Thomas J Herzog1, Bradley J Monk2, Peter G Rose3, Patricia Braly4, Jeffrey F Hines5, Maria C Bell6, Robert M Wenham7, Angeles Alvarez Secord8, Lynda D Roman9, Mark H Einstein10, Richard D Drake3, Barrett H Childs11. 1. Columbia University, NY Presbyterian Medical Center, New York, NY, USA. Electronic address: th2135@columbia.edu. 2. Creighton University School of Medicine, St. Joseph's Hospital and Medical Center, Phoenix, AZ, USA. 3. Cleveland Clinic, Cleveland, OH, USA. 4. Women's Cancer Care, Covington, LA, USA. 5. Wellstar Gynecologic Oncology, Austell, GA, USA. 6. Sioux Valley University Hospital, Sioux Falls, SD, USA. 7. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA. 8. Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA. 9. University of Southern California-Norris Comprehensive Cancer Center and Hospital, Los Angeles, CA, USA. 10. Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY, USA. 11. Sanofi U.S., Bridgewater, NJ, USA.
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/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.
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.
Authors: H Ozer; J O Armitage; C L Bennett; J Crawford; G D Demetri; P A Pizzo; C A Schiffer; T J Smith; G Somlo; J C Wade; J L Wade; R J Winn; A J Wozniak; M R Somerfield Journal: J Clin Oncol Date: 2000-10-15 Impact factor: 44.544
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: Gordon J S Rustin; Michael Quinn; Tate Thigpen; Andreas du Bois; Eric Pujade-Lauraine; Anders Jakobsen; Elizabeth Eisenhauer; Satoru Sagae; Kathryn Greven; Ignace Vergote; Andres Cervantes; Jan Vermorken Journal: J Natl Cancer Inst Date: 2004-03-17 Impact factor: 13.506
Authors: Jason A Konner; Diana M Grabon; Scott R Gerst; Alexia Iasonos; Howard Thaler; Sandra D Pezzulli; Paul J Sabbatini; Katherine M Bell-McGuinn; William P Tew; Martee L Hensley; David R Spriggs; Carol A Aghajanian Journal: J Clin Oncol Date: 2011-11-07 Impact factor: 44.544
Authors: Gavin C E Stuart; Henry Kitchener; Monica Bacon; Andreas duBois; Michael Friedlander; Jonathan Ledermann; Christian Marth; Tate Thigpen; Edward Trimble Journal: Int J Gynecol Cancer Date: 2011-05 Impact factor: 3.437
Authors: Timothy J Perren; Ann Marie Swart; Jacobus Pfisterer; Jonathan A Ledermann; Eric Pujade-Lauraine; Gunnar Kristensen; Mark S Carey; Philip Beale; Andrés Cervantes; Christian Kurzeder; Andreas du Bois; Jalid Sehouli; Rainer Kimmig; Anne Stähle; Fiona Collinson; Sharadah Essapen; Charlie Gourley; Alain Lortholary; Frédéric Selle; Mansoor R Mirza; Arto Leminen; Marie Plante; Dan Stark; Wendi Qian; Mahesh K B Parmar; Amit M Oza Journal: N Engl J Med Date: 2011-12-29 Impact factor: 91.245
Authors: Robert A Burger; Mark F Brady; Michael A Bookman; Gini F Fleming; Bradley J Monk; Helen Huang; Robert S Mannel; Howard D Homesley; Jeffrey Fowler; Benjamin E Greer; Matthew Boente; Michael J Birrer; Sharon X Liang Journal: N Engl J Med Date: 2011-12-29 Impact factor: 91.245
Authors: Robert A Burger; Michael W Sill; Bradley J Monk; Benjamin E Greer; Joel I Sorosky Journal: J Clin Oncol Date: 2007-11-20 Impact factor: 44.544
Authors: Richard T Penson; Don S Dizon; Stephen A Cannistra; Maria R Roche; Carolyn N Krasner; Suzanne T Berlin; Neil S Horowitz; Paul A Disilvestro; Ursula A Matulonis; Hang Lee; Modjulie A King; Susana M Campos Journal: J Clin Oncol Date: 2009-11-16 Impact factor: 44.544
Authors: Paul A Vasey; Gordon C Jayson; Alan Gordon; Hani Gabra; Rob Coleman; Ronnie Atkinson; David Parkin; James Paul; Andrea Hay; Stan B Kaye Journal: J Natl Cancer Inst Date: 2004-11-17 Impact factor: 13.506
Authors: Nonna V Kolomeyevskaya; Shashikant B Lele; Austin Miller; Grazyna C Riebandt; Bonnie L Blum; Kunle O Odunsi; Peter J Frederick Journal: Int J Gynecol Cancer Date: 2015-01 Impact factor: 3.437
Authors: Luigi Carlo Turco; Gabriella Ferrandina; Virginia Vargiu; Serena Cappuccio; Anna Fagotti; Giuseppina Sallustio; Giovanni Scambia; Francesco Cosentino Journal: Ann Transl Med Date: 2020-12