TY - JOUR
T1 - A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube
AU - Herzog, Thomas J.
AU - Monk, Bradley J.
AU - Rose, Peter G.
AU - Braly, Patricia
AU - Hines, Jeffrey F.
AU - Bell, Maria C.
AU - Wenham, Robert M.
AU - Secord, Angeles Alvarez
AU - Roman, Lynda D.
AU - Einstein, Mark H.
AU - Drake, Richard D.
AU - Childs, Barrett H.
N1 - Funding Information:
Study funding was provided by Sanofi U.S. LLC . Medical editorial writing assistance was provided by Maria Soushko, PhD, Phase Five Communications Inc., and supported by Sanofi U.S. LLC. The authors retained full editorial control over the content of the manuscript and received no compensation from any party for their work. Bevacizumab was provided by Roche-Genentech.
Funding Information:
Thomas J. Herzog has consulted for Roche, Johnson & Johnson, and Morphotek, Inc. Bradley J. Monk received a research grant from Genentech, Inc., for whom he is a consultant and speakers bureau member. Robert M. Wenham provides investigator trial support for investigator-initiated research. Angeles Alvarez Secord received grant support for two clinical trials from Sanofi-aventis and is a Genentech, Inc., advisory board member. Barrett H. Childs was an employee of Sanofi U.S. LLC. throughout the study and during preparation of the manuscript. Peter G. Rose, Patricia Braly, Jeffrey F. Hines, Maria C. Bell, Lynda D. Roman, Mark H. Einstein, and Richard D. Drake declare that there are no conflicts of interest.
PY - 2014/3
Y1 - 2014/3
N2 - 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/m2), docetaxel (75 mg/m2), 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.
AB - 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/m2), docetaxel (75 mg/m2), 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.
KW - Bevacizumab
KW - Docetaxel
KW - Fallopian tube carcinoma
KW - Ovarian cancer
KW - Oxaliplatin
KW - Primary peritoneal cancer
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U2 - 10.1016/j.ygyno.2014.01.035
DO - 10.1016/j.ygyno.2014.01.035
M3 - Article
C2 - 24476788
AN - SCOPUS:84896388779
SN - 0090-8258
VL - 132
SP - 517
EP - 525
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -