Journal article
A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy
Gynecologic Oncology, Vol.130(1), pp.19-24
07/2013
DOI: 10.1016/j.ygyno.2013.04.049
PMID: 23623830
Abstract
The efficacy and safety of bevacizumab and docetaxel were evaluated in women who developed recurrent epithelial ovarian, fallopian, or peritoneal cancer within 12months of platinum-based therapy. Patients received docetaxel (40mg/m2) on days 1 and 8 and bevacizumab (15mg/kg) on day 1 of a 21-daycycle. Primary endpoint was 6-month progression-free survival (PFS). Forty-one patients were evaluable for PFS and 38 for best response; 46% had platinum-free intervals (PFI) of <6months and 54% between 6 and 12months. The 6-month PFS was 43.9% (95% confidence interval (CI95%)=28.6–58.2%). Median PFS (months) was 5.2 (CI95%=4.4–7.2) for all patients, 6.2 (CI95%=4.1–7.4) for patients with PFI <6months, and 5.1 (CI95%=3.0–7.2) for those with PFI ≥6months. Twenty-two patients showed overall response (CR+PR) (57.9%; CI95%=40.8–73.7%), and 32 showed clinical benefit (CR+PR+SD) (84.2%; CI95%=68.8–94.0%). For those with complete or partial responses, median duration of response was 4.8months (0.7–14.5). Median overall survival was 12.4months (CI95%=10.0–21.9). The most common grade 3/4 adverse events (AEs) were neutropenia (14.6% of patients), followed by leukopenia, fatigue, metabolic, and gastrointestinal, with 66% showing any grade 3/4 toxicity. Most common AEs of any grade were gastrointestinal (93%), fatigue (73%), and pain (73%). Four (10%) patients developed hypertension, 1 a gastrointestinal perforation, and another a colovesicular fistula. Bevacizumab and docetaxel administered in patients with recurrent ovarian cancer is an active regimen without new unanticipated toxicities. This combination should be an option for further study or clinical use in recurrent ovarian cancer. •Docetaxel+bevacizumab has activity in recurrent ovarian cancers.•The combination is tolerable without new, unanticipated toxicities.•The combination should be considered for further study or clinical use in similar patients.
Details
- Title: Subtitle
- A phase II trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy
- Creators
- Robert M Wenham - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USAJames Lapolla - Women's Cancer Associates, St. Petersburg, FL, USAHui-Yi LinSachin M Apte - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USAJohnathan M Lancaster - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USAPatricia L Judson - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USAJesus Gonzalez-Bosquet - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USAAmber Herschberger - H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USALaura J Havrilesky - Duke University Medical Center, Durham, NC, USAAngeles Alvarez Secord - Duke University Medical Center, Durham, NC, USA
- Resource Type
- Journal article
- Publication Details
- Gynecologic Oncology, Vol.130(1), pp.19-24
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.ygyno.2013.04.049
- PMID
- 23623830
- ISSN
- 0090-8258
- eISSN
- 1095-6859
- Grant note
- DOI: 10.13039/100004339, name: Sanofi; DOI: 10.13039/100004328, name: Genentech
- Language
- English
- Date published
- 07/2013
- Academic Unit
- Obstetrics and Gynecology
- Record Identifier
- 9983930397202771
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