Letter: Bevacizumab in Ovarian Cancer — NEJM

Bevacizumab in Ovarian Cancer — NEJM

Correspondence

Bevacizumab in Ovarian Cancer

N Engl J Med 2012; 366:1256-1258  March 29, 2012

Article

To the Editor:

In their article on the findings of the Gynecologic Oncology Group study GOG-0218 (ClinicalTrials.gov number, NCT00262847), Burger et al. (Dec. 29 issue)1 state, as have others in a similar context,2 that the potential to see differences in overall survival in an ovarian cancer trial is limited by post-progression therapies, including crossover to the experimental agent bevacizumab. Post-progression therapies will attenuate differences in overall survival that would be seen if such therapies did not exist, but the observed attenuated differences are the correct measure of clinical benefit for the patients provided that standard-of-care post-progression therapies are used in both treatment groups.3,4

This would seem to be the case in the Gynecologic Cancer InterGroup (GCIG) International Collaboration on Ovarian Neoplasms (ICON7) bevacizumab trial (NCT00483782) reported by Perren et al. (also in the Dec. 29 issue),5 in which less than 4% of the patients in the control group received post-progression antiangiogenic treatments. To interpret the GOG-0218 results, one would need to know how many patients received post-progression antiangiogenic treatments. However, if one considered bevacizumab a standard treatment for progressing (recurrent) ovarian cancer given that it has shown activity, is recommended by National Comprehensive Cancer Network guidelines, and is covered by Medicare, then the observed difference in overall survival seen in the GOG-0218 and ICON7 trials1,5 is the appropriate estimate of clinical benefit for overall survival, regardless of post-progression treatments.

Edward L. Korn, Ph.D.
Boris Freidlin, Ph.D.
Jeffrey S. Abrams, M.D.
National Cancer Institute, Bethesda, MD
korne@ctep.nci.nih.gov

open access: Editorial - Ovarian cancer: breaking the silence : The Lancet Oncology (references Avastin studies and NEJM)

Ovarian cancer: breaking the silence

The Lancet Oncology

 

"The heterogeneous nature of cancer makes it a very difficult disease to manage. Although great progress has been made against many types of cancer (as highlighted by recent mortality data from the American Cancer Society), treatment of others has shown little change in the past few decades. Ovarian cancer, for example, has traditionally lagged behind: recent research, however, is starting to provide a better outlook for women with this cancer. Two phase 3 clinical trials published in December, 2011, in the New England Journal of Medicine (GOG018 and ICON7) showed that women with newly diagnosed advanced ovarian cancer given concomitant bevacizumab with a paclitaxel and carboplatin chemotherapy regimen following surgery, and then maintenance bevacizumab, had significantly longer progression-free survival compared with those who received chemotherapy alone. On the basis of these results, on Dec 19, 2011, the European Medicines Agency approved bevacizumab for first-line treatment of ovarian cancer, although it is uncertain whether the US FDA will follow suit....."

"Ovarian cancer is the seventh most common cancer in women worldwide, with nearly a quarter of a million women diagnosed every year. 5-year survival is just 30%, a figure that has not changed for the past 30 years—this contrasts with breast cancer, in which 5-year survival has improved from 50% to 80% over the same period."

open access: Combination Drugs — Hype, Harm, and Hope — NEJM

New Articles -- EvidenceUpdates: A phase 3 trial of bevacizumab in ovarian cancer - abstract, reference + professional commentaries

also see linked reference:
Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. (Original) PMID: 22204725

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'

NEJM -- The Path to Personalized Medicine (U.S.)

"...In February, the NIH and the FDA announced a new collaboration on regulatory and translational science to accelerate the translation of research into medical products and therapies; this effort includes a joint funding opportunity for regulatory science. Working with academic experts, companies, doctors, patients, and the public, we intend to help make personalized medicine a reality. A recent example of this collaboration is an effort to identify new investigational agents to which certain tumors, identified by their genetic signatures, are responsive.
Real progress will come when clinically beneficial new products and approaches are incorporated into clinical practice. As the field advances, we expect to see more efficient clinical trials based on a more thorough understanding of the genetic basis of disease. We also anticipate that some previously failed medications will be recognized as safe and effective and will be approved for subgroups of patients with specific genetic markers.


When the federal government created the national highway system, it did not tell people where to drive — it built the roads and set the standards for safety. Those investments supported a revolution in transportation, commerce, and personal mobility. We are now building a national highway system for personalized medicine, with substantial investments in infrastructure and standards. We look forward to doctors' and patients' navigating these roads to better outcomes and better health."

NEJM -- Gene Patenting -- Is the Pendulum Swinging Back?