GOG 0218 PDF

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GOG randomized, double-blind, placebo-controlled phase III trial: (A) study design; (B) progression-free survival analysis (reproduced with permission) Download scientific diagram | Design of Study GOG from publication: Time for a Level Playing Field: Inequalities in Regulatory/Approval Processes–The. ASCO Annual Meeting CHICAGO — The addition of bevacizumab as maintenance therapy to first-line treatment with standard.

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The number of patients with measurable disease at baseline was in the Avastin plus chemotherapy arm and in the chemotherapy alone arm Median OS: Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

Study design and patient population [ 1,54 ]. Efficacy data overview [ 1 ].

Avastin® (bevacizumab) Efficacy | Stage III or IV Ovarian Cancer & psOC, prOC

Efficacy data overview [1]. Ggog, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Analysis not designed to evaluate statistical significance between treatment arms or compare among the 3 chemotherapy cohorts. Summary of efficacy data from Avastin pivotal trials. Median OS by chemotherapy cohort. Click “OK” if you are a healthcare professional.

Bevacizumab Approved by FDA to Treat Ovarian Cancer Following Surgery

These data are likely to underestimate the true adverse event rates due to the reporting mechanisms used in this study. Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.

Thanks ggog sharing this page.

PFS data are based on investigator assessment. Pregnancy warning Based on the mechanism of action and animal studies, Avastin may cause fetal harm Advise female patients that Avastin may cause fetal harm, and to inform their healthcare provider of a known or suspected pregnancy Advise females of reproductive potential to use effective contraception during treatment with Avastin and for 6 months after the last dose of Avastin Advise nursing women that breastfeeding is not recommended during treatment with Avastin and for 6 months following their last dose of treatment Avastin may impair fertility.

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Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed Discontinue in patients with wound healing complications requiring medical intervention Hemorrhage Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin.

In patients receiving Avastin with lomustine, the adverse reaction profile was similar to that observed in other approved indications. The information contained in this section of the site is intended for U. Upon completion of indicated cycles of combination therapy, Avastin is indicated for continued use as a single agent until disease progression in patients with platinum-sensitive recurrent ovarian cancer.

Efficacy data overview in ITT population [ 1 ]. Efficacy Data Recurrent Glioblastoma Studies. Objective response rate ORR: Your email has been sent! Cohort analysis was exploratory. Recommended dosing for approved cancer types. ORR by chemotherapy cohort.

The safety data was consistent with the known safety profile established in first- and second-line Gogg 5.

Bevacizumab Approved by FDA to Treat Ovarian Cancer Following Surgery

Additional serious adverse events Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs chemotherapy arm included: Stage III or IV ovarian cancer OC after primary surgery Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

Persistent, recurrent, or metastatic cervical cancer CC Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer.

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Do not administer Avastin for at least 28 days after surgery and until the wound is fully healed Discontinue in patients with wound healing complications requiring medical intervention Hemorrhage Severe or fatal hemorrhage have occurred Do not administer Avastin to patients with serious hemorrhage or recent history of hemoptysis Discontinue for Grade hemorrhage. You may also report side effects to Genentech at Recurrent Glioblastoma GBM Avastin is indicated for the treatment of recurrent glioblastoma in adults.

Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer rOC Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

Overview of proposed MOA of Avastin. OS results in patients with psOC who have not received more than 1 prior chemotherapy regimen [ 1 ] Median overall survival OS: Metastatic renal cell carcinoma mRCC Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma. Prescribing Information Register for Updates References. Dosing and Usage Doses and Duration. The GOG study included a diverse population of women [ 1 ]. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc.

Avastin is not indicated for adjuvant treatment of colon cancer. Median progression-free survival PFS: Genentech does not recommend and does not endorse the content on any third-party websites. The GOG study evaluated Avastin plus chemotherapy vs chemotherapy alone in platinum-sensitive ovarian cancer [ 1,3 ].

Avastin plus chemotherapy carboplatin and paclitaxel demonstrated a 5.