GOG 0218 PDF

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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Avastin, 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. Study design and patient population [ 1,54 ].

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Your email has been sent! The GOG study included a diverse population of women [ 1 ]. 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 gig with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens.

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 go for 6 months following their last dose of treatment Avastin may impair fertility.

Median progression-free survival PFS: Avastin is not indicated for adjuvant treatment of colon cancer. Cohort analysis was exploratory. Additional serious adverse events Additional serious and sometimes fatal adverse events with increased incidence in the Avastin-treated arm vs chemotherapy arm included: Efficacy data overview in ITT population [ 1 ].

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Recurrent Glioblastoma GBM Avastin is indicated for the treatment of recurrent glioblastoma in adults. Click “OK” if you are a healthcare professional. Efficacy data overview [ 1 ]. Stage III or IV ovarian cancer OC after primary surgery Avastin, in combination with carboplatin and goh, followed by Avastin as a single agent, is indicated for the treatment gov patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection.

The information contained in this section of the site is intended for U. Metastatic renal cell carcinoma mRCC Avastin, in combination with interferon alfa, is indicated for the treatment of metastatic renal cell carcinoma.

Bevacizumab Approved by FDA to Treat Ovarian Cancer Following Surgery

In patients receiving Tog with lomustine, the adverse reaction profile was similar to that observed in other approved indications.

Objective response rate ORR: OS results in patients with psOC who have not received more than 1 prior chemotherapy regimen [ 1 ] Median overall survival OS: These data are likely to underestimate the true adverse event rates due to the reporting mechanisms used in this study.

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.

You may also report side effects to Genentech at Analysis not designed to evaluate statistical significance between treatment arms or compare among the 3 chemotherapy cohorts.

Avastin, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy, is indicated for the second-line treatment of patients with metastatic got cancer who have progressed on a first-line Avastin-containing regimen.

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.

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Recommended dosing for approved cancer types.

Bevacizumab Approved by FDA to Treat Ovarian Cancer Following Surgery

Overview of proposed MOA of Avastin. The GOG study evaluated Avastin plus chemotherapy vs chemotherapy alone in platinum-sensitive ovarian cancer [ 1,3 ].

Dosing and Usage Doses and Duration. Efficacy data overview [1]. Median OS by chemotherapy cohort. The number of patients with measurable disease at baseline was in the Avastin plus chemotherapy arm and in the chemotherapy alone arm Median OS: 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.

Genentech gpg not recommend and does not gkg the content on any third-party websites. ORR by chemotherapy cohort. The safety data was consistent with the known safety profile established bog first- and second-line MCRC 5. Prescribing Information Register for Updates References. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc.

Avastin plus chemotherapy carboplatin and paclitaxel demonstrated a 5. PFS data are based on investigator assessment.

Summary of efficacy data from Avastin pivotal trials. 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 Recurrent Glioblastoma Studies.