A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube.
OBJECTIVE
To determine the safety and efficacy of the novel combination of docetaxel, oxaliplatin, and bevacizumab as first-line treatment of advanced cancer of the ovary, peritoneum or fallopian tube after initial debulking surgery.


METHODS
Eligible patients (stage IB-IV) were treated with 6 cycles of oxaliplatin (85 mg/m(2)), docetaxel (75 mg/m(2)), and bevacizumab (15 mg/kg) every 3 weeks, followed by single-agent bevacizumab 15 mg/kg every 3 weeks to complete one year of therapy. The primary endpoint was 12-month progression-free survival (PFS).


RESULTS
A total of 132 patients (80 with measurable disease at baseline; 52 with non-measurable, evaluable disease at baseline) enrolled and received study treatment. At diagnosis, 76.5% of patients had stage III disease and 20% had stage IV. 62.9% were optimally cytoreduced. The most common grade 3/4 adverse events were neutropenia (42.4%), leukopenia (13.6%), hypertension (8.3%), fatigue (6.1%), and nausea (6.1%). One patient (0.8%) had a fatal gastrointestinal perforation. The best overall confirmed response rate (complete response+partial response [measurable disease subgroup]) was 58.6% (95% CI 49%, 67%). CA-125 response rates for the measurable and non-measurable disease subgroups were 83.0% and 81.5%, respectively. The 12-month PFS rate for the measurable disease subgroup was 65.7% (95% CI 53.4%, 76.7%); median PFS was 16.3 (95% CI 12.6, 19.6) months. Median overall survival was 47.3 (95% CI 34.1, upper limit not applicable) months.


CONCLUSIONS
This novel treatment regimen may provide a promising therapeutic approach for women with ovarian, primary peritoneal, or fallopian tube carcinoma. No unanticipated safety concerns were identified.
Columbia University, NY Presbyterian Medical Center, New York, NY, USA. Electronic address: th2135@columbia.edu.
Thomas J
TJ
Herzog
Creighton University School of Medicine, St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA.
Bradley J
BJ
Monk
Cleveland Clinic, Cleveland, OH, USA.
Peter G
PG
Rose
Women's Cancer Care, Covington, LA, USA.
Patricia
P
Braly
Wellstar Gynecologic Oncology, Austell, GA, USA.
Jeffrey F
JF
Hines
Sioux Valley University Hospital, Sioux Falls, SD, USA.
Maria C
MC
Bell
H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Robert M
RM
Wenham
Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA.
Angeles Alvarez
AA
Secord
University of Southern California-Norris Comprehensive Cancer Center and Hospital, Los Angeles, CA, USA.
Lynda D
LD
Roman
Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA.
Mark H
MH
Einstein
Cleveland Clinic, Cleveland, OH, USA.
Richard D
RD
Drake
Sanofi U.S., Bridgewater, NJ, USA.
Barrett H
BH
Childs
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D000077143:Docetaxel; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D000077143:Docetaxel; D000068258:Bevacizumab
Bevacizumab; Docetaxel; Fallopian tube carcinoma; Ovarian cancer; Oxaliplatin; Primary peritoneal cancer