OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Aghajanian, Carol; Blank, Stephanie V.; Goff, Barbara A.; Judson, Patricia L.; Teneriello, Michael; Husain, Amreen; Sovak, Mika A.; Yi, Jing; Nycum, Lawrence R.

doi:10.1200/jco.2012.42.0505

Cited by 1,208 publications

(901 citation statements)

References 22 publications

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“…There is evidence that the addition of bevacizumab to the regimen of carboplatin and gemcitabine improves progression-free survival compared with carboplatin and gemcitabine in platinum-sensitive disease [80].…”

Section: Chemotherapy For Recurrent Epithelial Malignanciesmentioning

confidence: 99%

Cancer of the ovary, fallopian tube, and peritoneum

Berek

Crum

Friedlander

2015

Intl J Gynecology & Obste

123

119

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Section: Chemotherapy For Recurrent Epithelial Malignanciesmentioning

confidence: 99%

Cancer of the ovary, fallopian tube, and peritoneum

Berek

Crum

Friedlander

2015

Intl J Gynecology & Obste

123

119

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“…(Table 1), bevacizumab (Avastin) was the first anti-angiogenesis agent to be advanced into the phase 3 randomized trial design for advanced EOC. To date, four pivotal trials have been completed, two in the primary setting and two for patients with recurrent disease (Table 2) [57][58][59][60][61][62][63][64][65][66].…”

Section: Phase 2 Studiesmentioning

confidence: 99%

“…OCEANS, an industry sponsored trial, evaluated the efficacy and safety of bevacizumab in the treatment of patients with recurrent, platinum sensitive ovarian cancer [61]. This trial was initiated in response to GOG 170D, which indicated response to single agent bevacizumab in platinum sensitive and platinum refractory disease [44].…”

Section: Phase 2 Studiesmentioning

confidence: 99%

Incorporation of anti-angiogenesis therapy in the management of advanced ovarian carcinoma—Mechanistics, review of phase III randomized clinical trials, and regulatory implications

Eskander

Tewari

2014

Gynecologic Oncology

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“…OCEANS [10] was a randomized phase III trial testing the combination of gemcitabine and carboplatin with or without the addition of bev given concurrently and then as maintenance until progression in platinum-sensitive OC. PFS for the bev arm was 12.4 months (vs. 8.4 months; p , .001).…”

Section: Recurrent Diseasementioning

confidence: 99%

Breaking Down the Evidence for Bevacizumab in Ovarian Cancer

Shu

Konner

2015

The Oncologist

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In 1971, Judah Folkman prophesized thatantivascular therapies could be used to fight cancer [1]. Since the 1990s, vascular endothelial growth factor (VEGF) has been recognized as a critical element in tumor angiogenesis and as an adverse factor in ovarian cancer (OC) [2]. It has now been 10 years since the U.S. Food and Drug Administration (FDA) initially approved bevacizumab (bev), the anti-VEGF monoclonal antibody that became one of the top-selling cancer drugs in the world. Its approved indications include colorectal, lung, kidney, cervix, and (previously) breast cancers, and it has been used widely as a standard therapy for OC for more than 5 years. Bev is licensed by the European Medicines Agency for use in first-line, first platinum-sensitive recurrence, and platinum-resistant OC. Bev was recently FDA approved for use in combination with singleagent chemotherapy for platinum-resistant disease; however, its optimal role in this cancer remains unclear. SINGLE-AGENT ACTIVITYIn early phase II trials, bev yielded single-agent activity beyond that seen in colorectal or lung cancer [3,4]. The addition of oral daily "metronomic" cyclophosphamide appeared to increase responses even further [5]. The initial enthusiasm generated was blunted, however, when an increased risk of gastrointestinal (GI) perforation was detected. In a study intended for registration, Cannistra et al. [6] evaluated bev in platinum-resistant OC and noted a median progression-free survival (PFS) of 4.4 months. The study was halted because of an 11.4% incidence of GI perforation, and a black box warning from the FDA ensued. Meta-analyses confirmed an increased risk of perforation and treatment-related mortality in a variety of cancer types [7,8].Since then, efforts to identify predictors of adverse GI events have successfully aided patient selection in clinical practice. Some of the compelling red flags in ovarian cancer include high-volume peritoneal carcinomatosis enveloping the bowel and history of malignant bowel obstruction. For patients receiving front-line therapy, history of treatment for inflammatory bowel disease and bowel resection at primary surgery [9] appear to increase risk. Presently, the risk of GI perforation from bev in recurrent OC is likely closer to 3% rather than the 11% observed in the population treated by Cannistra et al. [6]. RECURRENT DISEASEOCEANS [10] was a randomized phase III trial testing the combination of gemcitabine and carboplatin with or without the addition of bev given concurrently and then as maintenance until progression in platinum-sensitive OC. PFS for the bev arm was 12.4 months (vs. 8.4 months; p , .001). By the final analysis, however, there was no difference in overall survival (OS; 33.6 vs. 32.9 months) [11]. Of note, nearly all of the women in both arms went on to receive additional therapy, including bev.In the AURELIA trial [12], bev was combined with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, topotecan), in platinum-resistant OC...

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OCEANS: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Chemotherapy With or Without Bevacizumab in Patients With Platinum-Sensitive Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Abstract: GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC.

Cited by 1,208 publications

References 22 publications

Cancer of the ovary, fallopian tube, and peritoneum

Cancer of the ovary, fallopian tube, and peritoneum

Incorporation of anti-angiogenesis therapy in the management of advanced ovarian carcinoma—Mechanistics, review of phase III randomized clinical trials, and regulatory implications

Breaking Down the Evidence for Bevacizumab in Ovarian Cancer

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