Back to Search
Start Over
Phase II trial of bevacizumab with dose-dense paclitaxel as first-line treatment in patients with advanced ovarian cancer
- Source :
- Gynecologic oncology. 147(1)
- Publication Year :
- 2017
-
Abstract
- Objectives To assess the tolerability and efficacy of bevacizumab with carboplatin and weekly paclitaxel as first-line adjuvant therapy for advanced stage ovarian cancer. Methods After IRB approval, this single-institution, phase II study enrolled patients with stage III or IV epithelial ovarian cancer after primary cytoreductive surgery to treatment with carboplatin (AUC 5), weekly paclitaxel (80mg/m2), and bevacizumab (15mg/kg) every 3weeks for at least 6cycles. The primary endpoint was tolerability of at least 4cycles of therapy, with a target treatment success rate of >60%. Secondary endpoints included progression-free survival (PFS) and response rate. Plasma biomarkers were analyzed by the multiplex ELISA assays. Results Thirty-three patients were enrolled with 30 evaluable patients receiving at least one cycle of combination treatment. Twenty-three patients (77%) were able to complete at least 4cycles of therapy per protocol, and the posterior probability that the treatment success rate is >60% is 0.77. Twenty-one patients (70%) were able to complete ≥6cycles of therapy. Median PFS was 22.4months for patients with optimal (R0) compared to 16.9months for optimal≤1cm (HR 1.71, 95% CI 0.58–4.98, p=0.33), and 16.9months for suboptimal>1cm (HR 3.75, 95% CI 1.05–13.34, p=0.04) disease. Increases in mean Flt-3L was significantly higher in responders versus non-responders (83.4 vs. 28pg/mL, p=0.05). Conclusions Adjuvant bevacizumab with dose-dense chemotherapy is associated with acceptable toxicity and a high likelihood of completing 4cycles of therapy. Dynamic changes in Flt-3L may represent a predictive marker to treatment response.
- Subjects :
- Oncology
Adult
medicine.medical_specialty
Bevacizumab
Non-Randomized Controlled Trials as Topic
Paclitaxel
medicine.medical_treatment
Phases of clinical research
Angiogenesis Inhibitors
Disease-Free Survival
Drug Administration Schedule
Article
Carboplatin
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Predictive Value of Tests
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Adjuvant therapy
Biomarkers, Tumor
Humans
030212 general & internal medicine
Aged
Ovarian Neoplasms
Chemotherapy
Predictive marker
business.industry
Obstetrics and Gynecology
Middle Aged
medicine.disease
Tolerability
chemistry
030220 oncology & carcinogenesis
Cytokines
Female
Ovarian cancer
business
medicine.drug
Subjects
Details
- ISSN :
- 10956859
- Volume :
- 147
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Gynecologic oncology
- Accession number :
- edsair.doi.dedup.....b04028d8859e42b4101c377ed06dad54