A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube

Thomas J. Herzog, Bradley J. Monk, Peter G. Rose, Patricia Braly, Jeffrey F. Hines, Maria C. Bell, Robert M. Wenham, Angeles Alvarez Secord, Lynda D. Roman, Mark H. Einstein, Richard D. Drake, Barrett H. Childs

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)517-525
Number of pages9
JournalGynecologic Oncology
Volume132
Issue number3
DOIs
StatePublished - 2014

Fingerprint

oxaliplatin
docetaxel
Fallopian Tubes
Peritoneum
Ovarian Neoplasms
Disease-Free Survival
Therapeutics
Safety
Leukopenia
Neutropenia
Nausea
Fatigue
Bevacizumab
Survival Rate

Keywords

  • Bevacizumab
  • Docetaxel
  • Fallopian tube carcinoma
  • Ovarian cancer
  • Oxaliplatin
  • Primary peritoneal cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube. / Herzog, Thomas J.; Monk, Bradley J.; Rose, Peter G.; Braly, Patricia; Hines, Jeffrey F.; Bell, Maria C.; Wenham, Robert M.; Secord, Angeles Alvarez; Roman, Lynda D.; Einstein, Mark H.; Drake, Richard D.; Childs, Barrett H.

In: Gynecologic Oncology, Vol. 132, No. 3, 2014, p. 517-525.

Research output: Contribution to journalArticle

Herzog, TJ, Monk, BJ, Rose, PG, Braly, P, Hines, JF, Bell, MC, Wenham, RM, Secord, AA, Roman, LD, Einstein, MH, Drake, RD & Childs, BH 2014, 'A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube', Gynecologic Oncology, vol. 132, no. 3, pp. 517-525. https://doi.org/10.1016/j.ygyno.2014.01.035
Herzog, Thomas J. ; Monk, Bradley J. ; Rose, Peter G. ; Braly, Patricia ; Hines, Jeffrey F. ; Bell, Maria C. ; Wenham, Robert M. ; Secord, Angeles Alvarez ; Roman, Lynda D. ; Einstein, Mark H. ; Drake, Richard D. ; Childs, Barrett H. / A phase II trial of oxaliplatin, docetaxel, and bevacizumab as first-line therapy of advanced cancer of the ovary, peritoneum, and fallopian tube. In: Gynecologic Oncology. 2014 ; Vol. 132, No. 3. pp. 517-525.
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abstract = "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.",
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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.

PY - 2014

Y1 - 2014

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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