Work In Progress - PLOS Blogs - Avastin for Ovarian Cancer

Thursday, January 12, 2012 | Diverse Perspectives on Science and Medicine

Avastin for Ovarian Cancer

By Jessica Wapner
Posted: January 11, 2012
 
"You’ve probably already seen the headlines noting the disappointing outcomes of two phase III studies of bevacizumab (brand name Avastin, made by Genentech) for ovarian cancer. I’ve been trying to familiarize myself with the data this morning—I am pretty certain that practicing interpreting study reports can add years to my brain functioning—and figured I’d post a quick summary here.
There were two phase III studies published in the New England Journal of Medicine on December 29. (And don’t you want to know how that came about? Were the studies planned from the get-go to end at around the same time? Or were the analyses specifically timed to be reported simultaneously? And were there women with ovarian cancer being treated with Avastin off-label in the meantime, while these studies, funded in part by public dollars, were being prepared for publication?) One study looked at a couple of different ways of incorporating the drug into primary treatment. The other study was a direct comparison of two regimens...."

Ovarian Failure, VTE Risks Added to Avastin Label - in Product Alert, Prescriptions from MedPage Today

2013 results to show if bevacizumab (Avastin) prolongs life in ovarian cancer - - media

NEW YORK (Reuters Health) - The coauthor of a study that helped convince the European Commission on Friday to approve bevacizumab (Avastin) as an initial post-surgical treatment for advanced ovarian cancer predicted that some doctors may be reluctant to use the drug until mortality data become available in 2013.......

Obstetrics/Gynecology articles: The New England Journal of Medicine (2 articles)

SpecialtyObstetrics/Gynecology

original article

Bevacizumab in the Treatment of Ovarian Cancer

December 29, 2011 | R.A. Burger
and Others

Incorporating bevacizumab in a chemotherapy regimen (7.5 mg/kg every 3 weeks for five or six cycles) and then continuing bevacizumab alone for a total of 12 months of treatment extended progression-free survival in advanced and high-risk earlystage ovarian cancer.

Bevacizumab in Ovarian Cancer Treatment

December 29, 2011 | T.J. Perren
and Others

The addition of bevacizumab to chemotherapy (15 mg/kg for six cycles) followed by extended therapy with bevacizumab every 3 weeks for a total of 15 months of treatment improved progression-free survival by 4 months in incompletely resected stage III or IV ovarian cancer.

Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer — NEJM

Blogger's Note: see also the section 'Media in This Article'

Roche's Avastin - Trials And Triumphs (overview/history)

Two ways to fight a tumor - The Washington Post (Avastin)

avastin, bevTwo ways to fight a tumor - The Washington Post

Avastin for ovarian cancer slows tumors but fails to prolong life - The Washington Post

Avastin for ovarian cancer slows tumors but fails to prolong life - The Washington Post

A Phase 3 Trial of Bevacizumab in Ovarian Cancer — NEJM

A Phase 3 Trial of Bevacizumab in Ovarian Cancer — NEJM

Incorporation of Bevacizumab (Avastin) in the Primary Treatment of Ovarian Cancer — NEJM

Incorporation of Bevacizumab in the Primary Treatment of Ovarian Cancer — NEJM

An Observational Study of (Avastin) Bevacizumab-Induced Hypertension as a Clinical Biomarker of Antitumor Activity

press release: Ovarian Cancer National Alliance Urges FDA Not to Limit Access to Avastin (Bevacizumab) for Women with Ovarian Cancer | Ovarian Cancer National Alliance

overview ASCO text + video: Bevacizumab: The Sleeping Giant in Ovarian Cancer (maintenance, PARPs, mutations/genetics/molecular testing/genetic profiles/screening/single agent Avastin/ICON7....)

Bevacizumab: The Sleeping Giant in Ovarian Cancer

Maurie Markman, MD; Gini Fleming, MD

Posted: 06/13/2011

abstract: Consolidation paclitaxel is more cost-effective than bevacizumab following upfront treatment of advanced epithelial ovarian cancer (taxol/avastin)

Introduction

Randomized trials have demonstrated significant improvements in progression-free survival (PFS) with consolidation paclitaxel (P) and bevacizumab (B) following cytoreduction and adjuvant carboplatin/paclitaxel (CP) for advanced epithelial ovarian cancer (EOC). We sought to evaluate the cost-effectiveness (C/E) of these consolidation strategies.

