bayesian Network Meta‐Analysis

Wang

et al. 2020

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

Introduction. Considering the limitations of pure paclitaxel plus cisplatin chemotherapy in the treatment of non-small-cell lung cancer and the extensive exploration of Chinese herbal injections, this study performed a multidimensional network meta-analysis to systematically evaluate the clinical efficacy and safety of 12 Chinese herbal injections in the treatment of non-small-cell lung cancer. Methods. Randomized controlled trials were obtained from several databases according to the eligibility criteria, and the study quality was assessed by the Cochrane risk of bias tool. Data analysis was performed by Stata 13.1 software and WinBUGS 14.0 software. Multidimensional cluster analysis was performed with the “scatterplot3d” package in R 3.6.1 software (PROSPERO ID: CRD42020163503). Results. A total of 58 eligible randomized controlled trials involving 4578 patients and 12 Chinese herbal injections were included. Combined with paclitaxel plus cisplatin chemotherapy, Xiaoaiping injection exhibited a better impact on the clinical effective rate than paclitaxel plus cisplatin alone. Shenqifuzheng injection was associated with a preferable response in performance status and reduced leukopenia and gastrointestinal reactions. Kangai injection was dominant in the comprehensive results of the cluster analysis. Conclusions. Chinese herbal injections combined with paclitaxel plus cisplatin chemotherapy have a certain adjuvant effect in treating non-small-cell lung cancer, but the results of this study need to be verified by more well-designed, large-sample, multicenter randomized controlled trials.

show abstract

A single-arm study evaluating bevacizumab, cisplatin, and paclitaxel followed by single-agent bevacizumab in Japanese patients with advanced cervical cancer

Abstract: According to the specified primary objective, a regimen of cisplatin, paclitaxel and bevacizumab was tolerable in Japanese patients and demonstrated encouraging activity in this small single-arm study.

Cited by 22 publications

References 14 publications

Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)

Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240)

Evidence-Based Treatment Paradigms for Management of Invasive Cervical Carcinoma

Comparative Efficacy of Chinese Herbal Injections Combined with Paclitaxel Plus Cisplatin for Non‐Small‐Cell Lung Cancer: A Multidimensional Bayesian Network Meta‐Analysis

Contact Info

Product

Resources

About