Kaplan-Meier estimates of progression-free survival PFS based on investigator assessment, censoring for non—protocol-specified therapy randomly assigned patients. Progression-free survival PFS by baseline risk factor.
Vertical dashed line indicates the hazard ratio HR for all patients. The diameter of a circle is proportional to the square root of the number of events. Kaplan-Meier estimates of progression-free survival PFS assessed by independent review committee, censoring for non—protocol-specified cancer therapy randomly assigned patients. There was also a statistically significant improvement in ORR of The majority of responses in both the PL In both arms, the most common reason for treatment discontinuation was PD: In the PL arm, These results, based on deaths The median OS for the PL arm was These data remain immature, with a high degree of censoring beyond 18 months and a longer-than-expected median OS in both arms.
Adverse events are summarized in Table 3. All patients in both arms experienced at least one adverse event. Serious adverse events occurred in Two deaths resulting from an adverse event were reported: one as a result of acute myocardial infarction PL arm and one as a result of intracranial hemorrhage in the context of newly diagnosed brain metastases BV arm.
Grade 3 or higher hypertension 0. The baseline incidence of hypertension in enrolled patients was similar between treatment groups Hypertension led to discontinuation of treatment in 3.
Proteinuria led to discontinuation of BV treatment for 2. Three cases 1. No GIPs occurred during study treatment or within the day safety reporting period. Two GIPs occurred in the BV arm after study treatment discontinuation outside the day safety reporting window, both at 69 days after the last BV dose.
One patient, after 34 cycles of BV, had small bowel obstruction followed by a perforated gastric ulcer 69 days after study drug discontinuation by physician's decision.
She underwent surgery for the GIP but did not receive poststudy anticancer therapy and died as a result of disease progression 82 days after onset of GIP. She underwent surgery and died as a result of disease progression days after onset of GIP. The primary analysis results were consistent across clinically relevant patient subgroups, and the formal prospective IRC-determined PFS analysis supports the investigator-assessed PFS and provides evidence that the PFS end point was reliably determined.
With respect to toxicity, no new safety concerns were observed in this patient population with ROC, and most importantly, there were no reports of GIPs during treatment. The additional toxicity that resulted from the use of BV with GC primarily consisted of a higher incidence of hypertension, proteinuria, and reversible posterior leukoencephalopathy syndrome.
As ovarian cancer becomes a chronic illness, treatments that prolong PFS, and therefore time without cytotoxic chemotherapy, become increasingly relevant. The latest Gynecologic Cancer Intergroup consensus conference on ovarian cancer concluded that PFS is a valid end point for the treatment of recurrent platinum-sensitive ovarian cancer.
The OS data from OCEANS are not yet mature, and the percentage of patients receiving subsequent therapy with chemotherapy and with BV or other antiangiogenic therapy is being observed for subsequent analysis. The data from OCEANS demonstrate that the addition of BV to GC can improve outcomes, and ongoing studies will assess whether this ability to add benefit is universal to other platinum-based combinations.
Both of these trials met their primary end points and demonstrated an improvement in PFS. The median increase of 4 months in PFS is well above the frequency of radiologic reassessments 9 weeks. We thank Hoa Nguyen and Jakob Dupont for their contributions to the statistical and clinical trial designs of this study, respectively. Support for third-party editorial assistance for this article was provided by Genentech.
Supported by Genentech. Processed as a Rapid Communication manuscript. Listen to the podcast by Dr Konstantinopoulos at www. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article. Although all authors completed the disclosure declaration, the following author s indicated a financial or other interest that is relevant to the subject matter under consideration in this article.
For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.
Provision of study materials or patients: Carol Aghajanian, Stephanie V. Blank, Barbara A. Goff, Patricia L. Judson, Michael G. Teneriello, Lawrence R. Collection and assembly of data: Carol Aghajanian, Stephanie V. Blank, Patricia L. Teneriello, Amreen Husain, Mika A. Sovak, Lawrence R. Data analysis and interpretation: Carol Aghajanian, Stephanie V.
Goff, Michael G. Sovak, Jing Yi, Lawrence R. National Center for Biotechnology Information , U. J Clin Oncol. Published online Apr Carol Aghajanian , Stephanie V.
Blank , Barbara A. Goff , Patricia L. Judson , Michael G. Teneriello , Amreen Husain , Mika A. Sovak , Jing Yi , and Lawrence R. Find articles by Carol Aghajanian. Stephanie V. Gemcitabine was provided as commercially available drug. Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP. Outcome Measures. Duration of OR was analyzed in the subset of patients who achieved an OR.
Overall survival was defined as the time from randomization to death from any cause. A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol.
Epub Aug Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. Active ovarian oncologists and researchers are split as to whether PFS is a good enough measure and whether studies should always have overall survival as a primary endpoint. The FDA has been requiring more overall survival data, partly as a result of the increased cost of oncology drugs.
Researchers acknowledge that cost plays a role in consideration of treatment options. Kristensen, for example, stated that the cost of bevacizumab and a lack of substantial survival benefit in ovarian cancer patients may result in only high-risk patients being prescribed a bevacizumab regimen.
Additionally, it is not known how much of a benefit is added with a maintenance dose of bevacizumab. How bevacizumab will be utilized by oncologists remains to be seen, but for now, there is a consistent trend of a benefit in the utilization of bevacizumab in combination with chemotherapy as well as a documented benefit as a monotherapy in ovarian cancer.
About Advertise CureToday. June 21, Anna Azvolinsky. The ICON7 Trial Design ICON7 is a randomized two-arm global trial that is assessing the benefits of adding bevacizumab to a standard chemotherapy regimen of carboplatin and paclitaxel in newly diagnosed ovarian, epithelial, and fallopian tube cancer.
Future of Bevacizumab in Ovarian Cancer Although these trials are positive, adding bevacizumab to chemotherapy regimens is still being debated by oncologists because of the incremental increase in PFS.
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