Conclusions

In this model, B consolidation for advanced EOC was associated with a modest improvement in effectiveness that is less than that with P consolidation and more costly. A statistically significant improvement in survival may improve the value of B consolidation.

Research highlights

► Paclitaxel is a more cost-effective consolidation option in advanced ovarian cancer.
► Consolidation Bevacizumab is not cost-effective for advanced ovarian cancer.

Medscape article online 7:13pm: (Avastin) Bevacizumab Benefits Patients With Recurrent Ovarian Cancer

(discussion on stats) extract/s: (Avastin) Bevacizumab and Cancer Treatment-Related Mortality, June 8, 2011 — JAMA

plus Related letters Bevacizumab and Cancer Treatment-Related Mortality Cornelis J. A. Punt, Linda Mol, Miriam Koopman JAMA. 2011;305(22):2292.doi:10.1001/jama.2011.758 Extract Full Text Full Text (PDF) Bevacizumab and Cancer Treatment-Related Mortality Patricia B. Cerrito JAMA. 2011;305(22):2292.doi:10.1001/jama.2011.759 Extract Full Text Full Text (PDF) Bevacizumab and Cancer Treatment-Related Mortality—Reply Shenhong Wu, Vishal Ranpura, Sanjay Hapani JAMA. 2011;305(22):2292-2293.doi:10.1001/jama.2011.760 Extract Full Text Full Text (PDF)

abstract: Effects of bevacizumab and pegylated liposomal doxorubicin for the patients with recurrent or refractory ovarian cancers

OBJECTIVES:
Currently, pegylated liposomal doxorubicin (PLD) is regarded as one of the standard treatment options in recurrent ovarian cancers (ROC). Bevacizumab has shown significant antitumor activity for ROC in single-agent or in combination with cytotoxic agents. We have conducted a preliminary study to investigate effects of combination of bevacizumab and PLD for heavily pretreated patients with ROC.

CONCLUSION:
The present investigation suggested that combination therapy with bevacizumab and PLD was active and well tolerated for patients with ROC. We recommend the regimen be evaluated in further clinical studies.

When Combined with Chemotherapy, Bevacizumab Is Associated with Increased Risk of Death - National Cancer Institute (discusses various tumor types....

Note: this NCI article does not include ovarian cancer but does include platinum/taxane combination therapies (Carboplatin, Taxol); the JAMA paper most likely included ovarian cancer, however, the full text of the article is pay-per-view ($$$)

"The results were published February 2, 2011, in JAMA.":


JAMA abstract:
Treatment-Related Mortality With Bevacizumab in Cancer Patients
A Meta-analysis

"The overall incidence of FAEs (fatal adverse events) with bevacizumab was 2.5%."

OXiGENE, Inc. - OXiGENE Announces First Patient Enrolled in Phase 2 Study of ZYBRESTAT in Patients With Ovarian Cancer (comparing Avastin alone)

"SOUTH SAN FRANCISCO, Calif., April 11, 2011 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that clinical investigators have enrolled the first patient in a randomized Phase 2 trial of ZYBRESTAT in combination with bevacizumab in patients with relapsed ovarian cancer. The study, which is being conducted by investigators from the Gynecologic Oncology Group (GOG), is expected to enroll approximately 105 patients with a primary endpoint of progression-free survival. OXiGENE expects results of the study to become available in early 2013.

"We believe that the combination of an anti-angiogenic agent with a vascular disrupting agent in the treatment of ovarian cancer has the potential to represent an entirely new treatment paradigm for patients with relapsed disease," said Bradley Monk, M.D., FACS, Professor of Gynecologic Oncology at Creighton University Hospital and lead investigator of the study."Patients with recurrent ovarian cancer have few therapeutic options, and ZYBRESTAT could become a valuable addition to current treatment modalities."

The study is being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for ZYBRESTAT and a CRADA with Genentech for the development of bevacizumab. The aim of the trial, sponsored by the NCI's Division of Cancer Treatment and Diagnosis, is to determine if the combination of ZYBRESTAT and bevacizumab will enhance anti-tumor effects and further delay tumor progression when compared to bevacizumab alone....."

eCancer video: (Avastin) Bevacizumab and Ovarian Cancer: Results of ICON7 - interview Prof. Timothy J. Perren, MD discusses sgo presentation