Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013
Phase II study of gemcitabine, carboplatin, and bevacizumab in patients with advanced unresectable or metastatic urothelial cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed.
- Randomized Phase III Trial of Gemcitabine and Cisplatin With Bevacizumab or Placebo in Patients With Advanced Urothelial Carcinoma: Results of CALGB 90601 (Alliance).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Trial
- Cabozantinib in patients with platinum-refractory metastatic urothelial carcinoma: an open-label, single-centre, phase 2 trial.The Lancet. Oncology · 2020Trial
- Trial
- A Phase II Trial of Dovitinib in BCG-Unresponsive Urothelial Carcinoma withClinical cancer research : an official journal of the American Association for Cancer Research · 2017Trial
- A Phase II Clinical Trial of TRC105 (Anti-Endoglin Antibody) in Adults With Advanced/Metastatic Urothelial Carcinoma.Clinical genitourinary cancer · 2017Trial
- Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: results of an international randomized phase II trial (JASINT1).Annals of oncology : official journal of the European Society for Medical Oncology · 2016Trial
- PF-03446962, a fully-human monoclonal antibody against transforming growth-factor β (TGFβ) receptor ALK1, in pre-treated patients with urothelial cancer: an open label, single-group, phase 2 trial.Investigational new drugs · 2014Trial
- Analysis of plasma cytokines and angiogenic factors in patients with pretreated urothelial cancer receiving Pazopanib: the role of circulating interleukin-8 to enhance the prognostic accuracy.British journal of cancer · 2014Trial
- A Novel Entity of Renal Toxicity After Combination Chemotherapy: An Onco-Nephrology Kidney Biopsy Teaching Case.Kidney medicine · 2026Article
- Article
- Revisiting Treatment of Metastatic Urothelial Cancer: Where Do Cisplatin and Platinum Ineligibility Criteria Stand?Biomedicines · 2024Review
- Targeted therapies and molecular targets in the therapeutic landscape of advanced urothelial carcinoma: state of the art and future perspectives.Exploration of targeted anti-tumor therapy · 2024Review
- Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy: A Systematic Review and Meta-Analysis.Diagnostics (Basel, Switzerland) · 2022Article
- Carboplatin-based adjuvant chemotherapy versus observation after radical cystectomy in patients with pN1-3 urothelial bladder cancer.World journal of urology · 2022Article
- VEGF inhibition in urothelial cancer: the past, present and future.World journal of urology · 2021Review
- Novel Tyrosine Kinase Targets in Urothelial Carcinoma.International journal of molecular sciences · 2021Review
- Future Strategies Involving Immune Checkpoint Inhibitors in Advanced Urothelial Carcinoma.Current treatment options in oncology · 2020Review
- Pharmacological cancer treatment and venous thromboembolism risk.European heart journal supplements : journal of the European Society of Cardiology · 2020Article
- Targeted Inhibition of P4HB Promotes Cell Sensitivity to Gemcitabine in Urothelial Carcinoma of the Bladder.OncoTargets and therapy · 2020Article
- Transient Asymptomatic Sinus Bradycardia and Sinus Pauses with Bevacizumab: Case Report and Literature Review.Cureus · 2019Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
purposeAlthough gemcitabine and carboplatin (GCa) is a standard option for patients with advanced urothelial cancer (UC) who are ineligible for cisplatin, outcomes remain poor. This trial evaluated the efficacy and safety of bevacizumab with GCa in advanced UC. PATIENTS AND
methodsPatients with Karnofsky performance status of 60% to 70%, creatinine clearance less than 60 mL/min, visceral metastasis, or solitary kidney were eligible and received a lead-in dose of bevacizumab 10 mg/kg followed 2 weeks later by gemcitabine 1,000 mg/m(2) on days 1 and 8 and carboplatin at area under the [concentration-time] curve (AUC) 5.0 or 4.5 and bevacizumab 15 mg/kg on day 1 every 21 days for six cycles. Patients achieving at least stable disease (SD) continued bevacizumab 15 mg/kg every 21 days for 18 additional cycles. The study was powered to detect a 50% improvement in median progression-free survival (PFS) over a historical control.
resultsFifty-one patients, median age 67 years (range, 42 to 83 years), were enrolled onto the study and were evaluable for toxicity. Twenty (39%) experienced grade 3 to 4 toxicity, and 10 (20%) had thromboembolic events (deep venous thrombosis or pulmonary embolism). Four received one or fewer cycles leaving 47 evaluable for outcomes. Twenty-three (49%) achieved response (three complete; 20 partial), and 11 had SD. Median PFS was 6.5 months (95% CI, 4.7 to 7.8 months); PFS was greater in the carboplatin AUC 5.0 group (P = .04). Median overall survival (OS) was 13.9 months.
conclusionThe 95% one-sided lower confidence bound of 4.77 months for median PFS did not meet the predesignated PFS of more than 4.8 months considered sufficient for further study. Median OS was greater than expected. An ongoing phase III trial in patients who are eligible for therapy with cisplatin will define the role of bevacizumab in UC.
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